JP2005515841A - Compliance support device - Google Patents

Abstract

  A compliance reminder support device is provided for prompting a user to take a pharmaceutical dose at prescription intervals. The compliance support apparatus has a holder for holding the medication apparatus. The holder includes a detector for detecting the presence of a dosing device in the holder; a timer for measuring a period; a dosing interval memory for storing data relating to the dosing interval of the prescription; There are electronic dosing reminder systems that have a patient alert device to alert you to take a dose.

Description

  The present invention is directed to people who need to take a dose of a symptom relief, treatment and / or repair medication at a prescribed time to remember to comply with a treatment program for a medical condition The present invention relates to a support device. In particular, the present invention relates to a support device that can be used by people who suffer from conditions such as chronic asthma that require treatment by regular pharmaceutical administration.

  It is difficult for people who are busy to remember to take medication at the time they are prescribed. And it is particularly difficult for a moving person, especially when traveling, to calculate the dosing time and the period between doses so that they are not forgotten. .

  The present invention addresses such problems by providing a holder for an independent (ie, separate or separable) dosing device that incorporates an electronic system that provides dosing reminder information to the patient. It is intended to do.

  One advantage of the present invention is that the electronic reminder system is in the holder rather than the dosing device itself, so that existing (eg, non-electronically functioning) dosing such as an inhalation device for dispensing asthma medications It can be used with the device.

  According to one aspect of the present invention, in a compliance support apparatus for supporting patient compliance for taking medicines at prescription time intervals, the compliance support apparatus takes the form of a holder for holding a medication apparatus, and the support apparatus A holder for detecting the presence of a dosing device in the holder; a timer for timing; a dosing interval memory for storing data relating to the dosing interval of the prescription; and for alerting the user A compliance support device is provided having an electronic dosing reminder system that includes a patient alarm device.

  In one embodiment, the timer functions such as measuring a holding period corresponding to the time that the dosing device is held by the holder; and the dosing interval memory is a prescription (ie, predetermined) dosing interval period. Storing relevant data; the alarm device is triggered when the retention period exceeds the prescription dose interval period.

  In another aspect, the timer is a standard clock; the dosing interval memory stores data related to a prescription (ie, a predetermined) dosing time; and the alarm device indicates that the time indicated by the clock is the time Start when it corresponds to the time of administration of the prescription. Therefore, in an example where the medicine is scheduled to be taken once in the morning and once in the evening, the administration time of the prescription can be set to approximately 6 am and 6 pm, and the alarm device has a clock A warning is issued when The alarm device can be set to issue an alarm for a predetermined maximum period (eg, 3 hours after the time of administration of the prescription) and stop the alarm until the clock indicates the time of administration of the next prescription.

  The dosing device can have any suitable form and can be configured to administer the medicament in known forms such as powders, aerosols, tablets, liquids, solutions, gels and pastes. In its simplest form, the dispensing device can simply have a pharmaceutical container (eg, a blister pack or tablet bottle) that allows user access to allow pharmaceutical administration. More complex dosing devices have also been envisaged, including inhalers such as dry powder inhalers (DPI), metered dose aerosol inhalers (MDI) and inhalers for administering medication in the form of solutions (eg nebulizers) Etc. Injectable dosing devices such as needled and needleless syringe administration devices are also contemplated.

  The holder can have any suitable form. Functionally, the holder must be able to hold the dispensing device in a releasable form so that it can be dispensed from the dispensing device to administer the medication. In some embodiments, the holder can be configured to be a stand alone or wall mountable device suitable for carrying in a user's pocket or baggage.

  The holder may incorporate one or more unlocking mechanisms that serve to lock the dispensing device in a releasable form in a holding position. The lock can be released by a simple user action that can be mechanical (eg, release of fasteners) or electronic (eg, insertion of a password into the control system).

  In a preferred embodiment, the holder is in the form of a “docking station” for receiving a dosing device. When so fitted, the dosing device is partly received by the holder and part is approaching from it (eg in the exposed form).

  In another preferred embodiment, the holder has a casing that is structured to accommodate the dispensing device. Preferably, the casing is configured by the user in a sealed state in which the dosing device is fully contained within the casing, an open state in which the dosing device can be removed to allow a dose of medication to be taken, or Since the dispensing device is supported in the casing, any of the exposed states partially protruding therefrom can be taken.

  In one embodiment, the casing has a bivalve shell that is hinged for opening and sealing, and is sized to accommodate a substantially disc-shaped dosing device (eg, GlaxoSmithKline Inc. .) Inhalation devices sold under the trade name DISKUS). The top of the shell-like casing is laterally cracked, so that the individual front and rear parts of the top are formed and separately hinged so that access to the administration container and its More preferably, it is open for removal. In such a configuration, a casing can be used to support the container in another form of appearance similar to the configuration commonly employed in travel alarm clocks, in which case the dispensing device is removed from the casing. It can be repositioned so that it partially protrudes and at least partly held in place by reclosing the rear part of the top, so that it is disc-shaped at an angle inclined with respect to the vertical direction. A support surface for supporting the dispensing device is provided. Support for the dispensing device can be enhanced by providing a groove in the bottom of the shell-like casing.

  In a preferred embodiment, a holder (e.g. a casing) receives an adapter device for housing and / or supporting other types of dosing devices, e.g. In particular, an adapter can be provided to allow the casing to support an L-shaped metered dose inhaler (MDI) of the type known in asthma treatment. The casing may or may not be sealable when using adapters and L-shaped containers.

  In some embodiments, the casing can be provided with a controlled release opening mechanism that assists or assists the smooth opening of the casing. For example, the release mechanism can be spring loaded or controlled by a clutch such as a brake grease type.

  The casing can be made of any suitable material, but is preferably made of an elastic material and incorporates a bright color or pattern as desired to make the compliance support device more visible or simply enhance visual appeal. Can do. In particular, in the case of a compliance support device intended for use by children, the coloring and pattern can be specifically designed to make the device attractive and familiar. Furthermore, surface texturing can be used to obtain the desired visual and / or tactile effect.

  In one embodiment, the casing is formed by providing at least one transparent or translucent region that provides a window through which a user can easily check that the drug container is in place within the casing. In this regard, the container may be brightly colored, or a brightly colored area on the opposite side of the window may be provided on the bottom inside the casing. When the dosing device is installed, the bright area is darkened so that it can only be seen when the casing is empty.

  The holder has an electronic dosing reminder system. This can be configured to have any suitable form and can be powered by an outlet, a storage (eg battery) or a self-regenerative (eg solar) energy power source.

  An electronic dosing reminder system includes a detector for detecting the presence of a dosing device in the holder; a timer for measuring the period; a dosing interval memory for storing data related to the dosing interval of the prescription; and an alarm to the user Has a patient alarm device for emitting.

  The detector detects the presence of the dosing device in the holder. In one embodiment, the detector has a switch (e.g., a mechanical switch) that enters accordingly when the dosing device is inserted into the holder.

  Preferably the detector comprises a suitably configured sensor such as a proximity sensor which serves to detect that the dosing device is approaching.

  In one embodiment, the sensor has a radiation emitter and a detector. Preferably, the emitter emits electromagnetic radiation and the detector detects the electromagnetic radiation. The emitted radiation can be infrared, visible or ultraviolet. Preferably, radiation in the range of 0.95 μm to 0.35 μm is used. More preferably, the radiation is in the infrared region.

  Preferably the emitter is selected from the group consisting of light emitting diodes, lasers, incandescent lamps, electroluminescent and fluorescent light sources. In one embodiment, the emitter is provided with a filter, preferably an optical filter, preferably a polarizing filter (especially when the emitter is an incandescent light source) to select a specific wavelength, ie a narrow range or a narrow range of wavelengths. can do.

  Preferably, the detector is selected from the group consisting of a photodiode, a phototransistor, a light dependent resistor and a bolometer. In one embodiment, the detector further comprises a filter, suitably an optical filter, preferably a polarizing filter. By using the filter, the wavelength / a plurality of wavelengths that can be detected by the detector can be determined in advance. For example, by making the detector sensitive only to the wavelength selected for the emitter, the detector can be less sensitive to external light sources such as room light / sunlight. In yet another embodiment, an amplifier is attached to the detector because the output from the detector may be very small (on the order of microamperes). The amplifier is preferably placed as close as possible to the detector to avoid amplification of external noise, such as electrical noise picked up by the connection wiring. In certain embodiments, the amplifier is integrally formed with the detector. For example, the detector and the amplifier are placed on the same integrated circuit or “chip”.

  Preferably, the sensor is integral with the holder, for example molded or attached to the holder.

  The electronic dosing reminder system is preferably electronically coupled to the sensor so that when the detector detects that the dosing device has been removed from the holder, a signal is sent to record that the device has been disconnected. It is supposed to be. In one aspect, the system includes a microprocessor. Preferably, the microprocessor performs an operation on the data from the sensor and generates a signal output related to the data or the result of the operation on the data.

  The timer can have any suitable form, such as an electronic timer form.

  Of course, a timer is placed in communication with the detector so that a particular time measurement operation starts when the presence in the holder of the dosing device is detected and stops when the device is removed. It will be clear that this can be achieved. The timer can also be configured to have an automatic reset or re-zero setting mechanism so that the timer count will start again from zero when the device is later re-inserted.

  The dosing interval memory stores data related to the dosing interval of the prescription, particularly the dosing interval time or period of the prescription. For example, if the drug has to be taken twice a day at regular intervals, the prescription dose interval period can be set to 12 hours; Can be set to 24 hours. In some embodiments, the system may be configured such that the prescription dose interval time or duration can be easily readjusted, or only a designated prescriber (eg, medical professional or pharmacist) can readjust. Thus, you may comprise with high security. Passwords and / or other security measures can be used. The prescription dosing data may be configured to be variable over a specific dosing course or may be fixed at a set dosing interval over the entire course of treatment.

  The patient alarm device is designed to communicate an alarm to the user. In one embodiment, the alarm device operates only when the retention period exceeds the prescription dose interval period. For example, if the administration is performed once a day with a prescription administration interval of 24 hours, the alarm device will only operate when the corresponding period exceeds 24 hours. This is because another administration needs to be performed at that time. Thus, it is clear that the alarm device functions as a reminder for a patient to take a dose.

  In some embodiments, the alarm device may include a visual display device such as a liquid crystal display (LCD) or light emitting diode (LED) array connected to any convenient type of battery-powered timing device known to those skilled in the art. it can. The visual display device can be configured to display information such as the actual time or the elapsed time since the previous dose, or it may be overlaid with another message such as a textual medication instruction. it can. Alternatively, medication instructions can be notified by simply displaying an alarm color, or flashing the display or performing another technique.

  In yet another arrangement, no specific time or elapsed time information is displayed, and the alarm device simply provides an alarm signal indicating the required action to the user.

  Depending on the user's lifestyle, additional or separate alerts may be more useful compared to purely visual alerts. Accordingly, it is contemplated by the present invention that instead of (or in addition to) a visual alarm, an audible and / or tactile alarm such as vibration may be provided to the alarm device.

  The alarm device can provide a single on-off alarm. More preferably, the alarm device is configured to provide an alarm over a set period of time (“alarm period” or “alarm window”). In one embodiment, the alert period is calculated as a function of the dosing interval (eg, a fraction thereof). For example, in the case of treatment twice a day with a dosing interval of 12 hours, the alarm period can be set to ½ period (ie, 6 hours). In that case, the alarm is provided for 6 hours immediately after the alarm is activated.

  The system is configured such that the alarm signal is interrupted when the user removes the dosing device from the holder and allows for medication administration therefrom, or when the device is replaced after use. The system is then reset. Other manual block / invalidations are also included.

  The compliance support device in the present invention can be configured to operate in two slightly different modes herein, a “clock time independent” mode and a “clock time dependent” mode.

  In the “time-independent” mode, the relevant time frame (to which all subsequent timings are concerned) is set by the relationship of system elements, in particular by the relationship to the holder of the dosing device. In this mode, the timer operates to measure a holding time corresponding to the time that the dosing device is held by the holder. The dose interval memory stores data related to the prescription dose interval period, and the alarm operates when the retention period exceeds the prescription dose interval period.

  Thus, in the “clock time independent” mode, the time frame associated with detection, time measurement and alarm is determined by the user's actions related to the system, in particular by the user's actions to remove and reinsert the dosing device. It is understood that Therefore, dosing reminder capability is derived from a specific defined external time zone (eg, local time zone relative to Greenwich Mean Time as defined by the 24-hour clock), as the user's action defines its own “reminder time frame”. Are independent. This provides an advantage over a reminder system that relies on user references to a defined external time frame. The advantage is particularly useful for international travelers because it avoids complex calculations involving different local time zones.

  Conversely, in “clock time dependent” mode, the relevant time frame (the one to which all subsequent timings are related) is determined by the external time zone (eg, the local time zone for Greenwich Mean Time as defined by the 24-hour clock). To do. In this aspect, the timer is a standard clock set in a specific time zone. The administration interval memory stores data relating to the administration time of the prescription, and the alarm device operates when the time recorded by the clock corresponds to the administration time of the prescription. At the time of setting the standard clock, the suggested dosing time (eg once in the morning and once in the evening) can be entered into the dosing interval memory or can be started from a pre-specified entry into that memory .

  In some cases, in order to provide the user with another function, the compliance support apparatus may be provided with a standard time keeping clock having a clock alarm mechanism. The clock can be set to a specific “time frame” but is conventionally set to a local time zone.

  It will be apparent from the above description that the various components of the electronic dosing reminder system relate to each other and provide the necessary functionality. The system can be configured in any suitable form using known electronic components and circuit methods.

  In some cases, other system aspects may be included. In one aspect, a system for reading and / or writing information from an electronic dosing reminder system of a holder to a dispensing device inserted therein is included. In some embodiments, such a system can be used to determine whether the inserted device is actually that device.

  In one aspect, the holder has a first transceiver for transmitting and receiving data. In this embodiment, the medication device has a second transceiver for transmitting and receiving data. Data can then be transferred in two directions from the first transceiver to the second transceiver.

  Preferably the data is in digital form, for example suitable for transfer by electronic or optical means. Data can be transferred when the dosing device is fully or partially held in the holder. It is possible to establish a predetermined data transfer location in which a particular record exists between the holder and the dosing device fitted therein.

  The data can be in encrypted form that uniquely identifies the product or basic product information, such as the nature of the medication and dosing information, or a unique serial number stored in the password-protectable portion of the memory.

  Information written to memory can be provided in specific languages (eg, French, German), including non-Latin type languages (eg, Mandarin or Thai), or provided in multilingual form it can. In one aspect, the holder system is provided with the ability to show information read from the dispensing device in any selected language (eg, by suitable software).

  In one aspect, the information / language depends on what is written to the dispensing device (eg, at a conventional label location in the manufacturing process). The dispensing device will then take the form of a product that is specific to the geometry and / or language.

  In another aspect, the dispensing device has a plurality of geometric and / or linguistic information written thereon (eg, at a conventional labeling location in the manufacturing process). The dosing system thus has the form of an “international” product. The holder can then be configured to cause the patient to read / display only the information / language data set relevant to the particular market (or patient) of interest (eg, by the patient or pharmacist at the time of prescription).

  In yet another aspect, the dispensing device has information written in a default (eg, standard) language / character set (eg, at a conventional label location in the manufacturing process). The dosing device has the form of a “standard” product. Secondly, by adopting a holder capable of translating standard datasets into national formats, only information / language datasets relevant to the specific market (or patient) of interest will be displayed to the patient. It has become.

  When the medication device is loaded or reloaded in the holder, for example, the first transceiver can read the unique serial number, batch code and expiration date of the medication device and other information about the second transceiver. In this way, the nature and concentration of the medicament can be determined along with the number of doses used or remaining in the dosing device. This information can be displayed to the patient on the visual display unit. Other information can also be displayed, such as the number of times the dosing device has been reloaded into the holder.

  Other information such as the date and time of drug administration or environmental exposure data such as minimum / maximum temperature or humidity level to which the holder and / or dosing device was exposed can also be read and displayed to the user.

  Data can be transferred each time the patient uses the device. Alternatively, the data can be stored in a database memory of the holder's electronic data management system and downloaded to the transceiver on a regular basis. In either case, the history of medication device usage can be stored in the memory of the transceiver.

  Preferably, the first and second transceivers each have an antenna or equivalent for transmitting or receiving data and connecting a memory thereto. In some embodiments, the antenna can also deliver energy to a passive receiver. The memory typically has an integrated circuit chip. Any transceiver can be configured to have a memory structure capable of storing a large amount of information. The memory structure may be set so that part of the memory is read-only and programmed during / after manufacture, the other part is read / write, and part is password-protectable. it can. Arranged so that the initial transfer of information to or from any transceiver (eg, at the time of manufacture or at a single dose) is easily accomplished by use of a reader remote from the medication dispenser. This reduces the need to handle the product directly. In yet another aspect, the reader can be arranged to read or write to multiple transceiver memories on multiple pharmaceutical dispensers simultaneously.

  Preferably, data can be transferred bi-directionally between the first transceiver and the second transceiver, and no direct physical contact between them is required. Preferably, the data can be transferred wirelessly between the first and second transceivers.

  Preferably, the first transceiver is an active transceiver, and the second transceiver is a passive transceiver. The term active is used to mean receiving power directly, and the term passive is used to mean receiving power indirectly.

  Preferably, the second transceiver comprises a label or tag having an antenna for transmitting or receiving energy and an integrated circuit chip connected to the antenna, the first transceiver comprising a label or tag. It has a reading device. In this case, the label or tag is a passive transceiver and the reader is an active transceiver. Preferably, the reader need not be in direct contact with the tag or label in order to be able to read the tag or label.

  The tags can be used and / or integrated with other conventional product labeling methods such as visual text, machine readable text, barcodes and dot codes.

  The tag can be associated with the dispensing device in any suitable form. In one embodiment, the tag is attached or secured to the dosing device in some form by suitable means such as adhesive fastening, welding, snap-fit placement, or by using various attachment means. The attachment means can have, for example, an adhesive label, a wrapping tape or a collar arrangement.

  In another embodiment, the tag is placed in the dispensing device, for example, as a loose part with the pharmaceutical contents, or in a separate compartment or housing within the pharmaceutical container. An advantage of placing the tag in the dosing device is that it can be “hidden from view” to increase its usefulness as a security mechanism. Further, the tag and dispensing device can be configured (eg, shape and size) such that the tag can only be removed by breakage or other dispensing device or tag breakage.

  Preferably, the tag is on a carrier, which can be mounted on a holder or dispensing device.

  In one embodiment, the carrier is a flexible label. In another aspect, the carrier is a rigid disk. In yet another aspect, the carrier is a rectangular block. In yet another embodiment, the carrier is a collar (eg, in the form of a ring) suitable for fitting (eg, for mounting on) a dispensing device. Other shaped carriers are also envisioned, such as those defining a chip housing or enclosure.

  Preferably, the carrier contains a tag. More preferably, the carrier forms a hermetic seal for the tag. In one embodiment, the carrier comprises an insulating material such as a glass material or an organic polymer material such as a paper material, a ceramic material or polystyrene. Alternatively, the carrier includes a ferrite material.

  The energy that powers the transceiver can be of any suitable form such as ultrasonic, infrared, radio frequency, magnetic, light and laser forms. Suitable conductors such as waveguides and fiber optic paths can be used to pass energy.

  In one aspect, the second transceiver has a radio frequency identification device having an antenna for transmitting or receiving radio frequency energy and an integrated circuit chip connected to the antenna, the first transceiver A reader for the radio frequency identification device; In that case, the radio frequency identification device is a passive transceiver, and the reader is an active transceiver. The advantage of the radio frequency identification device technology is that the reader does not need to be in direct contact with the radio frequency identification tag or label for reading.

  The radio frequency identification device may be any known radio frequency identification device. Such identification devices are sometimes referred to as radio frequency transponders or radio frequency identification (RFID) tags or labels. Suitable radio frequency identification devices are those sold by Phillips Semiconductors of the Netherlands under the trade names Hitag and Icode, the United States under the trade name Intellitag. Such as those sold by Amtech Systems Corporation, and those sold by Texas Instruments in the United States under the trade name of Tagit.

  Preferably, the antenna of the RFID tag can transmit or receive radio frequency energy having a frequency of 100 kHz to 2.5 GHz. The preferred operating frequency is selected from 125 kHz, 13.56 MHz and 2.4 GHz.

  In one aspect, the second transceiver is an antenna for transmitting or receiving magnetic field energy; and a magnetic label or tag having an integrated circuit chip connected to the antenna; the first transceiver is the magnetic label Or it has a reader for tags. In this case, the magnetic label or tag is a passive transceiver, and the reader is an active transceiver.

  A preferred magnetic label or tag has a plurality of interrelated magnetic elements that move relative to each other in response to an interrogating magnetic field. This type of magnetic label or tag is described in US Pat. Another suitable magnetic label or tag has a magnetic restricting element that is readable by application of an interrogating alternating magnetic field in the presence of a magnetic bias field that causes resonance of the magnetic restrictive element at various predetermined frequencies. This type of magnetic label is described in PCT patent application WO92 / 12402. Another suitable magnetic label or tag having a plurality of individual magnetic active areas in a linear arrangement is described in PCT patent application WO 96/31790. Suitable magnetic labels and tags include those using Programmable Magnetic Resonance (PMR) technology.

  In another aspect, the second transceiver has a passive microelectronic memory chip, and the first transceiver has an active reader for the microelectronic memory chip. The microelectronic memory chip may comprise an electrically erasable programmable read only memory (EEPROM) chip or a SIM card type memory chip. In this case, the microelectronic memory chip is a passive transceiver, and the reading device is an active transceiver.

  Any transceiver in the present invention, in particular a passive transceiver, can be mounted or housed in any suitable inert carrier. The carrier can have a flexible sheet, which in some embodiments can receive printed text thereon.

  Preferably, said holder further comprises an electronic data management system, said electronic data management system being associated with at least the first transceiver. The electronic data management system has input / output capabilities, a memory for storing data; a microprocessor that performs operations on the data; and a transmission for transmitting signals related to the data or results of operations on the data Have a machine.

  Preferably, the electronic data management system is configured to respond to or be triggered by the user's voice. Thus, for example, the system can be switched on or off in response to voice commands.

  Incorporating functions for remote reminder stimulation, such as radio messages from the child's parents, into a shaped holder when the compliance support device is used by an unsupervised child, usually under the supervision of an adult be able to.

  An electronic dosing reminder system that includes a timer and visual display and / or other alarm mechanism is battery powered in one aspect, and preferably provides a known type of circuit mechanism to monitor the status of the battery being used. And gives an alarm that a replacement is necessary long before performance degradation occurs. In some situations, it may be desirable to have a battery change alarm (after keeping in mind that a timing device is incorporated) to occur after a set time regardless of the actual state of the battery.

  If desired, the holder can be provided with a suitable socket that can be powered through an adapter connected to a power outlet when the assistive device is used, for example, by a bedridden person at home for a long period of time. . As yet another embodiment, a rechargeable battery can be used by a known method.

  In order that the present invention may be clearly understood and readily implemented, one embodiment of the present invention will be described with reference to the accompanying drawings, which are given by way of example only.

  Referring to FIG. 1, specifically, FIG. 1A, a compliance support apparatus 1 according to an example of the present invention is shown. In this example, the compliance assisting device 1 has a casing 2 of elastic material, which is colored, patterned and / or textured as described above to achieve the desired visual and / or tactile feel. The effect is gained.

  The casing 2 has a top 3 and a bottom 4; the top 3 is divided laterally by a break line 5 to define a front part 6 and a rear part 7, respectively. Both parts 6 and 7 of the top 3 are independently hinged to the bottom 4; the arrangement is such that when the rear part 7 is closed first and a latching arrangement is provided, the front part 6 is also closed. The casing is closed in a snap manner so as to be in a closed state. The hinge of the rear portion 7 (not shown in FIG. 1 (a), but shown in FIG. 1 (c) and 1 (d) as 10) is a simple and free-moving hinge that can be easily attached. The hinge (not shown) of the front part 6 is preferably in a state of elasticity in the direction of the closed position, the reason of which will become clear below.

  When it is desired to open the casing 2, pressure is applied to the pair of release buttons 8 and 9 disposed near the front on both sides of the compliance support apparatus 1. The operation allows the front portion 6 of the top 3 to open slightly, thereby opening the rear portion as shown in FIGS. 1 (b) and 1 (c), thereby taking the time to take a dose of medication. In this case, the medicine container 11 can be grasped and taken out, and / or the position can be changed if it is desired to change the compliance support device to its exposed state.

  For example, if a user of the compliance support device 1 is traveling and wants to keep it closed when the container is not being used to take a medication dose, supply a set number of distinct doses of medication The container 11 (which in this case is a Diskus DPI device sold by GlaxoSmithKline) is removed simply to take the drug and then reinserted into the casing 2. Then close the casing again.

  On the other hand, if it is more convenient to configure the compliance support device in a display mode in which the drug container 11 is provided ready for use on a bedside table, for example, simply using the drug container 11 Pulling the front part 6 of 3 and opening it further opposite the elastic closing force of the hinge, closing the rear part 7 behind the front part and rearward in an inclined position by the elastic hinge of the front part 6 By allowing the container 11 to be held against the front edge of the portion 7, the casing 2 can be changed as shown in FIGS. 1 (d) and 1 (e). By providing a groove (not shown) at the bottom of the shell-like casing, the support of the discus DPI device can be enhanced.

  Preferably, at least a part of one or both of the parts 6 and 7 of the top 3 is transparent or translucent so that the presence of a drug container such as 11 can be visually confirmed easily when the casing 2 is closed I will provide a. To facilitate it, a portion of the inner bottom of the bottom 4 that can be seen through the window when the container is closed, but becomes obscured when the drug container is installed, is lightly colored and / or fluorescent. And

  The important point is that the compliance support apparatus 1 has an electronic circuit mechanism (not shown, although not shown) for measuring time (eg, a holding period corresponding to a time during which the dosing device is held in the casing). Is of a kind). In this example, the time recorded by the electronic circuitry is displayed on the LCD 12, and if there is a reset button 13, if the elapsed time is recorded, the count is reset to zero after the medication dose has been taken. The Other control means may be provided to set the date if it is necessary to record the time and possibly the absolute time, or in a specific order and / or if other information is provided to the circuitry. Button 13 can be driven for a selected period. Preferably the circuitry is built into the microprocessor.

  The presence of the drug container 11 in the casing 2 in a closed or exposed structure is detected by a proximity sensor 14 inside the front edge 15 of the front part 6 of the casing. Proximity sensors can send signals to electronic circuitry, in particular electronic timers. When it is first detected that the drug container 11 is present in the casing 2, a new retention period begins (eg, after the drug container is reinserted after a particular dosing event).

  Assuming that an elapsed time count needs to be displayed, operate button 13 or another control button (not shown) to select the appropriate inter-dose period, and the arrangement is compliant when the inter-dose period has elapsed. It is assumed that the support device 1 gives an alarm to perform the next medication. The alarm can be visual, audible (such as a beep, music or verbal instructions) and / or tactile such as vibration provided by the LCD or associated LED. Any or all of the alarms can be provided by a compliance support device according to the present invention.

  In any case, a warning is given to the user to take the medicine, and the medicine container 11 is removed from the casing 2 in a reasonable manner as described above, and replaced with the casing in the same state, or displayed from the closed state. Reconfigure to the outgoing state and vice versa. Reset the timing circuitry and restart the process.

  The electronic circuitry can be powered in any convenient manner, for example by one or more batteries (disposable or rechargeable) and / or a power outlet with an adapter.

  When the electronic circuit mechanism and visual display device and / or alarm mechanism are battery-driven, the circuit mechanism is configured after a predetermined number of reset operations, regardless of the actual state of the battery. It is preferable to issue an alarm prompting replacement (or charging). Alternatively, the circuitry can incorporate a known type of battery monitoring function to provide a replacement (or charge) alarm before battery performance is significantly degraded.

  FIG. 2 shows a device 101 in which the compliance support apparatus 1 shown in FIGS. 1 (a) to 1 (e) is slightly modified. In FIG. 2, components that are the same as or completely equivalent to the components shown in FIG. 1 have their reference numbers plus 100.

  FIG. 2A shows the compliance support apparatus 101 in the exposed state, which is equivalent to FIG. FIG. 2 (b) shows a known configuration in the exposed state shown in FIG. 2 (c), as opposed to the discus DPI device 111, by arranging in the casing 102 and reconfiguring the inside of the casing. An adapter device 116 is shown that can accommodate an L-shaped drug container 118 (eg, an MDI inhaler). Depending on the dimensions of the casing 102 and its internal shape, the casing 102 may or may not be able to be closed when the casing houses the L-shaped container 118. Either arrangement can be selected depending on the overall design criteria for the compliance support device 101 and its intended use.

  As mentioned above, the presence of the drug container 111 or 118 in the casing 102 in either a closed or exposed shape is detected by the proximity sensor 114 located inside the front edge 115 of the front portion 106 of the casing. The It will be apparent that by selecting the location of the proximity sensor 114 in this way, it is possible to detect both disc-shaped 111 or L-shaped inhalers. Proximity sensor 114 can send signals to electronic circuitry, particularly electronic timers.

  FIG. 2 (a) shows a window 119 provided to facilitate the presence of the drug container 111 as described above.

  In an advanced form of the invention, the electronic circuitry allows the compliance support device 1 or 101 to respond to remote stimuli such as a parent message sent over a radio or other telecommunication link that can be received. Can do.

  FIG. 3 shows that the compliance support apparatus 201 of the present invention having a holder at the top 203 is in the form of a cradle 202 for housing a medication apparatus (not shown). The bottom 204 of the compliance support device 201 forms a bottom that allows the compliance support device 201 to be placed on a horizontal surface such as a table next to the bed or a furnace shelf (not shown).

  Inside the cradle 202 is a mechanical switch 214 in the form of a lever scale that serves to detect the weight of a dosing device (not shown) held in the cradle 202. The cradle 202 has a cross shape, whereby a disc-shaped dosing device (eg, a Discus DPI device sold by GlaxoSmithKline) on the side of the cross, or an L-shaped dosing device (vertical portion on the cross) ( A known MDI aerosol device or the like can be accommodated. Inserting any type of device into the cradle causes the switch 214 to start operating.

  The compliance support apparatus 201 includes an electronic timing circuit mechanism (not shown) and a dose interval memory (also not shown) for storing dose interval data. Both the LCD display 212a and the LED light emitting device 212b provide patient alerts.

  The compliance support device of FIG. 3 can be set to operate in a “clock time independent” mode or a “clock time dependent” mode (as defined above).

  In the “clock time independent” mode, the timer operates to time a holding time corresponding to the time that the dosing device is held by the cradle 202. If the period of time that the dosing device is held in the cradle 202 exceeds the prescription dosing interval period in memory, an alarm is initiated. In this case, the alarm includes flashing of the LCD display device 212a of the message “administration reminder” and light emission of the LED light emitting device 212b. When the dosing device is replaced in the cradle 202, the alarm is turned off and the action triggers the switch 214.

  In “clock time dependent” mode, the timer is a standard clock set in a specific time zone. When the time recorded by the clock corresponds to the prescription administration time, an alarm is started. In this case, the alarm includes flashing of the LCD display device 212a of the message “administration reminder” and light emission of the LED light emitting device 212b. When the dosing device is replaced in the cradle 202, the alarm goes off, thereby causing the switch 214 to be activated. The system is configured such that the alarm automatically stops after a predetermined alarm period (eg, after an alarm action has been performed for 3 hours), regardless of whether the medication device has been removed from the cradle 202. You can also The next alarm is given at the time of administration of the next prescription.

  FIG. 4 shows the structure of an electronic dosing reminder system 110 suitable for the present invention, which can be used, for example, in any compliance support device shown in the previous figures. The electronic dosing reminder system 330 has a central processing unit (CPU) 340, a RAM 341 and a ROM 342. The CPU 340 also receives patient data from the sensor 350, which can be, for example, a proximity sensor or an electronic switch for detecting the presence of a medication device at the holder. CPU 340 can also be associated with clock 345. In an embodiment of the “clock time independent” mode, the clock can be configured to initiate a timed event in response to detection of the medication device by sensor 350. The CPU can receive and transfer data to the data storage device 343, which has two databases, one for storing the dosing interval data 343a, and one for prescription. It is for storing compliance data 343b relating to patient compliance to the prescription regime. The CPU 340 also interacts with a man-machine interface 344 for receiving patient input commands (eg, related to an associated dosing regime); and a display driver 311 and a display 312 for displaying alarm information to the patient. The display device can be, for example, in the form of an LED display device (as shown in FIG. 3).

  In addition to the basic functionality of the electronic dosing reminder system, additional capabilities are provided by the system of FIG. In one aspect, the CPU 340 is further associated with a communication port 355 that can communicate with a network computer system (not shown) via a modem 356 to communicate therewith. In another aspect, the CPU 340 can perform two-way data transfer with the reader 330. A reader, typically located on the holder, can read and write information to a passive transceiver in the form of a tag 320 (eg, on a medication device). The tag 320 includes an RFID tag or a magnetic tag. In a preferred system according to the invention, the reading device 330 forms part of a compliance support device holder and the tag 320 is mounted on a dispensing device in which the holder can be accommodated.

  In some embodiments, the compliance support devices and holders of the present invention dispense a medicament for the treatment of respiratory disorders such as lung and bronchial disorders such as asthma and chronic obstructive pulmonary disease (COPD), bronchitis and chest infections. Suitable for use with a dosing device.

Thus, suitable medications for dosing include analgesics such as codeine, dihydromorphine, ergotamine, fentanyl or morphine; angina drugs such as diltiazem; cromoglycic acid compounds (eg as sodium salts), ketotifen or nedocromil ( Examples: antiallergic drugs such as sodium salts; antiinfectives such as cephalosporins, penicillins, streptomycins, sulfonamides, tetracyclines and pentamidine; antihistamines such as metapyrylene; beclomethasone (eg dipropion) Acid ester), fluticasone (e.g. as propionate), flunisolide, budesonide, rofleponide, mometasone (e.g. as furoate), ciclesonide, Liamcinolone (eg as acetonide) or 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androst-1,4-diene-17β-carbothioic acid S- (2-oxo Anti-inflammatory agents such as tetrahydro-furan-3-yl) ester; antitussives such as noscapine; albuterol (eg as free base or sulfate), salmeterol (eg as xinafoate), ephedrine, adrenaline, fenoterol (eg : As hydrobromide), formoterol (eg as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pyrbuterol (eg as acetate), reproterol (eg as hydrochloride), limiterol Terbutaline (E.g. as sulfate), isoetarine, tulobuterol or 4-hydroxy-7- [2-[[2-[[3- (2-phenylethoxy) propyl] sulfonyl] ethyl] amino] ethyl-2 (3H)- Bronchodilators such as benzothiazolone; 2R, 3R, 4S, 5R) -2- [6-amino-2- (1S-hydroxymethyl-2-phenyl-ethylamino) -purin-9-yl] -5- (2 -Adenosine 2a agonists such as ethyl-2H-tetrazol-5-yl) -tetrahydro-furan-3,4-diol (eg as maleate); (2S) -3- [4-({[4 -(Aminocarbonyl) -1-piperidinyl] carbonyl} oxy) phenyl] -2-[((2S) -4-methyl-2-{[2- (2-methylphenoxy) acetyl] amino Pentanoyl) amino] propanoic acid (eg alpha ₄ integrin inhibitors, etc.) as the free acid or potassium salt; diuretics, such as amiloride; ipratropium (eg as bromide), tiotropium (tiotropium), atropine or oxitropium (Oxitropium Anticholinergic drugs such as cortisone, hormones such as hydrocortisone or prednisolone; xanthines such as aminophylline, choline theophyllate, lysine theophyllate or theophylline; therapeutic proteins and peptides such as insulin or glucagon; vaccines Class, diagnostics and gene therapy agents. The person skilled in the art will know that the pharmaceutical is suitably in the form of a salt (eg as an alkali metal salt or amine salt or acid addition salt), as an ester (eg lower alkyl ester) or as a solvate (eg water It will be clear that the activity and / or stability of the medicament can be optimized.

  Preferred components of the combination include a medicament selected from albuterol, salmeterol, fluticasone propionate and beclomethasone dipropionate and salts or solvates thereof (eg, albuterol sulfate and salmeterol xinafoate).

  The preferred component of the active ingredient combination is beclomethasone ester (eg as dipropionate) or fluticasone ester (eg as propionate) or an anti-inflammatory steroid such as budesonide, salbutamol (eg free) Base or sulfate) or salmeterol (eg as xinafoate) or formoterol (eg as fumarate). A particularly preferred combination of ingredients comprises fluticasone propionate and salmeterol or a salt thereof (particularly xinafoate). Yet another component combination of particular interest is budesonide and formoterol (eg as fumarate).

  In general, powdered pharmaceutical particles suitable for delivery to the bronchial or alveolar region of the lung have an aerodynamic diameter of less than 10 μm, preferably less than 6 μm. Other sizes of particles can be used when delivery to other parts of the respiratory tract such as the nasal cavity, mouth or pharynx is desired. The medicament can be administered as a pure drug, but more suitably, the medicament is preferably administered with an excipient (carrier) suitable for inhalation. Suitable excipients include polysaccharides (ie starch, cellulose, etc.), lactose, glucose, mannitol, organic excipients such as amino acids and maltodextrins, and inorganic excipients such as calcium carbonate or sodium chloride. is there. Lactose is a preferred excipient.

  Powdered drug and / or excipient particles can be produced by conventional methods such as micronization, grinding or sieving. Furthermore, pharmaceutical and / or excipient powders can be processed with specific densities, particle size ranges or properties. The particles can include active agents, surfactants, wall forming materials, or other components deemed desirable by those skilled in the art.

  An excipient | filler can be included with a pharmaceutical by well-known methods, such as mixing and coprecipitation. Excipient and pharmaceutical mixtures are typically formulated so that the mixture can be accurately metered and dispersed into individual doses. A standard mixture is, for example, mixed with 50 μg of pharmaceutical and contains 13000 μg of lactose, giving an excipient / pharmaceutical ratio of 260: 1. Dose mixtures with an excipient / pharmaceutical ratio of 100: 1 to 1: 1 can be used. However, if the excipient / pharmaceutical ratio is very low, the reproducibility of the pharmaceutical dose can be more variable.

  Aerosol formulations suitable for use with metered dose inhaler (MDI) dispensers typically include a propellant. Suitable propellants include P11, P114 and P12, and HFC-134a and HFA-227 which are hydrofluoroalkane propellants without CFC.

  The MDI aerosol formulation may further comprise volatile adjuvants such as propane, n-butane, isobutane and saturated hydrocarbons such as pentane and isopentane or dialkyl ethers such as dimethyl ether. Up to 50% by weight of the propellant can contain volatile hydrocarbons, for example 1-30% by weight. However, formulations that are free or substantially free of volatile adjuvants are preferred. In some cases, it may be desirable to include an appropriate amount of water that can be advantageous in changing the dielectric properties of the propellant.

Polar cosolvents such as ethanol, isopropanol and propylene glycol, preferably _C2-6 aliphatic alcohols such as ethanol and polyhydric alcohols, as sole excipients or other shaping such as surfactants In addition to the agent, it can be contained in a desired amount in the MDI aerosol formulation to enhance the dispersibility of the formulation. Suitably the pharmaceutical formulation may comprise 0.01-30% by weight of a polar co-solvent, such as ethanol, preferably 0.1-20% by weight, for example about 0.1-15% by weight, based on the propellant. In one aspect of the invention, the solvent is added in an amount sufficient to dissolve some or all of the pharmaceutical ingredients, but such formulations are commonly referred to as solution formulations.

  Surfactants can also be used in MDI aerosol formulations. An example of a conventional surfactant is disclosed in EP-A-372777. The amount of surfactant used is preferably in the range from 0.0001% to 50% by weight, in particular from 0.05 to 5% by weight, based on the medicament.

  The final aerosol formulation desirably comprises 0.005 to 10%, preferably 0.005 to 5%, in particular 0.01 to 1.0% by weight of medicament relative to the total weight of the formulation.

  In one embodiment, the compliance support device and holder of the present invention is suitable for use with a pharmaceutical administration device for the treatment of respiratory disorders such as lung and bronchial disorders such as asthma and chronic obstructive pulmonary disorder (COPD). . In another aspect, the compliance support device and holder of the present invention provides pharmaceutical administration for the treatment of conditions requiring treatment by the systemic circulation of the drug, such as migraine inhalation, for example migraine, diabetes, pain relief, etc. Suitable for use with the device.

  Accordingly, the use of a compliance support device and holder according to the present invention in combination with a suitable dosing device for the treatment of respiratory disorders such as asthma and COPD is provided. As another form, the present invention relates to a method for treating respiratory disorders such as asthma and COPD, from a suitable dosing device used in compliance with the use of the compliance support device and holder of the present invention. A method comprising administering by inhalation of an effective amount of a medicament as described herein.

  In another embodiment, the dosing device is a syringe for administering an injectable medicament to a patient. In a conventional syringe, a patient's skin is punctured with a hollow needle, and an injection (in the form of a solution or suspension) is administered from the needle to the muscle or tissue of the patient. A recently developed needleless system for injection administration uses a technique in which a drug or vaccine in the form of a particle is passed through the skin and rapidly injected into a physically accessible tissue. Other needleless systems use a similar high speed injection technique of drugs or vaccines coated on suitable carrier particles.

  It will be apparent that the present disclosure is for purposes of illustration only and that the invention encompasses modifications, changes and improvements thereto.

  The application of which this description and claims forms part may be used as a basis for priority in respect of any subsequent application. The claims of such subsequent application may relate to a feature described herein or a combination of features. It may take the form of a claim for a product, method or application, or may include, but is not limited to, one or more of the appended claims.

It is a figure which shows sequentially the closed state of the compliance assistance apparatus by one example of this invention, an open | release state, and an exposed state with a perspective view. It is a figure which shows what converted the compliance assistance apparatus by the example of this invention by the display method and form similar to FIG. 1 so that the administration apparatus of a different form might be accommodated. It is a perspective view of the cradle type | mold holder by another aspect of this invention. 1 is a system diagram of an electronic dosing reminder system in use according to the present invention. FIG.

Claims (32)

A holder for holding a dosing device, the holder having an electronic dosing reminder system, the system comprising:
A detector for detecting the presence of the dosing device in the holder;
Timer for measuring the period;
The holder comprising: a dosing interval memory for storing data relating to the dosing interval of the prescription; and a patient alarm device for alerting a user.   The timer is for measuring a holding period corresponding to the time the dosing device is held by the holder; the dosing interval memory stores data relating to the dosing interval period of the prescription; The holder according to claim 1, wherein the alarm device is activated when the prescription dose interval period is exceeded.   2. The timer according to claim 1, wherein the timer is a standard clock; the dosing interval memory stores data related to the prescription administration time; and the alarm device operates when the clock records the prescription administration time. The holder described.   4. A holder according to any one of claims 1 to 3, in the form of a docking station for receiving the dosing device.   The holder according to any one of claims 1 to 3, which is in the form of a casing having a structure for housing the dosing device.   The holder according to claim 1, wherein the holder has a structure for receiving an adapter device that enables holding of another dosing device.   7. A holder according to any one of the preceding claims, wherein the detector comprises a switch that is activated in response to the dosing device being placed in the holder.   The holder according to claim 1, wherein the detector comprises a sensor for detecting that the dosing device is in the vicinity.   The holder of claim 8, wherein the sensor comprises an emitter and a detector.   The holder according to claim 9, wherein the emitter emits electromagnetic radiation and the detector detects the electromagnetic radiation.   The holder according to any one of claims 1 to 10, wherein the timer has an automatic re-zeroing mechanism.   The holder according to any one of claims 1 to 11, wherein the dosing interval memory is configured in a safe form so that only a qualified prescriber can readjust the dosing interval data.   The holder according to any one of claims 1 to 11, wherein the administration interval memory is configured to be able to vary the administration interval over a specific treatment period.   12. A holder according to any one of the preceding claims, wherein the dosing interval memory is securely configured to fix the dosing interval over a specific treatment period.   The holder according to claim 1, wherein the alarm device has a visual display device.   The holder according to claim 15, wherein the visual display device is selected from the group consisting of a liquid crystal display device (LCD) and a light emitting diode (LED).   The holder according to claim 16, wherein the visual display device is configured to display information in text.   The holder according to any one of claims 1 to 17, wherein the alarm device provides an alarm signal selected from the group consisting of a visual signal, an auditory signal and a tactile signal.   19. A holder according to any one of the preceding claims, wherein the alarm device is configured to provide the alarm over a predetermined alarm period.   20. A holder according to claim 19, wherein the alarm period is calculated as a function of the dosing interval period.   21. A holder according to any one of the preceding claims, wherein the alarm device is configured to stop when the dosing device is removed from or replaced in the holder.   22. A holder according to any one of the preceding claims, further comprising a system for reading and / or writing information from the electronic dosing reminder system of the holder to the dosing device it holds.   23. A holder according to claim 22, wherein the holder comprises a first transceiver for transmitting and receiving data when the dosing device is fully or partially held in the holder.   24. A kit of parts comprising the holder according to any one of claims 1 to 23 and a dispensing device which can be held thereby.   25. A kit of parts according to claim 24, wherein the holder comprises a first transceiver for transmitting and receiving data and the dosing device comprises a second transceiver for transmitting and receiving data.   The component kit according to claim 25, wherein the first transceiver is an active transceiver, and the second transceiver is a passive transceiver.   A label or tag having an antenna for the second transceiver to transmit or receive energy and an integrated circuit chip connected to the antenna; the first transceiver has a reader for the label or tag The component kit according to claim 26.   The second transceiver has a radio frequency identification device having an antenna for transmitting or receiving radio frequency energy and an integrated circuit chip connected to the antenna; the first transceiver is the radio frequency identification device 28. The component kit according to claim 27, comprising a reading device for use.   The second transceiver has a magnetic label or tag having an antenna for transmitting or receiving magnetic field energy and an integrated circuit chip connected to the antenna; the first transceiver for the magnetic label or tag The component kit according to claim 28, comprising a reading device.   30. A component kit according to any one of claims 24 to 29, wherein the holder further comprises an electronic data management system associated with at least the first transceiver.   The component kit according to claim 30, wherein the electronic data management system includes a memory for storing data; a microprocessor that performs an operation on the data; and a transmitter that transmits a signal regarding the data or a result of an operation on the data. .   Use of the holder according to any one of claims 1 to 23 for holding a dosing device.

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