Combination of active ingredient and reproduction means

The present invention relates to a combination of at least one active ingredient and a reproduction means. The invention also relates to a reproduction means for providing information about medicines, information about diagnostic agents, information about vaccines, information about preventive treatment, information about medical examinations, information about medical treatment, information at the time of purchase, information at the time of borrowing, information when closing a mortgage, information about a statutory right, or information about a statutory obligation. Active ingredients, specifically medicines, are sold with inserts. Such an .insert describes the medicine and its actions, provides information about risks associated with the dose, the way it is to be taken and method of administration, specifies its risks and provides other information about the medicine.

The insert is commonly a text printed on paper, sometimes available in several languages. The information which must be provided to a party to an agreement at the time of concluding the agreement or earlier, generally also comprises, in addition to any information provided in a personal meeting or group presentation, a text printed on paper, sometimes available in several languages.

A problem arising in the context of the use of active ingredients as for example in particular substances and/or treatments which act on the human body, is that a written text explaining the use cannot be understood by those who are illiterate or functionally illiterate and that language problems may occur, as a result of which

the user of a medicine does not receive the required explanation.

It is an object of the present invention to provide a combination of at least one active ingredient whereby at least one of the above problems is reduced.

In one embodiment this problem is solved by the combination according to claim 1. The reproduction means according to the invention are capable of providing sensory, specifically auditory, instructions concerning an active ingredient, specifically as a replacement of or supplement to an insert for the active ingredient. In another embodiment, the medicine and the reproduction means are provided by the final provider, e.g. a pharmacist, after which the user can listen to the instructions for use by means of the reproduction means, in a language and terms they can understand.

The reproduction means according to the invention preferably embody a power supply. The power supply can be connected to components of the reproduction means, such as reading means, control means and operational means. An active ingredient is a substance which has a potential effect on matter or parts thereof, including humans, animals or plants.

The reproduction means according to the invention preferably comprise an information medium such as a memory card or CD or another medium on which information may be stored, including magnetic storage means. The use of a medium for storing data is known in the art, generally in the form of files or parts of the medium which may be read. The reproduction means comprise a reading means for this purpose. The reading means are adapted to read the medium. For example this may be by means of a laser if the medium is a CD. Magnets may be employed in another embodiment. In a further embodiment

the data is electronically read from a memory card. In this case the reading means are connected to the memory card.

The reproduction means according to the invention include input means which may be employed as a user interface. The user can use the input means to select the explanation they want to receive about the active ingredient using the combination according to the invention. In a preferred embodiment, the input means comprise one or more pushbuttons or rotary switches. The pushbutton or switch may be used to make a selection, for example the language of the explanation about the active ingredient. For example, the input means could be marked with one or more flags, for example the Dutch flag or the Surinam and Pakistani flag, or the French flag or the Iranian flag, etc. and the actuation of that input means will initiate the reproduction of the explanation in the relevant language . In another embodiment the input means may be marked with another symbol referring to a country or region, including internationally accepted country designations or a particular language, and operation of those input means leads to the reproduction of the explanation in a language associated with said symbol. In another embodiment the input means are marked with another indication.

The input means and reading means are connected to a control means capable of converting the user selection to an instruction to the reading means such that the reading means read the file corresponding to the user selection. The control means and interface may be integrated on a printed circuit board. Those skilled in the art are familiar with the construction of such control means.

Reference is made to known control means for CD players, MP3 players, etc.

The data read by the reading means from the medium is routed to the reproduction means, which reproduction means can convert the read information to an electronic signal which can be reproduced by an actuator such as a loudspeaker. The conversion may for example include digital to analogue conversion. Decompression means may also be used for decompressing a file, such as a sound file, for example an MP3 file on the medium. In a further embodiment modulation means are provided for the conversion, for example frequency modulation, etc. Reference is made to reproduction means according to the state of the art, such as CD players and MP3 players. The reproduction means according to the invention preferably include a connection point for a loudspeaker, and in a preferred embodiment the loudspeaker is incorporated into the reproduction means . More specifically, the reproduction means comprise a housing incorporating the loudspeaker. If a connection point is used, a connector may be used, for example for connecting earphones with a mating connector (male/female) for listening to the instructions. Other connections may also be made, for example to a stereo system or mobile telephone.

Preferably the reproduction means have a housing. The various means are included in the housing. In one embodiment the reproduction means comprise a substrate, preferably a flexible substrate. The substrate may be laminated. The electronic components are applied to the substrate, for example printed by lithographic techniques. The laminate or other coating may protect the electronic components against damage.

The components of the reproduction means are connected to a power supply, to supply electrical power to the components. Preferably the power supply is a rechargeable battery, but solar cells or other power sources may be employed.

Preferably the input means include a manually operated switch, such as a button. The advantage is that seeing or feeling such a button will invite most people to operate it; a relatively simple and cheap operable switch may be a component of a circuit, for example on a printed circuit board, A small number of operational elements, such as buttons, allows a large number of selections. For example, four buttons may be used for sixteen settings. In another embodiment the interface/means of operation may be provided by one or more manually operated rotating switches with multiple positions.

In another embodiment the input means comprise one or more pushbuttons. Switches of this type have two or more positions. The input means may comprise sliding switches of a type having several positions. A given switch position corresponds to the selection of a specific part or file on the medium. The control means are connected to a memory storing a table associating the switch settings with reading the relevant part of the data on the medium and correspondingly instructing the reading means. The advantage of a switch is that seeing and feeling it invites people to use it appropriately. Another advantage is that relatively few switches can provide many selection options.

In another embodiment the input means comprise a switching system which can repeatedly be set to different levels relative to a reference point and/or reference line and/or reference plane and/or reference volume. The

advantage of such a system may be that in cases where the files contain numerical data, the selection of such a file may be associated with the visualisation of a number by such a reference system. Another example in which such an interface is preferable is provided by cases in which the data is presented in a predictable sequence and the reference system provides a device to be associated with this sequence.

In a further embodiment the input means comprise a pressure-sensitive sensor. Touching this may be associated with touching a symbol. An advantage of the use of symbols is for example that they may provide supplementary information to the information presented by the reproduction means and that they do not require reading skills. In a further embodiment an interface is used which provides information in Braille about the input means .

In yet a further embodiment the input means include speech recognition means, specifically voice recognition means, instead of or in addition to the above combinations. An advantage of this is that in cases where the use of the reproduction means should be specific to one person, its abuse is made more difficult. The reproduction means contain a memory means for storing a voice pattern and comparison means for comparing the captured voice with the voice pattern. If these correspond, the control means may control the reading means accordingly.

Those issuing the reproduction means, in some cases the chemist/druggist, physician or pharmacist, may preprogram the reproduction means. For example, an input may be used to edit the memory of the reproduction means using a computer. The memory may contain software. The control means can execute the software. In another

embodiment the control means may be adapted for controlling various hardware elements, depending on an instruction.

The preprogramming by a pharmacist or physician may for example amount to entering a biometric characteristic or a voice pattern. The entered pattern is stored in a memory. The control means are programmed such that when reproducing an explanation that explanation is adapted to the patient or other user, such that the reproduction means only operate when a voice is recognised which can be defined using an input means and which corresponds to the stored pattern.

In a further embodiment the input means comprise means for recognising a biological or biometric characteristic. The advantage of this is that unauthorised use is made more difficult in cases where the use of an active ingredient in association with the reproduction means needs to be specific to a person. Examples of such observation means, including biosensors, are means which respond to an absolute value of or change in value of, for example, pressure, temperature, dimension, volume, length, area, location, humidity, force, velocity, acceleration, sound, sound pressure, sound quality, light, colour, illumination, voltage, radiation, electromagnetic radiation, electromagnetic field, potential difference, impedance, stress, strain, extension, pH, flow, turbulence, light transmission, sound transmission, radiation transmission, electromagnetic radiation transmission, radio waves, transmission of any other form of energy, concentration of one or more substances, of ions, of enzymes, of other proteins, in or of a gas, liquid or solid. Similarly there may be a response to any change in one or a plurality of people, in one or a plurality of animals; in

one or a plurality of plants, etc.; ; in one or a plurality of other life forms such as monocellular organisms, bacteria, viruses; in or of a tissue or plurality of tissues; in or of a bodily fluid; in or of a single cell or a plurality of cells or of a cell component or element of cell components (such as the cell membrane, nucleus or nucleotide) . Several possible embodiments shall be readily apparent to those skilled in the art. With some medical conditions patients dependent on medicines are instructed first to measure a given effect of that medicine and then to derive the dose to be used from that measurement . For such a medicine a reproduction means can measure this effect directly or indirectly using a sensor and then give the patient appropriate instructions for the measured condition, concerning the correct dose and use of the medicine, and any additional instructions. For this purpose the operating means of the reproduction means may comprise a control system which selects a file, for example, after manual input of the condition or conditions or after receiving the signal from the sensor. For example, a diabetes patient dependent on insulin first measures their blood sugar level and then decides how many units of what insulin to inject.

There may also be a sensor for measuring a condition external to the user. The sensor and connected activation means may measure a value. The control means may enter a state dependent on the measured value, for example an operating state, or may read and reproduce another file. The measured value may for example be the amount of radiation. The conditions for the control means may be that a condition exceeds a threshold value or remains below it.

An example of this is the connection of reproduction means to a badge, for example for measuring the amount of any radiation the wearer of the badge is exposed to. After exceeding a preset value the file associated with that value is selected and for example the reproduction means may give spoken instructions about the actions to be taken, possibly combined with a light signal. Another example is the connection of the reproduction means to a sensor for specific substances in soil samples. The reproduction means will then give instructions for the use of artificial fertiliser. In another embodiment a sensor on the reproduction means measure the storage conditions of the active ingredient and store them in a file which may be read. In yet another embodiment the reproduction means may release odours.

The active ingredient refers to a substance which may cause or initiate a desirable or undesirable effect in a living organism, including substances which can only cause said effect after removal from packaging or release from another substance or after conversion to another substance or after a period of time. An active ingredient also includes a composition of an active ingredient and other active ingredients and/or auxiliary substances, for example in a solution or dissolved, in a solid or as part of a solid, in gaseous form, as a gas in a gas mixture or any other way. Examples of active ingredients include medicines, therapeutic agents, poisons, vaccines, diagnostic agents, food supplements, fertilisers, cleaning agents, toxins, proteins, minerals, asbestos, flue gasses and radioactive materials.

The preferred embodiment comprises a combination of an active ingredient or treatment of the body, such as a

medicine or similar, accompanied by the reproduction means .

Preferably it shall be arranged that at the time of adding the insert to the medicine, the reproduction means are activated. A further advantage of this is that the operation of the insert to be provided can be guaranteed throughout the production process. A quality monitoring system of the manufacturer or the pharmacist can guarantee this. Preferably, activation means are provided. For example, the activation means are provided between the power dupply and the control means and may comprise a mechanical switch in the power circuit and/or the electronic circuit. A removable self-adhesive label is one possible embodiment.

The activation means may also be an application of the software stored in the reproduction means, for example dependent on the passage of time. Thus the activation means comprise an electromechanical operation on the basis of a file stored on a medium or in a memory of the reproduction means.

The activation means may be adapted to respond to external influences, for example a specific sound signal, or laser light or magnetic or other radiation. A relay or other switching element in the electronic circuit of the reproduction means may be closed, to power the circuit from the supply means .

In another embodiment it is arranged that at the time of issuing the combination of active ingredient and reproduction means the reproduction means are activated by removing an interruption in the electronic circuit. This may be done with the activation means described above. The advantage of this is that the capacity of the power source need only be small. The activated period is

short. An example is the manual removal of a self- adhesive label to remove the interruption of a circuit.

Preferably the reproduction means shall have a connection point for a power source, such as a battery. Preferably when issuing the combination of the medicine and reproduction means, the reproduction means are activated by connecting the reproduction means to another power source. For example, connection to the local public electricity supply network, with or without transformation of that power; other power sources such as electromagnetic radiation may be used for the supply.

In a specific embodiment, a switch is used which is activated by opening the outer packaging of the medicine, which packaging also incorporates the reproduction means according to the invention. In another specific embodiment the switch is activated by removing the medicine, in its packaging, from the outer packaging. In a further specific embodiment the switch is activated by removing the medicine from its packaging or by opening packaging such as a tube, jar or ampoule containing the medicine. By breaking a seal a switch is activated to activate the supply of power to the reproduction means for control means, reading means, operating means and any actuators including any loudspeaker. For example, the opening may involve the mechanical removal of an interruption of an electronic circuit or the supply circuit. An advantage of this is that the complete production process of the medicine and insert is handled by a manufacturer, after which the storage conditions are recorded. The period during which the insert is operational is therefore relatively short, thus a cheaper rechargeable battery may be used.

In one embodiment, light, sound, heat, cold, radio waves, electromagnetic fields, electromagnetic radiation,

electric current, magnetic fields or a physical, chemical or biochemical reaction, in combination or isolation maybe used as the activating means.

In a further embodiment the reproduction means have an input means which are also activation means, which activation means measure an environmental condition, such as the amount of radiation or a particular temperature. The observation can initiate the connection of the supply to the circuit to close the supply circuit. In another embodiment the reproduction means have a deactivation means. An example of deactivation means is provided by a counter to measure the use. Another example is provided by a nonreplaceable battery.

The invention will be elucidated on the basis of the attached drawings, in which:

Figure 1 shows an overview of those potentially associated with an embodiment of the invention,

Figure 2 shows a diagram for programming reproduction means according to the invention,

Figure 3 shows a possible embodiment of components of reproduction means according to the invention, Figure 4 shows an elevation of an embodiment of the combination according to the invention, Figure 5 shows an elevation of the combination according to the invention. Figure 1 shows this embodiment with five groups involved in the distribution chain of the combination according to the invention. Firstly, a manufacturer producing the relevant components. The manufacturer is

responsible for the active ingredient or treatment method.

There is also a manufacturer of the reproduction means. Said manufacturer is able to add preprogrammed data to the reproduction means. This may be stored on a medium such as a CD or electronic memory card. The stored data may be information which can be perceived with the senses, specifically audio information. This specifically concerns an explanation concerning a given active ingredient or an explanation concerning several active ingredients, possibly in several languages.

In one embodiment the manufactured means are delivered to the supplier of the reproduction means. Here the reproduction means are referred to as "Sense- Support", this being a possible brand name of reproduction means further to an embodiment of the invention.

The Sense-Support seller can select or add preprogrammed data. The standard data programmed by the manufacturer can be limited by making a selection from it. A seller of Sense-Support is also able to set or trigger activation means.

The next step in the user chain of the reproduction means and the combination according to the invention is formed by wholesalers of goods and services. These too are able to select or deselect preprogrammed data, add data about the good or service, and set or trigger activation or deactivation means.

In a next step according to the method of the invention the reproduction means and/or the combination of active ingredient and reproduction means enters the retail trade, where the retailer is a supplier of goods or services. The retailer can also select or deselect

preprogrammed data, add data specific to the user and or trigger the activation or deactivation means.

After the retailer, the combination or reproduction means reaches the user who can select or deselect certain preprogrammed texts.

Figure 2 shows schematically an embodiment of the reproduction means connected to programming means. By- means of an input, for example a USB port or input on the circuit board of the reproduction means, a data stream can be fed from the programming means to the reproduction means, which data stream may relate to the languages to be selected by the operating means. For example, the input may comprise an association table linking the operation of the various operating means or settings of the operating means to files to be read from the medium. In another embodiment the programming means provide data about the validity period of the insert, which is stored in a memory of the reproduction means and which may be used by the control means and a timer for deactivating the insert after a predetermined time.

It will be clear to those skilled in the art that there are several options for connecting reproduction means according to the invention to programming means. The programming means may be available to one of the five groups, as illustrated in Figure 1.

Figure 3 schematically shows reproduction means implemented as an interactive insert. A central control unit or control means 1 are incorporated in the reproduction means, indicated by a dotted line in Figure 3. A plurality of items is connected to programming means 1, including communications means or an interface provided by a connection, which may be connected to programming means 9. Interface 2 may be used as an input and/or output for the programming means . Control means 1

are capable of routing the input data to the other resources incorporated in the reproduction means. In another embodiment, data may be retrieved from other resources of the reproduction means, and may be output through interface 2 to programming means 9.

Control means 1 are also connected to a memory or other data medium. Examples include memory cards, magnetic media,- CDs, etc. The data stored in the memory may be divided into parts, specifically into files. Those skilled in the art are familiar with the subdivision of data, for example using a file structure according to an accepted operating system.

Control means 1 are also connected to operating elements or input means according to the invention. The operating means may be operated by a user 12 to select a choice. For example, the operating means are shown in Figure 4 as pushbuttons or operating buttons, with an actuation surface 24. The operating means also comprise flags 26, 27 and 28 to indicate the language in which the explanation can be reproduced. The use of a flag as an indication is convenient to the user of the reproduction means .

The user can hold the reproduction means in their hand and operate the operating means when required. Depending on the choice of button or switch operated by the user, the control means control the reading means to read a file from the memory and send it to processing or reproduction means. The file, preferably an audio file, for example based on the MP3 standard, is then converted to an electronic signal which can be converted to audible sound by a loudspeaker using conventional means.

The operating means 4 are connected to control means 1 and when operated by the user 12 the control means 1 can activate reading means 15 connected to memory 3. The

reading means are capable of reading the data stored on medium 3.

The control means may also be connected to an actuator- for sensory perception. This may be a loudspeaker 5 as shown in Figure 4. In another embodiment, the reproduction means 8 are fitted with a connection point which may be connected to earphones.

The control means 1 and the other elements are connected to a power supply 6. The activation and/or deactivation means 7 are connected to the control means and may incorporate a timer, counter, etc. The activation and deactivation means may comprise operating means which may be activated or deactivated by the user 12. A self-adhesive label which may be removed is an example of activation and deactivation means. The removal of the self-adhesive label activates the reproduction means.

In another embodiment the reproduction means 8 are connected to a sensor 10. The sensor 10 may make observations relating to the environment 11 or the user 12. In one particular embodiment the temperature is measured. In another embodiment a concentration in the blood, such as the blood sugar level, of the user 12 is measured. In another embodiment the acidity of a soil sample is measured. As a result, the instructions given by reproduction means 8 can be adjusted. Depending on the observations mad by the sensor, the control means 1 may be capable of retrieving a specific file from the memory and present it to the user 12 by the output means, whereby the output depends on the value measured by sensor 10. In the embodiment radiation is measured. For example this can be used by the reproduction means to adapt information about the dose of a given active ingredient .

The same reproduction means can announce "you now need three tablets per day" using loudspeaker 5. Alternatively, "you need four tablets per day" may be reproduced. This may depend on the sensor. In another embodiment, other biomedical information is available and/or said information is entered by the user and/or one of the persons shown in Figure 1.

For example, the medicine manufacturer may program the generally correct use of medicines by certain groups of patients, possibly combined with other medicines or food. For example, a pharmacist may program the reproduction means for use by an adult. The programming may also be specific to the medicine used and/or treatment provided and used elsewhere. In this way, the dose specified on the insert may be customised for a specific patient. In another embodiment the reproduction means are programmed by the pharmacist for use by a child and the output means will announce a different dose. For example, the prescribing physician may program that the patient is a woman aged 75, with a weight of 50 kg and impaired kidney function.

The control means 1 may be interfaced to other actuators 14. An example of an actuator 14 is a manual which controls a recording system when the manual is used; another example is a manual which activates a warning system if the user no longer uses it or uses it incorrectly.

An example of a consumer good 13 which in one embodiment is interfaced to an actuator or sensory perception is the addition of a substance, gaseous element or possibly a colony of bacteria on a nutrient substrate which can release a specific odour. Another example is the replacement of an energy source; another example is the addition of a substance with a specific

flavour; another example is the replacement of a surface component of an actuator - for example one which produces information which may be perceived by touch - and which is replaced once it has been touched or used repeatedly. Figure 5 shows a box 38 used as medicine packaging as an example. The medicine is contained in the box. The box has a closed state. The open state is illustrated. Seal 32 has been broken. The seal is connected to lip 33 of the box. Breaking the seal triggers the activation means (not shown) of the electronic insert or reproduction means 8 according to the invention and closes the power supply circuit of the reproduction means. The power is only supplied when the packaging is opened by the user, thus saving the battery.

In the illustrated embodiment the insert is attached to an inner surface of flap 34 of packaging 38. This is an example of an embodiment.

All or part of the reproduction means may be contained in an active ingredient or packaging of such an ingredient. Packaging includes any external envelope, regardless of its dimensions, shape, material or composition up to the time of use or application. Packaging also includes all materials used for packing or incorporated therein and anything which is directly or indirectly supplied or offered with packaging at the time of sale or issue of an active ingredient in connection with the supply or issue at any time.

Packaging also includes that which, at the time of supply to the user or their representative, holds or is used to combine a plurality of active ingredients.

Packaging also includes that into which, at the time of supply to the user or their representative, the active

ingredient is placed without a further envelope, in a dose, quantity and form intended for the end user. In another embodiment the invention relates to a combination of at least one agreement and at least one reproduction means, where the reproduction means comprise:

-a connection point for a supply to provide power to the reproduction means,

-a medium on which at least two sound files are stored, where the sound files contain a sound fragment with an explanation of the agreement,

-reading means for reading a file on the medium

-reproduction means connected to the reading means for the conversion of the read file into an electronic signal, where the reproduction means are connected to a connection point for a loudspeaker for reproduping the electronic signal, -input means for selecting from at least two options for an explanation about the agreement,

- control means connected to the input means and reading means arranged to cause the reading means to read the file with the explanation selected with the input means.

Here, an agreement could be an agreement concerning medical treatment in accordance with relevant legislation. This provides a combination which provides greater certainty that the agreement is understood. Preferably the agreement concerns medical treatment and the reproduction means form part of the provision of information about the treatment. Preferably the input means further comprise measuring means for measuring a

condition of the patient, whereby the control means select a file depending on the measured condition.

In another embodiment the invention relates to a combination where the agreement is a purchase agreement and the reproduction means forms part of the provision of information about the purchase agreement. Preferably the agreement is a loan agreement and the reproduction means forms part of the provision of information about the loan agreement. Preferably the agreement is a statutory right or duty and the reproduction means forms part of the provision of information about the statutory right or duty.

Although the invention has been described using a number of embodiments, those skilled in the art will be aware that various modifications and changes can be made within the scope of the invention. Specifically, the combination further to the invention may be applied in combination with active ingredients, but the invention may also comprise a combination of another good or service which can be accompanied by an explanation. Both are embodiments of the invention.

Although various embodiments are described above, those skilled in the art will be aware that the various measures and characteristics of the embodiments may be combined with each other or may be considered in isolation.