EP1600906A1

EP1600906A1 - Communication unit for a person's skin

Info

Publication number: EP1600906A1
Application number: EP04102382A
Authority: EP
Inventors: Jan De Geest; Wim De Geest
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-05-28
Filing date: 2004-05-28
Publication date: 2005-11-30
Also published as: CN100535950C; CN1989532A

Abstract

Electric communication unit to be placed on a person's skin, comprising a support element (3), a series of body contacts (7), a pulse generator (6) provided for generating a series of pulses and for transmitting the series of pulses to said series of body contacts (7), said series of body contacts (7) being provided to transmit said series of pulses onto the skin of said person. The electric communication unit is in the form of a patch.

Description

FIELD OF THE INVENTION

The invention relates to an electric communication unit provided to be placed on a person's skin, said unit comprising:

a support element comprising :
- a series of body contacts,
- a pulse generator connected to the series of body contacts, and provided for generating a series of pulses upon receipt of an activation signal and for transmitting the series of pulses to said series of body contacts, said series of body contacts being provided to transmit said series of pulses onto the skin of said person, and
- a power supply connected to the pulse generator.

BACKGROUND OF THE INVENTION.

The continuous need of new and better medical treatments results in the performing medication of today. Economic and social importance constantly push the pharmaceutical sector to create the most effective medicine possible. The following factors represent main influence in the final effect of a treatment :
1. The characteristics of the medicine per dose. Clinical trials are executed to study and determine the most adequate molecules and their necessary concentrations to cure the patient properly.
2. The timely administration of the medicine (with a frequency recommended by the manufacturer, the pharmacist or on doctor's orders) which is strongly depending on the patient's adherence.
Recent studies made by order of the World Health Organisation show the importance of the second factor, namely the patient's compliance. Half of the actual administrated medicine does not lead up to an effective treatment due to lack of adherence, despite the good intrinsic quality of the medicine. It is clear that this problem has an enormous impact world-wide both on social and on economic level.
These studies conclude that there is an urgent need for a modern solution to this problem. The present invention offers an answer based on a new concept.

PRIOR ART

The present state of the art offers some electric communication systems. An example of such a system is described in the UK patent 2 386 207 which discloses a silent anatomic alarm system comprising an emitter wireless base unit and an anatomic wireless unit (electric communication unit). The anatomic wireless unit is able to output an electric current onto the skin of the user on receipt of a signal transmitted from the base unit. This device consists of two rings connected together, and provided to be respectively fastened, for example on a user's foot and on the user's ankle. This device is bulky and not operable outside the transmission range from the base unit.
Known electric communication units have thus important limitations at several levels: too large, poor user-friendlyness, not easy to manufacture, no possibility to alert independently of the user's conditions, poor discretion, only applicable for specific types of medicine, not conceived for easy addition to existing medicament packaging.
It is an object of the invention to palliate at least some of these drawbacks by providing a broad applicable concept which helps improving compliance.

SUMMARY OF THE INVENTION

To this end, the invention provides a unit according to the preamble of claim 1, characterised in that the electric communication unit is in the form of a patch provided to be placed onto the person's skin.
The electric communication unit according to the invention is more easy to manufacture because of its planar shape, is small, user-friendly, not bulky, discrete, etc. Moreover the unit is very easy to place because of the patch concept. In addition, by being in permanent contact with the body, the device is able to transmit the alert signal in a silent way and at any moment to the user's body.
In an advantageous embodiment according to the invention, said pulse generator of the electric communication unit further comprises a processing unit with a memory, said processing unit being provided:

to store a signal, said signal comprising data indicative at which time an activation signal should be generated, and
to generate and transmit said activation signal to said pulse generator.

Such an electric communication unit is completely independent of the base unit after being pre-programmed. In fact, a user has just to enter the appointments or the administration time via the emitter base unit which will transmit a signal to the receiver-antenna of the electric communication unit. Said receiver-antenna is connected to the pulse generator comprising a memory and a processing unit. Since the data is stored in the memory of the processing unit, the pulse generator will generate an activation signal when required, without requiring to be within the transmission range of the base unit. In other words, the communication unit operates independently from the distance between the base unit and the receiver. Once programmed and initially activated, the system functions autonomously.
It should be appreciated by those skilled in the art that the signal and the activation signal may be the same or different signals. In the UK 2 386 207 patent, these two signals are in fact a single signal. According to the invention, these signals could be different, but are not necessarily different. The activation signal results from the signal emitted by the base unit, which has been processed by the processing unit and stored in the memory to be sent in an appropriate time during the day or the night to the body contacts.
In a particular embodiment, said series of electric pulses have a voltage ranging from 20 Vdc to 150 Vdc, preferably from 50 Vdc to 100 Vdc and more preferably around 75 Vdc.
This feature allows discretion, indeed only the user perceives the activity. No other person will notice the alert signal. Moreover, this feature allows the unit to be particularly safe.
Furthermore, the pulses have a width comprised between 1µs and 1 ms, preferably between 5µs and 200µs and more preferably around 30 µs and wherein the period between pulses ranges from 1 ms to 10s, preferably from 10ms to 1 s and more preferably around 200 ms. By this way, the generated impulses are enough effective to be noticed by awakened and if needed by sleeping people.
Advantageously, said series of pulses further comprises a plurality of bursts, each burst comprising a set of pulses, said bursts being separated form each other by a period of time without pulses. This allows to spread the output electric current, for example, in order to gently awake sleeping people or to not surprise working people, etc.
Preferably the patch comprises an adhesive layer such as Macfilm F 2023 commercially available from MacTac®, or the like. By the use of such an adhesive layer, the patch is hypoallergenic and resistant to soapy water, alcohol, to some hydrocarbons, etc.
Moreover, the invention relates to an electric communication system comprising said electric communication unit, a base unit, wherein said base unit is a wireless transmitter to transmit said signal to said electric communication unit without opening a unit packaging enclosing said communication unit.
This covers different advantages of the invention. First, in the case of an individual packaging provided for the patch, which patch was programmed in a wireless manner through the packaging, the user is ensured that the patch is a new one and the hygienic conditions are respected. Moreover, this packaging protects the patch from sun, moisture, etc. which can damage the adhesive layer or the like. Secondly, in some cases, the medicine packaging may contain one or more communication units according to the invention. The wireless programming allows the pharmacist to program the unit without opening the medicine packaging. Furthermore, when several patches are provided into the medicine therapy, they should advantageously contain an identifier allowing each patch for being differently programmed by suitable means. For example, the therapy may comprise the administration of a tablet twice a day during the first week, once a day during the second week, etc. By using patches with identifiers, this allows the pharmacist to program respectively the first and the second patch according to the instructions of the doctor.
The activity moment or frequency have to be easy programmable. Several means can be used to program the unit according to the invention. This could be done during manufacturing by hard coding the content of the memory, or "on site" at user location or also for example, by the pharmacist when selling some medicine. By hard coding during manufacture, the power source of the unit according to the invention is advantageously not used during this step. The wireless transmitter can be an RF transmitter, an inductive transmitter , a capacitive transmitter, an infrared transmitter, an acoustic transmitter or the like, comprising means allowing to program while avoiding the opening, for example, of the medicine or of the patch packaging. The most preferred transmitter is an inductive RF transmitter since it does not use the power source from the communication unit when storing the data into the memory. Preferably, the patch and the patch packaging are provided with predefined dimensions to be added to plenty of existing medicament packaging. Of course, patches included into the medicine packaging can also be pre-programmed during manufacturing (hard coded).
Furthermore, the invention relates also to the use of the electric communication system according to the invention in a medicine therapy to remember the timely administration of a medicine.
The use in a medicine therapy as referred herein comprises either the use in which the patch is used to remind the patient to take his or her medicine, the use in which the patient wears a separate transdermal patch and in which the patch reminds the patient that his or her transdermal patch should be changed or replaced or another use in which time could be an important factor. Moreover, the adhesive layer of the patch according to the invention may comprise various active agents usually used in a conventional transdermal patch therapy. This means that in common patches, the active agent is combined, possibly by using a membrane layer, with the adhesive layer to penetrate to the skin of a person. The patch according to the invention can be manufactured in such a manner that the adhesive layer of the patch also comprises the active agent. By this way, the communication unit (the patch) will remind the patient to remove or to replace his or her patch.
In a variant, the electric communication unit can be used as a wake-up device. This allows to wake-up only one person when several persons are sleeping in the same room and to preserve the sleeping time of the others. Further, the unit can also be used, for example, to educate a dog for learning it to wake-up and go out when required during the night or at any other period of the day, or to any other end in which reminding of time is essential or required.
In addition, the cost of the patch can be low in comparison with the cost of the medicine.
Other embodiments of the device according to the invention are mentioned in the annexed claims.
Other characteristics and advantages of the invention will appear more clearly in the light of the following description of a particular non-limiting embodiment of the invention, while referring to the figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is an exploded view of the device according to the invention.
Figure 2 is a transversal section of the device according to the invention.
Figure 3 is a graphic illustrating a preferred pulse shape for the set of pulses.
Figure 4 is a graphic illustrating a possible burst of the set of pulses.
Figure 5 is a graphic illustrating a possible activation scheme of the series of pulses.
Figure 6 is a graphic illustrating a possible daily scene.
Figure 7 is a schematic view of a first possible concept of the electric circuitry.
Figure 8 is a schematic view of a second possible concept of the electric circuitry.
In the drawings, a same reference sign has been allotted to a same or analogous element of the electric communication unit according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention concerns a patch, in particular a thin (self)-adhesive patch which is stick to the user's skin. The patch generates at pre-programmed or free programmable moments pulses. These pulses are felt by the human skin and remind the user to undertake a certain action, for example administrating a medicine.
Figure 1 and figure 2 show the components of the patch.
The support element 3 consists of a thin flexible synthetic material and is used as a printed circuit board (PCB). The design of this PCB integrates a receiver-antenna 4, the contact elements 5 for generating contacts between the power supply 2 and the body contacts 7. The electric components/ASIC (Application Specific Integrated Circuit) 6 are positioned on the support element 3 and connected with the power supply 2, the receiver-antenna 4 and the body contacts 7. The electric components/ASIC is forming the pulse generator 6. The cover 1 consists of a thin flexible synthetic material and is used to protect all fragile electronic components against external influences. An adhesive 9 is added on the bottom side of the support element 3. The liner 8 consists of a thin flexible synthetic material and is stick to the adhesive 9 during the preservation of the patch. The liner 8 is removed just before the moment of application to the user's body. The adhesive 9 keeps the patch stick to the skin during the time of use.
The pulse generator of the patch generates at well-determined moments a series of electric pulses. Each series of pulses has preferably a block wave form with the following properties as it can be seen at Fig. 3:

duration: from 1µs to 1 ms, preferably about 30 µs,
voltage: from 20 Vdc to 150 Vdc, preferably from 50 Vdc to 100 Vdc and more preferably around75 Vdc.
period between pulses: from 1 ms to 10s, preferably from 10ms to 1 s and more preferably around 200 ms
pulse width: from 1µs to 1 ms, preferably from 5µs to 200µs and more preferably around 30 µs
raising time: preferably less than 5 µs
falling time: preferably less than 5 µs.

As it can be seen on Fig. 4, a burst comprises a set of pulses. Exemplary values are the following: a burst preferably consists of 5 pulses with a duty-cycle of 30 ps/200 ms. The duration of a burst is generally consequently 1 s.
A series of bursts forming said series of pulses is called an activation, such an activation can be seen at Fig. 5. This latter preferably consists of 10 bursts with a duty-cycle of 1 s / 1s. The duration of an activation is consequently 20 s. Each burst in this case comprises a set of 5 pulses.
The activation times or activation intervals are determined by means of a programming device or a base unit.
A possible daily scene is illustrated on Fig. 6. This is an exemplary profile of the signal, but those skilled in the art should understand that it could be different. For example, each burst can be different, each burst can comprise a different number of pulses, each series can be also different, and furthermore, the differences can be used to remember different step of the therapy, for example, 5 times three pulses could indicate to take the medicine and 3 times four pulses could indicate to remove another patch (a transdermal one) or the patch itself.
The clock's drift is preferably at most 1/10.000 (100 ppm). This means approximately 1 minute per week.
In case the internal clock isn't accurate enough, a measurement of the clock frequency will be necessary after manufacture. With this measured data a value can be put into the memory fixing the counter's end value which represents for example a burst frequency of 1 Hz. This action preferably takes place at the patch factory. Executing this action during programming of the activation implies indeed that every programming device has to be equipped with an expensive measurement system for frequency or time.
At least 200 activations (8-Bit address-bus) with an accuracy of 10 s must be able to be programmed. This means that a 16-Bit data bus is needed for a weekly schema (2^16=65536).
The programming of the chip uses wireless technology, identical to the system used for programming of an active RFID tag. The distance between the programming device and the patch is small. The maximum distance is preferably less than 0,2 m to avoid interference with current applications.
The pulse generator may advantageously comprise a receiver integrated therein, but it should be noted that the pulse generator may also be connected to a receiver, external to said pulse generator. The receiver should not specifically be present into the unit once programmed. The receiver could be removed after programming or completely independent. If the programming of the unit is hard coded during manufacturing, no receiver is required in the communication unit according to the invention.
The energy needed for programming the (EE)PROM is, for example, delivered by the programming device by means of inductive coupling. A few examples of existing chips with a similar goal are given at Table 1.

Atmel T555714-DBW

EM Microelectronics EM4450
These chips need to be modified with an external access to the memory. The principle of programming is identical.
Before the chip is operated, only a very small leakage current is permitted to not discharge quickly the power supply. The power supply could be any type of portable power supply, such as battery and the like. This can be a rechargeable or a non rechargeable depending on the duration of the use, the cost of the unit and the dimensions of the unit for a particular application.
Because the input voltage is low (3V) and a relatively high output voltage is needed a voltage converter is used. Some examples of possible existing chips with a similar goal are given on Table 2.

Producer Product type

Micrel MIC4826

Supertex HV826X

Panasonic MIP804

NPC SM8142BD

Sipex SP4403

Toko TK65915M

Zywyn ZSP4403UEB
To reduce the dimensions of the electric circuitry it is recommended to use an ASIC.
A first possible concept (figure 7) is a generation of high voltage by use of induction. Hereto a set of discrete components (coil, diode and capacity) are needed.
A second possible concept (figure 8) uses a capacity charge pump which can be incorporated in the ASIC itself (for example, HV 850 available from Supertex).
In the first phase the memory of the ASIC (Application Specific Integrated Circuit) is programmed. In here the points in time of activation are recorded. The used technology is identical to that for programming of RFID tags (Radio Frequency Identification tags). The energy needed for programming the communication unit according to the invention is delivered by programming device (base unit) by means of inductive coupling. The memory can be (pre)programmed during in particular the production process of the ASIC or in a later phase during delivery by means of a programming device. The hardware of this programming device is similar to that of an RFID-programmer. The software, offering a user-friendly way of programming, calculates the data to be stored in a memory using the given points of time.
The ASIC is only put in operation at the moment of first use of the patch. This is done to keep the power consumption minimal when not in use. Starting the ASIC is managed by the block "power control" of the ASIC. The start of the ASIC is based on the principle that, at the moment of first application on the skin, a small leakage current is caused which triggers the ASIC in operation.
Once the ASIC has started, both Counter1 and Counter2 begin to count. Counter1 is a binary 8-bit counter and counts with a frequency of 32768Hz. Counter2 ensures that all memory locations (256) are read out in a sequential way. The FF1 is set when one of the 256 values is equal to the value of Counter1. After 20 seconds, FF1 is reset.
In case of use of the first concept (figure 7), if FF1 is set and the comparator C is high the clock-pulses are transported to the switching transistor T1. T1 is now switching during 20 s with a frequency of 32768Hz. The result is the generation of a high voltage by self-induction of the coil. The capacity is charged up to a voltage of about 75V.
In case of use of the second concept (figure 8), if FF1 is set then the Capacity Charge Pump is enabled and will generate the desired output voltage which is lead to the switching output-stage.
In both cases, Counter3 and the NAND-port manage the desired duty-cycle of the output voltage. T2 en T3 are used as output-stage.
Other advantages of such an electric communication unit are given hereinafter.
The electric communication unit is user friendly, the initialisation and the first use must be easy understandable for a normal adult person. The electric communication unit should have sufficient preservation. In particular, the preservation duration of the electric communication unit will preferably be function of the best before date of the medicine. The electric communication unit should also moreover be removable if desired. At the end of the user cycle, or at any other desired moment, the system must be easily removable. Another propriety of the electric communication unit is that it should be durable in soapy water. For practical reasons soapy water should neither damage nor detach the unit from the skin. A further characteristic is that the electric communication unit will preferably be employable by an assistant taking the patient's place: An assistant can take a patient's place if this is preferable considering the circumstances. For example parents can apply it on their own body to administrate their children's medicine correctly or geriatric helpers can use it instead of their elderly patients.
The invention has been described here with a preferred use in the context of a medicine therapy. Of course, the invention can be used in a lot of different contexts, like, for reminding appointments, for awaking a mother just before feeding her baby, etc.

Claims

Electric communication unit provided to be placed on a person's skin, said unit comprising :

a support element (3) comprising :

a series of body contacts (7),

a pulse generator (6) connected to the series of body contacts (7), and provided for generating a series of pulses upon receipt of an activation signal and for transmitting the series of pulses to said series of body contacts (7), said series of body contacts (7) being provided to transmit said series of pulses onto the skin of said person, and

a power supply (2) connected to the pulse generator,

characterised in that the electric communication unit is in the form of a patch provided to be placed onto the person's skin.
Electric communication unit according to claim 1, wherein said pulse generator (6) further comprises a processing unit with a memory, said processing unit being provided:

to store a signal, said signal comprising data indicative at which time said activation signal should be generated, and

to generate and transmit said activation signal to said pulse generator (6).
Electric communication unit according to claim 1 or claim 2, wherein said series of pulses have a voltage ranging from 20 Vdc to 150 Vdc, preferably from 50 Vdc to 100 Vdc and more preferably around 75 Vdc.
Electric communication unit according to anyone of the claims 1 to 3, wherein the pulses have a width comprised between 1µs and 1 ms, preferably between 5µs and 200µs and more preferably around 30 µs and wherein the period between pulses ranges from 1 ms to 10s, preferably from 10ms to 1 s and more preferably around 200 ms.
Electric communication unit according to anyone of the claims 1 to 4, wherein said series of pulses further comprises a plurality of bursts, each burst comprising a set of pulses, said bursts being separated form each other by a period of time without pulses.
Electric communication unit according to anyone of the claims 1 to 5, further comprising an adhesive layer (9) which is hypoallergenic.
Electric communication unit according to anyone of the claims 1 to 6, further comprising an adhesive layer (9) which is resistant to soapy water.
Electric communication system comprising said electric communication unit according to anyone of the claims 1 to 7, a base unit, wherein said base unit is a wireless transmitter to transmit said signal to said electric communication unit without opening a unit packaging enclosing said electric communication unit.
Use of the electric communication unit according to anyone of the claims 1 to 7 or of the electric communication system according to claim 8 in a medicine therapy.
Use of the electric communication unit according to anyone of the claims 1 to 7 or of the electric communication system according to claim 8 as a wake-up device.
Use of the electric communication unit according to anyone of the claims 1 to 7 or of the electric communication system according to claim 8 as general reminder device.