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Title:
POCKET-SIZED MEDICAL MONITORING AND SIGNALING SYSTEM
Document Type and Number:
WIPO Patent Application WO/2007/051796
Kind Code:
A3
Abstract:
A pocket-type medical monitoring and signaling system (1) for monitoring and signaling given time points for administering a medicine comprises a main pocket housing (201), in which are integrated a local data-input unit (202), a main storage unit (203), a display unit (204), a alarm unit (205), and a first data interface (207), and a medical determining device (300) which is integrated into a sensor pocket housing (301) being separate to the main pocket housing (201) and comprising a sensor (302), a sensor storage unit (303), and a second data interface (305), wherein the first data interface (207) and the second data interface (305) are arranged and adapted for transmission of data between the main pocket housing (201) and the medical determining device (300).

Inventors:
SLOT FRED J M (DE)
DOLL RAINER FRITZ ROBERT (DE)
Application Number:
PCT/EP2006/067971
Publication Date:
August 02, 2007
Filing Date:
October 31, 2006
Export Citation:
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Assignee:
MEDWATCHDOG GMBH & CO KG (DE)
SLOT FRED J M (DE)
DOLL RAINER FRITZ ROBERT (DE)
International Classes:
A61B5/00; A61J7/04; G16H20/10; G16H40/67
Domestic Patent References:
WO2002005702A22002-01-24
WO2005078248A12005-08-25
WO2004006828A12004-01-22
WO2001089368A22001-11-29
WO2005103991A12005-11-03
Foreign References:
US6561978B12003-05-13
EP1437674A22004-07-14
Attorney, Agent or Firm:
VIERING, Hans-Martin (Jentschura & Partner Steinsdorfstr. 6, Munich, DE)
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Claims:

Claims

What is claimed is:

1. A pocket-type medical monitoring and signaling system (1, 1', 1'', 1' ' ' ' ) for monitoring and signaling of prescribed administering time points for a medicine, comprising: a main pocket housing (201, 201'), in which are integrated: a local data-input unit (202) with push-buttons (208) arranged at an outside of the main pocket housing (201, 201') for inputting of personal data of a user and of administering data for the user; a main storage unit (203) for storing menu data, the personal data and the administering data; a display unit (204) with an alphanumeric display arranged at the outside of the main pocket housing (201); an alarm unit (205); a rechargeable main power supply unit (206); and a first data interface (207); wherein the alarm unit (205) comprises an acoustic signaling component (210), an optical signaling component (211) and a vibrational signaling component (212), and wherein these signaling components (210, 211, 212) are selectively selectable by means of the local data-input unit (202); and a medical determining device (300, 300') being integrated in a sensor pocket housing (301, 301') being separate from the main pocket housing (201, 201'), and comprising: a sensor (302) for determining a test value of a body fluid of the user; a sensor storage unit (303) for storing the test value; a rechargeable sensor power supply unit (304); and a second data interface (305) ; wherein the first data interface (207) and the second data interface (305) are arranged and adapted for transmitting data between the main pocket housing (201, 201') and the medical determining device (300, 300').

2. The pocket-type medical monitoring and signaling system (1, 1', 1' ' , 1' ' ' ) of claim 1, wherein the first data interface (207) and the second data interface (305) are serial data interfaces.

3. The pocket-type medical monitoring and signaling system (1, 1', 1'', 1' ' ' ) of claim 1 or 2, wherein the local data- input unit (202) comprises a fourfold D-pad (209) for navigation of the user in a selection menu pre-programmed in the main storage unit (203) .

4. The pocket-type medical monitoring and signaling system (1, 1', 1' ' , 1' ' ' ) of claim 3, wherein the pre-programmed selection menu comprises an alpha-numeric character table.

5. The pocket-type medical monitoring and signaling system (1, 1', 1' ' , 1' ' ' ) of any one of claims 1 to 4, wherein the medical determining device (300') comprises an optical test value output unit (306) and/or an acoustic test value output unit (307) .

6. The pocket-type medical monitoring and signaling system (1', 1'') of any one of claims 1 to 5, wherein each of the first data interface (207) and the second data interface (305) is formed as socket, which can be coupled with each other by means of an electric cable (350) having plugs (351) corresponding to the sockets, such that data are transmittable between the main pocket housing (201') and the medical determining device (300') in a bidirectional manner.

7. The pocket-type medical monitoring and signaling system (1'') of claim 6, further comprising an adapter (400) in which the main pocket housing (201') and the medical

determining device (300') are insertable, wherein the cable (350) and the plugs (351) corresponding to the sockets are integrated in the adapter (400).

8. The pocket-type medical monitoring and signaling system (1'') of claim 7, wherein the adapter (400) comprises at least one support (401) such that the adapter (400) can be placed on a table.

9. The pocket-type medical monitoring and signaling system (!''') of any one of claims 1 to 5, further comprising a first communication device (510) and a second communication device (520), wherein the first data interface (207) and the second data interface (305) are each formed as sockets, and wherein the first communication device (510) comprises a first plug by means of which the first communication device (510) is connectable to the first data interface (207), wherein the second communication device (520) comprises a second plug by means of which the second communication device (520) is connectable to the second data interface (305), and wherein the first communication device (510) and the second communication device (520) are provided each as both transmitter and receiver for a wireless, bidirectional data transmission between the main pocket housing (201') and the medical determining device (300').

10. The pocket-type medical monitoring and signaling system (1''') of any one of claims 1 to 5, wherein the first data interface (207) is a first communication device (510) integrated into the main pocket housing (201'), and the second data interface (305) is a second communication device (520) integrated into the medical determining device (300), wherein the first communication device (510) and the second

communication device (520) are provided each as both transmitter and receiver for a wireless, bidirectional data transmission between the main pocket housing (201') and the medical determining device (300').

11. The pocket-type medical monitoring and signaling system (1''') of claim 9 or 10, wherein the wireless, bidirectional data transmission is a radio transmission.

12. The pocket-type medical monitoring and signaling system (!''') of claim 11, wherein the wireless, bidirectional data transmission is a radio transmission at 433 MHz which is limited to less than 1 m.

13. The pocket-type medical monitoring and signaling system (1''') of claim 9 or 10, wherein the wireless, bidirectional data transmission is an infra-red transmission according to the IrDA standard.

14. The pocket-type medical monitoring and signaling system (!''') of claim 9 or 10, wherein the wireless, bidirectional data transmission is a Bluetooth transmission.

15. The pocket-type medical monitoring and signaling system (!''') of any one of claims 9 to 14, wherein each of the first communication device (510) and the second communication device (520) comprises both a coder and a corresponding decoder .

16. The pocket-type medical monitoring and signaling system (!''') of claim 15, wherein the first communication device (510) comprises a first circuit board pluggable into the first data interface (207), on which the coder and the

corresponding decoder of the first communication device (510) are arranged and connected, and wherein the second communication device (520) comprises a second circuit board pluggable into the second data interface (305) , on which the coder and the corresponding decoder of the second communication device (520) are arranged and connected.

17. The pocket-type medical monitoring and signaling system (I' ' ' ) of claim 16, wherein the first circuit board and the second circuit board each comprise a separate power supply unit .

18. The pocket-type medical monitoring and signaling system (I' ' ' ) of claim 15, wherein the control unit (214) in the main pocket housing (201') adopts the function of the coder and of the corresponding decoder of the first communication device (510), and wherein the control unit in the medical determining device (300') adopts the function of the coder and of the corresponding decoder of the second communication device (520) .

19. The pocket-type medical monitoring and signaling system (1, 1', 1'', 1''') of any one of claims 1 to 18, wherein the medical determining device (300, 300') is a measuring device for a blood value such as a blood sugar measuring device, a blood pressure measuring device, an electrocardiogram recording device, an intra-ocular pressure measuring device, a pulmonary function measuring device such as a tidal volume measuring device or a respiratory gas analyzing device, or an insulin pump.

Description:

Pocket-sized medical monitoring and signaling system

This invention relates to a pocket-sized medical monitoring and signaling system, i.e. a portable system to make the administering of a medicine easier, especially to signal the set administering time point for the medicine to a patient and to monitor the administering of the medicine by the patient by means of continuously signaling until confirmation of administering. Additionally, this invention can be used for determining the necessary amount of medicine to be administered and for documentation of the time point and the amount of the administered medicine.

Due to the development of pharmaceutical chemistry and medical science, pharmaceuticals (medicines) have been developed for the curing of an increasing number of illnesses or the treatment of their symptoms. The essence of these is that depending on the amount and the acting mechanism of the active agent, the medicine is to be administered orally at a determined frequency, in the prescribed amount in the form of a solution or tablet, or administered in the form of an injection into the body. In the case of a high number of medicines and varying administration intervals, furthermore, in the case of the elderly, it may be a problem to use the prescribed and/or necessary medicine in the appropriate amount and at the desired point in time.

The Hungarian patent specification HU 215.227 describes a device for the dosing out of various medicines to a given patient in a hospital. The essence of which is that the amounts and types of the medicines according to the treatment given are determined with the help of an identifier assigned to the given patient, which, following this, with the help of

a dosage device, are placed into a storage vessel, checked and only following this are they given to the patient being treated.

The international patent application WO 2004/006828 Al describes a monitoring and signaling device designed as pocket device of the kind as described above, which serves the facilitation of the administering of medicines. This pocket device comprises a data-input unit operable by the user via operating buttons for inputting of personal data and of administering data of medicines, a display unit having an alpha-numeric display, and an alarm unit having acoustic, optical and vibrational signaling components, the signaling components being selectively selectable.

With the mobile pocket-type medical monitoring and signaling system according to this invention, a system has been created with the help of which it is possible to signal a patient undergoing treatment the administering data, to determine a test value from a body fluid of the patient, and, if necessary, to determine and signal the required amount of the necessary medicine at a prescribed point in time.

A pocket-type medical monitoring and signaling system for monitoring and signaling of prescribed administering time points for a medicine according to this invention in particular comprises: a main pocket housing, in which are integrated a local data-input unit with push-buttons arranged at an outside of the main pocket housing for inputting of personal data of a user (henceforth partly also named patient) and of administering data for the user, a main storage unit for storing menu data, the personal data and the administering data, a display unit with an alpha-numeric

display arranged at the outside of the main pocket housing, an alarm unit, a rechargeable main power supply unit, and a first data interface, wherein the alarm unit comprises an acoustic signaling component, an optical signaling component and a vibrational signaling component, and wherein these signaling components are selectively selectable by means of the local data-input unit; and a medical determining device being integrated in a sensor pocket housing being separate from the main pocket housing, and comprising: a sensor for determining a test value of a body fluid of the user, a sensor storage unit for storing the test value, a rechargeable sensor power supply unit, and a second data interface; wherein the first data interface and the second data interface are arranged and adapted for transmitting data between the main pocket housing and the medical determining device. In particular, the first data interface and the second data interface may be serial data interfaces.

The test value of the body fluid of the user determined by the medical determining device, e.g. the present glucose value which has been gained from a drop of blood of the patient, is used for determining the appropriate amount of the necessary medicine before the medicine is administered, since the appropriate amount of the necessary medicine for a patient, e.g. the necessary amount of insulin, often depends on the time of day, the eating habits of the patient, the last and/or next meal, the general state of health of the patent, and so on.

The first data interface can be formed, for example, as a socket and the second data interface can be formed, for example, as a plug corresponding to that socket, such that the medical determining device can be plugged into the main

pocket housing for data transmission. Additionally or alternatively, the first data interface and the second data interface can be formed as optical data interfaces, for example as light emitting diodes together with matching photodiodes, which are directly communicating with each other for data transmission.

The medical determining device can be a measuring device for a blood value such as a blood sugar measuring device, a blood pressure measuring device, an electrocardiogram recording device, an intra-ocular pressure measuring device, a pulmonary function measuring device such as a tidal volume measuring device or a respiratory gas analyzing device, or an insulin pump. Given the medical determining device is a blood value measuring device, the medical determining device comprises as sensor preferably a measuring tape shaft, in which a corresponding measuring tape is inserted and wherein a body fluid of the user being present on the measuring tape is analyzed.

According to this invention, the local data-input unit is arranged such that the patient is enabled to locally program the main storage unit via the local data-input unit on basis of a pre-programmed menu program, other instructions, letters and numbers, which are stored in the main storage unit. The medical monitoring and signaling system can also be provided with a suitable interface such that the patient can program his/her personal data and the administering data alternatively via a suitable graphical user interface at his/her personal computer. Such a suitable interface can be a USB interface, i.e. an interface according to the Universal Serial Bus (USB) standard, an infrared transmission

interface, or a serial interface, e.g. according to the RS232 standard.

The medical monitoring and signaling system monitors the confirmation of the set administering time points of the medicine by the user, and outputs, if necessary, an emergency alarm by means of simultaneously operating the acoustic signaling component, the optical signaling component and the vibrational signaling component, if a predetermined number of signaling operations of the set administering time points of the medicine is not acknowledged. This emergency alarm is in particular advantageous in an emergency situation, when the user of the medical monitoring and signaling system, e.g., collapses on a park bench and needs help, for drawing the attention of other visitors of the park to the user who is in need of help.

The local data-input unit may comprise a fourfold D-pad for navigation of the user in a selection menu pre-programmed in the main storage unit. To this end, the pre-programmed selection menu preferably comprises an alpha-numeric character table. The fourfold D-pad can be compared with four individual push buttons, which are shaped and integrally formed as a rhombus, and is usually used as a cursor moving element.

Further, the local data-input unit preferably comprises a selection button. In this case, the menu program being preprogrammed in the main storage unit can be displayed on the display unit, can be retrieved and scrolled by operating the fourfold D-pad, and an individual menu program entry of a plurality of menu program entries can be selected by operating the selection button. The plurality of menu program

entries can comprise an alpha-numeric character set, i.e. letters, numbers and special characters. Further, a plurality of identical character sets in different font styles can be provided.

The medical determining device preferably comprises an optical test value output unit and/or an acoustic test value output unit. In particular, a liquid crystal display (LCD) is used as optical test value output unit, and a loudspeaker connected to a voice synthesizer or to a pre-programmed voice memory is used as acoustic test value output unit.

The first data interface and the second data interface can each be formed as socket, which can be coupled with each other by means of an electric cable having plugs corresponding to the sockets, such that data are transmittable between the main pocket housing and the medical determining device in a bidirectional manner. This electric cable together with the plugs can be integrated in, for example, an adapter in which the main pocket housing and the medical determining device are insertable, wherein the plugs corresponding to the sockets extend at suitable positions from the adapter or from inside of recesses of the adapter. This adapter preferably comprises at least one support such that the adapter can be placed on a table, in particular when the main pocket housing and the medical determining device are inserted into the adapter.

The medical monitoring and signaling system can also comprise a first communication device and a second communication device, wherein the first data interface and the second data interface are each formed as sockets, and wherein the first communication device comprises a first plug by means of which

the first communication device is connectable to the first data interface, wherein the second communication device comprises a second plug by means of which the second communication device is connectable to the second data interface, and wherein the first communication device and the second communication device are provided each as both transmitter and receiver for a wireless, bidirectional data transmission between the main pocket housing and the medical determining device.

Alternatively, the first data interface may be a first communication device integrated into the main pocket housing, and the second data interface may be a second communication device integrated into the medical determining device, wherein the first communication device and the second communication device are provided each as both transmitter and receiver for a wireless, bidirectional data transmission between the main pocket housing and the medical determining device .

Accordingly, it is possible to provide the wireless, bidirectional data transmission by means of a radio transmission, in particular a radio transmission at 433 MHz which is limited to less than 1 m, an infra-red transmission according to the IrDA standard, or a Bluetooth transmission.

Preferably, each of the first communication device and the second communication device comprises a coder and a corresponding decoder. Therefore, it is possible to enable an unambiguous data transmission between a plurality of medical determining devices, on the one hand, and a single main pocket housing of a medical monitoring and signaling system, on the other hand. To this end, the first communication

device may comprise a first circuit board pluggable into the first data interface, on which the coder and the corresponding decoder of the first communication device are arranged and connected, and the second communication device may comprise a second circuit board pluggable into the second data interface, on which the coder and the corresponding decoder of the second communication device are arranged and connected. The first circuit board and the second circuit board each preferably comprise a separate power supply unit. Alternatively, the control unit in the main pocket housing may adopt the function of the coder and of the corresponding decoder of the first communication device, and the control unit in the medical determining device may adopt the function of the coder and of the corresponding decoder of the second communication device.

The medical monitoring and signaling system may also provide a timer function. Such a timer function may be important when the user of the medical monitoring and signaling system goes in for sports. For example, if the user is a diabetic, the amount of insulin depends, among other things, on the physical fitness of the user. Therefore, the amount of insulin can be reduced according to the duration of the physical activity, if the user goes in for sports. Such a timer function can also be executed as a background function, i.e. the display unit may display any information other than the counting time of the timer, while the timer is active.

The control unit of the medical monitoring and signaling system is preferably arranged such that she determines the administering data of the medicine depending on at least the test value received from the sensor of the medical determining device. In particular, the control unit can

compare the received test value with values listed in a corresponding table of values which are stored in a medicine storage register in the main storage unit, and, then, can determine from this list the necessary amount of the medicine which the user shall administer.

Further, the medical monitoring and signaling system may comprise a supplementary power storage in the main pocket housing which is connected to the rechargeable main power supply unit, such that power is supplied to the medical monitoring and signaling system even if the rechargeable main power supply unit has run-down to guarantee that the user is reliably signaled.

Moreover, a fixing unit may provided at the medical monitoring and signaling system according to this invention, which is fixed to the main pocket housing and connected to the alarm unit. If the medical monitoring and signaling system is removed from the user without authorization, e.g. by a thief or by losing, the alarm unit signals the unauthorized removal for drawing the attention of the user thereupon .

The medical monitoring and signaling system according to this invention has many advantages. The most important advantage is its easy handling and the big amount of signaling time points despite its small size. Further, it is suitable for recording and storing the important personal data of the patient using the system. It does not only signal the user of the system at a predetermined time point to administer his/her medicine, but also states the name and the amount of the medicine which has to be administered at that time point. In particular, the amount of the medicine can be determined

at every time point via the sensor of the medical determining device by means of determining a test value from a body fluid of the user.

An additional advantage is that the suitably settable alarm unit can output different kinds of signals at the same time which makes it easier to be recognized, and by that it provides a much more efficient signaling of the patient. In particular, the alarm unit may be set such that the vibrational signaling component is activated at a pre ¬ programmed time point, e.g. if the user goes to a concert or in a restaurant and does not want to draw the attention of other visitors of the concert or the restaurant to himself/herself .

To the advantages belongs also that, due to storing of the personal data, of the illness concerning to the user, and of the name(s) of the life-saving medicine (s), the medical monitoring and signaling system can be used not only for signaling, but also as a device which can call for help.

Therefore, in the case the signaling signal is not reset, the medical monitoring and signaling system automatically outputs an emergency alarm which also causes the attention of persons in the vicinity of the patient, and these persons can help the patient which is in need of help on basis of the instructions displayed on the display unit of the medical monitoring and signaling system.

A further advantage is that the medical monitoring and signaling system according to this invention can both be easily fabricated and be easily handled and programmed by the user. Furthermore, it has a low service effort and this needs neither training nor specialist's knowledge.

The medical monitoring and signaling system has small dimensions, which serves for its placement. Therefore, it can be carried in the pocket or at a belt, and, thus, it can be at every time point in immediate vicinity, preferably at his/her clothes, of the person undergoing treatment, whereby its effectiveness is further increased.

The medical monitoring and signaling system according to this invention can well be used in such cases where it makes sense to remind patients of administering the prescribed medicines at specific time points. The medical monitoring and signaling system according to this invention may be life-saving for patients which undergo a continuous treatment and whose illness leads to unconsciousness or other serious states when the medicine is not administered.

In the following, embodiments of the medical monitoring and signaling system according to this invention are described in detail based on the accompanying drawings.

The drawings show in:

Fig.l a schematic diagram of a pocket-type medical monitoring and signaling system according to a first embodiment of this invention;

Fig.2 a top view onto the medical monitoring and signaling system according to the first embodiment of this invention;

Fig.3 a top view onto a medical monitoring and signaling system according to a second embodiment of this invention; Fig.4 a top view onto a medical determining device according to the second embodiment of this invention;

Fig.5 a general view onto the medical monitoring and signaling system according to the second embodiment of this invention;

Fig.6 a general view onto a medical monitoring and signaling system according to a third embodiment of this invention; and Fig.7 a general view onto a medical monitoring and signaling system according to a fourth embodiment of this invention.

In Fig.l is shown a schematic diagram of a pocket-type medical monitoring and signaling system 1 according to a first embodiment of this invention.

The pocket-type medical monitoring and signaling system 1 according to the first embodiment of this invention comprises a main pocket housing 201 having fixed to its outside a fixing unit 213. This fixing unit 213 serves for fixing the main pocket housing 201 to, for example, a belt. The main pocket housing 201 comprises an alarm unit 205 having an acoustic signaling component 210, an optical signaling component 211 and a mechanical, such as vibrational, signaling component 212. These signaling components 210, 211 and 212 may be operated independently from each other, but also all together at the same time, depending on how the user sets the alarm unit 205.

The main pocket housing 201 further comprises a display unit 204 which is embodied in this embodiment as a multi-line liquid crystal display (LCD) for displaying alpha-numeric characters, and also a local data-input unit 202 having multiple push buttons 208 and a fourfold D-pad 209 which have different functions. The push buttons 208 of the local data-

input unit 202 may comprise a function select component, an acknowledgment component, a delete component, a data fetch component and a start component. It is to be mentioned that other switching elements with a different assignment of the functions may be used for the local data-input unit 202 instead of the push buttons 208. A user of the medical monitoring and signaling system 1 can input external information into a main storage unit 203 via a control unit 214 by means of the local data-input unit 202, wherein these data may then be displayed on the display unit 204 and amended by means of the local data-input unit 202.

The control unit 214 and the main storage unit 203 are also comprised in the main pocket housing 201. In this embodiment, the main storage unit 203 comprises three parts: a basic storage register 215, a personal data storage register 216 and a medicine and time data storage register 217. The basic storage register 215 is preferably an electrically programmable read-only memory (EPROM) , and contains data pre- programmed on manufacture, such as a selection program displayed on the display unit 204, other instructions, pre ¬ programmed text elements, letters belonging to different languages, numbers and other parts of a font. The personal data storage register 216 and the medicine and time data storage register 217 are preferably random access memory

(RAM) . The personal data storage register 216 serves for the storage of the important personal data of the user, such as the user's name, the insurance number, the blood group, data on the names of illnesses, while the medicine and time data storage register 217 is used to record the name(s) of any life-saving medicine (s), the names of the other medical preparations used by the user, their dosages and/or their

dosage lists related to test values, and their time to be taken or otherwise used.

The control unit 214 comprises a programmable microprocessor, whose task is the interoperability of the main storage unit 203, the local data-input unit 202, the alarm unit 205, the display unit 204 and the medical determining device 300 (a detailed description thereof is given below) , to ensure the desired function. To this end, the control unit 214 is connected to a rechargeable power supply unit 206 which supplies the necessary electrical energy for the operation of the main storage unit 203, the alarm unit 205, the display unit 204 and the local data-input unit 202. The rechargeable power supply unit 206 can be recharged by means of a suitable adapter (not shown) which can be connected to every usual socket. Since such adapters are generally known by the person skilled in the art, a detailed description thereof is omitted here .

In the interest of increasing safety and avoiding accidental data loss, besides the rechargeable main power supply unit 206, the main pocket housing 201 also comprises a supplementary power storage 218, which preferably consists of two cadmium batteries. The supplementary power storage 218 supplies electrical energy to the medical monitoring and signaling system 1 even if the rechargeable main power supply unit 206 has run-down to guarantee that the user is safely signaled.

It is an important characteristic of this invention that the medical monitoring and signaling system 1 does not comprise a main switch for switching off the medical monitoring and signaling system 1. This guarantees that the user is not able

to deactivate the medical monitoring and signaling system 1 and, thus, that the user is safely reminded of administering of his/her medicines.

The control unit 214 further comprises an internal clock 219 and a comparator circuit 220. The internal clock 219 is a continuously operating internal clock, which is connected to the input of the comparator circuit 220. The medicine and time data storage register 217 is also connected to the input of the comparator circuit 220, while in this embodiment the output of the comparator circuit 220 is connected to the alarm unit 205 via the control unit 214.

In addition, the control unit 214 is connected to a first data interface 207 which enables the receipt of test data of a body fluid (e.g., blood, urine, saliva, breath) of the user determined by a medical determining device 300 (described below) and then the display thereof on the display unit 204. Preferably, the control unit 214 can compare these test data with pre-stored data in the main storage unit 203, and calculate or look up in a corresponding table a recommended dosage of a medicine to be taken by the user on basis of these pre-stored data. Then, this recommended dosage is displayed at the respective time point together with the name of the medicine to be taken on the display unit 204. Here, taking a medicine shall also be understood as administer the medicine by means of injection or similar administering forms .

The lock of the fixing unit 213 is connected to the alarm unit 205 which is advantageous due to the following reason: If someone were to take the main pocket housing 201 off the belt connected to the fixing unit 213 without authorization,

then the alarm unit 205 automatically signals the theft attempt .

Further, in Fig.l there is shown the medical determining device 300 comprising in a sensor pocket housing 301 being separate from the main pocket housing 201 a sensor 302, a sensor storage unit 303, a rechargeable sensor power supply unit 304 and a second data interface 305. The second data interface 305 serves for transmission of test data determined by the sensor 302 from a body fluid of the user to the control unit 214 in the main pocket housing 201. To this end, the second data interface 305 is brought in suitable manner into a communication connection (details thereof are described below) with the first data interface 207. The medical determining device 300 may further comprise a activation and control switch (not shown) , a control unit (not shown) and a test value output unit (not shown) . The test value output unit may be realized optically, i.e. in form of a liquid crystal display, and/or acoustically, i.e. in form of a loudspeaker connected to a voice synthesizer or a voice memory, such that a user who is not able to read, e.g. a blind person or an analphabet, is able to use the medical determining device 300.

The sensor 302 is adapted such that it determines a test value of a body fluid of the user, e.g. the present glucose level (blood sugar value) from a drop of blood of the user. Alternatively, the sensor 302 may be adapted such that it determines the blood pressure, that it records an electrocardiogram of the user, that it determines the intra ¬ ocular pressure in one or both eyes of the user, that it monitors the pulmonary function of the user, e.g. measures the tidal volume of the user and/or analyzes the respiratory

gases of the user, or that it monitors a insulin pump used by the user.

The medical determining device 300 may also be provided as autonomous device which can be operated independently from the main pocket housing 201. If a user likes to have a test value of a body fluid of him/her determined, he/she activates the medical determining device 300 by pressing the activation and control switch, whereupon the control unit of the medical determining device 300 firstly executes a switch-on self- test. Afterwards, the control unit informs the user via the test value output unit that some body fluid, e.g. a drop of blood, has to be put onto the sensor 302. Then, the sensor 302 and the control unit determine a test value thereof, which is stored in the sensor storage unit 303 and output via the test value output unit. Furthermore, the test value can be transmitted to the control unit 214 of the main pocket housing 201 via the second data interface 305 and the first data interface 207, if the second data interface 305 is in a communication connection with the first data interface 207.

If applicable, the medical determining device 300 may be adapted such that the medical determining device 300 is mainly controlled by the control unit 214 in the main pocket housing 201 during an active communication connection. In particular, in the latter case the medical determining device 300 can use the rechargeable main power supply unit 206 and the display unit 204.

A top view onto the medical monitoring and signaling system 1 according to the first embodiment of this invention is shown in Fig.2. Components, devices and elements already described with reference to Fig.l are not described once again. It has

to be noted that the fixing unit 213 shown in Fig.l is not shown in Fig.2. Further, the medical determining device 300 is illustrated without a test value output unit.

The main pocket housing 201 of the first embodiment comprises in top view a front surface formed as slightly elongated rectangle wherein the short sides of the rectangle are slightly bent and the corners of the rectangle are slightly rounded. In the first embodiment, the local data-input unit 202 is located at the bottom part of the rectangular front surface, whereas the display unit 204 is located between the middle part and the top part of the rectangular front surface. The local data-input unit 202 of the first embodiment is located with two push buttons 208 for function selection and acknowledgement and the fourfold D-pad 209 side by side in a first line, and with three push buttons 208 for deletion, for data fetching and for starting side by side in a second line below the first line.

The medical determining device 300 has in top view the form of an extremely elongated rectangular, wherein the sensor 302 is arranged adjacent to one end of the extremely elongated rectangular and an activation and control switch 308 is arranged adjacent to the other end of the extremely elongated rectangular, whereas the second data interface 305 is located in form of a plug in the middle at a long side surface of the extremely elongated rectangular.

After determination of the test value by the sensor 302, the test value is transmitted to the control unit 214 via the second data interface 305 and the corresponding first data interface 207 (here: in the form of a not shown socket) in the main pocket housing 201, if the second data interface 305

is plugged into the first data interface 207. For transmitting the determined test value through the second data interface 305 and the first data interface 207, no driver modules are required as long as a microprocessor is present in each pocket housing 201, 301 as control unit. The control unit 214 in the main pocket housing 201 compares the transmitted test value with data stored in the medicine and time data storage register 217 and drives the display unit 204, to display to the user the suitable amount of the necessary medicine (s), e.g. insulin, according to the transmitted test value. This is essential for the user, since the suitable amount of the necessary medicine often depends on the time of day, the eating habits of the user, the last and/or next meal, the general state of health of the patient, and so on.

The medical determining device 300 is detachable from the main pocket housing 201, can be operated autonomously and, therefore, is housed in a separate sensor pocket housing 301. The second data interface 305 is connected to the sensor 302 of the medical determining device 300 either directly or via a suitable driving and/or processing electronic, e.g. a control unit (not shown) , whereas the first data interface 207 in the main pocket housing 201 is directly connected to the control unit 214.

During the use of the medical monitoring and signaling system 1 according to this invention, after switching it on, preferably instructions appear on the display unit 204, which instructions have been pre-programmed during fabrication of the medical monitoring and signaling system 1, on basis of which the user can input menu-driven his/her own important personal data into the personal data storage register 216 of

the main storage unit 203 by means of the local data-input unit 202. To this end, the font desired by the user is shown on the display unit 204 by means of the push button 208 for function selection. The user then selects the desired character by means of the fourfold D-pad 209 - in a manner which is known in combination with other devices and which is thus not described in detail here - and confirms this selected letter, number or special character with the push button 208 for acknowledgment. Thereafter, he/she inputs the next character in the same manner as already described above.

After filling the personal data storage register 216 by means of the push button 208 for function selection, a series of operations can be started, by means of which one or multiple medicine (s) to be administered by the user can be stored into the medicine and time data storage register 217 of the main storage unit 203. Additionally, also the times at which the medicines have to be taken or administered, and the amounts which have to be taken or administered and/or the corresponding amount lists are stored by the user via the local data-input unit 202 into the medicine and time data storage register 217. For inputting the data, the push buttons 208 for function selection, for acknowledgement, for deletion and, if necessary, for data fetching as well as the fourfold D-pad 209 of the local data-input unit 202 are used. When this phase of the programming is completed, the medical monitoring and signaling system 1 is operable.

During operation of the medical monitoring and signaling system 1, the comparator circuit 220 of the control unit 214 compares the time signal continuously arriving from the internal clock 219 at its input with the programmed time data arriving from the medicine and time data storage register 217

also at its input. If the time signal arriving from the internal clock 219 and the time data received from the medicine and time data storage register 217 are identical at the input of the comparator circuit 220, then an instruction signal appears at the output of the comparator circuit 220, which instruction signal activates the alarm unit 205 either directly or, as in this embodiment, via the control unit 214. The alarm unit 205 reminds the user of the medical monitoring and signaling system 1 by means of sound and/or light and/or vibration that the time for administering a medicine has appeared. Besides activating the alarm unit 205, the control unit 214 drives the display unit 204 to display the data set belonging to a specific time point and being pre-programmed by the user into the medicine and time data storage register 217, such that the user can also read which preparation he/she has to take.

The alarm signal (s) - optical and/or acoustic and/or mechanical by means of vibration - output by the alarm unit 205 is/are maintained for a given time period and then stopped for a short time. In the case the user does not press the push button 208 for acknowledgement at the local data- input unit 202 upon occurrence of such (an) alarm signal (s) , the alarm unit 205 is activated once again. In the case that a predetermined amount of repeats, e.g. three to fifteen times, is reached, the alarm unit 205 automatically switches on the acoustic signaling component 210, the optical signaling component 211 and the vibrational signaling component 212 all together as an emergency alarm notwithstanding the former alarm settings, it even operates the acoustic signaling component 210 at its highest volume. Moreover, the medical monitoring and signaling system 1

displays the personal data of the user stored in the personal data storage register 216 at the display unit 204.

This emergency alarm which usually occurs at an emergency situation is maintained until somebody, e.g. a physician, presses the push button 208 for acknowledgement at the local data-input unit 202 or until the rechargeable main power supply unit 206 together with the supplementary power storage 218 have run-down.

If the user acknowledges the alarm signal (s) and the medicine belonging to the actual administering time point depends on the actual state of health of the user, the control unit 214 drives the display unit 204 to display a corresponding notice which informs the user that the suitable amount of the necessary medicine has to be determined first. Then, the user has to put a body fluid, e.g. a drop of blood, onto the sensor 302 of the medical determining device 300 which determines a test value from the tested body fluid. This test value is then transmitted to the control unit 214 which compares the transmitted test value with corresponding values contained in a list pre-stored in the medicine and time data storage register 217. Depending thereupon, the control unit 214 drives the display unit 204 to display to the user the suitable amount of the necessary medicine which the user has actually to take or to administer.

In the case of the use of a new medicine, the medicine and time data storage register 217 can be updated or the data stored therein can be overwritten or corrected. This process can be carried out by using the fourfold D-pad 209 and the push buttons 208 for function selection, for acknowledgement, for deletion, for data fetching and for starting.

Fig.3 shows a top view onto a main pocket housing 201' of a medical monitoring and signaling system according to a second embodiment of this invention. The main pocket housing 201' according to the second embodiment of this invention differs only slightly from the main pocket housing 201 according to the first embodiment of this invention. Components and elements already described with respect to Fig.l and Fig.2 are not described again.

The main differences between the main pocket housings 201, 201' according to the first and second embodiments of this invention are the outer form, and the arrangement and the form of the push buttons 208 of the local data-input unit 202.

The main pocket housing 201' of the second embodiment has in top view a front surface in the form of an elongated rectangular, wherein the short sides of the rectangular are slightly bent. In the second embodiment, the local data-input unit 202 is arranged at the middle of the rectangular front surface, whereas the display unit 204 is arranged at the upper part of the rectangular front surface. The local data- input unit 202 of the second embodiment is arranged with the fourfold D-pad 209 in the middle and with the push buttons 208 for function selection, for acknowledgement, for deletion, for data fetching and for starting being circularly arranged around the fourfold D-pad 209.

According to the second embodiment of this invention, the first data interface 207 is located centered at the bottom end surface of the main pocket housing 201', and is formed by means of an arrangement of a plurality of contact pads. The

first data interface 207 forms in particular a socket, i.e. a recess in the main pocket housing 201', in which the contact pads are arranged. For setting up a communication between the main pocket housing 201' and the medical determining device (compare Fig.4), a suitable plug of a connection cable or of another connection unit can be plugged in into this socket- like first data interface 207.

As further shown with reference to Fig.4, the form and the arrangement of the medical determining device 300' of the second embodiment differs slightly from the form and the arrangement of the medical determining device 300 of the first embodiment. However, it is to be noted that the functionality already described for the medical determining device 300 of the first embodiment is identical to that of the medical determining device 300' of the second embodiment.

The medical determining device 300' of the second embodiment comprises centered at the smallest top end surface of the medical determining device 300' as sensor a measuring tape shaft (not shown) into which a measuring tape for blood sugar analysis is insertable.

Further, different at the medical determining device 300' of the second embodiment is the arrangement of the second data interface 305'. As shown in Fig.4, the second data interface 305' is arranged centered at the smallest bottom end surface of the medical determining device 300' . The second data interface 305' is also formed by an arrangement of a plurality of contact pads. This second data interface 305' also forms a socket, i.e. a recess in the sensor pocket housing 301', in which the contact pads are arranged. For establishing a communication between the main pocket housing

201' and the medical determining device 300', a suitable plug of a connection cable or of another connection unit can be plugged in into this socket-like second data interface 305' .

According to the second embodiment of this invention, the first data interface 207 and the second data interface 305' are formed as USB interfaces, i.e. as interfaces according to the universal serial bus (USB) standard.

In Fig.4 is further shown an optical test value output unit 306 having a rectangular form which covers the major part of the elongated rectangular front surface of the medical determining device 300' of the second embodiment. At a long side surface of the medical determining device 300' of the second embodiment is arranged the activation and control switch 308.

Fig.5 shows now a general view onto the medical monitoring and signaling system 1' according to the second embodiment of this invention. Components and elements already described with reference to Fig.l to Fig.4 are not described again.

In this view, the medical determining device 300' is connected to the main pocket housing 201' by means of a suitable cable 350, according to the second embodiment corresponding to the USB standard, wherein two plugs 351 are fixed at the cable 350, which plugs 351 are pluggable into the first data interface 207 and the second data interface 305' . Now, the test data determined by the medical determining device 300' can be transmitted through this cable 350 to the control unit 214 in the main pocket housing 201' using a bidirectional connection, and finally be displayed on the display unit 204.

A general view onto a medical monitoring and signaling system 1'' according to a third embodiment of this invention is shown in Fig.6. The medical monitoring and signaling system 1'' according to the third embodiment differs from the medical monitoring and signaling system 1' according to the second embodiment in that the medical determining device 300' is connected to the main pocket housing 201' by means of an adapter 400 instead of the cable 350. The cable 350 is integrated into this adapter 400 (therefore it is not visible in Fig.6) . The plugs 351 of the cable 350 extend out from the adapter 400 for contacting the first data interface 207 and the second data interface 305', respectively.

The medical determining device 300' and the main pocket housing 201' are inserted into the adapter 400 for establishing a communication connection between the medical determining device 300' and the control unit 214 in the main pocket housing 201', wherein the plugs 351 contact the first data interface 207 and the second data interface 305' , respectively. As soon as the first data interface 207 is electrically connected to the second data interface 305' , the medical determining device 300' and the control unit 214 communicate with each other through the cable 350 integrated in the adapter 400.

For placing the adapter 400 with inserted main pocket housing 201' and with inserted medical determining device 300' on a table without tumbling down, the adapter 400 is equipped with two supports 401 extending to the back, which supports 401 can be fold. Alternatively, the adapter 400 may be equipped only with a single support 401 extending to the back.

Fig.7 shows a general view onto a medical monitoring and signaling system 1' ' ' according to a fourth embodiment of this invention. Components and elements already described above with reference to Fig.l to Fig.6 are not described again.

The medical monitoring and signaling system \' ' ' according to the fourth embodiment differs from the medical monitoring and signaling system 1' according to the second embodiment and from the medical monitoring and signaling system 1'' according to the third embodiment in that no communication connection based on a cable is established in the medical monitoring and signaling system 1' ' ' according to the fourth embodiment between the medical determining device 300' and the control unit 214 in the main pocket housing 201'. Contrary to the above described embodiments, the bidirectional communication connection happens at the fourth embodiment wirelessly, i.e. either via short range radio (e.g. at 433 MHz limited to a range of less than 1 m) or optical (e.g. on infrared-basis according to the IrDA standard) of according to the Bluetooth standard.

A first communication device 510 is connected by means of a first suitable plug (not shown) via the first data interface 207 to the main pocket housing 201' and a second communication device 520 is connected by means of a second suitable plug (not shown) via the second data interface 305' to the medical determining device 300' for enabling the establishing of a wireless communication connection. The first communication device 510 and the second communication device 520 are adapted with respect to their outer form to the main pocket housing 201' and to the sensor pocket housing

301', respectively, and have a height of less than 1 cm, ideally of less than 5 mm, and in particular of 3 mm.

The first communication device 510 and the second communication device 520 each comprise a circuit board (not shown) connected to the suitable plug, which circuit board may be bent for being well adapted to the form of the respective pocket housing 201', 301'. Each circuit board comprises an independent power supply, according to the fourth embodiment two button cells, a transmitter and a receiver for the wireless bidirectional communication connection as well as a coder and a corresponding decoder. Since the necessary circuits on the circuit boards correspond to common state of the art, a description thereof is omitted here.

On each side of the wireless bidirectional communication connection, a shared transceiver may be used as transmitter and as receiver.

The coder and the corresponding decoder are optional. When a plurality of identically constructed medical determining devices 300' exist, then the coder and the corresponding decoder serve for the purpose that the determined test data are not transmitted to the control units 214 in all reachable main pocket housings 201', but are transmitted only to the corresponding main pocket housing 201' owned by the user.

When the first communication device 510 and the second communication device 520 are plugged in to the medical monitoring and signaling system 1''', a communication connection can be established. Communication starts as soon as the second communication device 520 plugged in to the

medical determining device 300' enters the range of reception of the first communication device 510 plugged in to the main pocket housing 201' . The medical determining device 300' firstly sends out a first data packet including a check code. The main pocket housing 201' receives this first data packet including the check code and sends out for its part the received check code back to the medical determining device 301'. The medical determining device 301' waits during that time for the response of the main pocket housing 201' . After the receipt of the check code sent out back from the main pocket housing 201' by the medical determining device 301', the medical determining device 301' compares the check code sent back with the check code sent out. If both check codes are identical, the medical determining device 301' sends out the next data packet. If both check codes are not identical or if the medical determining device 301' does not receive a response to the sent out first data packet, the medical determining device 301' repeats the transmission of the first data packet together with the check code after a predetermined waiting period. This process is repeated with every data packet until all data packets are transmitted correctly .

In an embodiment being an alternative to the fourth embodiment of this invention, the first communication device 510 and the second communication device 520 are integrated into the respective pocket housings 201', 301' and adopt the function of the first data interface 207 and of the second data interface 305', respectively. Therefore, in this alternative embodiment, the first data interface 207 and the second data interface 305' , respectively, are no longer arranged in the form of sockets at the outer surface of the respective pocket housing 201', 301'. Since the control units

in the respective pocket housings 201', 301' are usually provided in the form of programmable microprocessors (or microcontrollers), the functions of the coder and of the corresponding decoder can be adopted by the control units in the respective pocket housings 201', 301' without the need of separate, physical existing circuits.