DE19731986A1 - Continuous, automatic monitor for ambulant patient's health state - Google Patents

Abstract

The monitor has signals of determined parameter amplified, processed, and forwarded to a central bus of connected microprocessor (5) coupled to program and operational memories (8, 9), small keyboard (7), LCD screen (6) and a series terminal. It is programmed to pick-up possible anomalies from received data, below or above comparison data and is designed to control the entire monitor operation. A transceiver block (15) of a mobile telephone is coupled to the microprocessor also via a special interface (14) and contains the patient's identification code and connects automatically the hospital control exchange, when activated, for data transmission/reception and speaking. A GPS block (22) is coupled to the processor and GSM block via an interface (21) and is activated by the control exchange.

Description

The invention relates to a portable device for continuous automatic monitoring of the electrocardiographic functions and / or others physiological parameters of deambulant external patients regardless of their location, d. H. independently whether they're at home, at work, or in one any other place within the range of a mobile or radio telephone system, e.g. B. the type GSM (Global System for Mobil Communication).

The invention is based on the significant experience which the applicant in the field of continuous Monitoring of the twelve electrocardiographic leads in hospitals, especially in departments for Diseases of the coronary arteries and in Intensive care units both in the usual direct Cable connection with a bedridden patient, as well by means of remote measuring devices for non-bedridden people Collected patients.

The object of the invention is to extend this method of monitoring also to non-hospitalized, ie to deambulent, external patients and to achieve the following advantages:

• 1) The possibility should be created, some Patients with special clinical pictures earlier than hitherto usual to discharge from the hospital, whereby however, their electrocardiographic monitoring to be continued and to record both the Arrhythmias as well as the ischemia-indicating ST deviation, causing a significant reduction in hospital costs is achieved.
• 2) The continuous electrocardiographic Monitoring should be extended to borderline patients the, though endangered, from economic or other Not be hospitalized for any reason.

The device according to the invention is characterized by the combination of the following circuit blocks:

• - An input circuit block represented by a especially for use by outpatients developed, protected against defibrillator discharges Cable and with the help of ten electrodes to the patient Control of the twelve electrocardiographic leads connected is. The input circuit block detects the from Patients coming electrocardiographic signals, amplifies these signals and gropes them in High frequency range with detection of the Pacemaker signal, after which it serializes the signals and forwarded to a gate array logic,  in which she reconstructs and again in one Frequency range can be sampled, which by about 1/20 is lower than the previous frequency range.
• - A processor that uses the goal logic mentioned above, with a program memory and a working memory, as well with a small keyboard and with a liquid crystal picture screen is connected. This circuit block is for Detection of possible arrhythmias and / or ST deviations due to the coming from the goal logic Data package as well as for the administration of the entire system programmed.
• - A mobile or radio telephone transmission / reception circuit block, e.g. B. the type GSM (Global System for Mobil Communication) with an assigned interface connected to the processor and for sending and Receive data and conversations over the phone Connection with a control center is formed.
• - A GPS (Global Positioning System) circuit block with an associated interface connected to the processor mentioned and in an emergency Command of the control center the location coordinates of the Device and consequently the related Patients determined and the relevant data to the Control center sends over the above-mentioned GSM block.
• - A power supply unit that the portable device according to the invention for its operation provides the required energy.

The device causes a continuous Monitoring the patient's electrocardiogram and stores the important parameters and the scanned ones Signals that correspond to uncritical alarm incidents. In Absence of other events, this data automatically at predetermined intervals or on manually triggered request to the z. B. in one Control center sent to hospital. If in contrast, the device critical alarm conditions in Heart rhythm or in the ST deviation (the Alarm criteria and values can be checked by the doctor at Patient assignment of the device according to the invention be set or modified), will automatically Consignment that corresponds exactly to the previous one, but also contains the electrocardiogram that triggered the alarm condition.

The control center has a telephone system with an easier input and an interface via which it is connected to a multimedia processor equipped with means for voice communication with the patient. If the control center receives an uncritical alarm, the supervisor can do the following:

• - ignore the event because it is meaningless
• - establish an online connection with the patient, around the electrocardiogram with twelve leads in real time to preserve, record and investigate  
• - a telephone voice connection with the patient establish to him eventual action and Give therapy instructions or advice to or around him recommend to go to hospital immediately or to let him know that an ambulance is already on the Ways to him is
• - The GPS circuit contained in the device activate the patient's location coordinates determine and the corresponding information to the To forward accident assistance service,
• - Alert the emergency service and thereby the relevant instructions for those to be applied Therapy e.g. B. for the immediate initiation of a give thrombolytic treatment.

Further features of the invention and the results achieved thereby Advantages result from the description below a preferred embodiment of the invention, the shown for example in the accompanying drawings is.

Show it:

FIGS. 1 and 4 is a block circuit diagram of the device carried by the patient and a block circuit diagram of the control center for the remote control of this apparatus.

Fig. 2 and 3 are flow charts of the apparatus of Fig. 1 and the control center of FIG. 4.

In Fig. 1, reference numeral 1 designates the patient to be monitored, to whom the medical specialist has attached the ten electrodes of a cable 2 . A cable with twelve leads, manufactured by MORTARA INSTRUMENT Inc., USA, is preferably used as cable 2 , which was developed by the applicant in particular for deambulent patients and is protected against defibrillator discharges. The cable 2 is connected to an input circuit block 3 which is intended to receive the electrocardiographic signals, to amplify them and to scan them in the frequency range of 10 kHz with detection of the pacemaker pulse, after which the said input block serializes the data packet and sends it to a gate logic logic) 4 , which reconstructs the sampled signals of the eight leading derivatives and reduces them to a number of 500 per second, whereupon these are sent to the central bus 105 of a microprocessor 5 , e.g. B. Type 68332 can be forwarded. Reference numerals 6 and 7 denote a small liquid crystal screen and a small keyboard, the latter of which is described in more detail below, while reference numerals 8 and 9 denote a PAM memory unit and a FLASH memory unit. With the reference numerals 10 and 11 stabilized supply units of different voltage z. B. of 3 V and 12 V, which are connected to a set of rechargeable batteries 12 and provide the device with the electrical energy required for its operation.

When the device is attached to the patient, the microprocessor 5 is programmed in such a way that it can perform the following functions:

• - Continuous monitoring of the Electrocardiogram of the patient with simultaneous Storage of significant parameters and signals that refer to uncritical alarm incidents;
• - Differentiation and registration of critical Alarm states of the heart pulse rate;
• - Automatic activation of the shipment of the routine data and the critical data in predetermined time intervals;
• - automatic activation of the shipment of a Electrocardiogram in case of a critical Alarm condition;
• - Authorization of an intentionally triggered on command Sending the electrocardiogram in real time;
• - possible activation of the automatic transmission of Information that shows the state of attachment of the electrodes on Body of the patient or the state of charge of the batteries affect.

The values, the trend of the shipments and the Alarm criteria or limits can affect from  Programmer attaching the device to the patient be chosen and fixed.

With the help of a button on the keypad 7 , the patient can send the data at the command of the hand if he determines that the control center has not responded to a persistent discomfort.

With the help of other keys of the keypad it is possible to show on the screen 6 some functions processed by the unit 3 and by the processor 6 , while on the same screen the messages appearing automatically showing the electrodes and the electrodes detached from the patient's body Display the charge status of the batteries 12 . By the reference numeral 13, a serial connection is indicated, which enables the connection of the device with associated test equipment.

Via an interface 14 , the processor 5 is connected to the central processor unit (CPU) 15 of a mobile telephone unit, e.g. B. the type GSM (Global System for Mobile Communication) connected to the corresponding transmitter / receiver circuit block 115 and associated antenna 215 . Reference numerals 16 and 17 denote the A / D converter block (analog-to-digital converter or converter) and the D / A converter block (digital-to-analog converter or converter), via which the central processor unit 15 and the interface 14 is connected to a microphone (via an amplifier) and to a loudspeaker 20 . In the initial programming phase of the device, block 15 receives the patient's identification code, while the memory 8 records the telephone number of the control center to which the device automatically connects on command (see below).

The central processor unit (CPU) 21 of a GPS system (Global Positioning System) is connected to the same processor 5 . Via this unit 21 and with the aid of the satellite receiver 22 and the associated antenna 122 , the location coordinates of the device in question and, consequently, of the patient equipped with it can be determined on the basis of the known satellite collimation.

There may be special shielding agents and / or others known protective means may be provided to prevent that the transmitter / em assigned to the blocks GSN and GPS pfänger units the mode of action of the others operational blocks of the device and / or other, the Devices assigned to patients, such as B. pacemaker or the like. falsify or disrupt.

The device thus constructed functions in the manner described below with reference to the flow chart according to FIG. 2. The patient is identified by reference numeral 23 . In phase 24 , the recording of the electrical diagram, the digitization, the signal shaping, the discrimination and the recording take place, ie the functions performed by the units 3 , 4 , 5 , 8 and 9 of FIG. 1. Phases 25 and 125 relate to the activity performed by processor 5 of FIG. 1 in relation to the presence or absence of arrhythmia anomalies and in relation to the ST deviation in the electrocardiographic signal coming from unit 3 . If such anomalies exist, the flow goes to phase 26 , where the events are registered in memory 9 of FIG. 1. The phase 27 also belongs to the activity of the processor 5 and follows the above-mentioned phases 25 , 26 , it being determined in this phase 27 whether the determined event is critical or non-critical. In the event that this event is found to be critical, phase 27 is followed by the phase designated by reference numeral 28 , an activation of the telephone system GSM 14 , 15 , 115 , 215 according to FIG. 1 and the subsequent phase 29 , in which the data A sent to the control center in the hospital (see also below). This broadcast is followed by phase 30 , in which the telephone connection is interrupted.

If, on the other hand, the processor 5 does not detect any critical alarm states as in phases 25 and 26 , the transmission is carried out in accordance with phases 28 , 29 , 30 via phase 31 of manual activation by the patient by actuating a key on keyboard 1 of FIG. 1, or via phase 32 at the command of said processor, which is programmed to send the determined data at predetermined time intervals.

If the control center deduces the existence of a critical alarm state from the data sent by the device according to the invention, it can send a signal B which is received by the GSM unit 215 , 115 , 15 , 14 of FIG. 1 and is recognized by the processor 5 , the latter consequently causing the unit 3 , 4 to send the patient's electrocardiogram in real time in phase 33 . This phase is followed by phase 34 of an activation of the GSM unit and phase 35 , in which the electrocardiogram C is transmitted in real time, and the final phase 36 , in which the transmission is interrupted after it has ended.

On a command D given by telephone from the control center or on the patient's command by pressing a key on the keyboard 7 of FIG. 1, phase 37 of FIG. 2 can be reached, in which the speech connection between the patient and the control center is established, with the subsequent one Phase 38 of an activation of the GSM unit and the subsequent transmission / reception phase 39 of a telephone voice connection, and with the final phase of an interruption of this connection.

If the patient does not respond to the request from the control center for a voice connection, phase 41 of an activation of the GPS system is initiated - on the basis of a command F issued by the control center itself or on the patient's request by actuating a corresponding key on the keypad 7 - with the subsequent phase 42 of an activation of the GSM unit, which forwards the command to the processor 5 , which in turn activates the unit 21 , 22 , 122 of FIG. 1 and triggers the phase 43 for determining the location coordinates of the patient. This information is sent to the control center via the same units described above, namely via phase 44 , which activates the GSM unit for transmission. This is followed by the transmission phase 45 of the location coordinates G and the final phase 46 , in which the telephone connection is switched off. In this emergency, the control center can give the rescue personnel the necessary instructions for the rescue of the patient and also for the immediate initiation of a suitable treatment (see below).

From Fig. 3 it can be seen that the control center in the hospital has a telephone line 47, optionally with an automatic search agent 48 , the latter enabling the simultaneous receipt of several calls and being connected via an interface 49 to a multimedia processor 50 , on the means 51 for voice communication connected to the patient, as well as other means normally provided in a monitoring center.

The mode of operation of the control center can be seen from the above description of FIGS. 1 and 2 and is therefore only to be briefly summarized below with reference to the flow diagram according to FIG. 4.

Reference number 52 denotes the reception phase of the information A, which is transmitted by the device worn by the patient according to FIG. 1 and can be either routine information or information about an arrhythmic or ischemic alarm state. Phase 52 is followed by phase 53 , in which the monitoring personnel assesses whether information A means a critical or non-critical alarm condition. In the case of an uncritical alarm state, phase 53 is followed by the phase of an observation completion designated by reference numeral 54 . In the event of a critical state, phase 53 can be followed by one or more phases 55 , 56 , 57 . In phase 55 , a decision is made as to whether the speech connection should be established with the patient or not. If the decision is in favor of a speech connection, the call signal D is sent to the patient in the following phase 58 , followed by phase 59 of a possible speech connection E between the control center and the patient. In the subsequent phase 60 , a decision is made as to whether the connection to phase 54 should be terminated in the event of an uncritical alarm or whether the emergency state phase 61 should be activated in the event of a critical alarm.

In phase 56 , a decision can be made as to whether the examination of the patient's electrocardiogram should be carried out in real time or not. If such an examination is to be carried out, phase 62 of a corresponding transmission request B to the patient's GSM unit is activated, which is then followed by phase 63 of online reception of the electrocardiographic signal C in the control center and the subsequent phase 64 in FIG which latter the monitoring personnel decides whether to terminate the connection via phase 54 in the event of an uncritical alarm or to switch to the emergency state phase 61 in the event of a critical alarm.

In phase 57 , the monitoring staff decides whether to request the location coordinates of the patient in the event that speech communication is impossible. If the request for the location coordinates is resolved, the transmission phase 65 is followed by a corresponding telephone request F from the control center, which phase 65 is followed by the reception phase 66 of the location coordinates G and then the emergency state phase 61 .

The above description relates to a preferred exemplary embodiment of the invention, a detailed explanation of the structural details of the various circuit blocks being dispensed with, since the structural design of these blocks can be carried out by the person skilled in the art on the basis of the corresponding functional characteristics specified here. The parts 2 , 3 , 4 described above can be replaced or supplemented by other means which are able to record and process other physiological parameters other than the heartbeat. As a result, the device according to the invention can generally automatically monitor the health status of a patient or a single elderly person and, at any time, when the monitored parameters exceed or fall below predetermined maximum or minimum values, also automatically send an emergency or help call , even if the event is not perceived by the patient or the elderly himself.

Claims (10)

1. Device for the continuous automatic monitoring of the health status of non-hospitalized external patients, characterized by

• Means for determining one or more physiological parameters which are decisive for the patient's state of health, and for amplifying, processing and forwarding signals corresponding to these parameters to the central bus of a subsequent microprocessor;
• - A microprocessor ( 5 ), which is connected with the means mentioned, as well as with program and working memories ( 8 , 9 ), with a small keyboard ( 7 ), with a liquid crystal screen ( 6 ) and with a series connection and for detection - on the basis of the received data - any anomalies are programmed which exceed or fall below predetermined comparison data, this microprocessor being designed to control the operation of the entire device;
• - The transmitter / receiver block of a mobile or radio telephone, for. B. the type GSM (Global System for Mobile Communication), which is also connected to said processor ( 5 ) via a special interface ( 14 ) and - due to the initial programming of the device - contains the patient's identification code and when activated for automatic Connection to the telephone of a control center in the hospital for sending or
• Receiving data and set up for voice communication;
• - A GPS block (Global Positioning System block) ( 22 , 122 ) which is connected via an interface ( 21 ) to said processor ( 5 ) and to said GSM block ( 15 ) and by the latter at least by one command sent by the control center to be sent to this center of the location coordinates of the device and, as a result, of the patient assigned to this device can be activated so that the monitoring personnel can rescue the patient in critical alarm states if he does not respond to the request for a voice connection;
• - A block ( 10 , 11 , 12 ) with rechargeable batteries, which supplies the device with the electrical energy required for its operation and the corresponding voltages.

2. Device according to claim 1, characterized in that it is adapted to provide continuous, automatic monitoring of the electrocardiographic functions of the patient and having an input circuit block (3) that detects the electrocardiographic signals from twelve leads of the patient by means of a multi-electrode cable (2), this Signals amplified and z. B. in the frequency range of 10 kHz with detection of the pacemaker signal, after which it forwards them through serial transmission to a downstream goal logic ( 4 ), which reconstructs the main signals, they in a frequency range of z. B. again scans 500 Hz and transmits the data packet to the central bus of the downstream microprocessor ( 5 ), the latter being programmed in such a way that it derives possible arrhythmias or an ischemia-indicating ST deviation from the electrographic data. 3. Device according to one of the preceding claims, characterized in that the device with the Patient connecting cables from the MORTARA INSTRUMENT, Inc., USA, manufactured cable with ten, for a correct one Attaching upstream electrodes, which is a flat, flexible and protected against defibrillator discharge Cable particularly suitable for ambulatory patients is trained. 4. Device according to one of the preceding claims, characterized by protective means, in particular by shielding means to prevent the interference of the transmitter / receiver of the GSM unit ( 15 ) and the GPS unit ( 22 ) on the operation of the other parts of the device or on the Mode of operation of any other electronic devices associated with the patient, such as. 5. Pacemakers or the like. 5. Device according to one of the preceding claims, characterized by means which, in the absence of critical alarm signals, the electrocardiographic signals processed by the processor ( 5 ) via the GSM block ( 15 ) to the control center at regular intervals send predeterminable time intervals when attaching the device to the patient or when programming and activating the device. 6. Device according to one of the preceding claims, characterized by means which, in the presence of a critical alarm signal, cause the processor ( 5 ) to activate the GSM block ( 15 ) immediately in such a way that it sends the electrocardiographic signal to the control center which sends the contains the mentioned critical signal and possibly also other parameters. 7. Device according to one of the preceding claims, characterized in that the processor ( 5 ) associated keyboard ( 7 ) has a key, the actuation of which enables the patient to directly and at any time send the electrocardiographic data to the control center. 8. Device according to one of the preceding claims, characterized in that the processor ( 5 ) associated keyboard ( 7 ) has a key, the actuation of which enables the patient, directly and at any time the GPS block ( 22 ) for determining the location coordinates of the patient and to activate the sending of these location coordinates to the control center. 9. Device according to one of the preceding claims, characterized in that the processor ( 5 ) associated keyboard ( 7 ) has a key that enables the patient to establish the speech connection with the control center directly and at any time. 10. Device according to one of the preceding claims, characterized in that the assigned processor ( 5 ) is set up in such a way that when the GSM block ( 15 ) is activated by the control center and when a predetermined command is received, the said GSM block is the the input unit ( 3 ) and electrocardiogram obtained from the goal logic ( 4 ) in real time to the control center. 11. The device according to one of the preceding claims, characterized in that the assigned control center contains the following components:

• - at least one telephone line ( 47 ) with a possible automatic connection broker ( 48 ) to enable the simultaneous receipt of several telephone calls,
• an interface ( 49 ) for connecting said telephone line and the possible connection broker with a multimedia processor ( 50 ) and with means ( 51 ) for voice communication with the patient,
• - For a control center usual, with the processor ( 50 ) connected means such as databases, keyboards, screens, recorders, writers and. the like