JP2008536607A - Congestive heart failure management system - Google Patents

Abstract

The present invention relates to a patient monitoring system, a patient monitoring method, and a computer program. In order to improve patient monitoring, particularly for monitoring cardiopulmonary capabilities, the patient monitoring system (100) has a patient station (10) connected to a number of sensors (12) for measuring patient data. , A number of sensors (12) are incorporated into the patient carrier and / or the patient's clothing, the patient station (10) is configured to analyze the measured patient data, and the patient station (10) It is proposed to be configured to provide feedback information based on the patient data provided to the patient by the knowledge base system (19). The present invention proposes a patient monitoring system (100) configured to act as a CHF monitoring system, especially for home use.

Description

  The present invention relates to a patient monitoring system, a patient monitoring method, and a computer program.

  Heart disease (eg, chronic heart failure) usually has a severe impact on the patient's daily life, even after the patient is discharged from the hospital. In addition to significantly reduced physical ability, patients can take medications that significantly affect their health in order to protect them from the following serious events and to maintain their physical health at the highest possible level. receive. A major factor in this regard is the control of water retention within the patient's body. This is done by applying a diuretic. Other drugs (eg ACE inhibitors, beta blockers, dioxins, anticoagulants, ...) are indicated for the treatment of intrinsic or associated cardiovascular diseases such as atrial fibrillation or hypertension May be.

Furthermore, monitoring of relevant parameters of patients with heart disease is standard in hospital environments. For example, US 2004/0111045 A1 describes a sensor device having at least two piezoelectric sensors provided on a surface, such as a bed, so that the patient can be coupled to the device simply by allowing the patient to lie on the surface. In use, shows an apparatus and method for patient monitoring of parameters such as body movement, body position, respiratory rate, and / or heart rate. It is also known to measure heart data or lung data at home.
US2004 / 0111045A1

  The present invention aims to improve patient monitoring, particularly for monitoring cardiopulmonary performance.

  The object is to have a patient station, which is connected to a number of sensors for measuring patient data incorporated in the patient carrier and / or the patient's clothes, the patient station being measured Achieved in accordance with the present invention by a patient monitoring system configured to analyze patient data and wherein the patient station is configured to provide feedback information based on the measured patient data to the patient via a knowledge-based system Is done.

  It is also an object of the present invention to measure patient data by means of a number of sensors incorporated in the patient carrier and / or the patient's clothes and connected to the patient station, and the patient data measured by said patient station. It is also achieved by a patient monitoring method comprising the steps of analyzing and providing feedback information based on the measured patient data by the patient station using a knowledge-based system.

  It is also an object of the present invention to analyze patient data measured by a number of sensors incorporated in a patient transport and / or patient garment and connected to a patient station when the computer program is executed on a computer. And a computer program further comprising computer instructions for providing feedback information based on the measured patient data from the patient station to the patient by a knowledge-based system. Therefore, the necessary technical effects according to the present invention can be realized based on the instructions of the computer program according to the present invention. Such a computer program may be stored on a medium such as a CD-ROM, or it may be made available over the Internet or other computer network. Prior to execution, the computer program is loaded into the computer. That is, the computer program is read from a medium or the Internet by a CD-ROM player, for example, and stored in a memory in the computer. The computer has, inter alia, a central processing unit (CPU), a bus system, memory means such as RAM or ROM, storage means such as a floppy disk or hard disk unit, and an input / output unit.

  The basic idea of the present invention is that in addition to monitoring the patient (eg, the patient's cardiopulmonary capability), the patient's illness is further provided by providing the patient with feedback information based on measured patient data via a knowledge-based system. (E.g., managing heart disease). In this regard, another advantage of the present invention is that some of the treatment received by the patient during hospitalization is brought into their home. It is known from nursing studies by nurses that continuous investigation of parameters associated with CHF (congestive heart failure) patients results in a significant reduction in readmissions and a reduction in patient mortality. The same effect is expected from the present invention. In other words, the present invention proposes a patient monitoring system that is configured to work as a CHF management system, particularly for home use.

  Information to be provided to the patient is generated by a knowledge-based system. The term “knowledge base system” describes a software program for querying a special knowledge base (database). Another term used to describe such software programs is “expert system”. An expert system is artificial intelligence that uses a knowledge base of human expertise as an aid in solving a problem. The degree of problem to be solved is based on the quality of data and rules obtained from experts. The expert system exchanges information with the user and derives the answer by executing the knowledge base with software and interface engine that processes the rules and data in the knowledge base. For example, the optimal medication is calculated by a knowledge-based system where the best medical practice, survey status, and rules are reflected. Preferably, the knowledge base system is implemented as a computer program that is executed on a computer in a patient station. Alternatively, the knowledge base system is implemented as a remote system to which patient stations connect autonomously.

  These and other aspects of the invention are further explained based on the following examples, which are defined in the dependent claims.

  It is essential to have available reproducible measurements of the patient's weight and heart rate for optimal patient care, especially in the monitoring of the patient's cardiopulmonary capacity. More important parameters are lung activity, bioimpedance, cardiac output, or diagnostic ECG.

  In a preferred embodiment of the invention, for example, a sensor for measuring the patient's weight and / or a sensor for measuring the heart rate of the patient and / or a sensor for measuring the lung activity of the patient and / or measuring the bioimpedance of the patient. And / or a sensor for measuring a patient's cardiac output and / or a sensor for measuring a patient's ECG signal and / or a sensor for measuring a patient's position and / or measuring a patient's water retention It is proposed to use a wide variety of sensors, such as sensors. The type of sensor can be selected depending on the desired information regarding the patient's condition.

  The sensor is incorporated into the patient's clothes and / or transport means. The transport means according to the present invention can be a conventional bed, hospital bed, couch, conventional chair, dentist chair, wheelchair, (surgical) table, etc. Is defined as

  Desirably, the patient data to be measured is sent from the sensor to the patient station via a wireless link, allowing free placement of multiple sensors at the bedside without the use of cables.

  The patient station is configured to provide feedback information, which preferably includes advice to change medications and / or diet or sport recommendations and / or contact a medical professional.

  In other embodiments of the invention, the patient station may interact with the system as needed, for example by providing input according to a personal health care plan (such as diet or exercise), and Allows to control the system. For this purpose, the patient station is preferably configured to receive direct patient input, for example by using a voice input system or a manual input system such as button presses or keyboard use. If such interaction is undesirable, the patient station and bed are designed to operate autonomously without external triggers or patient interaction. Interaction with the monitoring system may also be performed by an activity monitor, such as a patient-worn device such as a belt or other portable device that generates an input signal to the monitoring system.

  Desirably, the patient station is configured to control the measurement process, eg, to control the type and frequency of measurements. For this purpose, the patient station is configured to display the measured patient data with a suitable algorithm.

  In yet another embodiment of the invention, the patient station can be connected to an external device and / or an external network to provide, for example, better maintenance, data storage, and online visits and other features. . Desirably, patient data is sent periodically to the server, and the hospital and / or GP is provided with the necessary data on demand or in any emergency situation. Any change or other feedback of medication given to the patient can be included in an online consultation with GP or other types of appropriate medical services, as required, eg, by legal regulations.

  These and other aspects of the invention are described in detail below, by way of example, with reference to the following examples and the accompanying drawings.

  The patient monitoring system 100 has a patient station 10 connected to the front end 11. The front end 11 has a number of sensors 12 that measure patient data. Such desired parameters are detected by a combination of various sensors incorporated into the bed and / or the patient's clothing (sleepwear). A wide variety of sensors 12 are used in accordance with the present invention. For example, a sensor that measures a patient's weight (eg, a piezoelectric or strain gauge sensor) and / or a sensor that measures a patient's heart rate (eg, a suitable piezoelectric, bioimpedance, or inductive sensor) and / or. A sensor that measures the patient's lung activity and / or a sensor that measures the patient's bioimpedance (eg, by capacitive sensing) and / or a sensor that measures the patient's vibratory output (eg, by inductive sensing) and / or Or a sensor that measures the patient's ECG signal (eg, by electrode sensing or by capacitive sensing) and / or a sensor that measures patient position or activity (eg, a suitable piezoelectric, capacitive, or inductive sensor) and Sensors that measure patient water retention (eg, suitable bioimpedance or inductive sensors) Beauty / or (e.g., by capacitive sensing) is a sensor for measuring the respiration or breathing rate of the patient. All sensors 12 may be incorporated into a mattress or bed sheet or bed frame or attached to the bed. Alternatively, they may be incorporated into the patient's clothes. A scale may also be incorporated into the bed column.

  Desirably, a textile sensor is used for incorporation into a mattress or bed sheet. A washable textile or foam substrate is used for the sensor and has a standard area of 800 x 2000 mm. Furthermore, lead wires, electronic devices and cables are provided. Fabric sensors suitable for 24/7 use are preferred.

  Soft and / or hard sensors may be used to perform the measurement. A standard hard sensor is a strain gauge pack used for weight measurement with a bed column. Such sensors can typically perform weight measurements from 50 grams to 500 kilograms with 20 gram increments and a reproducibility of less than 0.2%. Other hard sensors are non-textile coils, for example incorporated into the bed, for inductive measurements.

  Various types of sensors are used. For example, there are a soft sensor for inductive measurement and a piezoelectric sensor. For example, a textile inductor (coil) in a carrier such as a sleeping gown is used as a sensor for inductive measurement. The inductor functions as a transmitter and a receiver. A typical resonant frequency is about 10 megahertz. The electrode structure is used for capacitive sensing, for example capacitive reading of electrical signals, as well as sensing body position and movement, for example breathing.

  The conductive dry textile region is used as a sensor for bioimpedance. Desirably, different electrode arrays are used to obtain different measurement positions. Measurements at varying positions on the body are performed by electrodes on a sheet carrier that provides direct skin contact.

  Other conductive dry textile regions are used as ECG electrodes. Desirably, different electrode arrays are used to obtain different measurement positions. Measurements at varying positions on the body are performed by electrodes on a sheet carrier that provides direct skin contact. An example of such an ECG electrode arrangement may be a pillow as one electrode and a foot region as another electrode.

  A first example of a sensor arrangement has a number of soft ECG electrodes built into the bed sheet to perform chest measurements and a soft sensor for bioimpedance measurement. The same arrangement may be used for bioimpedance and ECG measurements around the patient's leg, possibly with smaller contacts. A (small) contact matrix is ideal so that the optimal contacts can be “dynamically” selected. It is also possible to have one large ECG contact with a narrower leg area.

  The second example of the sensor arrangement again has a number of soft ECG electrodes incorporated into the bed sheet to perform chest measurements and a soft sensor for bioimpedance measurement. In addition, patients wear sleepwear everywhere with contacts built into shirts and pants.

  A third example of a sensor arrangement has a hard non-contact sensor built into the mattress to perform inductive measurements.

  A fourth example of a sensor arrangement has a sensor that performs a capacitance measurement with or without a counter electrode. The sensor may be implemented as a soft sensor in the form of a textile structure (eg bed sheet) or as a hard sensor incorporated in a mattress, bed frame or mediator device such as a sleeping pad. good. Of course, the soft sensor and the hard sensor may be combined in any structure in order to obtain a sensor arrangement that best suits the measurement situation.

  The measured patient data is sent from the sensor 12 to the bedside multi-channel acquisition unit 13 in the first step. The acquisition unit 13 is a part of the front head 11. The front head 11 has a computer 14 configured to execute front end software. The front end software controls the front end 11 to enable various main states (situations). In the “sleep” state, the front end 11 is stopped for zero power consumption. In the “standby” state, the front end 11 is ready to receive patient data and other signals such as internal control signals or status signals and transmit them to the patient station 10. In the “measurement preparation” state, the front end 11 is ready for measurement, and in the “measurement” state, the front end 11 measures the detection data. In the “data transmission” state, the front end 11 transmits data to the patient station 10. Data is stored at the patient station 10. In addition, an “unwanted signal detection” algorithm is implemented in the front-end software to test the measured signal quality. In view of the data, it assigns a “good” / “bad” label to the data. If the data is classified as “bad”, it should be discarded and a new measurement should be made.

  Data transfer from the sensor 12 to the acquisition unit 13 and from the front end 11 to the patient station 10 is via a wireless data communication link 15 using Bluetooth technology and a TCP / IP data transfer protocol. Desirably, link 15 allows bi-directional communication within a range of up to 10 meters. Accordingly, both the front end 11 and the patient station 10 have a communication interface 16 that is configured to perform data transfer as described above. Alternatively, the data communication link may be implemented (partially) as a wire, for example by a USB connection.

  An error handling procedure is inserted during all monitoring procedures as described above. In this procedure, all error handling steps are recorded. In general, if the step cannot be performed successfully, several iterations are performed. If the error cannot be corrected, the patient and / or GP and / or hospital is notified (eg, via a window on the patient station 10 and / or server monitor).

  The operator of the patient station 10 may be the patient himself or a caregiver, such as a spouse or nurse. This person is referred to below as a patient for simplicity. Patient station 10 is an interface between the patient and patient monitoring system 100. It can also be used when a patient interacts with a medical professional.

  The first measurement procedure is as follows. If the patient is not in bed, the “sleep” state is activated. The measurement procedure begins when the patient enters the bed. First, the patient's weight is measured. The measured data is compared with previous weight measurements by the patient station 10 (eg, by a suitable computer program executed on the patient station computer 17). If the patient is recognized, the patient's position is detected by the appropriate sensor 12. Depending on the position of the patient, the measurement sequence is started or not started. Finally, acoustic feedback is given to the patient. The feedback includes instructions for the patient to optimize the patient's position before going to sleep. While sleeping, the relevant parameters are measured and sent to the patient station 10.

  In other words, the patient station 10 is configured to automatically record relevant data. Patient station 10 detects a patient entering the bed (trigger condition), records the data, and allows the patient to view the data. The patient is also allowed to manage relevant parameters (eg, nutritional intake). The patient station 10 controls the entire measurement procedure. In addition, the patient station 10 controls an automatic warning procedure to alert the patient, GP or hospital. Data transfer to the GP or hospital and to the server station is performed automatically at the patient station 10 if desired. The patient station 10 is configured to give medication advice directly to the patient and report them and their approval from the patient to the server and GP. The system with the patient station / front-end electronics / bed sensor operates automatically without any interaction from the patient, GP or hospital required (indicated by the dashed line). To perform all these functions, the patient station 10 has a computer 17 and a suitable computer program configured to be executed on the computer 17.

  Patient station 10 may be a PC-type device, a laptop, a PDA, a television receiver (including a set-top box), etc., and has a data storage module 18 configured to store received measurement data. In addition, the patient station 10 has suitable electronic components (amplifiers, filters, multiplexers, etc.). The patient station 10 further includes an analysis module that analyzes the measured patient data. The computer 17 is configured to operate as an analysis module in the present embodiment. The computer 17 is configured to execute an appropriate computer program that analyzes patient data. Analysis of the measured patient data and / or control of the measurement procedure and / or generation of medication advice or patient advice is performed by the patient station 10. Patient station 10 uses knowledge base system 19 for this purpose. The knowledge base system 19 uses a knowledge base (not shown). In the knowledge base, a normal range is set for all patients, generally or individually, for each patient provided by GP or hospital (eg, resting pulse rate is 70-90 bpm). ). Standard values defined by the European Cardiac Society may be used for this purpose. If the monitoring system 100 measures a value outside the normal range, feedback is provided to the patient and / or the GP or hospital is notified. For example, the content of feedback regarding medication is provided by the knowledge base system 19.

  The patient station 10 is configured to provide feedback information to the patient based on the measured patient data. In addition, the patient station 10 allows a patient to interact with and / or control the system 100 as needed. A patient user interface 20 is provided for this purpose. The patient user interface 20 comprises a touch screen and / or PDA and / or laptop and / or personal computer and / or television receiver. Further, the patient user interface 20 is configured to provide feedback to the patient, such as by a speaker or a monitor.

  Patient station 10 is configured to provide the following types of user messages: User messages include suggestions regarding optimal measurement locations, medication advice, medication alerts, advice to contact the GP, warning signals, calibration procedure guidance, and user / GP input requests.

  Patient station 10 is configured to accept the following (partially optional) user input (away from the standard measurement routine). User inputs include inputs during calibration, medication changes (with confirmation), inputs arising from questions entered at regular intervals (self-assessment), and inputs from the GP / hospital.

  The patient station 10 is connectable to an external network having a server 21, a GP / hospital station 22, and a service station 23 (technical or maintenance station). Data transfer from the patient station 10 to the server 21 and the GP / hospital station 22 is performed via a communication link 24 using a GSM system (cellular phone). External devices 21, 22, 23 are connected to each other by a (computer) network using an Ethernet communication link 25. That is, data transfer between external devices is based on the TCP / IP data transfer protocol. Patient station 10, server 21, and GP / hospital station 22 each have a GSM communication link 26 for this purpose. Further, the server 21, the GP / hospital station 22, and the service station 23 each have an Ethernet (registered trademark) communication interface 27.

  The communication between the patient station 10 and the server 21 has different protocols: “periodic data transfer”, “maintenance data transfer” and “warning”. During regular data transfers performed daily, measurement data is sent to the server 21 for storage and backup in the server database 28. Data may be accessed from the GP / hospital station 22 and from the patient station 10 when manually triggered for diagnosis and / or evaluation and / or feedback. During maintenance data transfer, preferably triggered by a technician, changes in measurement procedures and alert trigger values apply mainly in the case of software updates. During an alert that is automatically triggered by the patient station software when one or more of the measured patient data exceeds a predetermined limit value, the measured data is sent to the server along with the cause of the alert. The alert confirmation by the GP and / or the hospital is also stored in the server 21. Errors are handled as described above.

  The communication between the patient station 10 and the GP / hospital station 22 has different protocols: “diagnosis”, “information” and “warning”. Both log in to the server database 28 with GP and / or patient triggered consultation protocols. The patient and doctor see the same desktop and talk by phone (hands-free). An automatically triggered information protocol gives the GP information about recommended changes in medication. Confirmation is given by the GP before information is sent to the patient. For this purpose, the GP / hospital station 22 has a user interface 29. With an automatically triggered warning protocol, the measurement data and the cause of the warning are sent to the server 21 and the GP station 22. The confirmation by the GP / hospital station 22 is also stored in the server 21. The error is handled as described above as before.

  All patient data is sent to the server 21. The server 21 provides a web-based interface to access, display and edit patient data via the GP / hospital station 22 and to display the data at the patient station 10. A further service station 23 allows system maintenance and data download, but does not allow changes to patient-related data.

  The server 21 provides the following functions: data management, data filing, control data access, binary data storage, and backup. In addition, the server 21 provides a patient management system by providing a patient database 28 and a web interface or client server application for GP access to the patient database 28. In addition, changes in patient data are recorded. Server 21 also provides automatic call handling. That is, the server 21 processes incoming calls at the same time and enables automatic data exchange with the patient station 10.

  Patient data and measurement data are stored in the database 28. Access to database 28 is made available to patient station 10 and GP / hospital station 22. Database 28 and database software are configured to ensure that only one GP handles a particular patient at any given time, thus avoiding multiple physician visits and extra labor. It is also ensured that all access to patient data can be stored and that data or analysis cannot be accidentally deleted.

  Data on the server 21 and in particular patient data in the database 28 are protected against data loss. Daily backups and physically redundant data storage are essential. In addition, the database 28 is maintained in a parallel RAID system, thus minimizing the risk of data loss and downtime due to hard disk drive failures. The database 28 is backed up at a fixed time every night. Data is stored in the patient station 10 for at least 24 hours, allowing for possible reloading of lost data.

  A firewall is installed to protect the database 28 against hacker attacks. That is, access is only permitted through the ports required for communication between the patient station 10 and the GP station 22. Furthermore, connections are only allowed to devices that have phone numbers that are present in the list of allowed phone numbers (ie, the phone numbers of patient station 10 and GP station 22). This is achieved, if possible, by a suitable internal telecommunications structure. Manual verification of the incoming calling telephone number (via CLIP) before granting access may require changes to standard data transfer protocols that introduce possible errors. In order to protect patient-related data, further measurements are made to provide a high level of data integrity, data security, and data protection.

  Error alerts are provided to handle errors that occur during operation of the patient monitoring system 100. When problems arise, the appropriate people are notified, for example, by SMS, email, or telephone call. If immediate delivery of SMS or email cannot be guaranteed, the responsible person should be notified by phone in case of serious problems. A possible trigger condition that warrants an error warning is that the patient station 10 did not measure data (which was determined if the patient station 10 contacted the server to pass this information). Station 10 measured the data but failed to transfer the data, patient station 10 tried to measure the data but failed, the patient could not be contacted (this is all Sent from the patient through the database and confirmed.), Server hardware failure, database backup impossible, server 21 crashed, or hard disk failure . In addition, an independent process is performed at the patient station 10 to periodically check the network connection with the server 21 to detect when the server 21 is down.

  The GP / hospital station 22 provides the following functions. That is, the GP station allows access to patient data stored on the server 21 for evaluation. Patient data can only be entered / changed via the GP station 22. In case of an alarm or warning, the GP and the patient are prompted to connect to the server 21. The GP / hospital station 22 has a GP user interface 29, such as a PC or laptop. If a new patient is to be added, a new database entry can be generated via the GP user interface 29. The following data can be verified at the GP / hospital station 22: alarm and warning notifications, medication status change notifications, medication status presentation, patient data viewing / editing, automatic diagnosis approval / rejection.

  Service station 23 is used for database management and for software and procedure management. The service station 23 provides the following functions: database management tasks, patient database verification (eg, generation of statistics), server function verification, and software distribution (to the GP / hospital station 22). Using a technician user interface 30, for example in the form of a PC or laptop, the following actions are read: access to all anonymous inputs in the database (ie no access to personal data), software management, And database management can be performed.

  All computers may be implemented as PC type computers. Preferably, however, they are implemented as small microprocessors or microcontrollers, or similar devices in a suitable operating environment, to fit in a small, patient-related or bed-related device.

  As will be apparent to those skilled in the art, the present invention is not limited to the details of the foregoing embodiments, and the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. obtain. Accordingly, the embodiments are to be considered in an illustrative rather than a restrictive sense, and the scope of the present invention is suggested by the appended claims rather than the foregoing description, and is therefore claimed. All changes that come within the meaning and range of equivalency are intended to be embraced therein. Further, the word “comprising” does not exclude other elements or steps, and the word “a” does not exclude a plurality, such as a single computer system or other unit, for example. It is obvious that this element may fulfill the functions of several means recited in the claims. Any reference signs in the claims should not be construed as limiting the claim.

1 is a schematic block diagram illustrating a patient monitoring system according to the present invention.

Claims (10)

A patient station,
The patient station is connected to a number of sensors for measuring patient data incorporated in the patient transport means and / or the patient's clothing,
The patient station is configured to analyze the measured patient data, and the patient station is configured to provide feedback information based on the measured patient data to the patient by a knowledge-based system. system. The multiple sensors are:
A sensor for measuring the weight of the patient, and / or a sensor for measuring the heart rate of the patient, and / or a sensor for measuring lung activity of the patient, and / or a sensor for measuring the bioimpedance of the patient, and / or A sensor for measuring the cardiac output of the patient, and / or a sensor for measuring the ECG signal of the patient, and / or a sensor for measuring the position of the patient, and / or a sensor for measuring water retention of the patient. The patient monitoring system according to claim 1.   The patient monitoring system according to claim 1, wherein a link between the patient station and at least one of the multiple sensors is a wireless link.   The patient monitoring system of claim 1, wherein the feedback information includes advice on medication changes and / or diet or sports recommendations and / or contact with a medical professional.   The patient monitoring system of claim 1, wherein the patient station is configured to receive direct patient input and allows the patient to interact with the patient station.   The patient monitoring system of claim 1, wherein the patient station is configured to control a measurement process.   The patient monitoring system according to claim 1, wherein the patient station is connectable to an external device and / or an external network.   8. The patient monitoring system according to claim 7, further comprising an external server and / or an external GP / hospital station and / or an external service station that can be directly or indirectly connected to the patient station. Measuring patient data by means of a number of sensors incorporated in the patient carrier and / or the patient's clothes and connected to the patient station;
Analyzing patient data measured by the patient station;
Providing feedback information based on the measured patient data by the patient station using a knowledge-based system. When the computer program is executed on a computer,
Computer instructions for analyzing patient data measured by a number of sensors incorporated in the patient transport means and / or patient clothing and connected to the patient station;
A computer program comprising computer instructions for providing feedback information based on the measured patient data from the patient station to the patient by a knowledge-based system.

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