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WO2007036835A1 - Systeme et procede de surveillance de la fonction cardiaque d'un patient a la maison - Google Patents

Systeme et procede de surveillance de la fonction cardiaque d'un patient a la maison Download PDF

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Publication number
WO2007036835A1
WO2007036835A1 PCT/IB2006/053362 IB2006053362W WO2007036835A1 WO 2007036835 A1 WO2007036835 A1 WO 2007036835A1 IB 2006053362 W IB2006053362 W IB 2006053362W WO 2007036835 A1 WO2007036835 A1 WO 2007036835A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
analyzing
monitoring
heart
ecg
Prior art date
Application number
PCT/IB2006/053362
Other languages
English (en)
Inventor
Ralf Schmidt
Josef Lauter
Michael Perkuhn
Patrick Schauerte
Original Assignee
Philips Intellectual Property & Standards Gmbh
Koninklijke Philips Electronics N. V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Philips Intellectual Property & Standards Gmbh, Koninklijke Philips Electronics N. V. filed Critical Philips Intellectual Property & Standards Gmbh
Publication of WO2007036835A1 publication Critical patent/WO2007036835A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/361—Detecting fibrillation

Definitions

  • the present invention relates to a system and method for monitoring the heart function of a patient in a home environment. Furthermore the present invention relates to a computer program for monitoring the heart function of a patient in a home monitoring system comprising a computer.
  • VF Ventricular fibrillation
  • This arrhythmia is a severe derangement of the heartbeat that usually ends in death within minutes unless corrective measures are promptly taken.
  • a large number of systems for monitoring ventricular fibrillation are known from the prior art. Because permanent monitoring of the patient's heart is needed, these systems are mostly realized in form of an implant.
  • Atrial fibrillation is an arrhythmia characterized by the uncoordinated contraction of the heart's atrium.
  • a major risk of AF is stroke caused by blood clots that form in the heart and are pumped into the brain, eventually blocking an artery. The disease is often undetected by the patient since up to 70% of all AF episodes come without symptoms.
  • the diagnosis of AF is mainly based on electrocardiographic monitoring (ECG) showing typical changes like irregularity and missing P-waves.
  • ECG electrocardiographic monitoring
  • the therapy of AF can be coarsely divided into two strategies: re-establishing the physiological rhythm (rhythm control) or ensuring an adequate and regular ventricular rate without termination of AF (rate control).
  • the patients must take anti- arrhythmic drugs to maintain the sinus rhythm and anticoagulation drugs for stroke prevention on a continuous basis.
  • the drugs for treatment of AF and prevention of stroke can have severe and even fatal side effects like arrhythmia and major hemorrhage.
  • relapses remain undetected over extended periods of time, leaving the patient without protection against stroke.
  • the termination of AF becomes more difficult the longer the AF episode persists.
  • a system for monitoring the heart function of a patient in a home environment comprising an electrocardiographic device adapted to measure the electrical activity of the patient's heart, an analyzing device adapted to analyze said measuring results regarding the occurrence of an atrial fibrillation, and a notifying device adapted to notify the patient of the analyzing results.
  • the object of the present invention is also achieved by a method of monitoring the heart function of a patient in a home environment, the method comprising the steps of measuring the electrical activity of the patient's heart using an electrocardiographic method, analyzing the measuring results regarding the occurrence of an atrial fibrillation, and notifying the patient of the analyzing results.
  • the object of the present invention is also achieved by a computer program for monitoring the heart function of a patient in a home monitoring system comprising a computer, the computer program comprising computer instructions for analyzing measuring results regarding the occurrence of an atrial fibrillation, said measuring results being obtained prior to the analyzing step by measuring the electrical activity of the patient's heart using an electrocardiographic method, and computer instructions for notifying the patient about the analyzing results, when the computer program is executed in a computer.
  • the technical effects necessary according to the invention can thus be realized on the basis of the instructions of the computer program in accordance with the invention.
  • Such a computer program can be stored on a carrier such as a CD-ROM or it can be available over the internet or another computer network.
  • the computer Prior to executing the computer program, it is loaded into the computer by reading the computer program from the carrier, for example by means of a CD-ROM player, or from the internet, and storing it in the memory of the computer.
  • the computer includes inter alia a central processor unit (CPU), a bus system, memory means, e.g. RAM or ROM etc., storage means, e.g. floppy disk or hard disk units etc., and input/output units.
  • the inventive method could be implemented in hardware, e. g. using one or more integrated circuits.
  • a core idea of the invention is to enable AF patients to monitor themselves daily at home.
  • the patient does three to ten minutes of ECG recording every day with an ECG sensing garment.
  • the system automatically analyses the ECG and notifies the patient whether or not AF is present.
  • the main advantages of the invention are: early detection of asymptomatic AF episodes, reduced risk of stroke, reduced hospital stays due to fast reaction to AF onset, and decelerated progression of AF due to fast termination of AF episodes.
  • the notifying device is adapted to forward a treatment recommendation to the patient, in particular a treatment recommendation including a medication adjustment.
  • the invention enables the patients to adjust their medication according to the feedback of the system. If a new onset of AF is detected the patient will receive a notification from the system, advising him to start or change medication in order to re-establish sinus rhythm and to prevent stroke. When the system acknowledges the termination of the AF episode the patient will receive a notification, advising him to stop or reduce the medication again.
  • the main advantage of this embodiment is an improved quality of life due to reduced medication.
  • the electrocardiographic device is adapted to perform the measuring step at regular intervals, in particular once or twice a day. If the electrocardiographic device is adapted to perform the measurement automatically, a completely unsupervised cardiac monitoring system for AF patients is provided.
  • a number of system components in particular a number of components of the electrocardiographic device, are integrated into a patient-worn textile carrier or garment.
  • a textile carrier or garment in particular in form of standard clothing, e.g. underwear or the like, combines permanent monitoring on a daily basis and easy system handling.
  • Fig. 1 shows a schematic block diagram of a system according to a first embodiment
  • Fig. 2 shows a schematic block diagram of a system according to a second embodiment
  • Fig. 3 shows a schematic and simplified view of an ECG garment as worn by a patient.
  • the system 1 shows a(?) centralized architecture of system components.
  • the system 1 comprises an ECG garment 2 adapted to measure the electrical activity of a patient's heart.
  • ECG electrodes 3, cables 4, amplifier and digital electronics 5 are incorporated into a textile carrier 6, thus simplifying the daily ECG measurement, see Fig. 3.
  • a textile carrier 6 preferably a cardiac belt is used, which is adapted to be mounted around the chest of the patient 6. With the ECG electrodes 3, different tracings of the heart's electrical activity can be made and recorded. Even a single channel ECG device provides sufficient data for detecting AF.
  • the patient 7 controls the measurement procedure from a patient station 11.
  • the patient station 11 is located in the vicinity of the patient 7, but separate from the ECG garment 2, and is adapted to communicate with the ECG garment 2 using a, preferably, short range wireless communication link 12, preferably employing the Bluetooth standard.
  • ECG garment 2 and patient station 11 comprise corresponding transceiver units 13.
  • the patient station 11 is adapted to read the ECG data from the ECG garment 2 after the ECG data has successfully passed a quality check performed by the ECG garment 2.
  • the ECG data is then transmitted from the patient station 11 to a central server 14, preferably using a fixed or mobile telephone line or another communication link 15, e.g. GSM, satellite link, POTS or LAN systems etc.
  • patient station 11 and central server 14 comprise corresponding transceiver units 16.
  • the central server 14 is adapted to handle the incoming calls from all patients, store the data in a patient database and run an algorithm that checks the ECG data for the presence of AF.
  • the central server 14 comprises a processing unit 17 adapted to perform all tasks of calculating and computing the measured data as well as determining the presence of AF and assessing results.
  • the processing unit 17 itself comprises functional modules, which may be implemented in form of hardware, software or in form of a combination of both.
  • the complete process of data processing, detecting AF, assessing the analyzing results as well as generating a treatment recommendation is performed preferably by means of computer software comprising computer instructions adapted for carrying out the steps of the inventive method, when the software is executed in the processing unit 17 of the central server 14.
  • the processing unit 17 the ECG measuring data is analysed.
  • the ECG On the ECG three major waves of electric signals appear. Each one shows a different part of the heartbeat.
  • the first wave is called the P wave. It records the electrical activity of the atria.
  • the second and largest wave, the QRS wave records the electrical activity of the ventricles.
  • the third wave is the T wave. It records the heart's return to the resting state. From the shape and size of the waves as well as from the time between waves and the rate and regularity of beating, information about the heart rhythm can be extracted.
  • the analyzing algorithm as implemented in the processing unit 17 determines irregularities of the heart rhythm. For this purpose, the QRS complex is located and an analysis of the RR intervals is performed. Subsequently, the other segments (P-wave, T- wave) are located. Based on this segmentation, a statistical analysis of the ECG data is performed, leading to information about the regularity of the RR intervals.
  • the presence of a P-wave can be used as an additional criterion for the final classification.
  • the central server 14 is further adapted to send the analyzing result back to the patient station 11.
  • the patient station 11 comprises a user interface 18 adapted to notify the patient 7 of the analyzing results including the treatment recommendation.
  • the user interface 18 comprises a monitor to display a text message or graphical message to the patient.
  • the analyzing results can be communicated to the patient via audio signals, e.g. using a speaker of the user interface 18, or via a printout, e.g. using a local printing device.
  • Physicians have access to the system via a physician station 21.
  • the physician station 21 comprises a user interface 22 adapted to the specific needs of the physician.
  • the user interface 22 of the physician station 21 comprises, inter alia, a data viewer.
  • the physician station 21 is adapted to set up the system 1 once for every patient 7, and to control data quality and parameter settings for the AF detection algorithm.
  • the physician station 21 is adapted to communicate with the ECG garment 2 over a short-range wireless link 12, preferably using the Bluetooth standard.
  • physician station 21 comprises a corresponding transceiver unit 13. The physician can check the online data stream coming from the ECG garment 2 and being displayed at the physician station 21.
  • the physician station 21 is adapted in a way that the physician can access a patient database 23 on the central server 14 via a wide area network (WAN) or another communication link 24.
  • physician station 21 and central server 14 comprise corresponding transceiver units 25.
  • the physician station 21 is further adapted in a way that the physician can use the same access to edit patient data, review recorded data and, if necessary, override the automatic ECG analysis result.
  • the central server 14 is preferably adapted to inform the physician about all AF detection and unclear cases prompting for a manual check of that specific data.
  • the patient station functionality in particular the data transfer functionality and the user interface functionality, is included into the ECG garment 2 and the ECG garment 2 is adapted to communicate directly with the central server 14 and/or the physician station 21.
  • FIG. 2 an AF Management system 1 ' for home use is illustrated.
  • the system Y shows a decentralized architecture of system components.
  • most of the system intelligence is located in the ECG garment 2' and thus at the patient's home. No data is transmitted to a central server.
  • the processing unit 17 implementing the AF detection algorithm and the patient database 23 are also included into the ECG garment 2'.
  • the ECG garment 2' comprises the processing unit 17, which is adapted to perform all data processing tasks as described above.
  • the user interface 18 for the patient is designed as an extra device implemented in the patient station 11.
  • the user interface functionality is also included into the ECG garment. In this case, besides the ECG garment no separate components are needed.
  • the physician station 21 enables the physician to set up multiple systems 2', each for a specific patient 7, by checking the ECG quality and adjusting parameters of the detection algorithm.
  • the physician station 21 is also used to review the data stored by the ECG garment 2'.
  • the physician can access the patient database 23 implemented in the ECG garment via a wireless communication link 12, preferably using the Bluetooth standard, and the physician station 21 and the ECG garment 2' comprisea corresponding transceiver unit 13.
  • the system 1, 1' in case of detection of an AF episode the system 1, 1' notifies the patient 7 of the analysing result, thus enabling the patient 7 to start stroke prevention and AF treatment.
  • the ECG garment 2, 2' is preferably adapted to perform ECG acquisition and processing automatically, once the patient 7 has put on the ECG garment 2, 2'.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne une technique permettant de détecter de manière fiable une fibrillation auriculaire à la maison et comprenant un système (1) permettant de surveiller la fonction cardiaque d'un patient (7) et comprenant un dispositif électrocardiographique (2) conçu pour mesurer l'activité électrique du coeur du patient, un dispositif d'analyse (17) conçu pour analyser les résultats de la mesure par rapport à l'occurrence d'une fibrillation auriculaire et un dispositif de notification (18) conçu pour notifier le patient des résultats de l'analyse.
PCT/IB2006/053362 2005-09-29 2006-09-19 Systeme et procede de surveillance de la fonction cardiaque d'un patient a la maison WO2007036835A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05109012.4 2005-09-29
EP05109012 2005-09-29

Publications (1)

Publication Number Publication Date
WO2007036835A1 true WO2007036835A1 (fr) 2007-04-05

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Application Number Title Priority Date Filing Date
PCT/IB2006/053362 WO2007036835A1 (fr) 2005-09-29 2006-09-19 Systeme et procede de surveillance de la fonction cardiaque d'un patient a la maison

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WO (1) WO2007036835A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3870039A4 (fr) * 2018-10-26 2022-08-10 Mayo Foundation for Medical Education and Research Réseaux neuronaux pour le dépistage de la fibrillation auriculaire

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5348008A (en) * 1991-11-25 1994-09-20 Somnus Corporation Cardiorespiratory alert system
WO2002030279A1 (fr) * 2000-10-10 2002-04-18 Alan Remy Magill Surveillance medicale
US20040152993A1 (en) * 1999-11-16 2004-08-05 Bardy Gust H. System and method for diagnosing and monitoring outcomes of atrial fibrillation for automated remote patient care

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5348008A (en) * 1991-11-25 1994-09-20 Somnus Corporation Cardiorespiratory alert system
US20040152993A1 (en) * 1999-11-16 2004-08-05 Bardy Gust H. System and method for diagnosing and monitoring outcomes of atrial fibrillation for automated remote patient care
WO2002030279A1 (fr) * 2000-10-10 2002-04-18 Alan Remy Magill Surveillance medicale

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3870039A4 (fr) * 2018-10-26 2022-08-10 Mayo Foundation for Medical Education and Research Réseaux neuronaux pour le dépistage de la fibrillation auriculaire

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