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WO2006117112A1 - Procede et dispositif pour detecter les defaillances d'identification de signaux d'un appareil cardiologique implantable - Google Patents

Procede et dispositif pour detecter les defaillances d'identification de signaux d'un appareil cardiologique implantable Download PDF

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Publication number
WO2006117112A1
WO2006117112A1 PCT/EP2006/003856 EP2006003856W WO2006117112A1 WO 2006117112 A1 WO2006117112 A1 WO 2006117112A1 EP 2006003856 W EP2006003856 W EP 2006003856W WO 2006117112 A1 WO2006117112 A1 WO 2006117112A1
Authority
WO
WIPO (PCT)
Prior art keywords
cardiac
time intervals
intervals
detected
excitations
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2006/003856
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German (de)
English (en)
Inventor
Ewald Himmrich
Philipp Nikolai
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johannes Gutenberg Universitaet Mainz
Original Assignee
Johannes Gutenberg Universitaet Mainz
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 Johannes Gutenberg Universitaet Mainz filed Critical Johannes Gutenberg Universitaet Mainz
Priority to DE112006001098.0T priority Critical patent/DE112006001098B4/de
Priority to PCT/EP2006/003984 priority patent/WO2006117148A1/fr
Publication of WO2006117112A1 publication Critical patent/WO2006117112A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate

Definitions

  • the invention relates to a device and a method for the detection of signal detection defects in an implantable cardiology device, in particular a device for the treatment of tachycardia cardiac arrhythmias, and a method for operating the same.
  • Cardiac arrhythmias are a particular class of cardiac pacemakers capable of detecting tachycardiac arrhythmias through intracardiac probes and delivering different types of therapeutic pulses to myocardial tissue as an antitachycardic therapy.
  • Such devices are commonly referred to as implantable cardioverter-defibrillators (ICDs), which devices are particularly useful for the prevention of sudden cardiac death.
  • ICDs implantable cardioverter-defibrillators
  • VT ventricular flutter
  • VF ventricular fibrillation
  • Conventional filters and amplifier systems can be used to process the signals thus obtained, so that at the end of the amplifier and filter chain a single heartbeat can be distinguished from further changes in potential, such as P-waves and T-waves.
  • a common measure for determining a heartbeat is, for example, the measurement of the time sequence of the so-called R-waves of an intracardiac electrocardiogram (EGM), wherein the period between two cardiac excitations can be measured from the thus determined RR intervals. This results in a determination the heart rate as the reciprocal of the averaged intervals of successive cardiac excitations.
  • EMM intracardiac electrocardiogram
  • an IDC device initiates a DC pulse on the myocardium to terminate such a tachycardic ventricular disorder, such a defibrillation pulse being both synchronous ie within a certain time frame of cardiac excitation, as well as unsynchronized with cardiac pacing, and its magnitude can be adjusted to the degree of arrhythmia.
  • a gradual coordinated therapy is therefore possible depending on the severity of the present cardiac arrhythmia.
  • a cardiac arrhythmia in addition to the determination of a mean heart rate and the presence of a sudden onset and unnaturally increased heart rate as another method, the determination of the number of heart intervals, which are shorter than a certain predetermined decision value, a so-called "X from Y Such a detected cardiac arrhythmia initiates an operating phase in the IDC device, hereafter referred to as
  • Cardiac arrhythmia episode is described in which the preparations for the initiation of a therapeutic measure and its implementation are carried out. During such a cardiac arrhythmia episode, a digital intracardiac electrocardiogram may also be recorded, which may be read out by a telemetry transmission by the physician for the purpose of diagnosis.
  • the ICD device measures potentials that have no cardiac causes.
  • Unphysiological, external signals which are caused in particular by electromagnetic fields. This can be triggered by electrical devices, in particular by mobile radio systems.
  • the invention has for its object to provide an implantable cardiac device for the treatment of rapid cardiac arrhythmia, in particular an ICD device, which includes a device for detecting signal detection defects and a method for operating such a device, which in the case of a tachycardia ventricular actually present Cardiac arrhythmia with a high triggering safety initiates the application of therapeutic measures and at the same time excludes the presence of signal detection defects with the highest possible degree of security.
  • Such an ICD device should be able to perform an analysis based on RR intervals of an intracardiac electrocardiogram for exclusion of signal detection defects and have a simple design with respect to the measurement and signal processing system used.
  • the object underlying the invention is solved by the features of the independent claim.
  • the inventive method is based on the fact that tachycardia
  • Cardiac arrhythmias have a relatively stable pattern, i. the time intervals between two consecutive RR spikes are essentially uniform in the presence of a real cardiac arrhythmia. Compared to this, erroneously detected signals are characterized by a chaotic distribution so that the resulting detected sequence of time intervals between putative cardiac excitations undergoes greater temporal variation ,
  • An inventive ICD device or the operating method according to the invention first applies the known criteria for determining the presence of a tachycardic ventricular arrhythmia. This may, for example, be a determination of a heartbeat rate averaged over a particular time interval, or the use of the "X out of Y" method, i.e. the determination of a certain relative number of time intervals between two detected cardiac paces below a certain limit duration.
  • the sequence of time intervals between the detected cardiac excitations are stored as from the initiation of a cardiac arrhythmia episode and these are examined for temporal irregularities. For each newly added measured value, the degree of uniformity of the present sequence of time intervals since the beginning of the cardiac arrhythmia episode is preferably redetermined. The more measured time intervals are available, the more certain is the statement about their uniformity. For the fastest and safest possible determination of
  • each of the above-described measures may be used individually, with each time a corresponding computational step is performed, a numerical value follows for the uniformity of the present series of time intervals, which can be compared with a certain critical threshold for the uniformity. Particularly preferred is the use of a combination of the measures described above for uniformity calculation. Furthermore, it is also conceivable to carry out a weighted combination.
  • the necessary calculation and comparison steps can be from a
  • Microprocessor accessing an internal or external memory with all stored within the present cardiac arrhythmia episode intervals.
  • Signal detection defects are preferably carried out at least until the preparatory measures for initiating a therapeutic measure, in particular the charging of a capacitor for the application of a DC voltage shock, are completed. The longer the investigation of the temporal uniformity of the time intervals between the detected
  • Heart stimulation can be performed, the more certain can a statement whether an actual cardiac arrhythmia or only a signal detection defect is present.
  • Cardiac perturbations are determined by a value that is constantly refined with increasing duration for the check, which is referred to below as the uniformity factor.
  • This uniformity factor can in turn be compared to a threshold based on a static evaluation.
  • the stored time intervals and the associated intracardiac electrocardiograms for a multiplicity of cardiac arrhythmia episodes have been investigated by means of telemetric transmission and a distinction is made here between actual cardiac arrhythmias and signal recognition defects. Accordingly, the associated uniformity factors are calculated according to the measures described above, and from this a threshold value for the uniformity factor is determined. On the basis of these threshold values, a comparison between the determined uniformity factor and the stored threshold value can be carried out on entry into a cardiac arrhythmia episode by the ICD device and, depending on the result thus obtained, a warning in addition to the stored sequence of
  • Time intervals and the intracardiac electrocardiogram are included in the data on the corresponding history of cardiac arrhythmia.
  • Such a warning can serve a doctor to recognize in an evaluation of the cardiac arrhythmia episode in question and specifically to search for possible causes.
  • organic causes which are triggered by a not necessarily cardiac disease, should be investigated.
  • the ICD device which has two modes, an active mode and a passive mode.
  • the passive mode is particularly preferred.
  • the comparison between the uniformity factor and the specified uniformity threshold is merely generated as a warning and stored. This can then serve, as described above, to adapt the threshold value to the individually present situation so as to carry out the most correct possible assessment of physiological artifacts. For example, signal detection defects that are due to interfering myopotentials may be different from patient to patient, so that an adjustment of the threshold for the uniformity of the time intervals of the detected cardiac excitations must be made.
  • an improved detection of signal detection defects is possible, so that in the following can be switched from the passive mode to an active mode of the ICD device, which is preferably again carried out telemethsch.
  • the comparison between the uniformity factor and the set threshold not only leads to a stored warning, but to a transmission of this information to the internal therapy decision tree for the application of a therapeutic measure. In general, this then leads to an intervention in the therapy function. This can range from a weakening of a therapeutic measure to a complete suppression of a therapy impulse. Furthermore, it is conceivable to delay only the therapy pulse further until the reliability of the statement, which is attributed to the uniformity factor, increases. Accordingly, the patient's safety increases before inappropriate shock delivery in active mode.
  • Fig. 1 shows the process sequence according to the invention in passive mode.
  • Fig. 2 shows the process sequence according to the invention in the active mode.
  • FIG. 3 shows an illustration of an intracardiac electrocardiogram with rapid ventricular arrhythmia with the internally detected heartbeats indicated by arrows.
  • the associated time intervals between the detected cardiac excitations are given in milliseconds.
  • FIG. 4 illustrates a representation corresponding to FIG. 1 in the case of the presence of signal detection defects.
  • Fig. 5 illustrates the determination of the uniformity factor based on a standard deviation.
  • FIG. 3 shows an intracardiac electrocardiogram which represents the occurrence of a ventricular fibrillation.
  • the RR intervals are correctly detected. Deviating from this, there is no tachycardiac arrhythmia in FIG.
  • the ICD device detects false signals and has therefore initiated a cardiac arrhythmia episode in the illustrated case.
  • the illustrated signal detection defect of this example interfering signals of the diaphragm occurred without adequate cardiac excitation.
  • the method according to the invention is initiated by the detection of a cardiac arrhythmia episode. At first, it is not clear whether it is an actual tachycardiac arrhythmia or a signal detection defect. For the passive mode shown in FIG.
  • a therapeutic measure is immediately prepared and then applied without any time delay.
  • all detected heart intervals are stored within the cardiac arrhythmia episode and subjected to an evaluation in order to determine the uniformity factor in a subsequent method step.
  • Shown is the application of three different methods for determining uniformity. These can be executed sequentially as shown. Also a parallel processing is conceivable. In modifications, only a single method of determining the uniformity factor can be used. It is also conceivable that the individual methods are weighted differently. As an example of such a method for determining the uniformity factor, the calculation of the standard deviation of the heart interval data shown in FIG. 3 may be performed.
  • FIG. 5 shows the schematic sequence of a preferred method for determining the uniformity factor. Based on all the time intervals between the detected cardiac excitations present within the cardiac arrhythmia episode, a standard deviation S is calculated. After each calculation, the currently existing value for the standard deviation S is compared with a threshold value E, so that after each recalculation a decision can be made between a correct and an erroneous detection of a cardiac arrhythmia.
  • the uniformity factor is determined in the passive mode for the stored heart interval data for the respective cardiac arrhythmia episode and, in the event of a signal defect, a uniformity factor is determined
  • Warning saved As described above, a physician may then, as part of a therapeutic procedure, make an individual adaptation to the given physiological situation of a patient before the device is switched to an active mode.
  • FIG. 2 shows the active mode for the method according to the invention.
  • a therapeutic measure is not immediately initiated when a rapid cardiac arrhythmia in need of therapy is diagnosed. Instead, based on the stored data, the cardiac intervals of the ongoing cardiac arrhythmia episode are entered
  • Uniformity factor determined. This is in turn by one or a combination of the above-mentioned methods, for example, the calculation of a standard deviation and / or the determination of the relative number of time intervals, which describe a certain predetermined duration and / or the determination of the relative number of quotients each successive time intervals between the detected heartbeats, which exceed a predetermined maximum value or below a predetermined minimum value made. Furthermore, further methods are conceivable which serve to prove the temporal uniformity of the heart interval data. If, in the active mode, a signal recognition defect is assumed due to the established uniformity factor, then again different interventions on the therapeutic measure are assumed conceivable.
  • this is a time delay with the aim of obtaining even more reliable data on the temporal uniformity of heart intervals.
  • a reduction of the therapeutic action or a phased application can be made.
  • a maximum time specification for the suppression of a therapeutic measure is prescribed to ensure therapy safety. After a certain set time has elapsed, a therapeutic measure is also initiated when it is indicated that a signal detection defect exists.
  • a warning which can be retrieved later by a doctor, stored together with the heart interval data of each cardiac arrhythmia episode.
  • the different methods of determining the uniformity factor may be linked such that the decisions leading to the detection of a signal detection defect are "AND" linked while those

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un appareil cardiologique implantable offrant la possibilité de sélectionner entre un mode actif et un mode passif. Lorsqu'au moins un nombre défini d'intervalles de temps entre des excitations cardiaques détectées est inférieur à une valeur déterminée dans un laps de temps prédéfini, l'appareil cardiologique détecte un trouble du rythme cardiaque au cours duquel un électrocardiogramme intracardial et la succession des intervalles de temps entre les excitations cardiaques détectées sont mesurés et enregistrés, l'uniformité temporelle des intervalles de temps étant évaluée en continu. En mode passif, l'appareil cardiologique applique un traitement antitachycardique aux tissus musculaires en cas d'apparition d'un trouble du rythme cardiaque, et si la succession des intervalles de temps n'est pas uniforme, un avertissement est généré et enregistré. En mode actif, en cas d'apparition d'un trouble du rythme cardiaque et si la succession des intervalles de temps n'est pas uniforme entre les excitations cardiaques détectées, non seulement un avertissement est généré et enregistré, mais encore l'application d'un traitement antitachycardique est retardée jusqu'à ce qu'une uniformité définie dans la succession des intervalles de temps soit détectée, ou jusqu'à ce qu'une durée maximale prédéfinie pour retarder le traitement antitachycardique soit écoulée.
PCT/EP2006/003856 2005-04-29 2006-04-26 Procede et dispositif pour detecter les defaillances d'identification de signaux d'un appareil cardiologique implantable Ceased WO2006117112A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE112006001098.0T DE112006001098B4 (de) 2005-04-29 2006-04-28 Implantierbares kardiologisches Gerät
PCT/EP2006/003984 WO2006117148A1 (fr) 2005-04-29 2006-04-28 Dispositif et procede de detection de d'erreurs de reconnaissance de signaux dans un appareil cardiologique implantable

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005019959.3 2005-04-29
DE200510019959 DE102005019959A1 (de) 2005-04-29 2005-04-29 Vorrichtung und Verfahren zur Detektion von Signalerkennungsdefekten in einem implantierbaren kardiologischen Gerät

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WO2006117112A1 true WO2006117112A1 (fr) 2006-11-09

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PCT/EP2006/003856 Ceased WO2006117112A1 (fr) 2005-04-29 2006-04-26 Procede et dispositif pour detecter les defaillances d'identification de signaux d'un appareil cardiologique implantable

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0985428A1 (fr) * 1998-08-12 2000-03-15 Pacesetter, Inc. Stimulateur cardiaque avec système de sécurité de synchronisation des ondes-R pendant la correction par contre-stimulation de fibrillation auriculaire
US20020068875A1 (en) * 1995-12-11 2002-06-06 Intermedics, Inc. Implantable medical device responsive to heart rate variability analysis
US6522925B1 (en) * 2000-05-13 2003-02-18 Cardiac Pacemakers, Inc. System and method for detection enhancement programming
US6567691B1 (en) * 2000-03-22 2003-05-20 Medtronic, Inc. Method and apparatus diagnosis and treatment of arrhythias

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6766194B1 (en) * 2001-12-12 2004-07-20 Pacesetter, Inc. Dynamic control of overdrive pacing based on degree of randomness within heart rate

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020068875A1 (en) * 1995-12-11 2002-06-06 Intermedics, Inc. Implantable medical device responsive to heart rate variability analysis
EP0985428A1 (fr) * 1998-08-12 2000-03-15 Pacesetter, Inc. Stimulateur cardiaque avec système de sécurité de synchronisation des ondes-R pendant la correction par contre-stimulation de fibrillation auriculaire
US6567691B1 (en) * 2000-03-22 2003-05-20 Medtronic, Inc. Method and apparatus diagnosis and treatment of arrhythias
US6522925B1 (en) * 2000-05-13 2003-02-18 Cardiac Pacemakers, Inc. System and method for detection enhancement programming

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