EP1536860A2 - Detecteur de capture - Google Patents
Detecteur de captureInfo
- Publication number
- EP1536860A2 EP1536860A2 EP03747937A EP03747937A EP1536860A2 EP 1536860 A2 EP1536860 A2 EP 1536860A2 EP 03747937 A EP03747937 A EP 03747937A EP 03747937 A EP03747937 A EP 03747937A EP 1536860 A2 EP1536860 A2 EP 1536860A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- signal
- event
- events
- ecg
- self
- 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.)
- Withdrawn
Links
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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
- A61N1/37—Monitoring; Protecting
- A61N1/371—Capture, i.e. successful stimulation
- A61N1/3712—Auto-capture, i.e. automatic adjustment of the stimulation threshold
-
- 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
- A61N1/37—Monitoring; Protecting
- A61N1/371—Capture, i.e. successful stimulation
Definitions
- the present invention relates to a device for obtaining and recognizing a sensed myocardial signal, in particular a signal related to cardiac stimulation. More particularly, the present invention relates to a detector for use in an implantable medical device for electrostimulation of the heart, such as a pacemaker or a cardioverter/defibrillator (ICD), or in a programmer for such device so that the detector may determine capture based on the signal morphology of a surface electrocardiogram (ECG). Even more, the present invention also relates to a detector for use in an implantable cardiac electrostimulation device so that comprising such a capture detector so that the detector may determine capture based on the signal morphology an intracardiac ECG. Even more particularly, the present invention also relates an implantable cardiac electrostimulation device comprising such a capture detector so that captured and non- captured events may be discriminated.
- an implantable cardiac electrostimulation device comprising such a capture detector so that captured and non- captured events may be discriminated.
- Capture refers to the process of applying an artificial stimulus of sufficient amplitude to myocardial tissue to result in contraction of the tissue.
- the artificial stimulus is, in most cases, an electrical stimulus not provided by the body's electrical system.
- Capture is an important and well-known feature that is utilized routinely in implantable devices for electrostimulation of the heart.
- a stimulation resulting in capture exceeds the so-called “capture threshold.”
- a successful stimulation is referred to as a "capture event " An unsuccessful stimulation, that is, one that does not exceed the capture threshold, is referred to as a "non-capture event".
- the ability to detect capture events in the heart is important to the design of an implantable automated cardiac electrostimulation device, because only by detecting capture can one be certain that a stimulation pulse has been successful, the act of capture embodying the definition of successful cardiac stimulation.
- the implantable devices be- come more and more sophisticated, they approach becoming a perpetually an-duty "cardiologist in the Patient" to detect rhythm abnormalities, to effectively treat the rhythm abnormality, and then to cease treatment when the abnormality has been corrected.
- Devices for the initial detection of the abnormality are known in the prior art.
- a capture detector and an implantable electrostimulation device that incorporates the mathematical modeling concepts described in more detail below for detecting capture events in myocardial tissue.
- a medical device comprising
- electrode connectors adapted to connect the medical device to intracardiac electrodes and to transmit electric stimulation pulses to electrode surfaces on the intracardiac electrodes and to receive electric signals sensed by electrode surfaces
- a stimulation unit adapted to generate stimulation pulses and being connected to at least one electrode connector
- an amplifier and filter unit connected to at least electrode connector and being adapted to amplify and filter sensed electric signals
- control unit being connected to the stimulation unit, the analog to digital converter and a data memory, the data memory being adapted to store a program for controlling of the control unit and to store event data derived from data received via the analog to digital converter.
- the program is designed to enable the control unit to carry out a method for capture recognition via evaluation of a signal representing an electro cardiogram (ECG), said ECG comprising ECG signal sections corresponding to paced of spontaneous cardiac events.
- ECG electro cardiogram
- the device preferably is a implantable medical device, in particular a cardiac pacemaker.
- the method comprises
- a first reference event signal is derived by analyzing measured
- a second reference event signal is derived by analyzing measured ECG data corresponding to spontaneous events and
- an event classification phase wherein signal sections representing cardiac events of a given or measured ECG signal are classified by correlating the ECG signal section to one of at least two classes of events, the first event class representing paced events and the second event class representing spontaneous events, wherein the classification comprises the step of comparison of the signal sections of the given or measured ECG signals with both, the first and the second reference events, whereby during the step of comparison it is determined, whether characteristics of the signal section to be classified are closer to characteristics to the first of the second reference event, respectively.
- correlating is not limited to using a correlation function in a mathematical sense but shall include any form of logical association or assignment of a signal section to a given event class. This will become clear from the following description of a preferred embodiment.
- the objects of the invention are also achieved by the afore mentioned capture detection method for a capture detector and an implantable electrostimulation device.
- characteristic signal parameters are preferably one or more of the group of: signal amplitude, signal morphology, and signal time delay.
- a method for adjusting a pacing output amplitude comprising in an event classification phase following the reference definition phase the steps of:
- a pacing output amplitude change is smaller than a predetermined accuracy limit, stop the pacing output adjustment procedure.
- Pacing output amplitude adjustment shall have the effect that the pacing amplitude is high enough to ensure reliable pacing of the myo- card above a capture threshold without being higher than necessary. To high a pacing output amplitude would only result in an unnecessary waste of energy in view of the limited energy resources of an implantable device, without any further benefit.
- the method for adjusting a pacing output amplitude may preferably include the step of reporting a pacing threshold if a pacing output amplitude change is smaller than a predetermined accuracy limit.
- the objects of the invention are achieved by a medical device for capture recognition via evaluation of a signal representing an electro cardiogram (ECG), said ECG comprising ECG signal sections corresponding to paced of spontaneous cardiac events.
- ECG electro cardiogram
- the device comprises
- reference event definition means for defining at least two reference event signals by analysis of measured ECG data during a reference definition phase, the reference event definition means being adapted
- event classification means being adapted to classify signal sections representing cardiac events of a given or measured ECG signal by correlating the ECG signal section to one of at least two classes of events, the first event class representing paced events and the second event class representing spontaneous events during a event classification phase.
- the event classification means comprises a comparator being connected to the data memory and being adapted to compare a signal section of the given or measured ECG signals with both, the first and the second reference events stored in the data memory, wherein the com- parator is adapted to determine, whether characteristics of the signal section to be classified are closer to characteristics to the first of the second reference event, respectively.
- the device is a detector for use in a programmer or a programmer for a medical device such as an implantable cardiac pacemaker or cardioverter/defibrillator.
- the device is an implantable cardiac pacemaker or cardioverter/defibrillator.
- a capture detector which first carries out at reference definition thereby creating at least two reference event signals and later on relies on these reference event signals for classification of a detected event, the latter being a section of an ECG signal.
- a method for operating a capture detector of a medical stimulation device comprising two phases, a reference definition phase and a event classification phase,
- said reference definition phase comprises the steps of:
- said event classification phase comprising the steps of:
- Such method and a capture detector based on said method as well as a medical electrostimulation device incorporating such capture detector allow for both, reliable capture detection and an reliable automatic pacing output amplitude adjustment.
- Fig. 1 a composite reference event signal as derived by the method and the device of the invention
- Fig. 2 a flow diagram of the claimed capture detection method and algorithm
- Fig. 3 a graph describing the classification criteria within the measurement window (MW);
- Fig. 4 the outcome of an event classification according to the invention.
- Fig. 5 a schematic drawing of an implantable device according to the invention
- Fig. 6 a schematical drawing of an alternative embodiment of the invention including an implantable device, in particular a pace maker, and a programmer being able to interact with the implantable device via telemetry.
- FIG. 5 is a schematic representation of an implantable device accord- ing to the invention.
- the implantable device 10 may be a cardiac pacemaker or a cardioverter/defibrillator or both.
- the implantable device 10 can be connected to an electrode line via a connector (not shown).
- the electrode line serves to sense electrical potential of the myocard and to deliver them to the implantable device 10.
- This sensed electrical signals are amplified and filtered by an amplifier and filter section 12 of the implantable device and thereafter converted from analogue to digital by an analogue to digital converter 14.
- the digitally sampled signal is fed to a detector unit 16 of the implantable device.
- the detector unit 16 cares a reference event definition unit 18 and a signal classification unit 20. Both share common memory 22 for program code and data.
- the signal classification unit 20 and the reference event definition unit 18 are realised in form of program code as given by the capture detection algorithm listed herein after.
- the detector unit 16 therefore is part of a microcontroller in combination with a pro- gram enabling the microcontroller to act as detector unit.
- a reference event definition phase only the reference event definition unit 18 is active. Samples of measured ECG data corresponding to paced events are fed to the reference event definition unit 18. From these data the reference event definition unit 18 calculates a composite first reference event signal representing paced events.
- the reference event signal is described by three main criteria which are
- the reference event definition unit 18 is also fed with spontaneous events and derives there from a composite reference event as a second reference event signal characterising spontaneous events.
- the second reference event signal is char- acterised by the same criteria as the first reference event signal.
- the two reference event signals or the values of the criteria describing these reference event signals, respectively, are stored in memory 22.
- each sampled signal section coming from analogue to digital converter 14 is fed to the signal classification unit 20, which compares the characteristics of these signal sections with both, the first reference event signal and the second reference event signal and delivers an outgoing signal, depending on whether the signal section matches the first reference event signal or the second reference event signal or non of both. If the signal section to be classified matches the first reference event signal indicating a paced event a signal is fed to a stimulation unit 24 indicating, that a pacing output amplitude is above an excitation threshold of the myocard.
- the stimulation unit 24 has sent a signal to the signal classification unit 20 indicating that the pacing stimulus was put out and the signal classifi- cation unit 20 in term determines, that the resulting ECG signal section does not match the first reference event signal indicating capture, then the pacing output amplitude is to be adjusted to a higher value.
- the stimulation unit 22 of cause is connected to the connector for an electrode line to feat stimulation pulses to a stimulation electrode in a heart.
- figure 5 shows an implantable medical device like a pace- maker with a built in detector unit
- an implantable medical device 32 comprising a general control unit 34 being connected to a transceiver 36 is able to wirelessly communicate with the external programmer 30.
- the external programmer 30 comprises a transceiver section 38 imaging the transceiver 36 of the implantable device 42.
- the reference event definition unit 18 and the signal classification unit 20 receive intracardiac electrocardiograms.
- a programmer may be designed to receive surface electrocardiograms since calculation of an adequate pacing output amplitude is done in the external programmer and successful stimulation resulting in a capture event can be judged from the surface electrocardiogram as well.
- the present invention is a device that incorporates the results of mathematical modeling of the excitation mechanism of myocardial tis- sue.
- One such mathematical model is the model developed by D. Mues- sig and B. Hensel of the Department of Biomedical Engineering at Frie- drich-Alexander University, Er Weg, Germany, and to be reported as "Mechanism for the Excitation of Myocardial Tissue: Results Based an a Three-Dimensional Numerical Model" in the September, 2002, issue of Progress in Biomedical Research. A pre-publication copy of the article is attached hereto and made a part hereof by incorporation.
- An algorithm performing this function must contend with numerous interfering factors, and perform as accurately as an experienced human observer. Practical application requires that the algorithm has minimal effect on current consumption of the implant device, and be compatible with (and simplify the procedure for) many device types.
- the capture detection algorithm is written in an object- oriented language (see Python 2.1.3. programming language. Reference manual available from: URL: http://www.python.org/) using a integrated development environment (IDE) (see Komodo integrated development environment. Active State, USA. Reference manual available from: URL: http://www.activestate.com/). Simulations were performed on a standard desktop computer.
- the input data are pacemaker threshold tests formated as four channels (one marker, three surface ECG) from the ECG output of a pacemaker programmer (TMS1000, Biotronik) sampled at 1024 Hz and 12 bits per channel (DAQCard700, National Instruments, USA).
- Pacemaker implant follow-up is the setting intended for the use of CDA.
- the CDA will be integrated into the programmer soft- ware.
- the requirements for the operation of the CDA are as follows.
- the CDA requires a start signal from the user, and outputs termination, and error signals that communicate completion of classification or the need for operator intervention.
- the CDA must have access to the programmed values for pacing rate and AV- delay to set the appropriate measurement window (MW) length.
- the CDA must also receive pace, sense markers, and a time- sampled ECG data stream of at least one channel. Additional simultaneous ECG channels can also be used.
- the CDA provides two outputs.
- the principal output of the CDA is an event-by-event classification of capture/non-capture. This datum is used for adjusting subsequent pacing output voltage in the search for a threshold.
- Second, error conditions are returned by the CDA to inform the operator of the need for adjustment of the pacemaker to control the rhythm, or that signal input is compro- mised.
- the CDA operates in two main phases, a reference definition phase, and an event classification phase.
- the reference definition phase collects two sets of reference events, spontaneous rhythm events, and unequivocal pacer-controlled rhythm events. Obtaining the latter may require adjustment of the basic pacing rate and the
- FIG. 1 An example of a reference pacing event (composed from the individual events in a paced rhythm) is shown in Figure 1.
- the reference definition phase starts a continual noise threshold calculation from sample-by- sample data.
- Implanted devices were Actros SR(2), Actros DR (2), Dromos DR (3), Philos DR (6), Tachos DR (1 ), Gemnos IV (1 ), MycroPhylax (1 ), and Phylax XM (1 ). All devices were equipped with a bipolar lead. The time from implantation to data collection ranged from 5 to 1961 days with a median of 495 days.
- the accuracy of the CDA was verified by a comparison of algorithm results with an event-by-event human review of the above pacing threshold test clinical data using the following methods.
- the defining criteria for each event occurs in an MW, which is the time window comprising 512 ms for atrial pacing and 256 ms for ventricular pacing.
- the MW commences with the pacing marker and terminates after the defined number of samples in the ECG chan- nel under consideration.
- the three main criteria that define an event are
- PD is defined as time from the pacing marker to the most prominent peak found within the MW.
- a paced event earlier than the PD range is premature; if later than the PD range or entirely absent from the MW it is considered late.
- the SA is the voltage potential from the isoelectric line to the most prominent peak in the MW.
- An event in the classification phase must exceed the noise threshold (NT) and approximate the mean amplitude of the reference events.
- Signal shape is the similarity of the morphology of the event to that of the reference events formed during the definition phase. Therefore, the reference definition phase (the initial ten pacing events) is inspected to familiarize the human reviewer with the fundamental timing relationships and morphologies used to analyze subsequent events in the event classification phase.
- the classification phase follows, and the human reviewer observes pacing and sensing markers while comparing each marked event with the criteria determined in the definition phase.
- the reviewer understands that the pacing output volt-age is being systematically reduced, thus, the ECG record evolves to non-captured events.
- FIG. 3 An example of a ventricular paced reference event is shown in Figure 3.
- Figure 4 shows some outcomes of event classification, the results of which are tabulated in Table 1.
- the first marker identifies the ECG event as paced.
- the human reviewer it is 'on- time', of typical amplitude, and shape.
- the second, third, and fifth markers identify paces that yield no events above the NT.
- the fourth marker is correctly identified as a sense.
- the sixth marker identifies a pace that does not capture but yields a spontaneous event that differs visually in morphology.
- the human reviewer established the "golden" reference classification of captured and non-captured events. In total, 615 events were classified and successfully discriminated into 538 captured and 77 non-captured events.
- the comparison of the classification output of the CDA to the evaluation of the human resulted in a count of true positive, false positive, false negative, and true negative events (A, B, C, and D, respectively in Table 2).
- the CDA correctly discriminated effective from ineffective pacing stimuli, fulfilling one of the essential requirements of a pacing capture algorithm (see Guilleman D, Bussilet H, Scanu P, et al. Output Adjustment with the DDD pacemaker with Automatic Capture. Prog. Biomed Res. 1999; 4: 291-294).
- the CDA only operates on the programmer during the implant or follow-up pacing threshold test. Within this scope, the CDA can free the physician/operator to focus on higher- level tasks. Additionally, the CDA will improve the repeatability and reliability of pacing threshold tests by executing an optimized search algorithm.
- the CDA performs this at no additional current- cost to the implanted device.
- the CDA includes certain improvements with respect to other algorithms in the litera- ture (see Binner L, Brummer T, Hombach V, et al. Clinical Evaluation of a New DDD Pacemaker with Automatic Capture Control Using the Ventricular Evoked Response. Prog Biomed Res. 1997; 2: 69-72.).
- An adaptive noise threshold generated in the definition phase, rejects line-frequency, quantization, and smaller artifacts
- Event pre-processing also compensates for baseline drift.
- the algorithm indicates to the user if the signal morphology is inconsistent or the lead system is compromised.
- CDA has no requirement for specific event morphology, amplitude of after-potential, or special parameters entered by the user other than initial programming to control the intrinsic rhythm (see Espinosa Reynoso JJ, Hernandez Garcia HR, Sassara M, et al. First Clinical Results of a New Capture Control Algorithm Implemented in a Dual Chamber Rate- Adaptive Pacemaker.
- CDA needs only consistent reference events from which it defines exemplars for sense and pace (see Guilleman D, Bussilet H, Scanu P, et al. Output Adjustment with the DDD pacemaker with Automatic Capture. Prog Biomed Res. 1999; 4: 291-294).
- the algorithm is intended for use with surface ECG conveniently available from the output of a programmer. In fact, we were pleased to find that the algorithm was also robust to nonstandard lead placement of the three surface leads, such as, all leads placed within the outline of a handprint over the sternum.
- CDA can be used with any implanted device that can be addressed through this interface. Future improvements will integrate the CDA into a pacing threshold test on the next programmer platform. At that time, a larger, on-line clinical study will be performed allowing a more significant statement of accuracy of this algorithm.
- FIG. 4 addressed in the article above shows the classification criteria within the measurement window (MW).
- the measurement window for the ventricular pace event here is 256 ms.
- the peak delay (PD) for the event is 105 ms, and the signal amplitude (SA) is 420 mV (rescaled due to ECG output amplification).
- the dynamic noise threshold (NT) is continually adjusted sample-by-sample.
- the noise threshold is about 30 % of the signal amplitude here and represents a minimum threshold that the amplitude of an event must exceed in order to be discriminated from collinear noise.
- append (monotonic (filtDist, noiseWin, eventLimit)) mrk. append(markerCkr (fileSpec[l] ) ) ecgChan . append(srMkrsEcg[1] [inx+1] ) paceEvntLst. append ( [ ] ] paceMagnLst. append ( [ ] ] paceNoizLst. ppend ( [ ] J mkr2PaceLst. append ( [ ] ,' sensEvntLst. append ( [] ] sensMagnLst. ppend ( [ ] ] sensNoizLst.
- eBuf [ : ] candidate [mkr2PaceTim, paceMagn, paceEvent]
- def trnsPoz accepts matrix data as [ [cl] , [c2] , ... , [en] ] column vectors note: single column vector [cl] must be passed as [[cl]] calls getRow to slice off a row vector for transpose to column vector. Returns [ [rl] , [r2] , ... , [rn] ] .
- T [] for tx in range (len (data [0] )) : T. append (getRo (data, tx) ) return T CDA Version 8 Rev 2 (Python Listing)
- prodctLst [] for fx in range (len (fltLstl) ) : prodctLst . append(fltLstl [f ] * fltLst2 [f ] ) return prodctLst
- '''expect unknown to be a list of peak delay, magnitude, and actual event samples, in that order.
- minPeakDelay paceStats [0] [0] - 12*paceStats[0] [1]
- maxPeakDelay paceStats [0] [0] + 12*pa ⁇ eStats[0] [1]
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
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Abstract
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US40687602P | 2002-08-29 | 2002-08-29 | |
| US406876P | 2002-08-29 | ||
| PCT/EP2003/009520 WO2004019775A2 (fr) | 2002-08-29 | 2003-08-28 | Detecteur de capture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP1536860A2 true EP1536860A2 (fr) | 2005-06-08 |
Family
ID=31978373
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP03747937A Withdrawn EP1536860A2 (fr) | 2002-08-29 | 2003-08-28 | Detecteur de capture |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP1536860A2 (fr) |
| AU (1) | AU2003267019A1 (fr) |
| WO (1) | WO2004019775A2 (fr) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11742094B2 (en) | 2017-07-25 | 2023-08-29 | Teladoc Health, Inc. | Modular telehealth cart with thermal imaging and touch screen user interface |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4766901A (en) * | 1985-12-18 | 1988-08-30 | Telectronics N.V. | Rate responsive pacing system using the integrated evoked potential |
| US5350410A (en) * | 1992-11-23 | 1994-09-27 | Siemens Pacesetter, Inc. | Autocapture system for implantable pulse generator |
| US5766229A (en) * | 1996-04-15 | 1998-06-16 | Pacesetter, Inc. | Capture verification method and apparatus for implantable pacemaker utilizing heart rhythm stability measurements to minimize the likelihood of fusion |
| US5954756A (en) * | 1998-04-09 | 1999-09-21 | Medtronic, Inc. | Microprocessor capture detection circuit and method |
| US6324427B1 (en) * | 1999-01-26 | 2001-11-27 | Pacesetter, Inc. | Implantable cardiac stimulation device having T-wave discrimination of fusion events during autocapture/autothreshold assessment |
| US6512953B2 (en) * | 2000-05-11 | 2003-01-28 | Pacesetter, Inc. | System and method for automatically verifying capture during multi-chamber stimulation |
| JP2005506097A (ja) * | 2000-11-10 | 2005-03-03 | シー・アール・バード・インコーポレーテッド | 重畳複合を有する心電図信号を処理するシステム |
-
2003
- 2003-08-28 WO PCT/EP2003/009520 patent/WO2004019775A2/fr not_active Ceased
- 2003-08-28 EP EP03747937A patent/EP1536860A2/fr not_active Withdrawn
- 2003-08-28 AU AU2003267019A patent/AU2003267019A1/en not_active Abandoned
Non-Patent Citations (1)
| Title |
|---|
| See references of WO2004019775A3 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11742094B2 (en) | 2017-07-25 | 2023-08-29 | Teladoc Health, Inc. | Modular telehealth cart with thermal imaging and touch screen user interface |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2003267019A8 (en) | 2004-03-19 |
| WO2004019775A2 (fr) | 2004-03-11 |
| WO2004019775A3 (fr) | 2005-02-10 |
| AU2003267019A1 (en) | 2004-03-19 |
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