U.S. patent application number 16/537271 was filed with the patent office on 2020-01-02 for systems and methods for evaluation of electrophysiology systems.
The applicant listed for this patent is BIOSIG TECHNOLOGIES, INC.. Invention is credited to Budimir S. DRAKULIC, Sina FAKHAR, Thomas George FOXALL, Branislav VLAJINIC.
Application Number | 20200001036 16/537271 |
Document ID | / |
Family ID | 53371535 |
Filed Date | 2020-01-02 |
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United States Patent
Application |
20200001036 |
Kind Code |
A1 |
DRAKULIC; Budimir S. ; et
al. |
January 2, 2020 |
SYSTEMS AND METHODS FOR EVALUATION OF ELECTROPHYSIOLOGY SYSTEMS
Abstract
A signal processing evaluator and methods that compare a digital
waveform of a cardiac signal to a first processed signal generated
by a test system such as an EP recorder or an EP mapping system and
generates a first finding evaluating how well the test system
filters non-cardiac signals or simulated body impedance. A
simulator and methods that send cardiac signals including
non-cardiac signals or simulated body impedance to a test system
and to a signal processing evaluator for evaluation of the test
system.
Inventors: |
DRAKULIC; Budimir S.; (Los
Angeles, CA) ; FOXALL; Thomas George; (Surrey,
CA) ; FAKHAR; Sina; (Encino, CA) ; VLAJINIC;
Branislav; (Los Angeles, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOSIG TECHNOLOGIES, INC. |
Los Angeles |
CA |
US |
|
|
Family ID: |
53371535 |
Appl. No.: |
16/537271 |
Filed: |
August 9, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15103279 |
Jun 9, 2016 |
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PCT/NZ2014/050021 |
Dec 11, 2014 |
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16537271 |
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61914635 |
Dec 11, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0825 20140204;
A61M 16/0633 20140204; B29C 66/14 20130101; B29C 66/1122 20130101;
B29C 66/43 20130101; A61M 2207/00 20130101; B29C 66/723 20130101;
A61M 2205/42 20130101; A61M 16/0875 20130101; A61M 16/06 20130101;
A61M 16/0616 20140204; A61M 2202/0225 20130101; B29C 65/62
20130101; B29C 66/244 20130101; B29C 65/08 20130101; B29C 66/2442
20130101; B29L 2031/4835 20130101; B29C 66/12881 20130101; A61M
16/0683 20130101; A61M 2202/0225 20130101; A61M 2202/0085
20130101 |
International
Class: |
A61M 16/08 20060101
A61M016/08; A61M 16/06 20060101 A61M016/06 |
Claims
1-203. (canceled)
204. An electrophysiology (EP) simulator for determining the
accuracy of an EP recorder or mapping system in the acquisition of
cardiac signals comprising (a) a database connection to a database,
wherein the database is configured to store: i. a cardiac signal,
and ii. a simulated body impedance waveform, a cardiac feature
waveform, or a non-cardiac signal waveform; (b) a first circuitry
that alters the cardiac signal by combining: i. the cardiac signal
and; ii. the simulated body impedance waveform, the non-cardiac
signal waveform, the cardiac feature waveform, or a combination
thereof, thereby generating a simulated waveform; (d) a first
connection to a first test system, wherein the first test system is
an EP recorder system or a mapping system; (e) a second connection
to a first evaluator, wherein the second connection couples the EP
simulator to an evaluator; and (f) a second circuitry that provides
to the first evaluator: i. the cardiac signal; and ii. information
about whichever the simulated body impedance waveform, the cardiac
feature waveform, or the non-cardiac signal waveform used to
generate the simulated waveform.
205. The simulator of claim 204, wherein the cardiac signal
comprises one or more of the following: an electrocardiogram, a
unipolar electrogram, a bipolar electrogram, a cardiac activation
map, and a data necessary to generate the cardiac activation
map.
206. The simulator of claim 204, wherein the cardiac feature
waveform comprises a parameter having comprising a parameter value,
a change parameter in the parameter value, a shape value parameter
of one or more parameters, a shape change parameter that alters the
shape of the cardiac feature waveform or a portion thereof value,
or any combination thereof.
207. The simulator of claim 204, wherein the cardiac feature
waveform comprises a parameter of an electrocardiogram waveform or
of an electrogram waveform, the parameter comprising an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
208. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change parameter value in the cardiac signal
over time that includes a ST elevation, a Q wave formation, a T
wave inversion, and a Q-wave normalization with a persistent Q
waveparameter.
209. The simulator of claim 204, wherein the cardiac feature
waveform comprises S-waves in Lead I of a surface electrode 12-lead
ECG, and Q-waves, and inverted T-waves in Lead III of the surface
electrode 12-lead ECG.
210. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with indicative of a sinus arrhythmia, sinus
bradycardia, sinus arrhythmia, sinus arrest or pause, sino-atrial
exit block, a sinus valve (SV) arrhythmia, a non-conducted
premature atrial complex (PAC), a normally conducted PAC, a PAC
conducted with aberration, ectopic atrial rhythm or tachycardia
(unifocal), multifocal atrial rhythm or tachycardia, atrial
fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
211. The simulator of claim 210, wherein the atrial flutter
comprises: atrial flutter with 2:1 atrioventricular (AV)
conduction, atrial flutter with 3:2 conduction ratio, atrial
flutter with variable AV block and rate-dependent left bundle
branch block (LBBB), LBBB and atrial flutter with 2:1 AV block,
atrial flutter with 2:1 and 4:1 conduction and rate dependent LBBB,
atrial flutter with variable AV block, atrial flutter with 2:1
conduction, and/or atrial flutter with 2:1 block.
212. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with indicative of a ventricular arrhythmia, a premature
ventricular complex, a ventricular escape or rhythm, an accelerated
ventricular rhythm, uniform ventricular tachycardia, polymorphous
ventricular tachycardia, torsade ventricular tachycardia, and/or
ventricular fibrillation.
213. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with indicative of an atrioventricular conduction
abnormality comprising a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
214. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with indicative of intraventricular conduction
abnormality, complete LBBB (fixed or intermittent), incomplete
LBBB, left anterior fascicular block (LAFB), left posterior
fascicular block (LPFB), nonspecific intraventricular conduction
defect (IVCD), and/or a Wolff-Parkinson-White (WPW) pre-excitation
pattern.
215. The simulator of claim 204, wherein the cardiac feature
waveform comprises a pattern change in the cardiac signal, the
cardiac signal comprising a cardiac signal related to waveform
associated with a the QRS pattern, complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
216. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with indicative of hypertrophy or enlargement of a
cardiac anatomic aspect, left atrial enlargement, right atrial
enlargement, left ventricular hypertrophy, and/or right ventricular
hypertrophy.
217. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with reflecting a ST-T and/or U abnormality, left atrial
enlargement, nonspecific ST-T abnormalities, a ST segment
depression, ST elevation (transmural injury), ST elevation
(pericarditis pattern), symmetrical T wave inversion, symmetrical T
wave inversion reflecting inferior myocardial infarction (MI)
(fully evolved), hyperacute T waves, prominent upright U waves, U
wave inversion, and/or prolonged QT interval.
218. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with reflecting myocardial infarctions (MIs) including
acute, recent, and old MIs, inferior MI, inferoposterior MI,
inferoposterolateral MI, true posterior MI, anteroseptal MI,
anterior MI, anterolateral MI, high lateral MI, non Q-wave MI,
and/or right ventricular MI.
219. The simulator of claim 204, wherein the cardiac feature
waveform comprises a change in the cardiac signal waveform
associated with reflecting clinical disorders, the clinical
disorders comprising chronic pulmonary disease, hypokalemia, giant
TU fusion waves, hyperkalemia, hypocalcemia, hypercalcemia, and/or
digoxin effects.
220. The simulator of claim 204, wherein: a) the first circuitry
further alters the selected cardiac signal by combining a set
abnormality boundary level, a power, and/or an amount of the
cardiac feature waveform with the simulated body impedance
waveform, the non-cardiac signal waveform, or a combination
thereof, at about the abnormality boundary for the cardiac feature;
b) the set abnormality boundary level, the power, and/or the amount
of the cardiac feature waveform, the simulated body impedance
waveform, and/or the non-cardiac signal is at or about a
detectability boundary of the first test system or of a second test
system; and c) the detectability boundary is "N" times a minimum
detectability limit of the first test system, the value of N being
selected by one of the following: equal to or less than 2, equal to
or less than 3, equal to or less than 5, equal to or less than 10,
or equal to or less than 20.
221. The simulator of claim 220, wherein the set abnormality
boundary level is about 1 to about 20 times a detectability
boundary of the EP recorder.
222. The simulator of claim 204, wherein the first test system
comprises at least one of a recorder system and a mapping
system.
223. The simulator of claim 204, wherein non-cardiac signal
comprises a noise signal, a baseline wander signal, or an artifact
signal.
224. The simulator of claim 204, wherein the first test system
comprises at least one of a recorder system and a mapping
system.
225. The simulator of claim 204, wherein non-cardiac signal
comprises a noise signal, a baseline wander signal, or an artifact
signal.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. application Ser.
No. 15/103,278, filed Jun. 9, 2016, which is a U.S. National Stage
Entry of International Application Number PCT/US2014/070165, filed
Dec. 12, 2014, which claims the benefit of priority from U.S.
Provisional Application No. 61/915,451, filed Dec. 12, 2013, all of
which are incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] Electrophysiology, also referred to Cardiac
Electrophysiology, Clinical Cardiac Electrophysiology, and/or
Arrhythmia Services is a branch of the medical specialty of
clinical cardiology that studies and treats rhythm disorders of the
heart. Experts in this field are typically Cardiologists who are
referred to commonly as electrophysiologists. These experts are
trained in the mechanism, function, and performance of the
electrical activities of the heart, and work closely with other
cardiologists and cardiac surgeons to assist or guide therapy for
heart rhythm disturbances such as arrhythmias. They are often
trained to perform interventional and surgical procedures to treat
cardiac arrhythmia.
[0003] Typically, Electrophysiology evaluations or studies include
the insertion of pacing and recording electrodes either in the
esophagus (intra-esophageal) or, through blood vessels, directly
into the heart chambers (intra-cardiac) in order to measure
electrical properties of the heart and, in the case of
intra-cardiac electrophysiology studies, to electrically stimulate
it in the attempt to induce arrhythmias for diagnostic purposes
("programmed electrical stimulation").
SUMMARY OF THE INVENTION
[0004] Provided herein are devices, systems, and methods that
provide objective assessments of electrophysiology (EP) recorders
and mapping systems' accuracy in the acquisition of cardiac
signals. During electrophysiology (EP) studies, cardiac signals are
obtained by attaching multiple electrodes to a patient's chest and
limbs for surface electrocardiograms (ECG), and by inserting
catheter(s) inside the patient's heart for intracardiac (IC)
electrogram recordings. Cardiac signals are small and, therefore,
require amplification so they can become visible for physicians to
interpret and ultimately make clinical decisions. This is achieved
by connecting the recording electrodes to an amplifier--an integral
part of every EP recorder and mapping system. However, both wanted
cardiac and unwanted spurious signals are picked up by the
recording electrodes and will be amplified. The main spurious
signals that hamper the acquisition process are baseline wander,
noise and artifacts. Baseline wander causes cardiac signals to
shift from the isoelectric line. Noise is usually manifested in
recordings as a thick line masking the signal of interest--it
represents a combination of various unwanted signals that are
generated by the patient's body and the recording environment. In
some cases, the noise signal can be as big, or bigger, than the
signal carrying the cardiac information. Artifacts come from the
patient's body movements, bad or loose connections of electrodes to
skin or cardiac tissue, the recording environment, and various
other sources. In order for the cardiac signals to be interpreted
accurately by the physician, baseline wander, noise and artifacts
must be minimized.
[0005] Provided herein is an electrophysiology simulator (EP
simulator or simulator, herein) comprising a database connection to
a database, wherein the database comprises at least one cardiac
signal, and at least one or more of a simulated body impedance, a
cardiac feature, and a non-cardiac signal; first circuitry
configured to alter the cardiac signal by combining a digital
waveform of the cardiac signal or an analog waveform of the cardiac
signal with the simulated body impedance, the non-cardiac signal,
or a combination thereof, thereby generating a digital simulated
waveform or an analog simulated waveform; a D/A converter
configured to convert the digital simulated waveform to the analog
simulated waveform; a test system connection configured to couple
the simulator to a first test system; a first evaluator connection
configured to couple the simulator to an evaluator; and second
circuitry configured to provide to the evaluator: the digital
waveform or analog waveform of the cardiac signal, and information
about whichever simulated body impedance, cardiac feature, and/or
non-cardiac signal was used to generate the analog simulated
waveform or the digital simulated waveform. Note that the test
system connection is called this only to differentiate it from
other connections such as the database connection 110 between the
database and a computer or between the database and the simulator,
or such as the simulator connection 116 which may be between a
computer and a simulator, or such as the first evaluator connection
which may be between the evaluator and the simulator or between the
evaluator and the database or between the evaluator and the
database, or such as the second evaluator connection which may be
between the first test system and an evaluator.
[0006] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal.
[0007] In some embodiments, the cardiac signal comprises an
intracardiac electrogram, a surface electrocardiogram, or a test
signal. In some embodiments, the cardiac signal comprises one or
more of an electrocardiogram, a unipolar electrogram, and a bipolar
electrogram. In some embodiments, the cardiac signal comprises a
cardiac activation map or data necessary to generate the cardiac
activation map.
[0008] In some embodiments, the test signal comprises an
Electrocardiograph Committee (EC) standard waveform. In some
embodiments, the EC standard waveform is a standard for testing the
recorder or the mapping system as defined by ANSI or AAMI.
[0009] In some embodiments, the simulator comprises the
database.
[0010] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system.
[0011] In some embodiments, the test system connection couples to a
junction box which couples to the first test system. In some
embodiments, the junction box couples to an amplifier of the first
test system. In some embodiments, the junction box comprises at
least one electrophysiology catheter connector. In some
embodiments, the junction box comprises multiple electrophysiology
catheter connectors. In some embodiments, each of the
electrophysiology catheter connectors couples a different brand or
version of electrophysiology catheter to the first test system. In
some embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter connector. In
some embodiments, the simulator comprises the junction box.
[0012] In some embodiments, the device simulator comprises third
circuitry configured to combine the digital waveform of the cardiac
signal, the analog waveform of the cardiac signal, the digital
simulated waveform or the analog simulated waveform with the
cardiac feature. In some embodiments, the cardiac feature comprises
a parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0013] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof
[0014] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0015] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0016] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0017] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0018] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0019] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0020] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0021] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0022] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0023] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0024] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0025] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0026] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0027] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0028] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this could be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0029] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0030] In some embodiments, the information comprises how the
cardiac signal was altered. In some embodiments, the information
comprises the digital waveform or analog waveform of the cardiac
signal. In some embodiments, the information further comprises the
simulated body impedance and/or the non-cardiac signal used to
generate the analog simulated waveform or the digital simulated
waveform. In some embodiments, the information comprises the
digital waveform or analog waveform of the cardiac signal as
combined with the cardiac feature. In some embodiments, the
information further comprises the simulated body impedance and/or
the non-cardiac signal used to generate the analog simulated
waveform or the digital simulated waveform.
[0031] In some embodiments, the simulator comprises controls that
allow a user to choose or provide the cardiac signal to be altered
choose or provide the simulated body impedance, the non-cardiac
signal, and/or the combination thereof that is used to alter the
digital waveform or the analog waveform of the cardiac signal,
and/or choose the amount by which the cardiac signal is altered by
such body impedance, non-cardiac signal, and/or combination
thereof.
[0032] In some embodiments, the simulator comprises controls that
allow a user to choose or provide the cardiac signal to be altered,
choose or provide the simulated body impedance, the cardiac
feature, the non-cardiac signal, and/or the combination thereof
that is used to alter the digital waveform or the analog waveform
of the cardiac signal, and/or choose the amount by which the
cardiac signal is altered by such body impedance, cardiac feature,
non-cardiac signal, and/or combination thereof.
[0033] In some embodiments, the simulator comprises circuitry that
determines for a ser which cardiac signal from the database will be
altered which simulated body impedance, non-cardiac signal, and/or
combination thereof will be used to alter the digital waveform or
the analog waveform of the cardiac signal, and/or the amount by
which the cardiac signal is altered by such body impedance,
non-cardiac signal, and/or combination thereof.
[0034] In some embodiments, the simulator comprises circuitry that
determines for a user which cardiac signal from the database will
be altered which simulated body impedance, cardiac feature,
non-cardiac signal, and/or combination thereof will be used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or the amount by which the cardiac signal is altered by
such body impedance, cardiac feature, non-cardiac signal, and/or
combination thereof.
[0035] Provided herein is a method of simulating an analog
electrophysiologic signal comprising providing a digital waveform
of a cardiac signal or an analog waveform of the cardiac signal,
wherein the cardiac signal comprises an intracardiac electrogram, a
surface electrocardiogram, or a test signal from a database of
cardiac signals, altering the cardiac signal by combining either
the digital waveform or the analog waveform with a simulated body
impedance, a non-cardiac signal, or a combination thereof, thereby
generating a digital simulated waveform or an analog simulated
waveform, converting the digital simulated waveform, if generated,
to the analog simulated waveform, providing to a first test system
the analog simulated waveform, providing to the evaluator the
analog simulated waveform and/or the digital simulated waveform,
and information about the digital waveform or an analog waveform of
the cardiac signal, and/or whichever simulated body impedance,
cardiac feature, and/or non-cardiac signal was used to generate the
analog simulated waveform or the digital simulated waveform.
[0036] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI.
[0037] In some embodiments, the simulator comprises the database.
In some embodiments, the first test system comprises at least one
of a recorder and a mapping system.
[0038] In some embodiments, providing the analog simulated waveform
comprises providing a coupling that can be used to couple a
simulator that generated the analog simulated waveform to a
junction box and providing a coupling that can be used to couple
the junction box to the first test system. In some embodiments, the
coupling couples the junction box to the first test system couples
the junction box to an amplifier of the first test system. In some
embodiments, the junction box comprises at least one
electrophysiology catheter connector. In some embodiments, the
junction box comprises multiple electrophysiology catheter
connectors. In some embodiments, each of the electrophysiology
catheter connectors couples a different brand or version of
electrophysiology catheter to the first test system. In some
embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter
connector.
[0039] In some embodiments, the method comprises combining the
cardiac signal with the non-cardiac signal. In some embodiments,
the method comprises combining the digital waveform of the cardiac
signal, the analog waveform of the cardiac signal, the digital
simulated waveform or the analog simulated waveform with the
cardiac feature.
[0040] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0041] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0042] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0043] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0044] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0045] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supravetricular
tachycardia.
[0046] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrail flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0047] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0048] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0049] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0050] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0051] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0052] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0053] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0054] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0055] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0056] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this could be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0057] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0058] In some embodiments, the information comprises how the
cardiac signal was altered. In some embodiments, the information
comprises the digital waveform or analog waveform of the cardiac
signal. In some embodiments, the information comprises the
simulated body impedance, and/or the non-cardiac signal used to
generate the analog simulated waveform or the digital simulated
waveform. In some embodiments, the information comprises the
digital waveform or analog waveform of the cardiac signal as
combined with the cardiac feature. In some embodiments, the
information further comprises the simulated body impedance and/or
the non-cardiac signal used to generate the analog simulated
waveform or the digital simulated waveform.
[0059] In some embodiments, the method comprises providing controls
that allow a user to choose or provide the cardiac signal to be
altered choose or provide the simulated body impedance, the
non-cardiac signal, and/or the combination thereof that is used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or choose the amount by which the cardiac signal is
altered by such body impedance, non-cardiac signal, and/or
combination thereof.
[0060] In some embodiments, the method comprises providing controls
that allow a user to choose or provide the cardiac signal to be
altered choose or provide the simulated body impedance, the cardiac
feature, the non-cardiac signal, and/or the combination thereof
that is used to alter the digital waveform or the analog waveform
of the cardiac signal, and/or choose the amount by which the
cardiac signal is altered by such body impedance, cardiac feature,
non-cardiac signal, and/or combination thereof.
[0061] In some embodiments, the method comprises providing
circuitry that determines for a user which cardiac signal from the
database will be altered which simulated body impedance,
non-cardiac signal, and/or combination thereof will be used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or the amount by which the cardiac signal is altered by
such body impedance, non-cardiac signal, and/or combination
thereof.
[0062] In some embodiments, the method comprises providing
circuitry that determines for a user which cardiac signal from the
database will be altered which simulated body impedance, cardiac
feature, non-cardiac signal, and/or combination thereof will be
used to alter the digital waveform or the analog waveform of the
cardiac signal, and/or the amount by which the cardiac signal is
altered by such body impedance, cardiac feature, non-cardiac
signal, and/or combination thereof.
[0063] Provided herein is a signal processing evaluator comprising:
a digital waveform of a cardiac signal or an analog waveform of the
cardiac signal, a first processed signal received from a first test
system, wherein the first processed signal is the result of digital
processing of an analog simulated waveform by the first test
system, wherein the analog simulated waveform was generated by
combining the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal with a simulated body impedance, a
non-cardiac signal, and/or a combination thereof, and third
circuitry that compares the digital waveform of the cardiac signal
or the analog waveform of the cardiac signal to the first processed
signal and generates a first finding evaluating the first test
system.
[0064] In some embodiments, the first finding depicts or describes
how closely matched the first processed signal is to the digital
waveform of the cardiac signal or to the analog waveform of the
cardiac signal.
[0065] In some embodiments, the evaluator comprises information
about the simulated body impedance, the non-cardiac signal, and/or
the combination thereof that was used to generate the analog
simulated waveform.
[0066] In some embodiments, the evaluator comprises second
circuitry that compares the first finding to a second finding in
order to evaluate the first test system, or in order to compare a
first test system to a second test system. In some embodiments, the
second finding depicts or describes how closely matched a second
processed signal that is the result of digital processing of the
analog simulated waveform by a second test system is to the digital
waveform of the cardiac signal or to the analog waveform, and
generates an evaluation regarding which of the first test system
and the second test system better processes the analog simulated
waveform.
[0067] In some embodiments, the first finding expresses the
effectiveness of the first test system in reproducing the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal from the analog simulated waveform.
[0068] In some embodiments, the first circuitry is configured to
compare a second digital waveform of a second cardiac signal or
second analog waveform of the second cardiac signal to a second
processed signal. In some embodiments, the second processed signal
is a result of digital processing of a second analog simulated
waveform by the first test system, wherein the second analog
simulated waveform is generated based on the second digital
waveform of the second cardiac signal or the second analog waveform
of the cardiac signal and a second simulated body impedance, a
second non-cardiac signal, and/or a combination thereof.
[0069] In some embodiments, the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal comprises a
cardiac feature. In some embodiments, the first finding expresses
how well the first test system preserves the cardiac feature in the
first processed signal as compared to the digital waveform of the
cardiac signal or to the analog waveform of the cardiac signal.
[0070] In some embodiments, the evaluator comprises information
about the cardiac feature.
[0071] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0072] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0073] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0074] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0075] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the the cardiac feature
comprises S-waves in Lead I of a surface electrode 12-lead ECG, and
Q-waves and inverted T-waves in Lead III of the surface electrode
12-lead ECG.
[0076] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0077] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrail flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0078] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0079] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0080] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0081] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0082] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0083] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0084] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0085] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0086] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0087] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this could be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0088] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0089] In some embodiments, the first finding expresses how well
the first test system removes the non-cardiac signal from the
analog simulated waveform. In some embodiments, the first finding
expresses how well the first test system removes the simulated body
impedance from the analog simulated waveform. In some embodiments,
the first circuitry is configured to assess the first processed
signal and the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal in the time domain, frequency
domain, or a combination thereof.
[0090] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, cardiac signal comprises an intracardiac
electrogram, a surface electrocardiogram, or a test signal. In some
embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI. In some embodiments, the
cardiac signal comprises one or more of an electrocardiogram, a
unipolar electrogram, and a bipolar electrogram. In some
embodiments, the first processed signal comprises a reconstructed
cardiac activation map or data necessary to generate the
reconstructed cardiac activation map.
[0091] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the recorder comprises an electrophysiology recorder. In some
embodiments, the mapping system comprises an electrophysiology
mapping system. In some embodiments, the first test system
comprises an analog filter or a digital filter or a combination
thereof configured to process the analog simulated waveform in
order to generate the first processed signal.
[0092] In some embodiments, the evaluator comprises an evaluator
connection to the first test system. In some embodiments, the
evaluator comprises a database or a database connection to a
database, wherein the database comprises the cardiac signal, and at
least one of the simulated body impedance and the non-cardiac
signal. In some embodiments, the database comprises a cardiac
feature.
[0093] In some embodiments, the evaluator comprises first circuitry
configured to alter the cardiac signal by combining the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal with the simulated body impedance, the non-cardiac
signal, or a combination thereof, thereby generating a digital
simulated waveform or an analog simulated waveform. In some
embodiments, the evaluator comprises a D/A converter configured to
convert the digital simulated waveform to the analog simulated
waveform. In some embodiments, the evaluator comprises the
database.
[0094] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the test system connection couples to a junction box which couples
to the first test system. In some embodiments, the junction box
couples to an amplifier of the first test system. In some
embodiments, the junction box comprises at least one
electrophysiology catheter connector. In some embodiments, the
junction box comprises multiple electrophysiology catheter
connectors. In some embodiments, each of the electrophysiology
catheter connectors couples a different brand or version of
electrophysiology catheter to the first test system. In some
embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter connector. In
some embodiments, the simulator comprises the junction box.
[0095] Provided herein is a method comprising: providing a signal
processing evaluator to a user, wherein the evaluator comprises a
digital waveform of a cardiac signal or an analog waveform of the
cardiac signal, a first processed signal received from a first test
system, wherein the first processed signal is the result of digital
processing of an analog simulated waveform by the first test
system, wherein the analog simulated waveform was generated by
combining the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal with a simulated body impedance, a
non-cardiac signal, and/or a combination thereof, and third
circuitry that compares the digital waveform of the cardiac signal
or the analog waveform of the cardiac signal to the first processed
signal and generates a first finding evaluating the first test
system.
[0096] Provided herein is a method comprising: receiving a first
processed signal from a first test system, wherein the first
processed signal is the result of digital processing of an analog
simulated waveform by the first test system, wherein the analog
simulated waveform was generated by combining a digital waveform of
a cardiac signal or an analog waveform of the cardiac signal with a
simulated body impedance, a non-cardiac signal, and/or a
combination thereof, comparing the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal to the first
processed signal, generating a first finding that evaluates the
first test system, and providing the first finding to a user.
[0097] In some embodiments, the first finding depicts or describes
how closely matched the first processed signal is to the digital
waveform of the cardiac signal or to the analog waveform of the
cardiac signal.
[0098] In some embodiments, the method comprises providing
information about the simulated body impedance, the non-cardiac
signal, and/or the combination thereof that was used to generate
the analog simulated waveform. In some embodiments, the method
comprises comparing the first finding to a second finding
evaluating a second test system. In some embodiments, the second
finding depicts or describes how closely matched a second processed
signal that is the result of digital processing of the analog
simulated waveform by a second test system is to the digital
waveform of the cardiac signal or to the analog waveform, and
generates an evaluation regarding which of the first test system
and the second test system better processes the analog simulated
waveform.
[0099] In some embodiments, the first finding expresses the
effectiveness of the first test system in reproducing the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal from the analog simulated waveform.
[0100] In some embodiments, the method comprises comparing a second
digital waveform of a second cardiac signal or second analog
waveform of the second cardiac signal to a second processed signal.
In some embodiments, the second processed signal is a result of
digital processing of a second analog simulated waveform by the
first test system, wherein the second analog simulated waveform is
generated based on the second digital waveform of the second
cardiac signal or the second analog waveform of the cardiac signal
and a second simulated body impedance, a second non-cardiac signal,
and/or a combination thereof.
[0101] In some embodiments, the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal comprises a
cardiac feature. In some embodiments, the first finding expresses
how well the first test system preserves the cardiac feature in the
first processed signal as compared to the digital waveform of the
cardiac signal or to the analog waveform of the cardiac signal.
[0102] In some embodiments, the method comprises providing
information about the cardiac feature.
[0103] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0104] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof
[0105] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0106] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0107] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0108] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0109] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0110] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0111] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0112] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0113] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0114] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0115] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0116] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0117] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0118] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0119] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this could be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0120] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is <1=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is <1=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0121] In some embodiments, the first finding expresses how well
the first test system removes the non-cardiac signal from the
analog simulated waveform. In some embodiments, the first finding
expresses how well the first test system removes the simulated body
impedance from the analog simulated waveform.
[0122] In some embodiments, the method comprises assessing the
first processed signal and the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal in the time
domain, frequency domain, or a combination thereof.
[0123] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, the cardiac signal comprises an intracardiac
electrogram, a surface electrocardiogram, or a test signal. In some
embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI.
[0124] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the recorder comprises an electrophysiology recorder. In some
embodiments, the mapping system comprises an electrophysiology
mapping system. In some embodiments, the first test system
comprises an analog filter or a digital filter or a combination
thereof configured to process the analog simulated waveform in
order to generate the first processed signal. In some embodiments,
the cardiac signal comprises one or more of an electrocardiogram, a
unipolar electrogram, and a bipolar electrogram. In some
embodiments, the first processed signal comprises a reconstructed
cardiac activation map or data necessary to generate the
reconstructed cardiac activation map.
[0125] In some embodiments, the method comprises generating the
analog simulated waveform by combining the digital waveform of the
cardiac signal or the analog waveform of the cardiac signal with
the simulated body impedance, the non-cardiac signal, or the
combination thereof. In some embodiments, the method comprises
converting a digital simulated waveform of the digital waveform of
the cardiac signal as combined with the simulated body impedance,
the non-cardiac signal, or the combination thereof to the analog
simulated waveform. In some embodiments, the method comprises
receiving the one or more of the digital waveform of the cardiac
signal, the analog waveform of the cardiac signal, the simulated
body impedance, the non-cardiac signal, or a cardiac feature from a
database.
[0126] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system.
[0127] In some embodiments, the method comprises providing a
junction box which couples to the first test system. In some
embodiments, the junction box couples to an amplifier of the first
test system. In some embodiments, the junction box comprises at
least one electrophysiology catheter connector. In some
embodiments, the junction box comprises multiple electrophysiology
catheter connectors. In some embodiments, each of the
electrophysiology catheter connectors couples a different brand or
version of electrophysiology catheter to the first test system. In
some embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter
connector.
INCORPORATION BY REFERENCE
[0128] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0129] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0130] FIG. 1A depicts a block diagram of an embodiment of a system
wherein an EP recorder is under test and workstation is remote.
[0131] FIG. 1B depicts a block diagram of an embodiment of a
simulator wherein the EP mapping system is under test and
workstation is remote.
[0132] FIG. 1C depicts a block diagram of an embodiment of a system
wherein the workstation is local.
[0133] FIG. 2 depicts a block diagram of an embodiment of the EP
simulator.
[0134] FIG. 3 depicts a block diagram of an example of an
embodiment of an EP catheter.
[0135] FIGS. 4A and 4B depict an embodiment of a shortened QT and a
prolonged QT interval, respectively, wherein the x-axis is time and
the y-axis is voltage.
[0136] FIG. 5 depicts an embodiment of an inverted T wave wherein
the x-axis is time and the y-axis is voltage.
[0137] FIG. 6 depicts an embodiment of a hyperacute T wave wherein
the T wave is prominent and pointed, and wherein x-axis is time and
the y-axis is voltage.
[0138] FIG. 7 depicts an embodiment of a wide QRS complex wherein
the x-axis is time and the y-axis is voltage.
[0139] FIG. 8 depicts an embodiment of a prominent U wave wherein
the x-axis is time and the y-axis is voltage.
[0140] FIG. 9 depicts an embodiment of a typical progression of
myocardial infarction represented by a sequence of ST elevation, Q
wave formation, T wave inversion, and normalization with a
persistent Q wave.
[0141] FIG. 10 depicts an embodiment of a typical characterization
of digoxin intoxication represented by a deeply curved ST wave.
[0142] FIG. 11 depicts an embodiment of a typical characterization
of pulmonary embolism represented by S-waves in lead I, Q-waves in
lead III, and inverted T-waves in lead III of a surface electrode
12-lead ECG.
[0143] FIG. 12 depicts an embodiment of a typical characterization
of epileptic seizures represented by abrupt changes in heart
rate.
[0144] FIG. 13 depicts an embodiment of a typical characterization
of atrial fibrillation represented by the absence of P-waves and
absence of the iso-electric line.
[0145] FIG. 14 depicts a flow chart of an embodiment of a
modification of a waveform by a simulator. Other examples and
embodiments are possible, based on the description herein, at
least.
[0146] FIG. 15 depicts an embodiment of a digital waveform of a
cardiac signal retrieved from a database.
[0147] FIG. 16 depicts an embodiment of a method of evaluating how
well a test system filters simulated body impedance and non-cardiac
signals from an analog simulated signal, and preserves certain
cardiac features or modifications to a cardiac signal.
[0148] FIG. 17 depicts the embodiment of a flow of data from the
database into the EP simulator and into the evaluator which
compares the original data and the data after testing under the EP
recorder, EP mapping system, or both.
DETAILED DESCRIPTION OF THE INVENTION
[0149] Provided herein are devices, systems, and methods that
provide objective assessments of electrophysiology (EP) recorders
and mapping systems' accuracy in the acquisition of cardiac
signals. During electrophysiology (EP) studies, cardiac signals are
obtained by attaching multiple electrodes to a patient's chest and
limbs for surface electrocardiograms (ECG), and by inserting
catheter(s) inside the patient's heart for intracardiac (IC)
electrogram recordings. Cardiac signals are small and, therefore,
require amplification so they can become visible for physicians to
interpret and ultimately make clinical decisions. This is achieved
by connecting the recording electrodes to an amplifier--an integral
part of every EP recorder and mapping system. However, both wanted
cardiac and unwanted spurious signals are picked up by the
recording electrodes and will be amplified. The main spurious
signals that hamper the acquisition process are baseline wander,
noise and artifacts. Baseline wander causes cardiac signals to
shift from the isoelectric line. Noise is usually manifested in
recordings as a thick line masking the signal of interest--it
represents a combination of various unwanted signals that are
generated by the patient's body and the recording environment. In
some cases, the noise signal can be as big, or bigger, than the
signal carrying the cardiac information. Artifacts come from the
patient's body movements, bad or loose connections of electrodes to
skin or cardiac tissue, the recording environment, and various
other sources. In order for the cardiac signals to be interpreted
accurately by the physician, baseline wander, noise and artifacts
can be minimized by evaluating the test system using the evaluator
described herein in order to determine if the test system can
sufficiently remove such non-cardiac signals and body impedance
without removing certain features of the cardiac signal (called
cardiac features, herein).
[0150] To form clinical decisions, physicians evaluate and measure
different parameters of electrocardiogram and electrogram
waveforms. These parameters typically include: the P wave, a QRS
complex, a T wave, a U wave, and the isoelectric line.
[0151] As waveforms represent underlying disease, differential
diagnostic decisions are made based on changes in shape and
parameter values at certain points. Values labeled as "normal" or
within certain boundaries will not require clinical intervention,
while changes in waveforms that are disease-related may require
clinical intervention.
[0152] For non-limiting example, waveforms depicting a shortened or
prolonged QT interval can indicate hypercalcemia, hypderkalemia,
hypocalcemia, certain drug effects, or certain genetic
abnormalities. FIG. 4A and FIG. 4B depicts a shortened QT interval
55 and a prolonged QT interval 56, respectively, where the x-axis
is time and the y-axis is voltage. Waveforms depicting a flattened
or inverted T wave can indicate coronary ischemia, hypokalemia,
left ventricular hypertrophy, digoxin effect, or certain drug
effects. FIG. 5 depicts an inverted T wave where the x-axis is time
and the y-axis is voltage. Waveforms depicting hyperacute T waves
can indicate acute myocardial infarction. FIG. 6 depicts a
hyperacute T wave where the T wave is prominent and pointed, and
where x-axis is time and the y-axis is voltage. Waveforms depicting
a wide QRS complex can indicate hyperkalemia. FIG. 7 depicts a wide
QRS complex where the x-axis is time and the y-axis is voltage.
Waveforms depicting a prominent U wave can indicate hyperkalemia.
FIG. 8 depicts a prominent U wave where the x-axis is time and the
y-axis is voltage.
[0153] Certain other diseases are indicated by specific patterns in
ECG recordings. Myocardial infarction is typically characterized by
an ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave (shown in FIG. 9). Digoxin
intoxication is typically characterized by a deep curved ST wave
(shown in FIG. 10). Pulmonary embolism is typically characterized
by S-waves in lead I, Q-waves in lead III, and inverted T-waves in
lead III (shown in FIG. 11). Epileptic seizures are typically
characterized by abrupt changes in heart rate (shown in FIG. 12).
Atrial fibrillation is typically characterized by absence of
P-waves and absence of the isoelectric line (shown in FIG. 13).
[0154] Test systems (such as EP recorders and mapping systems) use
a combination of analog and digital filters to remove noise,
baseline wander and artifact signals, which may be called
non-cardiac signals herein. The main problem with this approach is
that this technique not only partially removes spurious signals,
but this process also alters the true signal morphology and the
content of the original cardiac information. The shape and
amplitude of electrocardiograms, unipolar electrograms, bipolar
electrograms, and, consequently, the reconstructed cardiac
activation maps, are influenced not only by electrophysiological
and structural characteristics of the myocardial tissue involved,
but with characteristics of the recording system used for signal
acquisition.
[0155] Artifacts, or artifact signals, may be physiological and/or
non-physiological. Physiological artifact signals include, in
certain embodiments, signals from muscles other than the heart that
appear as narrow, rapid spikes associated with muscle movement, as
well as the skin which produces voltage of several millivolts that
can be generated by stretching the epidermis. Non-physiological
artifact signals include, in certain embodiments, the 60 Hz energy
from an electrical wall source which is received in the lead wires
and by the patient, the offset potential voltage that is stored by
the electrode, and breaks in the wires and connections between the
electrode and the monitor.
[0156] Amplitude and morphology of ECG and IC signals are
significantly affected by filters used to remove the unwanted
signals. As cardiac signals (generated by the human body) are
unknown, it is difficult to objectively evaluate the effect of
various analog and digital signal processing schemes used to remove
unwanted signals during signal acquisition. There are a number of
amplitude and interval measurements taken on the acquired signals
during an EP study. In order to make proper clinical decisions, it
is imperative that the recording system faithfully acquires
spatiotemporal characteristics of surface ECG and intracardiac
electrograms. If the EP recording system generates "phantom" data
which mimics a cardiac disease, it can cause the physician to make
a wrong clinical decision.
Simulator
[0157] The simulator described herein can change the waveshapes of
a cardiac signal to correspond to various waveshapes of diseases.
It can also or alternatively change the waveshape of the cardiac
signal in a fine-tuned manner to result in a small change in
waveshape, which may or may not be clinically abnormal. This fine
tuning may allow the evaluator described herein to determine if a
particular test system can detect the finely changed waveform and
detect smaller changes to the waveform relevant to particular
disease states that are associated with small changes, or are in
the early stages of development, or are typically undetectable by
standard test systems because these test systems filter out small
changes and do not flag or indicate such small changes as
abnormal.
[0158] Provided herein is an electrophysiology simulator comprising
a database connection to a database, wherein the database comprises
at least one cardiac signal, and at least one or more of a
simulated body impedance, a cardiac feature, and a non-cardiac
signal; first circuitry configured to alter the cardiac signal by
combining a digital waveform of the cardiac signal or an analog
waveform of the cardiac signal with the simulated body impedance,
the non-cardiac signal, or a combination thereof, thereby
generating a digital simulated waveform or an analog simulated
waveform; a D/A converter configured to convert the digital
simulated waveform to the analog simulated waveform; a test system
connection configured to couple the simulator to a first test
system; a first evaluator connection configured to couple the
simulator to an evaluator; and second circuitry configured to
provide to the evaluator: the digital waveform or analog waveform
of the cardiac signal, and information about whichever simulated
body impedance, cardiac feature, and/or non-cardiac signal was used
to generate the analog simulated waveform or the digital simulated
waveform.
[0159] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal.
[0160] In some embodiments, the cardiac signal comprises an
intracardiac electrogram, a surface electrocardiogram, or a test
signal. In some embodiments, the cardiac signal comprises one or
more of an electrocardiogram, a unipolar electrogram, and a bipolar
electrogram. In some embodiments, the cardiac signal comprises a
cardiac activation map or data necessary to generate the cardiac
activation map.
[0161] In some embodiments, the test signal comprises an
Electrocardiograph Committee (EC) standard waveform. In some
embodiments, the EC standard waveform is a standard for testing the
recorder or the mapping system as defined by ANSI or AAMI.
[0162] In some embodiments, the simulator comprises the
database.
[0163] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system.
[0164] In some embodiments, the test system connection couples to a
junction box which couples to the first test system. In some
embodiments, the junction box couples to an amplifier of the first
test system. In some embodiments, the junction box comprises at
least one electrophysiology catheter connector. In some
embodiments, the junction box comprises multiple electrophysiology
catheter connectors. In some embodiments, each of the
electrophysiology catheter connectors couples a different brand or
version of electrophysiology catheter to the first test system. In
some embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter connector. In
some embodiments, the simulator comprises the junction box.
[0165] In some embodiments, the device simulator comprises third
circuitry configured to combine the digital waveform of the cardiac
signal, the analog waveform of the cardiac signal, the digital
simulated waveform or the analog simulated waveform with the
cardiac feature. In some embodiments, the cardiac feature comprises
a parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0166] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0167] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0168] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0169] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0170] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0171] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0172] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0173] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0174] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0175] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0176] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of
an cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0177] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0178] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0179] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0180] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0181] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this could be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0182] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
EXAMPLE 1
[0183] Characteristics of the digitized waveforms in time domain
can be described with two parameters: time (ti (i=1, n)) and value
x at that specific point in time. Time can be expressed in seconds
or fraction of seconds. Usually, t1 denotes the start of the
recording, and ti represents the data point during the recording,
while .DELTA.t is time between two successive samples. Value x, at
a given point in time ti, can be expressed in different units
(voltage, current, pressure . . . etc.). This depends on what type
of transducer is used to transfer physiological parameters into
electrical signals.
[0184] For every position ti on the digitized waveform, the x value
can be modified. This process involves identification of a time
point at ti and changing the parameter value from x to
x.+-..DELTA.x. .DELTA.x represents the value of the desired change
expressed in p.times.q, where q is the lower end of resolution (for
example when x is voltage, the resolution q is the LSB or least
significant bit) of the A/D converter (function of resolution and
full scale range) and p is an integer that is a best fit to achieve
desired change. The A/D converter (also called an "ADC") may be in
the test system itself, thus the Simulator x value may be modified
based on the minimum resolution of the (lower end) of resolution of
the test system.
[0185] FIG. 14 depicts a flow chart of an example modification of a
waveform by a simulator. Other examples and embodiments are
possible, based on the description herein, at least. In step A of
FIG. 14, a simulator retrieves a digital waveform of a cardiac
signal from a database. That is, a digital waveform of a cardiac
signal may be provided to the simulator from a database. The
database may be part of the simulator or remotely existing (for
example in a computer workstation or handheld device). In Step B of
FIG. 14, a user decides and identifies the parameter value x at a
particular time (denoted as t.sub.i) that they wish to change.
Alternatively the simulator or computer program at a computer or
workstation may automatically choose such value and time, depending
on a particular disease that may be of interest, or based on the
limits of the test system, or based on another boundary
determination, or based on a user input. The digital value x at
time i (t.sub.i) in Step C of FIG. 14 is then altered by a delta x
(.DELTA.x) at the time point This may be repeated any number of
times for the value x at different times in order to change a
waveform shape or amplitude or other aspect, or a single change may
be made in order to evaluate the test system. Other values may
alternatively or additionally be changed at the same time (t.sub.i)
or at different times. The choice of the change of x (.DELTA.x) may
be based on the resolution of the test system itself, or on the
resolution of the A/D converter used in the test system. That is,
the value of the desired change expressed in p.times.q, where q is
the lower end of resolution (for example when x is voltage, the
resolution q is the LSB or least significant bit) of the A/D
converter (function of resolution and full scale range) and p is an
integer that is a best fit to achieve desired change. The A/D
converter (also called an "ADC") is part of the test system itself,
thus the simulator x value may be modified based on the minimum
resolution of the (lower end) of resolution of the test system.
[0186] In common ADCs, the LSB is the minimum change in voltage
required to guarantee a change in the output code level. Thus, the
resolution q of the ADC is equal to the LSB voltage.
[0187] The resolution of the ADC indicates the number of discrete
values it can produce over the range of analog values. The
resolution is usually expressed in bits and the number of discrete
values available, or "levels", is a power of two. The values can
represent the ranges from 0 to 255 (i.e. unsigned integer) or from
-128 to 127 (i.e. signed integer), depending on the application.
The voltage resolution of an ADC is equal to its overall voltage
measurement range divided by the number of discrete values:
Q=E.sub.FSR/(2.sup.M-1) wherein M is the ADC's resolution in bits
and E.sub.FSR is the full scale voltage range (also called `span`).
E.sub.FSR is given by E.sub.FSR=V.sub.RefHi-V.sub.RefLow wherein
V.sub.RefHi and V.sub.RefLow are the upper and lower extremes,
respectively, of the voltages that can be coded. Normally, the
number of voltage intervals is given by N=(2.sup.M-1) wherein M is
the ADC's resolution in bits. That is, one voltage interval is
assigned in between two consecutive code levels. In practice, the
useful resolution of a converter is limited by the best
signal-to-noise ratio (SNR) that can be achieved for a digitized
signal. An ADC can resolve a signal to only a certain number of
bits of resolution, called the effective number of bits (ENOB). One
effective bit of resolution changes the signal-to-noise ratio of
the digitized signal by 6 dB, if the resolution is limited by the
ADC. If a preamplifier has been used prior to A/D conversion, the
noise introduced by the amplifier can be an important contributing
factor towards the overall signal to noise ratio (SNR).
[0188] Once the value of x at time i (t.sub.i) is changed and any
other changes to the same or another value are complete (if any),
in Step D of FIG. 14 the digital waveform is converted by a D/A
converter ("DAC") and an analog simulated waveform is
generated.
[0189] Prior to or after this D/A conversion, a simulated impedance
or a non-cardiac signal may be combined with the digital simulated
waveform or to the analog simulated waveform, respectively. The
purpose of this is to simulate the non-cardiac and impedance that
may occur in real EC recordings which the test systems are designed
to try to filter in order to generate a processed signal that still
identifies and captures the change in value x (.DELTA.x) at time i
(and/or any other changes) that were introduced to the cardiac
signal from the database.
[0190] In some embodiments the retrieving, identifying of the value
x to change and the time i at which to change it and the
modification of the value x is done at a computer that is coupled
to a DAC. The modified digital simulated waveform is thus
downloaded to a microcontroller comprising circuitry that can
convert the digital simulated waveform to an analog simulated
waveform, or can combine the digital simulated waveform with a
non-cardiac signal or a simulated body impedance, or other signal.
Alternatively, prior to downloading, the digital simulated waveform
may be further altered by a non-cardiac signal or a simulated body
impedance or another signal and subsequently downloaded to the
microcontroller that can load the digital simulated waveform
(altered thereby) into the DAC. The DAC may be coupled to a
junction box, as described herein, or to the test system directly
or indirectly through a catheter or by another connection source
(cord, remote, wifi, etc.)
[0191] In some embodiments, the simulator converts a digital
waveform, such as the digital simulated waveform, which could be
the digital waveform of a cardiac signal either with or without an
additional cardiac feature combined therewith and including a
simulated impedance or a non-cardiac signal, to an analog simulated
waveform using a DAC. For non-limiting example, common types of
electronic DACs include the following forms.
[0192] One example DAC is a pulse-width modulator, the simplest DAC
type. A stable current or voltage is switched into a low-pass
analog filter with a duration determined by the digital input code.
This technique is often used for electric motor speed control, but
has many other applications as well.
[0193] Another example DAC is an oversampling DAC or interpolating
DAC such as the delta-sigma DAC, use a pulse density conversion
technique. The oversampling technique allows for the use of a lower
resolution DAC internally. A simple 1-bit DAC is often chosen
because the oversampled result is inherently linear. The DAC is
driven with a pulse-density modulated signal, created with the use
of a low-pass filter, step nonlinearity (the actual 1-bit DAC), and
negative feedback loop, in a technique called delta-sigma
modulation. This results in an effective high-pass filter acting on
the quantization (signal processing) noise, thus steering this
noise out of the low frequencies of interest into the megahertz
frequencies of little interest, which is called noise shaping. The
quantization noise at these high frequencies is removed or greatly
attenuated by use of an analog low-pass filter at the output
(sometimes a simple RC low-pass circuit is sufficient). Most very
high resolution DACs (greater than 16 bits) are of this type due to
its high linearity and low cost. Higher oversampling rates can
relax the specifications of the output low-pass filter and enable
further suppression of quantization noise. Speeds of greater than
100 thousand samples per second (for example, 192 kHz) and
resolutions of 24 bits are attainable with delta-sigma DACs. A
short comparison with pulse-width modulation shows that a 1-bit DAC
with a simple first-order integrator would have to run at 3 THz
(which is physically unrealizable) to achieve 24 meaningful bits of
resolution, requiring a higher-order low-pass filter in the
noise-shaping loop. A single integrator is a low-pass filter with a
frequency response inversely proportional to frequency and using
one such integrator in the noise-shaping loop is a first order
delta-sigma modulator. Multiple higher order topologies (such as
MASH) are used to achieve higher degrees of noise-shaping with a
stable topology.
[0194] Another example DAC is a binary-weighted DAC, which contains
individual electrical components for each bit of the DAC connected
to a summing point. These precise voltages or currents sum to the
correct output value. This is one of the fastest conversion methods
but suffers from poor accuracy because of the high precision
required for each individual voltage or current. Such
high-precision components are expensive, so this type of converter
is usually limited to 8-bit resolution or less. One type of
binary-weighted DAC is a switched resistor DAC which contains a
parallel resistor network in which individual resistors are enabled
or bypassed in the network based on the digital input. Another type
of binary-weighted DAC is a switched current source DAC, from which
different current sources are selected based on the digital input.
Another type of binary-weighted is a switched capacitor DAC which
contains a parallel capacitor network in which individual
capacitors are connected or disconnected with switches based on the
input.
[0195] Another example DAC is a R-2R ladder DAC, which is a
binary-weighted DAC that uses a repeating cascaded structure of
resistor values R and 2R. This improves the precision due to the
relative ease of producing equal valued-matched resistors (or
current sources). However, wide converters perform slowly due to
increasingly large RC-constants for each added R-2R link.
[0196] Another example DAC is a Successive-Approximation or Cyclic
DAC, which successively constructs the output during each cycle.
Individual bits of the digital input are processed each cycle until
the entire input is accounted for.
[0197] Another example DAC is a thermometer-coded DAC, which
contains an equal resistor or current-source segment for each
possible value of DAC output. An 8-bit thermometer DAC would have
255 segments, and a 16-bit thermometer DAC would have 65,535
segments. This is perhaps the fastest and highest precision DAC
architecture but at the expense of high cost. Conversion speeds of
more than 1 billion samples per second have been reached with this
type of DAC.
[0198] Another example DAC is a Hybrid DACs, which use a
combination of the above techniques in a single converter. Most DAC
integrated circuits are of this type due to the difficulty of
getting low cost, high speed and high precision in one device. One
type of hybrid DAC is a segmented DAC, which combines the
thermometer-coded principle for the most significant bits and the
binary-weighted principle for the least significant bits. In this
way, a compromise is obtained between precision (by the use of the
thermometer-coded principle) and number of resistors or current
sources (by the use of the binary-weighted principle). The full
binary-weighted design means 0% segmentation, the full
thermometer-coded design means 100% segmentation.
[0199] Most DACs, shown earlier in this list, rely on a constant
reference voltage to create their output value. Alternatively, a
multiplying DAC[1] takes a variable input voltage for their
conversion. This puts additional design constraints on the
bandwidth of the conversion circuit.
EXAMPLE 2
[0200] FIG. 15 depicts an example wherein a digital waveform of a
cardiac signal is retrieved from a database in Step 200. A
non-cardiac signal is retrieved from a database in step 208, and
alternatively, or additionally, a simulated body impedance is
retrieved from a database in step 210. These signals are combined
into a single waveform, by in some embodiments, combining the
digital versions of each of these signals. In other embodiments,
the digital waveform of the cardiac signal is combined with the
non-cardiac signal. Additionally or alternatively to the
non-cardiac signal, a cardiac feature may be combined with the
digital waveform of the cardiac signal. This combination may then
be combined with a simulated body impedance that simulates a signal
passing through a body impedance circuit. The digital simulated
waveform generated by the combination described herein or as
depicted in step 212 of FIG. 15, may be downloaded to a
microcontroller as noted in Step 214 of FIG. 15 which may comprise
circuitry that loads the digital simulated waveform into a DAC,
which generates an analog simulated signal as noted in Step 206 of
FIG. 15.
[0201] In some embodiments, the simulator passes information to an
evaluator that evaluates the test system's ability to filter
certain body impedance (simulated impedance) or non-cardiac signals
from the analog simulated signal. The information that the
simulator provides to an evaluator may comprise how the cardiac
signal was altered. In some embodiments, the information comprises
the digital waveform or analog waveform of the cardiac signal. In
some embodiments, the information comprises the cardiac signal. In
some embodiments, the information further comprises the simulated
body impedance and/or the non-cardiac signal used to generate the
analog simulated waveform or the digital simulated waveform. In
some embodiments, the information comprises the digital waveform or
analog waveform of the cardiac signal as combined with the cardiac
feature. In some embodiments, the information further comprises the
simulated body impedance and/or the non-cardiac signal used to
generate the analog simulated waveform or the digital simulated
waveform.
[0202] In some embodiments, the simulator comprises controls that
allow a user to choose or provide the cardiac signal to be altered
choose or provide the simulated body impedance, the non-cardiac
signal, and/or the combination thereof that is used to alter the
digital waveform or the analog waveform of the cardiac signal,
and/or choose the amount by which the cardiac signal is altered by
such body impedance, non-cardiac signal, and/or combination
thereof.
[0203] In some embodiments, the simulator comprises controls that
allow a user to choose or provide the cardiac signal to be altered
as well as choose or provide the simulated body impedance, the
cardiac feature, the non-cardiac signal, and/or the combination
thereof that is used to alter the digital waveform or the analog
waveform of the cardiac signal, and/or choose the amount by which
the cardiac signal is altered by such body impedance, cardiac
feature, non-cardiac signal, and/or combination thereof.
[0204] In some embodiments, the simulator comprises circuitry that
determines for a user which cardiac signal from the database will
be altered, which simulated body impedance, non-cardiac signal,
and/or combination thereof will be used to alter the digital
waveform or the analog waveform of the cardiac signal, and/or the
amount by which the cardiac signal is altered by such body
impedance, non-cardiac signal, and/or combination thereof.
[0205] In some embodiments, the simulator comprises circuitry that
determines for a user which cardiac signal from the database will
be altered, which simulated body impedance, cardiac feature,
non-cardiac signal, and/or combination thereof will be used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or the amount by which the cardiac signal is altered by
such body impedance, cardiac feature, non-cardiac signal, and/or
combination thereof.
[0206] Provided herein is a method of simulating an analog
electrophysiologic signal comprising providing a digital waveform
of a cardiac signal or an analog waveform of the cardiac signal,
wherein the cardiac signal comprises an intracardiac electrogram, a
surface electrocardiogram, or a test signal from a database of
cardiac signals, altering the cardiac signal by combining either
the digital waveform or the analog waveform with a simulated body
impedance, a non-cardiac signal, or a combination thereof, thereby
generating a digital simulated waveform or an analog simulated
waveform, converting the digital simulated waveform, if generated,
to the analog simulated waveform, providing to a first test system
the analog simulated waveform, providing to the evaluator the
analog simulated waveform and/or the digital simulated waveform,
and information about the digital waveform or an analog waveform of
the cardiac signal, and/or whichever simulated body impedance,
cardiac feature, and/or non-cardiac signal was used to generate the
analog simulated waveform or the digital simulated waveform.
[0207] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI.
[0208] In some embodiments, the simulator comprises the database.
In some embodiments, the first test system comprises at least one
of a recorder and a mapping system.
[0209] In some embodiments, providing the analog simulated waveform
comprises providing a coupling that can be used to couple a
simulator that generated the analog simulated waveform to a
junction box and providing a coupling that can be used to couple
the junction box to the first test system. In some embodiments, the
coupling couples the junction box to the first test system couples
the junction box to an amplifier of the first test system. In some
embodiments, the junction box comprises at least one
electrophysiology catheter connector. In some embodiments, the
junction box comprises multiple electrophysiology catheter
connectors. In some embodiments, each of the electrophysiology
catheter connectors couples a different brand or version of
electrophysiology catheter to the first test system. In some
embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter
connector.
[0210] In some embodiments, the method comprises combining the
cardiac signal with the non-cardiac signal. In some embodiments,
the method comprises combining the digital waveform of the cardiac
signal, the analog waveform of the cardiac signal, the digital
simulated waveform or the analog simulated waveform with the
cardiac feature.
[0211] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0212] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0213] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0214] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0215] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0216] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0217] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0218] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0219] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
a default AV disassociation with a subsidiary escape pacemaker that
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0220] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0221] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0222] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0223] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0224] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0225] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0226] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0227] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature may be added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such a cardiac feature.
Depending on the feature, this may be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0228] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is <1=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0229] In some embodiments, the information comprises how the
cardiac signal was altered. In some embodiments, the information
comprises the digital waveform or analog waveform of the cardiac
signal. In some embodiments, the information comprises the
simulated body impedance, and/or the non-cardiac signal used to
generate the analog simulated waveform or the digital simulated
waveform. In some embodiments, the information comprises the
digital waveform or analog waveform of the cardiac signal as
combined with the cardiac feature. In some embodiments, the
information further comprises the simulated body impedance and/or
the non-cardiac signal used to generate the analog simulated
waveform or the digital simulated waveform.
[0230] In some embodiments, the method comprises providing controls
that allow a user to choose or provide the cardiac signal to be
altered, choose or provide the simulated body impedance, the
non-cardiac signal, and/or the combination thereof that is used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or choose the amount by which the cardiac signal is
altered by such body impedance, non-cardiac signal, and/or
combination thereof.
[0231] In some embodiments, the method comprises providing controls
that allow a user to choose or provide the cardiac signal to be
altered, choose or provide the simulated body impedance, the
cardiac feature, the non-cardiac signal, and/or the combination
thereof that is used to alter the digital waveform or the analog
waveform of the cardiac signal, and/or choose the amount by which
the cardiac signal is altered by such body impedance, cardiac
feature, non-cardiac signal, and/or combination thereof.
[0232] In some embodiments, the method comprises providing
circuitry that determines for a user which cardiac signal from the
database will be altered, which simulated body impedance,
non-cardiac signal, and/or combination thereof will be used to
alter the digital waveform or the analog waveform of the cardiac
signal, and/or the amount by which the cardiac signal is altered by
such body impedance, non-cardiac signal, and/or combination
thereof.
[0233] In some embodiments, the method comprises providing
circuitry that determines for a user which cardiac signal from the
database will be altered, which simulated body impedance, cardiac
feature, non-cardiac signal, and/or combination thereof will be
used to alter the digital waveform or the analog waveform of the
cardiac signal, and/or the amount by which the cardiac signal is
altered by such body impedance, cardiac feature, non-cardiac
signal, and/or combination thereof.
[0234] A number of systems for generating cardiac waveforms are
described in literature. For example: U.S. Pat. No. 4,204,261
(Ruszala et al.) discloses a complex analog signal generator for
generating time varying analog signal waveforms, such as
electrocardiogram and blood pressure. U.S. Pat. No 4,736,322
(Clifford) discloses a device and method for simulating the
heartbeat, pressure and respiration waveforms of a human being.
U.S. Pat. No. 5,041,973 (Lebron et al.) teaches a cardiac mapping
system simulator, while U.S. Pat No. 7,917,774 (Ruiter) teaches
system, methods and apparatuses that produce human physiological
waveforms. Each of these references is incorporated by reference in
their entirety herein.
Evaluator
[0235] A device (digital signal processing and evaluation platform
(DSPEP), or signal processing evaluator, or "evaluator") that
allows for objectively evaluating the accuracy of a test system,
such as an EP recording system's acquisition strategy, is provided
herein. It can measure and characterize how the different signal
processing schemes used by EP recording systems (to eliminate
noise, baseline wander and artifacts) during acquisition affect the
true spatiotemporal characteristics of cardiac signals generated by
the body.
[0236] In some embodiments, a workstation 102 may be located
remotely from a DSPEP100 and/or from a database 108 that comprises
a repository of cardiac and/or non-cardiac signals to allow for a
centralized database 108; or it may be located locally (FIG. 1A,
1B, or 1C) to allow for an individual at the workstation 102 to
tailor, update, manipulate, and/or operate the database 108.
[0237] In some embodiments, the test signal database 108 comprises
the various cardiac signals 112 and non-cardiac signals 136. The
database 108 in such an embodiment may reside with the DSPEP 100 of
the workstation 102. The DSPEP is alternatively called an evaluator
100 herein. The test signal database 108 may be constructed by
combining data from public sources (for example, MIT's database),
previously recorded and annotated EP studies, ECG and IC data
scanned from paper recordings and various other sources. This
database 108 may also contain a test signal 112 (alternatively
called a cardiac signal 112 herein) or multiple test signals 112a,
112b, etc., from cardiac and/or various non-cardiac sources. In
some embodiments, non-cardiac sources of cardiac signals may
include waveforms specified by various EC standards for testing of
medical recorders developed by the American National Standard
Institute and the Association for the Advancement of Medical
Instrumentation (ANSI/AAMI). The database 108 may also include a
non-cardiac test signal 136 (or multiple non-cardiac test signals)
that can emulate noise, baseline wander and artifacts similar to
real EP recording situations. This database 108 may have an open
architecture so that additional or new signals (cardiac signals or
non-cardiac signals) can be added.
[0238] A computer 118 in the field may be located close to the EP
recorder 101 or EP electroanatomical mapping system 104 (either or
both of the EP recorder or the EP electroanatomical mapping system
may alternatively called a device under test and/or a test system).
The computer 118 may have a database connection 110 to the
workstation 102 that can download the test signal database 108 from
the workstation 102, or can download the cardiac signal 112 and/or
a non-cardiac test signal 136. The computer 118 may be connected to
the EP cardiac signal simulator 130 using a USB port or other type
of interface which is called a simulator connection 116 herein.
Galvanic isolation may also be provided between the computer 118
and the EP cardiac simulator 130, so the simulator 130 is
electrically isolated from the computer 118.
[0239] The database connection 110 may be local or remote.
[0240] FIG. 1A, therefore, depicts a block diagram of an embodiment
of a system wherein an EP recorder is under test and workstation
102 is remote. In this embodiment, test signals (cardiac signals,
non-cardiac signals, and/or simulated body impedance) may be put
into the database 108 as depicted by arrow 114. The database 108
may store test signals (cardiac signals, non-cardiac signals,
and/or simulated body impedance) and a user may choose which test
signals are to be used to evaluate the test system using the
computer 118, which may receive the test signals chosen by a user
from the database 108 through database connection 110.
Alternatively, the computer 118 may be set to randomly choose a
cardiac signal 112, non-cardiac signal 136, and/or simulated body
impedance 132 to combine therewith. The database 108 may be remote
from the computer 118, or reside within the computer 118. The
database connection 110 may be wired or wireless. Indeed, any
connection herein that is not a catheter-based or wire-based
connection intended to simulate the effect of a signal passed
through such catheter or wire in a patient, may be wired or
wireless. In the embodiment of FIG. 1A, the computer 118 combines
the cardiac signal with a non-cardiac signal and/or with a
simulated body impedance, and delivers this simulated waveform (in
digital or analog form) to the simulator 130 through simulator
connection 116. In the embodiment of FIG. 1A, the simulator 130
delivers the signal to the EP recorder 101 (the test system in this
embodiment) as an analog signal through a test system connection,
such as an ECG cable or other cable 120, or through a junction box
60 connected to the simulator and to an electrophysiology catheter
connecter, which may be a electrophysiology catheter handle (arrow
162). The test system 101 may then filter the signal it receives
from the simulator 130 and generate digital output files 124,
alternatively called a processed signal, a first processed signal,
or a recorded signal herein. The first processed signal 124 may
then be received by the digital signal processing and evaluation
platform (DSPEP) 100, alternatively called the evaluator herein. In
certain embodiments, the evaluator 100 also receives the cardiac
signal from the database 108, and may also receive the non-cardiac
signal 136 and/or the simulated body impedance 132 that was used to
generate the simulated waveform (digital or analog) from the
database 108. The evaluator 100 may then generate a first finding
126, which may be in the form of a report or other output that can
be seen or used by a user which is based on how well the test
system filtered the simulated waveform it received from the
simulator. This may be done by comparing the cardiac signal to the
first processed signal. This process may be repeated any number of
times and with variations chosen in order to generate additional
findings regarding how well the test system retains certain cardiac
features, or how well it filters the non-cardiac signal and/or the
simulated body impedance from the analog simulated waveform it
received. The process may be repeated for multiple test systems in
order to generate a comparative evaluation of several test systems
given controlled and known challenge test signals. For example, if
test systems are known to not allow detection of a certain cardiac
feature, this cardiac feature may be added to a cardiac signal and
multiple test systems may be evaluated in order to determine which
test system best allows for detection of this cardiac feature.
[0241] FIG. 1B, therefore, depicts a block diagram of an embodiment
of a system wherein an EP mapping system 104 is the device under
test and workstation 102 is remote. In this embodiment, test
signals (cardiac signals, non-cardiac signals, and/or simulated
body impedance) may be put into the database 108 as depicted by
arrow 114. The database 108 stores test signals (cardiac signals,
non-cardiac signals, and/or simulated body impedance) and a user
may choose which test signals are to be used to evaluate the test
system using the computer 118, which may receive the test signals
chosen by a user from the database 108 through database connection
110. Alternatively, the computer 118 may be set to randomly choose
a cardiac signal 112, non-cardiac signal 136, and/or simulated body
impedance 132 to combine therewith. The database 108 may be remote
from the computer 118, or reside within the computer 118. The
database connection 110 may be wired or wireless. Indeed, any
connection herein that is not a catheter-based or wire-based
connection intended to simulate the effect of a signal passed
through such catheter or wire in a patient, may be wired or
wireless. In the embodiment of FIG. 1B, the computer 118 combines
the cardiac signal with a non-cardiac signal and/or with a
simulated body impedance, and delivers this simulated waveform (in
digital or analog form) to the simulator 130 through simulator
connection 116. In the embodiment of FIG. 1B, the simulator 130
delivers the signal to the EP electroanatomical mapping system 104
(the test system in this embodiment) as an analog signal through a
test system connection, such as an ECG cable or other cable 120, or
through a junction box 60 connected to the simulator and to an
electrophysiology catheter connecter, which may be a
electrophysiology catheter handle (arrow 162). The test system 104
may then filter the signal it receives from the simulator 130 and
generates digital output files 124, alternatively called a
processed signal, a first processed signal, or a recorded signal
herein. The first processed signal 124 may then be received by the
digital signal processing and evaluation platform (DSPEP) 100,
alternatively called the evaluator herein. In certain embodiments,
the evaluator 100 also receives the cardiac signal from the
database 108, and may also receive the non-cardiac signal 136
and/or the simulated body impedance 132 that was used to generate
the simulated waveform (digital or analog) from the database 108.
The evaluator 100 may then generate a first finding 126, which may
be in the form of a report or other output that can be seen or used
by a user which is based on how well the test system filtered the
simulated waveform it received from the simulator. This may be done
by comparing the cardiac signal to the first processed signal. This
process may be repeated any number of times and with variations
chosen in order to generate additional findings regarding how well
the test system retains certain cardiac features, or how well it
filters the non-cardiac signal and/or the simulated body impedance
from the analog simulated waveform it received. The process may be
repeated for multiple test systems in order to generate a
comparative evaluation of several test systems given controlled and
known challenge test signals. For example, if test systems are
known to not allow detection of a certain cardiac feature, this
cardiac feature may be added to a cardiac signal and multiple test
systems may be evaluated in order to determine which test system
best allows for detection of this cardiac feature.
[0242] FIG. 1C depicts a block diagram of an embodiment of a system
wherein an EP recorder 101 and/or an EP electroanatomical mapping
system 104 are under test and workstation 102 is remote from the
simulator and/or the test systems (EP recorder 101 and/or the EP
mapping system 104, for example). In this embodiment, test signals
(cardiac signals, non-cardiac signals, and/or simulated body
impedance) may be put into the database 108 as depicted by arrow
114. The database 108 may store test signals (cardiac signals,
non-cardiac signals, and/or simulated body impedance) which may be
further transmitted to an EP cardiac signal simulator 130 via
database connection 110. The simulator 130 may deliver a signal to
an EP recorder 101 through a test system connection, such as an ECG
cable or other cable 120 and/or through a junction box 60 connected
to the simulator (arrow 122) and to an electrophysiology catheter
connecter, which may be an electrophysiology catheter handle (arrow
162). Alternatively or additionally, the simulator 130 may deliver
analog signals to an EP electroanatomical mapping system 104
directly using a cable, catheter, or other connection, or through a
junction box 60. The test systems 101 and/or 104 may then filter
the signal it receives from the simulator 130 and generate digital
output files 124, alternatively called a processed signal, a first
processed signal, or a recorded signal herein. The first processed
signal 124 is then received by the digital signal processing and
evaluation platform (DSPEP) 100, alternatively called the evaluator
herein. In certain embodiments, the evaluator 100 may receive the
cardiac signal 112 from the database 108, and may also receive a
non-cardiac signal 136 and/or the simulated body impedance 132 that
was used to generate the simulated waveform (digital or analog)
from the database 108. The evaluator 100 may then generate a first
finding 126, which may be in the form of a report or other output
that can be seen or used by a user which is based on how well the
test system filtered the simulated waveform it received from the
simulator. This may be done by comparing the cardiac signal to the
first processed signal. This process may be repeated any number of
times and with variations chosen in order to generate additional
findings regarding how well the test system retains certain cardiac
features, or how well the test system filters the non-cardiac
signal and/or the simulated body impedance from the analog
simulated waveform it received. The process may be repeated for
multiple test systems in order to generate a comparative evaluation
of several test systems given controlled and known challenge test
signals. For example, if test systems are known to not allow
detection of a certain cardiac feature, this cardiac feature may be
added to a cardiac signal and multiple test systems may be
evaluated in order to determine which test system best allows for
detection of this cardiac feature.
[0243] In FIG. 1A, 1B, and 1C, the workstation 102 is depicted as
comprising the database 108, the evaluator 100, and the first
processed signal 124 (or digital files generated by the test
system), and comprising the first finding 126. However, in certain
embodiments, the workstation 102 comprises one or more of the
database 108, the evaluator 100, and the first processed signal 124
(or digital files generated by the test system), and comprising the
first finding 126. In certain embodiments, the workstation 102
comprises a computer 118. In certain embodiments, the workstation
102 comprises the simulator 130. In certain embodiments, the
workstation comprises a junction box 60 that connects to an EP
recorder or a junction box 60 that connects to an EP Mapping
System, or elements thereof.
[0244] The EP simulator 130 (as depicted in FIG. 2 as an example
embodiment) contains a microcontroller 117 which receives the
various cardiac signals 112 and non-cardiac signals 136 from the
database 108 of the workstation 102. In some embodiments, the
database 108 resides on the computer 118 as part of the workstation
102. In other embodiments, the database 108 resides on a computer
118 separate from the workstation and the workstation pulls the
various cardiac signals 112 and non-cardiac signals 136 from the
database 108. In some embodiments, the EP simulator 130 may contain
a microcontroller 117 which receives the various cardiac signals
112 and non-cardiac signals 136 from the database 108 or the
computer 118 which may be a part of workstation 102. In yet other
embodiments, a computer 118 is separate from the workstation and
receives the various cardiac signals 112 and non-cardiac signals
136 from the database 108 which is part of the workstation 102. The
microcontroller 117 controls the digital to analog (D/A) converter
144. When instructed by the microcontroller 117, the D/A converter
144 may generate analog waveshapes 113 (alternatively called analog
waveforms of the cardiac signal herein), based on the digital data
of the cardiac signal, which may or may not include a non-cardiac
signal added thereto from the database 108. After signal
conditioning (e.g. conversion by the D/A converter 144), simulated
body impedance may be added to the analog waveform of the cardiac
signal (which may or may not include a non-cardiac signal added
thereto). In such embodiment, the D/A converter is connected to
various resistors, capacitors and inductive networks which simulate
different body impedances 132 and alter the waveform of the cardiac
signal (which may or may not include a non-cardiac signal added
thereto) to generate the analog simulated waveform. Different body
impedances 132 may be used to simulate different signal
conditioning coming from the electrode-body connections encountered
in real EP recordings. The output of EP simulator 130 may mimic the
human body and provide simulated analog cardiac signals 142.
[0245] The EP simulator 130 may also provide ECG and intracardiac
connectors 121 that allow the EP recording system 102 to connect to
the EP simulator 130 with its own cables. The same cable 120 that
is used during EP studies to connect the EP recorder 101 or the EP
electroanatomical mapping system 104 to the patient in order to
record surface electrocardiograms (ECG) may be used. This cable 120
may provide connections to the ECG electrodes (typically, but not
restricted to: four limb leads; left arm (LA), left leg (LL), right
arm (RA) and right leg (RL), and six precordial leads
V1,V2,V3,V4,V5 and V6). The EP simulator 130 also may also provide
special connectors for intracardiac signals. These connectors may
allow connections to the EP recorder 101 via the junction box
60.
[0246] FIG. 2, therefore, depicts an embodiment of an EP simulator
130 receiving various input signals through a USB port or other
type of interface 116, wherein the EP simulator 130 contains a
microcontroller 117 that controls the D/A converter 144. In the
depicted embodiment, a body impedance simulator 131 may modify
resultant analog signals from a D/A converter 144 which are
delivered as output or signals using ECG and/or and IC connections
121 via an ECG cable or other cable 120 to a test system such as an
EP recorder, EP mapping system, evaluator and or other device, or
via a connection (arrow 122) to a junction box which connects to a
test system such as an EP recorder, EP mapping system, evaluator
and or other device.
[0247] In some embodiments, the same connectors on the EP simulator
130 may allow connection to the EP electroanatomical mapping system
104, such as is depicted in FIG. 3. In that case the junction box
60 may provide places for one or more EP catheters 164 and has
connections for the cable (arrow 122) to enable connection with EP
simulator 130. The handle of the catheter 162 may be connected in
various EP settings to an RF generator, patient interface unit or
directly to an EP electroanatomical mapping system 104.
[0248] FIG. 3, therefore, depicts a block diagram of an embodiment
of a junction box 60, wherein a cable for the junction box connects
(at arrow 122) the junction box to the simulator, and a catheter
and electrophysiology catheter connector 162 may deliver signals
from an EP simulator 130 through the junction box to a test system
such as an EP recorder 101 or EP electroanatomical mapping system
104 or another test system.
[0249] In some embodiments, the EP recorder 101 or EP
electroanatomical mapping system 104 is set up to acquire cardiac
signals 112 and non-cardiac signals 136 from the simulator 130 as
they would be if connected to a real patient during EP studies.
Analog and digital filters used to remove noise and artifacts may
be used in the same fashion as they would be used during EP
studies. Digital output recordings 124 may be stored in the same
fashion as they would be during EP studies.
[0250] In some embodiments, digital data recorded by the EP
recorder 101 or EP electroanatomical mapping system 104 are
transferred manually or electronically to the workstation 102 and
stored as digital output files 124.
[0251] In some embodiments, the digital database 108 and digital
output 124 may be compared using DSPEP 100. The effect of various
digital signal processing schemes and filters used for removing
noise, baseline wander and artifacts may be compared, viewed and
completely evaluated off-line. A first finding 126 may be generated
to include various test results.
[0252] In some embodiments, different signal processing tools and
signal comparison modules in the workstation 102 allow for analysis
of cardiac signal waveform time and frequency. These tools may be
used to evaluate differences between the original signal from
database 108 and the recorded signal 124 acquired by EP recorder
101 or EP electroanatomical mapping system 104. DSPEP 100 may allow
for different software modules to be added, enhancing signal
processing and analysis.
[0253] In some embodiments, digital signal processing tools in the
workstation 102 allow for adding, removing or mixing together
various components of the database 108 which comprise cardiac
signals 112 and non-cardiac signals 136, to simulate and mimic
various recording situations encountered in a real EP
environment.
[0254] Provided herein is a signal processing evaluator comprising:
a digital waveform of a cardiac signal or an analog waveform of the
cardiac signal, a first processed signal received from a first test
system, wherein the first processed signal is the result of digital
processing of an analog simulated waveform by the first test
system, wherein the analog simulated waveform was generated by
combining the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal with a simulated body impedance, a
non-cardiac signal, and/or a combination thereof, and third
circuitry that compares the digital waveform of the cardiac signal
or the analog waveform of the cardiac signal to the first processed
signal and generates a first finding evaluating the first test
system.
[0255] In some embodiments, the first finding depicts or describes
how closely matched the first processed signal is to the digital
waveform of the cardiac signal or to the analog waveform of the
cardiac signal.
[0256] In some embodiments, the evaluator comprises information
about the simulated body impedance, the non-cardiac signal, and/or
the combination thereof that was used to generate the analog
simulated waveform.
[0257] In some embodiments, the second circuitry compares the first
finding to a second finding, evaluating a second test system. In
some embodiments, the second finding depicts or describes how
closely matched a second processed signal that is the result of
digital processing of the analog simulated waveform by a second
test system is to the digital waveform of the cardiac signal or to
the analog waveform, and generates an evaluation regarding which of
the first test system and the second test system better processes
the analog simulated waveform.
[0258] In some embodiments, the first finding expresses the
effectiveness of the first test system in reproducing the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal from the analog simulated waveform.
[0259] In some embodiments, the first circuitry is configured to
compare a second digital waveform of a second cardiac signal or
second analog waveform of the second cardiac signal to a second
processed signal. In some embodiments, the second processed signal
is a result of digital processing of a second analog simulated
waveform by the first test system, wherein the second analog
simulated waveform is generated based on the second digital
waveform of the second cardiac signal or the second analog waveform
of the cardiac signal and a second simulated body impedance, a
second non-cardiac signal, and/or a combination thereof.
[0260] In some embodiments, the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal comprises a
cardiac feature. In some embodiments, the first finding expresses
how well the first test system preserves the cardiac feature in the
first processed signal as compared to the digital waveform of the
cardiac signal or to the analog waveform of the cardiac signal.
[0261] In some embodiments, the evaluator comprises information
about the cardiac feature.
[0262] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0263] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0264] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0265] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0266] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG , and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0267] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0268] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0269] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0270] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
that takes over by default, a usurpation AV disassociation, and/or
a usurpation AV disassociation with incomplete AV dissociation due
to accelerated ventricular rhythm.
[0271] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0272] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0273] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0274] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0275] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0276] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0277] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0278] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature may be added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this may be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0279] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0280] In some embodiments, the first finding expresses how well
the first test system removes the non-cardiac signal from the
analog simulated waveform. In some embodiments, the first finding
expresses how well the first test system removes the simulated body
impedance from the analog simulated waveform. In some embodiments,
the first circuitry is configured to assess the first processed
signal and the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal in the time domain, frequency
domain, or a combination thereof.
[0281] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, cardiac signal comprises an intracardiac
electrogram, a surface electrocardiogram, or a test signal. In some
embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI. In some embodiments, the
cardiac signal comprises one or more of an electrocardiogram, a
unipolar electrogram, and a bipolar electrogram. In some
embodiments, the first processed signal comprises a reconstructed
cardiac activation map or data necessary to generate the
reconstructed cardiac activation map.
[0282] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the recorder comprises an electrophysiology recorder. In some
embodiments, the mapping system comprises an electrophysiology
mapping system. In some embodiments, the first test system
comprises an analog filter or a digital filter or a combination
thereof configured to process the analog simulated waveform in
order to generate the first processed signal.
[0283] In some embodiments, the evaluator comprises an evaluator
connection to the first test system. In some embodiments, the
evaluator comprises a database or a database connection to a
database, wherein the database comprises the cardiac signal, and at
least one of the simulated body impedance and the non-cardiac
signal. In some embodiments, the database comprises a cardiac
feature.
[0284] In some embodiments, the evaluator comprises first circuitry
configured to alter the cardiac signal by combining the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal with the simulated body impedance, the non-cardiac
signal, or a combination thereof, thereby generating a digital
simulated waveform or an analog simulated waveform. In some
embodiments, the evaluator comprises a D/A converter configured to
convert the digital simulated waveform to the analog simulated
waveform. In some embodiments, the evaluator comprises the
database.
[0285] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the test system connection couples to a junction box which couples
to the first test system. In some embodiments, the junction box
couples to an amplifier of the first test system. In some
embodiments, the junction box comprises at least one
electrophysiology catheter connector. In some embodiments, the
junction box comprises multiple electrophysiology catheter
connectors. In some embodiments, each of the electrophysiology
catheter connectors couples a different brand or version of
electrophysiology catheter to the first test system. In some
embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter connector. In
some embodiments, the simulator comprises the junction box.
[0286] Provided herein is a method comprising: providing a signal
processing evaluator to a user, wherein the evaluator comprises a
digital waveform of a cardiac signal or an analog waveform of the
cardiac signal, a first processed signal received from a first test
system, wherein the first processed signal is the result of digital
processing of an analog simulated waveform by the first test
system, wherein the analog simulated waveform was generated by
combining the digital waveform of the cardiac signal or the analog
waveform of the cardiac signal with a simulated body impedance, a
non-cardiac signal, and/or a combination thereof, and third
circuitry that compares the digital waveform of the cardiac signal
or the analog waveform of the cardiac signal to the first processed
signal and generates a first finding evaluating the first test
system.
[0287] Provided herein is a method comprising: receiving a first
processed signal from a first test system, wherein the first
processed signal is the result of digital processing of an analog
simulated waveform by the first test system, wherein the analog
simulated waveform was generated by combining a digital waveform of
a cardiac signal or an analog waveform of the cardiac signal with a
simulated body impedance, a non-cardiac signal, and/or a
combination thereof, comparing the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal to the first
processed signal, generating a first finding that evaluates the
first test system, and providing the first finding to a user.
[0288] In some embodiments, the first finding depicts or describes
how closely matched the first processed signal is to the digital
waveform of the cardiac signal or to the analog waveform of the
cardiac signal.
[0289] In some embodiments, the method comprises providing
information about the simulated body impedance, the non-cardiac
signal, and/or the combination thereof that was used to generate
the analog simulated waveform. In some embodiments, the method
comprises comparing the first finding to a second finding
evaluating a second test system. In some embodiments, the second
finding depicts or describes how closely matched a second processed
signal that is the result of digital processing of the analog
simulated waveform by a second test system is to the digital
waveform of the cardiac signal or to the analog waveform, and
generates an evaluation regarding which of the first test system
and the second test system better processes the analog simulated
waveform.
[0290] In some embodiments, the first finding expresses the
effectiveness of the first test system in reproducing the digital
waveform of the cardiac signal or the analog waveform of the
cardiac signal from the analog simulated waveform.
[0291] In some embodiments, the method comprises comparing a second
digital waveform of a second cardiac signal or second analog
waveform of the second cardiac signal to a second processed signal.
In some embodiments, the second processed signal is a result of
digital processing of a second analog simulated waveform by the
first test system, wherein the second analog simulated waveform is
generated based on the second digital waveform of the second
cardiac signal or the second analog waveform of the cardiac signal
and a second simulated body impedance, a second non-cardiac signal,
and/or a combination thereof.
[0292] In some embodiments, the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal comprises a
cardiac feature. In some embodiments, the first finding expresses
how well the first test system preserves the cardiac feature in the
first processed signal as compared to the digital waveform of the
cardiac signal or to the analog waveform of the cardiac signal.
[0293] In some embodiments, the method comprises providing
information about the cardiac feature.
[0294] In some embodiments, the cardiac feature comprises a
parameter having a parameter value, a change in the parameter
value, a shape of one or more parameters, or a change that alters
the shape of the analog simulated waveform or a portion
thereof.
[0295] In some embodiments, the cardiac feature comprises a
parameter of an electrocardiogram waveform or of an electrogram
waveform. In some embodiments, the parameter comprises: an RR
interval, a P wave, a PR interval, a PR segment, a QRS complex, a
J-point, an ST segment, a T wave, an ST interval, a QT interval, a
U wave, a J wave, or a combination thereof.
[0296] In some embodiments, the cardiac feature comprises a change
in the cardiac signal that is indicative of a disease.
[0297] In some embodiments, the disease is myocardial infarction.
In some embodiments, myocardial infarction may be exhibited by a
change in the cardiac signal over time that includes ST elevation,
Q wave formation, T wave inversion, and normalization with a
persistent Q wave. Thus, in certain embodiments, the cardiac
feature comprises a change in the cardiac signal over time that
includes ST elevation, Q wave formation, T wave inversion, and
normalization with a persistent Q wave.
[0298] In some embodiments, the disease is pulmonary embolism. In
some embodiments, pulmonary embolism may be shown by one or more of
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG. Thus, in certain embodiments, the cardiac feature comprises
S-waves in Lead I of a surface electrode 12-lead ECG, and Q-waves
and inverted T-waves in Lead III of the surface electrode 12-lead
ECG.
[0299] In some embodiments, the cardiac feature comprises a rhythm
abnormality. In some embodiments, the cardiac feature comprises a
conduction abnormality. In some embodiments, the cardiac feature
comprises a change in the cardiac signal indicative of a sinus
arrhythmia such as sinus tachycardia (>90 beats per minute);
sinus bradycardia (<50 beats per minute); sinus arrhythmia;
sinus arrest or pause; and/or sino-atrial exit block. In some
embodiments, the cardiac feature comprises a change in the cardiac
signal indicative of a sinus valve (SV) arrhythmia such as a
non-conducted premature atrial complex (PAC), a normally conducted
PAC, a PAC conducted with aberration, ectopic atrial rhythm or
tachycardia (unifocal), multifocal atrial rhythm or tachycardia,
atrial fibrillation, atrial flutter, premature junctional complex,
junctional escapes or rhythms, accelerated junctional rhythms,
junctional tachycardia, and/or paroxysmal supraventricular
tachycardia.
[0300] In some embodiments, the atrial flutter comprises: atrial
flutter with 2:1 atrioventricular (AV) conduction, atrial flutter
with 3:2 conduction ratio, atrial flutter with variable AV block
and rate-dependent left bundle branch block (LBBB), LBBB and atrial
flutter with 2:1 AV block, atrial flutter with 2:1 and 4:1
conduction and rate dependent LBBB, atrial flutter with variable AV
block, atrial flutter with 2:1 conduction, and/or atrial flutter
with 2:1 block. In some embodiments, the junctional tachycardia
comprises: exit block, no exit block, AV block, and/or no AV
block.
[0301] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of a ventricular arrhythmia such
as a premature ventricular complex, a ventricular escape or rhythm,
an accelerated ventricular rhythm, uniform ventricular tachycardia,
polymorphous ventricular tachycardia, torsade ventricular
tachycardia, and/or ventricular fibrillation.
[0302] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of an atrioventricular conduction
abnormality such as a first degree AV block, a first degree AV
block with a left atrial abnormality, a type I second degree AV
block (Wenckebach), a type II second degree AV block (Mobitz), an
advanced or high grade AV block, a third degree AV block, a third
degree AV block with junctional escape rhythm, a third degree AV
block with ventricular escape rhythm, a default AV disassociation,
and a default AV disassociation with a subsidiary escape pacemaker
takes over by default, a usurpation AV disassociation, and/or a
usurpation AV disassociation with incomplete AV dissociation due to
accelerated ventricular rhythm.
[0303] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of intraventricular conduction
abnormality such as complete LBBB (fixed or intermittent),
incomplete LBBB, left anterior fascicular block (LAFB), left
posterior fascicular block (LPFB), nonspecific intraventricular
conduction defect (IVCD), and/or a Wolff-Parkinson-White (WPW)
pre-excitation pattern.
[0304] In some embodiments, the cardiac feature comprises a change
in the cardiac signal related to the QRS pattern and/or the voltage
of the cardiac signal such as complete LBBB (fixed or
intermittent), incomplete LBBB, left anterior fascicular block
(LAFB), left posterior fascicular block (LPFB), low voltage frontal
plane (QRS amplitude <0.5 mV), and/or low voltage precordial
leads (QRS amplitude <1.0 mV).
[0305] In some embodiments, the cardiac feature comprises a change
in the cardiac signal indicative of hypertrophy or enlargement of a
cardiac anatomic aspect such as left atrial enlargement, right
atrial enlargement, left ventricular hypertrophy, and/or right
ventricular hypertrophy.
[0306] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting a ST-T and/or U abnormality such
as left atrial enlargement, nonspecific ST-T abnormalities such as
a ST segment depression, ST elevation (transmural injury), ST
elevation (pericarditis pattern), symmetrical T wave inversion,
symmetrical T wave inversion reflecting inferior myocardial
infarction (MI) (fully evolved), hyperacute T waves, prominent
upright U waves, U wave inversion, and/or prolonged QT
interval.
[0307] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting myocardial infarctions (MIs)
including acute, recent, and old MIs, such as inferior MI,
inferoposterior MI, inferoposterolateral MI, true posterior MI,
anteroseptal MI, anterior MI, anterolateral MI, high lateral MI,
non Q-wave MI, and/or right ventricular MI.
[0308] In some embodiments, the cardiac feature comprises a change
in the cardiac signal reflecting clinical disorders such as chronic
pulmonary disease, hypokalemia such as giant TU fusion waves,
hyperkalemia, hypocalcemia, hypercalcemia, and/or digoxin
effects.
[0309] In some embodiments, the cardiac feature comprises a change
in the cardiac signal listed in the Minnesota ECG Code
Classification System.
[0310] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about the abnormality boundary for the
cardiac feature. That is, the cardiac feature is added to the
digital waveform or to the analog waveform at a level that is close
to the boundary of an abnormality in such cardiac feature.
Depending on the feature, this may be expressed in any number of
ways, as a voltage level, a time, a duration, a pattern, a slope,
and any identifiable feature on the given waveform in time domain,
frequency domain or any other form of the waveform (whether digital
or analog). Such abnormalities may be indicative of an onset of an
abnormality or of an almost abnormal cardiac feature, according to
various coding guides, such as the Minnesota ECG Code
Classification System, or another Code or classification system for
non-limiting example.
[0311] In some embodiments, a level, power, and/or amount of the
cardiac feature is at about a limit of detection for the test
system under evaluation, for example the first test system or the
second test system, at least. In some embodiments, a level, power,
and/or amount of the cardiac feature, the simulated body impedance,
and/or the non-cardiac signal is at about a detectability boundary
of the first test system or of a second test system. In some
embodiments, the detectability boundary is </=20 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=10 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=5 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=3 times the
minimum detectability limit of the first test system. In some
embodiments, the detectability boundary is </=2 times the
minimum detectability limit of the first test system. The term
"about" as used herein with regard to the detectability limit
refers to variability of +/-10%, +/-25%, or +/-50%, depending on
the embodiment.
[0312] In some embodiments, the first finding expresses how well
the first test system removes the non-cardiac signal from the
analog simulated waveform. In some embodiments, the first finding
expresses how well the first test system removes the simulated body
impedance from the analog simulated waveform.
[0313] In some embodiments, the method comprises assessing the
first processed signal and the digital waveform of the cardiac
signal or the analog waveform of the cardiac signal in the time
domain, frequency domain, or a combination thereof.
[0314] In some embodiments, the non-cardiac signal comprises a
noise signal, a baseline wander signal, or an artifact signal. In
some embodiments, the cardiac signal comprises an intracardiac
electrogram, a surface electrocardiogram, or a test signal. In some
embodiments, the test signal comprises an Electrocardiograph
Committee (EC) standard waveform. In some embodiments, the EC
standard waveform is a standard for testing the recorder or the
mapping system as defined by ANSI or AAMI.
[0315] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system. In some embodiments,
the recorder comprises an electrophysiology recorder. In some
embodiments, the mapping system comprises an electrophysiology
mapping system. In some embodiments, the first test system
comprises an analog filter or a digital filter or a combination
thereof configured to process the analog simulated waveform in
order to generate the first processed signal. In some embodiments,
the cardiac signal comprises one or more of an electrocardiogram, a
unipolar electrogram, and a bipolar electrogram. In some
embodiments, the first processed signal comprises a reconstructed
cardiac activation map or data necessary to generate the
reconstructed cardiac activation map.
[0316] In some embodiments, the method comprises generating the
analog simulated waveform by combining the digital waveform of the
cardiac signal or the analog waveform of the cardiac signal with
the simulated body impedance, the non-cardiac signal, or the
combination thereof. In some embodiments, the method comprises
converting a digital simulated waveform of the digital waveform of
the cardiac signal as combined with the simulated body impedance,
the non-cardiac signal, or the combination thereof to the analog
simulated waveform. In some embodiments, the method comprises
receiving one or more of the digital waveforms of the cardiac
signal, the analog waveform of the cardiac signal, the simulated
body impedance, the non-cardiac signal, or a cardiac feature from a
database.
[0317] In some embodiments, the first test system comprises at
least one of a recorder and a mapping system.
[0318] In some embodiments, the method comprises providing a
junction box which couples to the first test system. In some
embodiments, the junction box couples to an amplifier of the first
test system. In some embodiments, the junction box comprises at
least one electrophysiology catheter connector. In some
embodiments, the junction box comprises multiple electrophysiology
catheter connectors. In some embodiments, each of the
electrophysiology catheter connectors couples a different brand or
version of electrophysiology catheter to the first test system. In
some embodiments, the junction box comprises a universal
electrophysiology catheter connector that can couple multiple
brands or versions of electrophysiology catheters to the first test
system using the universal electrophysiology catheter
connector.
[0319] As used herein ordinals such as first, second, third, etc.
are used merely for clarity in drafting, and not intended to imply
first in time, importance, or any other aspect, unless otherwise
identified and described with regard to the element.
EXAMPLE 3
[0320] FIG. 16 depicts the method of evaluating how well a test
system filters simulated body impedance and non-cardiac signals
from an analog simulated signal, and preserves certain cardiac
features or modifications to a cardiac signal. Step 216 retrieves
the digital simulated waveform from a simulator, such as the
digital simulated waveform generated in Step 204 of FIG. 14, or
generated in Step 212 of FIG. 15. Step 218 retrieves the processed
signal from the test system. As discussed herein, the processed
signal is the result of digital processing of the analog simulated
waveform (such as that generated in Step 206 of either FIG. 14 or
FIG. 15, for example), by the first test system, wherein the analog
simulated waveform was generated by combining the digital waveform
of the cardiac signal or the analog waveform of the cardiac signal
with a simulated body impedance, a non-cardiac signal, a cardiac
feature and/or a combination thereof. Step 220 of FIG. 16 compares
the digital simulated waveform to the processed signal. This
comparison may be by simple subtraction of these signals, or by
another comparison means, in order to generate an objective finding
of how well the test system filters the simulated body impedance or
the non-cardiac signal without losing the basic features of the
cardiac signal or of a cardiac feature within such signal or that
was combined with such signal, as shown in Step 222 of FIG. 16.
EXAMPLE 4
[0321] FIG. 17 depicts the embodiment of a flow of data from the
database into the EP simulator and into the evaluator which
compares the original data and the data after testing under the EP
recorder, EP mapping system, or both. In this figure, starting on
the left side from the top, a cardiac signal 112 is provided from a
database 108 (not shown) and a non-cardiac signal 136, a cardiac
feature 134, a simulated impedance 132, or a combination thereof
may be added to the cardiac signal 112 in order to form a digital
simulated waveform 140. The digital simulated waveform may be
converted by a D/A converter 144 into an analog simulated waveform
142, which is then transferred to a first test system 148 which
generates a first processed signal 128 in either analog or digital
form. As an alternative embodiment (not shown), the simulated
impedance 132 may be added after the conversion of the digital
simulated waveform 140 into the analog simulated waveform 142.
Thus, the digital simulated waveform 140 prior to conversion may
comprise a combination of a cardiac signal 112 and a cardiac
feature 134 or a combination of a cardiac signal 112 and a
non-cardiac signal 136, or may comprise only the cardiac signal
112. Once converted into analog form, the simulated impedance 132
may be added or generated and added in order to generate the analog
simulated waveform 142.
[0322] In another embodiment, starting on the right side from the
top of FIG. 17, an cardiac signal in analog form 113 may be
provided and a non-cardiac signal 136, a cardiac feature 134, a
simulated impedance 132, or a combination thereof may be added to
the cardiac signal 113 in order to form an analog simulated
waveform 140. In order to make this change to the cardiac signal,
it may be necessary to convert the analog form of the cardiac
signal 113 to a digital form using a A/D converter, then alter the
digital form of the cardiac signal, and then convert this back to
an analog form. The simulated impedance 132 may be added or
generated and added to the cardiac signal at any stage prior to
delivery to the test system. That is, it may be added before or
after D/A conversion, or not added at all. The analog simulated
waveform 142, may then be transferred to a first test system 148
which generates a first processed signal 128 in either analog or
digital form.
[0323] The first processed signal 128 may be then transferred to
the evaluator 100, which also receives at least the digital form of
the cardiac signal 112 or the analog form of the cardiac signal
113. The evaluator 100 may also receive the cardiac feature 134,
the simulated impedance 132, the non-cardiac signal 136, or some
combination thereof that was used to generate the analog simulated
waveform. Alternatively, the evaluator may receive some information
about the cardiac feature 134, the simulated impedance 132, the
non-cardiac signal 136, which may not be the actual waveform
itself, but rather information which indicates how the cardiac
signal was altered (for non-limiting example: cardiac feature
change type or extent, disease simulation, electrocardiogram
waveform parameter change, abnormality type). The evaluator 100 may
then take the first processed signal 128 and compare it to the
cardiac signal 112 or a digital form of the analog cardiac signal
113 that was sent to the test system to determine how well the test
system filters the simulated impedance and/or the non-cardiac
features from the analog simulated waveform, and generate a first
finding 126 indicating how well this filtering was done. The first
finding 126 may also or alternatively indicate how well a cardiac
feature was preserved by the test system, or whether such cardiac
feature was detected or detectable in the first processed signal.
The cardiac feature may have been one added to the cardiac signal,
or may have been existing in the cardiac signal received from the
database. Multiple findings may be generated using different
challenges of variables sent to the test system or to multiple test
systems.
[0324] A user will be able to choose the cardiac signal, whether or
not to add a cardiac feature or to choose a cardiac signal already
exhibiting a particular cardiac feature, whether or not to add a
non-cardiac signal to the cardiac signal, and whether or not to add
simulated impedance to the cardiac signal. This choice may be done
at a workstation that is either remote to or local to the simulator
that delivers the analog simulated waveform reflecting these user
choices to the first test system. Alternatively, a computer program
may randomly or methodically challenge the test system using any
one or more of these variables (cardiac signal, cardiac features,
non-cardiac signals, simulated impedance) as described infra.
Multiple test systems may be fed the same or different analog
simulated waveforms to evaluate these test systems alone or in
comparison with each other. The evaluator may also be remote to or
local to the simulator that delivers the analog simulated waveform
reflecting these user choices to the first test system. In some
embodiments a computer comprises logic, hardware, software, and/or
circuitry that allows a user to choose the inputs to the test
system (cardiac signal, cardiac feature, simulated impedance,
non-cardiac feature) and comprises the evaluator and its logic,
hardware, software, and/or circuitry configured to compare the
inputs to the first processed signal, at least, and generates the
output first finding 126, or a plurality of findings.
[0325] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *