US2020001036A1PendingUtilityA1

Systems and methods for evaluation of electrophysiology systems

66
Assignee: BIOSIG TECH INCPriority: Dec 11, 2013Filed: Aug 9, 2019Published: Jan 2, 2020
Est. expiryDec 11, 2033(~7.4 yrs left)· nominal 20-yr term from priority
A61M 2205/42B29C 65/08B29L 2031/4835A61M 2202/0225A61M 16/06B29C 66/1122B29C 65/62B29C 66/14A61M 2207/00B29C 66/723A61M 16/0616A61M 16/0633B29C 66/2442B29C 66/43A61M 16/0825B29C 66/12881A61M 16/0875B29C 66/244A61M 16/0683A61M 2205/0216A61M 16/0605A61M 16/208A61M 2039/1033A61M 39/1055A61M 39/10A61M 16/0816
66
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Claims

Claims

exact text as granted — not AI-modified
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.

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