Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2001-04-30
2004-03-16
Evanisko, George R. (Department: 3762)
Surgery
Diagnostic testing
Cardiovascular
Reexamination Certificate
active
06708058
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to implantable medical devices and, more particularly, to generating, with an implantable medical device, a template representative of one beat of a patient's normal cardiac rhythm.
BACKGROUND OF THE INVENTION
Proper cardiac function relies on the synchronized contractions of the heart at regular intervals. When normal cardiac rhythm is initiated at the sinoatrial node, the heart is said to be in sinus rhythm. However, when the heart experiences irregularities in its coordinated contraction, due to electrophysiologic disturbances caused by a disease process or from an electrical disturbance, the heart is denoted to be arrhythmic. The resulting cardiac arrhythmia impairs cardiac efficiency and can be a potential life threatening event.
Cardiac arrhythmias occurring in the atria of the heart, for example, are called supra-ventricular tachyarrhythmias (SVTs). SVTs take many forms, including atrial fibrillation and atrial flutter. Both conditions are characterized by rapid, uncoordinated contractions of the atria. Besides being hemodynamically inefficient, the rapid contractions of the atria can also adversely effect the ventricular rate. This occurs when the aberrant contractile impulse in the atria are transmitted to the ventricles. It is then possible for the aberrant atrial signals to induce ventricular tachyarrhythmias.
Cardiac arrhythmias occurring in the ventricular region of the heart, by way of further example, are called ventricular tachyarrhythmias. Ventricular tachycardia (VTs), for example, are conditions denoted by a rapid heart beat, 150 to 250 beats per minute, that has its origin in some abnormal location with the ventricular myocardium. The abnormal location typically results from damage to the ventricular myocardium from a myocardial infarction. Ventricular tachycardia can quickly degenerate into ventricular fibrillation (VF). Ventricular fibrillation is a condition denoted by extremely rapid, non synchronous contractions of the ventricles. This condition is fatal unless the heart is returned to sinus rhythm within a few minutes.
Implantable cardioverter/defibrillators (ICDs) have been used as an effective treatment for patients with serious ventricular tachyarrhythmias. ICDs are able to recognize and treat tachyarrhythmias with a variety of tiered therapies. These tiered therapies range from providing anti-tachycardia pacing or cardioversion energy for treating ventricular tachycardia to defibrillation energy for treating ventricular fibrillation. To effectively deliver these treatments, the ICD must first identify the type of tachyarrhythmia that is occurring, after which appropriate therapy is provided to the heart. In order to apply the proper therapy in responding to an episode of tachyarrhythmia, the ICD may compare sensed cardiac signals to a previously stored normal sinus rhythm (NSR) signal waveform. It is appreciated that the stored NSR signal waveform must accurately characterize a patient's true normal sinus rhythm in order to properly identify potentially fatal deviations from normal cardiac activity.
For the reasons stated above, and for other reasons stated below which will become apparent to those skilled in the art upon reading the present specification, there is a need in the art for reliably and accurately characterizing a patient's normal cardiac rhythm. There exists a further need for such an approach that is adaptive and accommodates changes in the patient's normal cardiac rhythm over time. The present invention fulfills these and other needs.
SUMMARY OF THE INVENTION
The present invention is directed to a method and system for generating a snapshot representative of one beat of a patient's normal cardiac rhythm. In accordance with one embodiment of the present invention, rate channel signals and shock channel signals are sensed. A fiducial point for the rate channel signals is determined. The shock channel signals are aligned using the fiducial point. A template is generated using the aligned shock channel signals. The template is representative of one of the patient's normal supra-ventricular conducted beats. The template may be updated on a periodic basis, such as several times per day.
Using subsequently detected beats, confirmation processes are carried out prospectively to confirm that the generated template is representative of one of the patient's normal supra-ventricular conducted beats. According to one approach, a confirmation process uses subsequently detected template beats to determine whether the generated template is or is not representative of one of the patient's normal supra-ventricular conducted beats.
One confirmation process involves determining that no template is presently stored, and, in response to confirming that each of a number of subsequently detected template beats correlates with the generated template, storing the generated template. Another confirmation process involves determining that no template is presently stored, and discarding the generated template in response to confirming that each of a number of subsequently detected template beats fails to correlate with the generated template. A further confirmation process involves determining that a template is presently stored, and retaining the stored template in response to determining that each of a number of subsequently detected template beats correlates with the stored template.
Another confirmation process involves determining that a template is presently stored, generating a new template in response to confirming that each of a number of subsequently detected template beats fails to correlate with the stored template, and replacing the stored template with the new template in response to confirming that each of a number of newly detected template beats correlates with the new template. A further confirmation process involves determining that a template is presently stored, generating a new template in response to the confirming that each of a number of subsequently detected template beats fails to correlate with the stored template, and retaining the stored template and discarding the new template in response to confirming that each of a number of newly detected template beats fails to correlate with the new template.
The template generation methodology typically involves averaging or median filtering the aligned shock channel signals. For example, averaging the aligned shock channel signals involves point-by-point averaging or median filtering of n samples acquired from the same time location of aligned n template beats. The template generation methodology also involves determining that the rate channel signals satisfy predefined normalcy criteria using a running average (RRavg) of a number of RR intervals.
For example, after initiating template updating, a running average (RRavg) of a number of RR intervals is compared to a predetermined rate threshold. If RRavg is less than a predetermined interval, template updating is suspended. By way of further example, a beat is classified as a regular beat if an RR interval associated with the beat falls within a predetermined percentage range of RRavg. Further, a heart rate is classified as regular if a predetermined percentage of the beats are regular beats.
Template generation may also involve skipping processing of a subsequently sensed rate channel signal if the subsequently sensed rate channel signal is detected before processing of a current sensed rate channel signal is completed. The rate channel is also monitored for noise. If the rate channel is determined to be noisy, the beat measured from the noisy rate channel is classified as a noisy beat.
An automatic gain control (AGC) operation of the template generation methodology involves computing an average peak amplitude of a number of beats. The shock channel gain is adjusted to an available gain that sets the average peak amplitude to a predetermined percentage of a maximum ADC (analog-to-digital converter) value, such as 60% of the maximum ADC v
Bocek Joseph
Hsu William
Kim Jae-ho
White Harley
Cardiac Pacemakers Inc.
Crawford & Maunu PLLC
Evanisko George R.
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