Non-programmable automated heart rhythm classifier

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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C600S518000

Reexamination Certificate

active

06192273

ABSTRACT:

FIELD OF THE INVENTION
The present invention pertains generally to cardiac arrhythmia detection and classification devices.
BACKGROUND OF THE INVENTION
Prior art cardiac monitoring devices such as cardioverter defibrillators, holter monitors, or ICU monitors often use the same criteria to detect and subclassify cardiac arrhythmias. Prior art devices commonly utilize a single criterion such as cycle length to detect tachyarrhythmias. These devices generally measure cardiac cycle length by measuring the time between the large electrical deflections produced when the ventricles depolarize. The electrical deflections are sensed when the signal amplitude exceeds the amplitude of a programmed threshold. Prior art devices detect tachyarrhythmias by determining when the cardiac cycle length, or time between consecutive ventricular contractions, falls below a programmed level. The programmed levels are typically as follows: a cycle length greater than 500 milliseconds (ms) is identified as normal, a cycle length between 500 and 333 ms is classified as monomorphic tachycardia, and a cycle length less than 333 ms is identified as polymorphic tachycardia.
Thus the effectiveness of prior art devices of this type depend on the accuracy of cycle length detection. There are two major disadvantages with these devices. First, these detectors sometimes miss low amplitude electrical activity, such as during ventricular fibrillation, which can cause the detector to miss dangerous polymorphic ventricular tachycardias. Second, cycle length is not an effective discriminator between monomorphic and polymorphic arrhythmias even when the threshold detectors sense the electrical events appropriately.
Other prior art devices have been developed to overcome these disadvantages by utilizing additional parameters which can be programmed by a physician. Examples of some detection parameters include cycle length cutoff for monomorphic ventricular tachycardias, cycle length cutoff for polymorphic ventricular tachycardias, cycle length regularity, and QRS width. The disadvantage with these programmable devices is that a large number of detection parameters must be programmed by a physician. Further, this programming process can be complex, time consuming and prone to physician error.
It is highly desirable to have a non-programmable device and method for detecting tachyarrhythmias, i.e., a device which does not require programming by a physician. Further, a device is needed for use with cardioverter defibrillators, or monitors which can more accurately classify and discriminate between normal, monomorphic and polymorphic arrhythmias. Still further yet, it is desirable to have a device which can accurately sub-classify and discriminate between different types of arrhythmias within the monomorphic arrhythmia class or the polymorphic arrhythmia class. Thus, it is highly desirable to have an improved device and method which eliminates the prior art problems of missing dangerous polymorphic ventricular tachycardias when there is low electrical activity, and discriminating between monomorphic and polymorphic arrhythmias.
SUMMARY OF THE INVENTION
The present invention provides in one aspect an apparatus comprising a transducer for measuring a patient's heart activity and outputting a cardiac electrical signal, means for conditioning said cardiac electrical signal, a microprocessor for extracting regularity and cycle length from the cardiac electrical signal, classifying means for determining whether the cardiac electrical signal is normal, monomorphic tachycardia, or polymorphic tachycardia from regularity and cycle length.
The present invention provides in another aspect an apparatus for detecting and classifying a patient's cardiac heart rhythms comprising a transducer for measuring a patient's heart activity and outputting a cardiac electrical signal; means for conditioning said cardiac electrical signal; a microprocessor for extracting regularity, morphology, and cycle length from the cardiac electrical signal; and classifying means for classifying whether the cardiac electrical signal is normal, monomorphic tachycardia, or polymorphic tachycardia from said regularity, morphology and cycle length.
The present invention provides in yet another aspect a method for detecting and classifying abnormal heart rhythms comprising the steps of: measuring the cardiac electrical signal of a patient's heart rhythm; conditioning the cardiac electrical signal; extracting cycle length and regularity from the cardiac electrical signal; and classifying whether the cardiac electrical signal is normal, polymorphic tachycardia or monomorphic tachycardia from the cycle length and regularity.
The present invention provides in still another aspect a method for detecting and classifying abnormal heart rhythms comprising the steps of measuring the cardiac electrical signal of a patient's heart rhythm; conditioning the cardiac electrical signal; extracting cycle length, morphology and regularity from the cardiac electrical signal; and classifying whether the cardiac electrical signal is normal, polymorphic tachycardia or monomorphic tachycardia from the cycle length, morphology and regularity.
The present invention provides in still another aspect a method for adaptively sampling a cardiac electrical signal for use in a heart rhythm classifier wherein a cardiac electrical signal of a patient's heart is measured, comprising the steps of: determining a threshold value; storing the cardiac electrical signal; comparing the magnitudes of the change in the cardiac electrical signal; digitizing the cardiac electrical signal when the change in the magnitude of the cardiac signal exceeds the threshold value.
These and other aspects of the invention are herein described in particularized detail with reference to the accompanying Figures.


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