Method of and apparatus for detecting arrhythmia and...

Surgery – Diagnostic testing – Cardiovascular

Reexamination Certificate

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Reexamination Certificate

active

06519490

ABSTRACT:

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
None
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
None
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to a method of and an apparatus for detecting irregular heartbeats and, more particularly, to monitoring and analyzing pulse rates for detecting possible atrial fibrillation.
2. Discussion of the Related Art
The heart is the major muscle that functions as the primary pump for blood flow throughout the body. The heart contains two upper chambers called atria and two lower chambers called ventricles. The right atrium receives oxygen-depleted blood while the left atrium receives blood enriched with oxygen from the lungs. When the atria are full, the outlet valves within the heart open and the atria squeeze blood into the ventricles. The right ventricle then pumps oxygen-depleted blood to the lungs while the left ventricle pumps oxygen-enriched blood to all parts of the body. In this fashion, the heart functions primarily as a double sided pump.
The heart's internal pacemaker, known as the sinus node, signals the start of each heart beat. This signal originates in the right atrium in the sinoatrial node and travels simultaneously to the left atrium and down to the interatrial septum to the atrioventricular node. The cycle of electrical stimulation that normally occurs is referred to as normal sinus rhythm.
When a rhythm abnormality is present, however, there may exist an abnormal condition known as fibrillation. Fibrillation may occur as a result of an abnormality with either the ventricle and/or the atria. Atrial fibrillation is an abnormal heart condition in which the atria of the heart provide irregular impulses to the atrioventricular node so that an irregular heartbeat results.
Atrial fibrillation is one of the most common arrhythmias requiring medical attention. Atrial fibrillation may be caused by a number of heart conditions, such as angina, myocardial infarction, heart valve abnormalities, and high blood pressure. These conditions may stretch or scar the atria, thereby causing irregularities in the heart system. Atrial fibrillation may also accompany lung problems or thyroid gland disorders and is also associated with significant morbidity and possible mortality. All persons, young and old, female or male, including the visually and/or sight impaired, may experience atrial fibrillation.
Atrial fibrillation may occur intermittently or chronically. The most serious complication of atrial fibrillation is formation of a blood clot in the left atrium which may result in a stroke. Many people who develop atrial fibrillation, however, are unaware of their abnormal rhythm, Some in the medical profession have, therefore, advocated self screening of the pulse rate to detect for the possible occurrence of atrial fibrillation. The literature, however, is generally limited to disclosing instructions for manually taking one's pulse rate accompanied with additional descriptive information.
The reason for taking the pulse rate to detect atrial fibrillation is that the pulse rate corresponds to the heart rate. The pumping action of the heart displaces blood in the rest of the body. The pulse is the movement of blood caused by the heart's pumping, and the pulse rate is the number of times that the blood is displaced during a fixed period, conventionally an interval of one minute.
Because of the correspondence between the heartbeat rate and pulse rate, atrial fibrillation causes an irregular detected pulse wherever a pulse can be palpated. Normal sinus rhythm produces a heartbeat of a fixed number of beats per minute with equal interval between beats. Fibrillation is detected when the time between the beats is irregular, that is the time between beats changes irregularly.
There are several devices available that measure both blood pressure and pulse rate, but none of these devices is capable of monitoring, detecting and/or communicating whether or not an irregular heartbeat is present to indicate possible atrial fibrillation. The commercially available devices measure the number of pulse beats over a preset time interval, usually ten (10) seconds, but these devices neither analyze nor determine the presence of irregular heartbeat rhythms.
Commercially available devices for determining pulse rates use several methods including: i) measuring a pulse beat when systolic pressure peaks are detected such as by using an inflated cuff that is wrapped around the upper arm, ii) utilizing electrodes to determine pulse rates in the same manner used while taking an EKG, and iii) detecting pulse beats from changes in light transmission through body appendages, such as through the fingers, where a pulse is recorded whenever the difference in the amount of light absorbed between one point of the appendage and another point on the appendage changes. The change in transmission results from the pulse moveably changing the volume of blood flowing through the appendage which changes, in turn, the amount of light absorbed in the appendage.
What is needed is a method and apparatus to detect the pulse beats during a certain interval of time.
What is needed is a method and apparatus to detect the presence of irregular heartbeats and communicate this condition to the user so that the user is alerted to consult a medical practitioner for further testing and/or treatment.
What is also needed is a method that can differentiate an irregular pulse rate pattern from a normal pulse rate pattern and from common heart rhythm patterns that are not of significant risk, such as regular sinus rhythm, sinus arrhythmia, atrial premature beats and ventricular premature beats.
What also is a needed is a home monitoring method and apparatus that analyzes pulse rates for the presence of irregular pulse rhythms and that communicates this information to the user.
What further is needed is a method of and an apparatus for detecting irregular pulse rhythms during a time period and storing this information so that comparisons may be made with the pulse rate rhythms at later times.
What is further needed is a noninvasive and relatively simple method and apparatus that monitors pulse rate irregularities to detect fibrillations, including the possibility of atrial fibrillation, and that is suitable for use of all ages, and by the hearing and/or visually impaired and that is relatively easy to use.
What is still further needed is a monitoring method and apparatus that detects the presence of irregular heartbeats and then displays and stores: i) the number of irregular pulse beats during a pre-selected time interval; and ii) the duration of time between beats during selected intervals.
Yet another need is for a monitoring method and apparatus that determine whether or not a heartbeat is irregular based on algorithmic or heuristic operations performed on selected pulse rate or heartbeat data.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a method and apparatus that (i) detects the presence of irregular heartbeats by analyzing a pulse rate pattern, that is, by analyzing the pulse beat rhythm during a time interval; (ii) determines whether this pulse rate pattern indicates a possible atrial fibrillation or other irregularity; and then (iii) communicates this information to the user so that a medical practitioner may be consulted for further testing and/or treatment. The present invention also provides a method of and an apparatus for detecting irregular pulse rhythms during a time period and storing this information for comparison with the pulse rate rhythm at later time periods. The present invention may also detect irregular pulse rhythms over multiple time periods and capture the similarities and/or differences in the pulse rate for selected intervals over various time periods.
The present invention further provides a noninvasive method of and an apparatus for monitoring pulse rate irregularities to detect atrial fibrillation. The invention may store and display information such as the number of irregu

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