Early warning apparatus for acute Myocardial Infarction in...

Surgery – Diagnostic testing – Cardiovascular

Reexamination Certificate

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Reexamination Certificate

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06339720

ABSTRACT:

CROSS REFERENCE TO RELATED APPLICATIONS
Not applicable
BACKGROUND
1. Field of Invention
The CARDIOST relates to a unit capable of informing a user with no medical background when he/she is suffering an Acute Myocardial Infarction in the first 4 to 6 hours of chest pain.
2. Description of Prior Art
There are many electrocardiographic (ECG) measuring apparatuses. Many of them can measure the ST segment (and other parts of the electrocardiogram wave) but are not meant to alert as to the possibility of an Acute Myocardial Infarction, and they have to be used by qualified medical personnel.
The portable electrocardiographic monitoring devices are used for long-term collection of ST segment data and many other measurements. Some of these devices perform simple real-time analyses limited to ischemia period detection and recording. These devices are used over a long period of time (usually 24 hour periods) for passive recording and analysis. After this period the data has to be downloaded from the device and analyzed by qualified medical personnel for the final opinion. These devices have to be carried by the patient for the complete period of data recording, which makes them uncomfortable no matter how small they are.
U.S. Pat. No. 5,433,209 issued to Gallant et al. July 1995 fully describes an ambulatory recording device that measures the ST segment for further analysis by a physician, which is incorporated herein as reference entitled “recorder unit for ambulatory ECG monitoring system”. This unit does not measure the ST segment in immediate analysis and therefore is not able to diagnose Acute Myocardial Infarction in real time at the moment of real pain when it is necessary for the patient to seek medical advice for early thrombolysis. This Patent is intended to analyze all the waves of the electrocardiogram other than the ST segment and the baseline. The mentioned Patent also includes accumulation and recording of “minute-by-minute”, “hour-by hour” and “end of period” summary information that is not used in acute settings.
U.S. Pat. No. 5,713,367 issued to Arnold et al. February 1998 for measuring and assessing cardiac electrical stability and the alternans pattern of cycle-to cycle variability in physiologic waveforms does not measure S-T segment but alternans of the QRS wave to asses the risk of ventricular arrhythmias, as does the signal average electrocardiogram by averaging many repetitive waveforms, and much of the existing hardware can be used for both systems. Neither of these systems is intended for acute ischemia diagnosis.
U.S. Pat. No. 5,584,868 issued to Salo et al. December 1996 is a cardiac stimulating apparatus and method for heart failure therapy that includes a dual chamber pacemaker on an invasive basis that is not intended with our invention, and a cardiac defibrillator for reducing cardiac lethal arrythmia and sudden death by the means of electric shock provided by the defibrillator.
U.S. Pat. No. 3,868,567 issued to Ekstrom et al. February 1975 is related to the PQ level of the same waveform employing delta modulation and demodulation for processing information overlapping the ST segment with a predetermined electrocardiographic form and making an average between two segments of waveforms, but does not trigger any visual or audible alarm intended for early diagnosis of Acute Myocardial Infarction.
U.S. Pat. No. 3,991,747 issued to Stanly et al. November 1976 is a electrocardiographic device for telephonic or radio transmission to an analyzing facility, converting the signs to audio output, not intended to be analyzed by the patient himself, and displays the full extent of the 12 EKG leads. The device described in this Patent does not have an audio or visual alarm.
U.S. Pat. No. 4,318,412 issued to Stanly et al. March 1982 is intended to provide and optimize the placement of cardiac electrodes and to improve the signal processing but is not intended for early diagnosis of Acute Myocardial Infarction nor does it examine the ST segment. This arrangement obtains 90% of the information from a 12-lead electrocardiogram.
U.S. Pat. No. 4,546,776 issued to Bellin et al. October 1985, which analyzes PQ and ST portions of an electrocardiogram waveform and establishes a normal or standard ST ratio deviation between the difference of ST and PQ level, has an actuating alarm if heartbeats exceeds or is lower than a predetermined rate. When the ST segment triggers the alarm it is made on the basis of a standard ST deviation value in this Patent. Also it is emphasized that the ST segment is measured continuously. This invention is intended to be used in exercise conditions such as jogging. While this Patent indicates that a depression of approximately 100 microvolts is usually “normal”, we consider that this degree of depression in acute pain is enough to trigger an alarm of “medium risk” (yellow light). In this Patent the alarm is intended in part to warn the user to “cease vigorous activity” and does not seek an immediate use of thrombolisys. The PQ level is used and compared to the ST level instead of comparing to the baseline, which is universal in the electronic signal of any electrocardiogram.
U.S. Pat. No. 4,679,144 issued to Cox et al July 1987 includes a programmable apparatus carried by an ambulatory patient for performing continuous real time analysis of EKG information by permanently carrying the device and analyzing the TP segment against the ST segment. Emphasis is made on the slope of the current EKG amplitude minus previous EKG amplitude, so only the patient intended to use the apparatus can take advantage of the diagnosis instead of any other person where the baseline is used as reference.
U.S. Pat. No. 4,930,075 issued to Kortas et al. May 1990 focuses only on the quantification of the ST depression, slope and length of the ST segment and is a software implemented method for analysis, but is not intended as a device for self diagnosis of acute ischemia. It studies principally a precise mathematical relationship between the values of the S-T segment.
U.S. Pat. No. 4,957,115 issued to Selker et al. September 1990 is intended as a device for determining the probability of death in cardiovascular patients and a method for assessing mortality risk at a health care facility. It is a computer adapted to receive the output and calculate a numerical value representing the output-based probability.
U.S. Pat. No. 5,003,983 issued to Dingwall et al. April 1991 is intended to provide an improved cardiac monitoring system to measure the deviation of the S-T segment and pulse rate in a package that can be easily and unobtrusively attached to a patient, for example, during an exercise routine, or long term monitoring.
U.S. Pat. No. 5,058,597 by Onoda et al. October 1991 has an R wave detector determining the heart rate and the ST value of the ECG signal over a long period of time while being carried by a subject who presses an event switch on feeling a subjective symptom (includes pain) but, instead of triggering an alarm after analyzing the ST segment, the electrocardiographic signal is written to another storage which is assigned to waveforms. The electrocardiograph records a minimum necessary amount of information for screening, i.e. the heart rates, ST values, and waveforms of electrocardiographic signal associated with subjective symptoms.
U.S. Pat. No. 5,181,519 issued to Bible et al. January 1993 detects the ST segment but is not intended to trigger an alarm when any shift of the segment is detected, the associated signal is then stored while the monitoring unit continues to search for further measured ST deviations exceeding the threshold ST deviation and subsequently the recorded signals and associated data can be displayed by transmitting it from the monitoring unit to a remote display unit via a data transmission unit.
U.S. Pat. No. 5,226,424 issued to Bible et al. July 1993 determines the ST segment characteristics useful in diagnosing myocardial ischemia, but operates continuously and focuses on a low energy consumptive portable heart monitor which derives fr

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