Cardiac rhythm monitoring device

• US 20060074332A1
• Filed: 11/22/2005
• Published: 04/06/2006
• Est. Priority Date: 05/29/2001
• Status: Active Grant

• Current Assignee: Edward T. Bischoff, Gary D. Menszer
• Original Assignee: Edward T. Bischoff, Gary D. Menszer
• Inventors: Bischoff, Edward T., Menszer, Gary D.
• Granted Patent: US 7,509,160 B2
• Time in Patent Office: Days
• US Class Current: 600/515
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/681 Wristwatch-type devices

Abstract

The present invention is a cardiac rhythm-monitoring device, which allows patients to perform a preliminary screening for supraventricular arrhythmia. The device detects beat-to-beat heart rhythms (i.e. the R-R interval between individual heart beats) and performs a screening test to determine if there are indications of arrhythmia. The test looks for variance in the R-R interval that is outside of the normal range, either using a pre-constructed chart based upon general population studies to determine the normal range of variance or using normal distribution analysis of the patient'"'"'s own heart rhythm to determine the normal range of variance for determining irregular heartbeats, and if there are multiple irregularities within the sensed time frame, the patient is warned of potential supraventricular arrhythmia. By sensing both electrical impulses form the heart and mechanical responses to the heartbeat, the device may augment its analysis.

Claims

1. A method for detecting potential arrhythmia comprising the steps of:

sensing a patient'"'"'s beat-to-beat heartbeat intervals;

storing said beat-to-beat heartbeat interval data;

normalizing said beat-to-beat heartbeat interval data;

analyzing each piece of normalized beat-to-beat heartbeat data in comparison to a stability criteria to determine if said data indicates stability or instability of the patient'"'"'s heart rhythm;

tracking the number of normalized beat-to-beat heartbeat data indicating stability and the number of normalized beat-to-beat heartbeat data indicating instability;

outputting a warning to the patient if the number of normalized beat-to-beat heartbeat data indicating instability exceeds the pre-set criteria.

2. A method for detecting arrhythmia as in claim 1 wherein said stability criteria for classifying a normalized beat-to-beat heartbeat interval as stable is approximately between 0.95 and 1.05, and wherein said pre-set criteria for outputting a warning to the patient is when the number of normalized beat-to-beat heartbeat intervals indicating instability exceeds the number of normalized beat-to-beat heartbeat intervals indicating stability.

3. A method for detecting arrhythmia as in claim 1 wherein at least 8 beat-to-beat heartbeat intervals are sensed and analyzed.

4. A method for detecting arrhythmia as in claim 1 wherein beat-to-beat heartbeat intervals are sensed and analyzed in sets of 32.

5. A method for detecting arrhythmia as in claim 1 wherein the method for normalizing the beat-to-beat heartbeat interval data is by dividing each sensed beat-to-beat heartbeat interval by the succeeding sensed beat-to-beat heartbeat interval.

6. A method for detecting arrhythmia as in claim 1 further comprising the step of calculating the average heartbeat interval for the sensed set of beat-to-beat heartbeat intervals, and wherein the method for normalizing the beat-to-beat heartbeat interval data is by dividing each sensed beat-to-beat heartbeat interval by the average heartbeat interval.

7. A method for detecting arrhythmia as in claim 1 further comprising the steps of:

ensuring that the patient'"'"'s heartbeat is within the normal resting range;

performing noise and bandwidth filtering on the sensed beat-to-beat heartbeat interval data; and

digitizing the sensed beat-to-beat heartbeat interval data signal.

8. A method for detecting potential arrhythmia using a tri-phase analysis comprising the steps of:

sensing a patient'"'"'s beat-to-beat heartbeat intervals;

storing said beat-to-beat heartbeat interval data;

analyzing said beat-to-beat heartbeat interval data in discrete sets;

calculating the average heartbeat interval for each set of beat-to-beat heartbeat intervals;

phase-one normalizing each piece of beat-to-beat heartbeat interval data within a set by dividing each sensed beat-to-beat heartbeat interval by the succeeding sensed beat-to-beat heartbeat interval;

analyzing each piece of phase-one normalized beat-to-beat heartbeat data in comparison to a stability criteria to determine if said data indicates stability or instability of the patient'"'"'s heart rhythm;

tracking the number of phase-one normalized beat-to-beat heartbeat data indicating stability and the number of phase-one normalized beat-to-beat heartbeat data indicating instability;

designating a phase-one result of “

Stable”

if the number of phase-one normalized beat-to-beat heartbeat interval data indicating stability exceeds a pre-set determination criteria, while designating a phase-one result of “

Unstable”

if the number of phase-one normalized beat-to-beat heartbeat interval data indicating instability exceeds a pre-set determination criteria;

phase-two normalizing each piece of beat-to-beat heartbeat interval data within a set by dividing each sensed beat-to-beat heartbeat interval by the average heartbeat interval for said set;

analyzing each piece of phase-two normalized beat-to-beat heartbeat data in comparison to a stability criteria to determine if said data indicates stability or instability of the patient'"'"'s heart rhythm;

tracking the number of phase-two normalized beat-to-beat heartbeat data indicating stability and the number of phase-two normalized beat-to-beat heartbeat data indicating instability;

designating a phase-two result of “

Stable”

if the number of phase-two normalized beat-to-beat heartbeat interval data indicating stability exceeds a pre-set determination criteria, while designating a phase-two result of “

Unstable”

if the number of phase-two normalized beat-to-beat heartbeat interval data indicating instability exceeds a pre-set determination criteria;

comparing said phase-one result and said phase-two result;

setting said overall result as “

Stable”

if both said phase-one result and said phase-two result are “

Stable,”

while setting said overall result as “

Unstable”

if both said phase-one result and said phase-two result are “

Unstable;

” and

outputting a warning if said overall result is “

Unstable.”

9. A method as in claim 8 further comprising the step of iteratively performing said phase-one and said phase-two analysis on additional successive sets of beat-to-beat heartbeat interval data until both said phase-one result and said phase-two result match.

10. A method as in claim 9 further comprising the step of outputting a warning regarding potential arrhythmia if said phase-one result and said phase-two result have not matched after three iterations.

11. A method as in claim 9 wherein the pre-set determination criteria is arranged so that a phase-one result of “

Stable”

is designated if the number of phase-one normalized beat-to-beat heartbeat interval data indicating stability exceeds the number of phase-one normalized beat-to-beat heartbeat interval data indicating instability, a phase-one result of “

Unstable”

is designated if the number of phase-one normalized beat-to-beat heartbeat interval data indicating instability exceeds the number of phase-one normalized beat-to-beat heartbeat interval data indicating stability, a phase-two result of “

Stable”

is designated if the number of phase-two normalized beat-to-beat heartbeat interval data indicating stability exceeds the number of phase-two normalized beat-to-beat heartbeat interval data indicating instability, and a phase-two result of “

Unstable”

is designated if the number of phase-two normalized beat-to-beat heartbeat interval data indicating instability exceeds the number of phase-two normalized beat-to-beat heartbeat interval data indicating stability.

12. A method as in claim 9 wherein said stability criteria for classifying a normalized beat-to-beat heartbeat interval as stable is approximately between 0.95 and 1.05.

13. A method as in claim 10 wherein said stability criteria for classifying a normalized beat-to-beat heartbeat interval as stable is approximately between 0.95 and 1.05.

14. A method as in claim 9 further comprising the steps of

ensuring that the patient'"'"'s heartbeat is within the normal resting range;

performing noise and bandwidth filtering on the sensed beat-to-beat heartbeat interval data; and

digitizing the sensed beat-to-beat heartbeat interval data signal.