(12) United States Patent
`Us 6,487,442 B1
`(10) Patent N0.:
`Wood
`(45) Date of Patent:
`Nov. 26, 2002
`
`USOO6487442B1
`
`(54)
`
`DETECTION OF ABNORMAL AND
`INDUCTION OF NORMAL HEAT RATE
`VARIABILITY
`
`(76)
`
`Inventor: Nicholas Wood, 16 Ensign Rd.,
`Rowayton, CT (US) 06853
`
`( * )
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`SU
`SU
`SU
`WO
`WO
`WO
`
`2/1999 Lanido et al.
`5,873,369 A
`5,891,044 A
`4/1999 Golosarsky et al.
`FOREIGN PATENT DOCUMENTS
`
`1607808 A1
`1683679 A1
`1769894 A1
`8809146
`9406350
`9602185 A1
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`11/1990
`10/1991
`10/1992
`12/1988
`3/1994
`2/1996
`
`OTHER PUBLICATIONS
`
`(21)
`
`(22)
`
`(51)
`
`(52)
`
`(58)
`
`(56)
`
`Appl. No.: 09/559,653
`
`Filed:
`
`Apr. 28, 2000
`
`Int. Cl.7 .............................................. A61B 5/0468
`
`US. Cl.
`
`........................................ 600/515; 600/519
`
`Field of Search ................................. 600/513, 515,
`600/516, 517, 518, 519
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`“The Functional Model Regulation Homeokinesis of Heart
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`Malik, Farrell, Cripps, Camm, Heart Rate Variability in
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`Primary Examiner—Scott M. Getzow
`(74) Attorney, Agent, or Firm—Stevens, Davis, Miller &
`Mosher, LLP
`
`(57)
`
`ABSTRACT
`
`An apparatus and method for predicting potentially fatal
`arrhythmias up to twenty four hours in advance of the event
`by employing formulas indicating either too little or too
`much heart rate variability. Anumber of these formulas have
`both predetermined upper and lower limits, which if
`exceeded for a period of time are a predictor of a potentially
`fatal arrhythmia. When a patient’s ALARM condition is
`predicted, whether the patient is indoors or outdoors, con-
`scious or unconscious, a redundant protocol is utilized to
`relay that ALARM condition to a central monitoring station.
`The central monitoring station informs the patient’s doctor,
`and then uses what ever means are available to transport the
`patient to the nearest emergency room for treatment. An
`apparatus and method for pacing the heart in a natural way,
`once a potentially fatal arrhythmia has been predicted is also
`disclosed.
`
`42 Claims, 22 Drawing Sheets
`
`
`
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`US 6,487,442 B1
`Page 2
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`OTHER PUBLICATIONS
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`Malik, Xia, Odemuyiwa, Staunton, Poloniecki, Camm,
`Influence of the Recognition Artefact
`in the Automatic
`Analysis of Long—term Electrocardiograms on Time—do-
`main Measurement of Heart Rate Variability, Med. Biol.
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`Malik, Camm, Components of Heart Rate Variability: What
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`Cardiol. 1993; 72:821—822.
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`Rate Variability After Myocardial Infarction: A Comparison
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`Malik, Camm, Heart Rate Variability and Clinical Cardiol-
`ogy, Br. Heart J. 1994; 71:3—6.
`Malik, Camm. Significance of Long—term Components of
`Heart Rate Variability for the Further Prognosis After Acute
`Myocardial Infarction, Cardiovasc. Res. 1990;24:793—803.
`Fei, Malik, Short— and Long—term Assessment of Heart Rate
`Variability for Postinfarction Risk Stratification, In: Malik,
`Camm, eds, Heart Rate Variability, Armonk, NY: Futura;
`1995: 341—346.
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`Heart Rate Variability Standards of Measurement, Physi-
`ological Interpretation, and Clinical Use, Circulation, vol.
`93, No. 5 (Mar. 1, 1996).
`Wood, NB. “The Prediction of a Potentially Fatal Cardiac
`Event in the Next 2 to 24 Hours and the Prediction of a
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`Myocardial Infarction Related Death or Sudden Death”,
`Computers in Cardiology conference proceedings (Sep.
`24—26, 2001).
`Schmidt, Georg, et al “Heart—Rate Turbulence after Ven-
`tricular Premature Beats as a Predictor of Mortality After
`Acute Myocardial Infarction”, The Lancet, vol. 353, Issue
`9162, p. 1390(1), (Apr. 24, 1999).
`de Bruyne, Martine C., et al “Both Decreased and Increased
`Heart Rate Variability on the Standard 10—Second Electro-
`cardiogram Predict Cardiac Mortality in the Elderly: The
`Rotterdam Study”, American Journal of Epidemiology, vol.
`150, No. 12, pp. 1282—1288 (Dec. 15, 1999).
`Ziegler, D., et al “Normal Ranges and Reproducibility of
`Statistical, Geometric, Frequency Domain, and Non—Linear
`Measures of 24—Hour Heart Rate Variability”, Horm Metab
`Res Issue 12, pp. 672—679 (Dec. 31, 1999).
`Pinar, Eduardo, et al “Effects of Verapamil on Indexes of
`Heart Rate Variability After Acute Myocardial Infarction”,
`The American Journal of Cardiology, vol. 81, Issue 9, pp.
`1085—1089 (May 1, 1998).
`Deligiannis, Asterios, et al “Effects of Physical Training on
`Heart Rate Variability in Patients on Hemodialysis”, The
`American Journal of Cardiology, vol. 84,
`Issue 2, pp.
`197—202 (Jul. 15, 1999).
`
`Hayano, Junichiro et al “Prognostic Value of Heart Rate
`Variability During Long—Term Follow—Up in Chronic Hae-
`modialysis Patients with End—Stage Renal Disease”, Neph-
`rology Dialysis Transplantation, vol. 14,
`Issue 6, pp.
`1480—1488 (Jun. 1999).
`
`Lotze, Ulrich, et al “Cardiac Sympathetic Activity as Mea-
`sured
`by Myocardial
`123—I—Metaiodobenzylguanidine
`Uptake and Heart Rate Variability in Idiopathic Dilated
`Cardiomyopathy”, The American Journal of Cardiology,
`vol. 83, Issue 11, pp. 1548—1551 (Jun. 1, 1999).
`
`Ho, Kalon K.L. et al “Predicting Survival in Heart Failure
`Case and Control Subjects by Use of Fully Automated
`Methods for Deriving Nonlinear and Conventional Indices
`of Heart Rate Dynamics” Circulation, vol. 96, pp. 842—848
`(1997).
`
`Makikallio, Timo H., et al “Heart Rate Dynamics Before
`Spontaneous Onset of Ventricular Fibrillation in Patients
`with Healed Myocardial Infracts”, The American Journal of
`Cardiology, vol. 83, pp. 880—884 (Mar. 15, 1999).
`
`Reardon, M., et al “Changes in Heart Rate Variability With
`Age”, Pacing Clin. Electrophysiol., vol. 11., Part 2, pp.
`1863—1866 (Nov. 1996)(Abstract).
`
`Skinner, J .E., et al “New Non—Linear Algorithms for Analy-
`sis of Heart Rate Variability; Low Dimensional Chaos
`Predicts Lethal Arrhythmias”, Nonlinear Analysis of Physi-
`ological Data, Springer, pp. 129—166 (1998).
`
`Fauchier, Laurent et al. “Prognostic Value of Heart Rate
`Variability for Sudden Death and Major Arrhythmic Events
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`1203—1207 (Apr. 1999).
`
`Cheng, T.O. “Decreased Heart Rate Variability as a Predictor
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`
`Soejima, Kyoko et al. “Age—Adjusted Heart Rate Variability
`as an Index of the Severity and Prognosis of Heart Failure”,
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`Reardon, Michael et al. “Changes in Heart Rate Variability
`with Age” Pace, vol. 19, pp. 1863—1866 (Nov. 1996).
`
`Makikallio, Timo H. et al. “Prediction of Sudden Cardiac
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`Cardiology, vol. 37, No. 5, pp. 1395—1402 (Apr. 2001).
`
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`US. Patent
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`Nov. 26, 2002
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`Sheet 1 0f 22
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`US. Patent
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`Nov. 26, 2002
`
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`US. Patent
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`Nov. 26, 2002
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`Sheet 3 0f 22
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`US. Patent
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`Nov. 26, 2002
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`Nov. 26, 2002
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`US. Patent
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`Nov. 26, 2002
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`US. Patent
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`Nov. 26, 2002
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`US. Patent
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`Nov. 26, 2002
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`US. Patent
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`Nov. 26, 2002
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`Sheet 10 0f 22
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`US 6,487,442 B1
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`|PR2018—01093
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`US. Patent
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`Nov. 26, 2002
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`Sheet 11 0f 22
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`US 6,487,442 B1
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`|PR2018—01093
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`Sheet 12 0f 22
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`US. Patent
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`Sheet 13 0f 22
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`US 6,487,442 B1
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`Fig. 8
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`Sheet 14 0f 22
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`US 6,487,442 B1
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`Fig. 93
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`Sheet 15 0f 22
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`US 6,487,442 B1
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`Fig. 9b
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`Sheet 16 0f 22
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`Fig. 90
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`THIS PAGE INTENTIONALLY LEFT BLANK
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`Nov. 26, 2002
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`Sheet 17 0f 22
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`US 6,487,442 B1
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`rom Fig.
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`RR Time Intervals
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`Sheet 18 0f 22
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`US 6,487,442 B1
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`Fig. 9e
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`Sheet 19 0f 22
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`Fig. 9f
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`From Fig. 9d From Fig. 9d
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`Sheet 20 0f 22
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`US 6,487,442 B1
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`Fig. 10
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`US 6,487,442 B1
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`1
`DETECTION OF ABNORMAL AND
`INDUCTION OF NORMAL HEAT RATE
`VARIABILITY
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`The normal heart rate is slightly irregular. Generally,
`normal irregularity of the heart rate reflects the permanent
`adaptation of the human body to the environment. In this
`context the first sign of an impaired heart rate is either a
`persistent increase or a persistent decrease in the variability
`of the heart’s rate. Sometimes the change in the heart rate
`alternates between increases and decreases in the variability
`of the heart’s rhythm, and vice versa. Prolonged increases,
`or decreases, and combinations thereof, can lead to cardiac
`adverse events ranging from non-sustained ventricular
`tachycardia to cardiac arrest.
`It is believed the variability of the heart rate is controlled
`by two branches of the autonomic nervous system;
`the
`sympathetic branch and the parasympathetic branch. The
`sympathetic branch increases the heart rate. Its prime func-
`tion is to prepare the body for stress, the so-called “fight or
`flight response.” The parasympathetic branch decreases the
`heart rate as when eating or sleeping.
`This invention relates to the detection of normal and
`
`abnormal heart rate variability and the induction of normal
`heart rate variability. More particularly, the invention relates
`to methods and apparatus for the detection of a patient’s
`heart rate variability that we believe is indicative of a
`patient’s sympathetic/parasympathetic stress balance, or dis-
`tress imbalance.
`
`The invention also relates to heart monitoring devices
`used by individuals monitored in hospital intensive care
`units; by patient’s after discharge from a hospital intensive
`care unit; and by patients when exercising to let them know
`that their stress state is optimal for conditioning their bodies.
`The invention further relates to control of a pacemaker or
`cardioverter defibrillator with a pacemaker so that when the
`patient’s heart rate is abnormal and distressful, according to
`the invention, a pacemaker or cardioverter defibrillator with
`a pacemaker induces a heart rate with a pseudo-normal or
`patient recorded variability for each particular patient.
`The invention still further relates to a pacemaker that
`induces pseudo-normal or patient recorded heart rate vari-
`ability.
`2. Background Description
`In the Soviet Union, Rhythmography, that is the study of
`normal and abnormal variations in the heart, was utilized
`extensively to determine the condition of individuals and
`their stress state. This was particularly true of cosmonauts.
`It was determined, for example, that the heart rate variability
`of a conditioned athlete is much greater than that of person
`with coronary disease. That is, the histogram of heart rate
`variation of a well conditioned athlete exhibits a broad range
`of variability in the Time Intervals between heart beats and
`a low relative Amplitude of the Mode. That is the highest
`number of Time Intervals recorded in a series of Time
`
`Intervals. The histogram of a person with a coronary disease
`exhibits a narrow range of variability and a high relative
`Amplitude of the Mode, that is the peak of the histogram.
`Boris Golosarsky, previously received two patents in the
`Soviet Union, namely SU-1683679 and SU-1769894.
`SU-1683679 is for an apparatus, which enables a physician
`to determine the arithmetic Mean, the Mode, the relative
`Amplitude of the Mode, and the range of variability of a
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`in the Soviet Union,
`In the second patent
`subject.
`SU-1769894, he disclosed how these measurements may be
`utilized together with electrosleep to treat post myocardial
`infarction e.g., heart attack patients.
`GW Scientific, Inc. measured a patient’s heart rate vari-
`ability in relation to the patient’s baseline heart variability
`using mathematical constructs such as UV, AMo, and DX,
`all as described in US. Pat. No. 5,718,235, incorporated
`herein by reference in its entirety.
`Polar Electro Oy of Finland has a patented apparatus
`comprised of a chest strap with a two lead ECG signal sensor
`and transmitter, which transmits the heart beat Time Inter-
`vals to a wrist mounted unit that can be conveniently used
`in this invention. See US. Pat. Nos. 4,625,733; Des. 278,
`746; and Des. 287,403, all incorporated herein by reference
`in their entirety.
`Pulse sensors of various types may also be used to detect
`the Time Interval between heart beats, (Start-of-Systole to
`Start-of—Systole, SOS),
`is essentially equal
`to the Time
`Interval between RR peaks in an electrocardiogram, (ECG).
`Additional background information is disclosed by
`Baevsky, R. M., Kirillow, O. I., Kleckin, C. Z., (1984),
`Mathematical Analysis of Stress Changes in Heart Rhythm,
`Moscow, Academy of Science, USSR.
`Schmidt et al, “Heart-rate Turbulence After Ventricular
`Premature Beats As a Predictor of Mortality After Acute
`Myocardial Infarction,” Lancet Apr. 24, 1999; 353 (9162)
`:1390—6, relates to ACRRs. This article discloses a formula
`for predicting myocardial infarction 21 to 24 months in
`advance. In contrast, the present invention predicts up 24
`hours in advance. The formula in this article is quite different
`from those employed in the present invention.
`
`SUMMARY OF THE INVENTION
`
`Definitions
`
`TABLE A shows there are five abnormal predictive
`markers, which are comprised of two continuums, the Heart
`Rate Variability continuum and the Heart Rate continuum, as
`well as Erratic Variability. The Heart Rate Variability con-
`tinuum has, as its extremes, high and low variability. The
`Heart Rate continuum has, as its extremes, bradycardia and
`tachycardia. Erratic Variability, is comprised of Premature
`Ventricular Contractions (PVCs) and Atrial Fibrillation
`(A-Fib). TABLE A lists the parameters in each continuum
`Values for these parameters are calculated by formulas and
`compared with values which are considered normal and
`values which are considered abnormal as explained in the
`specification. These parameters in TABLE A are also labeled
`by reference numerals and these reference numerals may be
`employed elsewhere in the specification when discussing the
`parameters.
`
`TABLE A
`
`HEART RATE VARIABILITY CONTINUUM
`
`High Variability
`dispersion of heart beats
`Absolute SPS(1)
`Absolute AMo(3)
`Absolute DX(5)
`Absolute DX/Median(7)
`
`Normal
`
`Normal
`Normal
`Normal
`Normal
`
`Low Variability
`centrality of heart beats
`Absolute SPS(2)
`Absolute AMo(4)
`Absolute DX(6)
`Absolute DX/Median(8)
`Low HRV(9)
`2.0 Caution > 2.5
`ALARM(10)
`
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`US 6,487,442 B1
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`3
`
`TABLE A-continued
`HEART RATE CONTINUUM
`
`bradycardia(11)
`
`tachycardia(12)
`Normal
`ERRATIC VARIABILITY
`
`ACRR(13)
`PVCs & A-Fib
`
`Data sources: ECG (RR) Time Intervals or pulse wave
`Start-of-Systole to Start-of-Systole (SOS) Time Intervals
`from the hardware sources discussed elsewhere. (Note: RR
`and SOS Time Intervals are used interchangeably to indicate
`the Time Interval between heart beats. 60 seconds divided by
`the Time Interval in seconds equals beats per minute, bpm.)
`Time Interval: A Time Interval is the duration of time
`between heart beats, or RR peaks, preferably measured to an
`accuracy of 20 milliseconds, 0.02 seconds. The accuracy of
`the Time Interval can range from 15 milliseconds to 30
`milliseconds.
`
`is a series of Time
`Time Segment: A Time Segment
`Intervals, which can vary in length from 51 Time Intervals
`to 301 Time Intervals. The preferred default setting is 101
`Time Intervals. Typically, from this 101 Time Intervals, up
`to about 6 outliers are removed.
`
`The time between each heart beat is designated an RR
`Time Interval. RR Time Intervals are then divided into three
`subsets as shown in TABLE B.
`
`TABLE B
`
`RR Time Intervals milliseconds
`
`NN
`
`ACRR
`
`MARR
`
`75 to 125
`
`1 to 74 and/or 126 to 169
`
`0 and/or 170+
`
`(Normal-to-Normal): Normal-to-Normal means a normal
`Time Interval between an RR peak. NN Time Intervals are
`used to calculate twelve of the thirteen predictive markers.
`NN equals 75 to 125 milliseconds.
`ACRR (Abnormal Cardiac RR): Abnormal Cardiac RR
`means when the present Time Interval differs from the
`previous Time interval by +25% or —25%, and this situation
`occurs 50 or more times while accumulating a Time Seg-
`ment of 101 NN Time Intervals, then this Time Segment is
`an ACRR Time Segment. If this condition persists for 52
`minutes, or longer, then this is either a +2.5 or —2.5 point
`ALARM, as influenced by the results of “Absolute SPS”
`through “2.0 Cauti0n>2.5 ALARM” formulas, the first 10
`formulas, for the parameters as set forth below. ACRRs are
`comprised of Premature Ventricular Contractions (PVCs),
`and Atrial Fibrillation (A-Fib). ACRRs equal intervals of 1
`to 74 milliseconds, and/or 126 to 169 milliseconds.
`MARR (Motion Activated RR): Motion Activated RR
`means some sort of motion influenced the Time Interval
`
`between the RR peaks. MARRs equal intervals of Zero
`and/0r 170+ milliseconds.
`Outliers are typically the three shortest and the three
`longest Time Intervals in a 101 NN Time Interval, Time
`Segment, and are discarded after ACRRs are removed from
`the Time Segment, and before calculations are made of the
`other 12 predictive markers.
`Non-Stationarity: If the Median and the Mode differ from
`each other in a 101 Time Interval Time Segment by 20% or
`more, than this is a case of non-stationarity and the values
`generated are discarded and not included in any calculations.
`
`4
`The following 10 formulas are for parameters all related
`to heart rate variability, HRV. The ALARM trigger points
`and the number of Time Segments the ALARM condition is
`present are for patients 55 years and older.
`Absolute Sympathetic/Parasympathetic Stress
`(ABS.SPS): Sympathetic/Parasympathetic Stress is deter-
`mined by the formula:
`
`SPS=‘/(0.5/DX)2+(AMo/10)2
`
`In a Time Segment of 95 NN Time Intervals (101 NN
`Time Intervals minus 6 outliers), if SPS equals or exceeds 48
`for any 25 Time Segments out of 50 Time Segments, then
`this is a +2.5 point ALARM. In a Time Segment of 95 NN
`Time Intervals, if SPS is between 47 and 3.0, then this is
`normal condition.
`In a Time Segment of 95 NN Time
`Intervals, if SPS equals or is less than 2.5 for any 25 Time
`Segments out of 50 Time Segments, then this is a —2.5 point
`ALARM (Parameters 1 and 2 of TABLE A).
`Absolute AMo (ABS.AMO): Amplitude of the Mode is
`the largest number of identical Time Intervals occurring in
`the Mode of a Time Segment, (e.g. 70 for 70 Time Intervals
`out of 95 Time Intervals.)
`In a Time Segment of 95 NN Time Intervals, if AMo, the
`most frequent heart rate, occurs 90 times or more for any 25
`Time Segments out of 50 is a 2.5 point ALARM. In a Time
`Segment of 95 NN Time Intervals, if the average rate occurs
`between 11 through 94 times is Normal. In a Time Segment
`of 95 NN Time Intervals, if AMo the most frequent heart rate
`occurs 10 times or less for any 25 Time Segments out of 50,
`then this is a —2.5 point ALARM. (Parameters 3 and 4 of
`TABLE A).
`Absolute DX (Delta X): Delta X is the difference between
`the longest value for a Time Interval in a Time Segment and
`the shortest value, after outliers, and ACRRs, if any, have
`been discarded (e.g. longest equals 0.72 seconds less short-
`est equals 0.64 seconds=0.08 seconds=Delta X).
`if the
`In a Time Segment of 95 NN Time Intervals,
`difference, DX, between the longest and the shortest heart
`rate is 0.06 seconds or less for any 25 Time Segments out of
`50 is a +2.5 ALARM. In a Time Segment of 95 NN Time
`Intervals,
`if the difference between the longest and the
`shortest heart rate is between 0.49 through 0.07 seconds is
`normal. In a Time Segment of 95 NN Time Intervals, if the
`difference, DX, between the longest and the shortest Time
`Interval is 0.50 seconds or more for any 25 Time Segments
`out of 50, then this is a —2.5 ALARM. (Parameters 5 and 6
`of TABLE A).
`Median (M): The Median is the Time Interval in a Time
`Segment, in which there are equal number Time Intervals
`equal to or larger than, and equal to or smaller than the
`Median Time Interval (e.g. the 47th Time Interval in a 95
`Time Interval Time Segment).
`Absolute DX/Median (ABS.DX/M): Delta X divided by
`the Median is a combination of the two markers above, DX
`and Median.
`
`if
`In a Time Segment of 95 NN Time Intervals,
`DX/Median equals or is less than 0.02 for any 25 Time
`Segments out of 50 is a +2.5 point ALARM. In a Time
`Segment of 95 NN Time Intervals, if DX/Median is between
`0.025 and 0.420 is normal in a Time Segment of 95 NN Time
`Intervals, if DX/Median equals or exceeds 0.425 for any 25
`Time Segments out of 50, then this is a —2.5 point ALARM.
`(Parameters 7 and 8 of TABLE A).
`Low Heart Rate Variability (Low-HRV): Low-HRV is a
`condition where 100 or more Time Segments, which have a
`maximum variation 0.62 seconds or lower, with no more
`
`10
`
`15
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`20
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`25
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`
`5
`
`then this condition is a +2.5
`than two (2) exceptions,
`ALARM. Low-HRV is a predictive marker of low heart rate
`variability. (Parameter 9 of TABLE A).
`2.0 Caution>2.5 ALARM: If CAUTION or ALARM
`
`signals, for the above four conditions (SPS, AMo, DX, and
`DX/M), exist for 960 minutes with a gap (a lack of a Caution
`or an ALARM) of no more than 60 minutes, then the +2.0
`Caution (calculated as 4 times 0.5 CAUTION points)
`becomes a +2.5 ALARM. This parameter is a predictive
`marker of low heart
`rate variability.
`(Parameter 10 of
`TABLE A).
`Moreover, a baseline for SPS, AMo, and DX is estab-
`lished between the 10th and 500th Time Segment. Any
`deviation above 150% or below 50% of the baseline for
`more than 45 minutes triggers both a Caution and an
`ALARM of 2.5 points for any one of the three formulas. The
`preferred baseline time is 24 hours. TABLE C summarizes
`the parameters for establishing a baseline.
`
`TABLE C
`
`Parameters for triggering a Caution/ALARM after a baseline
`has been established
`
`SPS
`
`AMo
`
`DX
`
`start = 10 Time Segments
`
`end = 500 Time Segments
`
`start = 10 Time
`start = 10 Time
`Segments
`Segments
`end = 500 Time
`end = 500 Time
`Segments
`Segments
`ALARMhigh = 1.50
`ALARMhigh =
`points
`1.50 points
`ALARMlow = 0.50
`ALARMlow =
`points
`0.50 points
`CAUTIONhigh = CAUTIONhigh = 1.50 CAUTIONhigh = 1.50 points
`1.50 points
`points
`CAUTIONlow = CAUTIONlow = 0.50 CAUTIONlow = 0.50 points
`0.50 points
`points
`ALARMtime =
`ALARMtime = 45.00 ALARMtime = 45.00
`45.00 minutes
`CAUTIONtime = CAUTIONtime =
`45.00
`45 .00
`
`ALARMhigh = 1.50 points
`
`ALARMlow = 0.50 points
`
`CAUTIONtime = 45.00
`
`The points assigned to these parameters in TABLE C for
`these formulas relative to the patient’s own baseline may
`differ from the points attached to these parameters SPS,
`AMo, and DX when measuring these parameters SPS, AMo,
`and DX as Abs.SPS, Abs.AMo, and Abs.DX against prede-
`termined upper and lower
`limits (see Tables 1a—c) as
`explained elsewhere in this specification.
`Moreover,
`in applying the formula for converting a 2
`point CAUTION signal to a 2.5 point ALARM signal the
`following time periods are employed.
`SpecialTime1=60; 60 minutes maximum time after AMo
`first triggers a Caution that other formulas must also trigger
`a Caution (SPS, DX, DX/Median). Then the following must
`occur.
`
`SpecialTime2=960; 960 combined total CAUTION min-
`utes of the formulas (SPS, AMo, DX, DX/Median), for the
`CAUTIONs to convert to a 2.5 point ALARM, except as set
`forth below.
`
`GapTimeIndivMax=210; If the combined total of gaps in
`the four formulas (SPS, AMo, DX, DX/Median), equals or
`ex