Method and apparatus for facilitating physiological...

Surgery – Diagnostic testing

Reexamination Certificate

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C600S500000, C600S547000

Reexamination Certificate

active

06358201

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to the evaluation of heart rate variability, and specifically to the analysis of the power spectrum distribution thereof.
BACKGROUND OF THE INVENTION
With the growing complexity of life, the relation between physiological conditions and emotional health becomes of increasing interest. Many studies have shown that stress and other emotional factors increase the risk of disease, reduce performance and productivity and severely restrict the quality of life. To this end, the medical communities around the world continually seek remedies and preventive plans. Recently a focus on the self-regulation of systems within the body has led to research in the areas of biofeedback, etc.
In the last 25 years, a variety of new techniques have been introduced as alternatives to more traditional psychotherapies or pharmaceutical interventions for improving mental and/or emotional imbalances. In addition to the more psychological approaches like cognitive re-structuring and neurolinguistic programming, psychologists have employed several techniques from Eastern cultures to “still the mind” during focused meditation. In yoga, for example, one generally focuses on the breath or parts of the brain, whereas in qigong one focuses on the “dan tien” point (below the navel). In a Freeze Frame® (FF) technique, developed by the Institute of Heart Math in Boulder Creek, Calif., one focuses attention on the area around the heart. All these techniques focus attention upon areas of the body which are known to contain separate but interacting groups of neuronal processing centers, and biological oscillators with which they interact. The heart, brain, and the intestines contain biological oscillators known as pacemaker cells. By intentionally focusing attention on any one of these oscillator systems, one can alter its rhythms. This is at least true for the brain (meditation), yogic breathing (respiration), the heart (FF), and most likely the gut (qigong), since it is also regulated by the autonomic nervous system (ANS). The body also contains other oscillating systems such as the smooth muscles of the vascular system. We have previously shown that this system, measured by recording pulse transit time (PTT), as well as the brain, measured by an electroencephalograph (EEG), the heart, measured by a heart rate variability (HRV), and the respiration system, measured by the respiration rate, can all entrain. Furthermore, they all synchronize to a frequency varying around 0.1 Hertz (Hz). Thus, one can intentionally bring these systems, acting as coupled biological oscillators, into synchronize with each other.
The FF technique is a self-management technique by which one focuses on the heart to disengage from moment-to-moment mental and emotional reactions. A study utilizing the FF technique in a psychological intervention program with HIV-positive subjects resulted in significant reductions in life-stress, state and trait anxiety levels, and self-assessed physical symptoms. Two other studies with healthy individuals using the FF technique to enhance positive emotional states showed increased salivary IgA and increased sympathovagal balance. Increased sympathovagal balance is known to protect against detrimental physiological effects associated with overactive sympathetic outflow from the brain. Other studies have shown the techniques to be effective in improving autonomic balance and decreasing the stress hormone cortisol and increasing DHEA, improving glycemic regulation in diabetics, reducing blood pressure in hypertensive individuals and significantly reducing psychological stressors such as anxiety, depression, fatigue and overwhelm in many diverse populations.
Sympathovagal balance has been measured using various techniques. For example, individuals can be trained to consciously control their heart rate using biofeedback techniques. However, the enhanced parasympathetic activity is probably mediated through control of respiration. Neutral hypnosis and operant conditioning of heart rate have been demonstrated to decrease in the sympathetic/parasympathetic ratio by increasing parasympathetic activity independent of controlled breathing techniques. The FF technique does not require biofeedback equipment nor does it require conscious control of respiration although a short breathing protocol is used this technique. Our results suggest that emotional experiences play a role in determining sympathovagal balance independent of heart rate and respiration. The shifts in sympathovagal balance toward increased low-frequency (LF) and high frequency (HF) power (measures of heart rate variability) were physiological manifestations of experiencing the emotional state of appreciation. The FF technique focuses on genuinely experiencing the feelings of sincere appreciation or love, in contrast to visualizing or recalling a previous positive emotional experience.
The results of our studies indicate that relatively short periods of practice of the FF technique and other tools developed by the Institute of HeartMath leads to either an “entrainment” or “internal coherence” mode of heart function (described in greater detail below). Most subjects who are able to maintain these states report that the intrusion of random thoughts is greatly reduced and that it is accompanied by feelings of deep inner peace and heightened intuitive awareness.
We also observed that positive emotional states, which lead to the entrainment mode, generated marked changes in the dynamic beating patterns of the heart. A method for quantifying and analyzing and quantifying these heart rhythms is called analysis of heart rate variability (HRV). The normal resting heart rate in healthy individuals varies dynamically from moment to moment. Heart rate variability, which is derived from the electrocardiogram (ECG) or pulse, is a measure of these naturally occurring beat-to-beat changes in heart rate and is an important indicator of health and fitness. HRV is influenced by a variety of factors, including physical movement, sleep and mental and activity, and is particularly responsive to stress and changes in emotional state. The analysis of HRV can provide important information relative to the function and balance of the autonomic nervous system, as it can distinguish sympathetic from parasympathetic regulation of heart rate. Decreased HRV is also a powerful predictor of future heart disease, increased risk of sudden death, as well as all-cause mortality.
Frequency domain analysis decomposes the heart rate tachogram or waveform into its individual frequency components and quantifies them in terms of their relative intensity, in terms of power spectral density (PSD). By applying spectral analysis techniques to the HRV waveform, its different frequency components, which represent the activity of the sympathetic or parasympathetic branches of the autonomic nervous system, can be discerned. The HRV power spectrum is divided into three frequency ranges or bands: very low frequency (VLF), 0.033 to 0.04 Hz; low frequency (LF), 0.04 to 0.15 Hz; and high frequency (HF), 0.15 to 0.4 Hz.
The high frequency (HF) band is widely accepted as a measure of parasympathetic or vagal activity. The peak in this band corresponds to the heart rate variations related to the respiratory cycle, commonly referred to as respiratory sinus arrhythmia. Reduced parasympathetic activity has been found in individuals under mental or emotional stress, suffering from panic, anxiety or worry and depression.
The low frequency (LF) region can reflect both sympathetic and parasympathetic activity, especially in short-term recordings. Parasympathetic influences are particularly present when respiration rates are below 7 breaths per minute or when an individual takes a deep breath. This region is also called the “baroreceptor range” as it also reflects baroreceptor activity and at times blood pressure wave activity and resonance.
When an individual's HRV pattern and respiration are synchronized or entrained, as can happen spontaneously in s

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