Method and apparatus for enhancing cardiovascular activity...

Surgery: kinesitherapy – Kinesitherapy – Exercising appliance

Reexamination Certificate

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C482S121000, C482S130000

Reexamination Certificate

active

06261250

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the human cardiovascular system, and more particularly to method and apparatus for enhancing blood flow through, or around, partially clogged coronary and other small arteries of the cardiovascular system.
2. Description of the Prior Art
Cardiovascular disease kills one out of two Americans. Conventional treatment tends to rely on suppressing symptoms with drugs or invasive procedures including balloon angioplasty and bypass surgery. Fortunately it is often possible to prevent, or even partially reverse, cardiovascular disease by changing one's lifestyle. For instance, avoiding smoking and following a low fat diet emphasizing fresh, whole fruits and vegetables, beans and whole grains, skinless chicken, poached fish, and the like, coupled with a reasonable exercise program, can be very helpful in this regard. In addition, there is ample evidence that the addition of nutritional supplements such as antioxidant vitamins C and E, and beta-carotene, B-complex vitamins, omega-3 fatty acids, Coenzyme Q10, L-carnitine, magnesium, DHEA and one mini-aspirin per day can help in avoiding heart attacks and in building healthy heart function.
Often, however, either because such a change in lifestyle is made too late, or simply for reasons of heredity, a comprehensive program such as outlined above may not be totally effective in reversing symptoms such as chronic angina pectoris. For those individuals who reject the conventional treatments with drugs and invasive procedures, a relatively old (e.g., dating from the 1950's) therapy known as EDTA chelation therapy is available from a handful of physicians. In spite of consistent opposition from orthodox medical circles, close to 500,000 patients have successfully undergone this therapy for cardiovascular disease.
More recently, a totally non-invasive procedure known as Enhanced External Counterpulsation (hereinafter EECP) has become available in the United States. During EECP treatments a patient lies in a prone position wearing a series of pressure cuffs around his or her calves, lower thighs and upper thighs. Then a pressure source inflates and deflates these cuffs in a sequential manner that forces blood from the legs toward the torso of the patient. The progressive inflation and deflation is electronically synchronized with the patients heartbeat via an electrocardiographic signal so that a wave of somewhat increased blood pressure arrives at the heart during diastole (e.g., when the heart is relaxing). As described in a pamphlet entitled “EECP Treatment” available from Vascomedical Inc. of Westbury, N.Y., it is believed that this may enhance “collateral circulation” of blood around blocked or narrowed arteries by opening up, or forming, tiny branches of nearby vessels. A course of EECP treatment normally comprises a series of thirty-five (35) one-hour sessions over a nominal period of seven (7) weeks.
Currently, EECP is a very exciting development. However, it also has not yet become an “orthodox” procedure and is presently available at only about forty (40) sites in the United States. Notably however, these include such prestigious sites as both medical schools of the University of California (e.g., UCSF and UCSD), New York's University Medical Center, Stoney Brook and the University of Pittsburgh Medical Center, so perhaps there is hope. On the other hand, EECP equipment is complex and its use involves electrocardiographic connection, so it must be performed under close technical and medical supervision. For these reasons, it is an expensive procedure (although it is not nearly as expensive as either of the orthodox alternatives of angioplasty or bypass surgery). Further, although it is generally performed on an out-patient basis, the fact that there are presently only forty EECP sites in the United States makes it an inconvenient choice for the overwhelming majority of Americans. It is the general object of this invention to present an alternative method and apparatus for similarly enhancing cardiovascular activity and health that is inherently even more economical and ultimately operable by the patient, without supervision, in his, or her, own home environment.
SUMMARY OF THE INVENTION
These and other objects are achieved in a method and apparatus for enhancing cardiovascular activity and health according to the present invention, in which Rhythmic Limb Elevation (hereinafter RLE) is utilized to rhythmically vary both systolic and diastolic blood pressure in the heart and generally throughout the torso, neck and head regions of the body concomitantly with the patient performing aerobic physical exercise. Systolic pressure is reached just as the heart has completed a pumping event while diastolic pressure is the resting blood pressure between pumping events.
As will be described hereinbelow, RLE apparatus comprises means for balancing or lifting the weight of the limbs. This, in turn, results in the patient being able to perform aerobic exercise at selectable intensity levels beginning at less than even the minimum level required for walking. Further, the aerobic exercise is performed with the heart at the lowest possible elevation whereat it is flooded with blood. These factors are important because as a result, RLE is a very safe way to start any patient on a program of aerobic physical exercise. This is opposed to any type of upright exercise (i.e., such as walking on a treadmill) wherein the heart is elevated and relatively starved for blood.
It has been found that individuals unable to walk aerobically without suffering unpleasant cardiovascular symptoms can easily begin a RLE exercise program leading to continuous aerobic RLE exercise, and eventually, to normal upright aerobic exercise. The pulse rate and blood pressure are minimally elevated while performing such aerobic RLE. Further, it has often been found that both systolic and diastolic blood pressure values can actually be lower immediately following RLE exercise, and still further, that these lower values may even persist between RLE exercise sessions. In any case, once a beginning level of performance is achieved, intensity levels can be gradually increased in order to achieve improving levels of cardiovasular fitness. It is believed herein that performing aerobic exercise at ever increasing intensity levels, while the heart is flooded with blood and subject to rhythmically varying blood pressure, enhances cardiovascular activity and health by enabling “collateral circulation” as described above.
The cardiovascular system is a hydraulic system subject to the same principles of hydrostatics as any other hydraulic system. Specifically, blood at the bottom of a vertical column achieves a higher pressure than that at the top of the column. In particular, blood is mostly water, the density of which is inversely related to the density of mercury by a factor of about 13. Thus, a nominally ideal systolic/diastolic pressure ratio of 120/70 mm of mercury translates to a nominally ideal systolic/diastolic pressure ratio of about 1560/910 mm of blood. If that blood pressure reading is taken at a height of about three feet, or about 915 mm off the floor, then blood pressure at the bottom of the feet must be about 2475/1825 mm of blood while at the top of the head it might only be about 950/300 mm of blood, or only 73/23 mm of mercury. This, of course, is why pilots must wear “G” suits for high performance flying, or why people sometimes feel faint if they get up too quickly. There is simply a lack of blood in the brain if the body is subject to substantial vertical acceleration.
On the other hand, consider an individual lying in a prone position with his, or her, limbs at torso height and having a pressure ratio of 1560/910 mm of blood. Should that individual then elevate all four limbs to nominally a vertical position, then it follows that the blood pressure in the limbs will drop. Because of this, and the fact that the arteries and veins are somewhat elastic and partially

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