A first step 12 of the example method 10 includes providing the BPM machine, which BPM machine comprises a generally horizontal and preferably contoured support member (hereinafter referred to as a “bed”) configured for retaining a person in a supine position thereupon generally along a longitudinal axis such that his or her upper torso and head are longitudinally spaced apart from his or her lower extremities. The BPM machine also comprises necessary support structure as well as a gearmotor and drive mechanism for pivotally supporting and moving the bed in a cyclical manner to be described in detail hereinbelow. A second step 14 includes positioning the person on the bed so that he or she lies supinely thereupon with his or her upper torso and head, and lower extremities spaced apart generally along the longitudinal axis.
A third step 16 includes activating the gearmotor for the purpose of cyclically moving or tilting the bed, and of course the person, in a “seesaw” manner in order to activate BPM therapy. This causes the person's upper torso and head to be elevated above his or her lower extremities, and then the person's lower extremities to be elevated above his or her upper torso and head, and vice-versa. In one example, the total angular range of motion (hereinafter “angular range”) of the support member relative to its nominally centered horizontal position can range between 10° and 60° and is preferably around 30°. As described in detail below, this procedure modulates blood pressure in both of the arterial and venous networks of the cardiovascular system. It is believed herein that resultant switching of venous blood pressure between positive and negative values and back again with respect to atmospheric pressure (hereinafter “venous blood pressure switching events”) during each cycle of blood pressure modulation is principally responsible for enhancement of blood and neural fluid flows within the human body and brain, which enhancement of blood and neural fluid flows is believed herein to account for the above-mentioned anecdotally observed improved quality of life for persons having various types of physical and neural diseases or ailments such as heart or other forms of cardiovascular disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, essential tremor, muscular dystrophy, autism, migraine headaches, brain injuries, or diabetic circulation problems (i.e., open wounds), etc.
Utilizing lesser angular ranges than the preferred 30° would of course result in a reduced modulation of blood pressure. Although it is believed herein that this would also be effective in enhancing blood and neural fluid flows within the human body and brain, it might materially compromise the desired venous blood pressure switching function over significant potions of the body. Thus, achieving an equivalent improvement therein could require extended treatment times and/or an extended series of treatments.
On the other hand, utilizing greater angular ranges than the preferred 30° would result in increased modulation of blood pressure. But this might require the person to be strapped or “velcroed” to the bed, in order to preclude him or her from sliding either upwards or downwards and would almost certainly be required in cases wherein a selected angular range of motion resulted in the person's torso assuming even a relatively modest negative angular attitude whenever the bed approached its extreme lower extremities-elevated position. In any case, it has been anecdotally observed that the preferred 30° angular range is quite sufficient for achieving desired therapeutic results. Furthermore, greater angular ranges might require the cyclical rate of alternate elevation of the person's upper torso and head, and lower extremities (hereinafter “cyclical rate”) to be reduced in order to maintain a comfortable and relaxed state of the person. This of course would reduce the number of venous blood pressure switching events, and thus could even be counterproductive.
The fourth step 18 of the example method 10 includes establishing and maintaining a comfortable and relaxed state of the person. In a preferred example, such a comfortable and relaxed state corresponds to establishing a sleep state of the person while he or she is experiencing BPM therapy. In another example, the comfortable and relaxed state corresponds to a relatively low blood pressure state of the person, such as at or even below an “at rest” blood pressure determined according the person's age, weight, height, or other factors. In yet another example, the comfortable and relaxed state corresponds to the heart rate of the person, such as an “at rest” heart rate determined according the person's age, weight, height, or other factors. Factors involved in establishing and maintaining the comfortable and relaxed state of the person include: locating the BPM machine in a relatively isolated and quite environment; avoiding any contact with the person (i.e., such as talking to him or her) during his or her treatment period with the purpose of inducing him or her into a sleep state; and/or failing that, engaging in quiet and relaxing conversation with the person for the purpose of calming him or her if he or she exhibits hyperactivity, hypersensitivity or hyperirritability symptoms.
Again, properly selecting the cyclical rate of alternate elevation of the person's lower extremities, and upper torso and head (hereinafter “cyclical rate”) is also important in establishing and maintaining the comfortable and relaxed state of the person. The combination of angular range and cyclical rate is chosen such as to preclude dizziness or other discomforts in the person and is a definite factor in inducing a comfortable and relaxed state conducive to the person attaining a state of sleep. In general, it has been found through anecdotal observation that the combination of angular range and cyclical rate should be chosen such that their product is between 90° cycles/minute and 360° cycles/minute. Thus in a further preferred example, the cyclical rate is set at an average 180° cycles/minute divided by the above-suggested angular range of 30° or at a preferred cyclical rate of six cycles per minute. This preferred combination of an angular range of 30° and a cyclical rate of six cycles per minute has been anecdotally observed to provide the above noted improvements in quality of life without inducing discomfort. Other combinations chosen from within the above mentioned angular ranges of 10° and 60°, and cyclical rates between two to ten cycles per minute could certainly be acceptable however.
Prior to beginning any treatment using the present invention, a preliminary workup comprising noting a person's vital statistics and perhaps performing any pertinent neurological testing could be done in order to establish a baseline status for that person as of the start of that particular treatment session. One might note a person's age, blood pressure, heart or neurological disease history for instance. In addition, special precautions should be taken in the case of a brain injured person or perhaps for one having Alzheimer's disease. Further, it would be desirable to do a comparative post treatment workup as well in order to record any changes related to the person having experienced BPM therapy during that session. And still further, it would be desirable compile each person's workup documentation in order to establish that person's progress over time.
The cardio-pulmonary portion of the human circulatory system includes the right side of the heart receiving oxygen-depleted blood from a person's venous system and pumping it through the lungs, wherein carbon dioxide is exchanged for oxygen, and then on to the left side of the heart from where the now oxygen-rich blood is pumped into the arterial network. The arterial network comprises arteries and arterioles that convey the oxygen-rich blood from the heart to an extraordinary multitude of capillaries. The arteries include a layer of smooth muscle cells that serve to maintain arterial blood pressure between systolic events. Similar layers of smooth muscle cells included in the arterioles are utilized by the person's brain for selectively controlling the size of the arterioles. In addition, each capillary is protected by a pre-capillary sphincter, which sphincters are utilized by the person's brain for selectively controlling proportions of capillaries open to blood flow in the person's body. These factors permit the person's brain to regulate blood flow throughout his or her cardiovascular system in addition to controlling instant blood pressure values and selectively servicing minor trauma such as a cut or scrape. In any case, the blood flows through the open ones of the capillaries, wherein the oxygen is exchanged for carbon dioxide, and then on to the venous system.
The venous system includes veins and venules that convey the now oxygen-depleted blood from the capillaries back to the vena cavas (e.g., the two large veins that enter into and return venous blood to the right atrium of the heart) and therethrough to the heart. Although the larger veins comprise semi-lunar folds that act like one-way check valves precluding flow in a reverse direction back toward the capillaries, generally the veins and venules of the venous network are simpler and more compliant than the arteries and arterioles. However, they also include layers of smooth muscle cells. These layers of smooth muscle cells are utilized by the person's cardiovascular control center for regulating the circumferential size of the veins themselves. In actuality this involves the person's brain and body continuously executing very complex and precise servo control of the volumetric size of the venous system. This complex function is implemented in accordance with a fairly long time constant however—lasting perhaps tens of seconds and definitely longer than a single cycle of operation of the BPM machine. In any case, the veins act as an active blood reservoir that contains about 65% of the body's total blood volume—with the size of the veins and thus the volume of the reservoir being controlled in apparent response to signals emanating from a cardiopulmonary mechanoreceptor located in the right atrium of the heart—such that average venous blood pressure in the extreme upper torso (i.e., normally a few inches below shoulder height when a person is disposed in an upright manner) is maintained at atmospheric pressure (hereinafter the “zero pressure point”).
As a result, venous blood pressure present at any particular point within a person's venous system can be determined by the formula
P=1.875 h
where P is the difference between venous blood pressure at that particular point and atmospheric pressure (in mmHg), and h is the vertical distance between that particular point and the vertical position of his or her zero pressure point (in inches). Thus, portions of the venous system that are instantly positioned vertically below the zero pressure point have positive pressure while portions of the venous system that are instantly positioned vertically above the zero pressure point have negative pressure (e.g., in each case relative to atmospheric or zero pressure). This means that there is a positive differential pressure value imposed between the outside of those portions of the person's body that are vertically positioned above the instant zero pressure point and the veins comprised therein. This compresses those veins and causes “pooled” venous blood contained therein to “drain” back toward his or her vena cavas (e.g., with the venous blood freely moving through the above described check valves) with the result that those veins are compressed or even flattened out.
On the other hand, there is a positive differential pressure value imposed between veins comprised within those portions of the person's body vertically positioned below the instant zero pressure point and the outside of those body portions. This allows those veins to fill (i.e., from blood flowing thereto from juxtaposed arterioles, capillaries and venules—and not back down through the larger veins themselves because of the one-way flow nature of the check valves) and expand. In either of these cases, it is believed herein that it is necessary to provide adequate time for allowing these “draining and filling” functions to fully occur. Thus the hereinabove described relatively slow preferred cyclic rate of 6 cycles per minute is, for this reason, herein deemed to be appropriate. In any case, it is believed herein that tissue comprised within portions of the person's body that undergo vertical transitions above and then below the zero pressure point is continually internally massaged by the rhythmic compression and expansion of its comprised veins. This is the essence of blood pressure modulation.
This general principle can be demonstrated by observing what happens to a visible peripheral vein running along the back of one's hand and arm as that hand and arm are slowly raised toward shoulder height. Portions of that vein will begin to flatten out as they reach a few inches below shoulder height and remain flattened while they are above that height. In fact, as one slowly raises the hand and arm he or she may even feel the progression of this flattening as different portions of the vein suffer a transition from positive to negative pressure. As next explained, it is believed herein that substantially the same action occurs within the upper torso and head, and also within the lower extremities of a person whenever he or she is supinely disposed upon a cyclically moving BPM machine.
In accordance with the above explained functioning of the venous system, utilizing a BPM machine for cyclically enabling alternate elevation of a person's upper torso and head, and then his or her lower extremities results in tie venous blood pressure in the upper torso and head first falling below and then rising above atmospheric pressure, and vice-versa in the lower extremities. These variations of venous blood pressure in a person 30 disposed on a BPM machine 20 are illustrated in
Assuming that a combination comprising the preferred angular range and cyclical rate values of 30° and six cycles per minute is chosen, gravitational forces resulting from cyclical alternate elevation of the person 30's upper torso 22 and head 24, and then lower extremities 26 in accordance with the example method 10 rhythmically modulate the venous blood pressure in the upper torso 22 and head 24, and also of course the lower extremities 26, over a range of perhaps 20-30 mmHg. Thus, when the upper torso 22 and head 24, and alternately the lower extremities 26, attain peak elevation above the zero pressure line 34 as respectively depicted in
On the other hand, as the upper torso 22 and head 24, or alternately, the lower extremities 26 are lowered as respectively depicted in
In either case, each venous blood pressure switching event causes an oppositely oriented three-dimensional pressure gradient to be formed across the tissue between the skin and the venous network of veins and fine veins in those portions of the person 30's body. As explained above, it is believed herein that the cyclical shrinking and swelling of the veins comprised within that tissue (e.g., occurring as a direct result of the venous blood pressure switching events) results in a cumulative internal massaging of juxtaposed tissue. It is further believed herein that this can result in opening up other juxtaposed fluid flow channels. This may be due to breaking down plaque deposits in the manner suggested below, or by straightening out flattened and twisted fluid flow channels (e.g., commonly associated with Alzheimer's and perhaps various other neural diseases). In particular, the internal massaging is believed herein to enable opening of neural fluid flow channels, as well as enhancing blood flow, in the brain. By way of example, before and after sets of MM studies have demonstrated that utilization of BPM therapy resulted in a significant reduction of scar tissue with an associated increase of blood flow and density in the brain of a brain injured person in one recent example case.
In addition to the above described possible opening up of fine arteries, arterioles, capillaries, venules, and neural channels, it is believed herein that similarly induced internal massaging of tissue juxtaposed to partially blocked portions of coronary arteries may induce comprised capillaries to extend, link up and form collateral bypass flow channels or passages around partially blocked portions of the coronary arteries. This is thought to be the primary operative mechanism behind observed alleviation of angina symptoms achieved through utilization of BPM therapy by persons suffering from heart disease.
It is further believed herein that cyclical internal messaging of tissue surrounding cyclically shrinking and swelling veins can also physically manipulate protein and metallic based plaque deposits and/or floating plaque particles present within arteries in such a manner as to encourage the plaque deposits and/or floating particles to break down into smaller and smaller particles. Then, and especially in conjunction with the use of chelator and bile enhancing supplements, it is believed that the plaque particles progressively dissolve, or at least disintegrate into micro-particles small enough to pass through the capillaries and into the venules and veins, and eventually on to the person's liver and/or kidneys where they can be eliminated naturally. This is thought to be the primary operative mechanism behind an apparent “cleansing function” whereby protein and/or metallic-based plaques in the circulatory system have been observed to be progressively eliminated over a succession of one or more treatment sessions to alleviate symptoms associated with the plaque deposits.
The extent of similar action on any plaque deposits trapped between tunica intima and tunica media tissue layers of the juxtaposed arteries is not known at this time. However, it has been anecdotally observed that should such trapped plaque deposits rupture through the tunica intima layer of tissue, the above described internal messaging of surrounding tissue can provide adequate blood flow for supporting heart function without an infarction occurring. In each of the anecdotally observed cases, chelator and bile enhancing supplements were utilized to attack the plaque and any possible clot formations resulting therefrom, with the clearing process typically taking about four days.
In the example method 10, it is believed herein that the step of establishing the comfortable and relaxed state of the person further enhances the operative mechanisms described above. Otherwise whenever he or she might be under stress from discomfort or even when actively engaged in conversation, the smooth muscle cells associated with the veins and venules could tend to activate and thus resist the desired swelling and collapsing action.
Reduction of medication dosages, or in some cases even total elimination thereof has been anecdotally observed to be a further benefit for persons utilizing the example method 10. By way of example, persons having Parkinson's disease normally use prescribed dosages of various medications in order to minimize their Parkinson's disease symptoms. In conjunction with using the example method 10 however, such normally prescribed dosages have been anecdotally observed to induce overdose symptoms in some persons having Parkinson's disease (i.e., such as uncontrolled and wildly gyrating arm and leg motions). Herein this is regarded as evidence that the method 10 does indeed improve natural neural fluid flow (i.e., such as in this case perhaps being a renewed flow of naturally generated dopamine). Therefore, an additional benefit of using the example method 10 may be that such medication dosages can be reduced, or in some cases even eliminated.
The bed 38 is pivotally mounted to a frame 44. The frame 44 includes a base section 46 that supports an angled section 48. In this example, the angled section 48 includes pivots 50a and 50b that pivotally connect to a portion of the bed 38 (
Co-pending U.S. patent application Ser. No. 11/209,813 depicts a Scotch yoke drive assembly 96, a crank and connecting rod mechanism 188, a servo controlled rack and pinion gear set 194, and a servo controlled hydraulic drive 196, any of which would be suitable for cyclically moving the bed 38. Because of its obvious relevance to the present invention, U.S. patent application Ser. No. 11/209,813 (hereinafter “application '813”) is expressly incorporated herein by reference. Because of the descriptive presentations of the Scotch yoke drive assembly 96, the servo controlled rack and pinion gear set 194, and the servo controlled hydraulic drive 196 made in incorporated application '813, no further description relating to any of these types of drive mechanisms is required herein. On the other hand, the example therapeutic device 20 does utilize the simplified example crank and connecting rod mechanism 54. Thus, its construction and operation is described hereinbelow with reference to
Either of the Scotch yoke drive assembly 96 shown in
The first step 82 of the example method 80 is executed prior to initiating a treatment session for a person 30 on the bed 38 and includes returning the bed 38 to its full upper torso and head-elevated position in order to provide a preferred entry/exit position of the bed 38. A second step 84 includes positioning the person 30 in a supine position upon the bed. A third step 86 includes either the person 30 or a therapist executing a “jog” command signifying that the person 30 has been properly placed on the bed 38, and enabling the program to continue. A fourth step 88 includes smoothly accelerating the bed 38 toward the horizontal position such that it reaches a maximum cyclical speed value concomitantly with reaching the horizontal position. A fifth step 90 includes executing a cyclical motion symmetrically about the horizontal position in accordance with the selected angular range and cyclical rate values for the duration of the treatment session. A sixth step 92 includes smoothly decelerating the bed 38 to zero speed at its preferred full upper torso and head-elevated entry/exit position, beginning with a final crossing of the bed 38 through the horizontal position as it moves toward the upper torso and head-elevated position. And finally, a seventh step 94 includes removing the person 30 from the bed 38 in order to terminate the treatment session. Given this description, one of ordinary skill in the art will recognize and be able to generate command sequences for obtaining suitable combinations of acceleration/deceleration characteristics, other treatment angular range and cyclical rate values, or varying values of angular ranges and cyclical rates during treatment sessions in order to meet the needs of particular persons.
Shown in
Surprisingly, there is also an advantage in not utilizing a controller such as the controller 130 shown and described in incorporated application '813. This is because such controllers typically utilize a bridge circuit comprising solid state switching devices that are usually relatively unshielded and therefore a source of high frequency electromagnetic radiation considered undesirable by a large percentage of potential users of the example therapeutic device 20. In fact, such high frequency electromagnetic radiation could conceivably be dangerous for individuals using pacemakers. Thus, utilization of the drive mechanism 52 as controlled by the simple switch 36 in example therapeutic device 20 is considered herein to be preferable.
In the example drive mechanism 52 the gearmotor 58 serves to rotate the crank 64. Rotation of the crank 64 cyclically moves the connecting rod 68 back and forth along an undulating thrust axis “Y” in order to position and exert necessary forces on the drive arm 70 as required for it to cyclically move the bed 38 rotatably in a seesawing manner about the pivot axis “A”. The resulting cyclical motion of the bed 38 alternately elevates the upper torso and head, and then the lower extremities of a person lying on the bed 38 in the cyclical manner described hereinbefore. As can be appreciated, the length of the crank 64 can either be designed for a larger or smaller stroke of the drive arm 70 and resulting angular range values, or even be configured in the manner of adjustable length crank arm 100 of application '813 in order to attain selected angular range values. Given these descriptions, one of ordinary skill in the art will recognize several variations in providing suitable drive mechanisms and drive modes for cyclically moving the bed 38.
Although preferred embodiments of this invention have been disclosed, workers of ordinary skill in the various arts associated with this invention would recognize that certain modifications would come within the scope of this invention. For instance, BPM therapy could be utilized for treating other diseases or conditions not named above, or alternately, the cyclic elevation step 16 of method 10 could be executed in a more complex fashion not described in detail above (i.e., such as comprising a programmed range of cyclical rates and/or angular ranges). Also, the construction details of the therapeutic device 20 could be altered without deviating from the spirit of this invention. By way of example, a modified bed 38′ could comprise independent torso and head, and lower extremity supporting portions capable of pivoting or rotating relative to each other. These could for instance, be utilized for altering the contoured shape of the bed 38. In another example, the speed-reducing gearbox 62 could be replaced by the combination of a hydraulic pump and hydraulic motor whose output shaft would then be utilized for driving the crank 64. For that reason, the following claims should be studied to determine the true scope and content of this invention.
The present application is a continuation-in-part of U.S. patent application Ser. No. 11/749,505 filed May 16, 2007 and entitled “Therapeutic Device for Inducing Blood Pressure Modulation” now abandoned, and claims priority of U.S. Provisional Patent Application Ser. No. 60/848,740 filed Oct. 2, 2006.
Number | Date | Country | |
---|---|---|---|
60848740 | Oct 2006 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 11749505 | US | |
Child | 11775507 | US |