Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2001-05-09
2002-12-24
Gibson, Roy D. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
Reexamination Certificate
active
06497718
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to luminescent biorhythm cycle adjustment systems and more specifically to a process for phase-locking human fertility or menstrual cycles. Luminescent biorhythm adjustment on some mammals has been implemented in such milestones as U.S. Pat. No. 6,210,923, Apr. 3, 2001, Mammalian circadian regulator M-RIGUI2 (MPER2), Lee, Cheng-chi, U.S. Pat. No. 5,562,719, Oct. 8, 1996, Light therapy method and apparatus, Lopez-Claros, and U.S. Pat. No. 5,923,398, Jul. 13, 1999, Interactive light filed for non-visual stimulation, by Goldman, the disclosures of which are incorporated herein by reference.
If the period of the fertility cycle of a woman could be influenced in some way to become highly regular, then the rhythm method, which has serious drawbacks at present, would become a valuable and reliable technique for birth control. It would be especially valuable for populations that are culturally, economically, or medically prevented from using other methods currently available.
It is very common in biology to find synchronization or “entrainment” phenomena between environmental influences and various types of rhythms, such as EEG, ECG, and circadian rhythms. This “entrainment” or “locking in step” phenomenon can also result in a regularization effect. This is illustrated in
FIG. 2
, which shows the regularization of an irregular electronic oscillator, by entrainment with a very regular external periodic stimulation. Therefore, it seems useful to consider the possibility of entraining the ovulation cycle. While there are encouraging indications that this might be accomplished by the periodic administration of drugs, one should not overlook the possibility of photic stimulation, since it is well known that photic stimulation can profoundly affect the pituitary-gonadal function in many vertebrates.
Estrus and ovulation regulation is more often accomplished by hormonal and chemical agents as shown in such references as U.S. Pat. No. 5,721,278, Feb. 24, 1998, Ovulation control by regulating nitric oxide levels, Garfield, Robert E., and U.S. Pat. No. 5,589,457, Dec. 31, 1996, Process for the synchronization of ovulation, by Wiltbank.
During research, Edmond Dewan reported that by simulating moonlight with nocturnal light exposures, the menstrual cycles of women could be brought nearer to the lunar cycle of 29.5 days. Dewan argued that such dim light might be used to augment natural contraceptive methods. More specifically, claims that a bedside 100-watt bulb could stabilize irregular menstrual cycles, was initially greeted with skepticism. Recent studies of light treatments of humans have indicated that both bright and dim light have real biological effects. To examine the validity of these ideas, experiments have treated two samples of women with irregular menstruation with randomly assigned 100-watt bedside night lights or dim red light placebos. In both groups, the 100-watt treatments significantly decreased the duration of menstrual cycles and reduced their variability.
A need exists for a practical process to implement the use of light to regulate menstrual cyclicity. The present invention is intended to satisfy that need.
The phenomenon of “entrainment” or “phase-locking” of circadian cycles in animals, including humans, by means of light-dark cycles of approximately 24 hour periods is now well known. It is also known that these cycles in man are of importance to the military (e.g. jet lag, nocturnal operations, etc.) The question raised here is whether or not another human biological oscillation, namely the fertility cycle of about 28 days, is also of interest to the Air Force.
In the sixties a paper was published entitled “On the possibility of a perfect rhythm method of birth control by periodic light stimulation” in the American Journal of Obstetrics and Gynecology, 99, 1016-1019 Dec. 1, 1967. In this paper, some preliminary evidence was shown that suggested that the menstrual cycles of women could be regularized by means of light. Later on, further evidence for this effect on a larger population was published by Dewan et al. in “Effect of photic stimulation on the human menstrual cycle” Photochemistry and Photobiology, 27, pp. 581-585 (1978). Still more recently a paper by Daniel F. Kripke entitled “Light regulation of the menstrual cycle” was published in a book edited by L. Wetterberg “Light and biological rhythms in man” Pergamon Press 1993, ISBN 0-08-0422799. Dr. Kripke repeated the earlier experiments mentioned above and found independent evidence for the regularization effect of the light schedule on the human fertility cycle. The mechanism for this effect may involve the pineal gland, the superchiasmic nuclei, the hypothalamus, melotonin and HIOMT. The original aim of the research was to see if light could serve as a “zeitgaber” or synchronizer of these cycles. One practical application would be a method to make the so-called “rhythm method of birth control” much more accurate. This could be used either to enhance or to avoid conception. From a purely scientific standpoint, the possibility of phase-locking human fertility cycles by means of periodic photic stimulation would have far reaching implications in biology of a fundamental nature.
An important question is whether or not such a possibility would be of practical value to the Air force. For example, would it be useful or beneficial in any way for women in the military to have highly predictable fertility cycles? The second question is whether or not the scientific issue involved should be explored as a basic question of general importance to our understanding, so that future practical problems, not now envisioned, can be solved.
The practical outcome of research on this subject could be a device that would control the brightness and schedule of light in a bedroom (or device covering the eyes) during sleep that would phase-lock human ovulation cycles. The idea behind it is that, during evolution, the fertility cycle of humans and other primates was phase-locked to the moon and that full moon coincided with ovulation. In other words, the original zeitgaber of the human 28-day cycle was the 28-day lunar cycle. Recently published papers show that this idea is no longer as strange as it appeared in 1967 when it was first proposed. The reason for this is that one now knows (as was not known then) that (a) light has such a large hormonal effects that it can be used to cure seasonal affective disorder, (b) the circadian cycles in humans can be phase-locked to light schedules. (Kronauer and Czeisler at Harvard showed this, see page 217 of Wetterberg's book cited above), and (c) the roles of various organs of the brain, nervous system, and the underlying biochemistry have become better understood the last 33 years.
SUMMARY OF THE INVENTION
The present invention is a luminescent ovulation/menstrual cycle adjustment process to entrain preselected biorhythms with a scheduled regimen of photic stimulation. The process is implemented by a control of the brightness and schedule of light in a bedroom (or device covering the eyes) during sleep that would phase-lock human ovulation cycles. The idea behind it is that, during evolution, the fertility cycle of humans and other primates was phase locked to the moon and that full moon coincided with ovulation. In other words, the original zeitgaber of the human 28-day cycle was the 28-day lunar cycle. The attached discussion shows that this idea is no longer as strange as it appeared when is was first proposed. The reason for this is that one now knows (as was not known then) that (a) light has such large hormonal effects that it can be used to cure seasonal affective disorder, (b) the circadian cycles in humans can be phase-locked to light schedules.
In one embodiment of the invention, the process is accomplished by subjecting a woman subject to a nocturnal light exposure that corresponds exactly to a lunar cycle of 29.5-days, said nocturnal light having a schedule of brightness and darkness with a maximum noctu
Auton William G.
Gibson Roy D.
The United States of America as represented by the Secretary of
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