Surgery – Sleep or relaxation inducing therapy – Sensory
Reexamination Certificate
2001-06-01
2003-01-14
Winakur, Eric F. (Department: 3736)
Surgery
Sleep or relaxation inducing therapy
Sensory
C600S545000
Reexamination Certificate
active
06506148
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the stimulation of the human nervous system by an electromagnetic field applied externally to the body. A neurological effect of external electric fields has been mentioned by Wiener (1958), in a discussion of the bunching of brain waves through nonlinear interactions. The electric field was arranged to provide “a direct electrical driving of the brain”. Wiener describes the field as set up by a 10 Hz alternating voltage of 400 V applied in a room between ceiling and ground. Brennan (1992) describes in U.S. Pat. No. 5,169,380 an apparatus for alleviating disruptions in circadian rythms of a mammal, in which an alternating electric field is applied across the head of the subject by two electrodes placed a short distance from the skin.
A device involving a field electrode as well as a contact electrode is the “Graham Potentializer” mentioned by Hutchison (1991). This relaxation device uses motion, light and sound as well as an alternating electric field applied mainly to the head. The contact electrode is a metal bar in Ohmic contact with the bare feet of the subject, and the field electrode is a hemispherical metal headpiece placed several inches from the subject's head.
In these three electric stimulation methods the external electric field is applied predominantly to the head, so that electric currents are induced in the brain in the physical manner governed by electrodynamics. Such currents can be largely avoided by applying the field not to the head, but rather to skin areas away from the head. Certain cutaneous receptors may then be stimulated and they would provide a signal input into the brain along the natural pathways of afferent nerves. It has been found that, indeed, physiological effects can be induced in this manner by very weak electric fields, if they are pulsed with a frequency near ½ Hz. The observed effects include ptosis of the eyelids, relaxation, drowziness, the feeling of pressure at a centered spot on the lower edge of the brow, seeing moving patterns of dark purple and greenish yellow with the eyes closed, a tonic smile, a tense feeling in the stomach, sudden loose stool, and sexual excitement, depending on the precise frequency used, and the skin area to which the field is applied. The sharp frequency dependence suggests involvement of a resonance mechanism.
It has been found that the resonance can be excited not only by externally applied pulsed electric fields, as discussed in U.S. Pat. Nos. 5,782,874, 5,899,922, 6,081,744, and 6,167,304, but also by pulsed magnetic fields, as described in U.S. Pat. Nos. 5,935,054 and 6,238,333, by weak heat pulses applied to the skin, as discussed in U.S. Pat. Nos. 5,800,481 and 6,091,994, and by subliminal acoustic pulses, as described in U.S. Pat. No. 6,017,302. Since the resonance is excited through sensory pathways, it is called a sensory resonance. In addition to the resonance near ½ Hz, a sensory resonance has been found near 2.4 Hz. The latter is characterized by the slowing of certain cortical processes, as discussed in the '481, '922, '302, '744, '944, and '304 patents.
The excitation of sensory resonances through weak heat pulses applied to the skin provides a clue about what is going on neurologically. Cutaneous temperature-sensing receptors are known to fire spontaneously. These nerves spike somewhat randomly around an average rate that depends on skin temperature. Weak heat pulses delivered to the skin in periodic fashion will therefore cause a slight frequency modulation (fm) in the spike patterns generated by the nerves. Since stimulation through other sensory modalities results in similar physiological effects, it is believed that frequency modulation of spontaneous afferent neural spiking patterns occurs there as well.
It is instructive to apply this notion to the stimulation by weak electric field pulses administered to the skin. The externally generated fields induce electric current pulses in the underlying tissue, but the current density is much too small for firing an otherwise quiescent nerve. However, in experiments with adapting stretch receptors of the crayfish, Terzuolo and Bullock (1956) have observed that very small electric fields can suffice for modulating the firing of already active nerves. Such a modulation may occur in the electric field stimulation under discussion.
Further understanding may be gained by considering the electric charges that accumulate on the skin as a result of the induced tissue currents. Ignoring thermodynamics, one would expect the accumulated polarization charges to be confined strictly to the outer surface of the skin. But charge density is caused by a slight excess in positive or negative ions, and thermal motion distributes the ions through a thin layer. This implies that the externally applied electric field actually penetrates a short distance into the tissue, instead of stopping abruptly at the outer skin surface. In this manner a considerable fraction of the applied field may be brought to bear on some cutaneous nerve endings, so that a slight modulation of the type noted by Terzuolo and Bullock may indeed occur.
The mentioned physiological effects are observed only when the strength of the electric field on the skin lies in a certain range, called the effective intensity window. There also is a bulk effect, in that weaker fields suffice when the field is applied to a larger skin area. These effects are discussed in detail in the '922 patent.
Since the spontaneous spiking of the nerves is rather random and the frequency modulation induced by the pulsed field is very shallow, the signal to noise ratio (S/N) for the fm signal contained in the spike trains along the afferent nerves is so small as to make recovery of the fm signal from a single nerve fiber impossibile. But application of the field over a large skin area causes simultaneous stimulation of many cutaneous nerves, and the fm modulation is then coherent from nerve to nerve. Therefore, if the afferent signals are somehow summed in the brain, the fm modulations add while the spikes from different nerves mix and interlace. In this manner the S/N can be increased by appropriate neural processing. The matter is discussed in detail in the '874 patent. Another increase in sensitivity is due to involving a resonance mechanism, wherein considerable neural circuit oscillations can result from weak excitations.
An easily detectable physiological effect of an excited ½ Hz sensory resonance is ptosis of the eyelids. As discussed in the '922 patent, the ptosis test involves first closing the eyes about half way. Holding this eyelid position, the eyes are rolled upward, while giving up voluntary control of the eyelids. The eyelid position is then determined by the state of the autonomic nervous system. Furthermore, the pressure excerted on the eyeballs by the partially closed eyelids increases parasympathetic activity. The eyelid position thereby becomes somewhat labile, as manifested by a slight flutter. The labile state is sensitive to very small shifts in autonomic state. The ptosis influences the extent to which the pupil is hooded by the eyelid, and thus how much light is admitted to the eye. Hence, the depth of the ptosis is seen by the subject, and can be graded on a scale from 0 to 10.
In the initial stages of the excitation of the ½ Hz sensory resonance, a downward drift is detected in the ptosis frequency, defined as the stimulation frequency for which maximum ptosis is obtained. This drift is believed to be caused by changes in the chemical milieu of the resonating neural circuits. It is thought that the resonance causes perturbations of chemical concentrations somewhere in the brain, and that these perturbations spread by diffusion to nearby resonating circuits. This effect, called “chemical detuning”, can be so strong that ptosis is lost altogether when the stimulation frequency is kept constant in the initial stages of the excitation. Since the stimulation then falls
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