Chemistry: molecular biology and microbiology – Treatment of micro-organisms or enzymes with electrical or...
Reexamination Certificate
1999-02-10
2001-05-29
Weber, Jon P. (Department: 1651)
Chemistry: molecular biology and microbiology
Treatment of micro-organisms or enzymes with electrical or...
C435S173200, C435S173300
Reexamination Certificate
active
06238899
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a method for using perpendicular or combined perpendicular and parallel magnetic fields to alter behavior of ions.
BACKGROUND OF THE INVENTION
Tissue and cell development have been studied extensively to determine the mechanisms by which maturation, maintenance and repair occur in living organisms. Generally, development of a cell or tissue can be considered as a transformation from one state or stage to another relatively permanent state or condition. Development encompasses a wide variety of patterns, all of which are characterized by progressive and systematic transformation of the cells or tissue.
In many instances it is desirable to control or alter the development of cells and tissue in vivo. It is hoped that means can be provided to restore or maintain the natural order of an organism after a debilitating injury, disease or other abnormality.
As will be appreciated by those skilled in the art, tissue and organic development involve complex processes of cellular growth, differentiation and interaction mediated by complex biochemical reactions. At the genetic level, development is regulated by genomic expression; at the cellular level, the role of membrane interaction with the complex biochemical milieux of higher organisms is instrumental in development processes. Moreover, remodeling of tissues or organs is often an essential step in the natural development of higher organisms.
A role for biologically active ions in cellular activity is well established. In Liboff et al., U.S. Pat. No. 4,818,697, techniques are disclosed for controlling the movement of a preselected ionic species across the membrane of a living cell. The inventors disclose that by exposing a region of living tissue of a subject such as a human or animal to an oscillating magnetic field of predetermined flux density and frequency, the rate of tissue growth can be controlled. For stimulating bone growth rate, a fluctuating magnetic field is tuned to the specific cyclotron resonance frequency of a preselected ion such as Ca
++
or Mg
++
. Additionally, Liboff et al., in U.S. Pat. No. 4,932,951, disclose the use of cyclotron resonance tuning to control the growth rate of non-osseous, non-cartiliginous connective solid tissue. In U.S. Pat. No. 5,067,940, Liboff et al. disclose a method and apparatus based on cyclotron resonance tuning which allow the growth rate of cartilaginous tissue to be regulated. An even more important use of cyclotron resonance tuning which is of particular significance in the treatment of elderly patients is disclosed in Liboff et al. U.S. Pat. No. 5,100,373, which deals with a method and apparatus for treating and preventing osteoporosis, both locally and systemically. Additional patents granted to Liboff and his co-workers in the field of ion cyclotron resonance include U.S. Pat. Nos. 4,818,697; 4,932,951; 5,045,050; 5,059,298; 5,067,940; 5,077,943; 5,087,336; 5,088,976; 5,100,373; 5,106,361; 5,123,898; 5,143,588; 5,160,591, and 5,193,456. All of the above-cited patents are hereby incorporated by reference in their entirety. These patents address various applications of the concept of field induced changes in ion transport in biological systems. The primary requirement for these applications is for a time varying (AC, preferably sinusoidal) magnetic field and a static magnetic field oriented parallel to the AC field. Liboff postulates, without explicit theoretical support, that the maximum influence will occur when B
ac
=B
dc
. Furthermore, there is the requirement for specific frequencies of AC field to tune to resonance conditions for particular ions of interest.
The results of a number of studies suggest that low-intensity and low-frequency electric and magnetic fields may influence physiologic processes in biological systems. However, most theoretical models developed to date have been unable to establish a predictive association between low-intensity field exposure and biological results. Some models of electric and magnetic field interactions with biological systems, for example, have focused on endpoints associated with direct energy deposition into the system from the fields or from the induction of body currents, and suggest that a single variable, such as AC field intensity, is responsible for the observed results. Partially as a result of these incomplete models, many experimental reports fail to document all relevant field exposure parameters and do not establish a clear protocol for obtaining repeatable results. Inconsistencies between experimental results have subsequently been interpreted by some as evidence that electric or magnetic fields may not be the causal factors (e.g., Adair, 1991; 1992). While there is much theoretical support for resolving AC and DC fields into parallel and perpendicular components in order to determine how they will affect biological systems, experimental efforts often fail to document the relative orientation between the AC and DC fields. In other experiments, different field variables such as frequency, temporal duration of fields, and relative alignment with the local geomagnetic field have been characterized on an ad hoc basis without clear guidance from a theoretical model to indicate which parameters were critical (Adey, 1992; Blackman et al., 1985, 1988, 1990; Blackman, 1992; Liboff, 1985, 1992; Liboff et al., 1987; Smith et al., 1987; Thomas et al., 1986).
A variety of theoretical models have been developed to describe the interaction of different combinations of static (DC) and extremely-low-frequency time-varying (AC) magnetic fields with living systems. In fact, most theoretical works, including quantum mechanics texts (e.g. Yariv, 1982), focus exclusively on how an AC magnetic field oriented perpendicular to the DC magnetic field will alter the spin of an ion. Edmonds (1993), for example, recently developed a model that concentrated on the case of perpendicular AC and DC fields. Most of the above-described models are largely descriptive, without being predictive. The ion cyclotron resonance (ICR) model, originally formulated by Liboff (cf. Liboff, 1985, McLeod and Liboff, 1987) and discussed by Durney (1988), Halle (1988) and Sandweiss (1990), describes how unhydrated ions might have distinct resonance type responses caused by the local DC magnetic field.
The fundamental premise of the ICR model is that parallel magnetic fields tuned for calcium, or a limited set of other selected ions, enhance the passage of those ions across the plasma membrane of the cell, only when B
ac
=B
dc
.
Theoretical support for the plausibility of measurable biological effects occurring as a result of exposure to parallel DC and AC magnetic fields can be found in the work of Chiabrera and colleagues (Chiabrera and Bianco, 1991; Chiabrera et al., 1991; 1993; Bianco and Chiabrera, 1992). They applied their model to a variety of biologically active ions in addition to calcium using the charge to mass ratio for the unhydrated state, a condition that may exist in ion-ligand components of biological molecules. Chiabrera and colleagues suggested that ions affected by ICR model conditions might be located in binding sites formed by molecular crevices that would exclude hydration of the ions. Although the ICR model predicts enhanced responses by specific ions when the AC frequency corresponds with the ICR model conditions, which are different for each ion, it does not indicate how the response might vary with different AC flux densities. Thus, the ICR model does not anticipate the distinct response form subsequently predicted for increasing B
ac
at constant B
dc
and f
ac
.
Lednev (1991) incorporated Liboff's model, in a limited sense, in his examination of how parallel AC and DC magnetic fields might influence ions bound in ligand structures specific to Ca
++
.
The ion parametric resonance (IPR) model, originally disclosed in Ser. No. 08/329,980, differs from Lednev's model in three critical ways: it specifically includes a (−1)
n
term m
Blackman Carl F.
Blanchard Janie P.
Browdy & Neimark
The United States of America as represented by the Environmental
Weber Jon P.
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