Abstract:
Method and apparatus are provided for therapeutic administration to body parts digitally generated electromagnetic fields with trapezoidal, square, triangular and sawtoothed and other complex temporal field waveforms that are microcontroller controlled for a range of amplitude, frequency, and dc offsets; the apparatus providing programmed sequences of radiation waveforms. Multiple electromagnetic antennas establish a variety of field configurations for exposure of various body parts in the treatment of a wide range of afflictions including exfoliation of calcium deposits causing improvements in arthritis and other rheumatic diseases—osteoarthritis, nervous interconnection (neuropathies), etc., the treatment of tremors and seizures, migraine, hypertension, lower back pain, urinary incontinence, and premenstrual tension. Temperature sensors within the antennas are provided to limit the temperatures therein.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Application No. 60/667,980 filed Apr. 4, 2005 entitled “Digital Electromagnetic Pulse Generator,” the entire content of which is expressly incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not applicable  
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC  
       [0003]     Not applicable  
       BACKGROUND OF THE INVENTION  
       [0004]     b  1 . Field of the Invention  
         [0005]     This invention relates generally to medical equipment for Magnetic Resonance Therapy (MRT), and more specifically to electromagnetic therapy for reduction of symptoms and for curing a large variety of physical and mental conditions.  
         [0006]     2. Description of Related Art  
         [0007]     There is abundant history of magnets being used for medical treatment. In 440 BC, Socrates utilized magnetite in the treatment of menstrual disorders. Magnetite is a member of the spinel group of minerals which has the standard formula A(B)2O4. The A and B usually represent different metal ions that occupy specific sites in the crystal structure. In the case of magnetite, Fe3O4, the A metal is Fe +2 and the B metal is Fe +3; two different metal ions in two specific sites. This arrangement causes a transfer of electrons between the different irons in a structured path or vector. This electric vector generates the magnetic field. Common present day systems utilize electric currents through conductive coils to flexibly generate variable magnetic fields spatially and temporally.  
         [0008]     In 1857 Dr. Al Pulvermacher of Vienna introduced an “Electromagnetic Belt” in England. More recently, Fallus, in U.S. Pat. No. 4,197,851, issued on Apr. 15, 1980, utilizes magnetic fields applied to a patient through the application of an electrode to the body for electrotherapeutic treatment. In Fallus&#39; U.S. Pat. No. 4,454,883, issued on Jun. 19, 1984, weak electromagnetic fringe fields are employed for the control of tremors and seizures, and disorders of the autonomic nervous system such as panic attack.  
         [0009]     Loos, in U.S. Pat. No. 6,167,304, issued on Dec. 26, 2000, teaches an apparatus for manipulating the nervous system using an external electric field with variable pulse parameters, and Long, et al. in U.S. Pat. No. 6,029,084, issued on Feb. 22, 2000, utilizes electromagnetic fields in synchronization with the heart, and in an earlier UK Patent GB-2156679-B, issued on Sep. 16, 1987, offers relief for migraine, hypertension, lower back pain, and premenstrual tension. No prior art has been found for electromagnetic therapy using digitally generated unipolar magnetic fields, nor with temperature control of the electrodes.  
         [0010]     Magnetic Resonance Therapy (MRT) involves the use of electromagnetic fields applied to the body for beneficial effects. The buildup of calcium phosphate and calcium carbonate in the cells of the body contribute to degradations in teeth, joints, heart, etc. Since calcium molecules are paramagnetic they align and become cemented together as stones, granulomas, and plaque. The application of periodic oscillatory magnetic fields to regions of the body loosens the calcium molecular bonds allowing these deposits to free and exfoliate into the blood stream for removal by the kidneys.  
         [0011]     Magnetic therapy has become a standard medical treatment for many conditions or diseases in Eastern Europe, Asia and former USSR countries. Magnetic therapy is an innovative, emerging medical technology, with an extensive biological research base. For example: the use of MRT in the healing of non-union fractures, and in nerve conduction testing.  
         [0012]     The roots of this bioscience come from the studies done in biomagnetics, the study of the body&#39;s own magnetic fields. All human activity is conditioned by the earth&#39;s magnetic environment, and in the last two decades biomedical knowledge has advanced dramatically in the area of bioelectricity, not only in nerve conduction but also in electrolytic phenomena.  
         [0013]     Magnetic forces exist in the space around moving electrical particles, which can affect other moving particles. The source of these forces can be electrons in wires where electric current flows, ions in electrolytic solutions, electrons in cathode ray tubes, etc. The static magnetic field around permanent magnets is based on the same principle. In the permanent magnet, motion of electrons (spin and orbital motion moment) is arranged such that “magnetic field” forces exist outside of the magnet as magnetic flux.  
         [0014]     Magnetic fields can be classified according to their space attributes as uniform or non-uniform. Uniform fields are those where in every point of the field area of interest substantially the same value (strength and sign) and direction is exhibited, such as the condition of a static passive magnet or electromagnet with direct current (DC) flowing therein. In current magnetic therapy applications non-uniform fields are generally used.  
         [0015]     In time varying magnetic fields, magnetic flux density or intensity changes with time, typically periodic at specific frequencies. Time varying magnetic fields result from electromagnets fed with non-constant currents, e.g. alternating (AC) currents. The most common varying fields are found around electrical wires conducting AC current, such as to electrical appliances.  
         [0016]     Magnetic fields are characterized by intensity (H) and magnetic flux density (B). The intensity of a magnetic field is directly proportional to the current flowing through a wire and indirectly proportional to the distance from the wire: 
 
 H=I/ 2 nr  
 
 Where I=current intensity in amperes, r=distance from the wire in meters. The unit of H is ampere/meter (A/m) defined as the intensity of a magnetic field at a distance r=½ n from the wire wherein a current of 1 A is flowing. 
 
         [0017]     Magnetic flux density is measured in units of Tesla (T). This unit is defined as follows: if a force acting on a wire 1 meter long with 1 A flowing in a uniform magnetic field is 1 N (Newton), this field has the magnetic flux density of 1 T.  
         [0018]     A field of one Tesla is quite strong: the strongest fields available in laboratories are about 20 Teslas, and the Earth&#39;s magnetic flux density, at its surface, is about 50 microteslas (μT).  
         [0019]     An alternate unit of magnetic flux is gauss (G), where 1 G=10-4 T (0.0001 T), 1 T=10 4  G.  
         [0020]     The relation between B and H is given as follows: 
 
B=μH 
 
 Where μ is the environment permeability. The relation μ=μr. μo is used, where μr is relative permeability and μo is the permeability of a vacuum. In biological systems permeability is close to that of air and therefore B≈H. 
 
         [0021]     There are three established physical mechanisms through which static and time-varying magnetic fields interact with living matter.  
         [0022]     Magnetic Induction: relevant to both static and time varying magnetic fields, originates through the following interactions: 
        1. Electrodynamic interactions with moving electrolytes are based on Lorenz forces on moving ionic charge carriers and thus electric fields and currents are induced. This type of interaction is the basis of magnetically induced blood flow potentials that have been studied with both static and time varying magnetic fields.     2. Faraday currents—relevant to time varying magnetic fields only. Most scientists consider this interaction as the key mechanism of magnetic therapy with time varying magnetic fields.     3. Magnetomechanical Effects: relevant mainly to static magnetic fields: In uniform magnetic fields, both diamagnetic and paramagnetic molecules experience torque, which tends to orient them in a configuration that minimizes their free energy within the field. When the fields used for magnetic therapy are relatively weak (10 to 100 mT), a magnetomechanical action may not be significant. Magnetomechanical translation can be found in high gradient static magnetic fields that leads to the motion of either paramagnetic or ferromagnetic particles. This action may not be a significant contributor of magnetic therapy effects.     4. Electronic Interactions: seen with static fields but may also be relevant to time varied fields: Some chemical reactions are based on an action on radicals. In these circumstances static magnetic fields exhibit an effect on electronic spin states. It is possible that, although the lifetimes of the intermediates caused by this interaction are short, they can still be a sufficiently strong influence on biological matter via changed kinetics of dynamic chemical reactions. 
 
 Faraday&#39;s Law and Current Density 
       
 
         [0027]     Generally, time varying magnetic fields, versus static fields, have been useful for therapeutic purposes since it is most commonly believed that if the key mechanism of action is induction of electrical currents, the appropriate approach is is the use of time varying magnetic fields. In accord with Faraday&#39;s law, magnetic fields that vary in time will induce potentials and circulating currents in biological systems, including the human body. Current density can be estimated using following formula: 
 
 J=E.σ=nr 2/2 nr. dB/dt.σ=σ r/ 2.dB/dt 
 
 For sinusoidal fields a simplified equation is appropriate: 
 
J=n.r.f.σ.B 
 
 Where J=current density (A/M 2 ) 
 
         [0028]     E=induced potential (V/M)  
         [0029]     r=radius of the inductive loop (M)  
         [0030]     σ=tissue conductivity (S/M)  
         [0031]     dB/dt=rate of change of magnetic flux density  
         [0032]     It has been determined that current density up to 100 mA/M 2  is safe. From this viewpoint, to assure maximum safety we consider the highest conductivity of tissue, i.e. 0.2 S/m. However, this calculation is more theoretical than practical since the human body constitutes many tissues with differing conductivity values. This is the primary reason why we cannot calculate exactly the level of induced currents in the complicated, non-homogenous structures of the body.  
         [0033]     Prior art MRT devices provide analog drive signals and analog electromagnetic fields, which are inefficient and result in excessive generation of heat. An object of the present invention is to provide efficient apparatus for the generation of electromagnetic waves utilizing digital electronics and providing magnetic waveforms with a variety of waveform patterns, and a thermal limiter or shutoff circuit when temperatures exceed a predetermined threshold.  
       BRIEF SUMMARY OF THE INVENTION  
       [0034]     This invention is directed to Digital ElectroMagnetic Resonance Therapy and provides efficient and flexible generation of magnetic fields for application to the body for a variety of therapeutic uses. The Digital ElectroMagnetic Pulse Generator (DEMP) of the present invention provides a selection from a plurality of waveforms, all generated digitally for the efficient creation of magnetic fields. The DEMP is useable with a variety of antennas, such as copper-coil electromagnets, well known in the art, for generating magnetic waveforms from the electrical current supplied thereto. Magnetic Resonance Therapy consists of the application of one or more antennas to different parts of the body. It requires that the antennas face each other to compliment each other&#39;s magnetic potentials. The north side of one must face the south side of the antenna on the same channel. It is important that the North-South axis of the antennas face the East-West geographic direction for maximum cell resonance.  
         [0035]     It is therefore an object of this invention to provide efficient and flexible generation of magnetic fields for application to the human body for a variety of therapeutic uses.  
         [0036]     In accordance with these and other objects which will become apparent hereinafter, the instant invention will now be described with reference to the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)  
       [0037]      FIG. 1  is a cross sectional plan view of the magnetic flux of an air-core electromagnetic antenna also showing a high-field region cross section.  
         [0038]      FIG. 2  is a perspective view of the high-field region surface.  
         [0039]      FIG. 3  is a functional diagram of a DEMP system of the invention in use.  
         [0040]      FIG. 4  is perspective diagram of the DEMP system in use with ocular antenna goggles.  
         [0041]      FIG. 5  is a perspective diagram of a tunnel antenna  
         [0042]      FIG. 6  is a perspective diagram of a paddle antenna.  
         [0043]      FIG. 7  is a perspective diagram of two paddle antennas oriented side-by-side.  
         [0044]      FIG. 8  is a cross sectional plan view of the two-paddle antenna of  FIG. 7  illustrating the magnetic field lines.  
         [0045]      FIG. 9  is a perspective drawing of a two-paddle application for lumbar therapy.  
         [0046]      FIG. 10  is a perspective drawing of a urinary antenna ensemble.  
         [0047]      FIG. 11  is a perspective drawing of a cranial antenna in use.  
         [0048]      FIG. 13  is a functional block diagram of the electronic elements of the system.  
         [0049]      FIG. 14  is a drawing of the basic time graph with a trapezoid wave output embodiment of the system.  
         [0050]      FIG. 15  is a drawing of an alternate time graph of a square wave output embodiment of the system.  
         [0051]      FIG. 16  is a drawing of a third alternate time graph of a triangular wave output embodiment of the system.  
         [0052]      FIG. 17  is a drawing of a fourth alternate time graph of a sawtooth wave output embodiment of the system. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0053]      FIG. 1  illustrates magnetic flux lines  30  emanating from a single air core antenna coil  10  wound with a substantial number of turns of electrical wire, preferably copper, with coil windings  20  arranged in a generally concentric pattern. When energized with electric current, the coil forms an electromagnet with a NORTH magnetic pole  40  and a SOUTH magnetic pole  50  having a region of relatively high flux density in a high-field region  32 . By convention of magnetic flux direction, flux lines such as outboard flux line  52  flow from NORTH to SOUTH indicated by flux direction arrow  45 . Inner flux line  54  originates near the inner diameter of coil  10  whereas outboard flux line  52  originates from a location closer to the axis  15  of coil  10 .  
         [0054]      FIG. 2  is a three-dimensional representation of the electromagnet high-field region  32  depicted as a surface that illustrates the depth of penetration of the high-field region. At surface  32  all flux within that solid boundary is of an intensity value greater than at the surface, and provides a graphic indication of the relative penetration of an arbitrary level of magnetic flux relative to the size of coil  10 .  
         [0055]      FIG. 3  illustrates a preferred embodiment of the instant invention Digital ElectroMagnetic Pulse Generator (DEMP) system  110 , including power source  130 , power connection  140 , DEMP control unit  120 , antenna cable  240 , connected to two antenna coils  10 . The two antenna coils are preferably arranged on opposing sides of a patient&#39;s arm  270  to create, upon excitation, two electromagnets and cause a strong magnetic field illustrated by magnetic flux lines  34  to pass therethrough. Electrical current flowing into coils  10  through source conductors  250  and returning through return conductors  260  create North poles  40  and South poles  50 . When the amplitude of current flow changes, a varying magnetic field is created within the patient&#39;s arm  270  to create therapeutic Faraday currents within the arm. Although two antenna coils are shown, a plurality of antenna pairs may be employed, and may be oriented in a variety of orientations within the scope of the invention. It is preferable to orient antenna coils  10  such that the axis of field lines  15  is normal to earth&#39;s magnetic north direction  280 . Coil construction follows methods well known in the art, including copper wire wound upon a plastic mandrel, wrapped with insulating tape, not shown, for strain relief and durability. Standard soldering and insulating methods are used to connect the conductors to the coil windings. Temperature sensor  35  is incorporated within the antenna assembly to reliably monitor and limit internal antenna temperature, and may be attached to the coil with commonly used epoxy adhesive.  
         [0056]     DEMP control unit  120  includes electronics described below, display  150 , Escape pushbutton  190 , Operate and Pause button  205 , five push-button navigation switches  200 , function push-button  170 , power button  160 , and six program buttons  180  for commanding specific electromagnetic field sequences of waveform shape and complexity and in predetermined sequence programs as described below. Channel lamps  210  and notification lamps  220  provide operational feedback to the operator. The display, pushbuttons, navigation switches, and power source are all common elements in modern electronic devices, with mechanical and electrical characteristics well known to those skilled in the art. DEMP control unit  120  includes two channels (one illustrated in detail) for connection to two pairs of antenna coils  10  through connectors  230  and  235 .  
         [0057]      FIG. 4  illustrates a preferred embodiment ocular goggles  310  for treatment of diseases of the eye, with air core ocular coil  360  allowing patient  300  vision therethrough along magnetic axis  350  during therapy sessions. The DEMP control unit is set to 250 watts, and is used to treat retinitis pigmentosa, retinal degeneration, senile macular degeneration, retinal dystrophy, neuropathy on optic nerves, corneal trauma, corneal perforation, glaucoma simplex, atrophy of the optic nerve, etc. Cover  340  holds protective pane  330 ; air vent  320  prevents excess humidity internal to the goggles. An antenna capacity of 7 watts per eye is appropriate to produce the maximum movement. Cord connector  370  interconnects ocular coil  360  to the DEMP control unit. Goggles  310  are constructed with structural plastics and cushioning fabrics well known in the art. Temperature sensors, not shown, are incorporated within the goggles in close proximity to ocular antenna coils  360  to monitor and limit internal antenna temperature.  
         [0058]     Table I provides electrical and mechanical characteristics of preferred embodiment antenna coils of the invention for connection to the DEMP control unit, and indicates the number of coils used. Multiple antenna coils such as intra-cranial  12  may be connected in series/parallel arrangements to be adapted to the DEMP control unit driver capacity.  
         [0059]      FIG. 5  is a single-coil tunnel antenna  380  with coil  400  illustrating a large air core center for generating magnetic flux along axis  410 . Table I lists three tunnel antenna sizes. The larger tunnel is for the legs. The smaller tunnels are used for the arms. The tunnels are used to treat various bone injuries, fractures, burns, carpal tunnel syndrome, limb grafts, infected skin wounds, rheumatic/Musculoskeletal diseases, etc. Generally approximately 500 watts is applied from the DEMP generator. A temperature sensor, not shown, is in close proximity to the antenna coil to monitor and limit internal antenna temperature, and may alternatively be located within support housing  420 .  
                                                                           TABLE I                           Preferred Antenna Coil Characteristics                    Antenna Wire   Internal   External                   Number   Gauge,   Diameter,   Diameter,           Antenna Use   of Coils   mm   mm   mm   H, Turns   Core                    Intra-cranial 6   6   0.15   10   24   31   Air       Intra-cranial 8   8   0.15   10   24   31   Air       Intra-cranial 12   12   0.15   10   24   31   Air       Intra-cranial 16   16   0.15   10   24   31   Air       Tunnel/LARGE   1   0.75   245   250   67   Air       Tunnel/MEDIUM   1   0.65   197   200   102   Air       Tunnel/SMALL   1   0.40   110   113   70   Air       Ocular   2   0.25   10   45   38   Air       Urology   1   1.00   90   206   14   Air           2   0.50   25   100   25   Air       Full Body   3   1.50   410   500   15   Air       Full Body   1   1.50   410   500   15   Air       Opponent       Local 30 W   2   0.35   25   60   40   Air       Local 60 W   2   0.50   25   100   25   Air       Local 100 W   2   0.75   60   145   19   Air       Facial   4   0.25/0.35   10   24/45   31/38   Air       Cervical   2   035   25   60   40   Air       Lumbar   2   0.35   25   60   40   Air                    
         [0060]      FIG. 6  illustrates the construction of a generic antenna paddle  430  illustrating coil  460  visible through drawing cutout  450  and interconnection  400  for coupling to the DEMP control unit. Since paddles may be used in various numbers and configurations, it important to consistently label paddles with polarity labels indicating NORTH  440  and SOUTH  445  (in  FIG. 7 ) to insure proper placement with respect to all antenna paddles in use for a specific therapy. Paddle  430  includes an internal temperature sensor, not shown, to monitor and limit antenna coil temperature. The temperature sensor measurement is useable in the DEMP control unit to modify generated current waveforms as described below.  
         [0061]      FIG. 7  illustrates a typical planar orientation of two antenna paddles  430  with NORTH  440  and SOUTH  445  labels to create a deep high-field region  36  illustrated in the magnetic flux cross sectional diagram  470  of  FIG. 8 , which indicates flux lines  30  created by the two coils  10 . Note that high-field region flux lines are common to both coils and flow in the direction  45  from NORTH to SOUTH.  
         [0062]      FIG. 9  illustrates the antenna paddle  430  pair of  FIGS. 7 and 8  applied to a patient  480  in a lumbar therapy treatment in which diseased or strained internal areas are exposed to high-field regions of the antenna magnetic flux to cause Faraday currents to flow therein. Multiple paddle pairs, not shown, are useful for upper back therapies. Full body treatment utilizes 5000 watts from the DEMP generator and is used to treat peripheral vascular diseases, liver function, heart disease, hypertension, lung diseases, gastrointestinal diseases, etc.  
         [0063]      FIG. 10  illustrates a urinary/countenance therapy antenna set  500 , including buttocks paddle  510  and two side paddles  430  in storage fixture  520 . Urinary antenna cables  370  interconnect to the DEMP control unit set to 1000 watts. The pelvic floor cells are excitable in multiple directions by virtue of the locations of the antennas. Buttocks antenna  510  also includes an internal temperature sensor, not shown, to monitor and limit antenna coil temperature.  
         [0064]      FIG. 11  illustrates an intra-cranial antenna helmet  540 , which includes neck structure  560 , chin structure  550 , and cranium structure  570  alignment elements of the helmet. Drawing cutout  580  exposes intra-cranial antenna coil  590 , which interconnects through cables  370  to the DEMP control unit set to 3 to 5 Hz and 30% to 90% power. This preferred embodiment is used to treat neurological diseases, brain neurosecretion, Parkinson&#39;s disease, etc. Helmet  540  is constructed with plastic structural supports as described above, with fabric liners commonly known in the art. Helmet  540  includes internal temperature sensors, not shown, to monitor and limit antenna coil temperatures.  
         [0065]      FIG. 13  is a functional block diagram of a DEMP system  110  of the invention. Power supply  700  within DEMP control unit  120  provides a variety of power forms  710  for connection within the electronics. LCD display  660  is driven through a typical bus interconnect  690  by Central Processor Unit (CPU) electronics  680 . The CPU receives current feedback signals from ADC  760  and from temperature sensor  35 , and drives Digital to Analog Converter (DAC)  720 . The DAC  720  in turn drives Low Frequency Power Amplifier  730  supplying the antenna coil current, which is monitored by current sensor  740  through output connection  240 . CPU  680  may be an integrated circuit microcontroller such as an 8-bit RISC microcontroller manufactured by ATMEL. LCD Display  660  may be DMF-50773 manufactured by OPTRIX, which may include touch screen  670  integrated therein. DAC  720  may be MAX5891 manufactured by MAXIM, or equivalent. Power Supply  700 , amplifier  730 , and ADC  760  are common electronic components commonly known in the art, and software algorithms associated with CPU  680  are well known in the art for generating waveform, sequence programs, and controls described above.  
         [0066]      FIGS. 14, 15 ,  16 , and  17  illustrate graphical plots of amplitude  800  vs. time  610  of four exemplary alternate trapezoidal output waveforms for generating a variety of temporally varying electromagnetic fields with five time duration portions of period “T”  880 . Amplitudes are normalized to a common peak value, whereas it should be understood that the peak amplitudes are controllable and adjustable by the operator and by the predetermined program sequences. Each of the four illustrated trapezoid waveforms is created with five temporal periods totaling the full period “T”  880 . Optimal waveforms are chosen as a function of antenna, power, and frequency configuration. The waveform portion “D”  860  is a negative peak and its length depends on the inductance of the antenna used and its discharge slope. The waveform portion “E”  870  is set sufficient for substantially all inductive energy dissipation prior to the next cycle.  
         [0067]     Referring to  FIG. 14 , standard trapezoid wave  810  is generated by programming A time duration  830 , B time duration  840 , C time duration  850 , D time duration  860 , and E time duration  870 . Standard trapezoid time duration table  820  provides time percentages of waveform period T  880  for said standard trapezoid wave  810 . Various amplitudes, periods, T  880 , and sequences are programmable in the DEMP control unit described above and further described in the functional block diagram of  FIG. 13 .  
         [0068]     Referring to  FIG. 15 , typical low frequency square wave  890  is illustrated with low frequency square wave time duration table  920 .  FIG. 16  illustrates typical mid-frequency triangular wave  910  with low-frequency triangular wave time duration table  920 .  FIG. 17  illustrates typical high-frequency sawtooth wave  930  with high-frequency sawtooth wave time duration table  940 .  
         [0069]     While the instant invention has been shown and described herein in what are conceived to be the most practical and preferred embodiments, it is recognized that departures may be made therefrom within the scope of the invention, which is therefore not to be limited to the details disclosed herein, but is to be afforded the full scope of the claims so as to embrace any and all equivalent apparatus and articles.