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Title:
HANDHELD PERMANENT MAGNET STIMULUS DEVICE (PMAGSTIM DEVICE)
Document Type and Number:
WIPO Patent Application WO/2024/085883
Kind Code:
A1
Abstract:
A device for applying noninvasive magnetic stimulation to a subject for a variety of medical therapies, with a low power, portable, handheld, battery operated system including permanent magnets that provide a high magnetic field. The device includes selectable frequencies by connecting a permanent magnet to either a small motor rotary shaft or to a small standard vibrating device. The permanent magnet, motor, or vibrator complex are connected to the battery bank and voltage-frequency selectable electronics.

Inventors:
KO HARVEY (US)
Application Number:
PCT/US2022/047379
Publication Date:
April 25, 2024
Filing Date:
October 21, 2022
Export Citation:
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Assignee:
KO HARVEY WAYNE (US)
International Classes:
A61N2/06; A61B5/05; A61B5/369; A61N2/12
Attorney, Agent or Firm:
KINNEY, Anna (US)
Download PDF:
Claims:
What is claimed is:

1 . A device for applying noninvasive magnetic stimulation to a subject’s body comprising: a stimulator comprising a motor and at least one permanent magnet configured to rotate upon operation of the motor and attached to the motor by a rotatable shaft; and a voltage controller in electronic communication with the motor, configured to manipulate a motor speed.

2. The device of claim 1 , further comprising a battery in electronic communication with the voltage controller and operative to power the motor.

3. The device of claim 1 , further comprising a voltmeter positioned to measure a voltage of a current supplied to the motor.

4. The device of claim 1 , further comprising a magnetic relay timer switch in electronic communication with the motor, configured to activate or deactivate the motor based on a predetermined input time.

5. The device of claim 1 , wherein the motor is configured to rotate the at least one permanent magnet, wherein the at least one permanent magnet is axially magnetized.

6. The device of claim 1 , wherein the motor is configured to rotate the at least one permanent magnet, wherein the at least one permanent magnet is diametrically magnetized.

7. The device of claim 1 , wherein the stimulator and the voltage controller are housed together in a casing.

8. The device of claim 1 , wherein the stimulator is housed in a stimulator casing and the voltage controller is a component of an electronics assembly housed within an electronics casing.

9. The device of claim 1 , further comprising a cuboidal spacer, a first face of which is affixed to the rotatable shaft, wherein the at least one permanent magnet is affixed to a remaining face of the cuboidal spacer, wherein the cuboidal spacer is configured to rotate by operation of the motor.

10. The device of claim 9, wherein the at least one permanent magnet is axially magnetized.

1 1. The device of claim 9, wherein the at least one permanent magnet is diametrically magnetized.

12. A method of treating for preventing a disease or disorder in a subject in need thereof comprising: providing a stimulator device operative to produce an alternating magnetic field, the stimulator device comprising at least one permanent magnet and a motor; positioning the stimulator device adjacent to a subject’s body at a predetermined position and predetermined distance; activating the stimulator device; and maintaining the predetermined position and predetermined distance of the stimulator device for a period of time.

13. The method of claim 12, further comprising selecting a magnetic field frequency by manipulating a voltage delivered to the motor.

14. The method of claim 12, further comprising: providing a second stimulator device operative to produce a second alternating magnetic field; positioning the second stimulator device adjacent to the subject’s body at a second predetermined position and a second predetermined distance; activating the second stimulator device; and maintaining the second predetermined position and second predetermined distance of the second stimulator device for the period of time.

15. A device for applying noninvasive magnetic stimulation to a subject’s body comprising: a stimulator comprising at least one permanent magnet and a motor configured to vibrate the at least one permanent magnet; and a voltage controller in electronic communication with the motor, configured to manipulate a motor speed.

Description:
HANDHELD PERMANENT MAGNET STIMULUS DEVICE (PMAGSTIM DEVICE)

BACKGROUND OF THE INVENTION

The present invention relates to magnetic devices and, more particularly, to a handheld permanent magnet magnetic stimulus device.

Electromagnetic (EM) technologies are commonly used for characterizing tissue measurements, imaging, and therapeutic medical uses (e.g., magnetic resonance imaging and electrocardiograms among others). EM effects arise from charges of biological particles undergoing movement from an application of an external electric or magnetic field.

Electric field measurements require the use of electrodes that contact or penetrate tissues. These measurements are hard to implement and analyze because the electric field vectors must obey strict boundary conditions and suffer from extraneous noise voltages due to serums and perspiration. Often, they require invasive implantation of electrodes, yielding a host of conductivity issues.

Magnetic fields do not have similar restrictions when compared to electric fields and have been implemented in a variety of medical uses. See Christiansen, Michael G., et al, “A Possible Inductive Mechanism for Magnetogenetics,” DOI preprint, 2020; Foletti, A., et al, “Bioelectromagnetic Medicine: The Role of Resonance Signaling,” Electromagnetic Biology and Medicine, 32, 2013; Miyakoshi, J., “Effects of Static Magnetic Fields at the Cellular Level,” Progress in Biophysics & Molecular Biol., 87, 2004; and Lai, J., et al, “Effects of 100-uT Extremely Low Frequency Electromagnetic Fields Exposure on Hematograms and Blood Chemistry in Rats,” Journal of Radiation Research, Volume 57, 2016. Medical uses of magnetic stimulation through magnetic fields are approved by the Food and Drug Administration (FDA) and have been shown to be effective in a variety of therapeutic fields. However, magnetic therapeutic applications have been limited by commercial systems and availability of devices, as presently available devices are only able to attain magnetic fields with a very low or extremely low frequency. For example, most presently available devices are only available at a frequency of approximately 23 Hz. For a description on a wide consensus of applications of magnetic stimulation, see: Christiansen, M.G. and Anikeeva, P., “Magnetic Fields For Modulating The Nervous System,” Physics Today, 74, 2021 ; Pashut,T, et al, “Mechanisms of Magnetic Stimulation of Central Nervous System Neurons,” PLoS Computational Biology, Volume 7, March 2011 ; Peterchev, AV, et al, “Fundamentals of Transcranial Electric and Magnetic Stimulation Dose: Definition, Selection, and Reporting Practices,” Brain StimuL, Volume 5, 2012; Rossi, Simone, et al, “Safety, Ethical Considerations, And Application Guidelines For The Use Of Transcranial Magnetic Stimulation In Clinical Practice And Research,’ Clin. Neurophysiol, Volume 12, December, 2009; and Goto, T., et al, “Natural Resonance Frequency Of The Brain Depends On Only Intracranial Pressure: Clinical Research,” Scientific Reports, Volume 10, 2020.

In addition, presently available magnetic stimulation devices require a large power consumption and high currents to generate a magnetic field measured up to two Tesla at an application coil plane. They further require signal generators to generate alternating current (AC) fields. These presently available devices operate by passing potentially dangerous, high electrical currents in wire loops. Said devices often require cooling large, heavy, and sophisticated electronics and high electrical power. For example, these devices produce a fixed magnetic frequency using very high electrical currents though an applicator coil, generating very high magnetic fields from 0.5 to 4 Tesla.

Recently, small neodymium permanent magnets have been utilized to attain high magnetic fields (HMFs) on the order of several Tesla, replacing high electric currents passing through large and heavy coil structure that often require coolants, excessive electronics, and high-power consumption. These neodymium magnets have strengths equal to the high current, heavy coil structures that are used today and achieve 0.5-4 Tesla. These magnets by themselves operate at 0.5-2 Tesla. These values for the HMF from coil emitters assume the maximum emission is at the plane of the emitter coil, i.e., the origin, and the HMF value at any distance (r) fall off as 1/r cubed. The same falloff rate applies to the PM where the origin of the PM is the surface of the magnet. However, presently available devices utilizing neodymium magnets are limited to a narrow magnetic frequency spectrum dependent on limitations of their electronic instrumentation. These frequency limitations are a byproduct of limitations of manufacturers and their manufactured devices.

Medical researchers have published results for magnetic stimulation via magnetic fields using only the available frequencies supplied by commercial manufacturers. There has been little research to deduce a proper frequency range for a given therapy. For example, magnetic stimulation has been utilized to treat erectile dysfunction (ED). Papers on male ED have reported on 23 Hz successes, while migraine papers using a different commercial device have reported successes at 10 Hz, for example, in tactile stimulation of the cavernous nerves during radical surgical removal of prostate tumors, see: Lee , Smith, Ko, Partin, “Bioimpedance: Novel Use of a Noninvasive Technique For Localization of Cancer in the Intact Prostate,” The Prostate, 39,1999; Ko, Smith, DG, “Apparatus for Sensing Human Prostate Cancer”, US Patent 7,283,868, Oct 2007; and Stein, Marshall J., et al, “New Advances In Erectile Technology,” DOI preprint 2014. To test at a different frequency, a different device from a separate manufacturer will be needed, as currently available devices are not able to adjust their frequency.

Magnetic fields have been utilized in treating a variety of ailments and physical conditions including ED. ED affects over 50% of the worldwide male population, especially noticeable between ages 40-70. The primary cause is aging, but stress, smoking, and drug and alcohol addiction are also major contributors. A common, temporary treatment is the use of pharmacology (e.g., Viagra™, Cialis™) that increases blood flow to the penis. More drastic treatments involving surgery or devices attached to the penis have been tried for decades.

Tactile stimulation of the cavernous nerves during a surgical removal of a prostate tumor causes the arousal and penile erection of anesthetized male patients. Direct manual stimulation of the cavernous nerve by invasive techniques using implanted electrodes have been utilized to treat ED. In addition, noninvasive methods such as acoustic devices have been utilized for ED treatments. See Skoufias, Spyridon, et al, ““Novel Concept Enabling An Old Idea: A Flexible Electrode Array To Treat Neurogenic Erectile Dysfunction,” International Society for Sexual Medicine, 2018; and Ardito, James R. and Knoll, L. Dean, “Cavernous Nerve Stimulation Device,” United States Patent 5,938,584, Aug. 17, 199.

Published papers have reported favorable sexual arousal in men suffering ED utilizing commercial, noninvasive magnetic stimulation with a high current coil at 18 to 20 Hz applied to a dorsal side of the penis. Shafik et al, Magnetic Stimulation of the Cavernous Nerve for the Treatment of Erectile Dysfunction in Humans. Int J Impot Res. 2000 Jun ; 12(3) : 137-41 . The magnetic field was applied for fifty seconds on and off for a period of ten minutes, resulting in erections lasting over 23 seconds. Shafik et al.

Other studies utilized relatively small current coil systems of only 5 microTesla that men had to wear for long periods of time (sometimes up to three weeks). Pelka et al, Impulse Magnetic-Field Therapy for Erectile Dysfunction: A DoubleBlind, Placebo-Controlled study. Adv Ther. 2002 Jan-Feb;19(1 ):53-60. This resulted in an average increase of intercourse erection duration from six minutes to thirty minutes. Pelka et al.

In addition, other magnetic stimulation devices operate by wrapping a coil around the penis and activating a dangerous 9000 ampere peak. US Publication 2004/0181261.

The above cited studies and references along with various others all suffer from a lack of Electrophysics and engineering precision, specifically control of measurement distances, magnetic frequencies, and magnetic field Tesla values of the HMF source. As such, proper variables cannot be assessed and studied for a clear understanding of ED via a stimulation of the cavernous nerve. This is made more difficult because the electromagnetic devices utilized are very large and overly cumbersome. In addition, they utilize hazardous levels of amperage to attain several micro-Tesla.

As can be seen, there is a need for a simple, handheld, powerful device effective for noninvasive therapeutic treatment over a wider frequency spectrum for magnetic stimulation, including magnetic stimulation for treatment of ED, without high electrical currents and power consumption.

In addition to males, females may often suffer sexual dysfunction. It is estimated that 40% of US women have reported sexual dysfunction with as many as 87% of elderly women complaining of sexual dissatisfaction. Azadzoi, Kazem M. and Siroki, Mike B., “Neurologic Factors in Female Sexual Function and Dysfunction,” Korean Journal of Urology, 2010. In an example clinical survey amongst 329 healthy women, 38% reported anxiety or inhibition during sex, 16% had lack of pleasure, 15% could not achieve orgasm, 14% had lack of lubrication, and 1 1 % had painful intercourse. US2006/0189839A1 . For a greater discussion on sexual dysfunction, see also Bitzer J, “Management of Sexual Dysfunction in Men and Women: An Interdisciplinary Approach 1 st ed.,” University Hospital, Basel, Switzerland, 2010; Vachon P., et al, “Increases in Clitoral and Vaginal Blood Flow Following Clitoral And Pelvic Plexus Nerve Stimulations In The Female Rat,” International Journal of Impotence Research, Volume 12, 2000; and Geris, M. “The Pudendal Nerve,” www.teachmeanatomy.com 2019.

Pelvic nerve stimulation has been used in combination with estrogen, progesterone, and testosterone therapies for sexual gratification of females. During some research on magnetic stimulation, it has been noted women become pleasantly aroused from magnetic stimulation tingling. US Patent 7,959,550. As with the case of male ED, the magnetic stimulation benefits to female arousal are directly related to the stimulation of the pelvic pudendal and cavernous nerves.

Several women have reported positive sexual responses of arousal, lubrication, and orgasm during electric stimulation of the tibial nerve in the ankle intended for bladder dysfunction because of its access to pelvic bladder nerves via the tibial nerve transmission from the spine. Zimmerman et al. “Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study” Published September 3, 2018.

Thus, for female sexual arousal, a device is needed which may be implemented at a variety of potential sites for simple, noninvasive, yet powerful (i.e., milli-Tesla amplitudes over broad frequencies) magnetic stimulation.

Transcortical magnetic stimulation (TMS) is becoming more popular and actively researched. Unlike passive recordings of neurological processes, TMS actively stimulates brain neurons and examines potential benefits for recovery from dementia and memory loss. Presently, TMS experiments use expensive, high current laden coil systems with limited magnetic field frequencies and limited magnetic polarization capabilities. TMS has been utilized for targeting migraine headaches. For examples of TMS and their application to various therapies, see Mantovani, Antonio, and Lisanby, Sarah, “Applications Of Transcranial Magnetic Stimulation To Therapy In Psychiatry,” Psychiatric Times, Volume 21 , 2004; Brizhik, L., et al, “The Working Principle Of TMR, Magnetic Resonance Therapy,” Ukraine National Academy of Science, 2016; Zschorlich, Volker R., et al, “Repetitive Peripheral Magnetic Nerve Stimulation (rPMS) As Adjuvant Therapy Reduces Skeletal Muscle Reflex Activity,” Frontiers in Neurology, August 2019; Beynel, L., et al, “Online Repetitive Transcranial Magnetic Stimulation During Working Memory In Younger And Older Adults: A Randomized Within-subject Comparison,” PLoS One, 2019; He, Qing, et al, “An Effective Meta-analysis Of Magnetic Stimulation Therapy For Urinary Incontinence,” Scientific Reports, June 2019; Kobayashi, Takuro, et al, “Therapeutic Effect Of Magnetic Stimulation Therapy On Pelvic Floor Muscle Dysfunction,” Juntendo University Graduate School of Medicine, 2021 ; Gershon, Ari A., et al, “Transcranial Magnetic Stimulation In The Treatment Of Depression,” Psychiatry Online, 2003; Klomjai, W., et al, “Repetitive Transcranial Magnetic Stimulation And Transcranial Direct Current Stimulation In Motor Rehabilitation After Stroke: An Update,” Annals of Physical and Rehabilitation Medicine, Volume 58. 2015; Michigan Medicine “Simple Nerve Stimulation May Improve Sexual Response In Women,” Univ. Mich. Newsletter, 2018; Mason, B. N. and Russo, A.F., “Vascular Contributions to Migraine: Time to Revisit?,” Frontiers in Cellular Neuroscience, Volume 12, August, 2018; Bhola, Ria, et al, “Single-Pulse Transcranial Magnetic Stimulation (Stms) For The Acute Treatment Of Migraine: Evaluation Of Outcome Data For The UK Post Market Pilot Program,” The Journal of Headache and Pain, 2015; Lan, Lihuan, et al, “The Efficacy Of Transcranial Magnetic Stimulation On Migraine: A Meta-analysis Of Randomized Controlled Trails,” The Journal of Headache and Pain, 2017; and Hammad, Azza B., et al, “Repetitive Transcranial Magnetic Stimulation As Prophylactic Treatment In Migraine,’ The Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 2021 .

Further, it has been shown that magnetic field amplitudes and frequencies may disrupt metabolism of coronavirus enough to reduce or eradicate its infectious capability. See US Patent 1 1 ,31 1 ,739. Other than inventions by the present invention, there is no presently available handheld device capable of eradicating viruses via magnetic stimulation.

The disclosures of the references discussed above are all incorporated herein by reference.

As can be seen, there is a need for a handheld device not limited to a narrow frequency spectrum capable of magnetic stimulation for a variety of purposes.

This present invention may be a small, battery operated, hand-held device that incorporates at least one PM to apply well researched, noninvasive, stimulating high magnetic fields (HMF) at multiple frequencies to a subject for a variety of medical treatments including male erectile dysfunction (ED), female sexual arousal (FSA), magnetothermal (MT) heating of pain, and transcortical magnetic stimulation (TMS) for various neurological therapies (e.g., migraine headaches, depression, dementia, stroke), and the interruption of the spike protein metabolism of the corona virus at smaller locales of the heart, liver, kidney and brain.

This present invention may replace functionally similar, commercial stimulation devices that generate HMF by passing potentially dangerous, high electrical currents in wire loops, a technique that often requires cooling, large (heavy suitcase sized) sophisticated electronics and high electrical power.

The present invention uses strong PMs to generate HMFs from the vector summation of safe PM dipole fields. The HMF frequency arises from the user 1 ) spinning of the PM array by a small, battery-operated motor, or 2) attaching the PM to a vibration device. The PM(s), motor or vibrator, frequency/field value display, and frequency select controller and battery may be contained either within a handheld probe, a cushioned seat, or a neck brace for maximum effect and ease of application.

A standard commercial magnetic stimulation device requires a) high power and high currents to generate up to 2 Tesla fields at the application coil plane and b) signal generators to get the alternating (AC) fields. The present invention may attain approximately 1 Tesla at the field origin with the use of modern neodymium permanent magnets (using zero electrified coils) and the AC is accomplished by the motor spinning (and/or vibration) of the PM at the measurement site. A net PM field may be dipolar in nature.

SUMMARY OF THE INVENTION

In one aspect of the present invention, a device for applying noninvasive magnetic stimulation to a subject’s body comprises a stimulator comprising a motor and at least one permanent magnet configured to rotate upon operation of the motor and attached to the motor by a rotatable shaft and a voltage controller in electronic communication with the motor, configured to manipulate a motor speed.

In another aspect of the present invention, a method of treating or preventing a disease or disorder in a subject in need thereof comprises providing a stimulator device operative to produce an alternating magnetic field, the stimulator device comprising at least one permanent magnet and a motor, positioning the stimulator device adjacent to a subject’s body at a predetermined position and predetermined distance, activating the stimulator device, and maintaining the predetermined position and predetermined distance of the stimulator device for a period of time.

In another aspect of the present invention, a device for applying noninvasive magnetic stimulation to a subject’s body comprises a stimulator comprising at least one permanent magnet and a motor configured to vibrate the at least one permanent magnet and a voltage controller in electronic communication with the motor, configured to manipulate a motor speed.

Advantageously, the present invention does not require high alternating current (AC) coil applicators, but a stimulator comprising a permanent magnet (PM) or PMs enables generation of a high magnetic field (HMF) at a comparatively low power consumption. In addition, the present invention is comparatively smaller, portable, and more convenient than high AC coil applicators. A large PM enables hand-held, often battery powered, devices to achieve results directly correlated with large, heavy power frequency limited commercial systems.

Advantageously, the device of the present invention may enable a controllable measurement distance from an HMF source and a controllable magnetic frequency, not limited to a narrow frequency spectrum. In addition, a neodymium PM of a predetermined size, predetermined shape, and predetermined strength may be chosen when constructing the present invention.

These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a stimulator and an electronics assembly shown in an assembled condition according to an embodiment of the present invention;

FIG. 2 is a perspective view thereof, shown in a disassembled condition;

FIG. 3 is a perspective view of the stimulator with an electronics assembly according to another embodiment of the present invention;

FIG. 4 is a perspective view of a stimulator according to another embodiment of the present invention and the electronics assembly of FIG. 3;

FIG. 5 is a perspective view of the stimulator of Figure 1 with the casing removed;

FIG. 6 is a perspective view of a stimulator without the casing according to another embodiment of the present invention;

FIG. 7 is a perspective view of the stimulator of FIG. 4 without the casing;

FIG. 8 is a schematic view of a stimulator and an electronics assembly according to an embodiment of the present invention;

FIG. 9 is a schematic view of components of a stimulator housed inside an electronics assembly according to an embodiment of the present invention;

FIG. 10 is a perspective view of a vibrational stimulator according to an embodiment of the present invention;

FIG. 1 1 is a schematic view thereof;

FIG. 12 is a schematic view of a person detailing anatomical locations for application of treatment by a method according to an embodiment of the present invention;

FIG. 13 is a schematic view of a penis, illustrating anatomical locations that may be targeted for treatment according to the inventive method;

FIG. 14 is a schematic view of a vagina, illustrating anatomical locations that may be targeted for treatment according to the inventive method; io FIG. 15A is a schematic view of virus particles on a host cell;

FIG. 15B is a schematic view of virus the particles of FIG. 15A after application of the present invention;

FIG. 16A is a graphical view of an oscilloscope illustrating a stable alternating magnetic field at a selected frequency with the device of FIG. 1 ;

FIG. 16B is a graphical view thereof illustrating an alternating magnetic field at a different selected frequency;

FIG. 17 is a graphical view of frequency as a function of direct current input voltage for various embodiments of the present invention; and

FIG. 18 is a schematic view illustrating details of axially situated magnets and diametrically situated magnets.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims with reference to the drawings.

A general overview of the various features of the invention will be provided, with a detailed description following. Broadly, an embodiment of the present invention provides a magnetic stimulation device comprising at least one permanent magnet (PM) for non-invasively generating high magnetic fields (HMF).

The present invention comprises a magnetic stimulator. The stimulator may further comprise a motor, such as a direct current (DC) motor, affixed to at least one PM. The PM may be configured to change positions, rotate, or vibrate by operation of the motor. The size is not particularly limited. Preferably, the stimulator is dimensioned to fit comfortably within a user’s hand. Some embodiments of the present invention may utilize extremely strong PMs, in the range of .6 Tesla to 2 Tesla, and generate HMFs from a vector summation of safe PM dipole fields where safe includes a range approved by the Food and Drug Administration (FDA). An HMF may be generated by 1 ) a spinning rotation per minute (rpm) of the PM, PMs, or PM array or 2) a vibration device vibrating the PM, PMs, or PM array.

In some embodiments of the present invention, rpm of the at least one PM may be achieved by a motor. The type of motor is not particularly limited, as any motor capable of rotating the at least one PM may be utilized. Similarly, vibrations of the at least one PM may be achieved by a motor. The type of motor is not particularly limited, as any motor capable of vibrating the at least one PM may be utilized. Motors of the present invention may rotate or vibrate a PM, PMs, or a PM array, generating an HMF.

An AC magnetic field may be generated by the motor spinning and/or a vibration of the PM at a measurement site. A net PM field may be dipolar in nature with net magnetization of a singular manufactured PM. The stimulator of the present invention may be in electronic communication with a voltage controller. The voltage controller may be configured to or operative to control voltage of the motor. The frequency of a magnetic field generated by rotation or vibration of the at least one PM may be determined by the motor biasing voltage, affecting rpm motor speed. RPM speed may include vibrational speed. As an rpm of the motor increases or decreases, frequency of the magnetic field generated by rotating or vibrating the PMs attached to the motor may accordingly increase or decrease, thereby manipulating the magnetic field by adjusting voltage to the motor. Any suitable controller, such as a knob or a digital input/output device, may be used to control the motor voltage and rotation rate, and thereby the frequency of the magnetic field.

Advantageously, the frequency of an embodiment of the present invention may be highly variable and dynamically selected by a user for each application scenario by way of adjusting voltage. The frequency may be adjusted without having to change the position of the device. in

The present invention may offer a range of frequencies, e.g., from approximately 5 to about 100 Hz, not available in presently available HMF generators. HMF values generated by the present invention may remain constant at all frequencies. In some embodiments of the present invention, the device may sustain a constant HMF at various frequencies ranging between approximately 2.5 and about 85 HZ.

A selection of HMF amplitudes and polar pointing, such as a pointing of the device and the magnetic field generated by the device, may vary by an initial vertical or trans bias formation of the PM polarity.

By way of example, in some embodiments of the present invention, 10 volts applied to a rotary motor may produce a spin rate of 5000 rpm, yielding a magnetic field with a frequency of 84 Hz for a transverse polarization PM. At 5 volts, the same device may operate at 2500 rpm and yield a frequency of 42 Hz. In other embodiments of the present invention with a different stimulator, 12 volts applied to a rotary motor may produce spin rate of 550 rpm, yielding a magnetic field with a frequency of 9.2 HZ for a transverse polarization PM.

In some embodiments, the motor may be powered by a battery or a battery bank, such as AA, AAA 1 ,5-volt batteries, or any batteries available for common use, such as such as a c123, 3-volt lithium-ion battery. The battery or battery bank may be rechargeable.

A digital display may display the voltage supplied to the motor. The display may also show a rating for health of the battery or battery bank powering the motor. The digital display may notify a use when the battery needs to be changed or replaced.

In some embodiments, the present invention may attain approximately one Tesla at a field of origin for a magnetic field with use of rare earth metal PMs, such as neodymium, advantageously without requiring electrified coils. The PM or PMs may be affixed to the motor in multiple configurations. In some embodiments, the PMs may be axially magnetized or diametrically magnetized. PM orientation and magnetism direction utilized in the present invention is not particularly limited and may include but is not limited to multi-poles diametrically, multi-poles axially, magnetized through thickness, magnetized through length, magnetized through width, axially oriented, diametrically oriented, radially magnetized, lateral multi-poles, and/or segmentally magnetized.

In some embodiments of the present invention, the PMs may be situated on or mounted on a spacer, such as a wood block. The spacer may be affixed to the motor and configured to rotate upon activation of the motor.

The spacer may be a cube or cuboidal. The PMs may be positioned on the spacer in such a manner that one face of the cube is affixed to the motor or motor shaft and at least one other face of the cube are affixed a respective PM. In some embodiments, as described in Cartesian coordinates centered on the cube, each face of the cube aligned on an X axis may be affixed with a PM, each face of the cube aligned on an Y axis may be affixed with a PM, and a face of the cube aligned on a Z axis may be affixed with a PM. The remaining face of the cube on the Z axis attaches to a motor shaft. Such a configuration may be referred to as a rotary cube magnetic array. The configuration may be repositioned within the Cartesian coordinates.

A complex, multi-polar pointing capability may be achieved by several PMs arranged within a single stimulator, such as in the rotary cube magnetic array. In some embodiments of the present invention, the rotary cube magnetic array may comprise axially polarized PMs, each having a strength of approximately 0.6 Tesla.

In some embodiments of the present invention, multiple stimulators may be utilized simultaneously to apply separate HMFs. The separate HMFs may have the same or different frequencies and amplitudes. This may produce additional beat frequencies in tissue. In some embodiments, two stimulators, each with a different frequency HMF may achieve the same beat frequency phenomenon as binaural acoustic therapies (BAT) as described in the below references. Vidrascu, Elena, “Sound Healing for Treatment of Chronic Pain, Anxiety, Stress, and Drug Addiction, Part 1 : An Introduction,” August 2018; Camila Agosto, Columbia University. The present invention may be utilized to provide a synergy between the two stimulators and BAT for the therapeutic benefits discussed in said references.

In some embodiments, the device of the present invention may be housed in a cushioned seat, a neck brace, or any other suitable device which may be positioned comfortably on a user’s body. The present invention may be portable and conveniently transported like a cell phone.

In some embodiments, the stimulator may be hand-held and may range approximately from 10 centimeters (cm) to 12cm in length. In some embodiments, the stimulator may be smaller or pocket size.

In some embodiments of the present invention, the PM, PMS, or PM array, the motor, and a frequency select controller may be housed in a single casing such as a handheld stimulator. Alternatively, the frequency select controller may be housed in a separate casing, electronics assembly, or a control box and electronically wired to or wirelessly connected to the motor.

The stimulator may be in electronic communication with electronic components housed within an electronics assembly or a control box. While the electronics assembly is not particularly limited in size, the electronics assembly may be approximately 7.5 cm x 7.5cm. The electronics assembly may house the voltage controller, a battery/battery pack, a voltage display, and in some cases, a timer switch. The timer switch may be a magnetic relay with a timer. A predetermined input time may be programmed into or selected on the timer switch to control an activation time or a length of activation time of the stimulator. The timer switch may enable a user to turn the invention on or off by way of a timer. The magnetic relay timer switch may be provided to enable a user to set or program an activation or deactivation time for the stimulator. For example, the user may utilize the magnetic relay timer switch to deactivate the stimulator after thirty seconds of use.

The present invention generally operates within an FDA approved range of magnetic strength values, typically utilized commercially for various medical therapies.

In some embodiments, a stimulator of the present invention may be situated directly on or adjacent to a subject’s skin at a desired or predetermined anatomical location or within a few inches thereof. The stimulator may be positioned in a predetermined position on a subject’s body or at a predetermined distance from the subject’s body. In some embodiments, the device may be deactivated and then reapplied to the same anatomical location. Alternatively, the device may remain powered on and moved to a different anatomical location, like a neck or a shoulder. The present invention may be applied through clothing without needing direct contact.

The stimulator is generally noninvasive. As used herein, the term “noninvasive” refers to a tool or procedure which does not break a patient's skin or puncture a membrane. Examples of noninvasive tools and procedures include but are not limited to X-rays, eye exams, CT scans, oral thermometer, and vaginal penetration.

The stimulator may be held in position for any suitable period of time. Said period of time may be predetermined. For example, the stimulator may be held in place for approximately 30 to about 60 seconds. In some embodiments, the device may be deactivated for approximately 30 seconds between applications.

When a stimulator of the present invention is applied directly to a desired or predetermined anatomical location, a vibration provided by the motor may also provide vibrational therapy for a user at the anatomical location. By way of example, the present invention may treat muscle aches via magnetic stimulation while simultaneously treating said muscle aches via vibrations of the muscles by the present invention.

The present invention may be utilized for a variety of medical treatments including but not limited to erectile dysfunction (ED), female sexual arousal (FSA), magnetothermal (MT) heating of pain, transcortical magnetic stimulation (TMS) for various neurological therapies (e.g., migraine headaches, depression, dementia, stroke), and the interruption of a spike protein metabolism of viruses such as the coronavirus at anatomical locations of a subject’s heart, liver, kidney, and brain.

Referring to Figures 1 through 15A, 15B, 16A, and 16B through 18, Figures 1 and 2 show a stimulator 10 with multiple permanent magnets (PMs) 12 attached to a direct current (DC) motor 14. The PMs 12 and the motor 14 are housed within a stimulator casing 16. The stimulator 10 (shown in better detail in Figure 5) is in electronic communication via a wire 32 with an electronics assembly 20 housed in an electronics assembly casing 30.

The electronics assembly 20 housed within the electronics assembly casing 30 includes a battery pack 22, a voltmeter 24, a voltage controller 26, and a timer switch 28. The electronics assembly 20 may include a power switch (not pictured). These components are housed within the electronics assembly casing 30 as best shown in Figure 2. The voltage controller may be adjusted by a knob 27 protruding from the assembly casing 30 as best shown in Figure 3. The timer switch 28 is optional.

Figure 3 details an alternate embodiment of the electronics assembly 120. The alternate embodiment of the electronics assembly 120 does not include the timer switch 28. Figure 3 illustrates a smaller, more compact version of the present invention.

Figure 4 depicts an alternate embodiment of the stimulator 1 10 with a single cylindrical PM 112 attached to the motor 14. Figure 5 details the stimulator 10 without the stimulator casing 16. The PMs 12 are positioned in a rotary cube magnetic array and affixed to a spacer 13. The spacer 13 is mounted on the motor 14 by a rotatable shaft.

Figure 6 shows a third embodiment of the stimulator 210 without the stimulator casing 16. The third embodiment of the stimulator 210 features a rectangular PM 212 according to another embodiment of the present invention. Figure 7 shows the alternate embodiment of the stimulator 1 10 without the stimulator casing 16. Both embodiments of the stimulator 1 10, 210 feature a single PM 112, 212, as opposed to the stimulator 10 illustrated in Figures 1 , 2, and 5 which features five PMs 12.

A stimulator and an electronic assembly may be housed together or separately. The schematic of Figure 8 shows a stimulator 310 and an electronics assembly 320 housed separately, with the stimulator casing 16 and the electronics assembly casing 30 connected by a wire 32. Figure 9 is a schematic of a stimulator 410 with the PM 12 and the motor 14 housed within the electronics assembly casing 30. The PM(s) 12 and the motor 14 of Figures 8 and 9 represent any embodiment thereof, described herein, including any stimulator configuration. The battery pack 22, voltage controller 26, and, optionally, the timer switch 28 represent any embodiment thereof described herein.

Figure 10 illustrates a vibrational stimulator 40 according to another embodiment of the present invention. In the vibrational stimulator 40, a PM 12 is affixed to a housing. The housing encloses a vibrator 44 powered by a battery pack 22. Figure 1 1 shows a schematic representation of the vibrational stimulator 40, illustrating the relative placement of internal components 12, 22, 44.

Figure 12 details various parts of a person’s body that may be targeted for treatment according to an embodiment of the present invention. The stimulator may be applied to a groin area 70 for sexual stimulation as better detailed in Figures 13 and 14. Alternatively, the stimulator may be applied to an ankle 72 for female sexual stimulation. The stimulator may further be applied to a user’s head 74 for treatment of depression, addiction, and migraines. Various muscles 78 may be treated with the stimulator for muscle therapy, such as physical therapy treatments, muscle strengthening, relaxation, or reducing physical discomfort of muscles. In addition, a virus, such as a coronavirus, may be treated with the stimulator by application to locations of virus infection 80 such as the lungs or the liver. Tendonitis may also be treated by applying the stimulator in proximity to an affected tendon 82. The inventive treatment method is not limited to the muscles 78, anatomical region of virus infection 80, and affected tendons 82 depicted in Figure 12, which are illustrated by way of example only. Various other muscle groups, virus infection sites, and tendons may be treated at other parts of the body not depicted in Figure 12.

Figure 13 depicts a prior art illustration of a penis 84 that may be targeted for treatment of erectile dysfunction (ED) with a stimulator of the present invention. The stimulator may be used to stimulate a cavernous nerve 90, dorsal nerve 92, or pelvic nerve 94 to provide sexual stimulation and arousal of the penis 84 or to stimulate the male prostate spot for overall arousal.

Figure 14 shows a prior art illustration of female anatomy indicating a location of the pudendal nerve 98 that may be targeted for treatment with the inventive stimulator of the present invention. The pudendal nerve 98 may be stimulated by a stimulator to provide sexual stimulation and arousal by insertion of the stimulator into either the vagina or anal canal openings.

Figure 15A is a depiction of virus particles 54 attached to a host cell 50. The illustrated virus particles 54 may represent any virus that attaches to a cell by way of a spike protein, such as a coronavirus. The inventive stimulator may apply a narrow, focused HMF capable of virus destruction to any anatomical region of virus infection 80 such as the brain or the kidney as described with Figure 12, enabling a user to target an area where the virus is most likely to be found. Figure 15B shows an example of destroyed virus cells 58 that may remain after exposure to magnetic fields induced by the device of the present invention. The magnetic field amplitudes and frequencies may disrupt metabolism of the virus particles 54 enough to reduce or eradicate its infectious capability by damaging and displacing the spike proteins 56, resulting in destroyed virus cells 58 and a gap 52 indicating separation from the host cell 50.

Figures 16A and 16B display HMF frequency and amplitude measured with a gaussmeter. The stability of the amplitude and frequency induced by the PM motion was tested with a Faraday receiver coil and was passively displayed with the corresponding voltage onto an oscilloscope, functioning as a gaussmeter. The Faraday receiver coil registers a voltage proportional to the number of coil turns, coil area, HMF value, and frequency. The number of coil turns, coil area, and HMF value were all held constant in testing and only frequency was varied. The frequency rate may be selected by a DC input voltage. Figure 16A and 16B show an oscilloscope voltage waveform for a rotary array of 5 PMs, as depicted in Figure 5, at a frequency of 5 Hz and 16 Hz respectively. The amplitude is stable as the array rotates at either the 5 or 16 Hz frequency rate. In Figure 16A, a peak-to-peak voltage (VPP) of 200. OmV, a prd of 189.1 ms, a mean of O.OOmV and a frequency of 5.29 Hz is displayed. In Figure 16B, a VPP of 640. OmV, a period (prd) of 82.00 ms, a mean of O.OOmV and a frequency of 18.31 Hz is displayed. When tested, all oscilloscope data shows a same voltage to frequency ratio for each tested stimulator indicating a constancy of the HMF for each stimulator as the PM or PMs are rotating. This stability was maintained at each of the ten DC input voltage selections (i.e., the corresponding ten frequency selections) illustrated as stimulator C in Figure 17. The readings, as measured, matches predictions of Maxwell’s equations.

Figure 17 demonstrates a correlation of HMF frequency in Hz as a function of selected motor voltage (V) for various embodiments of the stimulator of the present invention, labeled A-F. As shown, the motor voltage may be selected to achieve a desired HMF frequency. A higher frequency is attributed to a faster motor spin rate produced by an increased DC input voltage. Generally, all stimulators comprise a magnet with a strength of .6 T. Stimulators A-F vary by their motor and a size, shape, configuration, magnetization, and alignment of their respective PMs. For example, some stimulators have a smaller/larger motor with a smaller/larger power output. In other examples, some stimulators are comprised a rotary cube magnetic array. The graph illustrates that as the voltage increases, the frequency of the magnetic field generated increases. The graph shows a wide spectrum of frequencies is achievable by the present invention, even amongst the same stimulator. Stimulators A and E produce a frequency which may exceed an effective or desirable range for medical applications. Stimulators B, D, C, and F may produce an effective or desirable frequency range for medical applications, such as those described above and shown in Figures 12-15A, 15B.

Figure 18 demonstrates magnetism directions of an axially magnetized PM 60 and a diametrically magnetized PM that may be utilized in various embodiments of the present invention. The axially magnetized PM 60 as shown has a south pole 66 facing the motor 14 and a north pole 64 opposite the motor 14. In some embodiments of the present invention, the north pole 64 and the south pole 66 may be swapped and remain axially magnetized. The diametrically magnetized PM 62 as shown has the north pole 64 on a right-half and the south pole 66 on a left-half, illustrated in relationship to the motor 14. The axially magnetized PM 60 and the diametrically magnetized PM 62 of Figure 18 are included as examples of magnetism directions.

It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.