Patent ID: 12239842

DETAILED DESCRIPTION

As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. For example, “a” or “an” means “at least one” or “one or more.” Thus, reference to “an antibody or antigen binding fragment thereof refers to one or more antibodies or antigen binding fragments thereof, and reference to “the method” includes reference to equivalent steps and methods disclosed herein and/or known to those skilled in the art, and so forth.

Throughout this disclosure, various aspects of the claimed subject matter are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the claimed subject matter. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, where a range of values is provided, it is understood that each intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the claimed subject matter. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the claimed subject matter, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the claimed subject matter. This applies regardless of the breadth of the range.

A “subject” as used herein refers to an organism, or a part or component of the organism, to which the provided methods, apparatuses, and systems can be administered or applied. For example, the subject can be a mammal or a cell, a tissue, an organ, or a part of the mammal. Mammals include, but are not limited to, humans, and non-human animals, including farm animals, sport animals, rodents, and pets.

Living organisms proliferate by cell division, including tissues, cell cultures, microorganisms (such as bacteria,mycoplasma, yeast, protozoa, and other single-celled organisms), fungi, algae, plant cells, etc. Viruses may infect cells that are in the process of cell division or induce cells to undergo cell division in order to produce new virus progeny. When in the process of dividing, cells of organisms can be destroyed, or their proliferation controlled, by methods that are based on the sensitivity of the dividing cells of these organisms to certain chemical or physical agents.

It is well known that tumors, particularly malignant or cancerous tumors, grow uncontrollably compared to normal tissue. Such expedited growth enables tumors to occupy an ever-increasing space and to damage or destroy tissues and organs adjacent thereto. Furthermore, certain cancers are characterized by an ability to spread metastases to new locations where the metastatic cancer cells grow into additional tumors.

The rapid growth of tumors, in general, and malignant tumors in particular is the result of relatively frequent cell division of these cells compared to normal tissue cells. The distinguishably frequent cell division of cancer cells is the basis for the effectiveness of many existing cancer treatments, e.g., irradiation therapy and the use of various chemo-therapeutic agents. Such treatments are based on the fact that cells undergoing division are more sensitive to radiation and chemo-therapeutic agents than non-dividing cells. Because tumor cells divide much more frequently than normal cells, it is possible, to a certain extent, to selectively damage or destroy tumor cells by radiation therapy and/or chemotherapy. The actual sensitivity of cells to radiation, therapeutic agents, etc., is also dependent on specific characteristics of different types of normal or malignant cells. Unfortunately, in many cases the sensitivity of tumor cells to the applied therapeutic agent is not sufficiently higher than that of many types of normal tissue; therefore, existing cancer treatments typically cause significant damage to normal tissues, thus limiting the therapeutic effectiveness of such treatments. Also, certain types of tumors are not sensitive at all to existing methods of treatment.

It is well appreciated that microorganisms proliferate rapidly throughout the course of infection or stimulate proliferation of living tissue. Such proliferation allows the microorganisms to potentially spread throughout the body and to new hosts. Tissues can be damaged by the microorganisms themselves as they replicate, or by a sustained immune response.

Therapeutics may target microorganisms at multiple stages of the infection cycle, including during replication. Drugs may arrest replication of a microorganisms, inhibit production of necessary materials, or shut down protein production in an infected cell to block pathogen replication. Because these microorganisms have genomic material that is replicated, mutations may occur during the course of infection. Selective pressure from treatment with drugs targeting specific stages of the replication or infection cycle can lead to mutations that subvert a given drug's mechanism of action and efficacy. The rise of drug resistant “superbugs” is evidence of this phenomena, and these pathogens cannot be treated with conventional drugs. Additionally, because many of these drugs target specific microorganisms, when a new infectious microorganism emerges, there are no effective therapeutics that can be used to treat individuals with the infection because of the specificity of existing drugs.

Electric fields and currents have been used for medical purposes for many years. The most common use is the generation of electric currents in a human or animal body by application of an electric field by means of a pair of conductive electrodes between which a potential difference is maintained. These electric currents are used either to exert their specific effects, i.e., to stimulate excitable tissue, or to generate heat by flowing in the body since it acts as a resistor. Examples of the first type of application include the following: cardiac defibrillators, peripheral nerve and muscle stimulators, brain stimulators, etc. Currents are used for heating, for example, in devices for tumor ablation, ablation of malfunctioning cardiac or brain tissue, cauterization, relaxation of muscle rheumatic pain and other pain, etc.

Another use of electric fields for medical purposes involves the utilization of high frequency oscillating fields transmitted from a source that emits an electric wave, such as an RF wave or a microwave source, which is directed at the part of the body that is of interest (i.e., a target).

Historically, electric fields used in medical applications were separated into two types, namely (1) steady fields or fields that change at relatively slow rates, and alternating fields of low frequencies that induce corresponding electric currents in the body or tissues, and (2) high frequency alternating fields (above 1 MHz) applied to the body by means of the conducting electrodes or by means of insulated electrodes.

The first type of electric field has been used, for example, to stimulate nerves and muscles, pace the heart, etc. In fact, such fields are used in nature to propagate signals in nerve and muscle fibers, the central nervous system (CNS), heart, etc. The recording of such natural fields is the basis for the ECG, EEG, EMG, ERG, etc. The field strength in a medium having uniform electric properties is simply the voltage applied to the stimulating/recording electrodes divided by the distance between them. The currents thus generated can be calculated by Ohm's law. Those currents, however, can have dangerous stimulatory effects on the heart and CNS and can result in potentially harmful ion concentration changes. Also, if the currents are strong enough, they can cause excessive heating in the tissues. This heating can be calculated by the power dissipated in the tissue (the product of the voltage and the current).

When such electric fields and currents are alternating, their stimulatory power (e.g., on nerve, muscle, etc.) is an inverse function of the frequency. At frequencies above 10 kHz, the stimulation power of the field approaches zero. This limitation is due to the fact that excitation induced by electric stimulation is normally mediated by membrane potential changes, the rate of which is limited by the resistive and capacitive properties (with time constants on the order of 1 m) of the membrane.

Regardless of the frequency, when such current inducing fields are applied, they are often associated with harmful side effects caused by currents. For example, one negative effect is the change in ionic concentration in the various “compartments” within the system, and the harmful products of the electrolysis.

Historically, alternating fields of medium frequencies (about 50 kHz-1 MHz) were thought not to have any biological effect except due to heating. But more recently, the usefulness of such fields has been recognized, particularly when the fields are applied to a conductive medium, such as a human body, via insulated electrodes. Under such conditions the electrodes induce capacitive currents in the body. In U.S. Pat. Nos. 7,016,725, 7,089,054, 7,333,852, 7,805,201, and 8,244,345 by Palti (each of which is incorporated herein by reference) and in a publication by Kirson (see Eilon D. Kirson, et al., Disruption of Cancer Cell Replication by Alternating Electric Fields, Cancer Res. 2004 64:3288-3295), such fields have been shown to have the capability to specifically affect cancer cells and serve, among other uses, for treating cancer. These fields are often referred to as TTF or TTFields.

TTFields exert directional forces on polar microtubules and interfere with the assembly of the normal mitotic spindle. Such interference with microtubule dynamics results in abnormal spindle formation and subsequent mitotic arrest or delay. Cells can die while in mitotic arrest or progress to cell division. This can lead to the formation of either normal or abnormal aneuploid progeny. The formation of the tetraploid cells can occur either due to mitotic exit through slippage or can occur during improper cell division. Abnormal daughter cells can die in the subsequent interphase, can undergo a permanent arrest, or can proliferate through additional mitosis where they will be subjected to further TTFields assault. See M. GILADI et al. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells, Scientific Reports, 2015; 5:18046. Different cell types and/or organisms will exhibit different peak cytotoxic frequencies (PCF), that is, the frequency that exhibits the greatest cytotoxic effect on the target cell or organism.

In certain aspects, the present disclosure provides a portable device100comprising a transducer102that emits a specialized AC current and makes its user104the secondary coil to complete the circuit. Examples of similar devices and methods to use such devices are described in U.S. Pat. Nos. 5,514,283; 5,667,677; 9,032,610, 9,140,412; 4,863,344; 5,935,433; 8,029,669; 8,033,334; 8,168,059; 8,231,786; 9,032,610; and 9,140,412, each of which is incorporated by reference.

As shown inFIG.1A, the transducer102comprises a magnetically conductive material which passes through a conduction ring106. The conduction ring106is energized by an electrical signal generated by an AC voltage generator108(seeFIG.3). The conduction ring106may be rigid and may include padding110to make the conduction ring106more comfortable to the user104. As shown inFIG.1B, the conduction ring106may be coupled with a flexible ferrite112.

FIG.2illustrates a battery114which may be used to power the portable device100. Additionally, portable device100may comprise at least one wire116and an electrode118to carry the electrical signal to a location near the cells to be treated. In one aspect illustrated inFIGS.3and5E, a signal transmitter120communicates the signal wirelessly with a receiver122to produce the specialized AC current in the conduction ring106. The signal is initially generated and amplified by an amplifier124. The signal is then transmitted from the transmitter120through an antenna126. The signal is received by the receiver122that directs the signal to an amplifier128and mixer130. The amplifier128and mixer130then transmit the signal to a demodulator132. The demodulator132processes the signal, and the signal is then transmitted to an audio amplifier134that produces the final output signal that is then transmitted to the conduction ring106.

In certain aspects illustrated inFIGS.2and4A-4B, the portable device further comprises the battery114and a backpack136with a wire116connecting the battery114to the transducer102. The backpack136may be used to carry the portable device100. In such an embodiment, the conduction ring106may be worn by the user104(seeFIG.4A), or the conduction ring106may be carried in the backpack136(seeFIG.4B). If the conduction ring106is carried in the backpack136, the conduction ring106may be connected to the user104through a wire116and an adhesive pad138. The adhesive pad138may be a Transcutaneous Electrical Nerve Stimulation (TENS) pad.

In another aspect, the signal is generated and is transmitted through a wire116to the conductive metal ring.

In one aspect, the signal is a mid-level frequency AC current from (80 to 250 KHz) that has a modulating amplitude frequency and random duration. In another aspect, the signal may be modulated by a frequency modulator to adjust the mid-level frequency AC current based on the target's PCF before the signal is transmitted to the conductive metal ring.

The signal propagates throughout the body's vasculature and lymphatic system and the AC current has a cytotoxic effect on cancer cells and pathogenic microbes as well as improves nutrient uptake as well as other symptoms of cancer treatment. In certain aspects, the method improves symptoms associated with irritable bowel syndrome (IBS).

As shown inFIGS.5A-5E, in certain aspects, the method for transmitting the field is twofold:

Primary Method of Transmission—The conduction ring106is wrapped around an appendage or trunk of the user104, as shown inFIG.5A. This turns the actual body of the user104into the secondary coil of the System.

Secondary Method of Transmission—There are also one or more wires116that are passed through the conduction ring106and are placed with TENS or TENS-like attachment pads138placed strategically around the tumor area105or elsewhere on the body of the user104, as shown inFIGS.5B-5Dthat enhance the existing signal that is already propagating throughout the body. The one or more wires116can be wrapped around the conduction ring106once or many times to enhance voltage emission. These wires116can be used with the portable device100attached to the body or with the portable device100placed externally to the body. In some embodiments, including the non-limiting example shown inFIG.5B, a resistor139may be attached to a first wire connected to the body at a site distant from the tumor and a second wire connected at a site close to the cancerous tumor. In some embodiments, this resistor139may be a rheostat.

In addition to being directly connected to the body, the one or more wires116may alternatively be connected to an intravenous (IV) therapy fluid unit140that is directly connected to the circulatory system (seeFIGS.8A-8D). The one or more wires116may also be connected to the living tissue or IV therapy fluid unit140in tandem with the conduction ring106wrapping around living tissue on the user104, as illustrated inFIG.5C. In addition, the conduction ring106may not be wrapped around an appendage or trunk of the user104, and instead may only be connected to the user104through the one or more wires116, as illustrated inFIG.5D.

FIGS.6A-6Billustrate embodiments with increased intensity and directionality of the electrical signal. This is accomplished by wrapping the wire116around the conduction ring106multiple times.FIGS.7A-7Billustrate embodiments where the wire116wraps around the conduction ring106and couples with multiple users104.FIG.7Ashows that the wire116may be attached directly to the users104. Alternatively, the wire116may be attached to a ring142that passes over the head of the user104, or may wrap around the base of the bed144of the user104, as shown inFIG.7B.FIG.7Cshows that wire116may be directly attached to the patients' bodies after wrapping in opposite directions around the conduction ring.

In some embodiments, the device100does not have a battery114. Instead, the device100has an electrical plug146configured to plug into an electrical outlet, as shown inFIGS.9A-9B. The device100thus is effectively grounded by the electrical outlet when plugged in. In such an embodiment, the conduction ring106may be connected to the user104through a wire116, as shown inFIG.9A. Alternatively, the conduction ring106may be directly worn by the user104, as shown inFIG.9B.FIGS.9C and9Ddepict the implementations ofFIGS.9A and9Bhaving a split wire wrapping in opposite directions around the conduction ring before attaching to two locations on the patient's body.

In another embodiment, the one or more wires116is attached to a grounded item148, preferably a grounding sheet or mat, as illustrated inFIGS.10A-10C. The other end of the one or more wires116is connected to a grounded outlet149, preferably a grounded 110V outlet, and the ground wire is the only wire connected to the grounded outlet149, i.e., power wires are not connected to the outlet. In one embodiment, the conductive ring106wraps around living tissue on the user104and the one or more wires116is connected to a grounding sheet or mat148.FIGS.10A-10Cillustrate the grounded item148being used on a bed. However, the grounded item148could also be placed on a chair, in clothing, on a floor, in a car seat, or on some other item which the user104may be in contact with. As shown inFIG.10A, the conduction ring106may be connected to the grounded item148through a wire116. Alternatively, the user104may have the conduction ring106wrapped around a limb, with the conduction ring106still attached to the grounded item148through a wire116, as illustrated inFIG.10B. The device100may be powered by a battery114as disclosed above, or may be plugged into a wall outlet152separate from the grounded outlet149used to ground the grounded item148, as shown inFIG.10C.

As further shown inFIG.10C, the device100may comprise a volt meter150at the point of attachment. For example, the volt meter150may be at the end of the wire116where the wire116attached to the user104. In another example, shown inFIG.10C, the volt meter is located where the wire116attaches to the grounded item148, such as the grounding mat shown.FIGS.10D-10Fdepict the implementations ofFIGS.10A-10C, respectively, having a split ground wire wrapping in opposite directions around the conduction ring before connecting to the same grounding device.

A major use of the present apparatus100is in the treatment of tumors by selective destruction of tumor cells with substantially no effect on normal tissue cells, and thus, the exemplary apparatus is described below in the context of selective destruction of tumor cells. It should be appreciated however, that for purposes of the following description, the term “cell” may also refer to a single-celled organism (eubacteria, bacteria, yeast, protozoa), multi-celled organisms (fungi, algae, mold), and plants as parts thereof that are not normally classified as “cells”. In certain implementations, the “cells” are infected by a virus and inhibition of cell growth includes prevention of further infection of cells by the virus.

The exemplary apparatus100enables selective destruction of cells undergoing division in a way that is more effective and more accurate (e.g., more adaptable to be aimed at specific targets) than existing methods. Further, the present apparatus100causes minimal damage, if any, to normal tissue and, thus, reduces or eliminates many side-effects associated with existing selective destruction methods, such as radiation therapy and chemotherapy. The selective destruction of dividing cells using the present apparatus100does not depend on the sensitivity of the cells to chemical agents or radiation. Instead, the selective destruction of dividing cells is based on distinguishable geometrical characteristics of cells undergoing division, in comparison to non-dividing cells, regardless of the cell geometry of the type of cells being treated.

When a cell or a group of cells are under natural conditions or environment, i.e., part of a living tissue, they are disposed surrounded by a conductive environment consisting mostly of an electrolytic inter-cellular fluid and other cells that are composed mostly of an electrolytic intra-cellular liquid. When an electric field is induced in the living tissue, by applying an electric potential across the tissue, an electric field is formed in the tissue and the specific distribution and configuration of the electric field lines defines the direction of charge displacement, or paths of electric currents in the tissue, if currents are in fact induced in the tissue. The distribution and configuration of the electric field is dependent on various parameters of the tissue, including the geometry and the electric properties of the different tissue components, and the relative conductivities, capacities and dielectric constants (that may be frequency dependent) of the tissue components.

According to one aspect of the present disclosure, the electric fields that are used are alternating fields having frequencies that are in the range from about 50 kHz to about 500 kHz, and preferably from about 80 kHz to about 300 kHz. In certain aspects, the frequencies are in the range from about 50 kHz to 500 kHz, from about 50 kHz to 450 kHz, from about 50 kHz to about 400 kHz, from about 50 kHz to about 350 kHz, from about 50 kHz to about 300 kHz, from about 50 kHz to about 250 kHz, from about 50 kHz to about 200 kHz. In other aspects, the frequencies are in the range from about 100 kHz to about 500 kHz, from about 100 kHz to about 400 kHz, from about 100 kHz to about 300 kHz, or from about 100 kHz to about 200 kHz. In yet other aspects, the frequencies are in the range from about 150 kHz to about 500 kHz, from about 150 kHz to about 400 kHz, from about 150 kHz to about 300 kHz, or from about 150 kHz to about 200 kHz.

These frequencies are sufficiently low so that the system behavior is determined by the system's Ohmic (conductive) properties but sufficiently high enough not to have any stimulation effect on excitable tissues. Such a system consists of two types of elements, namely, the intercellular or extracellular fluid, or medium and the individual cells. The intercellular fluid is mostly an electrolyte with a specific resistance of about 40-100 Ohm*cm. The cells are characterized by three elements, namely (1) a thin, highly electric resistive membrane that coats the cell; (2) internal cytoplasm that is mostly an electrolyte that contains numerous macromolecules and micro-organelles, including the nucleus; and (3) membranes, similar in their electric properties to the cell membrane, that cover the micro-organelles.

When this type of system is subjected to the present electrical fields, most of the lines of the electric field and currents tend away from the cells because of the highly resistive cell membrane and therefore the lines remain in the extracellular conductive medium. In the above recited frequency ranges, the actual fraction of electric field or currents that penetrates the cells is a strong function of the frequency.

In certain aspects, passage of the electric field through the dividing cells in late anaphase or telophase transforms the electric field into a non-homogeneous electric field that produces an increased density electric field in a region of a cleavage furrow of the dividing cells, and the electric field has amplitude and frequency characteristics such that application of the electric field prevents the cells from completing mitosis and cell division.

In certain embodiments, the disclosed method or apparatus is useful for treating neoplastic diseases. Neoplastic diseases include any malignant growth or tumor caused by abnormal or uncontrolled cell division and these diseases may spread to other parts of the body through the lymphatic system or the blood stream or nervous system. Neoplastic disease includes, without limitation, lymphoma (a neoplasm of lymph tissue that is usually malignant), carcinoma (any malignant tumor derived from epithelial tissue), leukemia (malignant neoplasm of blood-forming tissues; characterized by abnormal proliferation of leukocytes), sarcoma (a usually malignant tumor arising from connective tissue (bone or muscle etc.), and blastoma (malignancy in precursor cells). Nonlimiting examples include squamous cell cancer, small-cell lung cancer, pituitary cancer, esophageal cancer, astrocytoma, soft tissue sarcoma, non-small cell lung cancer, adenocarcinoma of the lung, squamous carcinoma of the lung, cancer of the peritoneum, hepatocellular cancer, gastrointestinal cancer, pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, liver cancer, bladder cancer, hepatoma, breast cancer, colon cancer, colorectal cancer, endometrial or uterine carcinoma, salivary gland carcinoma, kidney cancer, liver cancer, prostate cancer, vulval cancer, thyroid cancer, hepatic carcinoma, brain cancer, endometrial cancer, testis cancer, cholangiocarcinoma, gallbladder carcinoma, gastric cancer, melanoma, and various types of head and neck cancer.

It should be appreciated that the present electronic apparatus can also be used in applications other than treatment of tumors in the living body. In fact, the selective destruction utilizing the present apparatus can be used in conjunction with any organism that proliferates by division, for example, tissue cultures, microorganisms, such as bacteria,mycoplasma, protozoa, fungi, algae, plant cells, etc. Nonlimiting examples of microorganisms that can be selectively destroyed using the present apparatus may be, but are not limited to,Listeria monocytogenes, Pseudomonassp.,Serratia marcescens, Clostridium difficile, Staphylococcus aureus, Staphylococcussp.,Acinetobacterspp.,Enterococcussp.,Enterobactersp.,Escherichia coli, Klebsiellasp.,Streptococcussp.,Haemophilus influenza, Neisseria meningitides, andCandidasp.

The selective destruction utilizing the present apparatus can also be used in conjunction with a virus that infects cells that undergo cellular proliferation and growth during the course of infection to enable spread and further infection of cells. Examples of viruses that may be targeted by the selective destruction of proliferating cells may be, but are not limited to, human immunodeficiency virus, cytomegalovirus, adenovirus, coronavirus, rhinovirus, rotavirus, variola virus, herpes simplex virus, hepatitis B virus, hepatitis A virus, hepatitis C virus, papillomavirus, orinfluenzavirus. In one embodiment, the virus is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes coronavirus disease 2019 (COVID-19).

The present invention is further illustrated by the following examples that should not be construed as limiting. The contents of all references, patents, and published patent applications cited throughout this application, as well as the Figures, are incorporated herein by reference in their entirety for all purposes.

EXAMPLES

Example 1. Treatment of Bladder Cancer with ACTT Technology

A male subject was diagnosed with an aggressive type of bladder cancer. He had lost a significant amount of weight in just two months. He was initially diagnosed in 2017, and the prognosis from his doctor was poor.

A chemotherapy treatment was being utilized with limited success. The apparatus described herein was placed on the body of the subject daily to utilize the Alternating Current Tumor Treatment (ACTT) technology for treatment. The unit was placed in close proximity to the bladder to enhance the signal and to improve the effectiveness of the lines feeding the signal. The subject also slept with the unit on his body.

After several days, the subject's symptoms started to improve, and he began to regain some of the weight he had lost. His irritable bowel syndrome (IBS) symptoms greatly improved. Later, the subject went in to be evaluated for surgery. He had been on chemotherapy before. Surprisingly, when the TTF therapy was combined with the chemotherapy the tumor was not Stage 4 but a Stage 1. The subject continued the TTF with chemotherapy as the combined treatments appeared to have a synergistic effect. Several months later, he was declared cancer free, and the cancer has not returned. Even though the cancer was expected to return, to date it has not.

Example 2. Treatment of Prostate Cancer with ACTT Technology

A subject was diagnosed with inoperable prostate cancer after having previously undergone surgery to remove his prostate. The subject had received chemotherapy and was being treated with androgen deprivation therapy (ADT). The subject experienced persistent irritable bowel syndrome (IBS) including diarrhea as a side effects of these therapies.

The Prostate Specific Antigen (PSA) levels of the subject were routinely monitored. Before initiating TTF therapy with the ACTT technology, the subject's PSA levels were above normal and indicated a possible metastasis of the cancer. TTF therapy with the apparatus described herein was applied as described in Example 1. Within several days after initiation of the TTF therapy, the subject no longer experienced diarrhea or any other IBS symptoms. Not long thereafter, the subject's PSA levels dropped to normal levels. Initially the PSA levels started to drop with just one use of the TTF apparatus. Testosterone treatment was added after TTF started to have an effect. Thereafter, the PSA levels dropped to 0.01 ng/mL which is almost non-detectable. They have remained there for over a year. The patient wears the unit for 10-12 hours each day in a small backpack. If the patient removed the TTF apparatus, within 12 hours explosive diarrhea returned. Upon returning to use of the TTF apparatus, the diarrhea problem was resolved within days.

Example 3. Configurations Improving the Intensity and Directionality of the Electrical Signal

It was observed that when the wire running through the conduction ring was then attached to the conduction ring itself at one end (seeFIGS.5A,5B,6A, and6B), the other end of the wire exhibited an unexpectedly large voltage that when attached to the body of the patient did not drop as much as in other configurations. The voltage was at times doubled or tripled in the body with this configuration compared to configurations where the wire was not attached to the conduction ring. When one end of the wire was attached to the conduction ring itself and then passed through and/or wrapped around the conduction ring once or multiple times, greater propagation of the signal into the body resulted compared to other previously tested configurations.

Additional configurations of the device are presented inFIGS.7and8. InFIG.7A, the wire is looped through the conduction ring with the ends of the wire connected to the bodies of two different subjects. The wire is attached to the subject as described herein (e.g., with TENS or TENS-like pads).FIG.7Cis a similar configuration, with wires wrapping in opposite directions around the conduction ring before attaching to the patients' bodies.FIG.8Aportrays one possible configuration involving an IV unit feeding into the circulatory system of a subject. As the fluids in the IV unit are in direct contact with the fluids of the circulatory system, the electromagnetic signal produced by the ACTT device described herein can be propagated throughout the subject body via a connection between the device and the IV unit.FIG.8Eshows a similar configuration, with the wire splitting before wrapping around the conduction ring in opposite directions before connecting to the IV unit. In another configuration related to that shown inFIG.8CandFIG.8D, the conduction ring of the ACTT device encircles the tubing extending from the IV unit.

Example 4. Treatment of Viral Infection with ACTT Technology

The device described herein is worn by a patient who is suffering from a viral infection (e.g., coronavirus orinfluenzavirus). The configuration of the device may be as shown in any of the Figures. Preferably, the device is worn and electromagnetic signals are applied to the infected patient for at least 10-12 hours each day.

The patient's symptoms are monitored regularly. Within a period ranging from 12 hours to a few days depending upon the severity of the infection, the symptoms from the viral infection will subside. In some cases where the viral infection causes irritation and/or inflammation of the respiratory tract, treatment with the ACTT technology will restore the respiratory tract to a healthy condition.

Unless defined otherwise, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials, similar or equivalent to those described herein, can be used in the practice or testing of the present invention, the preferred methods and materials are described herein. All publications, patents, and patent publications cited are incorporated by reference herein in their entirety for all purposes.

The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention.

While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth and as follows in the scope of the appended claims.