ASPHYXIATION

BACKGROUND OF THE INVENTION

There are many conditions and diseases under which a person can suffer from insufficient exchange of gases in the lungs and intake of oxygen into blood and tissue, leading to shortness of breath, lightheadedness, fainting, and eventually asphyxiation and death. There are many causes for this, including insufficient and compromised lung capacity and function due to smoking, disease, injury or occupational complications. One aspect of this has become particularly widespread with the onset of COVID-19 infections and the prevailing pandemic.

The most common intervention for this is to hospitalize and intubate a patient, and to provide assisted respiration through nebulization with air enriched in oxygen. Besides being complicated and dangerous, the process is slow and takes a long time for SpO2 (PO2) of the patient to be restored to normally comfortable and acceptable levels.

It is an object of the present invention to provide a solution and applications thereof for rapidly increasing oxygen concentration in the blood and tissue of a patient, as may be needed in an emergency situation or required for assisting patients with compromised lung or respiratory function. A further object of the invention is to provide for a simple, yet effective, solution for self-administration that could be used by the patient, or a minimally-trained care-giver in home-based care, or similar situation.

SUMMARY OF THE INVENTION

According to the invention there is provided a solution of stabilized hypochlorous acid and hypochlorite ions, having a pH of 4 - 9; with a concentration of 3 - 300ppm of free available chlorine; and a salinity of 0.1 - 10g/I of NaCI, for use in increasing PO2 levels in the blood and tissue of a patient to treat hypoxemia.

The solution preferably may comprise 5 - 195 ppm of free available chlorine.

The solution may have an ORP range of less than -300mV to more than +1 100mV.

The solution in addition may include up to 10 g/l of sodium bicarbonate or sodium carbonate.

In one embodiment of the invention, the solution may have a pH of 5 - 7; a concentration of 5 - 195 ppm of free available chlorine; an ORP of more than 625 mV, and salinity of 0.1 - 10 g/l of NaCI.

In an alternative embodiment of the invention, the solution may have a pH of 7 - 9; a concentration of 5 - 95 ppm of hypochlorite; an ORP of less than -225 mV; and salinity of approximately 0.1 -10 g/l of NaCI. In yet a further embodiment of the invention, the solution may have a pH of 5 - 8.5; a concentration of 5 - 195 ppm of free available chlorine; an ORP of more than +625mV; and salinity of 0.1 - 10 g/l of NaCI; and up to 5 g/l of sodium bicarbonate or sodium carbonate.

In yet a further embodiment of the invention, the solution may have a pH of 4 - 9; a concentration of 5 - 195 ppm of free available chlorine; an ORP of more than +625mV; and salinity of 0.1 - 10 g/l of NaCI; and up to 1 g/l of at least one species of nanometal particles selected from the group comprising Ag, Au, Ti, Cu, Zn, or the platinum group metals.

The solution may be produced through electrolytic treatment of a saline solution, diluted with water to a concentration of between 1 :100 and 1 :2, and preferably a concentration of between 1 :4 and 1 :3. Alternatively, the solution may be produced through electrolytic treatment of a brine solution (i.e., NaCI in water) with a salt concentration of between 50 and 10,000 mg/l, and preferably between 2,000 and 5,000 mg/l, and more specifically between 2,500 and 3,000 mg/l. Alternatively, the solution may be prepared through plasma activation cells instead of electrolytic treatment. Yet further alternatively, the solution may be produced through dissolution of sodium dichloroisocyanurate in water.

The solution may be used or applied either through generating an aerosol or a fog; through a nebulizer for inhalation; a spray for sinuses, the nasal and oral cavity; or by drinking it. The solution may be used in fogging machines, atomizers, nebulizers or humidifiers under high pressure, or via ultrasonic or spinning disc apparatus, as an aerosol, fog, through a nebulizer or a spray, having a particle size fraction of between 1 pm - 5 pm. It may be drank, nebulized or ventilated at a concentration of 0.1 - 360 g/i.

The solution may be used for treating diseases selected from the group consisting of Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Recalcitrant Asthma, Acute Respiratory Distress Syndrome (ARDS), COVID and non-COVID Septicaemia; and shingles.

DETAILED DESCRIPTION OF THE INVENTION

There are many diseases, syndromes and complications which can variously result in inefficiencies in exchange and transfer of oxygen to blood and consequently to various tissues, leading to shortness of breath, fainting and even death. It has been found that the composition of the invention is suitable for use in treating diseases selected from the group consisting of Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Recalcitrant Asthma, Acute Respiratory Distress Syndrome (ARDS), COVID and non-COVID Septicaemia. Referring only to Cystic Fibrosis (CF), by way of example, in order to treat this disease effectively, a patient needs to be nebulised daily with Pulmozyme (to break up the sticky phlegm in the airways), as well as Tobi (an inhalation antibiotic). Treatment costs are about R30,000 per month, compared to use of the solution of the invention, which costs less that R3,000 per month for the same efficacy and safety. Treatment of the diseases mentioned above are costing health departments of each country millions of dollars yearly. The solution of the invention has the potential to make a significant impact in the market of each of the illnesses mentioned above.

Many conditions are associated with functioning of the lungs, and oxygen exchange and uptake in the lungs and tissues. These can be chronic conditions, such as problems arising from smoking or occupational damage to the lungs; or might be due to seasonal or incidental causes, such as flue, pneumonia, asthma or various allergies. More recently, the incidence of infection by airborne pathogens, particularly virus particles, has become more severe and widespread, of which the COVID-19 pandemic is a prime example. Almost without exception, all patients carrying clinical signs of the disease have one thing in common: they all have difficulty in breathing due to them having developed Acute Respiratory Distress Syndrome (ARDS), with various degrees of intensity, leading to low PO2 levels in blood and tissue and eventually death by asphyxiation. The interventions presently accepted and widely used are generally slow and inefficient in their effect, complicated in implementation, and expensive to execute.

In contrast, it has been demonstrated that use of the solution of the invention, at the very least brings about a quick, significant and sustainable increase in PO2 levels of a critical patient. The applicants believe that such a treatment will render immediate relief to millions of sufferers globally, within a reasonably short period of time. This treatment protocol requires minimal approvals, as the solution can be applied as a liquid humidification agent that can be administered safely by anybody to anybody, similar to an asthma inhaler. The effect of this treatment protocol is that the rate of oxygenation is immediately increased through trans-membranous capillary action, the effects of which can be measured with an oximeter, and ceased above 90%, to ensure optimal treatment. The secret of the invention is the formulation and the type of water being used. Normal water, even when steamed or altered in any other way, will not have the same effect and consequence. Electrochemically activated solutions are ionic in nature, with an elevated Oxidation Reduction Potential (ORP) of anything between +500 mV to > +1200 mV, depending on the pH of the solution.

Alternatively, the solution of the invention can be dispensed through the alimentary canal, simply by drinking some solution. In empirical tests, anything from about 100ml to 500ml was effective, but often a standard-sized cup of 200ml - 250ml proved to be effective. The frequency of such drinking would be case-dependent, depending on the condition and requirements of a patient. However, in initial tests, both for prophylaxis and treatment, three times a day was adequate.

According to one aspect of the invention the solution is produced by electrolytic treatment of a saline solution, diluted with water to a concentration of between 1 :100 and 1 :2, and preferably a concentration of between 1 :4 and 1 :3. Alternatively, a brine solution (NaCI in water) is prepared with a salt concentration of between 50 and 10,000 mg/l, and preferably between 2,000 and 5,000 mg/l, and more specifically between 2,500 and 3,000 mg/l. Such a brine solution or saline is treated through an electrolytic cell, equipped with a membrane. The catholyte stream is then recirculated in whole or in part, through the anodic chamber, under operating conditions that result in an anolyte stream, with the following primary properties:

(i) pH between 4 and 9, preferably between 5 and 7, and more specifically between 5.5 and 6.5. It can easily be measured in the field by a pH meter or by swimming pool water pH measuring kits.

(ii) ORP (Oxidation Reduction Potential) between 600mV and 1200mV, preferably between 800mV and 1 100mV, and more specifically between 85mV0 and 950mV. ORP is measured by an ORP meter.

(iii) FAC (Free Available Chlorine) between 1 ppm and 500ppm (or mg/l), preferably between 50ppm and 200ppm, and more specifically between 90ppm and 150ppm. FAC is measured by a FAC meter or by swimming pool water FAC measuring kits.

In related formulations, it is possible to have carbonate, bicarbonate and phosphate species in solution at between 10 and 10,000 ppm, in addition to or instead of chlorides.

It is also possible to prepare similarly active solutions and effective inhalants by means other than electrolysis, such as through plasma activation cells.

The applicants have identified three solutions that have proven to have optimal treatment efficacies, namely -

(iv) A solution of stabilized hypochlorous acid, at a pH of 5 - 7, a concentration, typically of 3 to 200 ppm, but more specifically of 5 - 195 ppm of free available chlorine, ORP of more than 625 mV, and salinity of approximately 0.1 - 10 g/l of NaCI.

(v) A solution of stabilized hypochlorite, at a pH of 7 - 9, concentration, typically of 3 to 200 ppm, but more specifically of 5 - 95 ppm of hypochlorite, ORP of less than - 225 mV (negative 225 mV), and salinity of approximately 0.1 -10 g/i.

(vi) A solution of stabilized hypochlorous acid, at a pH of 5 - 8.5, a concentration, typically of 3 to 200 ppm, but more specifically of 5 - 195 ppm of free available chlorine, ORP of more than 625 mV, and salinity of approximately 0.1 - 10 g/l, of NaCI and up to 5 g/l of sodium bicarbonate, or sodium carbonate.

These solutions may further be diluted into or by normal saline for various applications.

The solution may be used or applied either through generating an aerosol or a fog; through a nebulizer for inhalation; a spray for sinuses, the nasal and oral cavity; or simply by drinking it.

It is believed that the solution of the invention works by increasing chlorine in the blood and thus oxygen delivery to the tissue. A rise in the HCO’ content of red cells is much greater than that in plasma as the blood diffuses out into the plasma. H ⁺ cannot easily diffuse out because the red cell’s membrane is relatively impermeable to cations. Therefore, to maintain electrical neutrality, Cl’ ions move into the red blood cell from the plasma. This is the so-called “chloride shift”, also known as the “Hamburger phenomenon”, named after Hartog Jakob Hamburger. The chloride shift is responsible for the fact that the chloride content of the red cells in venous blood is significantly greater than in arterial blood. The chloride shift occurs rapidly and is essentially complete in 1 second. For each CO2 molecule added to a red cell, there is an increase of one osmotically active particle, either an HCO’ or a Cl’ in the red cell. Consequently, the red cells take up water and increase in size. When the cells pass through the lung again, they shrink a little. The mechanism is illustrated in Figure 1 .

Similarly, drinking of, or ventilation or nebulization with the invention solution has an immediate and significant effect on PO2. As might be expected, the effect would vary depending on the dosage, i.e., the concentration of saline solution used. For example, in emergency situations, a hypertonic solution, up to the saturation levels of salt, generally about 360 g/l, would work more rapidly, whereas for chronic patients who may have to use the procedure a few times a day, it may be better to use less concentrated solutions, in order to reduce the load on other organs, such as the kidneys. It is therefore recommended that anything from a normal saline at about 9 g/l up to saturation levels of 360 g/l could be used, depending on the necessity of the situation.

The solutions according to the invention may be used as is; or may be electrolyzed in an electrolytic cell with or without a membrane, as anolyte, catholyte, or a mixture of the two; or a mixture of them with saline, or as an additive to it. It may be drank, nebulized or ventilated at a concentration of 0.1 - 360 g/l in order to induce higher PO2 in the blood and tissue and alleviate hypoxemia. The solutions may be used singularly, or as a mixture, similarly administered, for alleviation of such pain and sensitivity as may be induced in such complications and disorders as shingles.

A whole range of pressure- and ultrasonic nebulizers have recently been developed for various uses and are available in the market. These devices generate exactly the correct droplet size of 1 - 5 pM, affording up to 90% placement within the alveoli inner wall without being expired after inhalation. Without such devices it would have been difficult to imagine locating efficient applicators, as even hand-held models can readily be acquired. The devices generate effective solutions using very little electricity generated by A4 batteries in your hand, eliminating off-site production, packaging and transportation. At least 10 patients can be treated within one hour and generally after restoration of oxygen uptake, the condition resolves totally. If required further symptomatic treatment like pain killers or antibiotics may then be applied. Obviously, hand held models can be used during ambulatory transportation. It is of no use administering more oxygen to the patient who cannot absorb it.

Results obtained from preliminary tests for this invention, indicated that PO2 increased from approximately 73% to over 94% in just over 3 minutes, simply by drinking about 200 ml of the solution. The same liquid may be applied in formal ICU and theatre settings to treat the same condition. It is envisaged that ingestion of approximately 10 - 500 ml or, more specifically, 200 - 250 ml of the proposed solution, in both a hospital ICU or general ward setting, or at home, would improve blood and tissue oxygen concentration levels within minutes. In one case, an 84-year-old adult male patient, who had contracted ARDS during postoperative recovery in an ICU, and was intubated for mechanical respiration. Addition of 50 ml of neutral pH electrolysed solution at an ORP of 720 mV and a Free Available Chlorine (FAC) concentration of approximately 50 mg/litre into the humidification canister on his oxygen ventilation line resulted in his PO2 increasing from 72% to 95% within 45 minutes, and discharge from ICU into the general ward within 2 hours.

Anolyte solution is particularly effective in reducing the viscosity or “thickness” of the proteinaceous layer that builds up on the inside wall of infected alveoli. Such a layer drastically reduces and eventually prevents oxygen exchange not only by introducing an additional barrier to gas exchange, but also by producing bubbles and filling up the alveolar space. Due to its viscosity-reducing and surface-active properties, such as dispersion and detergency, anolyte easily thins the secreted mucus and destroys or bursts the bubbles, thus expediting gas diffusion and oxygen uptake by blood. In addition, such anolyte solution, which has amply been shown to act as a broad-based wide-ranging microbicide, is effective in keeping the oral cavity, respiratory tract and associated organs free of opportunistic infections, which is very important especially in otherwise compromised cases.

In applications in which dispersion of the solution is required, using such equipment as fogging machines, atomizers, nebulizers or humidifiers, generally two droplet size fractions are preferably required, together constituting a range of less than 5 pm. Due to the size of most viruses being less than 1 pm, it is preferable to have droplet sizes of similar magnitude so as to increase the probability of interaction between droplets and virus particles suspended in gas streams. Due to crucial particle size of between 1 pm and 5pm, preferred for nebulization, it is estimated that more than 90% of administered solution will reach peripheral alveoli. Smaller droplets are inhaled and exhaled without attaching to the inner alveolar surface to complete its intended function. Likewise, larger droplets condensate against the inner surface of the endotracheal tubes, never reaching the alveoli, rendering such an intervention ineffective. Usually, condensed liquids in such a situation can be a source of bacterial and fungal infection directly into the bronchial tree and have life threatening consequences. However, the proposed solution proposed in this invention is microbicidal, mitigating the risk of infection.

Administration of effective solutions (referring to particle size fractions of less than 1 pm, or between 1 pm - 5 pm), generated by fogging machines, atomizers, nebulizers or humidifiers under high pressure, or via ultrasonic or spinning disc apparatus, is preferable. Some devices are suited for high care environments where all parameters can be pre-set, whilst a vast range of hand-held devices are suitable for self-treatment and quarantine situations. These applicators are affordable, require no spare parts or disposable items like filters, are battery powered and lightweight.

Current devices deliver between 6ml and 10ml doses applied over 10 minutes, which can be regarded as optimal. The optimal volumes must be determined as largeframed patients can be expected to require larger doses than light-framed individuals or children. The effective or optimal dose for particular patients will be reflected in oximeters when reaching 90%, and discontinued when above that level. As used herein, a “therapeutically effective amount” refers to an amount sufficient to elicit the desired biological response. The therapeutically effective amount or dose can depend on the age, gender and weight of the patient, and the prevailing medical condition of the patient. The skilled artisan will be able to determine appropriate dosages depending on these and other factors in addition to the present disclosure.

Due to the large number of variables involved, determination of accurate dosage or duration of assisted ventilation or humidification of space is difficult and strict specification can easily result in inadequate- or over-dosage. However, measurement of an adequate dose administered to the patient by measuring the SpO2% or oxygen saturation with the aid of an oximeter attached to the fingertip, can easily be done by a care-giver or the patient. Normal levels are between 90% and 100%. The following serves as a guideline in the treatment of ARDS:

(vii) 90 % - 100%: No evidence of impairment.

(viii) < 90%: Hypoxemia

(ix) < 80%: Hypoxemia - respiratory and cardiac arrest if continued

(x) < 75%: Loss of consciousness

Thus, the solutions may be administered to critically ill patients by lay, even illiterate personnel in the case of need and in the absence of trained personnel, by simply filling in the humidifiers or nebulizers. Also, a large number of patients can be administered treatment in a short period without cumbersome sterilization like autoclaving of equipment due to the disinfecting and sterilizing properties of the solution. Treatment liquids may be stored and transported at ambient temperatures and will remain stable, therefore effective in all temperature ranges of the globe from the arctic to the tropics. The following are proposed treatment protocols: EGHA electro-saline is highly effective against all pathogens, but the solution must come into contact with the virus to kill it. Therefore, it is essential to apply thoroughly in the oral, nasal and throat, i.e., upper respiratory tract (URT), to disrupt and kill as much of the virus as possible. EGHA electro-saline must be used and applied as directed below, and not only partly, as partial treatment will leave some areas in the URT untreated where the virus can continue proliferating and multiplying. Begin treatment as quickly as possible to disrupt viral proliferation and multiplication as early and fast as possible.

EGHA electro-saline does not taste nice and has a slight salty and mild chlorine taste.

Do not stop treatment when you start feeling better. Continue full treatment for at least

5 to 7 days after you have fully recovered.