Patent Application
20190328957
The present invention generally relates to a method of using an ozone-oxygen mixture, we are calling Oxygen Ozone Regenerative Therapies or OORT, to treat various diseases. More specifically, the present invention intravenously administers the ozone-oxygen mixture to a patient through the use of a syringe and an infusion device, by reactivating our proposed (first time in western medicine), putative Regenerative Organ System.
The present invention concerns a method of administration of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) to cure disease. Usages of the method disclosed in the present invention include but are not limited to treating conditions such as Chronic Kidney Disease, End Stage Renal Disease, Diabetes, Heart Disease (Coronary Artery Disease, Congestive Heart Failure), Neurological diseases such as neuropathy and strokes and degenerative diseases, including dementia, Parkinsons's disease, ALS and MS, Hypertension, High Cholesterol, COPD, Atrial Fibrillation, Osteoporosis, Osteoarthritis, Asthma, Depression, Hepatitides, and Lyme Disease, genital herpes and HIV. It is also conceivable that the present invention may be used to treat every infectious disease including Ebola, inflammatory and autoimmune diseases, chronic fatigue, and like diseases. The present invention may be used in cancer with variable results.
To summarize the differences, the present application is for a human clinical procedure, given to 60 patients safely and highly effectively, in a pilot clinical trial conducted in Houston in 2015, given for therapeutic purposes, which yields improvements in the treatments of multiple chronic medical illnesses, including and especially Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD), heart disease, degenerative neurological diseases such as multiple sclerosis and others, diabetes both Types I and II, and other degenerative diseases such as osteoarthritis, depression, hypertension, early and easy fatiguability, fibromyalgia, stroke and multiple other chronic medical illnesses.
The present application discloses a method of administering an intravenous oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT). The method comprises the steps of: (A) providing a syringe, an infusion device and a tourniquet; (B) identifying an accessible peripheral vein on an upper extremity of a user; (C) preparing a volumetric dosage of an oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) with the syringe; (D) applying the tourniquet to a cannulation area on the upper extremity and inserting the infusion device into the accessible peripheral vein; and (E) transferring the volumetric dosage of the oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) from the syringe through the infusion device and into the accessible peripheral vein at a specified infusion rate by releasing the tourniquet from the cannulation area after a witnessed flash of blood. In other words, the present application transfers the volumetric dosage of the oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) from the syringe through the infusion device and into the accessible peripheral vein with specified concentrations and volumes, with and without obstacles to administration, locates the vein, and makes it prominent enough to make it accessible to receive the treatment.
A patient was given methylcobalamin (cyanocobalamin, if the patient does not have chronic kidney disease, or hydroxocobalamin may also be substituted instead.) intramuscularly as well, as needed, for which a sliding scale is utilized, depending upon the patient's bodily habitus, stress levels, prior deficiency status and disease status, age and other co-morbid conditions. On average patients run between 5 mg and 30 mg in weekly in divided doses between 3 times a week to daily, per the sliding scale. This is not to say that lower doses will not have a beneficial effect. This is just to add this to the protocol, and to demarcate that this is the dosage range within which optimal results are seen. Other steps have been added for individual patients. That work to enhance or optimize this protocol, including a particular kind of Vitamin and supplements mixture including living probiotics, and rudraksha beads usage and yoga therapy and other interventions such as IV supplements and vitamins and hormone supplementation, as the case may require. These are supplementary steps and require more clinical definition before adding specifically to a patent that in its most core form, applies to all diseases and all conditions, and all patients.
As mentioned previously, the Applicant had to undertake a pilot clinical trial in 60 human beings, with different degrees of chronic kidney disease, and other chronic medical illnesses, and observe minutely, changes in their blood and urine tests with different concentrations of the various oxygen containing gases, in mixture. The Applicant had to make extensive clinical observations (and correlate them with possible changes in Regenerative Organ System functionality improvement, based on observation of improvement in different organs and organ systems with the treatment, and hypothesize or postulate, particularly what stem cells or what progenitor cells could have increased in number and functionality—which has never been done before clinically—a clinical correlation based on regenerative changes in the human body) over the course of multiple treatments given to each patient, at different concentration compositions to study minimum effective dose in multiple chronic medical diseases, from a very small starting dose, in order to first not harm the patient, unlike the very high a dose utilized by other treatments, in one single dog with leukemia.
The Applicant's clinical observations of improvements in patients with significant chronic medical illnesses, such as improvement in creatinine and proteinuria in patients with Chronic Kidney Disease (in one patient creatinine reduced enough to delay dialysis by two years and in another patient, creatinine reduced from 1.3 mg/dl to 0.9 mg/dl with just 20 sessions), or improvement in kt/v from 0.9 to 1.58 in a patient with End Stage Renal Disease (with 30 sessions of treatment), while already on dialysis and previously not making any urine (strongly suggesting increases in circulating numbers of hematopoietic stem and progenitor cells, hemangioblasts and endothelial and nephron progenitor cells, who now started making copious quantities of urine, and very specific improvements in patients with Multiple Sclerosis, revealing an increase in growth in patient's muscles and strength and caliber, and the size and number of veins from thready and few, to many jungle vine like structures over a few short treatments, suggested to Applicant that the protocol she was using, of which this she believes is the keystone step, which are both results of reactivation of the Regenerative Organ System in the human body, which includes reactivating neurons supplying the bone marrow and the kidney (lead organ in the Regenerative Organ System) which release stem and progenitor cells from these locations, particularly the kidney even, which is a previously undescribed (beyond a certain embryonal stage) potential adult site of regenerative activity within the human body (which our keystone step is activating), which result in increases in stem and progenitor cell counts, specifically to the clinical disease or scenario, none of which have been enumerated by prior art.
Applicant as an expert in this art, feels that while there is an intuitive approach to all this on her part, about this protocol or treatment of the present application, that this is not intuitive to anyone else who is an expert in the field, or they will have proposed it, as the significance of what is being described, is monumental and Nobel-prize worthy. And the effect of this gaseous mixture on the human body, is ancient, ancestral and astrobiological, from when life entered planet earth atmospherically, and has been the transmission of a searing memory of exposure to various forms of oxygen in abundance, intergenerationally, across all earth life forms, and will be the subject of many, many Nobel prizes in the future. To one, it seems that there is likely to be nothing intuitive or practically obvious about Applicant's observations, for these reasons.
A method of administering intravenous oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) comprises the steps of providing a syringe, an infusion device and a tourniquet, identifying an accessible peripheral vein on an upper extremity of a patient, preparing a volumetric dosage of an oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) with the syringe, applying the tourniquet to a cannulation area on the upper extremity and inserting the infusion device into the accessible peripheral vein and transferring the volumetric dosage of the oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) from the syringe through the infusion device and into the accessible peripheral vein at a specified infusion rate by releasing the tourniquet from the cannulation area after a witnessed flash of blood.
This procedure is undertaken to reactivate a latent or dormant what we propose is a putative and yet highly likely to exist, Regenerative Organ System within the human body, by triggering a physiological signaling within the entire neuronal network of the body of the excess availability of oxygen, thereby activating neurons in the bone marrow (CEO organ of the Regenerative Organ System) and Kidney (brain or lead organ of this putative Regenerative Organ System), leading to an organism-wide reactivation of this Regenerative Organ System and the human body's own capacity to heal itself, which is very different from what has been previously proposed as the mechanism of action of a different combination of similar gases (0.14-1.7 ml/kg of human body weight), for different durations (30 treatments to 6-7 months for ours), different proposed mechanisms of action (activating normal hematopoietic cells to replaces leukemia cells in dogs, versus activating whole body neuronal network to reactivate latent and partially dormant Regenerative Organ System in ours via an ancient, ancestral and astrobiological trans-species signal about the abundant availability of oxygen, resulting in greater circulating numbers of hematopoietic stem and progenitor cells, endothelial progenitor cells, hemangioblasts and nephron progenitor cells and other stem and progenitor cells (both from the effector bone marrow organ and from the kidney), as evidenced clinically by increased muscle mass, hair growth, size and number and caliber of veins and other blood vessels, vastly improving kidney function chemistry parameters, vastly better cholesterol and lipids in blood work, reduced or eliminated proteinuria, better hemoglobin and white blood cell counts seen in immunosuppressed patients with autoimmune disease and many others, as seen in 60 patients enrolled in our pilot clinical trial expressly to determine efficacy of treatment utilizing this gaseous mixture in chronic kidney disease and other chronic medical illnesses, as well as therapeutic dosage window and not to exceed dose and lowest dose at which therapeutic effect is observed).
We would respectfully and humbly submit to the USPTO that this is original work undertaken after studying literature that has been published and others' work, and required a considerable degree of non-intuitive, non-standard, non-extrapolative, more intuitive and insightful work on our part, than anything that could be scaled up and down an experimental curve like a sliding scale, which our work has not been, or logically computed based on prior art or any other prior published paper.
It is an object of the present invention, to overcome deficiencies in prior art of the treatment of human beings suffering from chronic medical illnesses, such as chronic kidney disease, end stage renal disease, diabetes, osteoarthritis, multiple sclerosis, chronic fatigue syndrome, chronic pain related to injuries etc.
The Applicant is describing the present invention as it relates to the reversing of chronic kidney disease and end stage renal disease, without the other multiple steps provided by our institution, around this keystone step, in order to reverse kidney failure and all other chronic medical diseases.
This keystone step lies in the intravenous administration of a very specific concentration of a mixture of oxygen and ozone gases, in a very specific amount, in escalating dosages as observed works and described in the present application, with attention to possible contraindications, and potential side effects within human recipients, and with attention to what constitutes sufficient administration for the treatment of the chronic medical illness, clinically, and using this therapeutic administration of this very particular and specific gaseous mixture to optimally reactivate what we are reporting to be the Regenerative Organ System in the body and thereby reverse all chronic medical illnesses, effectively enough that patients may drastically reduce medication use, drastically improve disability and inability to work, and drastically improve healing from all acute illnesses and help regain youthfulness, disease-free state and longevity (as measured by multiple markers—telomere length, telomerase activity, return to normal gene expression (with the synthesis of adequate quantities of properly folded and functioning proteins), return to normal circulating and tissue count of stem and progenitor cells, reduction or elimination in gene expression errors, reduction or elimination in inefficient cellular communication, normally functioning proteins, as opposed to abnormally structured and low functioning proteins, balanced metabolism, healing of DNA damage and prevention of DNA damage more effectively, regaining and resumption of body energy production and machinery functionality from mal-functionality, and normal cell death utilizing normal dying and scavenging processes (without abnormal immortal processes being activate at a cellular level or abnormal inactivation of normal cellular death processes, or cell death occurring by abnormal death processes).
The state of chronic medical illness contributes to accelerated aging and more premature death, a state that costs our country almost $1 Trillion a year in CMS expenditure. Just as an example, $0.5 Trillion of that is expended on 8 million chronically ill patients with 6 or more diagnoses—all the rest is expended on another several million people with less than 6 chronic medical illnesses.
Stroke patients can regain mobility if seen within a few months' after the stroke.
The Applicant is describing in the present application, combination of gases, when administered thus within human beings, causes reactivation of a silenced regenerative organ system (REGENOS), and results in the release of multiple types of stem and progenitor cells, which facilitates reversal of the chronic medical illness, short-term. It is possible that this combination of stem and progenitor cells that are released by this protocol containing highly available and usable species of oxygen molecules caused by reactivation of the Regenerative Organ System, can also affect the outcome of cancer, as cancer thrives in hypoxia or low ambient tissue oxygen levels, whereas, cancer stem cells which proliferate in low oxygen environments, can be replaced or overthrown or overgrown by healthy stem and progenitor cells, which grow in high oxygen availability environments, such as is created by our procedure, something which has not been discussed or proposed as a mechanism of action by the prior art, nor is intuitive from her usage of very toxic, very, very high doses of reactive oxygen species in her prior art.
The Applicant is not utilizing a modulation of the immune system within this protocol, and however, that as in the patient described here, OORT maybe utilized carefully, in patients with organ transplant, to avoid precipitating acute rejection, as described here, and as performed previously herein.
The Applicant is not utilizing a modulation of the immune system within this protocol, the Applicant believes the protocol to administer IV combination of oxygen and ozone gases, must be considered to be carefully indicated, in any clinical situation in which the patient has a transplanted organ within their body; whereas, in our one patient with a failed kidney transplant who is currently back on hemodialysis, acute rejection of the organ has not been triggered by OORT.
The mechanism by which the Applicant believes this gaseous mixture is acting, is the triggering of endothelial cell and neuronal activation is the triggering of endothelial cell activation only at the exact instant of injection, and at the site of injection of the gaseous mixture, which is rapidly absorbed (within nanoseconds) by the blood cells by ozonation of their lipid membranes.
This application converts the anaerobic respiration within neurons of the vascular walls, a switch that might have been caused due to injury, inflammation or impenetrability of blood supply through the vascular walls to the neurons, into a full-fledged large-scale aerobic respiration, which results in the activation of all neurons including those in bone marrow, whose, electron transfer (or current) causes the generation (proliferation and activation) of stem cells and those neurons in the kidney, which causes a huge proliferation independent of the bone marrow produced stem cells, within the kidney even, which is not previously known to be an organ of regeneration, in any human life, other than embryonal (not in children or in adults). This transmission of the aerobic respiration activation signals to all neurons which are interconnected forming a sleeve along the length of all blood vessel walls, conduct the impulses conveying the excess availability of oxygen, this ancient, ancestral and astrobiological signal, to all networked neurons, all over the body, which results in the turning on of homing signals for stem cells where injury is now perceived (previously not, due to underlying neuronal inactivation or death), and reactivation of smooth and striated muscles overlying neurons everywhere (including a more rapid gut transit time and easier clearance of respiratory secretions and urine), by this potential reactivation of an entire putative and proposed by us alone and us for the first time, regenerative organ system.
This mechanism of action we have proposed based on our observations of our End Stage Renal Disease patient, who started making urine after receiving the very first dose of this therapy. When he subsequently underwent dialysis, his urine, which I'd asked him to collect in Mason Jars to show me that he was indeed making it, turned white, from clear yellow (and had solid matter in it, like tender coconut or buttermilk). Since I did not have a microscope or lab at the time, I proposed that these were stem cells and progenitor cells, including hemangioblasts, hematopoietic stem and progenitor cells, endothelial progenitor cells, that were being made post-filter de novo in the kidney for the first time ever, since the embryo stage of the patient, and that they were being shed into the urine owing to the systemic inflammation caused by being on hemodialysis for four hours (with multiple use recycled plastic capillaries within the dialysis filter), which culminated within the filtration units or glomeruli of the kidney, torching these cells and causing them to fall into the urine, to avoid the inflammatory burn, without forming adhesions between each other and differentiating into the cells that needed to form, to regenerate the kidney (40 types of cells within the kidney, which are lost during scarring and end stage renal disease). When the patient was administered a potent anti-inflammatory substance namely a form of curcumin which is absorbed without being detoxified by first-pass metabolism within the liver, and given electromagnetic therapy as a beacon to draw and retain these immature cells within the kidney and advance their maturation rapidly, the patient stopped spilling/shedding these regenerative cells in the urine, despite still being on dialysis (and continuing to still have systemic inflammation from dialysis) and the urine returned to yellow and clear, and he resumed recovery to normalcy, of his renal function, caused by the unhindered actions of these regenerative cells within the kidney itself.
The interesting thing about the metabolism of intravenous ozone-oxygen mixtures, is that the presence of the ozone component is only nanoseconds long, within which time, it combines with membrane lipids of red blood cells and white blood cells, thereby extinguishing its oxygen-abundance-signal almost instantly. However, the single neuron that has come into contact with a molecule of ozone oxygen, has already activated the entire network of neurons, which are now processing glucose via an aerobic pathway, leading to enhanced energy generation in every cell, leading to better structure and function of proteins and therefore better functionality of the cell, leading to its revivification.
This is an entirely new mechanism of action for the particular mixture that the Applicant is proposing for the very first time, and this mechanism that the Applicant is proposing is based on our clinical data and observations in human beings, and past in vitro and animal in vivo experimental data by others.
All illustrations of the drawings are for the purpose of describing selected versions of the present invention and are not intended to limit the scope of the present invention.
In reference to
As can be seen in
During an initial session for the plurality of treatment sessions, the volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) is within a preferred range of 10 to 20 mL for a 90-or-more pound (lb.) person. The exact volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) for the initial session is also proportionately depended upon a weight, a habitus, and an underlying health condition of the patient and is preferably determined by the administrator. Consequently, a lighter patient would require a dosage closer to 10 mL, and a heavier patient would require a dosage closer to 20 mL. However, the present invention allows for an even-lower volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) of 2.5 mL if the patient's weight is proportionately low as well.
From a tenth session to a twelfth session for the plurality of treatment sessions, the volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) is about 55 mL for an approximately 90-or-more lb. person. Likewise, the exact volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) for these later sessions is proportionately depended upon a weight, a habitus, and an underlying health condition of the patient and is preferably determined by the administrator.
The present invention also allows for different actions to improve the efficiency of Step E. In reference to
The present invention also allows the overall process to be simultaneously repeated between the patient and the administrator. Thus, the administrator is able to simultaneously execute a first iteration of Steps A through E with a first syringe and a second iteration of Steps A through E with a second syringe. This allows the administrator to double the volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) during a single treatment session, while first clamping (with taped jaws) the tubing at the distal end of the intravenous tubing, to prevent air entry, while switching out syringes. Special safety precautions need to be taken by the administrator for the patient while using two syringes. For the plurality of treatment sessions, the simultaneous execution of the first iteration and the second iteration is done during the later treatment sessions. In the preferred embodiment, the simultaneous execution of the first iteration and the second iteration allows the volumetric dosage of oxygen-ozone mixture (Oxygen Ozone Regenerative Therapies, OORT) to range between 110 mL to 120 mL.
Moreover, the infusion device is removed after the complete infusion of the desired dosage, whereupon it is desired that the patient compresses the cannulated vein for at least 5 minutes without bending the body part containing the vein. After the treatment, the administrator observes the patient for at least 10 minutes before allowing the patient to leave. The administrator must note symptoms such as cough, chest tightness, or anything unexpected. It is desired that the administrator leaves 5 mL of ozone in the syringe to keep the syringe from sucking in residual bodily fluids of the patient (and subsequently, when withdrawing needle-cannula out, push that 5 ml out, after withdrawing cannula, to sterilize needle and syringe contents and barrels to avoid any risk of disease transmission). The syringe should be reusable until a black ring inside the plunger become visible, or if the plunger gets too stiff to move it, or if the graduation markings fade and become obscure. It is also preferable that the administrator switch veins and arms being cannulated on a particular treatment session to allow the veins to recuperate and avoid repeated trauma to the same veins.
In regard to the side effects associated to the present invention, a cerebral paresis has been observed by the inventor in 1 out of 10,000 cases. A feeling of paresis may begin on one side of the patient's body within the first 30 minutes after the push starts. The feeling of paresis lasts from 2 to 30 minutes after the treatment and has not led to any residual effects. Cerebral paresis is only a sensation of weakness, not a related to actual physiological damage.
These side effects have never happened with the initial treatment session or during the actual treatment. If the patient has experienced cough or chest tightness, the dosage is not increased until he or she has the same dose again without any such experience.
In the rare event that distressing chest symptoms occur for the patient, oxygen is given at 3 litres per minute via the nasal cannula to speed the resolution of the chest discomfort. The patient is not discharged until he/she is well past the symptoms, and the patient is observed for 5 to 10 minutes after the symptoms disappear before patient leaves, whereupon the patient is breathing O2 for the whole time, which may take 30 minutes to an hour to settle down or resolve entirely.
For vein irritation, warm compresses every 10 minutes, Traumeel cream, and as a last resort, ibuprofen is applied to the cannulation area. To prevent vein irritation, the administrator makes sure that the patient is taking vitamin C to gut tolerance every 2 hours, 5 to 6 times a day. Also, the patient is made to drink 1 gallon of water everyday (if not contraindicated) and take at least 3 ounces of probiotic bio-juice daily to replenish bacteria in intestinal wall.
Although the invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed. A Herxheimer reaction may also present as feverishness, joint aches and pains, and whole body pain as in a flu-like syndrome—this can last 1-2 days, and maybe addressed by rest and hydration.
| Number | Date | Country | |
|---|---|---|---|
| 62281919 | Jan 2016 | US | |
| 62281616 | Jan 2016 | US | |
| 62264522 | Dec 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15413410 | Jan 2017 | US |
| Child | 16459535 | US | |
| Parent | 15373453 | Dec 2016 | US |
| Child | 15413410 | US |
