Pressure Differential-, Ultrasound-, and Magnetic-Based Methods for Treating Viral Infections and other Pathogenic Diseases, Sterilizing Medical Equipment, and Enhancing Fatty Tissue Reduction
20220008276 · 2022-01-13
Inventors
Cpc classification
A61B17/22004
HUMAN NECESSITIES
A61B2017/22007
HUMAN NECESSITIES
A61L2202/24
HUMAN NECESSITIES
International classification
A61G10/02
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
Abstract
The present disclosure is directed to methods of treating subject patients (such as humans, animals, plants) suffering from a pathogenic disease such as COVID-19 in humans, via the administration of pressure changes in the patient sufficient to cause a pressure differential to be created between the inside and outside of the outer membrane or envelope of the pathogen thereby destroying or disabling the pathogen. In one embodiment, a hyperbaric chamber is used to administer pressure increases and/or pressure decreases to create such pressure differential. The hyperbaric chamber could comprise a single user or multi-user unit, a pressurized body suit, or the pressurizable fuselage of an aircraft. In another embodiment, patients are placed in an aircraft, and the cabin pressure, while on the ground, or in flight, is adjusted upwardly or downwardly to create such pressure differential. The pressure differential methods can also include the use of external gases to enter the patient's body and/or lungs to facilitate disruption of the pathogen outer membrane as well as application of variations in temperature and/or humidity. A mobile treatment unit is also disclosed. Also disclosed are methods of using ultrasonic cavitation or MRI (or other sonic or magnetic field forces sufficient to disrupt the functionality of the pathogen), or a combination of ultrasound and MRI on the exterior of a patient in a desired anatomical region of the patient to assist with the destruction or disabling of a pathogen infecting that anatomical region of the patient, e.g., the patient's lungs, said method being employed at ambient pressures or in an increased or decreased pressure environment created within a hyperbaric chamber. The ultrasound and/or MRI methodologies could also be used to treat other pathogenically afflicted areas of the patient's body. Additionally, a pressure-differential method of sterilization of medical equipment is disclosed employing a hyperbaric or other pressure or vacuum chamber. Also disclosed is an enhanced method of nonsurgical fat reduction in humans by employing ultrasonic cavitation within a hyperbaric chamber, including the use of HBOT therapies. Furthermore, the use of these methodologies and systems have application in treatment of patients post-infection and in other areas of medicine and health, such as for example, treating wounds, the effects of aging, inflammation, and the effects of other maladies.
Claims
1. A method of treating a subject patient afflicted with a pathogenic disease caused by a pathogen, the pathogen comprising an outer membrane structure maintaining an internal pressure inside of the membrane, the method comprising the steps of: a. placing the patient in a hyperbaric chamber capable of being pressurized or depressurized to a desired internal chamber pressure; b. administering oxygen in the chamber to a desired level to enhance oxygenation levels within the human; and c. adjusting the internal chamber pressure sufficient to cause a pressure differential between the pathogen internal pressure and the internal chamber pressure to cause the outer membrane of the pathogen to rupture or to otherwise disable the pathogen.
2. The method of claim 1 wherein the pathogen is selected from the group consisting of viruses, bacteria, fungi, parasites, worms, protozoa and helminths.
3. The method of claim 1 wherein the subject patient is a human being afflicted with a viral infection caused by a novel coronavirus pathogen and its variants.
4. The method of claim 3 wherein the novel coronavirus pathogen is SARS-CoV-2 and its variants and the human being is suffering from COVID-19.
5. The method of claim 1 wherein the step of adjusting the internal chamber pressure is achieved by increasing the internal chamber pressure.
6. The method of claim 5 wherein the pressure is increased between about 1.0 atm up to about 7 atm according to the tolerances of the subject patient being infected with the pathogen.
7. The method of claim 1 wherein the step of adjusting the internal chamber pressure is achieved by decreasing the internal chamber pressure.
8. The method of claim 7 wherein the pressure is decreased to about 0.5 atm or less according to the tolerances of the subject patient being infected with the pathogen.
9. The method of claim 1 wherein a series of pressure adjustments are employed.
10. The method of claim 9 wherein the series of pressure adjustments comprise incremental step pressure increases.
11. The method of claim 9 wherein the series of pressure adjustments comprise incremental step pressure decreases.
12. The method of claim 9 wherein the series of pressure adjustments comprise cycling between incremental step pressure increases and incremental step pressure decreases.
13. The method of claim 1 wherein the hyperbaric chamber is a single occupant unit.
14. The method of claim 1 wherein the hyperbaric chamber is a multiple occupant unit capable of treating multiple subject patients.
15. The method of claim 1 wherein the hyperbaric chamber comprises a pressurized full body suit worn by the subject patient.
16. The method of claim 1 wherein the hyperbaric chamber comprises an aircraft cabin capable of being pressurized.
17. The method of claim 1 further comprising the step of administering breathing assistance to the subject patient.
18. The method of claim 1 further comprising the step of administering oxygen to the subject patient at a constant desired concentration or at intervals of 100% oxygen followed by intervals of lower levels of oxygen.
19. The method of claim 1 further comprising the step of performing ultrasonic cavitation on a region of the subject patient.
20. The method of claim 1 further comprising the step of applying magnetic fields to a region of the subject patient.
21. The method of claim 1 further comprising one or more of the following steps: a. varying the temperature in the chamber; b. varying the humidity in the chamber; and/or c. infusing additional gases into the chamber or directly into a part of the body of the human being at constant or varied concentrations, the additional gasses selected from the group consisting of: known respiratory inhaler gases such as those used in the treatment of asthma and COPD, e.g., corticosteroid inhalers (such as fluticasone), and bronchodilator inhalers (such as albuterol); inhalers infused with nasal decongestants (including natural menthol and camphor based products); ethyl alcohol vapor; oxygen; natural inhalable substances, e.g., herbal inhalers, aromatherapeutics; and treatment gases used for clearing mucus plugs in the human being's lungs.
22. The method of claim 21 further comprising the application of step pressure changes, magnetic fields, ultrasonic fields, or combinations thereof.
23. The method of claim 1 wherein the subject patient is afflicted with a bacterial infection.
24. The method of claim 3 wherein the human being is suffering from post COVID-19 syndrome.
25. The method of claim 1 wherein the subject patient is selected from the group consisting of humans, animals, livestock, plants and beneficial insects.
26. A mobile method of treating one or more human patients afflicted with a pathogenic disease caused by a pathogen, the pathogen comprising an outer structural membrane maintaining an internal pressure inside of the membrane, the mobile method comprising the steps of: a. placing the one or more human patients in an air transport vehicle located on the ground, the air transport vehicle capable of obtaining in-flight altitudes where the external air pressure ranges between about 0.3-0.2 atm, the air transport vehicle further comprising: i. a pressurizable fuselage integral to the air transport vehicle, the fuselage having climate control and oxygen supply; ii. one or more independently pressurizable treatment chambers located within the fuselage of the air transport vehicle, the one or more pressurizable treatment chambers further comprising climate control independent of the fuselage, pressure control independent of the fuselage, oxygen supply independent of the fuselage, one or more seats, beds or treatment tables for receiving and securing the one or more human patients, and medical supplies for maintaining the life of the one or more human patients; iii. controllers for adjusting the climate in the one or more pressurizable treatment chambers; and iv. controllers for adjusting the pressure in the one or more pressurizable treatment chambers; b. flying the air transport vehicle to an altitude having a desired ambient external air pressure; c. independently adjusting the air pressure in the one or more independently pressurizable treatment chambers to a desired treatment pressure sufficient to cause a pressure differential between the pathogen internal pressure and the internal chamber pressure to cause the outer membrane of the pathogen to rupture or to otherwise disable the pathogen; d. maintaining the desired treatment pressure for a desired length of time; and e. returning the air transport vehicle to the ground.
27. The mobile method of claim 26 further comprising the steps of varying the pressure in the one or more treatment chambers while the air transport vehicle is in flight to induce differential pressures sufficient to rupture or disrupt the pathogen membrane.
28. The mobile method of claim 26 further comprising the step of administering breathing assistance to the one or more human patients.
29. The mobile method of claim 26 wherein the one or more human patients are afflicted with a viral infection caused by a novel coronavirus pathogen and its variants.
30. The mobile method of claim 29 wherein the novel coronavirus is SARS-CoV-2 (and its variants) and the one or more human patients are suffering from COVID-19.
31. The mobile method of claim 26 wherein the step of independently adjusting the air pressure in the one or more independently pressurizable treatment chambers is achieved by increasing the air pressure in the one or more independently pressurizable treatment chambers.
32. The mobile method of claim 31 wherein the pressure is increased up to about 7 atm or to an upper limit value permitted in the air transport vehicle.
33. The mobile method of claim 26 wherein the step of independently adjusting the air pressure in the one or more independently pressurizable treatment chambers is achieved by decreasing the air pressure in the one or more independently pressurizable treatment chambers.
34. The mobile method of claim 31 wherein the pressure is decreased to about 0.5 atm or to a lower limit value permitted in the air transport vehicle or as can be tolerated by the one or more human patients.
35. The mobile method of claim 26 wherein a series of pressure adjustments are employed.
36. The mobile method of claim 35 wherein the series of pressure adjustments comprise incremental step pressure increases.
37. The mobile method of claim 35 wherein the series of pressure adjustments comprise incremental step pressure decreases.
38. The mobile method of claim 35 wherein the series of pressure adjustments comprise cycling between incremental step pressure increases and incremental step pressure decreases.
39. The mobile method of claim 26 wherein the one or more human patients are suffering from post COVID-19 syndrome.
40. A method of treating one or more subject patients afflicted with a pathogenic disease caused by a pathogen, the pathogen comprising an outer membrane maintaining an internal pressure inside of the membrane, the method comprising the steps of: a. placing the one or more subject patients in an air transport vehicle located on the ground, the air transport vehicle further comprising: i. a pressurizable fuselage integral to the air transport vehicle, the fuselage having climate control and oxygen supply; ii. one or more a pressurizable treatment chambers located within the fuselage of the air transport vehicle, the one or more pressurizable treatment chamber further comprising climate control independent of the fuselage, pressure control independent of the fuselage, oxygen supply independent of the fuselage, a seat/bed/table for securing one or more human patients, and medical supplies for maintaining the life of the one or more human patients; iii. controllers for adjusting the climate in the one or more pressurizable treatment chambers; and iv. controllers for adjusting the climate in the one or more pressurizable treatment chambers; b. pressurizing the one or more treatment chambers to a desired pressure sufficient to cause a pressure differential between the pathogen internal pressure and the internal chamber pressure to cause the outer membrane of the pathogen to rupture or to otherwise disable the pathogen; and c. returning the pressure in the one or more treatment chambers to an ambient pressure.
41. The method of claim 40 wherein the one or more subject patients are human patients afflicted with a viral infection caused by a novel coronavirus pathogen and its variants.
42. The method of claim 41 wherein the novel coronavirus is SARS-CoV-2 (and its variants) and the one or more human patients are suffering from COVID-19.
43. The method of claim 40 wherein the treatment chambers are beds.
44. The method of claim 40 wherein the treatment chambers are existing air transport vehicle seats.
45. The method of claim 40 wherein the treatment chambers are pressurized by the pressurizable fuselage.
46. The method of claim 40 wherein the one or more human patients are suffering from post COVID-19 syndrome.
47. A mobile treatment unit for treating one or more human patients afflicted with a pathogenic disease caused by a pathogen, the pathogen comprising an outer membrane maintaining an internal pressure inside of the membrane, the mobile treatment unit comprising: a. an air transport vehicle capable of flying to altitudes where the external air pressure ranges between about 0.3-0.2 atm; b. a pressurizable fuselage integral to the air transport vehicle, the fuselage having climate control and oxygen supply; c. one or more independently pressurizable treatment chambers located within the fuselage of the air transport vehicle, the one or more pressurizable treatment chamber further comprising i. climate control independent of the fuselage, ii. pressure control independent of the fuselage, iii. oxygen supply independent of the fuselage, iv. one or more seats, beds or treatment tables for receiving and securing the one or more human patients, and v. medical supplies for maintaining the life of the one or more human patients; d. controllers for adjusting the climate in the one or more pressurizable treatment chambers; and e. controllers for adjusting the pressure in the one or more pressurizable treatment chambers.
48. A nonsurgical method of destroying a pathogen present in a subject patient comprising the steps of: a. identifying a body region of the subject patient afflicted with the pathogen; and b. performing an ultrasonic cavitation procedure on an outer surface of the afflicted body region of the subject patient.
49. The nonsurgical method of claim 48 comprising the further steps of: a. before the step of performing the ultrasonic cavitation, placing the subject patient in a hyperbaric chamber capable of being pressurized or depressurized to a desired internal chamber pressure; and b. adjusting the internal chamber pressure to the desired internal chamber pressure.
50. The nonsurgical method of claim 48 comprising the further steps of using a guided ultrasound procedure in tandem with Magnetic Resonance Imaging.
51. The nonsurgical method of claim 48 wherein the pathogens are selected from the group consisting of viruses, bacteria, fungi, protozoa, helminths and parasites.
52. The nonsurgical method of claim 48 wherein the subject patient is a human patient afflicted with a viral infection caused by a novel coronavirus pathogen or its variants.
53. The nonsurgical method of claim 52 wherein the novel coronavirus is SARS-CoV-2 (and its variants) and the human patient is suffering from COVID-19.
54. The method of claim 53 wherein the human patient is suffering from post COVID-19 syndrome.
55. The nonsurgical method of claim 49 further comprising providing hyperbaric oxygen treatment.
56. A nonsurgical method of destroying pathogens present in an anatomical location of a subject patient, the method comprising the steps of: a. identifying the anatomical location of the subject patient where the pathogen is present; b. performing an ultrasonic procedure on a region of an outer surface of the subject patient proximate the identified anatomical location to direct ultrasonic forces toward the pathogens in such anatomical location.
57. The nonsurgical method of claim 56 comprising the further step of using a guided ultrasound procedure in tandem with Magnetic Resonance Imaging.
58. The nonsurgical method of claim 56 comprising the further step of carrying out the method within a hyperbaric chamber while also providing hyperbaric oxygen treatment to the subject patient.
59. The nonsurgical method of claim 56 wherein the pathogens are selected from the group consisting of viruses, bacteria, fungi, protozoa, helminths and parasites.
60. The nonsurgical method of claim 56 wherein the subject patient is a human patient afflicted with a viral infection caused by a novel coronavirus pathogen or its variants.
61. The nonsurgical method of claim 60 wherein the novel coronavirus is SARS-CoV-2 (and its variants) and the human patient is suffering from COVID-19.
62. The nonsurgical method of claim 60 wherein the human patient is suffering from post COVID-19 syndrome.
63. A nonsurgical method of destroying pathogens present in an anatomical location of a subject patient, the method comprising the steps of: a. identifying the anatomical location of the subject patient where the pathogens are present; b. applying magnetic field forces on a region of an outer surface of the subject patient proximate the identified anatomical location to direct the magnetic field forces toward the pathogens in such anatomical location.
64. The nonsurgical method of claim 63 wherein the magnetic field force is selected from the group consisting of Magnetic Resonance Imaging magnetic fields, pulsed magnetic fields, rotating magnetic fields, alternating magnetic fields, oscillating magnetic fields, dynamic magnetic fields, magnetic nanoparticles, and magnetic hyperthermia.
65. A nonsurgical method of destroying fat cells in a human or animal patient comprising the steps of: a. placing the human or animal patient in a hyperbaric chamber capable of being pressurized or depressurized to a desired internal chamber pressure; b. adjusting the internal chamber pressure to the desired internal chamber pressure; and c. performing an ultrasonic cavitation procedure on a desired portion of an outer surface of the human or animal patient where the fat cell destruction is desired.
66. The nonsurgical method of claim 65 further comprising the step of providing hyperbaric oxygen treatment.
67. An enhanced method of fatty tissue removal in a human being, the fatty tissue comprising one or more adipose cells each having a generally spherical membrane surrounding a fat reservoir, the fat reservoir having an internal fat reservoir pressure, the method comprising the steps of: a. placing the patient in a hyperbaric chamber capable of being pressurized or depressurized to a desired internal chamber pressure; b. adjusting the internal chamber pressure sufficient to cause a pressure differential between the fat reservoir internal pressure and the internal chamber pressure to place stress on the one or more adipose cell generally spherical membranes; and c. performing an ultrasonic cavitation procedure on a desired portion of an outer surface of the human where the fat cell destruction is desired.
68. The enhanced method of claim 67 further comprising the step of providing hyperbaric oxygen treatment.
69. A method of disinfecting medical equipment contaminated with a pathogen, the pathogen comprising an outer membrane maintaining an internal pressure inside of the membrane, the method comprising the steps of: a. placing the equipment in a hyperbaric chamber capable of being pressurized or depressurized to a desired internal chamber pressure; and b. adjusting the internal chamber pressure sufficient to cause a pressure differential between the pathogen internal pressure and the internal chamber pressure to cause the outer membrane of the pathogen to rupture or to otherwise disable the pathogen.
70. The method of claim 69 wherein the desired internal chamber pressure ranges between 0.0 atm to 100 atm excluding 1 atm.
71. The method of claim 69 wherein the step of adjusting the internal chamber pressure is carried out by rapidly increasing or decreasing the internal chamber pressure.
72. The method of claim 69 wherein the step of adjusting the internal chamber pressure is carried out by cycling between increasing and decreasing the internal chamber pressure.
73. The method of claim 69 wherein the pathogens are selected from the group consisting of viruses, bacteria, fungi, protozoa, helminths and parasites.
74. The method of claim 69 wherein the pathogen is a novel coronavirus pathogen and its variants.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] Certain embodiments will hereafter be described with reference to the accompanying drawings, wherein like reference numerals denote like elements. It should be understood, however, that the accompanying drawings illustrate only the various implementations described herein and are not meant to limit the scope of various technologies described herein. The drawings are as follows:
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DETAILED DESCRIPTION
[0092] Reference throughout the specification to “one embodiment,” “an embodiment,” “some embodiments,” “one aspect,” “an aspect,” or “some aspects” means that a particular feature, structure, method, or characteristic described in connection with the embodiment or aspect is included in at least one embodiment of the present disclosure. Thus, the appearance of the phrases “in one embodiment” or “in an embodiment” or “in some embodiments” in various places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, methods, or characteristics may be combined in any suitable manner in one or more embodiments. The words “including” and “having” shall have the same meaning as the word “comprising.” Moreover, inventive aspects lie in less than all features of a single disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. Reference is now made to the drawings which depict preferred embodiments, but are not drawn to scale.
[0093] In various embodiments, the present disclosure is directed generally to treatment of humans (or animals, including pets and livestock, beneficial insects including pollinator bees, plant life and foodstock) infected with viruses, or afflicted with other infectious or pathogenic diseases. By way of exemplary teaching, the present disclosure is directed primarily to methods of destroying the coronavirus (or other pathogen) through pressure variations, or as described below, other mechanisms for destroying the outer membrane of the pathogen or otherwise interfering with its functionality, such as via application of ultrasonic and/or magnetic forces or combinations of ultrasonic and/or magnetic forces with the use of a hyperbaric chamber.
[0094] Referring to
[0095] The basic recommendation of the World Health Organization is to wash your hands with soap because soap breaks the greasy bubble (lipid bilayer 12) that surrounds the coronavirus. The present disclosure provides a method for breaking the greasy bubble 12 that surrounds the coronavirus by applying pressure variations to create pressure differentials, applying ultrasonic forces and/or applying magnetic forces that disrupt the virus (e.g. destroy or interfere with its membrane 12). Likewise, the present disclosure is directed to disabling the functionality of pathogens via the use of pressure differentials, ultrasonic and/or magnetic forces or combinations thereof.
[0096] Microorganisms and infectious agents such as viruses and virions and other pathogens play a major role in disease manifestations. The term “virus” is a broad, general term for any aspect of the infectious agent which can act as an obligate intracellular parasite, whereas a virion is an infectious particle in the extracellular phase of the host. Virus is a non-cellular, obligate parasite that is self-replicative inside a specific host cell. Virion is another form of a virus. The main difference between virus and virion is that virus is the nucleoprotein particle whereas virion is the active, infectious form of the virus. This present disclosure is directed to the destruction or disablement of, e.g., viruses, virions and virons. All viruses contain nucleic acid, either DNA or RNA (but not both), and a protein coat, which encases the nucleic acid. Some viruses are also enclosed by an envelope of fat and protein molecules. In its infective form, outside the cell, a virus particle is called a virion.
[0097] Coronavirus, is defined as any virus belonging to the family Coronaviridae. Coronaviruses have enveloped virions (virus particles) that measure approximately 120 nm (1 nm=10.sup.−9 metre) in diameter. Club-shaped glycoprotein spikes 13 in the envelope 12 give the viruses a crownlike, or coronal, appearance.
[0098] Specific reference herein to treatment methods directed to destroying or disabling a virus is a reference to any part of the virus, virion, viron, etc. capable of being destroyed or disabled as a means of treating or abating, e.g., a viral infection in, e.g., a person.
[0099] Referring to
[0100] Referring also to
[0101] In view of the current understanding that the primary point of first entry of the coronavirus 10 into a human body (patient 30) is through an infection beginning in the lungs 32, one approach to the present disclosure is to safely subject a patient's lungs 32 to differing pressures to upset the static pressure equilibrium between the P.sub.internal and P.sub.external of the virus 10. A patient 30 infected with COVID-19 (coronavirus 10) residing at sea level has an internal lung air pressure of 1 atm (the atmospheric pressure at sea level). As such, it is logical to consider that the interior 15 of the greasy bubble (lipid bilayer 12) that surrounds the coronavirus 10 is also at an internal pressure of 1 atm at sea level. The object of the pressure differential methods of the present disclosure are to increase or decrease the air pressure inside the patient's lungs 32 to compress or expand the greasy bubble (membrane 12) that surrounds the coronavirus 10 and break this greasy bubble 12 with these pressure variations/pressure differentials, thereby destroying or disabling the coronavirus. Likewise, the object of the application of ultrasonic or magnetic energy (e.g., pulsed magnetic fields) to an infected area is likewise to cause a disruption in the functionality of the virus (or other pathogen) causing the infection or affliction, such as by damaging or destroying the membrane 12 of the virus 10 or the membranes important to functionality of other pathogens.
[0102] The coronavirus 10 is surrounded by a membrane or envelope layer 12 resembling a greasy bubble (thought to be a lipid bilayer). The coronavirus 10 lodges initially in the pulmonary alveoli. In one embodiment, the method of the present disclosure comprises the use of hyperbaric chambers to permit the patient 30 with coronavirus to be subjected to various pressure differentials within the patient's lungs 32 sufficient to disrupt the virus 10.
[0103] Pressure Differential Option 1: Referring now to
[0104] Pressure Differential Option 2: Referring now to
[0105] Pressure Differential Option 3: Still with reference to
[0106] Pressure Differential Option 4: Referring now to
[0107] Although aircraft cabins 51 are pressurized, cabin air pressure P.sub.cabin at cruising altitude is lower than air pressure at sea level. At typical cruising altitudes in the range 11,000-12,200 m (36,000-40,000 feet), air pressure in the cabin is equivalent to the outside air pressure at 1800-2400 m (6000-8000 feet) above sea level. As a consequence, less oxygen is taken up by the blood (hypoxia) and gases within the body expand. The effects of reduced cabin air pressure are usually well tolerated by healthy passengers.
[0108] The medical hyperbaric oxygen therapies for COVID-19 patients are preferably carried out at about 2 atmospheres of pressure, that is, 29.38 PSI. At ground level, the ambient air pressure is a little over 14 PSI, and at a typical aircraft cruising altitude (e.g., 30,000 to 40,000 feet) the air pressure may be just 4-5 PSI. Aircraft cabins are pressurized to simulate pressure felt at 8000 feet. The pressure differential in an airplane in flight (internal vs external pressure) varies up to 9 PSI. Then from the ground pressure 1 ATM=14.69+9.00=23.69 PSI. Therefore, an aircraft can easily make pressure variations from 14.69 PSI up to 23.69 PSI. To achieve the desired 2 atmospheres of pressure for the disclosed hyperbaric oxygen treatment in a pressurized aircraft cabin, we are missing 29.38 PSI−23.69 PSI=5.69 PSI. The air pressure of the aircraft is supplied by the compressors that the aircraft has in the aircraft's engines. Typically for an aircraft in flight, pressurization of the cabins takes place via the aircraft's jet engines compressing incoming air, heating it, and then diverting some of it to the cabin (after first having been cooled and humidified using climate control systems) until the desired cabin pressure is met. The pressure is typically maintained by an outflow valve. These aircraft cabin pressure regulation systems (or cabin pressure control and monitoring systems as are well known in the aerospace industry) as well as the aircraft's fuselage, are designed with very high safety margins, therefore, an aircraft's cabin can be pressurized to 2 Atmospheres of Pressure, even more so considering the embodiments described herein that utilize the aircraft positioned on the ground (not in flight). It is during an aircraft's flight when the engines and the fuselage are subjected to great extraordinary efforts due to the altitude, aircraft speed, etc.
[0109] Alternatively, the aircraft 50 could be outfitted with one or more separate climate-controlled treatment rooms or treatment zones 54 located within the airplane fuselage 51 that are capable of independent pressure adjustment. The present disclosure therefore also contemplates the possibility of using airplane cabins, or chambers within airplane cabins for use in subjecting the patient(s) to the aforementioned pressure differentials. In one example of this embodiment, a group of coronavirus patients are brought aboard a plane. Before taking off, one can assume that the air inside the lungs of these patients is at a 1 atm, and the interior of the greasy bubbles (external membranes) that surround the coronavirus in the patient's lungs are also at a 1 atm. The cabin can then be pressurized for the comfort of the passengers, and the airplane can take off and ascend to a height of 30,000 ft above sea level. At that time, in a controlled manner, the pressure in the cabin (or in a separate treatment unit within the cabin) can be reduced. Preferentially, the drop in pressure will be controlled enough to reduce the risk of rupturing the patient's eardrum, or creating other health issues, while at the same time being of a sufficient pressure differential to cause the outer membrane of the coronavirus to rupture due to the rapid expansion of the internal pressure of the virus' external membrane. Thus, in one embodiment, one or more virus infected patients are transported in an airliner to sufficient altitudes to permit the manipulation of cabin pressure (or pressure within a treatment unit in such aircraft) sufficient to disrupt the outer membrane of the virus. In one embodiment, a traditional airliner is employed, and the patients 30 are located in existing seats 53, and are accompanied by medical personnel 38 and any required ancillary medical equipment, such as oxygen 71, ventilators, etc. In another embodiment, an airliner is specially outfitted with one or more single- or multi-person treatment chambers that can permit separate manipulation of the ambient pressures therein, while the airliner is flying at desired altitudes. In these embodiments, the desired external pressure can be applied in varying protocols, such as, steady pressure increases, pulsed pressure increases, or variations between pressure increases and pressure decreases, and the like. The methodologies of this option could likewise vary other conditions of the treatment environment, such as temperature, humidity, and the level of oxygen (e.g., intervals of 100% oxygen interrupted with short periods of lower, or ambient oxygen levels).
[0110] Referring now to
[0111] For example,
[0112] Similarly,
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[0116] Similarly, an external climate control system (e.g., heater, air conditioner, humidifier, etc.) (not shown) may be employed to provide the desired climate within the cabin or within portions of the cabin.
[0117] Referring now to
[0118] Existing aircraft are capable of creating an internal cabin pressure of, e.g., 2 ATM, are already outfitted with large seating capacities (e.g., 300 seats 52), have climate control, and have existing oxygen delivery systems along with oxygen masks available for use at each seat. This makes existing aircraft ideal for rapid adaption and deployment for use as large-scale HBOT treatment units capable of treating many patients at a time. Each aircraft 50, whether used for on-ground treatments or in-flight treatments could be outfitted as desired to create one or more isolatable treatment zones 53, for example, by installing plastic curtains 54 or the like. More serious patients could be treated in a separate zone. Patients with less or non-serious conditions could be treated in another section. In one embodiment, the patients enter the aircraft 50 on the ground via one or more passenger boarding bridges (jet bridge or jetway) 60, boarding ramps or stairs or other suitable passenger boarding systems along with the requisite medical professionals. The patients 30 are then seated in seats 52 and provided with oxygen masks 70. Medical grade oxygen is provided to the patients' masks (and as may be desired, each seat can be outfitted with the ability to control the specific level of oxygen being provided to each patient's mask). The cabin doors are closed and the aircraft cabin 51 is pressurized to the desired cabin pressure for the duration (e.g., 90 minutes) of the treatment. The cabin 51 is then depressurized, and the patients 30 exit the aircraft 50. The aircraft 51 can then be quickly readied for next use by using appropriate disinfection protocol, including changing out the masks. In this embodiment, the aircraft remains stationary on the ground, and uses an external tank source of oxygen 71 that can be replenished as needed (e.g., a stationary large tank of oxygen 71a, or a large portable tank of oxygen 72, or large-scale oxygen concentrator 75. With these large external oxygen tanks or oxygen concentrator, enough oxygen can be provided to treat hundreds of patients in a day. In another embodiment, the oxygen 78 is provided via portable oxygen concentration units 78a for each seat (or group of seats) capable of providing medical grade oxygen.
[0119] Likewise, retired aircraft can be used as on-ground HBOT treatment units 62, even if they are no longer flight worthy. In one embodiment, the retired aircraft 50 can be flown to a final destination for use, and if desired for purposes of reducing space requirements, as depicted in
[0120] Although it is envisioned that an existing aircraft can create the desired internal cabin treatment pressure while positioned on the ground, it is also envisioned that if necessary or desirable, when an aircraft's cabin is used as a stationary HBOT treatment center 62 on the ground, it could be outfitted (retrofitted) with supplemental cabin pressurization systems if desired that operate independently of the aircraft's engines.
[0121] Referring now to
[0122] As an alternative to the use of a hyperbaric chamber or mobile pressurizable treatment unit, and in connection with the potential use of a ventilator, the pressurization of the patient's lungs could be achieved via the use of a continuous positive air pressure (CPAP), positive air pressure (PAP), BIPAP (bilevel positive airway pressure), or other means for administering pressure to the airways, such as via a non-invasive helmet system. Most CPAP machines have a pressure setting range from about 6 cm/H2O to 15 cm/H2O (measured in centimeters of water pressure) with the average typically 10 cm/H2O. Specialized CPAP machines can deliver CPAP pressure up to 25 to 30 cm H2O. It is envisioned, however, that for purposes of the present disclosure, a CPAP, BIPAP, PAP, or helmet device could be modified accordingly to deliver the desired treatment pressures. In these treatment regimens, the pressure could be applied in pulses to create the pressure differentials across the virus membrane to cause the virus membrane to rupture or to otherwise interfere with the virus's functionality.
[0123] As with all of these treatment methodologies, the employment of pressure differentials on the patient would be conducted with as much control as possible so as to avoid causing any collateral damage to the patient, such as, rupturing of eardrums. For example, in typical Hyperbaric Oxygen Treatments, the air pressure in the chamber is often 1.5 to 3 times greater than ambient air pressure. Most typical indications for HBOT involve the use of hyperbaric pressures above 2.0 atm. Higher atmospheric pressures are generally required to treat conditions such as carbon monoxide poisoning and to improve wound healing. The pressure increases in the present treatment methods are envisioned to range from greater than 1 atm to about 7 atm, again depending on the general physical condition of the patient. When applying the increased pressure treatments, it is preferred to gradually increase the pressure up to the maximum desired value. When placing a patient in a vacuum or partial vacuum atmosphere, it is likewise envisioned that 0.5 atm, 0.4 atm, etc. could be utilized according to the tolerances of the patient's body.
[0124] In addition to the use of pressure differentials to destroy the virus, it is also contemplated that these pressure differentials can also cause interference with the virus' ability to effectively interact with the ACE2 receptor functionality. It is also contemplated that these pressure differentials could potentially enhance the effectiveness of statins or ACE2 inhibitors or otherwise reduce risks associated with blood clotting that has been experienced in patients infected with COVID-19. Furthermore, it is also contemplated that these pressure variations can disrupt the virus' ability to adversely affect endothelial cell functions. It is also contemplated that the use of these pressure differentials could enhance other treatment regimens used to combat the virus in an infected human.
[0125] Although many of the teachings herein focus on the treatment of patients experiencing an active infection, the methodologies taught herein have equal applicability to post-infection therapy to treat or minimize the occurrence of post-infection syndrome. It is further envisioned that the treatment methods described herein could employ variations in the oxygen levels administered during the HBOT treatment, for example, by providing the patient with intervals of 100% oxygen followed by intervals of ambient air.
[0126] Furthermore, it is likewise envisioned that the hyperbaric chamber described herein could comprise a pressurized body suit (not shown) worn by the patient.
[0127] Referring now to
[0128] Referring now to
[0129] Referring now to
[0130] Referring now to
[0131] Thus, the mechanosensitive nature of the coronavirus can provide a unique opportunity to design ultrasonic therapies that target infected tissue and disrupt or disable the virus. In this respect, recent studies have shown that the Inventors' proposed ultrasonic (ultrasound) cavitation method for treatment of humans infected with a virus such as one in the coronavirus family, has theoretical promise as a means for deactivating or disrupting the coronavirus' functionality. For example, researchers at MIT (Wierzbicki et al.) recently published research concluding that simulations show that ultrasound waves at medical imaging frequencies can cause the virus' shell and spikes to collapse and rupture. See, Tomasz Wierzbicki, Wei Li, Yuming Liu, Juner Zhu, Effect of receptors on the resonant and transient harmonic vibrations of Coronavirus, J. Mechanics and Physics of Solids, Vol. 150, 2021, 104369, ISSN 0022-5096, https://doi.org/10.1016/j.jmps.2021.104369. (https://www.sciencedirect.com/science/article/pii/S0022509621000600)(incorporated herein by reference). Focused ultrasound has also recently been proposed for use in treating patients with Parkinson's disease. See Martinez-Fernández et al. Randomized trial of focused ultrasound subthalamotomy for Parkinson's disease, N Engl J Med December 2020; 383:2501-2513 DOI: 10.1056/NEJMoa2016311. The use of ultrasound or ultrasonic cavitation procedures for treatment of the active virus could also be enhanced with the combined use of focused ultrasound and MRI to permit focused therapies in the regions of the body requiring the treatment. See also Arvanitis et al., Combined ultrasound and MR imaging to guide focused ultrasound therapies in the brain. Phys. Med. Biol. 58 (2013) 1-13; and Sirsi S R, Fung C, Garg S, Tianning M Y, Mountford P A, Borden M A. Lung surfactant microbubbles increase lipophilic drug payload for ultrasound-targeted delivery. Theranostics. 2013; 3(6):409-419. Published 2013 May 20. doi:10.7150/thno.5616 (noting that at higher ultrasound intensities, excess lipid was observed to be acoustically cleaved in connection with targeted drug release therapies). It is preferable to use the ultrasonic therapies of the present disclosure in a guided (focused) fashion so that the unhealthy tissues could be targeted while avoiding to the greatest extent possible, the healthy tissues. Further, the ultrasonic methods of the present disclosure could also employ the use of nanoparticles or nano-bubbles to target the infection-damaged tissue. The use of low-intensity pulses of ultrasound can target the infected tissue.
[0132] Additionally, although the above pressure differential methods have focused on creation of pressure differentials across the virus membrane, it is envisioned that other treatment regimens could be utilized in parallel to enhance the potential for rupture or disabling of the virus. For example, given that one of the primary points of introduction of the virus is through the respiratory system, perhaps any number of influencers could be used with pressure. For example, most fluid-like “bubble” structures have a certain surface tension that causes the layer to behave somewhat like an elastic sheet, there being an optimal surface tension for bubble stability. It is therefore envisioned that factors external to the virus can be introduced, e.g., into the lungs, that can disrupt the surface tension of the virus wall to enhance the effects of the pressure differential and thereby enhance the likelihood of the virus membrane rupturing or becoming disabled. For example, temperature and humidity could be varied and optimized to place the virus membrane at highest risk of rupture. Also, use in connection with known inhalers, such as those used in the treatment of asthma and COPD, e.g., corticosteroid inhalers (such as fluticasone), and bronchodilator inhalers (such as albuterol) and those inhalers infused with nasal decongestants (including natural menthol and camphor-based products) might assist in enhancing the vulnerability of the virus membrane to rupture. Other natural inhalable substances, e.g., herbal inhalers, aromatherapeutics, etc. could be used in connection with the pressure treatments. Additionally, treatments used for clearing mucus plugs in the lungs might be useful in altering the virus surface tension to promote rupture or disabling of the virus membrane by the desired pressure differential.
[0133] For example, inhalable medical-food grade alcohol (EtOH) or the like, e.g., administered as a vapor, (at desired temperatures), as nebulized aerosol, mist, alone or in combination with air or oxygen, etc. into a patient's lungs in a controlled treatment regimen could also have a disruptive impact on the functionality of exposed virus located within the patient's lungs and serve as a valuable treatment regimen against COVID-19 or other virus located in the lungs. Use of this form of treatment, under controlled conditions, is thought to address any known concerns about this type of alcohol consumption becoming addictive. Research suggests that a controlled treatment with inhalable alcohol (as opposed to recreational use of the same) poses a negligible health risk associated with alcohol inhalation. See, e.g., MacLean R R, Valentine G W, Jatlow P I, Sofuoglu M. Inhalation of Alcohol Vapor: Measurement and Implications. Alcohol Clin Exp Res. 2017; 41(2):238-250. doi:10.1111/acer.13291. As such, vaping of EtOH vapor (or other administration of EtOH vapor into the lungs) has application as a means for contacting and disrupting a virus present within a patient's lungs. In this embodiment, the EtOH vapor could be delivered to the patient through suitable delivery methods, e.g., ventilator, mask, inhaler, etc. This methodology could be used alone or in combination with other methods described herein, e.g., during HBOT treatment, etc. See also, Feinberg, Alec. (Jul. 14, 2020). The Use of Alcohol Inhalation in Ventilators or Other Suitable Apparatus for the Treatment of Covid-19. 10.13140/RG.2.2.30657.38248/2.
[0134] It is further envisioned that the treatment methods described herein could employ variations in the oxygen levels administered during the HBOT treatment, for example, by providing the patient with intervals of 100% oxygen followed by intervals of lower oxygen levels, such as those in ambient air. These high oxygenation intervals followed by intervals of rapidly decreased oxygen are thought to enhance the overall effectiveness of HBOT therapies.
[0135] There is also disclosed a method of treating a living subject infected with a virus or other pathogen by the administration of magnetic forces, such as those provided by Magnetic Resonance Imaging (MRI) magnetic fields, pulsed magnetic fields, rotating magnetic fields, alternating magnetic fields, oscillating magnetic fields, dynamic magnetic fields, magnetic nanoparticles, and magnetic hyperthermia. Use of MRI and magnetic fields avoids the safety concerns encountered with radiotherapy. During the COVID-19 pandemic, medical professionals relied on MRI to provide scans of, e.g., a patient's lungs as a tool for the diagnosis of the COVID-19 infection. See, e.g., Vasilev Y A, Sergunova K A, Bazhin A V, Masri A G, Vasileva Y N, Semenov D S, Kudryavtsev N D, Panina O Y, Khoruzhaya A N, Zinchenko V V, Akhmad E S, Petraikin A V, Vladzymyrskyy A V, Midaev A V, Morozov S P. “Chest MRI of patients with COVID-19.” Magn Reson Imaging. 2021 June; 79:13-19. doi: 10.1016/j.mri.2021.03.005. Epub 2021 Mar. 13. PMID: 33727149; PMCID: PMC7955570. In the study by Vasilev et al., all patients underwent magnetic resonance imaging (MRI) examinations using MR-LUND PROTOCOL: Single-shot Fast Spin Echo (SSFSE), LAVA 3D and IDEAL 3D, Echo-planar imaging (EPI) diffusion-weighted imaging (DWI) and Fast Spin Echo (FSE) T2 weighted imaging (T2WI).
[0136] Although the American College of Radiology suggested that the use of MRI be severely limited during the pandemic due to concerns over transmission of the virus, other MRI facilities suggested that patients in need of an MRI for its conventional uses not delay obtaining such MRI, and noted the extraordinary sanitization steps being taken to protect against spread of the virus. Further, the U.S. Food and Drug Administration (FDA) issued important guidelines recommending that patients undergoing MRI during the pandemic wear a non-metallic mask.
[0137] Viruses are typically composed of the following three parts providing it with its structure: a nucleic acid genome (genetic material, e.g., RNA), a protein which encases the nucleic acid and aids in the virus' replication inside a host cell, and a fatty outer layer of lipids. However, there are no covalent bonds involved, but rather, the viral self-assembly is based on weak “non-covalent” interactions between the proteins, RNA and lipids. The coronavirus comprises weak non-covalent bonds where Van der Waals forces weakly assist in holding it together. Van der Waals forces are weak intermolecular forces caused by attractions between very small dipoles in molecules. Polar molecules have permanent dipole-dipole interactions, and non-polar molecules can interact by way of Van der Waals (or London dispersion) forces.
[0138] Virus inactivation in vitro by radiation therapy (radiotherapy) is a known technique, the required dose being of the order of the Mrad, i.e., 10 kGy, but this treatment method could cause further complications if directed to a patient's lung already damaged by the COVID-19 infection, and further would be difficult to target the virus, or if a large area of the lungs is affected, would likewise be difficult to treat. It has further been suggested that rotating magnetic fields could potentially be applied in COVID-19 antiviral treatments. For example, Shallcross, U.S. Patent Application Publication No. 2006/0049110 teaches a device and method for purifying water and other substrates, such as surgical instruments, from pathogens, such as, bacteria, viruses, fungi, parasites and worms, utilizing at least one magnet mounted in rows on the faces of a block for rotation on a shaft, and a means to rotate the shaft, the method of treatment being carried out by rotating the shaft and bringing the object to be treated in close proximity with the magnets. Further, Liang, U.S. Patent Application Publication 20190240498 presents methods for targeting and killing types of cells or organisms using Magneto-Electric Nano-Particles under the control of an external magnetic field. A method was also presented for using Magneto-Electric Nano-Particles to stimulate or rejuvenate cells under an external magnetic field. One aspect of the Jiang's work provides a method for disrupting, or killing bacteria or viruses comprising (i) coating, binding or conjugating Magneto-Electric Nano-Particles (MENPs) with a guiding agent that specifically binds to a targeted bacterium or virus to produce Guiding-Agent-Conjugated MENPs (GAC-MENPs), (ii) binding the targeted bacteria or viruses with the GAC-MENPs, and (iii) applying a magnetic field to the GAC-MENPs to generate an electric field for disrupting or killing the targeted bacteria or viruses.
[0139] It has also been reported that exposure to oscillating magnetic fields has potential for the treatment of malaria by damaging the malaria parasite. See Harrill, R., UW News, Mar. 3, 2000, Magnetic fields may hold key to malaria treatment, UW researchers find, www.washington.edu/news/2000/03/30/magnetic-fields-may-hold-key-to-malaria-treatment-uw-researchers-find/, last accessed 7/3/2021. It has further been reported that the cutaneous leishmaniasis (CL) parasite can potentially be treated by having iron nanoparticles taken up by macrophages in the host, and then subjecting the nanoparticles to oscillating magnetic fields to cause localized heat to destroy the parasite. See Price, H., BMC, Can we treat leishmaniasis with tiny magnets? (Mar. 22, 2019), https://blogs. biomedcentral.com/bugbitten/2019/03/22/can-we-treat-leishmaniasis-with-tiny-magnets/—Last accessed 7/3/2021.
[0140] In the current methodology, a patient with an infection, such as the COVID-19 infection (or other pathogenic infection or malady), could be treated via exposure to magnetic fields, such as a pulsed magnetic field, a rotating magnetic field or the magnetic field present in an MRI, etc., for various treatment periods. In one embodiment, for example, the MRI would first be used in a conventional manner as a diagnostic tool to locate the source of the infection, e.g., in one or more of the patient's lungs, in the brain, cardiovascular areas, eyes, kidneys, etc. as has been used in the past. If a patient has already been diagnosed as being infected with the pathogen, and is suffering respiratory distress (in one or both lungs), then the use of the MRI treatment could begin on the affected lung(s) without the need to first run a diagnostic MRI. The diagnostic capabilities of the MRI could also be used secondarily to monitor the effectiveness of the MRI treatments on, e.g., reducing the area of infection (with other diagnostic tools being used to test for positive presence of the infection). In one embodiment, the patient is treated with a conventional MRI unit. In another embodiment, the patient is treated with a point-of-care (POC) MRI that can be readily transported to the patient's bedside.
[0141] Additionally, guided ultrasound procedures noted above could be employed in tandem with MRI, where the MRI is used not only to provide imaging of the tissues being treated, but can also be used itself to treat the infected tissue. Thus, the hybrid approach of MRI-guided ultrasound (cavitation) procedures could cause a dramatic disruption of the virus functionality (e.g., disruption of its outer membrane).
[0142] Additionally, although the treatment methodologies noted herein have focused on the treatment of patients with COVID-19 infections and the side effects thereof (post-COVID syndrome or long-haul COVID-19), these treatment methodologies and systems have application for use in the treatment of wounds or other illnesses. For example, aircraft-based HBOT treatment units can treat many patients at a time. Thus, it is envisioned that these mobile units could be deployed anywhere in the world for use in treating large numbers of patients desiring or requiring HBOT treatment for any particular disease. This is particularly advantageous with respect to simultaneous treatment of a large number of patients that are not presently harboring an infectious disease, thereby providing mass treatment capabilities without enhanced risk of spreading an infection within the treatment unit.
[0143] The above methods directed to treating humans (one type of subject patient) afflicted with a pathogenic disease could likewise be employed to treat other subject patients, namely, animals, plants, bee hives (pollinating bees), and the like suffering from a pathogenic disease. It will be understood that although the treatment methods herein have been described for use with human patients, where applicable, it is envisioned that such methods could be used on other subject patients, such as animals, livestock, beneficial insects, e.g., bees, and plant life as well. Furthermore, it will likewise be understood that the above methods can be used alone or in combination with other of the above methods. For example, treatment of pathogenic disease with ultrasonic cavitation or ultrasound can also be combined with magnetic field therapies, hyperbaric chamber use as described herein, and/or HBOT therapies. Also, a hyperbaric chamber or a pressurized airplane cabin, can be employed with combinations of fluctuating temperature, humidity and/or pressure to weaken or disable the pathogen, and can further be combined with ultrasonic/ultrasound and/or magnetic field therapies. As yet another example, treatment of pathogenic disease with magnetic field therapy can also be combined with the use of ultrasound/ultrasonic cavitation and/or the use of a hyperbaric chamber as described herein to create pressure differentials, etc.
[0144] All references referred to herein are incorporated herein by reference. While the apparatus, systems and methods of the present disclosure have been described in terms of preferred or illustrative embodiments, it will be apparent to those of skill in the art that variations may be applied to the processes and systems described herein without departing from the concept and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope and concept of the invention. Those skilled in the art will recognize that the methods and apparatus of the present invention has many applications, and that the present invention is not limited to the representative examples disclosed herein. Moreover, the scope of the present invention covers conventionally known variations and modifications to the system components described herein, as would be known by those skilled in the art.