Abstract:
A system for administering a treatment to individuals infected with a virus such as hepatitis. The system includes an enclosure and at least one gas supply that is used to create an altered atmospheric environment within the enclosure. The patients walk into the enclosure, the super-atmospheric environment is created with the gas, and the patients remain in the super-atmospheric environment for a predefined length of time. The individuals are subsequently returned at a safe rate to normal atmospheric pressure. The treatment can be repeated daily, monthly or annually depending on the needs of the patient. The system includes a control unit that stores and runs at least one treatment program that helps determine treatment variables such as amount of pressure, length of time and the type of gas or gases. It is believed that the present viral treatment may be able to be used in combination with medications and other viral treatments.

Description:
[0001]     The present invention was originally disclosed in U.S. provisional patent application Ser. No. 60/685,110 filed on May 27, 2005, and priority is claimed to the provisional patent application. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention relates generally to the field of treatment of viruses and more specifically to a novel treatment for hepatitis.  
         [0003]     Viruses are infectious agents found in virtually all life forms, including humans, animals, plants, fungi, and bacteria. Viruses consist of genetic material, either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), surrounded by a protective coating of protein, called a capsid. Some viruses also include an outer lipid envelope. Viruses are between 20 and 100 times smaller than bacteria and hence are too small to be seen by light microscopy. Viruses vary in size from the largest poxviruses of about 450 nanometers (about 0.000014 in) in length to the smallest polioviruses of about 30 nanometers (about 0.000001 in). Viruses are not considered free-living, since they cannot reproduce outside of a living cell. Viruses have evolved so that they are able to inject their genetic information into a host cell and use the host cell&#39;s internal machinery for the purpose of replication.  
         [0004]     Viruses often damage or kill the cells that they infect, thereby causing disease in infected organisms. A few viruses stimulate cells to grow uncontrollably and produce cancers. Although many infectious diseases, such as the common cold, are caused by viruses, there are no cures for these illnesses. The difficulty in developing antiviral therapies stems from the large number of variant viruses that can cause the same disease, as well as the inability of drugs to kill a virus without also killing healthy cells.  
         [0005]     Hepatitis A is a liver disease caused by the hepatitis A virus. Hepatitis A can affect anyone. In the United States, hepatitis A can occur in situations ranging from isolated cases of disease to widespread epidemics. Good personal hygiene and proper sanitation can help prevent hepatitis A. Vaccines are also available for long-term prevention of hepatitis A virus infection in persons 2 years of age and older. Immune globulin is available for short-term prevention of hepatitis A virus infection in individuals of all ages.  
         [0006]     Hepatitis B is a serious liver disease caused by the hepatitis B virus (HBV). The hepatitis B virus can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. Hepatitis B vaccine is available for all age groups to prevent hepatitis B virus infection.  
         [0007]     Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). Those at risk for hepatitis C include those that: have been notified that they received blood from a donor who later tested positive for hepatitis C; have ever injected illegal drugs; received a blood transfusion or solid organ transplant before July, 1992; were a recipient of clotting factor(s) made before 1987; have ever been on long-term kidney dialysis; and, have evidence of liver disease (e.g., persistently abnormal ALT levels).  
         [0008]     Hepatitis D is a liver disease caused by the hepatitis D virus (HDV), a defective virus that needs the hepatitis B virus to exist. Hepatitis D virus (HDV) is found in the blood of persons infected with the virus.  
         [0009]     Hepatitis E is a liver disease caused by the hepatitis E virus (HEV) transmitted in much the same way as hepatitis A virus. Hepatitis E, however, does not occur often in the United States. While vaccines are available for some of the hepatitis viruses, the vaccines only prevent a healthy individual from becoming infected with the virus. Once an individual is infected with the virus, the currently available treatments provide only limited effectiveness.  
         [0010]     Applicant&#39;s research, in a related field, showed that exposing patients to super-atmospheric conditions strengthened the patients&#39; immune systems. Atmospheric pressure can be thought of as the amount of pressure the environment surrounding an individual exerts on the individual. If the person is at sea-level elevation, meaning zero elevation, the person will experience approximately 1 atmosphere (atm) of pressure. A super-atmospheric condition exists when the atmospheric pressure is above 1 atmosphere (atm). Super-atmospheric conditions exist in nature, such as underwater, and can also be created artificially, such as in the fuselage of passenger airliners during flight. Hyperbaric chambers have traditionally been used to treat scuba divers that ascended from their dive too fast and subsequently come down with a painful syndrome called the bends, wherein nitrogen gas bubbles are created in the diver&#39;s bloodstream. Hyperbaric chambers are another example of artificially created super-atmospheric conditions. In the case of the bends, the hyperbaric chamber recreates the super-atmospheric pressure that the diver was under while diving. In the super-atmospheric conditions, the nitrogen is allowed to safely diffuse back into the diver&#39;s body. Most of the nitrogen is removed from the diver&#39;s body through normal respiration. Traditional hyperbaric chambers are simple one-room air locks that can be pressurized with regular air. Newer chambers that provide for the introduction of oxygen, have found widespread use in the treatment of wound healing. Traditional wound healing, using oxygen under pressure, is conducted within an environment of 2.4 atm, which is equal to a depth of 45 feet.  
         [0011]     What is needed in the field is a comprehensive system that can support testing the efficacy of treating the many forms of Hepatitis as well as other viruses with super atmospheric conditions. The ideal system would be able to treat a large number of patients at a relatively low cost.  
       SUMMARY OF THE INVENTION  
       [0012]     A system that is adapted to strengthen the immune system of an individual. The system comprises an enclosure, a gas supply, a monitoring network and a control system. The enclosure has at least one air-lock that is able to sustain super-atmospheric conditions. The gas supply includes gas supply hardware that connects the gas supply to the enclosure. The gas supply may include one gas or a combination of gases. The monitoring network is used to monitor the statuses of the enclosure, the gas supply, and the gas supply hardware. The control system is connected to the monitoring system and includes at least one display screen that is capable of displaying the statuses of the different parts of the system. The control system also includes at least one processor and at least one memory. The control system is capable of controlling the pressure and the concentration of gas in the enclosure. A treatment program can be temporarily stored in the memory of the control system and executed by the processor. The treatment program is associated with a content of the gas supply, and can be used to define the pressure to be achieved within the enclosure and the duration of time for maintaining the pressure.  
         [0013]     The enclosure may comprise multiple air-locks wherein each air-lock is connected to the monitoring network and to the gas supply. The control system is able to control the pressure within each air-lock. The pressures can range from below atmospheric to many times greater that atmospheric pressure. The system may also include more than one gas supply, wherein each gas supply is connected to the gas supply hardware, the monitoring network and the control system. The control system can control the concentration of gas in each of the multiple air-locks. The control system also preferably includes a permanent storage device and the treatment program can be stored on the permanent storage device. The control system may optionally include an Internet connection and a remote control software module that allows a remotely located computer to access and control the system via the Internet. The pressures within the enclosure may range between 0.75 to 20 or more atmospheres, and the duration of time for sustaining the pressure is preferably between 15 and 60 minutes.  
         [0014]     It is an object of the present invention to provide a treatment that strengthens a person&#39;s immune system so that the person&#39;s immune system is better able to fight off diseases, especially viral diseases.  
         [0015]     It is another object of the present invention to provide an apparatus for administering the present treatment.  
         [0016]     It is a further object to provide an apparatus that will create an environment of predetermined gas mixtures and surrounding pressure that will enhance the administration of therapeutics agents or other efficacious treatments. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]     The invention of the present application will now be described in more detail with reference to the accompanying drawings, given only by way of example, in which:  
         [0018]      FIG. 1  shows an exemplary apparatus for administering the present treatment;  
         [0019]      FIG. 2  shows a mobile apparatus for administering the present treatment;  
         [0020]      FIG. 3  shows an alternative apparatus for administering the present treatment;  
         [0021]      FIG. 4  shows another alternative apparatus for administering the present treatment; and,  
         [0022]      FIG. 5  is a flow chart showing exemplary steps of the present treatment. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]      FIG. 1  shows an exemplary apparatus  100  for administering the present viral treatment. Enclosure  105  is used to create a super-atmospheric environment, which is the preferred delivery means for the present treatment. The enclosure  105  includes a first air-lock  110  and a second air-lock  120 . Each air-lock  110  and  120  is a room that is capable of being sealed and pressurized to at least 10 atmospheres, which is equal to a depth of approximately 300 feet. The second air-lock  120  is the primary treatment room and preferably includes beds, benches or chairs for the patients to use during the treatment. The first air-lock  110  is a safety room that allows an assistant to enter to the second air-lock  120 , if needed. The patients enter the enclosure  105  through seal-able door  115  and then enter the second air-lock  120 , or treatment room, through a second seal-able door  125 . Once the patients are inside the second air-lock  120  the seal-able door  125  is closed and sealed. Control unit  150  is then used to start the flow of gas from the gas supply  130  into the second air-lock  120 . Control unit  150  sends a “start” signal to the gas flow switch  135 , which starts the flow of gas through the gas flow pipe  140  into the treatment room, air-lock  120 . Gas flow switch  135  and gas flow pipe  140  can collectively be referred to as the gas supply hardware. Control unit  150  is preferably programmed with the atmospheric pressure to be obtained and automatically sends a “stop” signal to the gas flow switch  135  when the desired pressure has been obtained inside the second air-lock  120 . A control and monitoring network  145  connects the control unit  150  to a set of sensors and to the gas flow switch. At least one sensor is provided inside each of the air-locks  110  &amp;  120  in the enclosure  105 . The sensors inside the air-locks provide information, including interior pressure and gas concentrations, to the control unit  150 . Other sensors are used to monitor the statuses of the seal-able doors  115  &amp;  125 , the gas supply  130 , the gas flow switch  135 , and within the gas delivery hoods that are discussed in conjunction with  FIG. 4 . All information received from the sensors can be displayed on the screen of the control unit  150 . Of course, the control unit  150  may also include LED lights and analog gauges to display the sensor information. Once the desired pressure and gas concentration has been obtained in the second air-lock  120 , the patients remain in the air-lock  120  for a predefined length of time. The present treatment includes the use of pressures that are three and four times greater than current therapies. The predefined length of time is determined by the treatment program and is based on the pressure and gas, or gas mixture, to be used during the treatment. The control unit  150  can be programmed with the desired length of time so that at the end of the desired length of time an alert is sounded and/or displayed indicating it is time to start decompression. When the desired length of time has passed, the pressure inside the second air-lock  120  is slowly released so that the patients are safely returned to a normal atmospheric environment (1 atmosphere). Preferably, decompression is started automatically by the control unit  150  at the end of the predefined length of time. Decompression tables that define safe decompression rates are widely available. The control unit  150  is preferably programmed with at least one of these decompression tables and uses this stored information to control the rate at which the pressure is released from the second air-lock  120 . Once the environment within the second air-lock  120  has been reduced to normal, the sealable doors  125  &amp;  115  can be opened and the patients are free to exit the enclosure  105 . Gas supply  130  preferable contains nitrogen gas. However, other gases and combination of gases may also be used. The amount of oxygen in the second air-lock  120  at the beginning of the treatment is usually enough to sustain the needs of the patients. This is true because the percentage of oxygen required by humans is inversely proportional to the atmospheric pressure. Thus, as the pressure increases in the air-lock  120  the percentage of oxygen required by the patients decreases. Of course, the amount of oxygen in the air-lock  120  may be supplemented when needed, as in when large numbers of patients are treated at the same time or when the patients spend an extended length of time in the air-lock. The current preferred length of time for remaining in the super-atmospheric environment is approximately 40 minutes. However, it is believed that shorter lengths of time at pressure will also prove to be useful. The preferred super-atmospheric environment is at least 5 atmospheres. However, it is anticipated that higher super-atmospheric environments will also prove to be beneficial.  
         [0024]     The control unit  150  may also be connected to a network  155  such as the Internet. Connection to a network  155  allows monitoring of the present treatment from remote locations. The control unit  150  may also include a remote control software module that further allows the apparatus  100  to be controlled from a remote location. The control unit  150  preferably includes a treatment program that defines all of the steps for carrying out the present treatment. In the preferred embodiment, after the patients have entered the treatment room, an administrator simply presses a button on the control unit  150  and the desired treatment is automatically administered by the apparatus  100  under the control of the control unit  150 . Of course, whether the control unit is operated locally or remotely, an administrator should always be present to handle any emergencies and to provide instructions to the patients. The present treatment is directed toward combating the various forms of Hepatitis. However, the treatment may also be used to combat other viruses as well. It is believed that, under pressure, atoms in the gas strengthen potential host cells in the patient and prevent the virus from taking over the replication machinery of the host cells and thereby prevents the virus from replicating. While the virus may be able to attach to the cell wall of a host cell and inject its genetic information into the host cell, once inside, the present treatment prevents the virus&#39; genetic information from taking control of the replication hardware of the cell, as normally occurs. Mammalian cells have evolutionarily developed an inherent mechanism (the “silencing RNA”, or iRNA apparatus) to sequester potentially damaging viral genetic material and preclude their fatal consequences. It is possible that the present treatment/apparatus may simply be harnessing that corrective capacity within the invaded cell. Applicant further proposes that the present treatment also strengthen the walls of the host cells thereby stopping the virus before it even enters the host cell. It is believed that the present treatment strengthens cell walls to the point that viruses are simply unable to penetrate the cell walls and inject their genetic material for subsequent replication. In either case, the virus is prevented from replicating and the number of virus particles in the patient&#39;s body eventually decreases and the patient&#39;s immune system is able to effectively deal with the remaining virus particles.  
         [0025]      FIG. 2  shows a mobile apparatus  200  for administering the present treatment. The mobile apparatus  200  comprises tractor  210  and trailer  205 , which are used to transport the exemplary apparatus  100 . The mobile apparatus  200  can be used to treat viral patients in remote areas where the local population does not have access to traditional treatment facilities. The trailer  205  can be enclosed, as is shown in  FIG. 2 , or the trailer could also be a simple flatbed trailer, in which case the exemplary apparatus  100  would be exposed for passersby to see. The exemplary apparatus  100  is used to administer the present treatment in the same manner as described above, with the gas supply  130  being used to create a super-atmospheric environment within air-lock  120 , while all operations are monitored and controlled by the control unit  150 .  
         [0026]      FIG. 3  shows an alternative apparatus  300  for administering the present viral treatment. In  FIG. 3 , a submarine  305  is used to provide multiple enclosures for creating super-atmospheric environments. A submarine  305  is a good choice for treating large numbers of patients because submarines are large and they are built for withstanding great amounts of pressure. In this example, three levels of the submarine  305  are used to provide three separate treatment facilities. Air-locks  315  &amp;  320  are provided on the top level and control room  310  is used to monitor and control the operations of the air-locks  315  &amp;  320  on the top level. Air-locks  330  &amp;  335  are provided on the middle level and control room  325  is used to monitor and control the operations of the air-locks  330  &amp;  335  on the middle level. Air-locks  345  &amp;  350  are provided on the bottom level and control room  340  is used to monitor and control the operations of the air-locks  345  &amp;  350  on the bottom level. The gas supplies  355  for the multiple air-locks are consolidated on the middle level in this example. In other embodiments, the gas supplies can be distributed so that they are co-located with the air-locks that they service. The gas supply hardware and the control and monitoring network are not shown for clarity purposes, however each air-lock is connected to the gas supply  355  and each air-lock is also connected to a control and monitoring network. The primary treatment rooms, air-locks  320 ,  335  &amp;  350 , can each be used independently to provide different treatments, meaning different pressures, different gas concentrations and different lengths of time at pressure. Alternatively, control room  310  could be used to control the operations of all of the air-locks, so that a large number of patients can be treated with a relatively small number of staff personnel, or administrators. The treatment provided by this alternative apparatus  300  is the same as that described above, with at least one gas being used to create a super-atmospheric environment and having the patients remain in the super-atmospheric environment for a predefined length of time.  
         [0027]      FIG. 4  shows another alternative apparatus  400  for administering the present treatment. Apparatus  400  is a modification of the exemplary embodiment  100  shown in  FIG. 1 . In apparatus  400 , a second gas supply  405  is provided. The second gas supply  405  is fed to the air-lock  120  where the patients are located, via flow switch  410  and flow pipe  415 . The second gas is delivered directly to the patients via supply tubes  420  and gas delivery hoods  425 . The apparatus  400  of  FIG. 4  can be used when the gas to be inhaled by the patients is an expensive gas or gas mixture. In this case, a less expensive gas, such as air, is used in gas supply  130  to pressurize the interior of air-lock  120 . The more expensive gas from the second gas supply  405  is then delivered directly to the patients via hoods  425 . The direct delivery device is preferably a hood that substantially covers the head of the patient. However, the direct delivery device could be a partial hood or, a full or partial mask that is connected to the supply tubes  420 . This variation on the present gas administration treatment also allows sensor monitoring of an individual patient&#39;s gas and the incorporation of a gas-retrieval device to recover exhaled gases when extremely expensive (or short supply) gases are being breathed.  
         [0028]      FIG. 5  is a flow chart showing exemplary steps of the present viral treatment. In step  500  the patient or patients enter the enclosure, have a seat in the treatment room, the door to the air-lock is closed and the treatment room is sealed. Each patient has previously been screened to make sure they are healthy enough to endure the super-atmospheric conditions to which they will be exposed, and so that the amount of virus in their body, called their viral load, is known. In step  505 , a gas or gas mixture is added to the enclosure and pressurization begins. The preferred gas is a specific non-air gas mixture, however a single gas and combinations of gases may also be used in other embodiments. In step  510 , the gas is continually added until a desired super-atmospheric environment is achieved within the enclosure. The present treatment may require creating a super-atmospheric condition that is equal to a diving depth of over 250 feet. In step  515 , the treatment program checks to see if a second gas supply is required. If a second gas supply is to be used, then the flow of the second gas is started in step  520 . If there is no second gas to be used, then the program moves to step  525 , in which the patients remain in the enclosure, within the super-atmospheric environment, for a predefined length of time. The current preferred length of time is 40 minutes however, other lengths of time may be used and similar results may be achieved by using higher pressures, and/or different gas mixtures, for shorter lengths of time. For example, a super-atmospheric environment of 6 atmospheres may achieve similar results with only 20 minutes of exposure. In step  530 , after the predefined length of time has passed, the enclosure is returned to normal pressure, 1 atmosphere. The pressure is released from the enclosure at a rate that is consistent with well-known decompression tables so that the patients are not harmed. In order to insure there are no incidences of decompression sickness, or the bends, operators of the present system will have to be trained and certified for its operation. Certification may include training in various changes in a compression-decompression “profiles” mandated by the composition of the specific gas mixture employed. In step  535 , the doors of the enclosure are opened, the patients walk out the enclosure and their treatment is over for that day. It may be possible to treat a patient with only one exposure to the super-atmospheric environment, however the preferred treatment regimen dictates that daily exposures be repeated for five to seven days. Treatments can be personalized and some patients may require more or less days of exposure. Depending on the effectiveness of the above method, some patients may require exposures that are repeated monthly or yearly.  
         [0029]     The therapeutic gases used the present treatment have the ability to cross the blood-brain barrier and therefore is able to treat all areas of the patient&#39;s body. Current retroviral therapies do not have this ability. The present treatment may also be used in combination with other viral therapies. It is believed that by augmenting traditional therapies, such as prescribed drugs, with the present treatment that the patient may be able to reduce the total amount of prescribed drugs needed to maintain his health. With the severe side effects associated with many prescription drugs, any reduction in the total number of pills the patient has to take every day will greatly benefit the patient.  
         [0030]     The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept. For example, the control unit and the gas supply could be integrated with the enclosure to provide a single unit for carrying out the present treatment. Further, the enclosure is not required to have rounded corners and, structures that resemble traditional buildings could also be used as the enclosure. Therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology of terminology employed herein is for the purpose of description and not of limitation.