Prevention and treatment of skin and nail infections using germicidal light

A technique of treatment and prevention of parasitic infections that exist on, or just under, the skin and nails of a person comprising electromagnetic radiation to inactivate the germs thus making them harmless. The treatment includes irradiating an area of the skin and claws for a period of time long enough to inactivate the organisms. Some additional attributes that aren’t essential to the treatment but boost the protection of the treatment include protecting of non-infected areas from irradiation along with a cover to prevent damage to sight which may result from viewing the electromagnetic radiation.

 

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BACKGROUND

 

 
1. Field of Invention
 

 
This invention relates to preventing and treating nail and skin infections with germicidal radiation to inactivate and kill pathogens which cause such infections.
 

 
2. Background of the Invention
 

 
The germicidal effects of particular types of light have been known for many years. As early as the late 1890’s specific types of ultraviolet light were discovered to possess a germicidal effect. However, the wavelengths of light utilized to begermicidal have very little power to permeate that limited their usefulness in treating illnesses. The most germicidal group, branded UVC and extending out of 240 to 280 nm, is completely absorbed by the air before it reaches the Earth’s surface.Published research indicates that UVC can only penetrate skin around 0.1 mm. Although germicidal light was discovered useful to sterilize air or water and to take care of challenging surfaces such as laboratory benches, its insufficient penetration made it look unsuitableto treat skin and nail infections.
 

 
Niels Finsen received the 1903 Nobel Prize in Medicine for his discovery that light in the ultraviolet region can be used as a treatment for skin tuberculosis, an extremely serious disease at that moment. The remedy as described from the 1903 Nobel Prizeacceptance address consisted of concentrating the rays of sunlight and eliminating its more heat generating rays or employing a carbon arc lamp. The skin is subjected to one hour or so until it becomes inflamed and red. This treatment was repeated asnecessary before skin scarred over and then afterwards grew in clear. The treatment was described as having no unpleasant consequences, but was expensive, and required constant supervision. The mild used had an extremely low percentage of UVC and it had been thoughtthat the main effect of the light used was to stimulate the body’s natural defenses. It had been thought that germicidal light couldn’t effectively penetrate the skin to treat the disease but the primary purpose of the mild was supposed to excite the body’snatural defenses.
 

 
This sort of treatment for skin tuberculosis and lots of other skin ailments continued throughout the 1950’s but was finally replaced by the usage of antibiotics. Early usage of ultraviolet light was much more of an art than a science. In theearly 1900’s science was only beginning to form its contemporary concept of the composition of the science of genetics has been many decades off. Thus researchers did not have the theoretical knowledge of the way germicidal light damages genetic material toguide them into their remedies.
 

 
Early practitioners of phototherapy for the treatment of skin ailments were conscious of the germicidal effects of light but did not believe they contributed substantially to UV phototherapy. In Ultra-Violet Radiation and Actinotherapy (Russel,1933) it was noted that’Ultraviolet light is absorbed by the protoplasm of the organism, and in a culture, or on the surface of a wound, 1 bacterium will shield a second lying under itso in an lesion like lupus very little advantageous therapeuticeffect could be considered to be due to the bactericidal effects of the rays. It’s due rather to the higher lymphocytosis from the part, and stimulation of cicatrisation. ‘ (Russel, 1933, pg. 288). The text also notes that’the absorption from the skinof very short wave-length, is quite good, all rays shorter than 3000 angstroms [300 nm] being consumed by a later of epidermis 0.1 millimeters in thickness’ (Russel, 1933, pg. 272-273). The lamps which were utilized to treat skin ailments had at least 95 percent oftheir energy emitted at wavelengths over 300 nm and thus had very little energy in wavelengths considered germicidal. This compares to modern low pressure mercury germicidal lamps where 95 percent of light is emitted at 254 nm–virtually the exact opposite ofearlier lamps used to treat skin ailments.
 

 

U.S. Pat.

No. 1,856,969 by Reiter and Gabor in 1932 describes a type of phototherapy to modulate living tissue that was used as part of empirically based treatment of skin ailments. The patent describes the use of UV to invigorate the naturaldefenses of the human body and includes a filter to prevent light significantly less than 320 nm from reaching the skin because light below 320 nm has been believed to be harmful to treatment. This patent illustrates that most ancient UV treatment was focused on the stimulatingeffects of UV rather than on its germicidal qualities because the wavelengths considered germicidal (less than 315 nm) were regarded as harmful to treatment.
 

 
Treatment of skin ailments continued on an empirical basis throughout the 1950’s with a multiplicity of units being produced each with distinct approximated guidelines of how to best utilize them for various disorders and infections. The empiricalbasis of treatment of those disorders was based on judiciously applying ultraviolet light to induce erythema (redness) to grow. The treatment was then adjusted to bring about different levels of sunburn based on the disease being treated. Milderythema (slight redness) was assigned a value of E-1 whereas the most sever erythema (blistering and third degree burns) was assigned an E-4. The most serious ailments often merited a treatment bringing about an E-4 erythema for a sustained period.The induced erythema was thought to trigger the body’s defenses, particularly increasing the bactericidal ability of their blood. Although this is the most prevalent concept of why this treatment was efficacious there was no absolute consensus. Thelack of consensus with regard to how this kind of treatment worked and the large number of lamps which were being marketed from the first half of the twentieth century was likely bewildering to a lot of physicians. But in the absence of modernantibiotics, the empirical use of ultraviolet light to treat skin ailments.
 

 

Electrotherapy and Actinotherapy; A Textbook for Student Physiotherapists authored by E. B. Clayton and Printed in 1952 (2.

Sup.nd edition) shows of the state of the art of phototherapy before use of modern antibiotics induced by this form oftreatment to lose favor. This 451 page futon covers all aspects of phototherapy beginning with the theory, the kind of equipment utilized, and treatment of various types including skin disorders. Portions of this treatment section for epidermis tuberculosisread as follows,”The Finsen-Lomholt water cooled carbon dioxide or the Kromayer lamp is employed. The latter has the drawback that its spectrum includes a quantity of abiotic rays which are not required and merely boost the superficial inflammation. … The first exposure is generally five occasions a fourth level erythema.” (pgs. 413-414). This infusion of this publication notes that abiotic (germicidal) light is not regarded as useful for treatment. Additionally, it shows that dosages for treatment were basedon empirically derived rules of thumb related to how severe the produced erythema was. Although almost 100 pages are devoted to describing various treatments there is no mention of dosage in terms of the amount of energy employed nor is there mention ofany specific wavelengths.
 

 
Empirical use of ultraviolet lighting had a variety of undesirable side effects such as a broad spectrum of light such as high levels of UVB light known to be carcinogenic. The relative amount of germicidal lighting was exceptionally low whichmade any potential advantage owing to its addition very little and probably undetectable. Additionally, the treatment rate was also considerably lower than could be expected using a well understood notion of how germicidal light inactivates organisms. Therefore, when safer and moreeffective antibiotics were introduced in the 1950’s the practice of using ultraviolet light to treat skin infections was quickly abandoned by the medical profession generally. While ultraviolet light might nevertheless be employed to treatskin infections in remote areas of the planet its general use has been abandoned.
 

 
There appears to have been no application of the recent advances in genetics, air handling, and water and wastewater disinfection to transform the use of germicidal mild to clinically treat skin ailments. The present invention combinesthese advances in other areas to come up with a novel and one of a kind approach to scientifically treat skin and nail infections in a manner that increases the efficacy of treatment while minimizes the side effects of such remedies.
 

 
It should be noted that there isn’t any indication that this sort of therapy was ever applied to healing nails. While the text talk lots of different ailments affecting different areas of the body (like nose, skin, throat, anus,etc.. ) the reference of nails isn’t found in any text. This is understandable given the limited capacity of nails to transmit light in the ultraviolet selection and also the truth that nail diseases generally are somewhat less life threatening than skin infections.
 

 
Together with the discovery of DNA and RNA from the 1950’s and the subsequent evolution of the science of genetics, scientists discovered that each cell contained an exceptionally complex code allowing the cell to reproduce. Later, it was discovered thatcertain kinds of ultraviolet light can harm this genetic material and prevent a cell from reproducing. This knowledge was applied in several different fields including water and wastewater treatment (in which it had been used to disinfect water), to sterilizesurfaces, and to purge atmosphere. However, it was not employed to treat skin ailments. This was possibly due to several reasons including these: The widespread knowledge that UV can’t penetrate deeply made it a less than ideal candidate to treatan infection that may not be totally on the surface of the epidermis. Since it is well documented that mild less than 300 nm can’t penetrate under the first 0.1 mm of the skin, its penetrating power was thought inadequate to treat ailments. Theold empirical usage of UV lighting made use of lights of varying characteristics and advantages. It’s likely that these lights cause some tenderness and pain due to their non-specificity. Also, since there wasn’t any knowledge of the way the mild clearedinfections, it had been implemented in a wide fashion and likely had considerable side effects because of overtraining including cancer due to high amount of carcinogenic UVB.
 

 
While Niels Finsen is mentioned as the creator of phototherapy by many authors, the sector has abandoned the use of ultraviolet light to treat infections and has instead concentrated on the infrared and visible portion of the spectrum from400 nm to 1000 nm. The invention disclosed in this application builds on Finsen’s work and expands it in new and innovative ways by combining new knowledge of genetics and improvements in the use of ultraviolet light to disinfect air and water. Thecombination of diverse knowledge that the invention builds on isn’t generally known to those skilled in the art of phototherapy and if this new knowledge is coupled with the existing empirical base supplied by Finsen along with other ancient phototherapists,new and unobvious applications of this knowledge to treat and prevent skin and nail infections emerge.
 

 
The germicidal effects of nitric oxide have been known for several decades. Presently, germicidal radiation (also known as germicidal light) is being used more frequently at water and wastewater treatment plants to render water-bornepathogens benign. Additionally, germicidal light is utilized to purge and purify air, especially in labs and health care establishments. It’s also used to sterilize equipment at such establishments. Germicidal light has been used for severalyears to sterilize and disinfect food products and has also been utilized to purify the hands to prevent the spread of germs to other people. Over the years a large body of knowledge about germicidal radiation has been developed but hasn’t beensystematically applied to address important difficulties with respect to treating nail and skin infections.
 

 
While germicidal light is not used alone to treat nail and skin infections, certain kinds of light which are considered non-germicidal are frequently combined with other additional chemical compositions to deal with existing psoriasis, rashes,and other non-infectious skin ailments. It is believed that this type of therapy, termed phototherapy, is effective because it has an immunosuppressive effect which permits the body to heal itself. Lately, lasers alone have been successfully usedto treat psoriasis by draining localized chronic plaque. Phototherapy is also utilized in the treatment of jaundice which is also a non-infectious disease. However, no method of using germicidal light has been discovered to successfully cure existingmicrobial infections nor has this type of light been utilized as a preventative therapy for infections.
 

 

Perceived Inability of Germicidal Light to Penetrate Skin and Nails

 

 
The most important reason that germicidal light alone has not been used to prevent and cure skin and nail infections is the most potent germicidal lighting is in the UVC range (240 nm to 300 nm) and this kind of light cannot penetrate the skin andnails deeply. Significantly less than one% of UVC light can penetrate the deeper than 0.1 mm of skin (i.e. doesn’t permeate the skin ).
 

 
UVB (280 nm 315 nm) while not generally considered germicidal has some restricted germicidal ability particularly in the 280 nm to 300 nm part of this spectrum. However, in addition, it has restricted penetrability. For example UVB it is estimated thatless than 5 percent of light in 315 nm penetrates the skin (approx. 0.125 mm deep) or nails. The perceived inability of germicidal light to penetrate skin and nails is among the significant reasons this type of light has not yet been used to prevent andtreat infections. If the light cannot penetrate nails or skin and reach the infectious organisms it isn’t of any use for treating ailments. But it is this difference between no penetration and little penetration the disclosed invention makesinnovative and unobvious use of. Although less than 1 percent of UVC light may penetrate nails or may penetrate skin more powerful than 100 mm, less than 1 percent of light that is able to penetrate deeper is sufficient to treat and prevent nail and skin infections whenapplied correctly.
 

 
Less than 8 percent of UVB at 315 mm can penetrate skin or nails deeper than 0.1 mm. This is much greater than the penetration capacity of UVC, however, given its lesser germicidal ability it does not seem to be as powerful treatment for infections.Nevertheless, UVB can be utilized germicidally to treat infections if it is of adequate strength or if it is accompanied using UVC light.
 

 
There is a large amount of literature which teaches that germicidal light can’t penetrate well. The Physics Society at its July 1998 paper titled”Ultraviolet Radiation and the Public Health” notes that”UVC, used in germicidal lamps, causesalmost no damage due to its reduced penetration of skin.” INTERSUN, the global UV project sponsored by the United Nations suggests only 5 percent of UVC (at 254 nm) can penetrate to about a quarter of their depth of the skin and less than 1 percent canpenetrate more than half the depth of the skin. Many other sources indicate that UVC can’t penetrate skin or can do this only to a very limited depth. But this depth is enough to treat infections since organisms are particularlysusceptible to germicidal radiation. Additionally, in regards to nail infections, the additional radiation necessary to penetrate the nail isn’t damaging to the nail since it’s composed of dead keratin.
 

 

UVC Dose Necessary to Inactivate Microbes

 

 
Another major reason the usage of UV has not been contemplated are the comparatively high doses required to kill several types of organisms. However, it’s been discovered it isn’t always required to kill pathogens to render them harmless. It hasbeen demonstrated that cows can be inactivated and rendered harmless using far less radiation than is necessary to kill them entirely. Therefore, although its use as a treatment for has been overlooked previously, nitric oxide ofsufficient power can be used to treat human and animal infections.
 

 
There are several publications that notice that organisms can be rendered harmless with much less energy than is required to kill them. The inactivation of organisms by harmful RNA and DNA and preventing them from reproducing is a method used fordisinfection of highly transparent potable water and is discussed in more detail from U.S. Pat. No. 6,129,893 into Bolton. The patent describes a method for preventing the replication of Cryptosporidium parvum using ultraviolet light. This patentindicates that ultraviolet light can inactivate bacteria (as measured by infectivity research ) at doses which are 3% to 10 percent of the dose necessary to really kill the organisms (as measured by microscopic evaluation of ruptured membranes). The method ofinactivation is described as damage to the DNA and RNA that prevents the organisms from replicating. Since organisms are not long-lived in themselves, they are not able to continue to induce disease if they’re not able to replicate. This discovery isapplied to the inactivation of a pathogen in drinking water to render it safe for ingestion. However, this method is simply to irradiate 1 kind of organism and only in highly transparent drinking water.
 

 
The EPA guidance manual on Alternate Disinfectants and Oxidants (April 1999) devotes Chapter 8 to a talk of germicidal UV as a disinfectant for drinking water. The guide notes that a UV wavelength of 240 to 280 nm is highly consumed bythe RNA and DNA of a microorganism. The absorbance of UV from the organisms leads to the harm to the organism’s capacity to reproduce. The damage can be brought on by the dimerization of both pyrimidine molecules. A dimer is a molecule comprising twoidentical molecules that are simpler and dimerization is the process of connecting the two molecules together. Dimerization of the pyrimidine molecules distorts the DNA helical structure. The EPA guidance manual also notes the dose to inactivate 90% of mosttypes of organisms is quite low with a typical range of 2 to 6 mJ/cm. sup.2. The guide notes the radiation can be generated by numerous resources including a low pressure mercury lamp emitting 254 nm, a moderate pressure lamp emittingat 180 to 1370 nmlamps or lamps which emit at other wavelengths at a high intensity pulsed manner.
 

 
It should also be noted that it is not required to kill and inactivate all organisms in order to effect a cure for an infection. If a sizable quantity of the organisms that have caused an infection are destroyed or rendered inactivated, thebody’s natural defenses will frequently work to clear the infection. Therefore, doses of radiation needed to effect a cure for the infection may be much lower than those required to sterilize a place by complete destruction of organisms.
 

 
While germicidal light is often said to inactivate organisms by damaging their genetic material and preventing them from reproducing, germicidal light may be implemented in higher doses to damage enough of the genetic material from the mobile andprevent it from having the ability to properly function, thus resulting in its death. By way of instance, mRNA (messenger RNA) is used to control mobile processes, however, if it is severely damaged it cannot perform this function.
 

 

UVB as Germicidal Light

 

 
While UVB lighting has some germicidal qualities it isn’t often utilized to inactivate or kill organisms. Although approximately 10 times more UVB light can penetrate a given thickness of nails and skin than UVC light, its lower germicidal ability doesnot make it attractive a choice. UVB can also be considered the band of UV that causes the most damage to skin, and is therefore considered more carcinogenic, and is thus avoided where possible. Additionally, UVB lighting is more difficult to generate thanUVC light which is readily produced by a mercury vapor lighting (which is similar in manufacture into a fluorescent lighting ). Nevertheless, UVB may be utilized germicidally and it could be desirable to use it especially in conjunction with UVC light. The portionof the UVB range that adjoins that the UVC range (UVB between 280 nm and 300 nm) is nearly as germicidal as a group of bands of UVC. Practitioners of photobiology occasionally term UV light between 200 nm and 300 nm as’Much UV’ light (instead of’Near UV’ lightwhich is often listed in the range of 300 to 400 nm). The current invention makes use of UVB for therapy of skin and nail infections although most literature dismisses its germicidal ability and instructs that UVB does not penetrate deeply. Theinvention additionally encircles Near UV light in the range of 200 nm to 300 nm owing to the germicidal nature.
 

 

Other Kinds of Germicidal Radiation

 

 

U.S. Pat.

No. 5,900,211 shows that it is not only UVC and UVB which can be used to purge food and water. Dunn discusses using pulsed polychromatic light to inactivate organisms. Dunn uses much lower quantities of electricity to inactivate anorganism than would be required to destroy it by excessive heat. But, Dunn uses this technology only to the sterilization of food and other materials and doesn’t consider it for treatment of skin or nail infections. This can be presumablybecause of their perceived inability of this light to permeate skin or nails. (Dunn indicates that the effectiveness of the light depends on its capacity to penetrate a moderate efficiently.)
 

 

Prior Art Using UVC to Kill and Inactivate Organisms

 

 

U.S. Pat.

No. 6,254,625 shows an apparatus to sterilize hands to prevent the spread of infectious organisms. This apparatus uses light to sanitize the face of their hands to prevent diseases from spreading form person to person.In all its embodiments it consists of at least two things. It uses light to kill organisms along with either additional light to recuperatively cure the skin that has been irradiated or using ozone to increase the efficacy of killingorganisms. The recuperative recovery light uses the phenomenon of photoreactivation whereby cells and organisms that have been damaged can fix the damage using such light of another wavelength. The inclusion of the source of light as a portion of theapparatus signals that the illness causing organisms are murdered and not merely inactivated otherwise they also could fix damage by photoreactivation. Additionally, the patent does not contemplate using their apparatus to treat an infected region ofthe skin and it makes no reference of treating any infection of the nails using electromagnetic radiation. The apparatus depends on using ozone to kill any organisms beneath the nails or shielded by debris and notes erroneously that UVC radiation willnot permeate the nail. Rosenthal appears to be unaware that germicidal UV can penetrate the skin and nails and can be used in the treatment of infections.
 

 

U.S. Pat.

No. 6,283,986 discusses using UVC radiation to treat wounds. But, Johnson only applies radiation to open wounds, which can be readily exposed, and notes that”given the short wavelength of UVC, no penetration of theunderlying tissue will be anticipated.” The patent makes no mention of skin infections and mention of the claws is totally absent in the application although nail infections comprise a huge part of total dermal diseases. Possibly, the reason thepatent only applies to wounds is that by their own nature wounds are open and so capable of getting their surfaces irradiated. It appears that Johnson is also unaware of the ability of germicidal radiation to penetrate the skin and nails.
 

 
It is the misconception that germicidal light cannot penetrate skin and claws that has in part prevented the discovery that germicidal radiation, including UVC, can really cling to a depth adequate to be used efficiently to treat skinand nail infections. While it’s true that skin and nails will absorb a large percentage of UVC, enough can permeate to effectively treat and prevent diseases.
 

 

Nail Infections and Therapy

 

 
Nail infections are a particularly important problem in the general population, affecting an estimated 5% to 15% of the general population (roughly 15 to 45 million individuals ). This percentage is considerably higher in the older agegroup and among athletes and other individuals who have elevated moisture in the region of their toes. Nail infections tend to be caused by fungus and this kind of disease is termed onychomycosis. Right now, the preferred method for the prevention andtreatment of skin and nail infections relies on use of topical medications or ingestion of medications. These medications are used to treat an present disease, not for the avoidance of an infection. Price of therapy using medication can bebetween $600 and $1200 per course of therapy and can last three to six weeks. This is the amount of time it takes the medicine to be integrated into the fingernails. The following one to six weeks will be then required for the nail to become free of infection.It should be noted that the cost noted above does not take into consideration doctors visits or diagnostic testing to find out whether the patient can tolerate the drug (many medications can cause liver and other harm ).
 

 
The problems connected with oral anti-fungal medications can be exemplified by several quotes from the clinical testing outcomes for Itraconazole capsules (marketed under the trademark name SPORANOX.RTM. Made by Janssen Pharmaceutica,Inc.) which was the most prescribed antifungal from the U.S. in 1996. The success rate for treatment of onychomycosis of the toenail is reported as follows–“Results of these studies revealed mycological cure. . . At 54% of the patients.Thirty-five (35%) of patients have been considered an overall success (mycologic cure also clear or minimum nail participation with significantly decreased signs) and 14% of patients demonstrated mycological cure (lack of all signs, with or withoutresidual nail deformity).” In regards to adverse reactions–“SPORANOX.RTM. Has been associated with rare cases of serious hepatoxicity, including liver failure and death. Some of the cases had pre-existing liver disease nor a seriousunderlying medical state.” In a study of 602 patients treated for systemic bacterial disease,”treatment was discontinued in 10.5% of these patients because of adverse events.”
 

 
Although it’s relatively rare, death is another serious side effect of oral antifungal medications. The two most popular antifungal medications used in the treatment of nail infections had been implicated in a total of 35 deaths from the U.S. between 1996 and2001. That caused the FDA to issue a health advisory for these medications in May of 2001.
 

 
Though the preferred way of nail infections is that the use of oral medication, there are several different remedies in use. There are numerous topical applications which are utilized to treat fungal infections of this nails.However, these have a much weaker success rate than oral drugs and the infections are inclined to re-occur.
 

 

U.S. Pat.

No. 6,090,788 into Lurie shows destruction of fungal infections of the nails by introducing a pigment in to an infected area and then heating the pigment in the infected region using a laser in order to elevate the temperature tokill the organisms which have caused the infection by excess heat. The energy recorded in the preferred embodiments is from 5 to 15 J/cm. Sup.2 and it has a relatively long wavelength (generally 500 to 700 nm) so as to penetrate the nail. The highamount of energy and long wavelength of light is good enough to cause excessive heating of the surrounding region thus destroying the organism. However, such high energy levels have undesirable effects on the surrounding tissues like redness andswelling.
 

 
Lurie erroneously notes that average fungi don’t have pigment and, therefore, can’t absorb light. However, the fact is that all cells will absorb light at a wavelength of between 240 and 280 nm because the DNA from the organism will absorb lightat this particular wavelength. Also, Lurie isn’t conscious of how organisms can be inactivated at substantially lower doses than those required to ruin them by excess heating. Because of the complex nature of the treatment, U.S. Pat. No. 6,090,788 isproposed as a process to deal with an infection, not to stop you.
 

 
Lurie also notes the mild he uses for treatment should easily permeate the skin that’s something that UV doesn’t do. Therefore it would not be a natural extension of Lurie’s remedy to use UV light to treat nail infections.
 

 
Lurie notes”there is a widely recognized need for, and it could be highly advantageous to have, a phototherapy method for treating nail and skin pathogens as well as also a pharmaceutical composition to influence same.” It may be added that there is even agreater need to treat nail and skin infections with germicidal radiation simply, especially if said radiation may be effective at a much lower dose and not have the side effects related to high energy lasers.
 

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