Abstract:
It is an object of the present invention to provide a hand-held radiation device for treating bacterial, viral, fungal and parasitic infections found on the skin of a patient and in various of the body&#39;s anatomical orifices. The device of the invention is particularly effective in treating Methicillin resistant  staphlococcus aureus  (MRSA) colonies in the nose and on the skin surface of a patient. The device includes a reusable UV light source and a UV-transparent disposable cover for covering the probe portion of the reusable UV light source. The device further includes a combination probe cover ejector and disabling assembly for safely ejecting the probe cover after use without the necessity of the operator touching the contaminated probe cover and for disabling the device if the cover is not in place over the probe.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates generally to irradiation devices for therapeutic purposes. More particularly, the invention concerns a readily portable, hand-held irradiation treatment device for treating infections that occur on the skin of the patient and in various of the body&#39;s anatomical orifices. 
         [0003]    2. Discussion of the Prior Art 
         [0004]    Ultraviolet (UV) light has long been used for disinfection and sterilization. In recent years, the widespread availability of low to medium pressure mercury bulbs has led to the development of devices which use UV-C for air purification and to decontaminate water supplies. UV-C has also found some limited use in food processing and in medical device sterilization. UV-C is a high frequency wavelength of light within the ultraviolet band and has been shown to be the most bactericidal type of ultraviolet light. 
         [0005]    By way of background, UV light consists of high energy photons, which occupy the 200 to 400 nanometer wavelengths of the electromagnetic spectrum. This means that UV light emits slightly less energy than soft X-ray radiation, but significantly more than visible light. UV energy does not directly kill pathogens, but rather causes a photochemical reaction within the genetic structure which inhibits the ability of the pathogens to reproduce, therefore, in effect, killing the pathogen. 
         [0006]    The amount of energy delivered by UV light is inversely proportional to its wavelength; therefore, the shorter the wavelength, the greater the energy produced. In general, the UV light portion of the spectrum is made up of three segments; UV-A (315-400 nm), used for sun-tanning lamps, UV-B (280-315 nm) and UV-C (200-280 nm). The UV-B and, as previously mentioned, UV-C regions contain wavelengths with the best germicidal action. Studies have shown that the wavelengths most effective in killing microbes are between 250-265 nm. This value corresponds nicely with the light energy output of a typical, commercially available UV-C germicidal lamp, which produces most of its energy output in the range of 254 nm. 
         [0007]    An application of particular interest for devices of the present invention is the treatment of  Staphylococcus aureus. Staphylococcus aureus  (SA) is a bacteria commonly found on the skin and in the nose of healthy people. Occasionally, SA can enter the body and cause various types of infections. These infections can be minor, i.e., pimples or boils, or more serious and, in some cases, fatal, i.e., in blood infections or pneumonia. SA is a common organism and can be found in the nostrils of up to 30% of the population. 
         [0008]    Methicillin resistant  staphylococcus aureus  (MRSA) are  staphylococci  that are resistant to the antibiotic methicillin and other commonly used antibiotics such as penicillin and cephalosporins. These germs have a unique gene that causes them to be unaffected by all but the highest concentrations of antibiotics. Over the past 30 years, the overuse of antibiotics has resulted in an increase in the incidence of MRSA in hospitals and, now, in the community at large. Studies indicate that since 1968, when the first reported MRSA cases were reported in hospitals, the proportion of MRSA causing infection in hospitalized patients has risen from 2% in 1974 to about 40% in 1997, and it is still rising! Over the past twenty years, infections with MRSA have been limited primarily to patients in hospitals or long-term care facilities. However, recent reports of community-acquired MRSA infections raise concern that the problem is now spreading to a larger population. 
         [0009]    As with most SA, MRSA bacteria reside on the skin surface and in the nose. Colonies within the nose are usually within 1 cm of the nostril opening. If these colonies are transferred from the nose to an open cut, a MRSA skin infection may result and, if they are transferred into the blood stream via a more serious cut or skin break; then septicemia may result. 
         [0010]    Published literature also indicates that the germicidal properties of short-wave UV light are also effective in killing viruses of the character that first congregate in and then multiply in the mucous membranes of the nose before they spread to other parts of the body. With this in mind, use of the devices of the present invention in the manner presently to be described tend to eliminate or at least reduce the severity of certain viral infections, such as avian influenza. 
         [0011]    As previously mentioned, in addition to having clinical application in treating infections in the nostril and on the surface of the patient&#39;s skin, the present invention is also effective in treating bacterial, viral, fungal and parasitic infections found in various of the body&#39;s anatomical orifices. By way of non-limiting examples, applications of interest for devices of the present invention include the treatment of strep throat in the mouth of the patient; for treating various sexually transmitted diseases, such as Gonococcal and Non-gonococcal Urethritis and various other urinary tract infections in the urethra; for treating common yeast infections (fungal) in the vagina; for treating various sexually transmitted diseases, such as Gonococcal and Non-gonococcal Urethritis and parasitic infections in the rectum and for treating infections in the external ear canal of the patient. 
         [0012]    The probe covers are designed so that they slightly dilate the lumen of the orifice into which they are inserted. This dilation sets the distance from light source to tissue surface very accurately as the dilated tissue conforms to the probe cover, giving uniform coverage of the light energy to the tissue. 
         [0013]    Pre-setting the distance between light source and tissue, which would require the probe cover to touch the infected skin, is quite different than simply holding a UV light over the tissue as this method does not stretch the tissue. Stretching the tissue so that the entire surface is exposed to the light energy is critical to the successful germicidal use of UV light as it is a ‘line of sight’ process. Creases or folds can hide bacteria from exposure to the light energy, preventing them from receiving a lethal dose of irradiation. 
       SUMMARY OF THE INVENTION 
       [0014]    It is an object of the present invention to provide a novel hand-held UV radiation device that is particularly effective in treating bacterial, viral, fungal and parasitic infections found in various of the body&#39;s anatomical orifices. 
         [0015]    It is another object of the present invention to provide a device of the aforementioned character that is particularly effective in treating MRSA colonies in the nose and on the skin surface of a patient. 
         [0016]    Another object of the invention is to provide a device of the character described in the preceding paragraph that can eliminate, or greatly reduce, the MRSA colonies without significantly damaging the underlying tissue of the patient. 
         [0017]    Another object of the present invention is to provide a novel hand-held radiation device that is effective in eliminating, or at least significantly reducing, the severity of certain viral infections such as avian influenza. 
         [0018]    Another object of the invention is to provide a device as described in the preceding paragraphs that includes a reusable UV light source and a UV-transparent disposable cover for covering the probe portion of the reusable UV light source. 
         [0019]    Another object of the invention is to provide a device as described in the preceding paragraph in which the disposable probe cover is uniquely designed to slightly dilate the lumen of the orifice into which it is inserted. This dilation sets the distance from light source to tissue surface very accurately as the dilated tissue conforms to the probe cover, giving uniform coverage of the light energy to the tissue. 
         [0020]    Another object of the invention is to provide a device of the type described in which the disposable probe cover is uniquely designed to shield the tissue surrounding the radiation site so that only the radiation site receives the germicidal UV energy. 
         [0021]    Another object of the invention is to provide a device as described in the preceding paragraphs that is effective in the treatment of strep throat in the mouth of the patient. 
         [0022]    Another object of the invention is to provide a device as described in the preceding paragraphs for treating various sexually transmitted diseases, such as Gonococcal and Non-gonococcal Urethritis and various other urinary tract infections in the urethra. 
         [0023]    Another object of the invention is to provide a device as described in the preceding paragraphs for treating for treating common yeast infections (fungal) in the vagina. 
         [0024]    Another object of the invention is to provide a device as described in the preceding paragraphs for treating various sexually transmitted diseases, such as Gonococcal and Non-gonococcal Urethritis and parasitic infections in the rectum. 
         [0025]    Another object of the invention is to provide a device as described in the preceding paragraphs for treating infections in the external ear canal of the patient. 
         [0026]    Another object of the invention is to provide a hand-held radiation device of the character described that includes a safety, disabling assembly that is so constructed and arranged to permit the UV radiation source to be energized only when the probe cover is in position over the device probe. 
         [0027]    Another object of the invention is to provide a device of the type described in the preceding paragraphs that includes a novel, easy-to-use ejection mechanism for safely ejecting the probe cover after use without the necessity of the operator touching the contaminated probe cover. 
         [0028]    Another object of the invention is to provide a device of the character described that is compact, light weight and of simple construction, is easy-to-use and can be inexpensively manufactured. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0029]      FIG. 1  is a generally perspective view of one form of the irradiation treatment device of the present invention. 
           [0030]      FIG. 2  is an enlarged, fragmentary, perspective view of the area designated in  FIG. 1  as “ 2 ”. 
           [0031]      FIG. 3  is an enlarged, generally perspective view of one form of a disposable probe cover usable with the apparatus shown in  FIG. 1  of the drawings. 
           [0032]      FIG. 4  is a generally perspective, foreshortened, exploded view of the device illustrated in  FIG. 1 , here shown interconnected with an energy source and depicted with the disposable probe cover in position over the forward portion of the device. 
           [0033]      FIG. 5  is a generally schematic view illustrating the interconnection of the various operating components of the device shown in  FIG. 1 . 
           [0034]      FIG. 6  is a generally schematic view illustrating the interconnection of the various operating components of an alternate form of treatment device of the invention. 
           [0035]      FIG. 7  is a side-elevational view of one form of the disposable probe cover of the apparatus of the present invention. 
           [0036]      FIG. 8  is a cross-sectional view taken along lines  8 - 8  and  FIG. 7 . 
           [0037]      FIG. 9  is a side-elevational view of an alternate form of the disposable probe cover of the apparatus of the invention. 
           [0038]      FIG. 10  is a side-elevational view of another alternate form of the disposable probe cover of the apparatus of the invention. 
           [0039]      FIG. 11  is a side-elevational view of still another form of the disposable probe cover of the apparatus of the invention. 
           [0040]      FIG. 12  is a top plan view illustrating the device of the invention being used with still another form of the disposable probe cover designed to treat the skin of the patient. 
           [0041]      FIG. 13  is a generally illustrative view showing the device of the invention in position preparatory to treating bacterial colonies in the patient&#39;s nose. 
           [0042]      FIG. 14  is a generally illustrative view showing the device of the invention moved into position to treat bacterial colonies in the patient&#39;s nose. 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0043]    Referring to the drawings and particularly to  FIGS. 1 through 5 , one form of the novel irradiation device of the invention for treating bacterial colonies on the skin of the patient and in various body orifices, such as the mouth, the urethra, the vagina, the rectum and the external ear canal is there shown and generally designated by the numeral  14 . This form of the device here comprises a housing  16  having a hollow, generally cylindrical-shaped body portion  18  and an elongated probe portion  20  that is connected to housing portion  18  and extends outwardly therefrom. Probe portion  20 , which has a forward irradiating portion  20   a  and rearward portion  20   b , is connected to the forward hub portion  18   b  of body portion  18  in the manner shown in  FIGS. 1 and 5 . Operably associated with probe  20  is a conventional radiation source  22  for emitting UV radiation in a direction toward the elongated probe portion  20   a . Disposed within housing  16  is a timer  24 , the function of which will presently be described ( FIG. 5 ). 
         [0044]    Removably connected to the forward irradiating portion of the elongated probe is a uniquely constructed, substantially UV radiation-transparent probe cover  26 . As best seen in  FIGS. 3 ,  7  and  8 , probe cover  26  includes a generally tubular-shaped forward portion  28  that covers the forward portion of the probe and a generally tubular-shaped, slotted connector portion  30  that is telescopically receivable over the forward hub portion  18   b  of housing portion  18 . Forward portion  28  can be constructed from polypropylene, certain varieties of Teflon that are transparent to UV light in the UV-C range (200-280 nm) and other amorphous fluropolymers. Disposed intermediate forward portion  28  and connector portion  30  is an enlarged diameter radiation shield  32  that functions to shield the user&#39;s hand from radiation (see also  FIGS. 8 and 9 ). 
         [0045]    As indicated in  FIG. 8 , shield  32  is constructed from a UV radiation-opaque material, such as polycarbonate, polystyrene and like materials that will effectively shield the surrounding tissue so that only the target areas of the patient will receive the germicidal UV energy. 
         [0046]    It is to be understood that the unique design of the probe cover as shown in the drawings not only provides protection for the UV light probe  20  and a method of preventing probe contamination, the probe also sets the proper distance from the light source to the tissue being exposed to the UV radiation. This factor is especially important because the energy transmitted to the tissue decreases exponentially with the distance between the light source and the tissue surface. In this regard, it should be appreciated that in carrying out the method of the invention for treating bacterial, viral, fungal, and parasitic infections in the patient&#39;s tissue, pre-setting the distance between light source and tissue in this manner is quite different than simply holding a UV light over the tissue as this approach does not stretch the tissue as does the UV light probe  20 . In accordance with one form of the method of the invention, the tissue is uniformly stretched so that the tissue is uniformly exposed to the light energy which is critical to the successful germicidal use of UV light as it is a ‘line of sight’ process. Creases or folds can hide bacteria from exposure to the light energy, preventing them from receiving a lethal dose of irradiation. 
         [0047]    Additionally, the probe covers of the apparatus are designed so that they slightly dilate the lumen of the orifice into which they are inserted, such as the vagina and rectum. In accordance with the method of the invention, this dilation sets the distance from light source to tissue surface very accurately as the dilated tissue conforms to the probe cover, giving uniform coverage of the UV light energy to the tissue to be treated. 
         [0048]    Carried by housing  16  is switching means for controllably energizing the source of UV radiation  22 , which here comprises a conventional, readily commercially available UV-generating lamp. In the present form of the invention this switching means, which comprises a part of the electrical circuitry of the invention (see  FIG. 5 ), is provided in the form of a conventional, readily commercially available, one-touch activator switch  34 . Switch  34  is mounted on the exterior wall  16   c  of the housing  16  ( FIG. 1 ) and, as shown in  FIGS. 4 and 5 , is operably interconnected in a conventional manner with a source of electrical power  36  and with the UV radiation source  22  via a conventional transformer  33 , a conventional relay  35 , the timer  24  and the novel disabling means of the invention, the character of which will presently be described. Timer  24 , which ensures that the tissue is irradiated for a predetermined period of time, is here provided in the form of a conventional, readily commercially available, adjustable timer that can be pre-set to control the length of time that the UV radiation source remains energized after the circuit is closed. Radiation source  22 , timer  24 , switch  34 , relay  35  and transformer  36  are interconnected within the electrical circuitry in a manner well understood by those skilled in the art. 
         [0049]    An important feature of the present invention is the provision of a novel combination cover-ejecting means and safety-disabling means. The cover-ejecting means permits the operator to safely eject the cover after it becomes contaminated without touching the cover. The novel safety-disabling means here functions to prevent energizing the UV radiation source by the switching means of the invention unless the probe cover  26  is correctly in position over the probe  20 . In the present form of the invention this novel combination cover-ejecting means and safety-disabling means comprises an assembly generally designated by the numeral  40  that is carried by housing  16  in the manner best seen in  FIGS. 2 and 5 . In this embodiment of the invention, assembly  40  comprises an ejector member  42  that is movable by portion  30  of the cover  20  from a first extended position shown in  FIG. 2  to a second retracted position shown in  FIG. 5 . 
         [0050]    With the ejector member having been moved by the rim portion  30   a  of the cover (see  FIGS. 3 ,  4  and  5 ) into the second retracted position shown in  FIG. 5 , the electrical circuit between points  44  and  46  is completed so that the source of radiation can be energized by the operation of switch  34 . Once energized, the UV radiation source will remain in its energized state for the period of time set on the timer  24 . At the expiration of this time, the UV energy source will be automatically de-energized and the probe cover can be safely ejected from the hub portion  18   b  of the housing. 
         [0051]    It is to be noted that as the probe cover is ejected from the hub portion  18   b  of the housing, the ejector member is urged by the biasing means, or spring  48 , into the extended position shown in  FIG. 2 , thereby breaking the electrical circuit between points  44  and  46  so that the source of radiation  22  cannot be re-energized by the operation of switch  34 . 
         [0052]    On the other hand, as can be seen by referring to  FIGS. 2 and 5 , movement of the ejector member toward its retracted position by positioning the cover  26  over the probe  20  in the manner shown in  FIGS. 4 and 5 , will once again complete the electrical circuit between points  44  and  46 . 
         [0053]    Movement of the ejector member into the retracted position shown in  FIG. 5  will also move a finger-engaging ejector slide assembly  49 , which is slidably connected to housing  16 , rearwardly of the housing against the urging of spring  48 . Finger-engaging ejector slide assembly  49 , which comprises a part of the cover-ejecting means of the invention, includes a finger-engaging ejector slide  52  and an integrally formed ejector frame  54 . Portion  54   a  of ejector frame  54  is in operable engagement with spring  48 , while portion  54   b  of the frame is in operable engagement with ejector member  42 . With this construction, after the irradiation treatment has been completed, the contaminated cover can be readily ejected from the hub portion  18   b  by merely sliding the finger-engaging ejector slide  52  forwardly of the housing. In this regard, as the finger-engaging ejector slide  52  moves forwardly, the ejector member  42  will be caused to move toward its extended position and, in so doing, will safely eject the contaminated cover from the hub portion  18   b  of the housing. In this way, the operator can safely and conveniently eject the contaminated cover into an appropriate disposal container without touching it. 
         [0054]    In using the device of the invention to carry out the method of the invention, the user first positions a clean probe cover  26  over the probe in the manner shown in  FIGS. 4 and 5 . This done, timer  24  is set and the tip portion of the cover is inserted into the body orifice, such as the patient&#39;s nostril, in the manner illustrated in  FIG. 14  for a timed application to the nose of germicidal UV energy. 
         [0055]    Turning to  FIG. 6 , an alternate form of the apparatus of the invention is there shown and generally designated as  56 . This alternate form of the invention is identical in construction and operation to the embodiment of  FIGS. 1 through 5 , save for the use of a different source of electrical power. As depicted in  FIG. 6 , where like numerals have been used to identify like components, the source of electrical power here comprises a plurality of conventional, appropriately interconnected batteries  58 . Batteries  58  are interconnected with the electrical circuitry in the manner shown in  FIG. 6  and provide power to the UV energy source  22 . 
         [0056]    For treatment of skin lesions, the user replaces the probe cover  26  of the apparatus with an appropriately sized and shaped skin contact cover  60  of the character shown in  FIGS. 11 and 12 . Substantially UV radiation-transparent probe cover  60 , which is similar in construction and operation to cover  26 , here comprises a generally tubular-shaped forward portion  62  that covers the forward portion of the probe and a generally tubular-shaped, slotted connector portion  64  that is telescopically receivable over the forward hub portion  18   b  hub of housing portion  18 . Forward portion  62 , which includes a tip cover portion  62   a , can be constructed from polypropylene, certain varieties of Teflon that are transparent to UV light in the UV-C range (200-280 nm) and other amorphous fluropolymers. Disposed proximate tip portion  62   a  is an enlarged diameter radiation shield  66  that functions to shield the user&#39;s hand from radiation (see  FIGS. 11 and 12 ). As before, shield  66  is constructed from a UV radiation-opaque material, such as polycarbonate, polyethylene and like materials that will effectively shield the surround tissue so that only the target areas of the patient will receive the germicidal UV energy. 
         [0057]    The alternate form of the invention shown in  FIG. 12  is identical in construction and operation to the embodiment of  FIGS. 1 through 5 , save for the use of the differently configured probe cover  60 . 
         [0058]    In certain instances, germicidal UV energy may be selectively applied both to various body orifices, such as the nostril, as well as to the skin of the patient using the probe cover  70  illustrated in  FIG. 10  of the drawings. Probe cover  70 , which is also similar in construction and operation to cover  26 , here comprises a generally tubular-shaped forward portion  72  that covers the forward portion of the probe and a generally tubular-shaped, slotted connector portion  74  that is telescopically receivable over the forward hub portion  18   b  hub of housing portion  18 . Forward portion  72 , can be constructed from polypropylene, certain varieties of Teflon that are transparent to UV light in the UV-C range (200-280 nm) and other amorphous fluropolymers. Disposed intermediate forward portion  72  and slotted connector portion  74  is an enlarged diameter radiation shield  76  that functions to shield the user&#39;s hand from radiation. As before, shield  76  is constructed from a UV radiation-opaque material such as polycarbonate, polyethylene and like materials that will effectively shield the surrounding tissue so that only the target areas of the patient will receive the germicidal UV energy. 
         [0059]    Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.