Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Diagnostic or test agent produces in vivo fluorescence
Reexamination Certificate
1998-11-17
2002-08-27
Jones, Dameron L. (Department: 1616)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
Diagnostic or test agent produces in vivo fluorescence
C424S001110, C424S009100, C424S009800, C536S020000
Reexamination Certificate
active
06440388
ABSTRACT:
BACKGROUND OF THE INVENTION
Numerous human and animal diseases are caused by the bite of or infestation by arthropods. Arthropods include insects such as lice and arachnids such as mites and ticks. Because of the small size of these creatures and their larvae, it is often difficult to detect their presence on people or their pets.
Human pediculosis, or lice, is caused by infestation of the head, body, or pubic area by the arthropods
Pediculus capitus, Pediculus humanus, Pediculus corporis
or
Phithirus pubis
, respectively. Head lice lay eggs, called nits or louse eggs, on the hair of the head, and the nits eventually hatch into mature forms. Body lice lay their eggs in warm moist skin crease areas. Treatment is with shampoos, creams and lotions containing various insecticides such as lindane, Malathion, or permethrin. Following treatment, the residual nits must be removed by careful examination of the affected hair or clothing and mechanical removal. The shampoo treatment does not remove nits which tenaciously adhere to hair.
Most pre-schools and elementary schools in the U.S. have periodic checks of their students for lice to limit infections. The child's head is checked for the presence of either nits or lice, and if found, the child is sent home for treatment. After treatment, the child is rechecked in school. Often, however, a successfully treated child will have residual nits that were missed and not removed. This usually results from an inability to see the small (0.8 mm×0.3 mm) eggs that blend in well with hair, especially light hair. For the untrained observer, it is often difficult to differentiate nits from exfoliated scalp skin (dandruff). This may lead to further embarrassment of a child who might have been treated but is sent home again after finding residual nits.
U.S. Pat. No. 4,830,790, issued Apr. 19, 1993 to Saferstein, A. for “Multi-Function Light Device” describes a source of blacklight blue light for the detection of nits and adult lice. Since autofluorescence of nits and adult lice is minimal, however, it is still extremely difficult to detect nits and adult lice in hair and clothing.
Lyme disease or erythema chronicum migrans is a multi system disease affecting the skin joints and central nervous system caused by the organism
Borrelia burgdorefi
. The disease is contracted by the bite of the deer tick
Ixodes scapularis
which secretes the Borrelia organism in its saliva when it feeds off the human host. Other tick vectors found to be associated with the Borrelia organism are
Ixodes pacificus
, found in the west,
I. ricinus
, found in Europe, and
I. persulcatus
, found in Asia. Rocky Mountain spotted fever is an acute rickettsial disease that is transmitted by the bite of a wood tick,
Dermacentor andersoni
. Rapid removal of the deer and wood ticks after attachment could prevent the transmission of the Borrelia and Dermacentor organisms and thus prevent Lyme disease or Rocky Mountain spotted fever, but is often difficult since the attachment and bite of the tick are most often not seen or felt by the host.
Other organisms that are small in size and thus difficult to detect are mites, such as chiggers. These organisms also cause human disease. Accordingly, a need remains for an effective and expedient method of detecting small organisms, such as lice, nits, mites, ticks, and fungi.
SUMMARY OF THE INVENTION
The present invention provides a precise and efficient method of detecting chitin-containing organisms such as lice, nits, mites, ticks, and fungal infections of the skin. The method provided herein enables a quick and accurate detection of chitin-containing organisms on areas such as the hair, skin and clothing of humans and the fur and skin of animals.
The method provided by the present invention involves the steps of treating the hair, scalp, skin, or clothing with a dye that fluoresces when exposed to ultraviolet or visible light. If a chitin-containing organism is present in the treated area, the chitin of the organism will bind the dye. The area is then exposed to ultraviolet light and the chitin-containing organism fluoresces and can be visualized and removed.
The present invention also provides solutions and suspensions that contain a dye capable of binding to a chitin-containing organism in an amount effective to bind to a chitin-containing organism and emit fluorescence upon exposure to light. The solutions and suspensions provided herein may be in the form of a shampoo, cream, lotion or detergent for the detection of chitin-containing organisms present in body hair, on the skin, clothing or the fur of animals. The solutions and suspensions may also be in a form suitable for spraying on clothes, as well as on the hair, skin and fur.
The present invention also provides a kit comprising a solution or suspension that contains a dye capable of binding to a chitin-containing organism and a source of light that emits a wavelength capable of exciting fluorescence from the chitin-bound or chitin-conjugated dye.
The method provided herein is extremely useful for the detection of nits, which are difficult to see with the naked eye. Another useful application of the novel method of the present invention is the detection of ticks, such as the deer tick which carries Borrelia, the organism which causes Lyme disease. Deer ticks are extremely small, and must be immediately removed from the site of attachment in order to prevent transmission of the Borrelia organism.
Additional objects of the invention will be apparent from the description which follows.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a precise and efficient method of detection of chitin-containing organisms. The method provided by the present invention allows for the visualization of chitin-containing organisms by treating an area of a human or animal with a dye that renders the chitin-containing organism fluorescent when exposed to ultraviolet or visible light. Chitin is a nitrogen containing polysaccharide within a class of polymers of N-acetylglucosamine present in the covering layer of insects and in the cell walls of many fungi. In particular, chitin is a major component of arthropod shells and the cell walls of lice, nits, mites, ticks, and fungi. Chitin is suitable for staining and is unique to the arthropod while absent from humans and other mammals.
The present invention provides a method for detecting chitin-containing organisms. The novel method provided herein employs a dye that stains chitin by binding or conjugating to chitin and fluoresces when exposed to ultraviolet or visible light. The particular dye is capable of fluorescing only when bound or conjugated to chitin. The dye is placed in contact with the area to be tested, and the chitin-containing organisms that come into contact with the dye will absorb the dye and fluoresce upon exposure to ultraviolet or visible light. The organism can then be easily located and removed.
The preferred dyes employed in the method of the present invention are those that both bind or conjugate chitin and fluoresce in ultraviolet or visible light. Non-limiting examples of dyes that bind or conjugate chitin and fluoresce in ultraviolet or visible light include calcofluor white, Uvitex 3B (distyryl biphenyl fluorescent whitening agent), Rylux BA, Rylux BSU (1,4-benzenedisulfonic acid-2,2′-[ethyleneidylbis[(3-sulpho-4,1-phenylene)imino[6-bis (2-hydroxyethyl)amino]-1,3,5-trihexasodium salt) (Ostacolor, Pardubice, Czech Republic) and Blankophor (disodium 4,4′-bis{(4-anilino)-6-morpholino-1,3,5-triazin-2-yl) amino}stilbene-2,2′-disulphonate)_(Bayer). Calcofluor white and Uvitex 3B (distyryl biphenyl fluorescent whitening agent) a colorlees dyes that fluoresce brightly on exposure to long wave ultraviolet light and short wavelengts visible light. Calcofluor white may be obtained as fluorescent brightener 28 (Tinopal UNPA-GX) in the salt or the free acid form (Sigma Chemical Co., St. Louis, Mo.) or calcofluor white M2R (Poly-sciences, Inc., Warrington, Pa., or S
Burns Edward R.
Faskowitz Fagie
Wittner Murray
Albert Einstein College of Medicine of Yeshiva University
Amster Rothstein & Ebenstein
Jones Dameron L.
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