Dye treatment solution and photodynamic therapy and method...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application

Reexamination Certificate

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C607S089000, C606S002000, C606S003000, C606S011000

Reexamination Certificate

active

06251127

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to use of a dye treatment solution with a photodynamic therapy (PDT) treatment device. More specifically, the invention relates to photodynamic inactivation of bacteria and fungal wound infections and sterilization of tissue using methylene blue or toluidene blue and a flexible conforming patch or pad and a shaped article which provides light sources for topical PDT. The present invention advantageously uses light energy in combination with photosensitizing agents to treat or detect pathologies of living tissue, including cancer and microbiological pathogens.
U.S. Pat. No. 4,822,335, entitled, Apparatus For Treatment Of Cancer With Photodiode, purportedly discloses an apparatus for the treatment of a cancerous lesion part by irradiating a light energy from a light source to the cancerous lesion part having absorbed and accumulated in advance therein a photosensitive substance with an affinity for tumors. The light source comprises a first diode adapted to excite the photosensitive substance from the ground state to a singlet state of higher energy level and a second photodiode adapted to excite an energy level of the photosensitive substance which has transited from the singlet state to a triplet state to a still higher energy level.
U.S. Pat. No. 5,358,503, entitled, Photo-Thermal Therapeutic Device and Method, purportedly discloses an apparatus for simultaneous or selective treatment of an area of the skin and adjacent subcutaneous structure of a patient utilizing photo energy and therapeutic heat, which includes a plurality of juxtaposed diodes. Each diode has a longitudinal axis and is capable of projecting a non-coherent cone of light which overlaps the cone of light from each juxtaposed diode so that the light completely covers the treatment area. A flexible pad or appliance holds the diodes in juxtaposed position with each other.
U.S. Pat. No. 5,611,793, entitled, Laser Treatment, purportedly discloses a method of disinfecting or sterilizing tissues of the oral cavity or a wound or lesion in the oral cavity. The method includes applying a photosensitizing compound to the tissue and irradiating with laser light at a wavelength absorbed by the photosensitizing compound.
All documents cited herein, including the foregoing, are incorporated herein by reference in their entireties for all purposes.
SUMMARY OF THE INVENTION
The invention relates to use of methylene blue and toluidene blue as a photosensitizing agent in combination with a PDT treatment device for treatment of bacterial or fungus infections. The treatment device is configured to deliver light energy to an infection from a plurality of light emitting members disposed in the device. The treatment device includes light emitting members which operate at wavelengths ranging from about 450 nm to about 850 nm; provide a dosage rate ranging from about 0 to about 150 mw/cm
2
; and provide a light dose ranging from 0 to about 300 J/cm
2
.
The use of methylene blue or toluidene blue combined with mediated PDT advantageously acts as a broad spectrum antimicrobial, i.e., antibacterial and antifungal agent when used as a topical treatment for acute and chronic wound infections or for the sterilization of acute wounds and skin. The dye and PDT may be used, for example, before an operation. The present invention advantageously results in the destruction of gram positive and gram negative bacteria and fungus. Importantly, the present invention acts to destroy antibiotic resistant bacteria and works as a different destruction mechanism than antibiotics.
Microbiological data includes testing results of methylene blue and toluidene blue and PDT showing the efficacy of destruction of
Staphylococcus aureus
in in-vivo infected wounds; in vitro destruction of antibiotic resistant staphylococcus, streptococcus, enterococcus,
E
-
coli,
pseudomonas,
Hemophilus influenza
and
Candida albicans;
and wavelength spectrum of activation of methylene blue and toluidene blue in the presence of various concentrations of the above bacteria and candida.
Results show that at fixed concentrations of dye, total eradication of the bacteria or fungus requires proportionally increased total light administration (Joules) as the bacteria or fungus concentration is increased.
The present invention may be used in conjunction with or in relation to inventions disclosed in the following applications, filed on the same date concurrently herewith, Aug. 25, 1998.
U.S. patent applications: M. Biel, Inventor:
Method of Enhancing Photodynamic Therapy by Administering an Immunologic Adjuvant, Ser. No. 09/139,861.
Spatial Orientation Grid and Light Sources and Method of Using Same for Medical Diagnosis and Photodynamic Therapy, Ser. No. 09/139,862, now U.S. Pat. No. 6,048,359.
Rectangular Laser Irradiation Field Producing Apparatus for Medical Treatment, Ser. No. 09/139,480.
Methylene Blue and Toluidene Blue Mediated Fluorescence Diagnosis of Cancer, Ser. No. 09/139,481.
PCT patent application No. PCT/US98/17589 entitled, Treatment Device For Topical Photodynamic Therapy And Method Of Making Same, filed in the United States Receiving Office. M. Biel, Inventor.
All documents within these applications are herein incorporated by reference in their entireties for all purposes.
In sum, the invention relates to a method of treating an infection including identifying an in-vivo area of infection; applying a concentration including at least one of methylene blue, toluidene blue, polymyxin B, or combinations thereof to the area of infection; and exposing the area of infection with a light having a light wavelength, light dosage and a light dosage rate. The light wavelength may range from about 610 nm to about 680 nm. The light dosage may range from about 30 J/cm
2
to about 60 J/cm
2
. The light dosage rate may range from about 50 mw/cm
2
to about 150 mw/cm
2
. The wavelength may range from about 630 nm to about 664 nm. The concentration may range from about 10 &mgr;g/ml to about 500 &mgr;g/ml. The concentration may range from about 10 &mgr;g/ml to about 250 &mgr;g/ml; the light wavelength may range from about 630 nm to about 670 nm; the light dosage may range from about 20 J/cm
2
to about 60 J/cm
2
; and the light dosage may rate range from about 50 mw/cm
2
to about 150 mw/cm
2
. The concentration may range from about 50 &mgr;g/ml to about 250 &mgr;g/ml; the light dosage may range from about 30 J/cm
2
to about 60 J/cm
2
; and the light dosage rate may range from about 100 mw/cm
2
to about 150 mw/cm
2
. The concentration may be about 250 &mgr;g/ml; the light dosage may be about 60 J/cm
2
; and the dosage rate may be about 150 mw/cm
2
. The infection may include gram positive and gram negative bacteria and fungus including, but not limited to, at least one of staphylococcus,
Candida albicans, Escherichia coli,
enterococcus, streptococcus,
Pseudomanus aeruginosa, Hemophilus influenzae,
or
E
-
coli.
The invention also relates to an infection treatment kit including a volume of a concentration including at least one of methylene blue, toluidene blue, polymyxin B, or combinations thereof. The concentration ranges from about 10 &mgr;g/ml to about 500 &mgr;g/ml. Also included is a light emitting treatment device having a thickness, one or more surfaces and one or more light dosage members disposed therein. The light dosage members are configured to emit light at an infection at wavelengths ranging from about 450 nm to about 850 nm; a dosage rate ranging from about 0 to about 150 mw/cm
2
; and a light dose ranging from 0 to about 300 J/cm
2
.
The invention also relates to a method of treating an infection including providing one or more cells; disposing a concentration of dye on the one or more cells; applying a light having a wavelength ranging from about 450nm to about 850nm; a dosage rate ranging from about 0 to about 150 mw/cm
2
; and a light dose ranging from 0 to about 300 J/cm
2
to the one or more cells wherein the combination of light and dye is adapted to cause intracellular enzyme deactivation of the one or

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