Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2001-01-09
2004-12-28
Cohen, Lee (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
C607S090000, C128S898000, C606S009000
Reexamination Certificate
active
06835202
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to an apparatus and method for the photodynamic therapy treatment of acne vulgaris and seborrhea and, more particularly, to a violet/blue light radiating system that illuminates a collimated narrow bandwidth beam on the treated skin area. The method relates to the combined photodynamic skin treatment including narrow band violet/blue light radiation and topical application of oxidative and/or keratolytic agents.
The enlargement and obstruction of sebaceous glands cause acne vulgaris. Due to the accumulation of sebum in the glands, bacteria, mainly
propionibacterium acnes
(
p. acnes
), proliferate in the glands. These bacteria cause inflammation and later the formation of pustular lesions and acne cysts, which heal by scarring.
It is known that
p. acnes
produce porphyrins. It is also known that visible light in the violet/blue (405-410 nanometer range), or less efficiently, red (630-670 nanometer range) are able to induce a photodynamic effect in which the porphyrins in the enlarged sebaceous glands react with oxygen to form peroxides. These peroxides are short-lived toxic compounds that are able to eliminate, or considerably diminish, the number of bacteria in the glands.
Photodynamic therapy (PDT) is based on the optimal interaction of four elements; light, photosensitizer, oxygen and skin penetration. Prior patents and publications related to acne phototherapy dealt only with the first two elements of PDT, i.e., and light exposure and sebaceous gland porphyrins. Studies have shown that the photodestruction of
p. acnes
is increased exponentially in an oxygen rich environment.
Various attempts have been made to treat acne with light; Mendes et al. (U.S. Pat. No. 5,549,660) described a method for the light therapy of acne using low intensity red light. Their apparatus was meant to treat acne through it effect on macrophages in the skin. Its low light intensity is not sufficient for an efficient photodynamic destruction of
p. acnes
in the deeper layers of the skin, High intensity visible light phototherapy for acne was described by Meffert et al, (Dermatol-Monatsschr. 1990; 176(10): 597-603) but they used a light source emitting not only visible light but also UVA comprising up to 15-20% of the total irradiation dose. Sigurdsson et al (Dermatology 1997; 94:256-260), used Philips HPM-10 400 W combined with an UVILEX 390- filter (Desag. Germany) that filters most but not all ultraviolet A (UVA) harmful rays. The spectrum of their lamp peaked at 420 nanometer and had 2 other small peak of emission at 405 and 435 nanometer. Their apparatus emitted at 40 cm; 0.5 J/cm
2
of UVA, 20 Jcm
2
/of violet/blue and 5 J/cm
2
of green light.
SUMMARY OF THE INVENTION
Basic science research has shown in vitro that the viability of
p. acnes
relates inversely to light intensity and to oxygen levels to which the
p. acnes
are exposed. Sigurdsson et al achieved with their apparatus 30% reduction of the total severity of acne and particularly 49% reduction of the number of pustules. The rate of success can be drastically improved by adding and penetrating oxygen to the skin daily and/or immediately before skin exposure to high intensity violet/blue light
According to the present invention there is provided an apparatus and a method for acne phototherapy, achieved by the use of a specially designed apparatus having a narrow spectral band violet/blue light emission with a possible additional spectral line, combined with a pre-treatment application on the treated skin area of an oxygen transporting compounds, based on the use of one or more of the materials from the group of compounds consisting of perfluorocarbons, oxidative substances, keratolytic substances and external photosensitizer such as methylene blue 0.1-5%.
There is thus provided, in accordance with an embodiment of the present invention, apparatus for treatment of a skin disorder. The apparatus includes at least one light source with spectral emittance concentrated in at least one specific narrow spectral band, wherein one spectral band is in the range of 405 to 440 nm, an optical system for collecting and shaping light emitted from the at least one light source and an electronic unit to control parameters associated with the spectral emittance from the at least one light source.
Furthermore, in accordance with an embodiment of the present invention, the parameters include at least one of a group including duration, power and emitted spectral bands of the light source emittance.
Furthermore, in accordance with an embodiment of the present invention, the apparatus further includes a mechanical fixture for holding the light source at an adjustable distance and direction related to a treatment area.
Furthermore, in accordance with an embodiment of the present invention, the illumination energy of the light source flux, is higher than a predetermined threshold level. The threshold level is a level required for biological destruction of acne and seborrhea causing factors.
Furthermore, in accordance with an embodiment of the present invention, the illumination energy threshold level of the illumination light source is at least 40 mw/cm2 at a distance from the light source of 30 cm.
Furthermore, in accordance with an embodiment of the present invention, the illuminated area on a patient body includes an illumination area large enough to illuminate an infected typical size skin area from a fixed position of the light source related to the skin area, In accordance with an embodiment of the present invention The illuminated area is at least 400 cm2.
Additionally, in accordance with an embodiment of the present invention, the apparatus further includes an illumination head having at least two converging collimated beams from at least two directions, each of the beams generated by a separate light source positioned at a distance from the other at least one light source.
Additionally, in accordance with an embodiment of the present invention, the apparatus further includes a computer controlled imaging unit for imaging an illuminated treated area and for monitoring by counting lesions on the treated area, using computerized counting techniques.
Additionally, in accordance with an embodiment of the present invention, the apparatus further includes a computer controlled display unit for displaying the imaged illumination treated area, wherein counting is carried out by an operator marking lesions on the display of the illumination treated imaged surface area. Alternatively, the computer lesions counting by image processing techniques to detect and count each lesion in the illumination treated imaged surface area. The score of the computer lesion counting is recorded in a computer memory to enable monitoring the lesion healing process through a series of consecutive treatments.
Furthermore, in accordance with an embodiment of the present invention, the computer controlled imaging unit idisplay image includes at least one of a group includes a graph of the number of counted lesions versus accumulated treatment time and a table consisting of number of counted lesions in each treatment session.
Furthermore, in accordance with an embodiment of the present invention, the apparatus further includes at least one optical element of a group includes a liquid filled light guide, a solid transparent light guide, a fiber bundle light guide and an array of lenses and mirrors for collecting and conducting the light source radiation and illuminating the skin treated area at an adjustable distance, energy density and direction.
Furthermore, in accordance with an embodiment of the present invention, the light source is a Gallium, Mercury and halides gas mixture discharge lamp with peak emission in the 405-440 spectral band. Alternatively, the light source is selected from the group including Ion Krypton gas laser with a spectral emission in the range 405 to 440 nm, and a diode. The diode is selected from the group consisting of violet/blue laser diodes, and light emitting diodes (LED) with narr
Harth Yoram
Korman Avner
Cohen Lee
Curelight Ltd.
Johnson, III Henry M
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