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WO2011058048A1 - Appareil de traitement dermatologique - Google Patents

Appareil de traitement dermatologique Download PDF

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Publication number
WO2011058048A1
WO2011058048A1 PCT/EP2010/067192 EP2010067192W WO2011058048A1 WO 2011058048 A1 WO2011058048 A1 WO 2011058048A1 EP 2010067192 W EP2010067192 W EP 2010067192W WO 2011058048 A1 WO2011058048 A1 WO 2011058048A1
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WO
WIPO (PCT)
Prior art keywords
light
dermatological treatment
treatment device
leds
irradiation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2010/067192
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German (de)
English (en)
Inventor
Günther Nath
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US13/508,898 priority Critical patent/US20120283622A1/en
Publication of WO2011058048A1 publication Critical patent/WO2011058048A1/fr
Priority to PCT/EP2011/069888 priority patent/WO2012062884A1/fr
Priority to EP11793358.0A priority patent/EP2637743B1/fr
Priority to US13/884,557 priority patent/US20130344454A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0616—Skin treatment other than tanning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0632—Constructional aspects of the apparatus
    • A61N2005/0633—Arrangements for lifting or hinging the frame which supports the light sources
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0642—Irradiating part of the body at a certain distance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/065—Light sources therefor
    • A61N2005/0651—Diodes

Definitions

  • the present invention describes an optical irradiation device, which is primarily for the treatment of nail fungus, in particular toenail fungus and hand nail fungus, is suitable. In addition, it is also suitable, due to its flexible structure, for the treatment of localized inflammatory areas, such as. in psoriasis, atopic dermatitis and acne.
  • Cumbie is a very detailed description of the methods that have been used to treat fungal infections, especially of nail fungus, using optical radiation. In Cumbie, the spectral range of 100 nm-400 nm is particularly preferred. Cumbie's Cumbie patent also mentions the combined use of UVA radiation with one of Cumbie's "polychromatic" radiators such as low pressure mercury and xenon lamps Peroxide solution to increase the gericidal effect.
  • Object of the present invention is to provide a simple and safe to use device for effective optical treatment of nail fungus diseases. This object is achieved by the treatment defined in claim 1. solved.
  • the subclaims relate to preferred embodiments.
  • the present invention is a practical optical irradiation device for the treatment of nail fungus, which meets the following requirements:
  • a positive treatment effect must already be evident in the first session with the dermatologist or podiatrist.
  • the essentially complete removal of the externally visible nail fungus must be achieved in practice after a few (3-5) sessions.
  • the optically effective beam power density on the nail surfaces is extremely high, ie in the range of> 50 mW / cm 2 .
  • externally applied ointments, jellies, pastes or liquids with peroxide content can cause a softening of fungus-infected nail material, which can then be easily removed mechanically.
  • the device must be constructed so that it is convenient for the podiatrist to simultaneously treat one foot for podiatry and prepare for optical irradiation while the second foot is being irradiated.
  • the dermatological radiation device can optionally have different optical spectral ranges:
  • UVA radiation 320 nm ⁇ ⁇ 400 nm
  • UVA + blue radiation 320 nm ⁇ ⁇ 500 nm
  • only short-wave visible radiation without UV components eg in the wavelength range 380 nm ⁇ ⁇ 500 nm, or 390 nm ⁇ ⁇ 450 nm.
  • the spectral requirements for the application of the dermatological irradiation device according to the invention for the irradiation of limited inflammatory areas in atopic dermatitis, psoriasis or acne can be covered by the spectral ranges required for nail fungus.
  • the dermatological irradiation device builds up when using a conventional gas discharge lamp of four units: a) a radiation source, consisting of a housing and a gas discharge lamp with Elliptoidreflektor, which forms a beam focus.
  • the spectral range can be varied via a filter wheel with different band pass filters, arranged in the beam path, between reflector aperture and focus.
  • a shutter, an intensity control and a timer which controls the shutter are also components of the radiation source.
  • a flexible light guide preferably a liquid light guide, which conducts the desired radiation from the housing and whose light entry end is arranged in the focus of the reflector lamp.
  • the light exit end of the liquid light guide opens into the applicator part, which is designed differently depending on the medical application.
  • a beam cross-section transducer which receives the radiation of the liquid light guide and transforms the circular light beam into an oblong rectangular beam profile, which covers the foot nail strip well.
  • the cross-section converter is constructed according to the principle of the shoe gauge detector from the German patent application DE102005022305.
  • the cross-section converter can also be constructed from a triangular-shaped thick glass plate with polished surfaces or from a combination of crossed cylindrical lenses made of quartz glass or from a combination of cylindrical lenses and spherical lenses or simply from a diverging lens.
  • the applicator part contains a shielding housing, which covers the foot or the hand of the patient as far as possible.
  • the applicator portion and the cross-sectional transducer may either be completely absent, i.
  • the toenail or handheld irradiation device instead of a gas discharge lamp contains light-emitting diodes, and does not use a light guide.
  • Figure 1 is a perspective view of the optical irradiation device of a dermatological treatment apparatus according to a first embodiment of the invention
  • Figure 2 is a perspective view of a portion of the irradiation apparatus according to the first embodiment
  • FIG. 3 is an exploded view of a portion of the irradiation apparatus according to the first embodiment
  • FIG. 4 a shows a plan view of a partial region of the irradiation device according to the first exemplary embodiment in a first rotational position
  • FIG. 4b shows a plan view of a partial region of the irradiation device according to the first exemplary embodiment in a second rotational position
  • Figure 5 is an exploded view of the optical irradiation device of a dermatological irradiation apparatus according to a second embodiment of the invention.
  • FIG. 6a shows a bottom view of the irradiation device according to the second embodiment
  • Figure 6b is a perspective view of the irradiation apparatus according to the second embodiment
  • Figure 7 is a sectional view of the irradiation apparatus according to the second
  • Figure 8 is a sectional view of the optical irradiation apparatus of a dermatological irradiation apparatus according to a third embodiment of the invention from the side;
  • FIG. 9 is an exploded view of the irradiation apparatus according to the third embodiment.
  • FIG. 10a shows a bottom view of the optical irradiation device of a dermatological irradiation device according to a fourth exemplary embodiment of the invention.
  • FIG. 10b shows a detailed view of the illumination source of the irradiation device according to the fourth exemplary embodiment
  • Figure 10c is a sectional view of a portion of the irradiation apparatus according to the fourth embodiment from the side;
  • Figure 1 1 a is a partially sectioned side view of the optical irradiation device of a dermatological irradiation apparatus according to a fifth embodiment of the invention.
  • Figure 1 1 b is a bottom view of the irradiation apparatus according to the fifth embodiment of the invention.
  • FIG. 1 shows the overall arrangement of a toenail irradiation unit.
  • the lamp housing (10) contains the optical radiator, preferably an ultra-high pressure mercury lamp, with a Hg vapor operating pressure in the range of 100-200 bar, an electrode spacing of about 1 -2 mm and a power consumption between 50 watts and 350 watts ,
  • the lamp bulb is cemented into an elliptoid reflector, which produces a beam focus of about 3-10 mm light active cross section (0).
  • the elliptoid reflector is vapor-deposited with a dielectric multilayer thin-film coating, so that high broadband reflectivity is present in the entire spectral range of approximately 280 nm-1000 nm.
  • Preferred lamps are e.g. the reflector lamp HXP R120W45C VIS or UV from the company Osram® with 120 Watt or 200 Watt electrical power or a UHP (Ultra High Pressure) lamp from Philips® in the similar electric power range.
  • the elliptoid reflector can also be a UV reflector with particularly high reflectivity in the UVB, UVA and blue region of the spectrum, the reflector having a lower reflectivity in the green-yellow-red spectral range.
  • lamps as sources of radiation conceivable as Xe-high pressure lamps, also pulsed Xe lamps, or Hg high pressure or medium pressure lamps or tungsten halogen lamps or one or more LED arrays, which z. B. in the UVA range at 365nm, or emit in the violet spectral range around 405nm.
  • the lamp housing (10) contains inside a filter wheel, which is operated by the outer knob (13). This allows you to select up to twelve different spectral ranges, of which the following are important for the applications in question:
  • UVA 320 nm - 400 nm
  • Application Nail fungus irradiation in combination with peroxide-containing gel or peroxide-containing paste or peroxide-containing liquid.
  • the output power refers to a liquid optical fiber series 300, 05 mm x 1200 mm from Lumatec®.
  • the lamp used here is a 120 watt HXP reflector lamp from Osram® or a HXP lamp with 200-300 W output.
  • the radiation of the lamp is coupled in the housing (10) into the light inlet end of the flexible liquid light guide (14) and guided into the light inlet opening of the cross-section converter (16) positioned vertically here and fixed there by means of the adjusting screw (15), wherein the rotability of the liquid light guide in the housing of the cross-section converter (16) should be preserved.
  • the liquid light guide used here has been described, for example, in German patent DE4233087.
  • the liquid core of the liquid light guide is the solution: CaCl2 in H2O, as well as, due to better red light transmission, the deuterated variant: CaCl2 in D2O.
  • Typical dimensions of the liquid light guide are: length: 100 cm - 200 cm, diameter of the light active core about 03 mm - 08 mm, preferably 05 mm or 05-6.5 mm.
  • the lamp housing (10) still contains controls for the intensity control (12) and for the light shutter (1 1).
  • a timer which limits the exposure time by controlling the shutter may also be integrated in the lamp housing (10).
  • the cross-section converter (16) is mounted on a turntable (17) which is fixed here with 2 thumbscrews on the roof of a housing (1 10).
  • the housing (1 10) serves to receive the foot or the hand of the patient for Light irradiation of all five toe and hand fingernails.
  • the housing (110) has primarily the function of light shielding, since neither the patient, nor the doctor or podiatrist could otherwise endure the extreme brightness of the scattered light during the light exposure. Wearing goggles as an alternative would be annoying.
  • the foot of the patient rests on the base plate (1 12), which is connected to the housing (1 10). Housing (1 10) and base plate (1 12) form a kind of shoe ("light shoe”), in which the foot is pushed in.
  • the bulge (1 1 1) facilitates the "slip-in" in the shoe.
  • an insert (1 13) can be positioned on the base plate (1 12), which is replaced with each patient, so to speak as a disposable part, or as a metal plate, which can be easily removed and disinfected in liquid media.
  • the insert (13) can be a sheet of paper with raised edges adapted to the light shoe, on which the patient's foot rests during the irradiation. The patient may sit during the irradiation, which typically lasts about 10 minutes, while the podiatrist is treating the second foot (cutting, grinding, preparation for irradiation, or post-processing after irradiation).
  • the shielding housing (10) also fulfills two additional functions: First, it must have a certain, greatly attenuated optical transparency, which allows the patient or the podiatrist to observe the position of the toenails at all times during the optical irradiation and to control.
  • the walls of the housing (1 10) should fulfill the function of a long-pass filter, ie it should be permeable to long-wave orange and / or red light and impermeable to short-wave (blue, green) visible light.
  • This property is favorable because, when the nails are irradiated with UVA, violet or blue light, best in the spectral range 390 nm ⁇ ⁇ 430 nm, the remaining nail fungus can excite fluorescence in the orange, reddish spectral range Diagnosis of nail fungus is very beneficial.
  • This additional optical property of the housing (110) has the important advantage for patients and podiatrists that with the dermatological irradiation device according to the invention it can also at any time confirm the status of fungal infestation. can judge, and drastically more clearly, than would be possible with lighting with strong white light.
  • An embodiment of the housing (1 10), which has been proven for all 3 functions (glare protection, position control, fluorescence diagnosis), is that the walls of the housing (1 10), i. Side surfaces, face, roof surface and the turntable (17), consist of 3mm thick Plexiglas, which is light or dark red or orange.
  • the optical transmission (T) of this colored 3 mm thick Plexiglas plate may have approximately the following transmission characteristics:
  • T 50% is in a range of 500 nm ⁇ ⁇ 600 nm
  • T 90% is in a range 600 nm ⁇ ⁇ 750 nm
  • the cross-sectional transducer (26) in whose tapered light entry end the liquid light guide (24) is inserted, produces a rectangular, oblong beam profile (216), indicated here by the geometric boundary beams 215.
  • the beam profile (216) completely covers all five nail plates of the toes, allowing or requiring a certain overlap of about 10 mm at each of the four boundary lines is, so that a complete beam coverage of the toe-nail-bar is guaranteed, taking into account different foot sizes and anatomically individual deviations.
  • a further enlargement of the surface of the light profile (216) is not recommended, because otherwise an unnecessary reduction in the optical power density, measured in watts / cm 2 , on the surface of the toenail to be irradiated, the consequence would be.
  • this optical power density should be as high as possible in practice, ie it should go up to the limit of thermal pain generation, because otherwise no sufficient therapeutic effect in a reasonable, tolerable for practical operation time, on the order of 5-20 minutes , is achieved.
  • Gel + carbamide peroxide whereby the gel can consist of the gelling agent PCN 400, (chemical name: sodium carbomer or sodium polyacrylate), stirred in H2O, and the peroxide in the form of carbamide peroxide is mixed in the same amount by weight with the PCN 400 gel , The total peroxide content is then approximately 15% (weight fraction).
  • the addition of the carbamide peroxide may also be much higher, e.g. 150 or 200% by weight, based on the weight of the gel, more precisely: the gel fraction.
  • organic peroxides such as. T-butyl hydroperoxide, di-t-butyl peroxide,
  • Peracetic acid or dibenzoyl peroxide can be used for the substance to be applied, but they have a lower content of "active oxygen" compared to the hydrogen peroxide.
  • the organic peroxides can be represented by the structural formula R-O-O-R, where the radicals R can be identical or different and can be H, alkyl, aralkyl, acyl or aroyl. Particularly preferred examples thereof are t-butyl hydroperoxide or peracetic acid.
  • Component A consists e.g. from a 30-40% aqueous hydrogen peroxide solution as readily available commercially.
  • this solution can also be diluted with H2O if a weaker effect is desired, e.g. to a H2O2 level of only 15-20% or even less.
  • the component B may consist of S1O2 powder, wherein the particle size of the glass particles may vary from only 10 nm to 0.1 mm.
  • the glass from which the powder was made does not necessarily have to be pure quartz glass. It may also contain other additives commonly used in glassmaking, such as alkali or alkaline earth oxides or boron (such as the 3M® "Glasbubble” powder which consists of hollow glass spheres.)
  • a pure, highly dispersed one has proved useful S1O2 powder with particle size in the nano range around 12 nm. Also the so-called “Aerosil” S1O2 powder with particle size in the nano range rich you can use.
  • the optical transparency of the paste is important because it depends precisely on the oxygen evolution or the formation of OH radicals at the interface nail plate paste.
  • the small amount of solid (S1O2) in this paste makes it possible for the high concentration of H2O2 to decrease only slightly from the original 30%, which benefits the effect desired here, namely the softening of the fungus-penetrated nail substance in only a few minutes.
  • This softening effect is caused by the reactive oxygen or the strong oxidizing effect of the OH radicals generated by the radiation, which increases the hydrogen peroxide, excited by the irradiation with light.
  • Component C contains catalysts for accelerating the decomposition of the hydrogen peroxide. These may be bases, such as KOH or NaOH. NH4 (ammonium) or small additions of heavy metals or a small amount of finely grained carbon also favor this decay. The amount of the substances of the component C are in the range of less weight percent, even less than one percent by weight, based on the total weight of the paste.
  • Examples include dimethyl sulfoxide or dimethyl sulfone. These substances increase the penetration depth of the paste into the tissue.
  • these carrier substances singly or in combination in the composition of the paste, however the effect of the paste, especially in combination with the intense light is usually sufficient even without a carrier, so that one can usually omit the carrier substances.
  • a surfactant (component E) improves the wettability of the nail plate by the liquid phase A.
  • anionic surfactants are linear alkylbenzenesulfonates; a useful example of a cationic surfactant is cetyltrimethylammonium bromide; A useful example of a nonionic surfactant is polyalkylene glycol ether.
  • Substances capable of transferring light energy to the peroxide may obscure the use of UV light or enhance the effect of longer wavelength light.
  • suitable dyes are eosin Y (tetrabromofluorescein), erythrosin (tetraiodofluorescein), rose bengal (tetraiododichlorofluorescein), but also chlorophylls and porphyrins.
  • the nail plate must be roughened mechanically before applying a peroxide-containing substance (gel, paste or liquid), because otherwise only a much weaker therapeutic effect is achieved.
  • a peroxide-containing substance gel, paste or liquid
  • the roughening or grinding of the nail plate is done in practice usually with a rotating cutter.
  • the roughened nail plate to be treated should also be absolutely free of grease.
  • the podo- gin protects the skin tissue adjacent to the nail, eg. As with a sunscreen with high SPF from UVA radiation and the slightly caustic peroxide gel. But it is also sufficient to apply a greasy protective cream, such as Vaseline TM or Bepanthen TM, to the tissue.
  • the toenails are exposed in the light shoe for about 10 minutes with radiation in the spectral range UVA plus blue, ie in the range 320 nm ⁇ ⁇ 500 nm or in the UV-free spectral range 380 nm ⁇ ⁇ 500 nm.
  • the total output from the cross-section converter is about 5 watts.
  • the radiation incident on each nail plate has a power density of approx. 100 mW / cm 2 .
  • the applied radiation dose can thus be up to about 60 joules / cm 2 .
  • the podiatrist determines that most of the fungus-infected nail material has softened and can be scraped away or cut away.
  • the non-fungus-infected, still healthy nail material remains essentially unchanged.
  • the same procedure of irradiation in combination with the peroxide gel can also be repeated immediately.
  • Most of the nail fungus can be destroyed in this way in a session, or at least soften, and mechanically ablate. After that, 2-3 more similar treatments may be required, depending on the severity of the original fungal infection. Applying the same high radiation dose on the fungus nail, but omitting the peroxide, so obtained no therapeutic effect, even after repeated repetition of irradiation, even with daily irradiation for weeks away.
  • the therapeutically important softening effect is achieved exclusively by the action of the peroxide-containing substance, here caused by the radiation and / or optionally catalyzed by additions of the component C to the paste.
  • protoporphyrin IX in aqueous or alcoholic solution instead of peroxide in combination with the radiation was tried.
  • aqueous solution with protoporphyrin IX can also be brought into a paste-like consistency by admixing, for example, finely divided S1O2 (for example 5% by weight), which is advantageous for application to the nail plate.
  • one or more carriers for example DMSO or dimethylsulfone
  • the wavelength of light would then conveniently be centered around 405 nm or in the red spectral range, eg at 630 nm ⁇ 10 nm.
  • PDT photodynamic therapy
  • a strong oxidizing effect with destructive effect against the nail fungus or a softening of the infected nail material could be observed.
  • the disadvantage of this method is that the nail is darkened by the porphyrin. This discoloration is retained after the irradiation, so that the patient has the purely visual impression that his nail fungus, which also discolored the nail, has not improved.
  • the cosmetic effect thus leaves much to be desired in this application variant, although the discoloration produced by the porphyrin can be largely bleached by a subsequent treatment with peroxide, as described above.
  • the shielding housing (310) here has a rectangular recess (316) which can not be seen in FIG. 2 and which can be covered from the inside with a glued-on transparent Plexiglas plate (also transparent in the UVA region). This recess is necessary because of the necessary rotation of the cross-sectional transducer by up to ⁇ 30 ° about its vertical axis, measured to the transverse axis of the light shoe, with no optical shading of radiation emitted by the cross-section converter radiation may take place.
  • Figure 2 shows, for example, the outermost rotational and angular position of the cross-sectional transducer as it is required for the irradiation of the right foot, especially since the toe-nail bar forms approximately an angle of 20 ° - 30 ° to the transverse axis. If the rotatability of the cross-sectional transducer were not given, the rectangular radiation profile (216) in FIG. 2 would have to be wider, with a corresponding reduction in the available beam power density (mWatt / cm 2 ) at the nail plates. If the left foot is to be irradiated in FIG. 2, the knurled nuts (28) in FIG. 2 or (38) in FIG.
  • the abutment of the two rotational positions is defined by the two circular-arc-shaped grooves (39) in the rotary plate (37) in FIG. 3 as well as the screw pins (317) projecting into these grooves.
  • the knurled nuts (38) fix the rotational position. For anatomically differing feet, any average rotational position between + 30 ° and -30 ° can also be set.
  • the rotary plate (37) has a rectangular recess (315), which coincides with the light exit opening of the cross-sectional converter (36).
  • Rotary plate (37) and cross-sectional transducers (36) are firmly glued together or otherwise mechanically interconnected.
  • FIG. 3 also shows a slide-in plate (319) which can optionally be inserted into the interior of the shielding housing (310) on four pins (320), approximately at a height of one third above the base plate.
  • This plate should be as close as possible to the toenails. It consists of Plexiglas, which is colored very highly concentrated with one of the dyes from the series of Lumogene®. It can e.g. the dyes Lumogen® red or Lu- mogen® orange or Lumogen® yellow, all dyes from the chemical group of perylene dyes. In the case of staining with Lumogen® red, this plate fluoresces red with emission between 600 nm and 700 nm, the maximum of the emission being 630 nm. Instead of a fluorescent flat plate, one can also use a U-shaped bent sheet of Plexiglas, doped with the fluorescent dye, which can be used more quickly in the light shoe.
  • a radiation centered at 630 nm is therefore advantageous for toenail fungus because it penetrates much deeper into the nail and surrounding tissue than short-wave UVA and blue radiation, and because the endogenous or externally applied porphyrins have a secondary maximum at 629 nm of absorption, which can be of importance for the control of nail fungus infection by the method of photodynamic therapy.
  • This plate (319) doped with a red fluorescent dye thus has the function of a wavelength shifter. Due to the random peak emission at 630 nm, this Lumogen® red or Lumogen® orange-doped fluorescent plate may also be useful in all other applications where endogenous or externally applied porphyrins play a role in healing, such as, e.g. in the treatment of light eczema, psoriasis, acne or other skin diseases.
  • FIGS. 4a and 4b show once again, in the plan view of the light shoe, the positions of the cross-section transducer with rotating plate (47a) and (47b) when the toenails of the left foot are irradiated under the shielding housing (410a) and the right foot under red Light transparent shielding housing (410b).
  • FIGS. 5-1 An alternative toe or hand nail irradiation apparatus is described with reference to FIGS. 5-1 1, which likewise generates an intensive light strip covering the nail strip with the aid of linearly arranged powerful light emitting diodes (see FIGS. 5 through 6) or more circular light beams. stains, as in FIGS. 8-11.
  • FIG. 5 shows the structure of such an irradiation device.
  • an approximately 10 mm thick copper plate (54) six powerful LEDs (541) with good thermal contact, e.g. glued on with the help of a thermal adhesive.
  • the electric power of such an LED is about 10 watts in this example and consists of an "array" of four lower-power single diodes connected in series, three each of these LED arrays being connected in series and the two triplets being connected in parallel 60-90 watts maximum, the maximum voltage applied to three series-connected diodes is about 30-60 volts, the current through the diodes is 500-1500 mA Irradiance applied voltage still in the low voltage range, which is important for the safety of the patient.
  • the plate (54) with the diodes is well thermally conductive with a heat sink (55), e.g. made of aluminum, which can contain inwardly directed cooling fins (551).
  • the pin (556), attached to the heat sink (55), and the washer (557) and the snap ring (558) are used to suspend the irradiation body, as shown in Figure 6b.
  • On the copper plate (54) on the diode-side surface of the reflector (53) by means of the four screws (52) is fixed, wherein the reflector through the light exit window (51), here e.g. Made of UV-permeable Plexiglas, also with the help of four screws (52) is completed and protected.
  • the reflector (53) contains two V-shaped reflector plates (531 and 532) which open outwards towards the light exit side and can consist of highly mirrored aluminum with S1O2 protective layer. Instead of a single V-shaped reflector (531, 532), one can also equip each of the LED diodes (or arrays) with a round reflector, similar to that shown in FIG. 9 (94).
  • a convex attachment lens can also be provided on each individual reflector (as in FIG Figure 9 with reference numeral 96), or an elongated cylindrical lens covering all reflectors.
  • the fan (552) provides airflow through the heat sink (55) and attaches to it with the four screws (553).
  • FIG. 6a again shows in detail the arrangement of the 6 powerful light-emitting diodes (641) on the copper base (694).
  • the arrangement of the diodes is substantially linear but not necessarily equidistant.
  • the spacing of the two middle diodes may be greatest, with the spacing of each pair of adjacent diodes decreasing from the center to the edges to the left and right.
  • the light strip (696) which lies over the toenails, obtains a sufficiently uniform beam power density.
  • 6 x 10 Watt LED Engine® LEDs were selected, with peak emission at approximately 400 nm ⁇ 10 nm.
  • Figure 6b shows the entire composite lighting complex consisting of fan (652), heat sink (695), copper plate (694) and reflector (693), suspended over the pin (656) on a support frame (699).
  • the entire lighting fixture can be rotated along the axis of the pin (656) by up to about ⁇ 30 °, so that the light strip (696) can be aligned for the left and right feet, analogous to the irradiation device of Figure 2.
  • the principle is to limit the light radiation as possible on the bar of 5 toenails to maximally hold and use the beam power density generated by the six expensive power diodes.
  • a beam power density of about 100-300 mW / cm 2 could be measured on the nail plates of all five toes , at a distance of the nail plates from the reflector (693) of about 3-4 cm.
  • This power density is sufficient for the softening of a fungal infected nail plate area with simultaneous application of a highly concentrated hydrogen peroxide-containing paste (or solution or gel), as described above, within an irradiation time of only 10 minutes.
  • the patient's foot rests on a base (698) with footbed.
  • a serving (697) of the substrate (698) for the purpose of optical shielding may also be provided and may also consist of yellow or orange colored transparent plexiglass for the reasons stated above.
  • FIG. 7 shows a side view of the LED irradiation unit with suspension on a support frame (799). Height adjustment is possible with the adjusting screw (7100), which is advantageous for the fungal fluorescence diagnosis and for the regulation of the irradiation inten- sity.
  • FIG. 7 also contains a pedestal (7101) which is very useful for podological practical operation and which is adjustable in inclination and height. B. is used by guitarists as a footrest. This footrest, which is available on the market very cheap and which is optimally suitable for the podological practice, can of course also be used as a pedestal for the irradiation device of Figure 1 and Figure 2.
  • the only change that needs to be made is a cross boom rod on the front floor support (7102) to increase the tipping stability.
  • the light emitting diodes in contrast to the gas discharge lamp, as used in the apparatus of Figure 1, usually monochromatic.
  • diodes with emission at 400 nm - 405 nm and with high power as in the aforementioned example one has the advantage of not requiring UV radiation, but with the radiation as close as possible to the UV boundary lies. While oxygen scavenging or OH radical formation is more effective by exposure to H2O2 in the UV region of the spectrum, monochromatic radiation at 400-405 nm, as can be produced by high power LEDs, is a good compromise, especially if legislation requires exposure of human tissue to UV radiation, which is generally the case.
  • the LEDs for conversion to other wavelengths as a complete unit, so to replace the LEDs of a first emission spectrum by those of another spectrum.
  • the plates (54, 694) with the associated heat sinks (55, 695) in Figures 5 and 6 or the heat sink (101 a) with the attached LEDs (103a) in Figure 10a easily removably attached to the irradiation device according to the invention so that they can easily be replaced by replacement elements with LEDs of a different emission spectrum.
  • FIGS. 8 and 9 show a toe / hand-nail irradiation device which has only a single light diode (83, 93) or only a single diode array (83, 93), for example consisting of 4-6 individual diodes, which are in series or in groups may be connected in parallel contains.
  • the light-emitting diode or the diode array is connected to good thermal conductivity with an elongated heat sink (81, 91) made of aluminum.
  • the heat sink (81, 91) has in this example, the outer dimensions 30 x 30 x 123 mm with inwardly directed cooling fins (551), analogous to Figure 5, and a small fan (82, 92) which provides for air flow inside ,
  • the elongated heat sink (81, 91) can serve as a handle when the irradiation device is to be guided by hand.
  • the to the axis The handle's vertical or angular radiation of the LED also has a safety effect, because the risk of glare of the operator or other people by this geometry is unlikely.
  • the emitted radiation of the light-emitting diode or the diode array is focused by a funnel-shaped reflector (84, 94), on whose extended light exit surface is a convex shaped lens (86, 96) made of quartz glass or normal optical glass or Plexiglas.
  • the lens has a focal length of about 3-4 cm and an opening of about 22 mm.
  • the lens (86, 96) and the reflector (84, 94) are captured in the outer lens barrel (85, 95) with an O-ring (98) of elastic material providing the seal to the outside.
  • FIG. 8 also includes a funnel which can be fitted onto the lens barrel (85, 95) and which can fulfill up to three functions: a) The long-pass optical filter effect for observing the fluorescence of fungal nail or skin areas. b) Glare protection for the practitioner as well as for the patient. The annoying placement of goggles can be omitted, c) compliance with a minimum distance to the irradiated area, so that the beam power density on the nail plate or the tissue not higher than z. B. 100 mW / cm 2 .
  • the LED light source used in this embodiment is an array consisting of 4 single diodes with a peak emission at ⁇ ⁇ 405 nm ⁇ 10 nm and an electrical input power of 10-15 watts.
  • the required electrical voltage is about 15 volts (in series connection of individual diodes), ie in harmless low voltage range.
  • the beam output in violet at about 405 nm is at least 2.1 watts.
  • the nail plate was roughened and degreased before the irradiation and a layer was applied, be it a gel, a paste or a liquid containing about 30% by weight H2O2.
  • the irradiation device of Figure 8 or 9 has only one diode array and you can not all 5 toenail plates of a foot, but only 1 -2, irradiate at most 3 adjacent nail plates at the same time, but this is sufficient in many cases.
  • this irradiation device allow it to irradiate like a flashlight even by hand and to irradiate not only toenail fungus, but also toenail fungus or skin fungus and to make visible by fluorescence or generally skin tissue by hand irradiate.
  • a tube in the form of a cap or a cap (eg with a clamping seat) whose light exit surface is made of a translucent plastic consists of, or which consists entirely of such, and which can be easily replaced and cleaned.
  • a cap allows the direct surface pressure of the light exit opening on the tissue or on the nail plate (or at least their approach to the limit of the touch) during irradiation.
  • the Lichtaustritts- or pressure surface with the active substance-containing paste which is located on the nail plate or the tissue to be smeared, which is why the cap should either be designed as a disposable part, or at least easy to clean.
  • Suitable materials for the contact with the fabric or the pressure on the fabric are: highly transparent or at least translucent, soft silicone elastomers, highly transparent and soft polyurethane, PVC, PE® or other soft, highly transparent plastic materials that adapt to the contour of the nail plate with slight area pressure.
  • Soft, highly transparent silicone which can be up to 1 cm thick as a flat pressure body, is also preferred because it adapts very well under pressure to outer contours.
  • the pressure surface may be flat, concave or convex.
  • the latter carbon-fluoropolymers are preferred for their anti-sticking properties, chemical inertness, and ease of cleaning.
  • the tube in the form of a cap or a cap can be formed wholly or partly from one of the aforementioned materials and can preferably be produced by injection molding or rotate on the lathe made of solid material. If the application hygiene allows it, instead of the cap of the same materials but also light exit windows can be formed, which are attached directly to the lens barrel (85, 95), for example. By the window is crimped on the inner circumference.
  • the pressure technique is not only favorable when using peroxyd restroomr or porphyrin inconveniencer substances under short-wave ( ⁇ ⁇ 400 nm) irradiation but can also be applied to other salves on the skin or on nail plates when irradiated in the longer wavelength spectral range (red, infrared).
  • the pressure technique or the maximum approach of the light exit opening to the tissue also has the advantage that you need the lowest possible electrical power for the LED (s), which is beneficial to the economy.
  • the device of FIGS. 8-9 instead of an array with emission at 405 nm also with an LED array around 365 nm, or around 465 nm, or for the irradiation of deep-lying fungal spores with longer-wave emitting diodes z. B. at 630 nm, 740 nm, 850 nm or 940 nm populate.
  • the LEDs around 465 nm are particularly powerful. With the use of an LED array with 4 individual diodes and a total of 10-15 watts of electrical power in the blue at ⁇ "465 nm, the beam output of the small device according to FIGS. 8-9 is almost 3 watts.
  • FIG. 10a shows an irradiation arrangement completely analogous to that shown in FIGS. 8 and 9, but with 2 (maximum 3) LED arrays (103a, 103b) including reflector and lens.
  • the two complete optical attachments (shown again in section in FIG. 10 c) are identical to those shown in FIGS. 8 and 9, and are likewise based here on an elongate rectangular heat sink (101 a) at a distance of approximately 40-60 mm (at 3 LED arrays at a distance of 20 - 40 mm), mounted to each other.
  • the metallic heat sink (101 a) made of aluminum with screwed-on fan (102 a) is slightly larger in this embodiment than that in Figure 8 and 9. It has the outer dimensions: 50 x 50 x 120 mm, and also has the inwardly directed cooling fins on.
  • the 2 (3) diode arrays with 4 single diodes (103b) can also emit either at 365 nm, 405 nm or 465 nm or in the red or infrared range.
  • the arrangement 10a can irradiate all five nail plates of a foot simultaneously and is expediently placed on a light shoe housing, analogous to that shown in Figure 2 (21 1), instead of the cross-section converter (26) used there with rotary plate (27).
  • a light shoe housing analogous to that shown in Figure 2 (21 1), instead of the cross-section converter (26) used there with rotary plate (27).
  • two (three) passport openings for the two roundish optical attachments (105c) in the roof panel of the light shoe housing (21 1) are sufficient.
  • the rotation of the irradiation unit of FIG. 10a analogously to the rotatability of the cross-section transducer (26) in FIG.
  • a rotation by about ⁇ 25 ° analogous to the rotation of the cross-section converter (26) in Figure 2 of the radiation arrangement of Figure 10a is still easily possible if one in the roof panel of the light shoe housing (21 1) of Figure 2 instead of the two outer Round holes milled two circular slots.
  • the light shoe housing (21 1) used here in connection with the LEDs not only fulfills the function of glare protection but also that of a long-pass filter, and may consist of transparent orange colored Plexiglas, analogous to the irradiation devices of FIGS. 1 and 2.
  • the optics attachment which collects and focuses the emitted radiation of the LEDs, and substantially includes the reflector (94) and the lens (96), and which is used in all of the described irradiation devices of Figs. 8-1 1 can also be modified somewhat.
  • the reflector (94) does not necessarily have to have circular symmetry. He can z. B. also have a pyramid-truncated symmetry with reflective inner surfaces, wherein the lens (96) covers the larger light exit surface of the reflector, and the LED is located in the smaller light entrance opening of the reflector.
  • the reflector does not necessarily have to have a square cross-section. It can also have an oblong rectangular light exit and entry opening, being very similar to the cross-section converter (36) of FIG. 3, but much smaller.
  • the non-circular symmetry of the reflector (94) may be advantageous when it comes to joining 2 Lichteinrahlungsareale adjacent LEDs, such as. B. in Figure 10 or 1 1, with the smallest possible overlap region of the light spots in order to achieve the most homogeneous beam power density in the elongated irradiation field of all five nail plates of a foot.
  • a transparent plane plate, a cylindrical lens or a diffuser plate can also be used.
  • FIG. 11 illustrates a device with four LED light sources (13b) for the irradiation of all ten nail plates of both feet.
  • the LEDs (1 13b) are mounted on the elongate heat sink (1 1 1 a, 1 1 1 b), wherein each two of the two outer LEDs slightly offset from each other, for. B. by the angle ⁇ of about 20 °, are arranged, whereby the angular position of the nail plate strips both feet is taken into account.
  • the heat sink (1 1 1 a, 1 11 b), the fan (1 12a, 1 12b) and the optical heads (1 15a, 1 15b) are similar or identical as in Figure 10a and 10b.
  • the Lichtabcapgetude not shown here and the foot pad as shown in Figures 1-7, can also be used here.
  • the irradiation device of FIG. 11 preferably serves for the post-treatment after the specialist has carried out the first photochemical treatment with short-wave light and the radical-forming peroxide-containing paste (gel, liquid).
  • the patient can also do the after-treatment at home, irradiating the toenails daily with long-wave light for about 10 to 20 minutes.
  • LEDs or arrays can be used with z. B. 10 watts of electrical power, which z. At 630 nm, 670 nm, 740 nm, 850 nm or 940 nm, short in the red or near-infrared spectral region, where the beam power density on the nail plate should be greater than 10 mW / cm 2 .
  • the regular irradiation with light in the red or near-infrared spectral range reaches the fungal spores deeper in the tissue, which were not reached in the first photochemical treatment with the short-wave radiation due to the lower jet penetration depth. It is observed that the nails regrow in this procedure of regular irradiation with longer-wave light, but only after months clear and unpickled. Applying ointments or oils with fungicidal active ingredients to the nail plates and the surrounding tissue at the same time as this treatment can only improve and accelerate the healing effect because the light radiation also increases the penetration of the active ingredients into the tissue.

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Abstract

L'invention concerne un appareil de traitement dermatologique approprié principalement au traitement de l'onychomycose, notamment la forme affectant les orteils. L'utilisation d'une substance à activité photochimique permet de lutter efficacement contre les champignons par exposition à un rayonnement lumineux dans une plage de longueurs d'onde ne présentant relativement pas de risque pour la santé. Pour la construction de l'appareil de photothérapie, plusieurs réalisations techniques sont possibles, lesquelles fonctionnent soit avec une lampe à décharge, soit avec des DEL en tant que source de lumière. On utilise de préférence un boîtier de blindage optique en forme de chaussure, qui laisse passer la lumière dans la partie des grandes longueurs d'onde du spectre visible et est absorbant dans la plage thérapeutique à courtes longueurs d'onde du spectre.
PCT/EP2010/067192 2009-11-10 2010-11-10 Appareil de traitement dermatologique Ceased WO2011058048A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US13/508,898 US20120283622A1 (en) 2009-11-10 2010-11-10 Dermatological treatment device
PCT/EP2011/069888 WO2012062884A1 (fr) 2010-11-10 2011-11-10 Appareil d'irradiation optique pour la dermatologie et la cosmétique
EP11793358.0A EP2637743B1 (fr) 2010-11-10 2011-11-10 Appareil d'irradiation optique pour la dermatologie et la cosmétique
US13/884,557 US20130344454A1 (en) 2010-11-10 2011-11-10 Optical Irradiation Appliance for Dermatology and Beauty Care

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DE202009015220 2009-11-10
DE102010014591 2010-04-09
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US10180248B2 (en) 2015-09-02 2019-01-15 ProPhotonix Limited LED lamp with sensing capabilities
CN117582610A (zh) * 2024-01-19 2024-02-23 中国人民解放军总医院第一医学中心 一种光疗用紫外led封装器件及其使用方法

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US20130344454A1 (en) 2010-11-10 2013-12-26 Günther Nath Optical Irradiation Appliance for Dermatology and Beauty Care
ITUA20162197A1 (it) * 2016-03-17 2017-09-17 Tommaso Virnicchi Lampada a led per abbronzatura o fototerapia
FR3084262B1 (fr) * 2018-07-27 2021-01-01 Institut Nat Superieur Des Sciences Agronomiques De Lalimentation Et De Lenvironnement Agrosup Dijon Procede d’elimination de microorganismes presents dans et/ou a la surface d’un materiau a decontaminer
DE102022212158A1 (de) * 2022-11-15 2024-05-16 Kbl Gmbh Körperbestrahlungsvorrichtung für eine Anwendung von aktinischer Strahlung an einem Lebewesen

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CN117582610A (zh) * 2024-01-19 2024-02-23 中国人民解放军总医院第一医学中心 一种光疗用紫外led封装器件及其使用方法
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