Classifications

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  • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
  • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
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  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00452—Skin
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  • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
  • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
  • A61B2018/2255—Optical elements at the distal end of probe tips
  • A61B2018/2261—Optical elements at the distal end of probe tips with scattering, diffusion or dispersion of light
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  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/06—Measuring instruments not otherwise provided for
  • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
  • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
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  • 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
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  • A61N2005/065—Light sources therefor
  • A61N2005/0651—Diodes
  • A61N2005/0652—Arrays of diodes
• • A—HUMAN NECESSITIES
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  • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
  • A61N2005/0662—Visible light

Definitions

• This invention relates generally to dermatologic treatment devices and methods, and more particularly relates to devices and methods for treating acne using optical techniques.
• Acne is an age old problem of many adolescents and adults. The causes of acne are not entirely understood, although it appears based on at least some research that the P. acnes bacteria plays a significant role in at least certain types of acne. Propionibacterium acnes (P. acnes) or other naturally present organisms can proliferate in the mixture of sebum and epithelial cells and promote inflammation.
• Porphyrins are well- known ring molecules that are widely prevalent in biological processes, have strong absorption around 400 nm in the Soret band with features that vary slightly with specific porphyrin species, and can be photosensitizing agents which can induce cell damage after irradiation.
• the present invention provides a method and device for treatment of common forms of acne.
• the method involves exposing the affected areas of the skin with light at an appropriate fluence and wavelength.
• the result is to disrupt one or more aspects of the process that leads to inflammation of the skin up to and including the formation of lesions, such as pustules, thereby improving significantly the appearance and condition of the skin.
• the present invention comprises a method of illuminating the affected areas with light of a first wavelength to identify areas susceptible of inflammation by the P. acnes bacteria, where the light of a first wavelength causes the porphyrins produced by the bacteria to fluoresce.
• Another aspect of the invention also comprises illuminating the affected areas with light of an appropriate wavelength and sufficient fluence such that a sufficient dose of light of that wavelength is delivered to the bacteria to disrupt the inflammatory cascade. More specifically, this latter aspect of the present invention involves either a photochemical mechanism, selective photothermolysis, or both, of an affected pilosebaceous duct, gland and contents. The contents of an infected area have been discovered to comprise, in significant portion, the P. acnes bacteria themselves.
• the wavelength of light used to identify the affected areas is the same as the wavelength of light used for treatment, for example, approximately 413 nm, although in other embodiments the wavelengths can be different from one another.
• a device in accordance with a first embodiment of the present invention comprises a housing together with a light source within the housing configured to operate at a wavelength in the range of 390 nm to 430 nm, and, in an embodiment, at nominally 413 nm, and an outlet for the light, adapted to be placed in proximity to the area being treated whereby the light will illuminate the area under treatment.
• the light source is powered either by an internal battery or an external power source or both.
• Also included within the housing is a switching device for causing the light source to turn on for a period of time, either by action of the operator or by proximity or direct contact of the device to an area to be treated.
• the duration for which the light is on can be predetermined in some embodiments, or can be determined automatically in other embodiments by sensing the heat of the skin being treated. An upper limit of the period during which the light is on can be pre-fixed to ensure safety.
• the light can be on continuously and an audible beep can be used to indicate when a sufficient dose has been delivered.
• the device can include means for making an optical measurement of the skin, such as remitted fluorescence intensity to limit exposure time or otherwise indicate optimal dose.
• a substantially improved treatment for acne involves, in an embodiment, reduction of hyperkeritinization, bacterial destruction, sebaceous gland strengthening with, for example, gamma-linolenic acid (GLA), and reduction of inflammation.
• GLA gamma-linolenic acid
• a method and device for illuminating the affected areas with a blue-light source having a wavelength in the range of 390 nm to 430 nm, and, in an embodiment, at nominally 413 nm, and an outlet for the light, adapted to be placed in proximity to the area being treated whereby the light will illuminate the area under treatment.
• the second embodiment is, in the illustrated implementation, hand-held, shaped generally as a cylinder and powered by a battery.
• the device of the second embodiment includes from six to eight LED's mounted on a single circuit board, and treatment with this embodiment is at a reduced power density and reduced total dosage as compared to the power density and total dosage typically provided by the first and third embodiments.
• Other embodiments can comprise as few as one large LED or as many as twenty, although small numbers require high power devices for efficacy, and large numbers of LED's tend to involve increased manufacturing costs.
• timing cartridges which are inserted into the device to activate and enable treatment.
• the timing cartridges can be configured in multiple ways, depending upon the particular implementation.
• the timing device is configured as a timer and limits the treatment time.
• the timing cartridge is programmed to provide controlled treatment regimens.
• a treatment method using the second embodiment includes moving the output window over a selected treatment area while applying light energy, with an option to dwell on lesions.
• the rest of the surrounding area such as the face, or other affected area, is also treated with a reduced total dosage amount to provide preventative care by reducing P. acnes bacteria levels, thereby lessening the development of new lesions.
• the second embodiment is particularly efficacious in avoiding any hyperpigmentation of the skin following treatment.
• violet-blue light 400-450 nm
• Violet-blue light is believed to be absorbed by endogenous porphyrins produced by the bacteria present in acne lesions, reducing or reversing the proliferation of the bacteria, and thereby helping to clear the lesions.
• This embodiment is a method and device that includes an intense violet-blue diode light source and an output window that contacts the skin during the light emission to provide a heat sink for the skin.
• a handheld and cordless device is provided, having an intense violet-blue light source and a contact-based heat sink for the skin.
• a method and device is disclosed with small area illumination and contact-based heat sink.
• a fourth aspect of this embodiment provides a handheld and cordless device having a small area illumination and contact-based heat sink.
• Figure 1 illustrates a system for visually identifying the affected areas on a patient, and for subsequently treating those areas.
• Figure 2 illustrates in greater detail a device for visualizing the affected areas on a patient.
• Figure 3 illustrates an embodiment of a device for treating affected areas on a patient.
• Figure 4 illustrates in an exploded perspective view the treatment device of Figure 3.
• Figure 5 illustrates in greater detail the light source of the treatment device of Figures 3 and 4.
• Figure 6 illustrates in schematic diagram form an embodiment of the circuitry of the treatment device shown in Figures 3 and 4.
• Figure 7 illustrates in greater detail the airflow venting of the treatment device of Figures 3 and 4.
• Figure 8 illustrates in flow diagram form an embodiment of a process for treating acne in accordance with the present invention.
• Figure 9 illustrates a second embodiment of a device for treating affected areas on a patient.
• Figure 10 illustrates the end of the treatment device of Figure 9 opposite the outlet window and shows the aperture for inserting a removable timing cartridge.
• Figure 11 A illustrates an exploded perspective view of the treatment device of Figures 9 and 10, and Figures 11 B-11 D show views of the mixer.
• Figure 12 illustrates in greater detail the light source of the treatment device of Figures 9 and 10.
• Figure 13 illustrates in greater detail the air intake and outlet venting of the treatment device of Figures 9 and 10.
• Figure 14 illustrates in schematic diagram form an embodiment of the circuitry of the treatment device shown in Figures 9 and 10.
• Figures 15, 16A, and 16B illustrate, respectively, the display window of the device of Figures 9 and 10, the display window when the timing cartridge is full, and the display window when the timing cartridge is fully discharged.
• Figure 17 illustrates in flow diagram form an embodiment of a process for treating acne in accordance with the present invention.
• FIG. 18 is a schematic illustration of one embodiment of the invention.
• FIG. 19 is a graphical illustration of the results of a skin temperature calculation for a first set of conditions.
• FIG. 20 is a graphical illustration of the results of a skin temperature calculation for a second set of conditions.
• FIG. 21 is a graphical illustration of the results of a skin temperature calculation for a third set of conditions.
• FIG. 22 is a graphical illustration of the results of a skin temperature calculation for a fourth set of conditions.
• FIG. 23 is a schematic illustration of one embodiment of a light source comprising light emitting diodes which is suitable for use in the invention. DETAILED DESCRIPTION OF THE INVENTION
• a patient 10 is illuminated with light from light source 20.
• the light source 20 typically comprises light emitting diodes, laser diodes, flashlamps, or other light sources emitting light in the frequency range of 390 to 430 nm, to overlap with the optical absorption in the Soret bands of the porphyrins produced by the P. acnes bacteria.
• the P. acnes porphyrins can also be excited at other absorption bands such as the Q-bands having various absorption peaks in the range 550 nm to 700 nm.
• the light source can also encompass these longer wavelengths in the 600-700 nm range, either by a source with a broader spectral range, or by a source comprising multiple LED's or laser diodes operating at different wavelengths. These longer wavelengths have the advantage of penetrating deeper into the skin than shorter wavelengths.
• an optical filter 30 is interposed between the patient and the light source to ensure that the light 40 that illuminates the patient does not contain undesirable wavelengths.
• Light emitted from LED's has been found to contain undesirable light in wavelength bands other than the dominant wavelength of the LED. This undesirable light, although of low relative intensity, can hinder observation of the fluorescence due to the low intensity of the fluorescence emission itself.
• the filter 30 can be configured to prevent the patient's skin from being illuminated with light of the same wavelength as that at which the porphyrins in the P. acnes bacteria fluoresce.
• An example of such a short-pass filter is a model BG3 from Schott North America, of Elmsford, New York.
• filter 30 can, in some embodiments, be a polarizing optical element.
• Another means for reducing emission of light from the LED at undesirable wavelengths is to remove those portions of the LED which can be the source of the undesirable emission.
• Such LED's are available from Medical Lighting Solutions, Inc. of Jacksonville, Florida. This can, in some embodiments, obviate the need for the filter 30.
• Light 50 remitted from the patient's skin comprises a portion of the light 40 from light source 20, together with fluorescence 80 from the porphyrins in the P. acnes bacteria.
• a second optical filter 70 is provided in at least some embodiments to block the remitted light from the source 20, so that only the fluorescence 80 reaches the observer.
• the filter 70 is not needed in all embodiments.
• the optical filter 70 is provided in the form of glasses such as, for example, the model 700-ARG manufactured by the NoIR Laser Company, LLC, of South Lyon, Michigan.
• a mirror 60 is provided to permit the patient to observe the affected areas, indicated by the areas of fluorescence.
• a camera, photodetector or its equivalent can be used instead of a mirror 60.
• the optical filter 70 which again can be a pair of glasses, will transmit light in the range of 550 to 700 nm, to allow for a variety of porphyrins with different fluorescence spectra to be observed. In some embodiments, the filter 70 simply blocks light below approximately 550 nm. Further, it will be appreciated that the light source 20 can be configured to emit light across a broad range of wavelengths or in multiple ranges of wavelengths. In such arrangements, the optical filter 70 can be configured to filter out some or all of the ranges emitted by the source 20.
• a treatment regimen begins.
• a treatment device is configured to be actuated to illuminate the affected areas with an appropriate dose of light at a predetermined wavelength.
• the user can forego the step of visualizing the fluorescence and, instead, can treat regions of the skin containing active acne lesions, or can treat prophylactically regions of the skin that may not contain active acne lesions.
• the subject 10 is illuminated by light source 20 with light 40 of an appropriate wavelength, such as 413 nm, typically although not necessarily through a filter 30.
• the light 50 reflected or remitted by the skin of the subject is filtered out by filter 70, while the fluorescence 80 passes through the filter 70 and can be observed by a physician or other observer 90.
• the device 300 shown in exploded perspective view in Figure 4, comprises a housing 305 which in an embodiment, is comprised of a top housing 305A, a bottom housing 305B, a vent 305C and a nosepiece 305D, which provides an output aperture 305E.
• the housing is configured to be hand held. It will be appreciated that other embodiments need not be entirely hand held, but can comprise a base station and hand-held head unit connected by an umbilical, or any other suitable physical arrangement.
• a circuit board 315 onto which is mounted a light source 310, which can, for example, be one or more devices such as an LED, an LED array, or other suitable source including one or more laser diodes, flashlamps, or other light emitting devices.
• the light emitted by the source 310 is in the range of 380 - 500 nm, and in an embodiment is in the range 400-420 nm, such as for example, 413 nm.
• the size of the light source 310 is determined by aperture size and desired output power density. In some embodiments, higher output power density is currently believed to result in disproportionately higher treatment efficacy at least up to the limit of patient comfort.
• the light source 310 and circuit board 315 are illustrated in greater detail in Figure 5, discussed hereinafter.
• light emitted by the light source 310 passes through an optional optical mixer 320 and then through a diffuser 325 in order to optimize eye safety with respect to maximum permissible exposure (MPE) time for a given optical power.
• the optical filter 70 can be located within the housing, typically in line with the diffuser 325.
• the forward propagating light then passes through an output window 330.
• Output window 330 can be glass, sapphire or other similar material such as quartz, diamond, and so on.
• the window 330 can be coated with a transparent anti-microbial layer such as TiO2. It will be appreciated that not all of the foregoing elements are required in every embodiment and in some embodiments none of these elements is required.
• the output window can be configured in a variety of shapes, including square, rectangular, circular and oval. However, in at least some embodiments, the shape of the output window is rectangular, and can have a short axis on the order of one centimeter and a long axis on the order of two to five centimeters. In an embodiment, the output window is rectangular and on the order of one centimeter by three centimeters, which appears to provide a good combination of patient comfort and speed of treatment while also allowing ease of positioning on the patient's face.
• the optical mixer 320 can be comprised of a suitable transparent material such as polymethyl methacrylate (acrylic), or glass (BK7 or similar), or quartz.
• the optical mixer 320 can also be a hollow tube with reflective walls.
• the diffuser can be a bulk diffuser such as opalized glass, Teflon, or similar scattering media.
• the diffuser 325 can, in some embodiments, also be a surface scatterer such as ground glass, or engineered substrates having surfaces composed of a multiplicity of microscopic diffractive or refractive elements as for example can be fabricated by lithographic, holographic or other means.
• the eye-safety of the light source is optimized in some embodiments by the use of a diffuser to create a nearly Lambertian virtual source at the output plane of the diffuser with a larger area than the sum of the output area of the individual LED's.
• the housing in the illustrated embodiment also contains a heat sink 335, to which the circuit board 315 can be mounted.
• a fan 340 can also be mounted within the housing 305 in the event additional cooling is deemed desirable.
• a fan 340 can be provided to supplement heat sink 335.
• fan 340 can instead be a blower or similar device for achieving forced convection.
• Heat sink 335 can have fins that are splayed so that the resistance to airflow is reduced with respect to a heatsink with a similar front surface having fins that are not splayed.
• a thermo-electric cooling device can also be used in some embodiments either in the alternative or in addition to the heat sink and fan.
• a second circuit board 345 also contained within housing 305, provides mounting for a microcontroller and other low-power components not requiring low thermal impedance to the ambient. Power to the device can be supplied by means of a battery (not shown) or connection via conductor 350 to an electrical mains or an external supply.
• the circuit boards 315 and 345 can be connected by any suitable means, such as a ribbon cable or flexible circuit board 390, for example, one comprised of polyimide substrate so that it can withstand the high assembly temperatures that may be used to affix components to circuit board 315.
• a rechargeable battery can be used, which can, for example, be nickel-metal hydride, lithium ion, lithium ferrous phosphate, or other rechargeable design.
• skin sensors 355 are also positioned on the nosepiece 305D, and can also, for example, be positioned on either side of an optical chassis 360.
• the sensors 355 can be either capacitive, as disclosed in U.S. Patent Application S.N. 12/189,079, filed August 8, 2008, incorporated herein by reference, or can be mechanical or optical, and are intended to ensure close proximity or contact with an area undergoing treatment.
• the optical chassis 360 supports the mixer 320, filter 70, diffuser 325 and output window 330 in at least some embodiments, although some of these components can alternatively be supported by the nosepiece 305D.
• an on-off switch can also be enclosed within the housing, together with one or a plurality of capacitive sensors 355, which can be positioned around the output window 330 in some embodiments.
• a board 365 supporting switches 370 is also contained within the housing 305. Although only two switches are shown, the exact number is determined only by the particular implementation, and can be one or more.
• the switches 370 are actuated by buttons 375 positioned on top grip 380. Depending upon the embodiment, the switches can be used to turn on power to the device, and/or to cause the light source 310 to emit light. Alternatively, in other embodiments the function of the switches 375 can be performed by the sensors 355 as discussed above.
• the on-off switch(es) 370 and/or the sensors 355 are connected to the circuit board 345, directly or indirectly.
• a bottom grip 385 can also be provided, and can be affixed to the housing bottom 305B by any convenient means.
• the thermally conductive circuit board 315 and light source 310 can be better appreciated.
• the circuit board 315 can be configured of ceramic, such as BeO or AIN, or diamond, or any other material suitable for the thermal environment of the device of the present invention.
• circuit board 315 should be thermally conductive while being electrically non-conductive.
• circuit board 315 is comprised of three substrates 315A-C, but any convenient number of substrates can be used.
• One or more light sources can be mounted onto each substrate of the circuit board 315 in various convenient arrangements, such as the illustrated array of six LED's on each of three substrates. As noted above, the number of sources is largely determined by the desired aperture size and output power density. LED's with emission at a suitable wavelength and power are available from several sources, including, Medical Lighting Solutions, Inc. of Jacksonville, Florida, Cree, Inc. of Durham, NC, or Nichia Corporation of Tokyo, Japan.
• a temperature sensor 505 such as a thermistor or semiconductor-based thermal detector is also mounted on circuit board 315 to prevent overheating.
• any high power electronics such as current control FET 600, that would benefit from low thermal impedance to the ambient can be assembled onto circuit board 315.
• a circuit board 315 that is both electrically insulating and thermally conductive that comprises the LED's, temperature sensors, and high power electronics permits circuit board 345 to be designed with neither extraordinary provisions for heat dissipation nor a means for separately detecting the heatsink / LED array temperature.
• the drive electronics for the high power light source 310 can include buck, boost, or buck-boost architectures. These architectures employ the use of relatively high-energy inductors to control current for the LED's.
• the LED current to the one or more LED's 310A-n on each substrate 315A-m using a single FET 600 (shown as FET's 600A-m for m substrates) operating in a linear mode.
• Current control FET 600 can be located remotely on the same ceramic substrate 315 on which one or more LED's 310 are mounted in order to take advantage of the low thermal impedance of such a configuration.
• the remaining circuitry components do not dissipate excessive heat so they do not require any special thermal consideration and can be assembled onto a conventional FR4 printed circuit board 345.
• Simple and inexpensive microcontrollers 605 often do not have facilities to provide analog outputs suitable to drive the gate of current control FET 600.
• a simple digital output from the microcontroller 605 using pulsewidth modulation together with a single capacitor 610 and a resistor 615 as a low pass filter, can be used to generate a suitable quasi-DC control signal to drive the gate of each FET 600.
• capacitors 610A-m and resistors 615A-m are used, although this arrangement is not required in all embodiments.
• a current sense resistor, shown as 620A-m, in series with the LED's can be used to provide feedback to the microcontroller for proper current setpoint.
• this circuit architecture also permits use of common low-voltage microcontrollers powered by voltage supply Vdd 650, that can provide a separate, distinct voltage as that provided by voltage supply Vsupply 645.
• Voltage supply, Vsupply 645 provides a voltage greater than the sum of the forward voltage(s) of the LED(s) comprising high power light source 310. A voltage required to overcome the forward voltage of more than a few series LED's would damage common, low voltage microcontrollers. Since only two pins of a microcontroller are required to interface and control the high power light source, the use of especially small and inexpensive microcontrollers is possible.
• This simple and inexpensive architecture can achieve electrical efficiency similar to more complicated buck-boost architectures through careful selection of the value of Vsupply so that only a small voltage is dropped across current control FET 600.
• the circuitry shown at 625A provides, for each array of LED's 310A-n, voltage dividers that enable the microcontroller to sense the forward voltage of the LED array so that a non-functional, shorted LED can be detected. It is desirable in some embodiments to detect a shorted LED because the optical output power would decrease and result in diminished treatment efficacy. Also, the forward voltage of one or more shorted LEDs would appear across current control FET 600. The additional voltage across FET 600 would cause additional heat to be generated and could lead to failure of the FET if the microcontroller were to continue to operate the device. Fuse 640 provides an additional safety measure. It will be appreciated that, while only circuit 625A is shown in Figure 6, similar sense circuits are implemented in at least some embodiments, such that sense circuits 625A-m actually exist.
• circuitry discussed to this point can be appropriately duplicated so as to independently control, in parallel, multiple LEDs or multiple LED arrays using multiple control FETs on one or more LED array assemblies 310.
• the additional components needed are a few resistors and a single capacitor - all low power and inexpensive.
• Each parallel array requires the availability of a modest number of additional microprocessor pins.
• the additional, parallel LED arrays can be of the same wavelength or provide for distinct optical wavelengths within the same device.
• Safety circuitry 630 shows an additional safety FET 635 that can be used as a backup to the current control FET 600 in some embodiments, together with to a current sense low line tied to an analog input of the controller 605, and a digital out signal 630B tied to the gate of safety FET 635. Intended to merely act as a switch and not to control the level of current flowing through the LED array, FET 635 can be a small inexpensive FET that does not need to dissipate the large amounts of heat dissipated by current control FET 600. If the voltage dropped across FET 635 is significant compared with the voltage appearing across the current sense resistor, then an additional current sense input to measure the voltage of the negative terminal of current sense resistor 620 can be used.
• Safety FET 635 can be used to stop current flow to the LED array(s) in the event current control FET 600 fails.
• the safety FET 635 provides the ability to modulate the light source current at higher frequencies than is possible with current control FET 600. By modulating safety FET 635, it is possible to precisely dim the light source to especially low average optical power without the need to resolve the very low current levels required if a DC current level were used to drive the light source. Only one safety FET 635 is required even for multiple parallel LED array assemblies, although additional such FET's can be used if desired.
• the device 300 as illustrated in Figures 3 and 4 is placed against, or at least near to, the affected area.
• the sensor(s) 355 or switch(es) 370 trigger the energizing of the LED array, promptly after which a pulse or continuous beam is emitted at a wavelength of approximately 413 nm.
• the device emits a beam with power density of approximately 1 W/cm 2 and the affected area of the skin is illuminated for 15-30 seconds.
• it can be desirable to significantly increase the power density for example to 2 W/cm 2 or, in some embodiments, as much as 10 W/cm 2 or more.
• a coolant mechanism such as a cryogenic spray onto the area for treatment
• a thermally conductive window such as sapphire or the like
• the window can also be cooled in some embodiments.
• the treatment device can be targeted to the affected areas.
• the power density of the device can be in the range of 0.5 to 2 W/cm 2 , where a power density of about 1 W/cm 2 appears to offer, for Caucasian skin, a good compromise among comfort, treatment speed and electrical/optical design considerations where the treatment mechanism is a combination of photochemical and photothermal effects.
• a good compromise among comfort, treatment speed and electrical/optical design considerations can be achieved at power densities of up to 20 W/cm 2 or higher.
• a dose on the order of 20 - 40 Joules/cm 2 has been found to be effective for reducing lesion counts.
• the treatment mechanism is largely based on the photochemical reaction of light with the porphyrins contained within or proximal to the P. acnes bacteria.
• the treatment mechanism may be primarily photothermal, in which the thermal trauma to the bacteria is believed sufficient to break the inflammation cascade, although photochemical mechanisms may still be involved.
• One mechanism by which photothermal treatment may be effective is lysing of the bacterial apoptotic vesicle. It will be appreciated that embodiments of the present invention can be implemented which use either or both treatment mechanisms, and accordingly different dosage ranges.
• the diffuser 325 is provided primarily for the purpose of increasing, up to its optimum in some embodiments, the maximum permissible exposure (MPE) of the device, as MPE is defined by the International Standard for the photobiological safety of lamps and lamp systems, (IEC 62471 ). Other standards may also exist and provide similar guidance.
• MPE maximum permissible exposure
• IEC 62471 International Standard for the photobiological safety of lamps and lamp systems
• Other standards may also exist and provide similar guidance.
• the issue of eye safety in the wavelength range of the present invention also involves a photo-chemical reaction in the retina of the eye, which tends to be more restrictive than the photothermal limit at these wavelengths. To prevent damage to the eye, a limit on the amount of exposure per day can be imposed.
• Such an exposure limit can be implemented by a timer integrated into the electronics of the device that would allow the device to be active for only a limited time per day.
• a suitable diffuser is a .003" thick wafer of Teflon PTFE 7A, manufactured by DuPont Fluoroproducts, Inc. of Wilmington, Delaware.
• Photon recycling can also be helpful in the device of the present invention. If the mixer has side walls perpendicular to the plane of its input and output faces, and the index of refraction is greater than ⁇ 1.41 , then no light will escape the mixer through its side walls because all rays incident on the side walls will experience total internal reflection (TIR). Thus, if the source is substantially reflective, any light returned to the source is again reflected back to the diffuser.
• the mixer serves to spatially homogenize the light so that, at the diffuser of the device, the intensity of the beam is spatially uniform, thus avoiding hot spots.
• a mixer which ideally has flat side walls and thus cross-sections that are polygonal, such as square, hexagonal, etc., will achieve a high degree of spatial uniformity. Mixers with curved side-walls do not tend to achieve spatial uniformity in all cases but can be useful in some embodiments. Other shapes can be used in other embodiments.
• the airflow of the present device can be better appreciated.
• a fan 340 is provided and placed behind heat sink 335.
• the fan 340 draws air into the device through an inlet in the housing 305, where the air is forced past the fins of the heatsink and then out the vent portion of the housing 305C.
• alternative heat- management arrangements include a blower, or one or more thermo-electric devices can be used.
• the process for use of the present invention can be better appreciated. As shown at step 800, the process begins by illuminating the skin of a patient with low power light of a wavelength that will cause the porphyrins produced by the P.
• acnes bacteria to fluoresce either from optical absorption in the Soret band or one or more of the Q bands. Because penetration depth varies with wavelength, light composed of select wavelengths matched to the absorption of the Soret and various Q bands can be employed to optimize the treatment of tissue at various depths. Then, as shown at step 805, one can identify or visualize those areas colonized by the fluorescent bacteria. Next, as shown at step 810, expose the affected areas to high intensity blue light at a sufficient power density, for example approximately 0.4 watt/cm 2 or greater.
• the user lays down a dose on the order of at least 10 Joule/cm 2 over the affected areas.
• Various methods can be used for application of the desired dose.
• the device is used to "paint" the skin by slowly moving the device over the skin while the device continuously emits light. The user can be instructed to move the device slowly while not keeping the device over the same area of skin so long that the skin becomes uncomfortably hot. The sensation of warmth can be relied upon by the user as an indicator to move to an adjacent location of tissue.
• a timing mechanism can be provided to indicate when to move the device to the next area of skin, such as an audible beep or buzzer, a visual indicator, a vibration source, or a mechanical roller.
• the user can be instructed to treat an affected area for a pre-determined about of time per unit area.
• Another alternative is to monitor the fluorescence quenching achieved by the device, and use that feedback to indicate to the user when to move to the next area.
• Such a monitor can employ an optical fiber to unobtrusively and conveniently sample the fluorescence emitted by the tissue and convey the light to a suitable detector.
• a pulsed device is used and the device is touched to the skin briefly for a single treatment pulse, then lifted and moved to the next treatment area.
• step 820 the user repeats the process on a regular basis, such as daily or weekly, initially to reduce the lesions and then to maintain the concentration of P. acnes bacteria at a sufficiently low level to reduce their ability to induce further lesions.
• the device 400 shown in exploded perspective view in Figure 11 , comprises a housing 405, which is comprised of an upper housing 405A, a lower housing 405B, cap 405C, which provides cap aperture 405D, and a nosepiece 405E, which provides an output aperture 405F.
• Suitable materials for the housing 400 include, but are not limited to, polymers and polymer blends, such as a polycarbonate/ABS (acrylonitrile butadiene styrene) blend, and it will be recognized by those skilled in the art that other materials, such as light-weight metals and other plastics can also be utilized for the housing.
• the bezel or front of the nosepiece 405E is made of nonconductive material such as plastic, although in other embodiments the nosepiece 405E can be made of metal or metalized plastic.
• treatment device 400 is battery powered, alternatively, the device can be attached to an external power source using external power conductor 406 which is mounted with screws to the housing 405 and communicates with housing external power aperture 407.
• the housing 405 can include a decorative design or logo 409, and in the illustrated embodiment, the design element is a cut-out logo design in the housing and can be backlit by light 408 installed within the housing 405.
• a vent 411 made of a lightweight material such as aluminum is disposed on each side of treatment device 400.
• the aluminum material of the vents 411 is configured as a mesh having multiple apertures, and each vent 411 includes both air intake and air outlet regions, as described more fully below in connection with Figure 13.
• the housing 405 is configured to be hand held and is generally shaped as a tapering, somewhat flattened cylinder. It will be appreciated that other embodiments need not be entirely hand held, but can comprise a base station and hand-held head unit connected by an umbilical, or any other suitable physical arrangement.
• a circuit board 415 onto which is mounted a light source 416, which can, for example, be one or more devices such as an LED, an LED array, or other suitable source including one or more laser diodes, flashlamps, or other light emitting devices.
• the light emitted by the source 416 is in the range of 380 - 500 nm, and in an embodiment is in the range 400-420 nm, such as for example, 413 nm.
• the size of the light source 416 is determined by aperture size and desired output power density.
• the light source 416 is six or eight LED's mounted on a single BeO ceramic circuit board 415, which can also be made from, for example, AIN, or diamond, or any other material suitable for the thermal environment of the device of the present invention.
• the light source 416 and the circuit board 415 are illustrated in greater detail in Figure 12, discussed hereinafter.
• other embodiments can comprise as few as one suitably powerful LED or as many as twenty or more LED's.
• light emitted by the light source 416 passes through a hollow optical mixer 417, the tubular wall of which is approximately 1 cm in length.
• the mixer 417 has reflective walls and is made from aluminum or another light-weight metal, or from metalized plastic. If a solid mixer is preferred for the particular implementation, the mixer can be comprised of a suitable transparent material such as polymethyl methacrylate (acrylic), or glass (BK7 or similar), or quartz. In some embodiments, a hollow mixer is preferred because it allows greater light divergence and thereby enables a more uniform distribution of the light at the outlet aperture 405F.
• the mixer 417 serves to spatially homogenize the light so that, at the output side of the diffuser 425, the intensity of the beam is substantially uniform, and hot spots are reduced or avoided. It will be appreciated by those skilled in the art that the term "uniform" as used in this context can still allow for significant variation, depending upon how "uniform” is measured.
• a mixer which ideally has flat side walls and thus cross-sections that are polygonal, such as square, hexagonal, etc., will achieve a high degree of spatial uniformity. Mixers with curved side-walls tend not to achieve as much spatial uniformity in all cases but can be useful in some embodiments. Other shapes can be used in other embodiments.
• the hollow mixer 417 includes a gasket 418, to which a diffuser 425 is attached.
• the diffuser can be a bulk diffuser such as opalized glass, Teflon, or similar scattering media; in an embodiment, the diffuser can comprise Virgin Electrical Grade Teflon having a thickness of .003" to .005".
• Teflon PTFE 7A manufactured by DuPont Fluoroproducts, Inc. of Wilmington, Delaware.
• the diffuser 425 can, in some embodiments, also be a surface scatterer such as ground glass, or engineered substrates having surfaces composed of a multiplicity of microscopic diffractive or refractive elements as for example can be fabricated by lithographic, holographic or other means.
• the diffuser 425 is provided primarily for the purpose of increasing, up to its optimum in some embodiments, the maximum permissible exposure (MPE) of the device, as MPE is defined by the International Standard for the photobiological safety of lamps and lamp systems, (IEC 62471 ). Other standards may also exist and provide similar guidance.
• MPE maximum permissible exposure
• IEC 62471 International Standard for the photobiological safety of lamps and lamp systems
• Other standards may also exist and provide similar guidance.
• the issue of eye safety in the wavelength range of the present invention also involves a photochemical reaction in the retina of the eye, which tends to be more restrictive than the photothermal limit at these wavelengths.
• the eye-safety of the light source is optimized in some embodiments by the use of a diffuser having sufficient scattering characteristics to create a nearly Lambertian virtual source at the output plane of the diffuser while also providing a larger output area for the emitted light than the sum of the output area of the individual LED's.
• an optical filter such as the filter 325 shown in Figure 4 can be located within the housing, typically in optical alignment with the diffuser 425. However, such a filter is not required in all embodiments.
• the forward propagating light passes through the output window 420.
• Output window 420 is a polycarbonate material, and also can be made of glass, sapphire or other similar material such as quartz, diamond, and so on.
• the window 420 can be coated with a transparent anti-microbial layer such as TiO2.
• the output window can be configured in a variety of shapes, including square, rectangular, circular and oval.
• the shape of the output window is generally a rounded rectangle, and can have a short axis on the order of one half to one centimeter and a long axis on the order of two to five centimeters.
• the output window is a rounded rectangle and on the order of 0.5 centimeter by 3.5 centimeters, which appears to provide a good combination of patient comfort and speed of treatment while also allowing ease of positioning on the patient's face.
• a heat sink 435 is provided within the housing 405 and is made of aluminum coated with an adhesive, such as a silver-filled epoxy adhesive, which forms an interface film 436 between the heat sink 435 and the circuit board 415.
• the heat sink 435 is fixedly mounted within the housing by means of post 438 projecting upwardly from the lower housing, together with screw 437B.
• a conductor 439 encircles the post 438 and also extends forward to make a good electrical connection with both the underside of the metal-coated mixer 417 and a contact pad (not shown) on the underside of a second printed circuit board assembly (PCBA) 445.
• PCBA printed circuit board assembly
• a fan assembly 440 mounted to fan mounting bracket 442, is disposed behind the heat sink 435.
• the fan assembly comprises two fans and is a 1.1 Watt assembly with a voltage of 5.5 VDC, manufactured by Sunonwealth Electric Machine Industry Co., Ltd.
• the fan assembly 440 is provided to supplement heat sink 435 in embodiments where such supplementation is desired.
• the fan assembly 440 can be a blower or similar device for achieving forced convection.
• Heat sink 435 can have fins that are splayed so that the resistance to airflow is reduced with respect to a heatsink with a similar front surface having fins that are not splayed.
• a thermo-electric cooling device can also be used in some embodiments either in the alternative or in addition to the heat sink and fan.
• the second PCBA 445 also contained within housing 405, provides mounting for a microcontroller and other low-power components not requiring low thermal impedance to the ambient.
• the screws 437A provide a good thermal connection between the components on the PCBA 445 and the heatsink 435, and particularly provide a good thermal connection between the heatsink and a control FET, discussed hereinafter in connection with Figure 14.
• a battery 447 which can comprise, for example, a 3-cell triangular 9.6 VDC battery, although other choices of power sources can be used in other implementations.
• a poron foam battery support is provided on the top and the bottom of the battery, and both ends of the battery 447 have an insulator layer 449.
• the device 400 can be connected to an electrical mains or an external supply by conductor 406.
• the circuit boards 415 and 445 can be connected by any suitable means, such as a ribbon cable 446 or a flexible circuit board 490, for example, one comprised of polyimide substrate so that it can withstand the high assembly temperatures that can be used to affix components to circuit board 415.
• Foam sheet 446A can be provided to prevent undesirable wear and contact.
• a rechargeable battery can be used, which can, for example, be nickel-metal hydride, lithium ion, lithium ferrous phosphate, or other rechargeable design.
• one or more skin sensors 355, as shown in Figure 4 are also positioned on the nosepiece 405E.
• the sensors 355 can be either capacitive, as disclosed in U.S. Patent Application S.N. 12/189,079, filed August 8, 2008, incorporated herein by reference, or can be mechanical or optical, and are intended to ensure close proximity or contact between the device and an area undergoing treatment.
• the one or more capacitive sensors 355 can be positioned around the output window 330.
• the mixer 417 can be metal coated and can serve as the capacitive sensor when properly connected to the device's controller, as described above, by means of conductor 439 forming a connection to PCBA 445 and the control electronics mounted thereon.
• the conductor 439 which can be copper, for example, can be turned up at the end which contacts mixer 417.
• the nosepiece 405E can serve as the capacitive sensor, for example when the mixer is a solid mixer, in which case the nosepiece should be made of metal or metalized plastic and connect to the electrode 439.
• the nosepiece 405E should not be metal or otherwise electrically conductive, to minimize interference with the operation of the mixer 417 as the sensor.
• the second embodiment ensures safe and controlled use of the treatment device by the user by controlling activation and timing of treatment through the use the control electronics discussed in connection with Figure 14.
• the timing cartridges 450 illustrated in Figure 14 and in Figure 11 are inserted into the device and can be configured to activate treatment, although in at least some embodiment the sensors 355 discussed above function to turn the device on and off.
• the cartridges 450 are, in one embodiment, disposable brushed stainless inserts that can be configured to provide different, selectable treatment regimes appropriate for the user.
• a cartridge 450 which is configured with a carrier 452 attached to the cartridge 450 by bracket 454, is inserted into the housing through the cap aperture 405D, as best shown in Figure 10.
• the inserted cartridge 450 attaches to PCB connector end 456 of the main PCB 445.
• the selected regime is then executed by the electronics of the PCB 445 to provide treatment.
• the cartridge 450 provides a means for storing the amount of time remaining available for use of the device, typically either by recording time of use or decrementing from a pre-stored time value.
• the control function can be embedded in a controller which forms part of the drive electronics discussed hereinafter. Determining the optimum dosage can also involve aspects of eye safety. To prevent damage to the eye, a limit on the amount of exposure per day can be imposed.
• the mixer 417 is hollow, and includes an end wall 470 through which an orifice 475 is formed, as shown in Figures 11 B-11 D. Light from the LED array enters the mixer through the orifice 475, and the interior of the mixer 417, including the inside portion of the end wall 470, is highly reflective.
• the diffuser 425 typically transmits approximately 50% of the light illuminating it; the other 50% is returned back into the mixer.
• That returned light strikes either the LED array or the rear wall, and light hitting the rear wall is returned toward the diffuser.
• light transmitted through the diffuser into the skin can also be scattered by the skin and returned to the diffuser. Again, since the diffuser transmits only about 50% of the light striking it, and returns the rest, a portion of the light returned from the skin is re-transmitted back into the skin.
• the thermally conductive circuit board 415 and light source 416 can be better appreciated.
• the circuit board 415 preferably is configured of ceramic, such as BeO or AIN, or diamond, or any other material suitable for the thermal environment of the device of the present invention.
• circuit board 415 should be thermally conductive while being electrically non-conductive.
• circuit board 415 is a single substrate, and one or more light sources can be mounted onto the substrate of the circuit board 415 in various convenient arrangements, such as the illustrated array of six LED's 416 on the single substrate.
• the number of LED's generally is six or eight but can range from a single large LED to twenty or more, as previously discussed.
• LED's with emission at a suitable wavelength and power are available from several sources, including, Medical Lighting Solutions, Inc. of Oviedo, Florida, Cree, Inc. of Durham, NC, or Nichia Corporation of Tokyo, Japan.
• a temperature sensor 505 such as a thermistor or semiconductor-based thermal detector as shown in Figure 5
• a temperature sensor 505 can also be mounted on circuit board 415 to prevent overheating, although in other embodiments it can be more desirable to mount the temperature sensor 505 on PCBA 445 to ensure a low thermal impedance between the sensor and the heatsink.
• any high power electronics, such as current control FET 600, that would benefit from low thermal impedance to the ambient can be assembled onto circuit board 415.
• a circuit board 415 that is both electrically insulating and thermally conductive that comprises the LED's, temperature sensors, and high power electronics permits circuit board 445 to be designed with neither extraordinary provisions for heat dissipation nor a means for separately detecting the heatsink / LED array temperature.
• Low thermal impedance between the LED junction and the ambient forms an aspect of the present invention, and allows devices built in accordance with this aspect of the invention to drive more electrical current through the die, resulting in greater optical output power, without the creation of more waste heat than can be dissipated without undesirably large increases in junction temperature and without the use of extraordinary cooling efforts.
• thermal impedance much less that 10°C/Watt can be achieved.
• thermal impedances of approximately 2.7°C/Watt are achieved, whereas conventional LED mounting architectures with package die mounted on a PCB can have a thermal impedance of more than 100°C/Watt, and perhaps as high as several hundred °C/Watt. This significant reduction in thermal impedance allows the use of fewer LEDs to achieve the desired system power.
• a fan assembly 440 is provided and placed behind heat sink 435.
• the intake of the fan assembly 440 draws air into the housing through the intake region 412 of the mesh aluminum vents 411 , the intake region being positioned contiguous to the fan intake.
• the fan assembly directs the air into and through the heat sink 435, where the air is forced past the fins of the heatsink and then out of the housing through the outlet region 413 of the vent 411 , the outlet region being positioned contiguous to the outlet end of the heat sink 435.
• alternative heat-management arrangements include a blower, or one or more thermo-electric devices can be used.
• a battery 1400 supplies power directly to a plurality of channels, only one of which is shown in Figure 14 for purposes of clarity.
• Each channel comprises a plurality of LEDs 1405 marked LED-1 through LED-n through one or more fuses 1410; for example, a device can have three or four channels of two LEDs per channel, for a total six or eight LEDs.
• the LEDs are series connected to a sentinel FET 1415 and a control FET 1420, the gates of which are controlled by a controller or other processor 1425, which can, for example, be a Freescale MC9S08LL64CLH.
• the controller 1425 applies appropriate voltage to the gate of control FET 1420 to enable drive current to flow to the LEDs 1405. Some controllers, such as the one noted above, cannot output analog voltages and require a D/A converter, which can be a simple RC circuit as shown in Figure 6 and not repeated here for clarity.
• the controller 1425 also monitors the status of the node 1430 between the sentinel FET and the control FET. The controller also monitors the status of each channel by means of a sense resistor 1435, which is sensed through a signal conditioning mux 1440.
• the signal conditioning mux 1440 also receives inputs representative of heat sink temperature and battery temperature, through a second signal conditioning mux 1445.
• the controller monitors in real time the LED current, voltage and temperature, as well as the battery voltage, charge and temperature.
• the sentinel FET essentially functions as a safety switch. While the controller 1425 normally maintains the sentinel FET in the "on" state, in the event an error condition occurs for any of the monitored parameters, the controller defaults to turn off the gate to the sentinel FET, thus disabling the device from energizing the LEDs in that channel.
• the controller can also turn off the control FET in the event of an error condition, in at least some configurations.
• a FET switch actuated by the controller can also be provided to disconnect the battery charger 1455.
• the capacitive or other skin sensor 1450 connects to the controller 1425 through conductor 439 or similar arrangement, as discussed above.
• the controller provides inputs to the user interface LCD and backlight, indicated at 1460, as discussed hereinafter in greater detail in connection with Figures 15 and 16A-B. Power regulation to the controller is provided by regulator 1465 in a conventional manner.
• the controller communicates with a cartridge interface 1470, which serves two functions.
• the interface 1470 permits the manufacturing systems to communicate directly with the device through manufacturing interface 1475, thus enabling loading of firmware, system calibration, and testing of system performance.
• the interface 1470 receives replaceable cartridge 1480, which in some configurations comprises a secure EEPROM that provides to the controller an allotment of treatment time.
• the cartridge1480 provides a complete treatment regimen.
• one or more treatment regimens can be programmed into the controller and its associated memory.
• the cartridge 1480 cooperates with the controller and a security coprocessor 1485.
• the security coprocessor can be a device such as the DS2460 by Maxim, with a corresponding device such as the Maxim DS28CN01 in the cartridge 1480.
• Authenticity is assured through the use of any convenient security mechanism, such as, for example, a secure hash algorithm.
• a multi-part authentication scheme can be implemented by storing a first portion of the authentication data in the coprocessor 1485, and a second portion of the authentication in the cartridge.
• the authentication data maintained in the coprocessor can, in at least some embodiments, be created in the specific unit by means of a sequenced installation process, where the order of the data affects the result, and the full device-side authentication data resides only in the coprocessor.
• This installation process is managed during manufacturing through the interface 1475 by loading into the device controller "coprocessor initialization" firmware. That firmware places the device in a known and safe state, and then installs at least the first piece of authentication data.
• the device is reset after the first piece of authentication data is installed, after which a second piece of coprocessor initialization firmware is loaded into the processor and a second portion of the coprocessor authentication data is loaded into the coprocessor. It can be appreciated that, in some implementations, the authentication data can be loaded in less or more steps that the two described above, with one or more firmware installation functionalities.
• the authentication data maintained in the cartridge exists only in each specific cartridge.
• the authentication data can, in some embodiments, be derived from, for example, all or a portion of the serial number of the cartridge, together with a static portion, plus some or all of the contents of a read-only memory page.
• the authentication data in the cartridge is installed in multiple steps for at least some embodiments, with the sequence of those steps impacting the final result.
• the cartridge when installed in the device, the cartridge is verified by the coprocessor 1485 through the main controller 1425, and is continually authenticated as long as it is connected to the interface 1470. Once the cartridge is authenticated, the memory in the cartridge is read and the data used by the controller 1425.
• the device 400 as illustrated in Figures 9-11 is placed against, or at least near to, the affected area.
• the capacitive sensor(s) enable the energizing of the LED array, with the timing cartridge 450 controlling the maximum amount of treatment time available, or, in some embodiments, providing the treatment regimen.
• the timing cartridge 450 controls emission of a pulse or continuous beam at a wavelength of approximately 413 nm.
• the device emits a beam with power density of approximately 0.5 W/cm 2 and the affected area of the skin is illuminated for 30 seconds.
• the power density of the device can be in the range of 0.3 to 1 W/cm 2 , where a power density of less than 0.5 W/cm 2 , and in some instances about 0.3 to 0.4 W/cm 2 , appears to offer, for Caucasian skin, a good compromise among comfort, treatment speed and electrical/optical design considerations.
• the treatment mechanism is a combination of photochemical and photothermal effects. Such a low dosage further reduces or eliminates hyperpigmentation of the skin following treatment.
• an embodiment of a treatment regimen includes a prophylactic portion as well as a more intense portion.
• the treatment regimen discussed below is divided into a first portion covering the first two weeks, and a second portion covering the period after the first two weeks.
• the process is enabled by inserting the treatment cartridge 450.
• the cartridge 450 provides an amount of available treatment time, or provides all or part of a treatment regimen.
• the user performs morning and nighttime treatments by illuminating the area of the patient's skin to be treated with light having a power density of about 0.3 -0.5 W/cm 2 and a 413 nm wavelength for three (3) minutes while utilizing a sweeping/painting motion. This results in a prophylactic dose of about one Joule/cm 2 for each of the morning and night treatments, or a total daily prophylactic dose of about two Joules/cm 2 .
• each of the night and morning treatments results in a prophylactic dose of about one Joule/cm 2 , and a dwell dosage for areas having lesions of approximately an additional 12 Joules/cm 2 .
• the treatment goal is to provide the right daily dosage to the patient, which is typically 1 -4 Joules/cm 2 as a prophylactic treatment, and 20-40 Joules/cm 2 for areas having lesions.
• the treatment goal is to provide more times per day, with each treatment being for a shorter time; or, alternatively, a single, longer treatment per day.
• step 930 provides, for instance, the following treatment regime for weeks 3 through 8: The treatment area is treated for 3 minutes with a sweeping/painting motion in the morning and evening, providing an estimated daily dose of approximately two Joules/cm 2 .
• the treatment regime can be repeated on a regular basis, such as daily or weekly, initially to reduce the lesions and then to ensure that the concentration of P. acnes bacteria remains at a sufficiently low level that the inflammatory cascade is inhibited, and the likelihood that other lesions will form is reduced.
• steps 930 and 940 are illustrative of one treatment regimen, it is also permissible, and in some cases desired, to continue the regimen of weeks one and two into weeks three and four, and longer if desired.
• the dwelling portion of the treatments can be omitted, or the prophylactic painting treatment could be reduced in time, for example to two minutes rather than three, or either the evening or the morning session could be omitted.
• the device is used to "paint" the skin by slowly moving the device over the skin while the device continuously emits light.
• the user can be instructed to move the device slowly while not keeping the device over the same area of skin so long that the skin becomes uncomfortably hot.
• the sensation of warmth can be relied upon by the user as an indicator to move to an adjacent location of tissue.
• the timing cartridges or the device itself can be programmed to indicate when to move the device to the next area of skin, such as an audible beep or buzzer, a visual indicator, a vibration source, or a mechanical roller.
• the user can be instructed to treat an affected area for a pre-determined about of time per unit area.
• the polycarbonate treatment device window 460 has a liquid crystal display (LCD) to provide information about the inserted timing cartridge.
• LCD liquid crystal display
• the LCD display provides, for example, treatment times and an indication of when the cartridge needs to be replaced. It will be recognized by those skilled in the art that the display 460 can also show the amount of power delivered and other parameters of interest, such as a number or name identifying a particular treatment regime.
• the method, system and apparatus taught herein can effectively reduce the level of colonization of a patient's skin by the P. acnes bacteria.
• concentration of bacteria in the sebaceous ducts and glands can be significantly reduced.
• Lower bacterial load reduces the concentration of inflammatory bacterial metabolites, thereby reducing the likelihood of the induction of an inflammatory cascade of the type that produces lesions.
• the present invention reduces and prevents the formation of lesions, and/or can enhance the rate at which lesions clear.
• some embodiments of the present invention use selective photothermolysis of the pilosebaceous duct, gland and/or contents. It has been determined that the bulk of the material within an infected gland is composed of P. acnes bacteria. This allows selective targeting of absorbing chromophores produced by the bacteria, rather than the sebum produced by the sebaceous gland. This also provides the possibility of delivering a sufficient dose to the affected area within an acceptably short time. The result is a treatment regimen that can also involve reduction of hyperkehtinization, bacterial destruction, and reduction of inflammation. In addition, the ability of the sebaceous gland to prevent leakage of its content into the surrounding dermis can be increased through dietary supplementation of GLA or similar long-chain fatty acids which are typically deficient in the sebum of acne sufferers.
• FIG. 18 A schematic of a third preferred embodiment of the device is shown in FIG. 18.
• the device is contained within a housing 80 that includes an output window 10 through which intense violet-blue light can be delivered to a region of the skin.
• window 10 Prior to the light emission, window 10 is placed in intimate contact with the region of skin to be treated. During the emission, window 10 is held in contact with the skin. After emission, the window can be repositioned to a new region of skin and the treatment can be repeated.
• window 10 One purpose of window 10 is to transmit the light produced by the light source 20 to the region of the skin to be treated. Therefore, window 10 must be formed of a material transparent to the therapeutic wavelengths produced by light source 20. Sapphire is a preferred material but other transparent materials can be used, including fused quartz, fused silica, polymeric materials, opal glass, or glass. By transparent it is meant that the material has a transmissivity at the therapeutic wavelength of at least 50%, although lower transmissivity can be acceptable for various reasons, including the use of diffusive materials such as opal glass to improve uniformity or eye safety or if the light that is not transmitted on the first pass has additional opportunities for transmission, say, because of a reflector surrounding the light source.
• diffusive materials such as opal glass to improve uniformity or eye safety or if the light that is not transmitted on the first pass has additional opportunities for transmission, say, because of a reflector surrounding the light source.
• window 10 Another purpose of window 10 is to provide a heat sink for the skin so that the skin temperature does not increase to a temperature that is high enough to cause excessive discomfort or damage the skin.
• Violet-blue light is absorbed within a short distance in skin (effective absorption length of approximately 0.3 mm) and causes the skin temperature to increase. Heat transfer from the skin into window 10 mitigates this temperature rise.
• a 5 mm thick sapphire disk one centimeter in diameter has enough heat capacity and has a high enough thermal diffusivity to accept 25 Joules/cm 2 of heat during a 10 second exposure with a temperature increase of less than 20 ° C. Materials other than sapphire can be used for window 10.
• window 10 is at or near the nominal skin temperature prior to contact with the skin and does not substantially cool the surface of the skin below its nominal temperature.
• the nominal skin temperature is the temperature of the skin prior to contact or illumination, and is generally around 32 to 35 ° C.
• the window does not pre-cool the skin but serves as a heat sink during light emission so as to prevent the skin from reaching too high a temperature.
• the heatsink would limit the maximum temperature rise in the epidermis to less than about 25 ° C.
• Another aspect of the third embodiment of the invention involves cooling window 10 to a temperature below the nominal skin temperature, for example to a temperature between 0 ° C and the nominal skin temperature.
• window 10 When window 10 is placed in contact with the skin prior to light emission, the skin is pre-cooled by the window to lower the skin temperature below the nominal skin temperature.
• the window 10 provides heat sinking for the skin that is concurrent with the emission.
• window 10 The most preferred area dimension for this window 10 is about 1 cm 2 so that small regions of skin like the side of the nose or even individual acne lesions can be treated.
• window 10 can be as large as 5 cm 2 or even 25 cm 2 so as to be able to treat a number of lesions or somewhat larger area at a time.
• the maximum size of window 10 is limited by the need for the entire area of the window to be in contact with skin so that it can provide a heat sink to the entire region of skin being illuminated. Too large a window would not conform to the skin where the body is curvaceous, such as regions of skin on or near the nose and upper lip.
• spot size refers to the area of the treatment beam at the emitting surface of window 10.
• the perimeter of this area can be defined by the locations where the intensity of the treatment beam drops to 1/e 2 of the intensity at the center of the spot.
• the output window 10 can have a larger size than the spot size in order, for example, to accommodate an optical skin sensor, or can have a different geometry, for example the treatment beam is square and the output window 10 is round for lower cost and ease of manufacturing.
• the spot size is about 0.81 cm 2 with a square cross-section and the window is circular with an area of about 1.3 cm 2 .
• One aspect of the third embodiment of the invention includes a mixer 30 that is used to make the light emitted by the light source 20 more spatially uniform upon illuminating the skin. It is desirable for the spatial uniformity of the illumination at the skin to have a variation of less than +/-40% so that all of the treated skin receives a similar dose of light.
• mixer 30 is a hollow aluminum tube with square cross-section about 2 cm in length. The walls of mixer 30 are substantially non- absorbing at the therapeutic wavelengths emitted by source 20 so that light impinging upon the walls of mixer 30 is reflected. As the light travels through mixer 30 from light source 20 to output window 10, the spatial uniformity of the light increases. The length, maximum absorption, and cross-sectional geometry of mixer 30 required for sufficient mixing of the light are dependent upon the size of window 10 and the size and output characteristics of light source 20.
• mixer 30 could be a solid light guide in which light from source 20 is totally internally reflected along the light guide to window 10.
• a mixer that is a solid light guide could itself form the exit aperture for the light and thereby serve as window 10.
• a two-dimensional array of LED's is used for light source 20.
• Multiple LED's with optical emission at a wavelength of 405 nm are used to construct a source that delivers about 2.5 Watts of optical power.
• a 2.5 Watt source delivers about 25 Joules of energy to a 1 cm 2 region of the skin in 10 seconds. This is approximately equivalent to the dose delivered by the aforementioned ClearLight device in a single 15-minute treatment.
• Available LED's are currently about 10-15% efficient at converting electrical light to optical power so that about 250 Joules of waste heat is generated for a 25 Joule treatment dose.
• FIG. 23 One aspect of a two-dimensional LED light source is shown schematically in FIG. 23.
• the light source is a two dimensional array of 128 light emitting diode dice 210, such as available from Medical Lighting Solutions, Inc. (Oviedo, FIa.).
• the dice are the raw semiconductor light-emitting device, by which it is meant that the die are not part of an assembly or package, and therefore do not include lenses.
• the foregoing are referred to as "unlensed" LED's.
• Commercial LED's are often sold as lamp assemblies that include the die, a substrate upon which the die is mounted, electrical leads, and an encapsulation that is shaped to form a lens.
• the dice are bonded to a copper heatsink 200 with thermally conductive epoxy that serves to remove heat from the die when they are energized. Electrical contact to the dice are made with wire-bonds, with 32 parallel strands each having four die connected in series. Each series is wire- bonded to a positively-charged busbar 220 and a negatively-charged busbar 230 such that current flows through the series of four dice.
• the busbars are electrically isolated from the copper heatsink. This particular configuration uses a supply voltage of approximately 16V.
• Each die has nominally 4.5 mW of optical output at 405 run with 20 mA of drive current, which provides about 575 mW of intense violet-blue light from the array.
• the dice can be driven with substantially higher current than 20 mA to yield a light source approaching 2.5 W, without an excessive reduction of lifetime, as long as adequate cooling is provided.
• Such adequate cooling can take the form of good coupling to the copper heatsink, and even thermally coupling the heat sink to another heat removal element.
• violet-blue diode lasers are used as light source 20.
• Nichia America, Inc. manufactures diode lasers with 30 mW of optical output with peak wavelengths available in the 400-415 nm band with 70 mA of drive current (Nichia part no. NDHV31 OACA). Therefore, a light source of 100 mW, 500 mW, and 2.5W of intense violet-blue light can be created by an array of about 3, 16, or 83 laser diodes, respectively.
• the laser diodes can be driven with a higher current if well-coupled to an adequate heatsink and/or if a reduction of lifetime is acceptable, reducing the number of diode lasers required.
• violet-blue diode lasers are currently in an active area of research with regular performance improvements, making diode lasers an increasingly viable light source in the present invention.
• the light source of this embodiment most preferably has an output concentrated in the wavelength band of approximately 400-420 nm which generally matches the absorption peak of the porphyrins believed to be most prevalent in the acne regions. This band also generally matches the in vitro action spectrum reported by Kjeldstad and Johnsson (1986), which has a peak around 412-415 nm. However, the output could also be in a broader wavelength band from 400-450 nm.
• the light source preferably has an output power of at least 100 mW/cm 2 in the violet-blue band, but more preferably has an output power of at least 500 mW/cm 2 in the violet-blue band.
• alternate constructions of light source 20 can be used. Additional embodiments also emit light energy in wavelength bands in addition to the violet-blue band, such as green or yellow bands that may also have porphyrin absorption or red bands that are believed to have anti-inflammatory benefits.
• mixer 31 also has the function of transferring heat absorbed by output window 11 to a thermal battery 41.
• the heat transfer of mixer 31 should be high enough to ensure that the heat conducted from the skin and deposited in window 11 during a previous exposure has been substantially removed from window 11 prior to the commencement of a subsequent exposure.
• the functions of mixer 31 namely light mixing and heat transfer, could be performed by two distinct components. It will also be appreciated by those skilled in the art that such a thermal battery is not required in all embodiments, particularly if a fan or a thermoelectric device is used for cooling.
• the illustrated embodiment of the device also employs the use of a temperature sensor 51 to ensure that the assembly comprised of window 11 , mixer 31 , light source 21 , and thermal battery 41 are not at an excessive temperature prior to the commencement of a treatment pulse. An excessive temperature may be reached after several treatment pulses.
• a temperature sensor is more important in the aspect of the device that cools the window 10 below room temperature prior to illumination. In such an aspect, it may be desirable to have temperature sensor 51 closer to window 11 to ensure the window is at the proper temperature prior to contact with the skin.
• the illustrated embodiment of the present invention also has a thermal battery 41 that is composed substantially of a material with sufficient heat capacity as to allow the device to work for tens or hundreds of ten-second pulses with a temperature rise of less than 10 ° C.
• This heat removal element can be simply a mass of metal.
• a material that undergoes a phase change near room temperature can be used. These phase change materials can absorb large amounts of heat with little temperature increase.
• Optimized materials designed for phase change near room temperature or near skin temperature are available from several manufacturers, such as TEAP Energy (Perth, Australia). These materials can be contained within a metal housing designed to efficiently transfer the heat to the phase change material. Phase change materials with energy densities of about 50 J/cm 3 / ° C are readily available.
• thermal battery that accepts the waste heat of over 100 exposures is inexpensive and is easily contained within a hand held device.
• Another type of thermal battery involves the use of a compressed substance, such as CO2, which cools upon expansion and can thereby absorb heat energy from a higher temperature source.
• a thermal battery 41 of the device can be "re-charged” by simply allowing the device to sit in a room-temperature environment, by placing the device into a refrigerator, or by placing the device in contact with a second device designed to actively conduct heat from thermal battery 41 , by replacing or re-pressurizing the compressed substance, or by some other recharging mechanism.
• Another aspect of the current invention contains a finned heat sink and fan to more efficiently reject heat from the thermal battery into the room.
• a heat sink and fan that requires less than 1 Watt and fits into a hand-held device are available from several manufacturers, including Wakefield Thermal Solutions (Pelham, N. H.).
• the finned heatsink can be open to the air outside the housing, the element is to be considered inside the housing.
• thermoelectric cooler module also known as a Peltier-effect device, such as available from Melcor (Trenton, N.J.) to remove heat from thermal battery 41.
• a device using a thermoelectric cooler module requires a small thermal battery or even no thermal battery at all.
• Still another feature of the embodiment is a finned heat sink and fan as a heat removal element to reject heat directly from the device.
• the light source and the output window can be thermally coupled directly to a finned heatsink that is air-cooled by a fan.
• a finned heatsink that is air-cooled by a fan.
• Such an aspect operates in a steady-state condition where the device does not need to be thermally recharged and could operate indefinitely from a heat transfer standpoint.
• This aspect can also use a thermoelectric cooler module.
• the embodiment of the invention also contains an electrical battery 61 and control electronics 71. Batteries with energy densities greater than 500 J/cm 3 are readily available and a battery that powers the current invention for more than 100 exposures is inexpensive and is easily contained within a hand-held device. An alternative embodiment can be powered from mains power rather than from a battery or battery pack.
• the light output of some embodiments of the present invention may not be eye safe without mitigation, particularly in the case of diode laser-based light sources.
• preferred aspects employ an optical diffuser so that an integrated radiance of the light is reduced to an eye safe value.
• the diffuser can include a transmissive diffuser, such as PTFE or opal glass, and can include a reflective diffuser, such as Spectralon (Labsphere, Inc., North Sutton, N. H.).
• a preferred aspect of the embodiment of the present invention also includes a contact sensor that enables light emission only when the device is in substantial contact with a surface, including the surface of the skin. Most preferably the contact sensor is indicative of contact between the output window 11 and the skin, thereby helping to ensure that the output window 11 provides an effective heatsink for the skin.
• a contact sensor can also act to reduce emission into the ambient environment that may be uncomfortably bright or may even not be eye safe.
• a contact sensor can be made of mechanical switches, capacitive switches, piezoelectric materials, or other approaches, and can include sensors located around the periphery of the output window 11.
• the contact sensor also preferably works only on compliant materials such as skin, so that contact with eyeglasses or flat transparent surfaces would not result in a positive indication of contact. This can be achieved, for example, by recessing the actuation buttons of a contact sensor below the emitting surface of window 21 , such that contact with a flat, hard surface would not actuate the buttons. Also most preferably the contact sensor acts as a trigger for light emission, such that light emission is automatically triggered when substantial contact is made with the skin. The light emission can be terminated after a fixed exposure time or if contact is broken or for other reasons. An automatic trigger upon contact is convenient for the user and removes the requirement for a separate trigger, such as one actuated by a finger.
• a preferred aspect of a battery-powered embodiment is one in which the battery would directly power the light source in a direct drive configuration.
• directly power and “direct drive” it is intended to mean that the instantaneous current flowing through the battery and the instantaneous current flowing through the light source at a particular moment in time are substantially equivalent.
• the instantaneous currents differ only in that a comparatively small amount of current drawn from the battery is used to power the non-light-source components, such as the control electronics.
• a finite element model of the first embodiment and of skin has been developed to simulate the heat transfer occurring prior to, during, and after light exposure of the skin.
• Many different cases have been modeled.
• Four cases have been included with this application. They are labeled Case 1 , Case 2, Case 3, and Case 4 and the graphical results are shown in FIG. 19, FIG. 20, FIG. 21 , and FIG. 22, respectively.
• the initial temperature of the skin is 37 ° C for the purposes of these calculations.
• the first case simulates the treatment where the window is not held in contact with the skin so that there is only air in contact with the skin.
• the initial temperature of the window is 37 0 C, representing the nominal skin temperature.
• the initial temperature of the window is 5 0 C.
• the skin is illuminated with light for 10 s at an intensity of 2.5 W/cm 2 .
• the skin is illuminated for 2 s at an intensity of 12.5 W/cm 2 .
• an effective absorption length in skin of 0.3 mm was used to model the absorption of the incident light. This effective absorption length, 0.3 mm, is approximately that of 405 nm light in skin.
• the graph of the results for Case 2 in FIG. 20 shows that when a sapphire window with thickness of 5 mm and initial temperature of 37° C placed in contact with the skin for 10 s prior to the pulse of illumination, the maximum temperature of the skin is only approximately 52° C. This temperature is below the threshold for damage to the skin. It is perceived as hot but easily tolerated with little or no pain.
• the maximum temperature of the skin in Case 3 is approximately 63 0 C.
• the graph of the results for Case 4 in FIG. 22 shows that by cooling a sapphire window to 5° C prior to contacting the skin, the maximum temperature of the skin is less than 45 0 C even though the illumination of 12.5 W/cm 2 is much more intense than in the previous three cases.
• the method, system and apparatus taught herein can effectively reduce the level of colonization of a patient's skin by the P. acnes bacteria.
• concentration of bacteria in the sebaceous ducts and glands can be significantly reduced.
• Lower bacterial load reduces the concentration of inflammatory bacterial metabolites, thereby reducing the likelihood of the induction of an inflammatory cascade of the type that produces lesions.
• the present invention reduces and prevents the formation of lesions, and/or can enhance the rate at which lesions clear.
• some embodiments of the present invention use selective photothermolysis of the pilosebaceous duct, gland and/or contents. It has been determined that the bulk of the material within an infected gland is composed of P. acnes bacteria. This allows selective targeting of absorbing chromophores produced by the bacteria, rather than the sebum produced by the sebaceous gland. This also provides the possibility of delivering a sufficient dose to the affected area within an acceptably short time. The result is a treatment regimen that can also involve reduction of hyperkehtinization, bacterial destruction, and reduction of inflammation. In addition, the ability of the sebaceous gland to prevent leakage of its content into the surrounding dermis may be increased through dietary supplementation of GLA or similar long-chain fatty acids which are typically deficient in acne sufferers.

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