SYSTEM AND METHOD FOR TREATING SKIN AND AREAS PROXIMATE THERETO
20210275406 · 2021-09-09
Inventors
Cpc classification
A61B2018/0047
HUMAN NECESSITIES
A61N5/0624
HUMAN NECESSITIES
A61M35/003
HUMAN NECESSITIES
A61M37/0092
HUMAN NECESSITIES
A61N5/062
HUMAN NECESSITIES
A61B17/50
HUMAN NECESSITIES
A61N2005/0633
HUMAN NECESSITIES
A61M2037/0007
HUMAN NECESSITIES
A61B2017/00761
HUMAN NECESSITIES
A61K8/0204
HUMAN NECESSITIES
A61K2800/28
HUMAN NECESSITIES
International classification
A61B17/50
HUMAN NECESSITIES
A61M37/00
HUMAN NECESSITIES
Abstract
A system and method for treating skin and areas proximate thereto, preferably using at least one of an exfoliant, a transducer operating at a frequency ranging from approximately 20 kHz to approximately 250 MHz, and/or a light source having a predominant wavelength ranging from approximately 400 nm to approximately 2,500 nm.
Claims
1. A system for treating skin and areas proximate thereto, comprising: an air source; an input tube coupled to a skin exfoliating abrasive container; an output tube for collecting waste from a skin treatment site; and an exfoliating hand piece with an angle of impingement with respect to a subject tissue comprising: a hose-end on one side and a skin treatment end on the other side; and an input channel and an output channel, wherein the input channel is under a positive pressure from the air source and channels an abrasive to the skin interface, and wherein the output channel channels used abrasive and dermal waste from the hand piece.
2. The system according to claim 1, wherein the container contains a skin exfoliating abrasive comprising sodium chloride.
3. The system according to claim 1, wherein the container contains a skin exfoliating abrasive comprising aluminum oxide.
4. The system according to claim 1, wherein the container contains a skin exfoliating abrasive comprising sodium bicarbonate.
5. The system according to claim 1, wherein the container contains a skin exfoliating abrasive comprising saline.
6. The system according to claim 1, wherein the angle of impingement of the hand piece ranges from 15 degrees to 50 degrees.
7. The system according to claim 1, wherein the angle of impingement of the hand piece ranges from 20 degrees to 45 degrees.
8. The system according to claim 1, wherein the angle of impingement of the hand piece ranges from 25 degrees to 30 degrees.
9. The system according to claim 1, wherein the angle of impingement of the hand piece is approximately 27 degrees.
10. The system according to claim 1, further comprising a transducer.
11. The system according to claim 10, wherein the transducer operates at a frequency ranging from approximately 20 kHz to approximately 250 MHz.
12. The system according to claim 10, wherein the transducer operates at a frequency of at least one of 20 kHz, 50 kHz, 100 kHz, 500 kHz, 1 MHz, 2 MHz, 3 MHz, 3.3 MHz, 5 MHz, 7.5 MHz, 8 MHz, 10, MHz, 12 MHz, 15 MHz, 20 MHz, 50 MHz, 100 MHz, 200 MHz, and 250 MHz.
13. The system according to claim 1, further comprising an adjustable lamp that emits light having a predominant wavelength ranging from approximately 400 nm to approximately 2,500 nm.
14. The system according to claim 1, wherein the pressurized air is controlled to a maximum of approximately 60 PSI and is provided to ensure the positive pressure is managed and adjusted to a level of between approximately 0.05 PSI and approximately 45 PSI.
15. A system for treating skin and areas proximate thereto, comprising: an air source; an input tube coupled to a skin exfoliating abrasive container; an output tube for collecting waste from a skin treatment site; and an exfoliating hand piece with an angle of impingement with respect to a subject tissue, wherein the angle of impingement of the hand piece ranges from approximately 25 degrees to approximately 30 degrees.
16. A method for treating skin and areas proximate thereto, comprising the steps of: providing an air source, an input tube coupled to a skin exfoliating abrasive container, an output tube for collecting waste from a skin treatment site, and an exfoliating hand piece with an angle of impingement with respect to a subject's skin; and directing an abrasive onto the subject's skin through an angled handpiece, having an angle of impingement between approximately 25 degrees and 30 degrees, and, in turn, treating the subject's skin.
17. The method according to claim 16, further comprising the step of applying an ultrasonic signal with a frequency of at least one of approximately 20 kHz, 50 kHz, 100 kHz, 500 kHz, 1 MHz, 2 MHz, 3 MHz, 3.3 MHz, 5 MHz, 7.5 MHz, 8 MHz, 10, MHz, 12 MHz, 15 MHz, 20 MHz, 50 MHz, 100 MHz, 200 MHz, and 250 MHz to a treatment area.
18. The method according to claim 17, further comprising the step of applying a light having a predominant wavelength ranging from approximately 400 nm to approximately 2,500 nm to the treated area.
19. The method according to claim 16, further comprising the step of applying a light having a predominant wavelength ranging from approximately 400 nm to approximately 2,500 nm to a treated area.
20. A method for treating skin and areas proximate thereto, comprising the steps of: applying an ultrasonic signal with a frequency of at least one of approximately 20 kHz, 50 kHz, 100 kHz, 500 kHz, 1 MHz, 2 MHz, 3 MHz, 3.3 MHz, 5 MHz, 7.5 MHz, 8 MHz, 10, MHz, 12 MHz, 15 MHz, 20 MHz, 50 MHz, 100 MHz, 200 MHz, and 250 MHz to a treatment area; and applying a light having a predominant wavelength ranging from approximately 400 nm to approximately 2,500 nm to a treated area.
21. The method according to claim 20, further comprising the steps of providing an air source, an input tube coupled to a skin exfoliating abrasive container, an output tube for collecting waste from a skin treatment site, and an exfoliating hand piece with an angle of impingement with respect to a subject's skin; and directing an abrasive onto the subject's skin through an angled handpiece, having an angle of impingement between approximately 25 degrees and 30 degrees, and, in turn, treating the subject's skin.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Certain embodiments of the present invention are illustrated by the accompanying figures. It will be understood that the figures are not necessarily to scale and that details not necessary for an understanding of the invention or that render other details difficult to perceive may be omitted.
[0027] It will be further understood that the invention is not necessarily limited to the particular embodiments illustrated herein.
[0028] The invention will now be described with reference to the drawings wherein:
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
DETAILED DESCRIPTION OF THE INVENTION
[0037] While this invention is susceptible of embodiment in many different forms, there is shown in the structural formulas and described herein in detail several specific embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. It will be understood that the structural formulas disclosed herein are intended to comprise all stereochemical configurations regardless of graphical representations.
[0038] The removal of the uppermost layers of the stratum corneum via mechanical exfoliation techniques can be performed by particle abrasion or non-particle abrasion means. Particle-based mechanical exfoliation involves accelerating crystalline particle abrasives along a closed loop vacuum circuit interposed by a roughly linear handheld apparatus (i.e. a handpiece) that opens to the skin to provide a focal point for skin abrasion. Motive force for the flow of crystalline particle abrasives is typically provided by an apparatus that utilizes negative pressure applied at one end of the circuit to create suction pressure at the other end of the circuit. Flexible tubing is employed that is capable of withstanding pressure sufficient to deliver the crystalline particle abrasives onto the skin and thereafter remove the spent particles and cellular debris from the site of application to the skin without collapsing or kinking the tubing.
[0039] Typical prior-art particle-based dermabrasion/microdermabrasion apparatuses use a vacuum circuit that includes at least i) flexible input tubing to provide unidirectional flow of crystalline abrasive particles from a particle storage repository joined to one end of a ii) user-controlled handpiece, which comprises internal parallel input and output channels that are open to each other only at the skin-contacting surface of the handpiece to thereby provide for the controlled delivery of the accelerated crystalline abrasive onto the skin, and iii) flexible output tubing, which carries spent particles and cellular debris to a waste container. Contact of the skin-contacting window of the handpiece with the skin closes and seals the vacuum circuit. Application of negative pressure to one end of the circuit thus pulls skin into the skin contacting window of the handpiece, and also provides for the abrasive particle flow that bombards the epidermis and subsequently removes the resulting particle and cellular waste material from the site of skin contact.
[0040] However, such prior art systems introduce the prolonged application of negative pressure to the skin, which, more often than not, can cause a variety of side effects and problems. For example, studies indicate that the skin typically cannot tolerate prolonged suction/vacuum exceeding 22 mm Hg, and that exceeding this limit for a period of time can result in vacuum-induced bruising, erythema and edema as a result of this type of aggressive microdermabrasion. This is especially true for certain skin types, such as skin that is particularly thin, of color (Fitzpatrick scale III through VI), is sensitive to pulling, tugging or tearing, or bruising/edema induced discoloration. Furthermore, applying a constant vacuum level to different regions of the skin having different thickness and elasticity may result in an unpredictable range of effects given the degree of suction-induced stretching experienced by the skin. For example, acute trauma is more likely in regions where the skin is very thin such as the eyelid, while conversely insufficient trauma may be experienced by thicker skin, such as that on the back.
[0041] Thus, in view of the shortcomings of the prior art, there has been a long-standing need for a dermal-exfoliation system that reduces or eliminates the exposure of skin to the prolonged high vacuum pressures typically employed during treatments of the prior art. Such a system would reduce the trauma to structures underlying the epidermis such as blood vessels and extracellular compartments induced by prolonged exposure to negative pressure, and would increase the pool of patients for whom current therapies are presently unusable given the presence of contraindications such as particularly thin skin, of color (Fitzpatrick scale III through VI), as well as skin that is sensitive to pulling, tearing, bruising or discoloration.
[0042] Concomitant to the need to reduce or eliminate the prolonged vacuum effects, it is known that a variety of crystalline particle abrasives have been used to accomplish dermal abrasion, with a preference in the prior art for the use of aluminum-based crystals, including aluminum oxide. The use of sodium chloride has been attempted given its compatibility with human skin and non-toxic nature when applied externally, but its use has fallen by the side since the microscopic structure of the typical salt crystal used is very irregular and fragile, and has not been able to provide the consistency necessary for the level of skin abrasion necessary for cosmetic and/or therapeutic efficacy. In contrast, aluminum oxide is able to maintain its crystalline structure and abrasive capabilities as it is propelled onto the skin, but the presence of aluminum has been implicated in a variety of complications experienced by the human body, ranging from the clogging of skin pores to some evidence suggesting that in women it was found in greater quantities in the brains of those who have suffered from Alzheimer's disease.
[0043] Correspondingly, there has also been a long-standing need in the art for the design of an apparatus capable of performing dermal-exfoliation by utilizing sodium chloride, for example, as the abrasive media in a manner that allows for the sodium chloride to retain its crystalline abrasive property as it contacts the skin.
[0044] In view of the above, an improved design of the mechanism of providing for the flow of such particles, and/or an improved design of the handpiece is provided that allows the operator to optimize control of the particle stream as it relates, for example, to the angle of contact between the handpiece and the skin to be treated.
[0045] Therefore, one or more of the exemplary embodiments described here relate to an apparatus for treating skin for dermabrasion, microdermabrasion, or skin exfoliation, using a handheld assembly (e.g. a handpiece) specially configured to deliver a stream of crystalline abrasive particles from the housing to the surface of the skin optionally under positive pressure, and further to collect the delivered (waste) crystalline abrasive particles, dislodged skin cells and/or skin debris back to the housing. The one or more various embodiments comprise means of providing positive pressure and optionally negative pressure from the central control unit to the handpiece. A user input device allows for control of the amount of pressure applied. The handheld assembly is connected to the housing (which includes a dehumidification device that keeps the housing at humidity levels below 50%) where by a hose or hoses that provide a means of passaging cargo such as abrasive salts and/or crystals and/or skin debris to an input and/or output repository.
[0046] The handpiece can also be used to direct air flow containing tiny crystals of a desired media, for example, aluminum oxide, sodium chloride, or sodium bicarbonate, etc. The one or more embodiments relate to the function and structure of the positive pressure system for providing propulsion to the crystalline particle abrasive along the input channel and through the handpiece to accelerate a particle current on to the skin. An output channel capable of providing negative pressure from the skin-contacting portion of the handpiece can be used in order to remove cellular, and or crystalline particle abrasive debris from the site of skin contact. It will be understood that the handpiece of the present invention is operably compatible with a plurality of skin exfoliants, including, for example, salts (e.g., sodium chloride, potassium chloride, sodium bicarbonate, etcetera), minerals (e.g., augites, biotites, calcites, chlorites, dolomites, garnets, gypsums, halites, hematites, hornblendes, feldspars, kaolinites, kyanites, muscovites, olivines, plagioclases, pyrites, quartz, serpentines, staurolites, etcetera), metals or metal oxides (e.g., aluminum oxide, a group I metal or metal oxide, a group II metal or metal oxide, a transition metal or metal oxide, etcetera), plastic beads (e.g., polypropylene, polystyrene, etcetera), a wax (e.g., jojoba beads, etcetera), liquids (e.g., saline, etcetera) and/or rheology modified liquids and/or oils—just to name a few.
[0047]
[0048]
[0049]
[0050] In one embodiment, positive air pressure source 320 is preferably dehumidified 330 and transports salt 310 from its reservoir, whereupon the dehumidified salt is filtered through one or more primary filters 340 to result in a “1.sup.st stage filtered and dehumidified” abrasive. The extracted moisture (or water) from the dehumidifier 330 is evacuated as waste 335, either as vented moisture or through a waste tank (not shown) or drain (not shown), as is the waste-filtered salt 345 and/or 365. In some embodiments, the dehumidifier may be a moisture absorbent solid that is controlled to provide the desired moisture level in the salt (for example, through one of the switches/controls shown in
[0051] It should be noted that in some embodiments, the various wastes (345, 355, 365) may be channeled to a single “waste” container, if so desired. Also, while the dehumidifier 330 is shown as only affecting the 1.sup.st stage process, it is understood that in some embodiments, the dehumidification will also be applied to the 2.sup.nd stage process, thus ensuring that the salt is not re-humidified by ambient air once exiting the 1.sup.st stage process. Therefore, in these latter embodiments, the “dehumidification” will comprise a closed system, for example, the entirety of the interior of the chassis 110 as shown in
[0052]
[0053]
[0054] Air compressor 520 provides the system and salt movement air pressure with relief valve 525 (shown here as being set at, for example, approximately 50 pounds per square inch (PSI)), which provide a single stage step down pressure adjustment. Heat exchanger 530 and dehumidifier (H.sub.2O Separator) 533 are in line with the compressor 520, operating to cool and dehumidify the pressurized air as well as for the salt being moved. The heat exchanger 530 can be a coil-based system capable of dehumidifying down to 35% relative humidity. The dehumidifier 533 can provide multiple functions, such as providing variable pressure to the powder bottle (565) and overall pressure to the venturi/vacuum eductor (543), as well as pressure to evacuate moisture. A series of first stage air filters 542, 544, and 546 provide various finer degrees of filtering air to move the salt. For example, filter 542 provides 0.3 um size filtering for removing water vapor from heat exchanger 530. A series of two one-way filters 544 and 546 provides 0.020″ filtering and prevent back-flow. Any water/waste (moisture) from the various filters is channeled to drain or waste collector 580. A secondary adjustable relief valve 535 with a maximum of approximately 60 PSI is provided to ensure the positive pressure is managed and adjusted to a level of between 0.05-45 PSI.
[0055] Pressure regulator 540 is also connected to the compressor stream with venturi/vacuum eductor 543, which directs the waste to waste bag 545. The pressure regulator 540 provides a pressure “step-down” to better pull the used salt and waste to the waste bag 545. Additionally, this pressure is also sent to the handpiece vacuum tube 547 for transport of used material. Venturi/vacuum eductor 543 is also connected to vacuum tube 547, which is in turn coupled to a vacuum switch 515 and 0.3 um filter 562. Next, secondary filters 0.3 um 552, 0.020″ 554, and 0.020″ 556 are used in combination with coalescing filter 550. Coalescing filter 550 operates as the beginning of the second stage filtering, which is similar to the first stage filtering. An electronic regulator 560 is downstream from the coalescing filter 550. The regulator 560 controls the voltage and the pressure settings set at the user interface/control panel. Thus, regulated, stepped down, adjustable and variable PSI positive pressure from the regulator 560 is sent through a 0.025″ orifice 561, which is followed by an additional filtering level comprised of a 0.3 um filter 563 which leads to powder bottle 565. This moisture filtered, adjustable pressured air creates the positive pressure in the powder bottle 565, to push the abrasive in the powder bottle 565 to the pinch valve 567.
[0056] Pinch valve 567 is connected to the powder bottle 565 and is then connected to the powder feed housing 577 through the 0.070″ orifice 569. The pinch valve 567 is set to be in a closed state until the loop of pressure is “closed” at the handpiece when in contact with the skin. When contacted, the pinch valve 567 is opened and abrasive material is fed through the 0.070″ orifice 569. Powder feed housing 577 mixes dehumidified positive pressure and filtered air and distributes the filtered and dehumidified salt at the intensity set on the control panel 120. Pressure distributor 570 is downstream from electrical regulator 560 and is coupled to a 3.5 PSI relief 573, and connected to a tubing through the 0.070″ orifice 575 and to the subsequent powder feed housing 577. The pressure distributor 570 distributes the adjusted pressure to propel the abrasive material into the handpiece. The air velocity is optimized by passing through the 0.070″ orifice 575 where it mixes with the abrasive material from the powder feed housing 577. The powder feed housing 577 is connected to the powder tube 590 that leads to the-handpiece.
[0057]
[0058] The handpiece assembly 610 may be designed so that its longitudinal axis with respect to the skin-contacting surface 640 constitutes an “angle of impingement.” The “angle of impingement” or the angle at which the abrasive medium impacts the tissue has a direct correlation to the patient's discomfort level. The greater the angle of impingement, the greater the degree of discomfort. Thus, in one embodiment, the handpiece assembly 610 may be designed to have an angle of impingement wherein the plane of the skin-contacting surface relative to the axis of the handheld assembly 610 is at an angle less than 90°, specifically between 15° and 50°. In most embodiments, the angle will be between 20° and 45° and an optimal angle range is somewhere in the range of 25° and 30°. In a prototype embodiment, the angle was set to 27° (i.e., +/−10 percent) with superior results. Use of these lesser angles results in less discomfort and a more aggressive, efficient procedure.
[0059]
[0060] In a prototype embodiment, the deflection chamber 780 was configured to be approximately 13 mm in longitudinal length, with a depth of approximately 7 mm. The height of the deflection chamber 780 was approximately between 13-16 mm and approximately 14 mm tall. The angle of impingement was approximately 25 degrees. Of course, these values are simply representative of a prototype and therefore other sizes, dimensions and so forth may be used without departing from the spirit and scope of this disclosure.
[0061] The input channel 752 is situated below the output channel 754 and targeted to a “rear” portion of the skin-contacting interface 734, with separation allowance from the deflection wall 784 to minimize “wall” ricochet effects from the impinging salt. At one side of the terminal end of the skin-contacting interface 734, a bulbous or curved surface 736 is provided to make it easier for the head 730 to be tilted without causing the “unsealing” of the skin-contacting interface 734 from the skin and/or allowing the head 730 to be moved across the patient's skin without causing “edge” discomfort.
[0062] In operation, when the handpiece is in contact with the skin, pressure is applied to the output channel 754 by means of a suction mechanism to create a vacuum that causes crystalline particle abrasives to be aspirated from a humidity controlled storage repository into the input channel 752. Thus, crystalline particle abrasives are propelled through the input channel 752 of the handpiece, which directs the flow of tiny particulate crystalline abrasives onto the skin at high speed, which abrades the skin and wears away cell layers with each pass of the handpiece. At the skin-contacting interface 734 of the handpiece, the crystalline abrasives are aspirated propelled through the input channel 752 and dislodged skin cells and debris from the skin surface are removed from the site of contact through the output channel 754 of the handpiece.
[0063] The mechanism by which force and momentum are conferred to the abrasive particles occurs by means of generating a positive pressure loop at the one end of the input channel 752 onto the skin, and back out through the output channel 754 through a vacuum loop. Accordingly, both a positive pressure and negative pressure system is utilized. Specifically, positive pressure applied to one end of the loop provides abrasive particles to the skin-contacting interface 734 of the handpiece when in contact with the skin and is evacuated by negative pressure in the output channel 754. A balance of pressures is required and is accomplished as a closed system which and requires contact with the skin to form the closed system.
[0064] It should be appreciated that contact with the skin can be amplified through one or more orifices (not shown) on the handpiece, to thereby engage the skin, and further to create the force which draws the particles from an input orifice on the handpiece, and thereafter away from the skin and into the waste repository. It should further be appreciated that the closed loop may be a semi-closed loop system, wherein a complete seal is not necessary since even with reduced pressure, there is sufficient force to provide adequate operation.
[0065] The handpiece of the inventive apparatus has thus been designed to deliver crystalline abrasives via a pressure cycle in a semi-closed loop system. The handpiece is contacted with the surface of the skin to provide abrasive particles from a storage repository and thus direct the particulate stream at an angle that is substantially not perpendicular to the plane of the skin.
[0066] The direction reduces the total number of collisions between particles as they rain down onto the skin, and thus better preserves their crystalline abrasive properties. The size of the crystalline particle abrasives may be modulated through a process of preparing this for the ideal particle size. Particularly, the average size of the particles may range from 60 microns to 750 microns.
[0067] The apparatus further comprises a central control console comprising a housing that comprises a user input means for controlling the delivery of a crystalline abrasive to the skin via the handheld assembly at a velocity sufficient to remove at least some of the epidermis, and for collecting the delivered crystalline abrasive and any skin cells. The user input device may comprise a computer, and/or a touchscreen, and/or a keyboard, humidity controlled chamber and the like. The apparatus may comprise a storage repository (i.e. a hopper) for providing crystalline abrasives to abrade the skin. In some embodiments, the apparatus may further comprise a storage repository for receiving waste material such as crystalline abrasives that have contacted the skin. In some embodiments any such repository is contained within the housing of the apparatus.
[0068]
[0069] Treatment in Combination with Ultrasound
[0070] Upon completion of the treatment skin using dermal-exfoliation, the skin may be exposed to cosmetically enhancing or therapeutic substances, followed with the use of ultrasound. The use of ultrasound to enhance the delivery and absorption of cosmetically and/or therapeutically enhancing substances is known in the art. Preferably, the transducer operates at a frequency between approximately 20 kHz and 250 MHz (e.g., 20 kHz, 50 kHz, 100 kHz, 500 kHz, 1 MHz, 2 MHz, 3 MHz, 3.3 MHz, 5 MHz, 7.5 MHz, 8 MHz, 10, MHz, 12 MHz, 15 MHz, 20 MHz, 50 MHz, 100 MHz, 200 MHz, 250 MHz, etcetera)
[0071] Treatment in Combination with Light-Emitting Devices
[0072] Any of the treatments of the present invention may be utilized in combination with light therapy, for example via the adjustable lamp. Light may be provided by any means, with a preference for LED light emission equipment. Regarding the use of light-emitting devices, it is preferred that such devices are selected for spectral power output, rather than total output power. The wavelengths of light may range from approximately 100 nm to 3,000 nm (i.e., +/−10 percent), and more preferably from 400 nm to 2,940 nm, and yet more preferably from 401 nm to 1,550 nm, and most preferably from 404 nm to 950 nm.
[0073] Combined treatments of the invention may be focused on treatment of acne. Such treatment may be focused on the range of wavelengths known to kill acne bacteria (404-414 nm) and the wavelength to promote skin repair (660 nm). For anti-aging treatments & for the treatment of stretch marks, red light is used at 660 nm to stimulate skin cell growth and improve collagen networks. Near Infrared light at 930 nm expands capillaries causing better tissue oxygenation and improved access to nutrients, growth factors and the immune system for the treatment of anti-aging treatments and the treatment of stretch marks.
[0074] Accordingly, preferred light settings include blue for acne to kill subsurface bacteria that causes pimples. Another preferred light setting includes a combination of red and blue light to treat acne, acne scars, inflammation from acne and pigmentation. Another preferred light setting includes a combination of red and amber (590 nm) for general skin rejuvenation, and particularly to treat superficial reds & browns on the skin. Another preferred light setting includes a combination of red & near infra-red (NIR) for treating pigment and stimulating collagen, skin tightening and for the treatment of stretch marks. Light exposure programs may range from 3-minute exposures to 30-minute program exposures, or any time in between, including, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28 and 29 minute exposures, as well as any secondhand interval there between. Exposure of the skin to the lights may occur in a range from 0.1″ to 8.0″, including any intervening distance, with a preferable distance being 4.5″ from the skin. Such treatment may or may not be combined with other known treatments including antibiotics, retinoic acid, or ACCUTANE™.
Example 1
[0075] A typical dermal exfoliation procedure is performed in order to achieve skin rejuvenation, reduction of sun-damage, weather damage and age spots, reduction of irregular pigment patterns in healed scars, smoothing of fine lines, wrinkles and acne pitting, improvement of skin strength, elasticity and smoothness, and for the improvements in the appearance of stretch marks. A typical dermal exfoliation treatment. The protocol will typical be: [0076] Clean any oil, make-up or other dirt and debris from the area to be treated. Make sure the skin is dry [0077] Perform the dermal-exfoliation. It is done by keeping the skin taut and pulling the handpiece over the area to be treated. As few as 1 pass across are to be treated and as many as 8 passes across the area to be treated is performed. The treatment can be done in one, two or three different directions (horizontal, vertical and oblique) across the area to be treated. [0078] Cleanse the treated area of any remaining particle. [0079] Optionally perform steaming, sonic cleansing and extractions. [0080] Dermal-exfoliation is used before laser and IPL light therapy, or before micro-needling for the treatment of the appearance of stretch marks, skin rejuvenation, acne, pigmented and red lesions [0081] Optionally perform the ultrasonic application of topical products to penetrate products such as Vitamin C serums, collagen peptides, glycolic acids, and other antioxidants, and skin rejuvenation topicals, deep into the skin cells [0082] Optionally use light phototherapy of the invention to help further penetrate and activate topical treatments such as Vitamin C serums, collagen peptides, glycolic acids, other anti-oxidants and skin rejuvenation topicals.
Example 2
[0083] The following method is performed order to achieve skin rejuvenation, reduction of-sun-damage, weather damage and age spots, reduction of irregular pigment patterns in healed scars, smoothing of fine lines, wrinkles and acne pitting, improvement of skin strength, elasticity and smoothness and for the improvements in the appearance of stretch marks.
[0084] Treatment Modalities:
TABLE-US-00001 Treatment Red Light NIR Light Time Period (J/cm2) (J/cm2) (Minutes) Skin 1 × per weekly, 35.8 14.4 20 Rejuvenation 6-12 weeks*8 Maintenance 1 × monthly 35.8 14.4 20 *Skin remodeling includes reduction of sun-damage, improvement of skin texture and firmness, reduction of wrinkles, etc. Results usually visible on the third treatment. When dermal-exfoliating, cleanse the treated area of any remaining particle. Optionally perform the ultrasonic application of topical products to penetrate products such as Vitamin C serums, collagen peptides, glycolic acids, and other anti-oxidant, and skin rejuvenation topicals, deep into the skin cells Optionally perform steaming, sonic cleansing and extractions. Use light phototherapy of the invention to help penetrate topical treatments such as Vitamin C serums, or collagen peptides. Light phototherapy of the invention, used in conjunction with collagen peptides, produces visible improvement in smoothing the appearance of stretch marks, wrinkles and fine lines faster than either phototherapy or collagen treatments alone. Light phototherapy is a useful after chemical peel treatments to speed the recovery of the skin.
Example 3
[0085] This study used a LED device capable of delivering light at a variety of energies including 5 J/cm.sup.2. A variety of tissue culture and animal model studies were performed to determine the effect of LED light on skin cells. This research study includes tissue culture studies, animal studies and clinical studies with humans. Several wavelengths and intensities were studied in fibroblast (skin cell) tissue culture. In this experimental design, the optimum wavelength for cell proliferation and collagen production was determined to be red light. 660 nm wavelength red light was found to be particularly effective. Animal studies indicated that the edges of wounds were the source of increases in two types of skin cells (fibroblasts and keratinocytes) that were stimulated by the red and near-infrared light. These two cell types then move into the wound area to form new skin. Wound healing in the treated animals was accelerated. Accelerated wound healing was accompanied by increased amounts of tissue growth factors. Studies were performed on soldiers who are required to live for long periods in diving chambers and injured in deep diving conditions. Abrasions, bruising and small cuts under these conditions can become serious due to very slow healing rates. Wound healing with near-infrared light showed improvement to near normal conditions.
Example 4
[0086] Promotion of Collagen and Cellular Regeneration
[0087] Red & amber light provides an effective skin remodeling treatment useful in anti-aging treatments. Anti-Aging Treatment utilize the following method:
TABLE-US-00002 Treatment Red/Amber Light Time Period (J/cm2) (Minutes) Skin 1-2 × weekly, 12 20 Remodeling* 6-12 weeks** *Skin remodeling includes reduction of sun-damage, improvement of skin texture and firmness, reduction of wrinkles, and promotes collagen production. Results usually visible on the third treatment. **Assuming no other active ingredients; red/amber light treatments are used to help penetration and activation of active ingredients such as antioxidants and collagen peptides.
[0088] Red & amber light phototherapy is integrated into the current method between the cleanser and the final moisturizing.
[0089] 1. When dermal-exfoliating, cleanse the treated area of any remaining crystals and follow it with the light phototherapy.
[0090] 2. Perform steaming, sonic cleansing and extractions first and follow with light phototherapy.
[0091] 3. Use amber and/or light phototherapy to help penetrate topical treatments such as Vitamin C serums, or collagen peptides.
[0092] 4. Light phototherapy, in the context of the invention, and used in conjunction with collagen peptides, produces visible improvement in smoothing wrinkles and fine lines faster than either phototherapy or collagen treatments alone.
Example 5
[0093] Near Infrared Light to Promote Skin Regeneration: Systemic Effects of Low Intensity Laser Irradiation on Skin Microcirculation in Patients with Diabetic Microangiopathy.
[0094] Persons with long-standing diabetes suffer poor circulation in the legs and arms leading to pain, numbness and eventually to neuronal damage and paralysis. A low-level laser device with output comparable to high end LED devices delivering only near-infrared light at 30 J/cm2. Blood flow was measured in the skin area afterwards. Comparisons were made to the blood flow on the other foot or hand which was not illuminated. An improved and sustained blood flow was measured in the illuminated areas that persisted for at least 30 minutes after the illumination was turned off.
[0095] The sustained improvement in blood flow in the skin is believed to be due to the near-infrared illumination. It is believed that near infrared light on skin opens the capillaries wider by vasodilation. The near infrared light improves the effect of red light on skin regeneration by improving tissue oxygenation and nutrient access. Near infrared light at this wavelength (930 nm) does not cause tissue heating, or the sensation of heat.
Example 6
[0096] Effects of phototherapy on pressure ulcer healing in elderly patients after a falling trauma: A prospective, randomized, controlled study.
[0097] The most common treatment for pressure wounds (bedsores) is antibiotics and mechanical manipulation. Typical Stage II wounds take 12-14 weeks to heal. A Stage II pressure wound is serious and poses a threat of severe infection; it is marked by a loss of skin covering and comes before destruction of the underlying tissue. This study used a wand-type LED device delivering red and near-infrared light at up to 5 joules/cm.sup.2. Patient wounds were illuminated 3-5 times weekly until the wounds closed. Daily measurements of the wound dimensions were taken. The wounds on these patients healed in 50% of the time compared to untreated wounds.
Example 7
[0098] The presently disclosed methods utilizing blue and red light effectively treats mild to very inflamed acne in a period ranging from 0.5 to 3 months, and typically in 1 month. LED in blue mode efficiently activates Amino Levulonic Acid [(ALA)+; (LEVULAN™)] with the optimum wavelength and intensity of blue light. Intense blue light penetrates deep into hair follicles and underneath oil glands where acne colonies remain after benzoyl peroxide treatments. Blue light penetration, approximately 1.5 mm is about four times deeper than most topical treatments are able to penetrate. In addition the effect is highly localized. Blue light creates a toxic event within the bacteria, but is neutral to the skin itself. Topical treatment may be administered prior, including 5% benzoyl peroxide and the oral antibiotic tetracycline. ALA absorbs blue light and becomes activated. This activation is highly toxic to the acne bacteria, but not to surrounding skin cells. The present invention provides the medically proven optimum wavelength and intensity required for this effect.
[0099] The foregoing description merely explains and illustrates the invention and the invention is not limited thereto except insofar as the appended claims are so limited, as those skilled in the art who have the disclosure before them will be able to make modifications without departing from the scope of the invention.
[0100] While certain embodiments have been illustrated and described, it should be understood that changes and modifications can be made therein in accordance with ordinary skill in the art without departing from the technology in its broader aspects as defined in the following claims.
[0101] The embodiments, illustratively described herein may suitably be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. Thus, for example, the terms “comprising,” “including,” “containing,” etcetera shall be read expansively and without limitation. Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the claimed technology. Additionally, the phrase “consisting essentially of” will be understood to include those elements specifically recited and those additional elements that do not materially affect the basic and novel characteristics of the claimed technology. The phrase “consisting of” excludes any element not specified.
[0102] The present disclosure is not to be limited in terms of the particular embodiments described in this application. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and compositions within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds compositions or biological systems, which can of course vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.
[0103] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.
[0104] As will be understood by one skilled in the art, for any and all purposes, particularly in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, etcetera. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etcetera. As will also be understood by one skilled in the art all language such as “up to,” “at least,” “greater than,” “less than,” and the like, include the number recited and refer to ranges which can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member.
[0105] All publications, patent applications, issued patents, and other documents referred to in this specification are herein incorporated by reference as if each individual publication, patent application, issued patent, or other document was specifically and individually indicated to be incorporated by reference in its entirety. Definitions that are contained in text incorporated by reference are excluded to the extent that they contradict definitions in this disclosure.
[0106] Other embodiments are set forth in the following claims.