BACKGROUND

Field

100011 The disclosure .herein generally relates to m apparatus ami method for skin treatm nt which Includes applying skin formulations, typically to the skin area, which operate i the sonic frequency range, in. combination wi th electromagnetic radiation, to the skin ares.

SUMMARY

p< >2J According to an embodiment, there is provided an apparatus including an applicator assembly thai includes an applicator tip which is configured to apply a cyclical mechanical force to a skin surface area of a user and to deli ver a. skin formulation- to a skin surface area of a user. In an embodiment, the cyclical mechanical force includes a. normal component. In an -embodiment,, the cyclical mechanical force includes a shear component. In an embodiment, the cyclieal mechanical force includes and normal component and a shear component. In an e bodiimetit, the applicator tip is configured to apply a normal stress and a shear stress to a region of skin.

|OO03| The apparatus futther includes an electromagnetic energy assembly that includes at least one electromagnetic energ sourc adjacent to or within, the applicator assembly and is configured to deliver pulses of electromagnetic energy stimulus, of a character and for a duration sufficient to penetrate one or more dermal layers within the skin surface area of a use. In an; embodiment, factors that affect penetration depth of electromagnetic energy in tissue include wavelength, frequency, intensity, duration, and the like.

J0094] Noii limiting examples of electromagnetic energy sources i ncl ude elect romagnetic energy emitters, fiber lasers, laser diodes, lasers, light-emitting diodes, mieroeavity light- emitting diodes, organic Rght-em ng diodes, polymer light-eniiiting diodes, quantum dots. «ltra~fe$t lasers, and the like.

|0005| According to an. embodiment, the at least one electromagnetic energy source is adjacent to an outer edge of the applicato assembly.

|Ο0Ο&] According to a embodiment, the at least one electromagnetic energy source comprises plurality of light-enritting diodes and is configured to concurrentl or sequentially generate at least a first continuous electromagnetic energy stimulus having a peak emissive wavelength of about 590 nanometers and a second continuous electromagnetic energy stimulus having -a peak emissive wavelength ranging from, abo t 850 nanometers to about 870 nanometers,

(8 071 According to an embodiment, the at feast one electromagnetic energy source is configured to produce a single dominant emissive wavelength via narrowband

multkhromatie radiation.

£0OO8| According to an embodiment, the single dominant emissive wavelength is about 590 nanometers.

{0009} According to a embodiment, the at least on electromagnetic energy source includes at least one light emitting diode (LED),

00l Of According to an embodiment, the at least one light emitting diode (LED) includes a first LED which emits light at a dominant emissi ve wavelength of about 590 nanometers and a second LED which emi ts light at about 850-870 nanometers.

{00111 According to an embodiment, the first light emitting diode (LED) emits visible yellow light and the second LED emits infrared light.

{00121 According to an embodimen t, the ratio of power radiation of the first LED to the second LED is 4: 1. [0033f According to an embodiment, the first light emitting diode (LED) emits light at about 2 milliwatts per -square centimeter (nrW/cm ³ ) and the second LED emits light at .about 0,5 fflW/cm ² .

[00141 According to an embodiment, a energy fluence of the electromagnetic energ assembly received at the skin surface area is less than about 4 #cro ² .

|W1.SJ According to a¾. embodiment, the electromagnetic energy assembly further includes a diffusing lens configured io diffuse light emitted from the electromagnetic energy assembly on the skin to spread an interrogation region.

|iSl6| According to an- erabediraent, the at leas one. electromagnetic energy source includes, a plurality of electromagnetic energy, sources which surround the applicator assembly.

[00171 According to an embodiment, the at feast one electromagnetic energ source is included within the applicator assembl .

0181 According to an embodiment, the at least one electromagnetic energy source emits pulses of light to the skin surface area of the user at a f equency of abou 3 Hz.

[001 ¾ According to an embodiment, there is provided a method of skin treatment, implemented by a skin treatment apparatus, including applying a cyclical mechanical force to a skin surfac e area of a user of a character and fo r a duration sufficient to cause a

compressive force on the skin suriace area of a user arid to affect the permeability of a skin formulation. The method further include interrogating the skin surface- rea of the user with pulses of electromagnetic energy stimulus of a character and for a duration sufficient t penetrate one or more rmal layers within the skin surface area of a user.

[00201 According to an embodiment, a method of skin treatment is provided,, implemented by a skin treatment apparatus, that includes applying a cyclical mechanical, force to a ski suriace area of a user of ciiaracter and for a duration sufficient to cause a compressive force and a shear force on the skin surface area of a user and to affect the pemiea tiiiy of a skin formulation.

|00231 According to an. embodiment, the method of skin treatment includes applying th cyclical mechanical ^' force to the skin surface area of a user of a character and for a duration sufficient to cause a compressive force on the skin surface area of a user and to affect the permeability of a skin formulation includes: apply ing a substantially normal, oscillatnig force to the skin suriace area,

|0i22| According to an embodiment, the method includes applying the cyclical mechanical, force to the skin surface area of a user of a character and i r a duration sufficient to cause a compressive force on the skin surface are of a user and to affect the permeability of a skin formication includes applying an normal mechaakal force having an amplitude of .motion perpendicular to the suriace of the skin ranging from about 0.01 inches to about 0.075 inches.

[09231 According to an embodiment, the method includes interrogating the skin surface area of the user with the pulses of electromagnetic energy stimulus of a character and for a duration sufficient to penetrate at least one or more derraal layers within, the skin surface area, of a user includes concurrently or sequentially emitting at least a first pulsed electromagnetic energy stimulus having a peak emissive wavelength of about 590 nanometers and a second pulsed eieetatnagnetic energy stimulus having a peak: emissive wavelength ranging from about 850 nanometers to about 870 nanometers;.

p024| According to an embodiment, the method includes interrogating- the skin suriace area of the user w i th the pulses of electromagnetic energy stimulus of character, and for a duration sufficient to penetrate at least one or more dermal layers within the skin surface area of a user includes concurrently or sequentially emitting at least a first continuous

electromagnetic interrogation stimulus having peak irradiance of about 2 milliwatts per square centimeter (mW/cm ² ) and emitting a second continuous electromagnetic interrogation stimulus having a peak: irradianee at about 0.5 rtiW/cin ⁵ .

|0025| According to an embodiment, an electromagnetic energy assembly includes at least one electromagnetic energy source adjacent t or within the applicator assembly and configured to deliver a continuous electromagnetic energy stimulus of a character and for a deration sufficient io penetrate o«e or more denna! layers within, the skin, surface area of a user and to affect ^regulation of one or more epidermis-associated proteins,

dennoepidernial^nnction-assoeiated proteins, or dermis-assoeiated proteins in the portion of skin.

026J According io an embodiment, an electromagnetic energy assembly inclodes at least one electromagnetic energy source adjacent to or within, the applicator assembly and configured to deliver a continuous electromagnetic energy stimulus of a character and for a duration sufficient to penetrate one or more dermal layers within the skin surface are of a user and to affect upregniation of one or more epidermal proteins selected from the group consisting of fi.la.grin; transglutaminase I (TOO); glycoprotein (CD44); keratin 10 (IG 0); kerati .14 ( 1.4); tenadn C; globular actio (ActmG); fibrillar ^■ actin (ActinF); and syndeean I . |8027| According to an entbodiniertt, an electromagnetic energy assembly includes at least one- electromagnetic energy source adjacent to or within the applicator assembly and configured o deli ver a continuous -electromagnetic energy stimulus of a character and for a duration sufficient to penetrate one or more dermal layers within the skin surface area of a user and to affect upregulatioii of one or more dermQepidsrmal ..junction, proteins selected from. the. group consisting of collagen 4 (Coil 4); collagen 7 (Coll. 7); lamium V; and per!ecaa,

{0028] According to an embodiment, an electromagnetic energy assembly includes at least, one electromagnetic energy source adjacent to or within the applicator assembly and configured ίο deliver a eontuiuous electromagnetic energy stimulus of a character and for a duration sufficient to penetrate one or more dermal layers within, the skin surface area of a user and to affect ^ egul ion of one or more dermal proteins selected from the group consisting of hyaluronan synthase 3 (HA$3); fibronectfra; tamoelastin; p.rocoUl; Integrin; and decoriii.

BRIEF DESCRIPTION OF THE DRAWINGS

|0029| A more complete appreciation of the disclosure and man of the attendant advantages thereof wit! he readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

| 030| Fig. I illustrates an applicator apparatus according to an embodiment,

[00311 Figs.2A _? 2B, 2C, and 2D illustrate a sequence of a desired motion of an applicator tip of the ap licator apparatus.

[00321 Fig; 5 is a eross-sectional diagram showing the overall operating parts contained within the applicator apparatus.

[00331 Fig. 4 illustrates a first vie of the motor and its related components of the applicator apparatus.

[00341 Fig. 5 ill ustrates second vi ew of the motor and its related components of the applicator apparatus,

[0035] Fig. 6 ilhtsirates a third view of the motor and its related components of the applicator apparatus.

[ 61 F¼ ^s 7A, 7B ₅ 7C, and 7D Illustrate a .method of installing a lighting unit into a housing of the applicator apparatus. |0037| Fig. 8 shows a block diagram of hardware om one ts ^' used in conjunction with the LED assembly.

|0038| Figs. A and 9B illustrate details of the individual lighting units con tained in the LED assembly.

|0039| Fig. ^' 10 illustrates an embodiment of the applicator apparatus which includes a di fusing lens.

£9 01 Fig, 11 illustrates a frequency of pulsing of the received light at the surface of the skin of a user.

£00411 Figs, 12A and 1.2B Illustrate an embodiment in ich a plurality of light ssemblies surround the applicator tip,

(90421 Figs. 13A and 13B illustrate an embodiment in which a light assembly is included within the applieator tip,

0431 Fig. 1 illustrates an embodiment of a process performed by the applicator apparatus, (i044| Like reference numerals designate identical or corresponding pans throughout the several views.

DETAILED DESCRIPTION

|0045f Power appliances. for applyin skin formulations, typically to the skin area, which operate in the: sonic frequency range, are effective for producing significant absorption of the skin formulation to improve skin appearance, and are also comfortable with respect to the physical contact between the applicator and the skin. Such as -appliance, is described in U.S.. Patent No. 8,469,909, which is owned by the assignee of the present applica tion, and the contents of which are ncorporated by reference. |0046Ί light therapy can be used for treatment of skin condi tions using narrowband light Many such light therapy devices illuminate are very large and are used to illuminate the entire fac in a stationary manner,

i ? However, there is currently no device which effectively combines the benefits of a sonic application of a skin f mudation with the benefits of light therapy into a single compact personal appliance that is convenient, inexpensive, and simple to use.

|99 S| FIG, 1 shows an applicator appliance, is which one or more methodologies or technologies can be 'implemented such as, for example, .concurrently o sequentially

providing a normal ^' cyclical, mechanical force and a plurality, of electromagnetic stimuli to a facial area of a u ser. n an em bodiment, an applicator appliance includes a body portion 2, which is separate from a ca portion (not shown). Extending .from the upper surface I S of body portion 12 is an applicator tip 20 which contac ts the skin of the user, in an embodiment,, tir applicator tip 20 comprises one or more elsstomerie materials. In an embodiment, the applicator tip 20 comprises one or more polymeric materials, to an embodiment, the applicator tip 20 is formed from silicone. In an embodiment, the applicator tip 20 Is formed from super soft, silicone having a shore 00-30 hardness. Further non-limiting examples of applicator tip materials include ethylene propylene diene rubbers, _, flourosilicones, chemical resistant materials, and the like.

|9© 9| In an embodiment, the applicator tip 20 comprises one or more waveguides operahly coupled to at least one electromagnetic energy emitter. In an embodiment the applicator ti 20 comprises one or more transparent, translucent, or ligh tra mitting materials..

OS0| Among transparent, translucent, or light-transmitting materials, examples include those materials that offer a. low optical .attenuation rate to the transmission, or propagation of light waves. In an embodiment, the applicator tip 20 comprises _, one or more optically clear materials, semi-clear materials, plastics, thermo piastics, polymers, rosins, thermal resins, ^" and die like. I« an embodiment, the applicator tip 20 comprises one or more ofaceiaJ.

copolymers, acrylic, glass, Ag.Br, AgCt Α½0 _¾ , GeAsSe glass, .BaF _2i Gaf CdTe,: AsSeXe glass, Csl, -diamond, GaAs, Ge, ITRAN materials, Br, thallium bromide-Iodide, LiF, Mg.F _; , NaO _> polyethylene, Pyres., Si , Si(¾, ZnS, XnSe, thermoplastic polymers, thermoset

polymers, and the like,

|§ i J Farther nan-.li«)iiihg. examples of op tically transparent, translucent, or iighi- transmitting materials include one or more of acryionitrile butadaine slyrene polymers, celiulosic, epoxy; ethylene butyl aeryJate, ethylene tetrafluoroethylene, ethylene vinyl

i«fluoromethoxy-l,3-diox le-co-ietrallttoroetliylen- e], pdly[2,2-bistriflttorQmethyl-4,5- difluo.ro- l,3-dioxole-eo-teirafl«oroeth- ykne], poly[2,3- <per8«orcalkenyl)perfl¾oi¾te rahydrofoi»n. ^' j, polyacry.lonitrile. butadiene styrene,

polyeiliersitiforie, . polyethylene, oiyimide, qlymethyl methaerylaie, polynorboniene, polypertluoroalkoxyetbykhe,. polystyrene, polysulfone, potyuretk e, polyvinyl chloride, polyvinylideiie fluoride, diallyl phthalate, thermoplastic elastomer, transparent polymers, vinyl esters, and the like.

10052) In an embodiment, the applicator tip 20 is configured to. deli ver . continuous electromagnetic- energy stimulus of a character and fo a duration sufficient to penetrate one or more dermal layers within the skin surface area of a user. For example, in an embodiment, the applicator tip 20 comprises an optically transparent _* translucent, or light-transmitting materials; is operably coupled to one or more electromagnetic energy emitters; and is configured to generate a continuous electromagnetic energy -stimulus of a character and for a duration sufficient to penetrate one or more dermal layers within the skin surface area of a user, in an embodiment, factors that affect penetration depth of electromagnetic energ m tissue inehide wavelength, frequency, intensity, and the like.

|0eS31 In the embodiment shown, applicator tip 20 includes a concave portion 22 at a orward end thereof. The concave portion will temporarily hold a selected, quantity of a skin fotm Jation whic is to be applied to the user's facial skin area during operation of the appliance, included in. the upper surface 18 is an. LED fight assembly 100, the installation of which will be described in more detail later in this document. The appliance is controlled by an on/off switch (not shown).

}§§S4J For effective operation: of the appli ance, speci fically, operation which, produces effective absorption of the skin fonnulation, with comfortable contact ^' between the applicator tip and the user's skin, a complex motion of the applicator tip 20 has been found to be important, A first component of the app licator tip motion is perpendicular to the sur face of the skin, a second component of motion is paral lel to the surface of th skin, and a third component is arcuate which results, in progressively increasing contact between the applicator tip and the skin.

|0O55| FIG, 2 shows a sequence of this desired motion. At a time tO (FIG. 2 A), initial contact between applicator tip 20 and skin area 1 is shown. The inside edge 2 OA o f the applicator tip 20 comes first into contact with the surface of the skin 21. Force is beginning to be applied downwardly, perpendicular to the surface of the skin, producing an initial amoun of

compressive force on the skin. Initial tensile stress is also produced on the skin 21. At time tl (FIG. .2B:) _S applicator tip 2(T.is rotating clockwise as well as moving downwardly

perpendicular to and against the skin, continuing to compress the skin, as shown. In addition, the applicator tip moves to the left, parallel to the surface of the skin .21. This parallel motion component produces a sufficient but relatively small tensile. stress in the skin, which when combined with the compressive force lias been discovered to be important hi impro ving absorption of skin .formulations but witho fiferoaging the skin, or causing discomfort.

|® ^β 56| The applicator tip motion changes at time 12 (FIG. 2C), and again at time B (FIG. 2 ) _S at whic point the contacting surface of the applicator tip is essentially parallel to the surface of the skin 21 with the contacting surface of the applicator tip in full contact with the skin, and with both the compressive force perpen ieoiar to the ski and. th tensile stress parallel to the surface of the skin reaching a maximum value. The applicator tip produces a compressive force against the s kin along the entire contacting surface of the applicator tip, as shown in FIG. 2D, The motion -of the applicator ti then is reversed by motor action, with the applicator rip ending up at its initial position. The sequence 2A-2D is then repeated, at a selected frequency.

| 57| It has been discovered that the progressively increasing contact. between the surface of the skin due ^" to ^" the arcuate component of the applicator ti mo tion is important in maintaining a comfortable contact, i.e. sensation, in the user. The above described motion, while complex, has the dual advantage of producing effective absorption, of the skin formulation as well as maintaining a satisfactory comfortable level of contact for the user,, such that the average user will continue to use the applicator. The complex motion, combined with the concave shape of the forward surface of the applicator tip, helps to keep the quantity o skin formulation present in the- concave portion from being immediately displaced from th area of application on the user's skin..

i58J FIG. 3 is a cross-sectional diagram showing, the overall operating parts contained within the appliance body 12, The appliance body 12 includes a motor referred to generally at 30, which will he described in..more detail below, and a source of po wer, which in the embodiment shown are rechargeable batteries 32, but which could be other power sources as well, such as primary ^' cells or an external power supply. The control signal to th motor, as

I I well as other operational control functions, such as sensing the state of the on off switch -24, controlling the duration of a single application, use and moni toring battery charge state are provided by a microprocessor 34, Microprocessor 34 is conventional in structure and operatio for such an appliance. Ail of the above parts are contained within housing portion 16 of body 12 of the appliance.

FIGS, 4-6 show the motor 30 for the appliance in. more detail. The motor includes an -anchor member 36 which is made f om a stiff material which, m the embodiment shown, is hard plastic. The anchor member in the embodiment shown, includes two slots 40 and 42 ^' hich- are at right angles to each other, and which fit securely into corresponding rib elements 44: and 46 which are pair of the housing portion 1 (FIG. 3). The anchor member 36 is thus fixed in position in the housing and is not tree to move during operation of the motor.

|00S9| Motor 30 also includes an annaime assembly 48 which includes two spaced permanent magnets 50 and 52 mounted on a metal baekiron 51 (FIGS. 3, 6). In the embodiment shown, the permanent magnets are spaced approximately 0.18 inches apart, but this can be varied. Further, the permanent magnets, in the embodiment shown, are 0.15 inches square by 0, 1 inches thick, ^' although these dimensions ca also vary.

|U06O] A t one end 53 of the armature member 48 is a removable applicator tip assembly 56, at the forward end of which is positioned, applicator ti .20. The applicator tip 20 is described in more detail in co-pending U.S, patent application Ser. No. 12/474,426, owned by the assignee of the present disclosure, the contents of w hich are hereby incorporated by reference. The applicator tip has a concave forward surface, to .hold the skin formulation and is made from a very soft .material, Shore scale OO Durometer 30. The flexibility of the material is similar to that of human skis and thus transmits motion and force efficiently. }tMM>lJ Positioned between anchor member 36 and armature 48 is an electromagnetic stator assembly 60. The electromagnetic stator -assembly 60 includes a conventional electromagnet 6.1 and an E-core laminated stack 62, the outer legs of which, m separated from the center leg ^' by 0.257 inche and 0.267 inches,, respectively, in. th embodiment shown. The stator pole are the ends of th three legs. The siator assembly Is mou n ted to two opposing ribs 64 and 66 whi ch are also pari of hous i ng portion 16» Hence, in operation of the motor the stator assembly 60 also remains fixed irs position.

f0662f The motor further includes two l eaf springs 8 ^' and 70 which extend between and connect anchor member 36 and opposing extending en portions 53 and 55 of ^' armature 48. | ⁽ MM3| The extending end portions of armature 48 are at right angles to each other. In the embodiment shown, the leaf springs are approximately 0.2 inches wide and.0,012 inches thick and are made of stainless steel The leaf springs 68 and 70 also extend approximately at .right angles to each other. Leaf springs 68 and 70. have different free lengths. The ratio of the free lengths of the leaf springs is important to achieve the desired rmtlii-component motion of the. applicator tip to produce effective and comfortable application of skin formulations. The rati of the length of _. spring 70 to the length of spring 68 is within the range of 0.75: i to 0,95: 1 , In an embodiment, the tree length ratio is within the range of 0,79: 1 to 0.S3 : 1 , When the appliance is properly oriented relative t the skin, leaf spring 68 ill be approximately perpendicular to the skin, while leaf spring 70 will he approximately parallel wi th the skin . It is this arrangement of leaf springs, which produces the desired combination of effective absorption of skin formulation and com&rt to the user,

|Θ064| In operation, following actuation of the on/off switch ^' 24 ₁ an alternating current electrical signal from microprocessor 34 is ro ^v ide to the electromagnetic stator assembly 60. During one half cycle of the alternating current signal, the two outer poles of the electromagnet will attract one of the permanent magnets and repel the other permanent magnet The center pole will also repel one permanent magnet while attracting the other. The resulting force moves -armature 48:, including the applicator tip, in a complex slightly arcuate motion counterclockwise (as viewed in FIG. 5) relative to the stator assembly 60 and toward the skin. This motion, as indicated above, a d. as shown, in FIG . 2A-2D, includes a component of perpendicular motion, a component of parallel motion and a small component of arcuate motion. On the o ther half cycle, the direc tion of ^' .the- current i s reversed, and the armature responds by moving the tip applicator away from the skin in a clockwise direction relative to the stator.

1®86S1 The frequency of the action is typically within a range of 50-200 Hz. In an embodiment, the .frequency of the action ranges from about of 110 Hz "to about 135 Ηζ·. The range of amplitude ^' of the motion, perpendicular to the surface of the skin j$ within the range of 0.01 inches to 0.075 inches, in an embodiment., the range ofamplita.de of the motion perpendicular to the surface of the skin ranges if a m about 0.02 inches to about 0.035 niches. The range of motio parallel, to the surface of the skin is within the range of 0.005 inches to 0.07 inches. In an embodimeni, the range of motion parallel to the surface of ihe skin ranges from about 0,013 inches to about 0.032 inches. The arcuate- motion that results from these dimensions is relatively small, following a» arc in the range of 0.5°-3°. in an embodiment, the arcuate motion thai results from these dimensions is about 2 although this value will vary with the actual dimensions used,

100661 In operation, leaf springs 68 an 70 act to both center fee armature when i t is at rest and to produce a mechanicall resonant system when combined with the mass of the moving armature and the applicator tip assembly. When the electrical current alternates direction at a frequency - roughly equal to the mechanical resonance of the overall system, the amplitude of motion of the armature structure increases significantly, thus producing the required motion for effective action with the desired high efficiency relative to the electrical power input. Hence, the appliance is both effective in producin rapid and effective absorpiioa of the skin formulation, but also is a practical appliance to operate. |6Θ67| ΪΆ one embodiment, Ihe above-described structure further includes single -or multiple light sources, to produce either a single dor nattt-ejnaissive. wavelength, i.e., la ^' narrowband maUichromatie radiation, or multiple wavelengths (either monochromatic, narrowband multichromatic, wideband muitichromatie, or combinations -thereof). The single or multiple combinations may be applied either simultaneously or sequentially,

fio68J Although preferred embodiments of the present disclosure rnay use LEDs, ultrasound and/or laser or light energy, the present disclosure is not limited to the use of these energy sources. Other sources of energy, including (without limitation) microwave energy and radio frequency en ergy may also be used. Exemplary of -known l ig ht so urces are -fluorescent, lights, fiash!amps, filamentous lights, etc. One skilled in the art will recognize that any light source capable of emitting electromagnetic radiation at a medically useful wavelength, as described herein, directly, or by means of optical filtration, is within the scope of suitable light sources according to the present disclosure. For purposes of the photomodulatory and pfaototherraat treatment methods described, any source capable of emitting light havin a wavelength from about 300 »m to about 1 00 ran, or producing electromagnetic radiation which is filtered or otherwise altered to exposure the skin , a topical composition, or -other component of t he present treatmen t regime to a wavelength of light in -the- aforementioned range is medically useful.

f»0691 The targeted skin may fee ex osed to one or mote wavelengths of LED, laser or nonlaser light such as filtered filamentous sources or fluorescent sources or single or multiple frequencies; of ultrasound. A. variety - of parameters may fee used (including pulse duration, energy, single or multiple .pulses, the interval between pulses, the total number of pulses, etc.) to deliver sufficient cumulative energy to interact with the agent or tissue complex. This results in the inhibition or desu-uction of the sebaceous oil gland or the supporting skin tissue through photomodulatory means, photothermal means, or combinations thereof, i an embodiment, these devices may be used by the patient for at-home treatment or as part of an ongoing skm-care system after receiving treatment by a physician.

|8870| Wavelength— Each target ceil or subcellular component or molecular bond therein, tends to .have at least one nique and .characteristic "action spectrum" at which t exhibits certain electromagnetic or light absorption peaks or maxima. Different cell tines fo.ft.be same cell— for example fibroblasts from.3 differen patients) exhibit same differences in. their absorption spectra and thus using narrow band, multicliromatic light (rather than

monochromatic light) is also useful in producing the optimal ciinicai effect. When these cells or subcellular components are irradiated with wavelengths corresponding to the absorptioi ^' !. peaks or maxima, energy is -transferred f om the light photon and absorbed by the target The particular features of the delivered energy determine the cellular effects. The complexity of these combinations of parameters has produced muc confusion in the prior art. Basically, the wavelength should roughly correlate with an absorption maxima fa the target cell or subcellular component or tissue, or exogenous chromophobe, ha some eases it may be desirable to target more than one maxima- either simultaneously or sequentially on the same or different treatment dates. The presence of multiple maxima action spectra are common for a given cell or subcellular component or exogenous chromophore and different wavelength maxima irradiation may produce different results.

£08711 if the wavelength hand is overly broad, then the desired photomodulatiori effects may be altered .from those intended. Consequently, use of broad band noncoherent intense tight sources may be less- desirable than those specified for use with the present disclosure, in contrast to the use of multiple narrowband emitters. The lase diodes are also multicbroraatic with narrow wavelength bauds around a dominant band, i.e., they are nanovyhand multichromatic devices— devices which emit electromagnetic in a narrow band of radiation either symetrically or asymetrically around a dominant wavelength. In an embodiment, a ^' narrowband ^' mmtichromatic electromagnetic radiation emitter emits electromagnetic radiation in a bandwidth, of +/- about ^: 1.00 nanometers around, a dominant wavelength. In an ern ^' bodim nt, a -narrowband maliichromatie electromagnetic radiation emitter em ts

electromagnetic radiation, in. a bandwidth of +/- about 50 nanometers around a dominant wavelength. In .an. embodiment, a narrowband mnltichromatic electromagnetic radiation emitter emits electromagnetic radiatio in a bandwidrb. of -*·/« about. 20 nanometers around a dominant wavelength. In an embodiment, a narrowband mmtichromatic electromagnetic radiation emitter emits electromagnetic radiation in a bandwidt of + ~ about 1.0 nanometers around dominant wavelength. In an embodiment, a narrowband multiclnx>matic electromagnetic radiation emitter emits eleciromagnetic radiation in a bandwidth- of +/- about 6.5 nanometers around a dominant wavelength. LEDS, while not iaonochromatie, emit in such a narrow band as to be considered narrowband mitlticfe'omatic emitters. The narrow band allows pho tons of slightly different wavelengths to be emitted. This can potentially be beneficial &r creating certain desirable multi photon interactions. In contrast, most

commercial lasers emit light ^' at. a single wavelength of light and are considered

monochromatic. The use of lasers, according to the prior art, has relied npon the coherent, i.e., monochromatic, nature of their electromagnetic emissions.

|0O72f Wavelength may also determine tissue penetration depth. It is important for the desired wavelength to reach the target cell* tissue or organ. Tissue penetration depth for intact skin may be different than the tissue penetration depth for ulcerated or burned skin and. may also be. different for skin that has been abraded, or enxymatically peeled or that has had at least a portion of the stratum corneum removed by any method. t is also important to penetrate any interfering ehromophore that also absorbs at this same wavelength (e.g. dark ethnic skin, plastic Peine dishes for tissue or cell culture, etc.). It is important to penetrate any issties or organs in its pathway. |0673| For example,, light having a dominant wavelength emission in the range of about 400 ran to about 420 um has -such, a short wavelength that iot all sebaceous glands or acne cysts can be effectively treated due to the li mited depth of penetration of the radiation, whereas light having a wavelength of about 600 ran to about 660 ran can more easily penetrate to a _. greater depth, if treatment of the lower dermal layers or even deeper is desirable.

Accordingly, the selection, of th dominant wavelength of the radiation emitter i also dependent on the depth of treatment desired. The selection of the proper wavelength is one of the significant parameters for effective use of the ^' : present disclosure _* bat others are important as well:

|8674| Energy Densit— The energy density corresponds to the amount of energy delivered during irradiation and. is also referre to as energy intensity and light intensity. The optimal

'dose' is affected by pulse duration and wavelength thus, these are interrelated and pulse duration is very importan— in general high energy produces inhibition and lower energy produces stimulation.

196751 Pulse duration The exposure time for the irradiation is very critical ^' and varies with the desired effect and the target ceil, subcellular component, exogenous ehromophore tissue or organ (e.g. 0.5 microseconds to 10 mitt may be effective for human, fibroblasts, though greater or lesser may also be used successfully).

16 61 Continuous Wave (CW) vs.. pulsed ¹ — e..g. the optimal pulse duration is affected by these parameters. In general, the energy requirements are different if pulsed mode is used compared to continuous (CW) modes. Generally, the poised mode is preferred for certain, treatment regimen and the CW mode for others.

166771 Frequency (if pulsed)— -e.g. higher frequency tends to be inhibitory while lower frequency tends to be stimulatory, but exceptions may occur. |097S| .Duty cycle— his is the device Light output repetition cycle whereby the irradiation is repeated, at periodic intervals, also referred to herein as the interpulse delay {time between pulses when the treatment session, comprises a series of pulses).

i79| Suitable active agents for use in topical compositions applied to the skin by the applicator tip 20 in. accordance with the presen description include one or more of Vitamin C, VUamia E, Vitamin D. Vitamin A, Vitamin , Vitamin F, Retin A (Tretinoin), Adapak e, Retiiio!, Hydroquinoiie, ojic acid, a growth factor, echinacea, an antibiotic, an antifungal., an ^• antiviral, a bleaching agent, an alpha hydroxy acid, a beta hydroxy acid, salicylic acid, antioxidant triad compound, a seaweed deri ative, a salt water derivative, algae, an antioxidant, a pbytoanthocyanin, a phytonuirieat, plankton, a botanical product, a- erbaceous product, a hormone, an enzyme, a mineral, a genetically engineered substance, a cefaclor, a catalyst, an aniiaging substance, . insulin, trace elements (including ionic calcium, magnesium, etc), minerals, ogaiae, a hair growth stimulating substance, a hair growth inhibiting substance, a dye, a natural or synthetic melanin, a metailoproteinase inhibitor, proline, hydroxyproiihe, an ^' anesthetic substance, chlorophyll, bacteriochlorophyll, copper ch ^' lorophyliin, chloropiasts, ca oteno s, phycobilih, rhodopsra, ahthocyaniri, and derivatives, subcomponents, immunological complexes and antibodies directed towards any componen of the target skirt structure or apparatus,, and analogs of the above items both -natural and synthetic, as well as combinations thereof.

fO080| Further non-limiting examples of topical compositions applied to the skin by the applicator tip include anti-wrinkle: compositions (e.g., PRO-XYLAN.E™, and the like), anti- dark circle composition (e.g., HALOXYL™, and the like), or anti-puffiness compositions (e.g., FRI A.L1FT™, and the like). |ββ8Ι I Further iK>a umting examples of active agents for use to. topical compositions applied to the skin by the applicator tip include xyloses, hydroxypropyl tetrahydropyrantriol and the like.

ft>i82J Further non-limiting examples of acti ve agents for nse i topical compositions applied to the skin by the applicator tip include capryloy! salicylic acid, adenosine, 'adenosine triphosphate, retinol linoleate, and the like.

fiMISSJ In an embodiment, an applicator assembly includes an applicator tip that is configured to apply a cyclical mechanical force to a skin, surface area of a user and to deliver a skin iorrnulatio including one or more of Acrylates/Ci 0-30 Alkyi Acrylate CrossPoiymer, Adenosine, Alcohol, Argmtne. BHT, B!S-PEG-1 S Methyl Ether Dimethyl Silane, Butylene Glycol Caffeine, Capryioyl Salicylic Acid^ Caprylyl Glycol, Carbomer, centantea eyaoiis flower water, ehlorhexidme digiueoBa e, chrysia. Citric Acid, Coco-Betadiae,

CycJohexasiioxane, dimeiliicone, Disodium Ethylenediamineteimcetie acid (EDTA), Glycerin, Hydregenated Lecithin, Hydroxypropyl Tettahydropwaniriol, Laitrayi Lysine, Methyl GIueefh-20, N-Hy-droxysucciiiimide, Octyldodecanol,. Pahnitoyl Oligopeptide, Palraitoyl Tetrapepiide-7, Polyethylene. Glycol (PEG)-20 _:J Pentylene Glycol, Pheaoxyethaaol, Polysilieone-l l., Potassium. Sorbate, Propanediol, Propylene Glycol., Sodium Hydroxide, Squalane, Steareih-20,. Toeophetyt acetate. Water, Xanthan Gum, Yeast Extract, and the like. P&84J in an example, a device emits natxo baiid, nndticltrontatic electromagnetic radiation with a dominant emissive wavelength of about 590 am ( · - about 10 nm) arid also some light in the 830-870 ran range and, optionally, a small amount in the 1.060 nm range. It has been discovered that the combination of the visible 590 and the infrared 850-8.70 am is bioa.ctive. A special IR filter may also be added to reduce the IR component of the radiation that the target skin, or tissue is exposed to, as this is believed to unsymmeiricaHy dampen the shape of the l ^' R 850 curve. At 850-870 ni, there is believed to he a ^' dose dependent ⁵ effect o fibroblasts. Further, at a power lev el of about I mW/cm ² , pliotomodulaiion occurs for anii aging phenotype effec (those skilled i the art will recognize thai power meters cannot measure this precisely, so there may be some variation error in meter methods); Generally, where a treatment tha does not cause thermal injury is desired, an energy Ouenee of less ifcan about 4 J cor (4-/- 0.5 J cm?) is preferable.

{0085J The ratio of yellow light to IR radiation in the radiation used for treatment has been found to have an effect on the overall performance of the present system. Specifically, through testing with iouoehronieter and single wavefettgih LEDs, and later using ratio. ONA microarrays studies it was determined that one specific combination ratio of yellow and IR was very effective for wrinkles. Relative amounts of each type of radiation are believed to be important-more ^' s than the actual radiation level (provided that ablation does not occur). At about .2.0 mW/cm ² (+ - about 0,5 mW/cm ² ) for 590 nra. and about 0.5 raW/cai ² ÷/- about 0.5 mW/cm ² ) for the 850-870 am (i.e., a 4; 1 ratio of yellow to IR) has been foun to produce good results. Another factor to consider is the shape of the amplitude vs. wavelength curve for the IR component of the system.

{0086| Fig. 7 sho s^ a method of installing the lighting unit into the bousing 12. As shown in Fig. 7A, a slot or hole is created proximal to the applicator tip 20.- As shown in Fig, 7B and 7C, LED assembly 100 ^' is inserted into the slot. As shown in Fig. 7D, the wiring 104 for die LED assembly 1 Of) is routed to a driver circuit and a power supply as will he explained below,

f0087| Fig. 8 shows a block diagram, of hardware components ased in/conjunction, with, the LED assembly TOO. The LEDs in LED assembly are driven by an LED Driver Board 820, which in turn receives power from Power Supply 810. Power Supply can he the same or di ferent from batteries.32 _. mentioned above. Additionally, LED Dri ver 820 can he included as part of microprocessor 34 mentioned above, or it can he a i ndependent component. Fig, 8 also shows thai the LED Driver 820 can he connected to a light on off control unit which.

■receives- an input from he user -to toggle on/off the LE -units.

|β0881 Hg- shows that the LED assembly includes an infrared- LEO unit 1 10 and a yellow LED unit Ϊ 1.2, which each eroii a cone-shaped beam of light The LED units can. be standard commercially available LEDs as known to a person of ordinary -skill in the art . For nstance, ^' _. the LEDs could be types LY G6SP-CADB~36~1-2 (for providing the- 590.nm wavelength) and VSMF4720 (for providing the 870 nm wavelength).

00891 Fig; 9B shows that the LEDs I 10 and 112 are. spaced apart by ^: 4mm. _} and. the LEDs are spaced apart from the applicator tip by 11.2 mm. When the LEDS are configured to emit light at an 80 degree cone angle, this produces, light intensity at 77 % with no tip occlusion. from the applicator tip.

00901 Fig. 10 shows an embodiment which farther, includes a lens 1010 used in conjunction with the LED units ^" to diffuse or broaden the ligh exposure of a specific area. The lens 1010 can have positive or negative focal length properties to achieve the desired emission of light, and can be made of any number of materials, such, as, but not limited, to, glass, plastic, or resin, in one example, an acrylic material placed external to the LED units m he used to achieve such a diffusing lens.

10091 _. 1 In conventional light- therapy systems, a pulse scheme is used for the light emissions on the, skin surface. A code ^' refers to: the pulse scheme for various .treatment regiment. This includes various, factors such as- pulse length, mterpulse delay, and pulse repetition. For example a treatment may comprise a pulse code of 250 msec "on" time, 100 msec "off time (or dark -period), and 100 pulses. This produces a total energy fluence, in J/cm ^' % of 25 seconds times the power output level of the emitters . This permits a comparison, -of pulsed versus continuous wave treatment (the "code" for continuous wave treatment would be I pulse, an "on" time of whatever the treatment length is chosen to be, and an "off time of sec.) |6β92 | The present embodimen allo ws for use of pulsed wa ve treatment of 3 Hz. pulsed waves on. the skin, surface of the user a.s shown, in. the .right side of Pi . 11. This is accomplished by assuming no movement of the device over an isolated skin area since, natural movement alone may ^■ .produce the effect of 1 Hz poises as shown, on the left, side of Fig. 1.1. However., the claimed disclosure is not. limited to 3 Hz pulsed treatmen and may be more or less as needed.

93| I a modification to the embodiment described above, one or a plurality of LED assemblies 1 0 (which may include LED units 1 10 and. 1 12) are provided such that they surround the applicator tip 20, as shown in Figs. 12 A and 128, The lens UHO described above may optionally be provided with each LED assembly 100 to focus or diffuse the emitted light.

|0094| In another modification, die LED assembly 100 may be provided within the applicator tip itself -as shown in Figs. 13 A and 13B. The lens 101 described above may optionally be provided with the LED assembl 100 to focus or diffuse the emitted light

£08951 Fig. 1.4 shows a. method implemented by the applicator apparatus 1 described above, in step 1410, the applicator tip assembly 20 performs a process of contacting and delivering a skin formulation to a skin surface of a user according to the cyclic movement of the applicator tip described .above. Simultaneously, in step 1420, the light ^' assembly 100 performs a process of emi tting pulses of li ght, to the skin surface are of the user according to the light emission of the specific light described above. These two processes can be. -started and ended at separate tiroes according to separate on/off switches, or they can be started and ended simultaneously according to the same on/off switch (such as the on/off switch shown, in Tig. 8).

{00961 Numerous modifications and variations of the present disclosure are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the claimed invention may be practiced otherwise than as specifically described herein.