Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N5/0613—Apparatus adapted for a specific treatment
  • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N5/0613—Apparatus adapted for a specific treatment
  • A61N5/0616—Skin treatment other than tanning
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
  • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M35/00—Devices for applying media, e.g. remedies, on the human body
  • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00137—Details of operation mode
  • A61B2017/00154—Details of operation mode pulsed
  • A61B2017/00172—Pulse trains, bursts, intermittent continuous operation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • 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
  • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/0091—Handpieces of the surgical instrument or device
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B2018/1807—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 light other than laser radiation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
  • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
  • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
  • A61N2005/0644—Handheld applicators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/065—Light sources therefor
  • A61N2005/0651—Diodes
  • A61N2005/0652—Arrays of diodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
  • A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
  • A61N2005/0662—Visible light
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
  • A61N2005/0662—Visible light
  • A61N2005/0663—Coloured light

Definitions

• the disclosure generally relates to m apparatus ami method for skin treatm n which Incl udes 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.
• 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 deliver a. skin formulation- to a skin surface area of a user.
• the cyclical mechanical force includes a normal component.
• the cyclical mechanical force includes a shear component
• the cyclical mechanical force includes and normal component and a shear component.
• the applicator tip is configured to apply a normal stress and a shear stress to a region of skin.
• the apparatus further includes an electromagnetic energy assembly that includes at least one -electromagnetic energ sourc adjacent to or within, the applicator assembly and configured to deliver a continuous electromagnetic energy stimulus of a character and for a dar tion sufficient to penetrate one or more dermal layers within, the skin surface area of a user.
• factors that affect penetration depth of electromagnetic energy in tissue include wavelength, frequency, intensity, duration, and the like.
• electromagnetic energy sources i include electromagnetic energy emitters, fiber lasers, laser diodes, lasers, light-emitting diodes, mier cavity light- emitting diodes, organic Rght-em ng diodes, polymer ligto-etraitiag diodes, quaaiuffl dots, idtni-fest lasers, and the like.
• the at least one electromagnetic energy source is adjacent to an outer edge of the applicator assembly.
• the at leas one electromagnetic energy source comprises a plurality of light-enriiting diodes and is configured to concurrently or sequentially generate at least a first continuous electromagnetic energy stimulus having a peak emiss ive wavelength of abou t 5:90 nanometers and a second continu us electromaguetic exiergy stimulus having a peak emissive wavelength ranging from, about 850 nanometers to about 870 nanometers,
• the at least one electromagnetic energy source is configured to produce a single dominant emissive wavelength via narrowband
• the single dominant emissive wavelength is about 590 ran.
• the at least on electromagnetic energy source includes at least one light emitting diode (LED),
• the at least one LED includes a first LED which emits tight at a dominant, emissive wavelength: -of about 590 am and a second LED which emits light at about 850-870 nm.
• the fi st LED emits visible yellow light and the second LED emits infrared light.
• a ratio of power radiatio of th first LED to the second LED is 4: 1.
• the first LED emits. Sight at about 4 milliwatts per square centimeter ( W/enr) and th second LED emits light a a out 1 mW cm 2 ,
• an energy uenee of the electromagnetic energy assembly received at the skin, surface area is less than about 4 J/cm 2 ,
• the electromagnetic, energy assembly further comprises
• a hood configured to limit an interrogation region on. the skin .
• the electromagnetic energy assembly further includes a lens configured to focus electromagnetic energy stimulus: emitted from the electromagnetic energy assembly to limit a» interrogation region oft the: skin.
• the at least one electromagnetic energy source ncludes a ⁇ plurality of electromagnetic energy sources which surround (he applicator assembly.
• the electromagnetic energy assembly further comprises
• the at least one electromagnetic energy source is included within the applicator assembl .
• a method of skin treatment is provided, iffipiemented b a skin treatment apparatus, that includes applying a cyclical mechanical force to a skin surface area of a user of a character and for a dur tion sufficient to cause a compressive force on the skin surface area of a user and to affect the permeability of a skin formulation.
• the method further in cludes interrogating the skin, surface area of the user with, a con tinuous electromagnetic energy stimulus of a character and for duration sufficient to penetrate one or more dermal layers within the skin .surface area of a user.
• a method of skin treatment is provided, implemented by a skin treatment: apparatus, thai includes applying a cyclical mechanic l force to a skin surface area of a user of a character and for a dura ion sufficient to cause a compressi ve force and a shear force on the skin surface area, of a use and to affect the peraieahility of a skin formulation.
• the method includes applying the .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 applying a substantially normal oscillating force to the skin surface area, f0023
• the method includes applying the cyclical mechanical force to the skin surface area of a use of a character and for a duration -sufficient to cause a compressive force on the skin surface are of a user and to affect the permeability of a skin formulation includes applying an normal mechanical force having an amplitude of .motion perpendicular to the surface of the skin ranging from about 0,01 inches to about 0.075 inches.
• the method includes interrogating the skin surface area of the user with the continuous electromagnetic energy stimulus of a character and for a duratio 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 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 about 830 nanometers to about 870 nanometers,
• the method includes interroga ing the skin surface area of the user with the continuous eleeiromsgnede energy stimulus of a character and for a duration sufficient to penetrate at least one or more dermal layers within the- skin surface area of a user includes concurrentl or sequentially emitting at least a first continuous
• electromagnetic interrogation Stimulus having peak kradiance of about 4 milliwatts per square centimeter (mW/cm 2 ) and emitting a second continuous electromagnetic ntterrogation stimulus having a peak, irradianee/at about 1 m /cruA
• an electromagnetic energy assembly includes at least one electromagnetic energy source adjacent to or thiri the. applicator assembly and configured to deliver a continuous electromagnetic energy stimulus of a character and for a duration sufficient io penetrate one or more dermal, layers within the ski surface area of a user and to affect ⁇ regulation of one or more epidermis-associated proteins,
• an electromagnetic energy assembly includes 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 rjser and to affect tipregniation of one or more epidermal proteins selected from the group consisting of filagrin; transglutaminase 1 (TOO); glycoprotein (CD44); keratin 10 ( J9); keratin 1 ( 1.4); tenacin C; globular aciin ' (ActinG); fibrillar ⁇ actin (AeiinF) and syndecan 1.
• an electromagnetic energy assembly includes at least one- electromagnetic energy source adjacent to or within the applicator assembly and configured to 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 upregulaiio of one or more derenoepidermai.
• junction proteins selected from. the. group consisting of collagen 4 (Coil 4); collagen 7 (Coll. 7); lamiuin V; and perleeaa.
• an electromagnetic energy assembly includes at least, one electromagnetic energy source adjacent to or within the applicator assembly and configured ⁇ deliver a continuous electromagnetic energy stimulus of a character and for a dardtion sufficient to penetrate one or .more dermal layers within, the skin surface area of a user and to affect ⁇ regul ion of one or more dermal proteins selected from the group consisting of hyaluronati synthase 3 (HA$3); fibronectra; tropoeJastin; . procolli ; integrin; and decorift.
• HA$3 hyaluronati synthase 3
• Fig. I illustrates an applicator apparatus according to an embodiment
• Figs. 2A ? 2B, 2C, and 2D illustrate a sequence of a desired motion of an applicator tip of the applicator apparatus.
• Fig. 5 is a cross-sectional diagram showing the overall operating parts contained within die applicato apparatus.
• Fig, 4 illustrates a first vie of the motor and its related components of the applicator apparatus.
• Fig. 6 ' illustrates a third view of the motor and its related components of the applicator apparatus.
• ⁇ 99371 F s» 7A, 70, 7C, a».d 7D illustrate a .method of installing a lighting unit into a housing of the applicator apparatus.
• 0038J Fig. 8 shows a block diagram of hardware om one ts ' used in conjunction with the LED assembly.
• 06391 Bgs. 9A and 9B illustrate details of the individual lighting- units contained in the LED assembly
• ⁇ 00401 Fig. 1.0 illustrates an embodiment of the applicator apparatus which includes a hood.
• ⁇ I J Fig. 1 i illustrates an embodiment of the applicator apparatus which Mffles a lens.
• f0 421 Fig, 12 illustrates a particular method of using the applicator apparatus,
• Figs, 14A and 14B illustrate an embodiment in which a plurality of light assemblies surround the applicator tip.
• Figs. ISA and 15B illustrate an embodiment in which a light assembly is included within the applicator tip.
• Fig, 16 illustrates an embodiment of a process performed by the applicator apparatus
• FIG. 1 shows an applicator appliance, is which one or more methodologies or technologies can be ⁇ . implemented such as, for example, concurrently or sequentially
• an applicator appliance includes a body portion 12, which is separate from a ca portion (not shown). Extending from the u er surface IS of bod portion 12 is an applicator tip 20 which contacts the skin of the user.
• the applicator ti 20 comprises one or more elastomeric materials. In an embodiment the applicator ti 2.0 comprises one or more polymeric materials. In 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 dhari rubbers,
• the applicator tip 20 comprises one or more waveguides operahiy coupled to at least one electromagnetic energy emitter.
• the applicator ti 20 comprises on or more transparent, translucent, or ligh transmitting materials...
• the applicator tip 20 comprises one or more optically clear materials, semi-clear materials, plastics, thermo piastics, polymers, resins, thermal resins, and die like. I « an embodiment, the applicator tip 20 comprises one or more ofaceiaJ.
• copolymers acrylic, glass, Ag.Br, AgCt ⁇ 1 ⁇ 20 3 ⁇ 4 , GeAsSe glass, .BaF 2i Gaf CdTe,: AsSeXe glass, Csi, -diamond, GaAs, Ge, ITRAN materials, Br, thallium bromide-Iodide, LiF, Mg.F ; , NaO > polyethylene, Pyres., Si , Si(3 ⁇ 4, ZnS, XnSe, thermoplastic polymers, thermoset
• examples of op tically transparent, translucent, or iighi- transmitting materials include one or more of acrylonitrile butadaine slyrene polymers, celiulosic, epoxy; ethylene butyl aerylate, ethylene tetrafluoroethylene, ethylene vinyl
• poiyeiliersitlforie . polyethylene, oiyimide, qlymethyl methaerylaie, polynorboniene, polypertluoroalkoxyetbykhe,. polystyrene, poiysu!fone, po!yurethane, polyvinyl chloride, polyvinylideue fluoride, diaMyl phthalate, thermoplastic elastomer, transparent polymers, vinyl esters, and the like.
• 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 sur&ee area of a user.
• 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 stimulu 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 mibodinient, factors thai affect penetration depth of electromagnetic energy in tissue include wavelength, frequency, intensity, duration, and the like.
• 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 limita ion which, is to be applied to the iter' facial, skin area daring operation of the appliance.
• Included, in the u er ' surface ' 18 is a»..L.ED light assefnbly 100, the instaHatioft o which will be described in mo e detail later in this document.
• the appliance is controlled by an on/off switch (not shown).
• a complex motion of the applicator tip 20 has been found to be important
• a first component of the app licator tip motion is perpendicu l ar to the sur face of tire skin, a second componen of motion is parallel to the surface of the skin, and a third component is arcuate which results, in progressively increasing contact between the applicator tip and the skin.
• FIG. 2 shows a sequence of this desired motion.
• 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.
• S applicator dp 20 is rotating clockwise as well as moving downwardly
• 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 wltk both the compressive force perpendicular 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.
• 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 ski formulation present in me concave portion from being immediately displaced from th area of application on the user's skin.
• 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 was, 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
• Microprocessor 34 is conventional in structure and operation for such n a liance. All of the above parts are contained within housing portion
• FIGS, 4-6 show the motor 30 for the appliance. in. more detail.
• the motor inclodes an anchor member 36 which is made from a stiff material: which, in the embodiment shown, is bard plastic.
• the anchor member i 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 n of the boosing portion 1 (FIG. 3).
• the anchor member 36 is thus fixed in position in the housing and is not free to move during operation of the motor.
• Motor 30 also includes an armature assembly 48 which includes two spaced permanent magnets 50 and 52 mounted, on a metal baekiron 51 (FIGS. 3, ).
• 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 can also vary.
• 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 th assignee of the present disclosure, the contents of which 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.
• ⁇ 00641 Positioned between anchor member 36 and armature . 8 is a 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.
• 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.
• 0i66J The extending end portions of armature 48 are at right angles to each other.
• 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,
• an alternating current electrical signal from microprocessor 34 is rovide to the electromagnetic stator assembly 60.
• 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
• the frequency of the action is typically within a range of 50-200 Hz.
• the .frequency of the action ranges from, about of 110 Hz "to about 135 ⁇ .
• 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 inches.
• the range of motio parallel, to the surface of the skin is within the range of 0.005 inches to 0.07 inches.
• 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.
• leaf springs 68 and 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.
• 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.
• the appliance is both effective in producin rapid and effective absorpiioa of the skin formulation, but also is a practical appliance to operate.
• the above-described structure further includes single -or multiple light sources, to produce either a single dominant-emissive wavelength, i.e., la ' narrowband maUichromatie radiation, or multiple wavelengths (either monochromatic, narrowband midilehroma ic, wideband muitichromatie, or combinations -thereof).
• the single or multiple combinations m be applied either simultaneously or sequentially,
• embodiment of the present disclosure may 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 energy may also he used.
• Exemplary of -known light so rces are uoreseent lights, fiash!anips, filamentous lights, etc.
• any light source capable of emitting electromagnetic radiation at a medically useful wa velength, as described herein, directly, or by means of optical filtration is within the scope of suitable light sources according to the present disclosure.
• any source capable of emitting light havin a wavelength from about 300 »m to about 1 00 am, or producing electromagnetic radiation which is filtered or otherwise altered to exposure the skin, a topical composition, or -other component of the present treatmen t regime to a wavelength of light in the aforementioned range is medically useful.
• the targeted skin may foe; exposed to one or more 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 be used (including pulse duration, energy, single or m ultiple pulses, the interval between pulses, t he total number of p ulses, 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, in 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.
• 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.
• 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.
• a ' narrowband ' mmiichromatic eieciiomagnetic radiation emitter emits eleciiomagneiic radiation in a bandwidth of +/- about : 1.00 nanometers around a dominant wavelength.
• a narrowband mnltichromatic electromagnetic radiation emitter emits electromagnetic radiatio in a bandwidrb. of -* ⁇ / « aboiit. 20 nanometers around a dominant wavelength
• a narrowband muHichromatic electromagnetic radiation emitter emits electromagnetic radiation In a bandwidt of ⁇ /- about 1.0 nanometers around, a dominant wavelength
• a narrowband molticbromatic electromagnetic radiation emitter emits electromagnetic 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 roultichroma ⁇ c emitters.
• the narrow band allows photons of slightly different wavelengths to be emitted. This can potentially be beneficial for creating certain desirable rnulti photon interactions, in contrast, most
• Tissue penetration depth may be di fferent than the tissue penetration depth for ulcerated or burned skin and. may also be. different for skin that has been : abraded, or enzymaticaily peeled or that has had at least a portion of the stratum, corneum. removed by any method. It is also important to penetrate any interfering chromophore 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.
• 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:
• 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 t— in general high energy produces inhibi tion and lower energy produces stimulation.
• the exposure time for the irradiation is very critical and varies with the desired effect and the target ceil, subcellular eoraponerit, exogenous ehromophore tissue or organ (e.g. 0.5.microseconds to 10 rain may be effective for human fibroblasts, though greater or lesser may also be used successfully).
• Suitable active agents for use in topical compositions applied to the skin by the applicator tip in accordance with the present disclosure include one or more of Vitamin C. Vitamin E, Vitamin D, Vitamin A. Vitamin K t Vitamin F. Retin A (Tretinoin), Adapaleue, Retinol, 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, m antioxidant, a phytoantlmeyanin, a hytonnirieat, plankton, a botanical product a- erbaceous product, a hormone, an nz me, a mineral, a genetically engineered substance, a cefaclor, a caiaiyst, an aniiaging substance, .
• Vitamin C
• a hair growth stimulating substance a hair growth inhibiting substance
• a dye a natural or synthetic melanin, a metalloproteinase inhibitor, proline, ydroxyproline, an anesthetic substance, chlorophyll, bacteriochlorophyll, copper
• chiorop!ryllin chloropiasts, qa oteno s, phyeobil n, rhodopsra, aiuhocyanm, and derivatives, subcomponents, immunological complexes and antibodies directed towards any component of the target skin structure or apparatus, and analogs of the above items both natural and synthetic, as well as combinations thereof.
• topical compositions applied to the skin by the applicator tip include aiiti-wrinMe co.n pos.itioris (e.g., PRO-XYLANETM, and the like), anti- dark circle compositions (e.g., HALOXYLTM, and the like), or anti-poffiness compositions (e.g., FRI ALIFTTM, and the like).
• aiiti-wrinMe co.n pos.itioris e.g., PRO-XYLANETM, and the like
• anti- dark circle compositions e.g., HALOXYLTM, and the like
• anti-poffiness compositions e.g., FRI ALIFTTM, and the like.
• topical compositions applied to the skin by the applicator tip include xyloses, hydroxypropyl tetrahydropyrantrioi and the like.
• active agents for use m topical compositions applied to the skin by the applicator tip include capryloyl salicylic acid, adenosine, 'adenosine triphosphate, retinol Imoleate, and the like.
• an applicator assembly incl udes an applicator tip that is configured to apply a cyclical mechani cal force to a skin, surface area of a user and to deliver a skin formulation including one or more of Aoyktes GI 0-30 Alky Acrylate CrossPolymer, Adenosine, Alcohol, Argmine, B ' HT, B!S-PEG-1 S Methyl Ether Dimethyl Silane * Buiylene Glycol Caffeine, Capryioyi. Salicylic Acid ⁇ Caprylyl Glycol, Carbomer, centanrea cyaous flower water, ehlorhexidine digiucona e, chrysia. Citric Acid, Coco-Betadine,
• a special 1 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 unsymmeincally dampen the shape of the l ' 850 eurve. At 850-870 nm, there is believed to be a ' dose dependent' effect oil fibroblasts.
• Fig. 7 sho s ⁇ a method of installing the lighting unit into the housing 12.
• a slot or hole is created proximal to the applicator tip 20.
• LED assembly ! 00 ' is inserted into the slot.
• the wiring 104 for the LED assembly 1 Of is routed to a driver circuit and a power supply as will he explained below.
• Fig. 8 shows a block diagram, of hardware components - used ' in:conjunclion. with, the LED assembly 1 0.
• 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 be the same or di ferent from batteries 32 mentioned above.
• LED Dri ver 820 can be included as part of microprocessor 34 mentioned above, or it can he an i ndependent component.
• Fig, 8 also shows thai the LED Driver 820 can be connected to a light on/off control unit which.
• the LED assembly includes an infrared- LEO unit 1 10 and a yellow LED unit 112, which each emit 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.
• the LEDs could be types LY G6SP-CADB ⁇ 36 ⁇ 1-2 (for providing the 55K ) .ftm wavelength) and VSMF4728- (for providing the 870 nm wavelength).
• Fig. 9B shows that the LEDs 110 and ⁇ 1 are. spaced apart by : 4tnni. ⁇ and. the LEDs are spaced apart from the applicator tip by 1 ,2 mm.
• 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.
• FIG. 10 shows an embodiment which further includes a hood 114 for explicitly defining or limiting the area of light emission on the skin.
• F g- 1 shows that a lens 11 1 may be used in
• the lens! 1 101 can- have positive or negati e focal length properties to achieve the desired emission of light, and can he made of any number of materials, such as, hut not limited to,, glass, plastic or resin.
• the lens 1 101 may also diffuse o broaden the light exposure of a specific area.
• an acrylic material placed external to the LED units may be used, to achieve such a diffusing lens.
• a pulse scheme is used, for the light emissions on the skin surface.
• a “code” refers to the poise scheme for various treatment regiment. This includes various factors such .as- ulse- length, i erpulse delay, and pulse repetition,
• a treatment may comprise a pulse code of 250 msec "on” time, 100 msec “off time (or dark period), and 100 pulses.
• This- roduces a total energy fluence, in J/cm 2 , of 25 seconds limes (lie power output level of the emitters. This permits a comparison of pulsed verses continuous wave treatment (die “code” for continuous wave treatment would be 1 pulse .
• the present embodiment allows for use of a continuous light wave treatment that simulates a pulsed treatment This is accomplished by assuming, movement of the device over an isolated skm ' area as shown, in. Fig. 1.2. which is estimated, to produce a simulated 1 Hz "pulse" as viewed from a particular area on. the skin as shown, in Fig. 13. Therefore, the present embodiment provides the .advantage of simulating a pulsed treatment on the skin, area by using continuous wave treatment in combination with the natural .movement: of a user.
• a plurality of LED assemblies 100 (which may include LED nite 1 10 and 112) are provided such that they surround the applicator tip 2.0, as shown in Figs, ⁇ 4 ⁇ and 14B.
• the lens i 101 described above may optionally be provided with each LED assembly 100 to focus or diffuse the emitted light
• the LED assembl 100 may be pro vided within the
• Fig. 16 shows a method- -implemented by the applicator apparatus 10 described above.
• the applicator tip assembly 20 performs a process of contacting and delivering a skin formulation to a skin surface ofa user according to the cyclic movement of the applicator tip described above.
• the light -assembly 1 0 performs a process of emitting light continuously to the skin surface are. of the. user

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• 2015
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