Classifications

• • 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
  • A61B18/1815—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 microwaves
• • 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
• • 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
• • 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
  • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
• • 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
  • A61B18/1815—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 microwaves
  • A61B2018/1823—Generators therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
  • A61N2005/0642—Irradiating part of the body at a certain distance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N2005/065—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
  • A61N2005/0662—Visible light

Definitions

• the present invention relates generally to the field of weight loss, and more particularly, to a device and method for reducing body fat utilizing optical emitters.
• Weight loss products such as pharmaceuticals, holistic treatments and/or diet plans, for example, are a multi-billion dollar a year industry dedicated to assisting consumers in the reduction of unwanted fat and weight gain. The majority of these products function to reduce the feelings of hunger or reduce the absorption of nutrition taken in by the dieter. While these products may be useful for a short time, studies have shown that continued use often results in diminishing returns. To this end, it has long been held that the best way to reduce fat deposits without surgical and/or medical devices is through behavior modification that includes proper diet and exercise. In many cases, however, there is a high rate of recidivism and
• U.S. Patent Application Publication No. 2007/0197884 to Bornstein discloses a fat reduction approach.
• U.S. Patent No. 7,993,382 to Shanks et al. discloses a fat reduction method using external laser radiation and niacin.
• U.S. Patent No. 7,351,252 to Altshuler et al. discloses a method and apparatus for photothermal treatment of tissue at depth. This method may cause heat damage to the epidermis.
• FIG. 1 illustrates one example of the distribution output pattern of a conventional laser device used to reduce fat.
• the laser output pattern comprises an elongated beam 2 having a fixed width W that is typically between 2 and four inches.
• the beam is directed onto the skin 1 of a patient 5 at a location where fat is present.
• This beam 2 is then rotated, see arrow a, about a central axis 3 for a predetermined period of time.
• the area of skin being treated 1 does not receive uniform coverage of the laser, as the central axis 3 remains generally fixed, while the remainder of the beam 2 covers a constantly moving area.
• multiple lasers must be used to treat larger target areas such as the stomach, thighs, and buttocks, for example. Such a procedure further exposes the patient to less than desirable results, as one of the lasers may be more or less powerful than another, thereby causing uneven results. Because all of the energy of the laser is focused on a very small area at any point in time, the power of the laser must be very low to avoid permanently damaging the cells, resulting in a far less effective outcome than could otherwise be achieved.
• the conventional laser devices are capable of
• Lipo-Light is a commercially available product that is produced by Innovate Photonics Ltd.
• the product utilizes six paddles each containing 25 LEDs that produce a total of 2.4 watts at full fluency (combined effect from all 6 paddles).
• the device requires that each of the paddles be strapped directly to the skin of a patient for at least 20 minutes, and purports to achieve "slimming and toning" results.
• the medical practitioner is not able to directly view the interaction of the device paddles with the skin, and may not be able to quickly or adequately respond to an unanticipated reaction by the patient, such as burning, or an allergic reaction, for example.
• the direct application of the paddles results in a patchwork approach wherein gaps between the paddles are not exposed to the light.
• the present invention is directed to a fat reducing device and method utilizing optical emitters.
• One embodiment of the present invention can include an array housing a plurality of optical emitters which can be positioned to produce an optical output directed to a recipient, and a controller for instructing an operation of the array.
• the optical output can be generated by a plurality of LED's cumulatively producing red light at approximately 635nm, and at approximately 40,000 Lux, measurable at the array.
• Another embodiment of the present invention can include components for modulating the power delivered to the array based on a reference waveform created internally or via an external device.
• Yet another embodiment of the present invention can include a method of reducing lipid content of subcutaneous adipocytes using the optical emitting device.
• the method including delivering red light at approximately 313.6 Lux at a wavelength of approximately 635nm for between 1 and 8 minutes, resulting in a total delivery of 2.88 Joules to the subcutaneous adipocytes of the target area of the recipient.
• FIG. 1 is a perspective view of a laser device in accordance with background art.
• FIG. 2 is a perspective view of the fat reducing device utilizing optical emitters in accordance with one embodiment of the invention.
• FIG. 3a is a bottom side view of the array for use with the fat reducing device utilizing optical emitters in accordance with one embodiment of the invention.
• FIG. 3b is a perspective side view of the array of the fat reducing device utilizing optical emitters in accordance with one embodiment of the invention.
• FIG. 4a is a perspective view of the controller of the fat reducing device utilizing optical emitters in accordance with one embodiment of the invention.
• FIG. 4b is a perspective view of the controller of the fat reducing device utilizing optical emitters in accordance with another embodiment of the invention.
• FIG. 5a is a schematic block circuit diagram of the controller of the fat reducing device utilizing optical emitters in accordance with one embodiment of the invention.
• FIG. 5b is a schematic block circuit diagram of the controller of the fat reducing device utilizing optical emitters in accordance with another embodiment of the invention.
• FIGS. 6a and 6b are diagrams of the modulation input signal and the rectified input signal, respectively, in the controller of FIG. 4a.
• FIG. 7 is a perspective view of the fat reducing device utilizing optical emitters in operation, and in accordance with one embodiment of the invention.
• FIG. 8 is a perspective view of the fat reducing device utilizing optical emitters in operation, and in accordance with an alternate embodiment of the invention.
• FIG. 9 is a perspective view of the fat reducing device in accordance with another alternate embodiment of the invention.
• a fat reducing device and method utilizing optical emitters can act to decrease the lipid content of adipocytes without permanent or adverse effects on the cells and their surrounding tissues.
• the device can illuminate the epidermis, dermis and underlying adipose tissue by applying light/radiation from an array of optical emitters at a target wavelength causing a photochemical reaction that stimulates specific cellular enzymatic processes, such as lipolysis, stimulation of production of collagen, elastin, leptin, and adiponectin. Modulation is not required, but may enhance results.
• an "optical emitter” can include virtually any type of light emitting device including, but not limited to, light emitting capacitors, light emitting diodes (LEDs) and/or super-luminous light emitting diodes, for example, that are capable of individually and/or jointly creating optical emissions of light/radiation at a target wavelength.
• LEDs light emitting diodes
• super-luminous light emitting diodes for example, that are capable of individually and/or jointly creating optical emissions of light/radiation at a target wavelength.
• subcutaneous adipocytes will expel their lipid content when receiving red light at approximately 313.6 Lux at a wavelength of approximately 635nm for between 1 and 8 minutes, resulting in a total delivery of 2.88 Joules.
• red light at approximately 313.6 Lux at a wavelength of approximately 635nm for between 1 and 8 minutes, resulting in a total delivery of 2.88 Joules.
• the measurable light/radiation output leaving the array be greater than the amount that is desired to make contact with the subcutaneous adipocytes of the recipient.
• a target wavelength and an “optical output” shall be used interchangeably to describe the measurable light/radiation output of the array that is sufficient to apply about 313.6 Lux subcutaneously to the adipocytes of the target area of a human recipient for a total delivered energy of 2.88 Joules (typically requiring an exposure duration of between 1 and 8 minutes).
• this measurable optical output shall include an output of red light at approximately 635nm, at approximately 40,000 Lux.
• approximately 313.6 Lux of the 40,000 produced by the array
• the distance and time can be slightly adjusted to account for the inherent variances of skin makeup from one person to another.
• the desired energy of 2.88 Joules will be delivered thereby causing the lipid content to be expelled from the adipocytes without causing cellular damage.
• Visceral fat is also known as intraabdominal fat, and is located inside the abdominal cavity, packed between the organs. To this end, when the array is positioned at a distance of between 1 and 2 inches from the skin/target area, the requisite 313.6 Lux at 635nm for approximately 12-16 minutes, the desired energy of 2.88 Joules can be delivered to the visceral fat.
• LEDs unlike lasers, which are monochromatic and can be manufactured to produce an identifiable and constant wavelength, LEDs have a distribution of colors. Therefore, LEDs have a spectrum distribution as opposed to a fixed wavelength that takes into account light output and color. As such, current manufacturing techniques may be unable to provide a plurality of LEDs which can each deliver an exact peak or dominant wavelength at exactly 635nm on a consistent basis. Therefore, when utilizing LEDs, within the below described array, the optical output can include an output spectrum approaching or as close to 635nm as possible so as to deliver about 313.6 Lux subcutaneously. Such a feature can be accomplished by individually testing the output of each LED prior to positioning the light within the array.
• the device when operating in the target wavelength i.e. at a suitable power dosimetry, e.g., from about 50mW/cm2 to about 110mW/cm2, the device can stimulate an increase in biochemical processes, and in addition, emptying of contents of adipocytes over a large portion of a person's body.
• a suitable power dosimetry e.g., from about 50mW/cm2 to about 110mW/cm2
• the device of the present disclosure it is normally possible to decrease the lipid content of treated adipocytes in a noticeable manner within minutes of treatment. Moreover, by utilizing an array of optical emitters, the device of the present disclosure can uniformly treat a much larger target area.
• the target area of the array described below in FIG. 3a is
• the presently claimed invention can allow a recipient to experience the many biological processes that take place in tissues that have been shown to respond to light in the 630-640 nm wavelength range.
• One of these processes is the enhancement of ATP production in the mitochondria, which provides more energy substrate for cellular healing and tissue recovery post injury.
• the target wavelength has also been shown to decrease
• FIG. 2 illustrates one embodiment of a fat reducing device utilizing optical emitters that is useful for understanding the inventive concepts disclosed herein.
• the device 20 can include an array of optical emitters 30 (array) which can operate to produce
• a multi-positional stand 25 can be secured to array 30 for precise alignment and positioning over a recipient.
• the controller 40 can include a power cable 26 for mating with a conventional 120V AC power source, and a second cable 27 can be provided to supply power from the controller 40 to the array 30.
• FIGS. 3a and 3b illustrate one embodiment of a suitable array 30.
• the array can include a generally rectangular main body having a top surface 31a, a bottom surface 31b, a front surface 31c, a back surface 3 Id and opposing side surfaces 31e and 3 If, each forming a generally hollow interior space.
• a plurality of optical emitters 32 are positioned within the main body 31 so as to allow the emissions therefrom to be directed outward from the bottom surface 31b.
• a plurality of ventilation devices such as fans 33 heat syncs (not shown) and/or air vents 34 can be provided on or within the main body to allow proper air ventilation.
• the main body can be constructed from metal, and the plurality of optical emitters 32 can include 150 2-Watt LEDs that receive 120V AC power from the cable 27, at the discretion of the controller 40.
• the plurality of emitters 32 can produce an optical output sufficient to ensure about 313.6 Lux and can be subcutaneously delivered to the adipocytes of the target area of the recipient in order to remove the stored lipids.
• optical emitters 32 can also be flush mounted in accordance with known manufacturing techniques.
• FIG 4a illustrates an exterior view of one embodiment of the controller 40.
• the controller can include a main body 41 having a plurality of user controls and/or interface devices secured thereon. These devices can include, for example, a key switch 42, a stop button 43, a volume selector 44, an exposure time selector 45 an array indicator 46, a modulation signal strength indicator (VU meter) 47, a start button 48 and a signal input jack 49.
• VU meter modulation signal strength indicator
• FIG. 5a illustrates one embodiment of a circuitry block diagram of the controller 40 described above.
• the internal components can include, for example, a signal generator 50, an amplifier 51, one or more speakers 52, a rectifier 53, one or more solid state relays 54, a timer 56, a control switch relay 57, an hours meter 58, an AC power input device 59b, and a DC power module 59a.
• Each of these components and the user interfaces described above can be communicatively linked via one or more internal cables 55, bus or other suitable device.
• the controller 40 can be manufactured in accordance with any number of known construction methodologies, and one or more of the internal components, although listed as separate elements, can be formed together to form a printed circuit board or other such component, for example, in accordance with known manufacturing processes.
• the main body 41 can act to securely position each of the elements 42-59 in secure manner so as to form a single unit which can be operated by a user.
• the body itself can take any number of distinct shapes and sizes, and can be constructed from any number of known materials such as plastic or metal, for example. Of course, other known materials and manufacturing processes are also contemplated.
• the key switch 42 can function to provide security against operation of the device by unauthorized persons.
• the key switch can interface with a physical key and an internal relay 57 to switch the device between a plurality of operating states.
• the key can switch the device between: on with internal modulation selected, device off, and device on with external modulation source selected.
• other access control devices can also be utilized herein. Several non-limiting examples including: key fob, access code (via an integrated keypad), biometric sensors and the like.
• the stop button 43 can function to immediately cease power distribution to the array 30 when engaged.
• the speaker volume selector 44 can comprise a switch or knob, for example, which acts to control the output of the one or more speakers 52.
• the exposure time selector 45 can comprise a switch or knob, for example, which can allow a user to specify how long power will be sent to the array during a particular treatment.
• the array indicator 46 can include a light or other such notification instrument suitable for notifying a user when power is being sent to the array.
• the modulation signal strength indicator 47 can act to indicate the presence of an external modulation signal, and to display a visual representation of the signal to a user. The visual representation also indicating the delivery of power to the array 30.
• the start button 48 functions to initiate the device timer 56 and allows power to be sent to the array 30.
• One or more input jacks 49 can be provided to allow the controller 40 to interface with an external device such as a computer/tablet device, radio, television, CD player, DVD player, or MP3 player, for example. These external devices can generate and transmit an audio or sub audio input signal i.e., reference waveform such as music or words, for example, to the controller 40.
• the input jack 49 can include a standard 1/8 inch modulation input jack (e.g., mini-phone plug) and/or other forms of input devices such as a USB port, for example.
• the input jack 49 can be connected to the internal signal generator 50 such as an audio oscillator, for example, which can act to either generate or pass through the received reference waveform.
• the internal signal generator 50 such as an audio oscillator, for example, which can act to either generate or pass through the received reference waveform.
• the controller 40 can be connected to a conventional 120V AC input source, which can supply power to the internal DC module 49 for powering the controller interfaces.
• the received AC power can also be modulated and subsequently transferred to the array 30 which can utilize the same to generate an optical output.
• the controller 40 and/or array 30 can also include any number of fuses to protect the recipient, operator and device in the event of an electrical problem or excessive current flow through the device components.
• the flow of electricity (120 VAC) to the array 30 can be controlled by the timer circuit 56, which can interface with the start button 48, stop button 43, the exposure time selector 45 and the array indicator 46.
• the controller 40 can vary the fluency of the photonic energy delivered to the skin and underlying tissue.
• the start button 48 begins the timer circuit 56, which allows power to be sent to the array 30 for conversion into light via the plurality of optical emitters 32.
• the hours meter 58 advances to record the total operation time of the device.
• the controller 40 can execute a method to control the fluency by modulation of the current transmitted to the optical emitters 32 of the array 30.
• the current to the array 30 can vary based on the frequency of the reference waveform (i.e., audio input signal) that is internally generated 50 or that is generated by an external device and connected to the input jack 49.
• the reference waveform 61 (see FIG. 6a) can be supplied to the amplifier 51 before being sent to the rectifier 53.
• the rectifier can function to produce an output voltage representing only the positive portion of the reference waveform.
• This output voltage 62 (See FIG. 6b) can function to activate the Solid-State Relay (SSR) 54, and the negative portion is shunted to ground.
• SSR Solid-State Relay
• 120V AC power can be passed to the array 30 for conversion into light via the plurality of optical emitters 32.
• the SSR can prevent the 120V AC power from passing to the array 30 until the next positive cycle of the reference signal 61.
• modulation of the array output is accomplished by varying the current and pulse width of the 120V AC voltage supplied to the array 30 from the controller 40.
• the VU Meter 47 can be in communication with the signal generator and rectifier in order to provide a visual indicator of the input frequency strength for purposes of adjustment.
• the audio amplifier 51 can also provide the input signal to the speaker 52 so as to allow the operator to simultaneously listen to the input signal.
• Each of the amplifier and speaker can be controlled by the volume selector 44 in order to vary the volume of the monitored input signal.
• the content of the audio input signal controls the array fluency with respect to time, affecting and controlling the photonic energy delivered to the skin and underlying tissue.
• a different audio recording (or video recording with sound) will result in the array having a different fluency and excitation patterns with respect to time, which further results in varying photochemical and biochemical responses and outcomes at a cellular level.
• the controller 40 can allow an operator maximum flexibility for generating a virtually unlimited number of array fluencies through modulation of various audio input signals.
• the device 20 can be operated without modulation, wherein the controller 40 can provide a constant and steady power source to the array 30 for a specific period of time.
• FIGS. 4b, and 5b illustrate but one possible alternative embodiment of a controller for operating the array 30.
• controller 40' can also include a main body 41 ', having one or more user controls and/or interface devices secured thereon. These devices can also include a key switch 42, an array indicator 46, a modulation signal strength indicator 47, and a signal input jack 49. Of course any number of other interface devices can also be provided. As shown by the exemplary circuitry block diagram., the controller 40' can include, for example, an amplifier 51, a rectifier 53, one or more solid state relays 54, an hour meter 58, an AC power input 59b, and a DC power module 59a.
• the key switch 42 functions to replace the start button and the stop button.
• the controller 40' provides power to the array 30 based on a reference waveform received by the input jack 49, as described above.
• the key is in the off position, no power is sent to the array, and the DC power to the controller components is disabled.
• Such a feature can allow the size of the controller to be small in nature, typically between about 14 and 20 inches, so as to enable the device to be easily transported.
• FIG. 7 illustrates one embodiment of the fat reducing device utilizing optical emitters 20 in operation to treat a recipient.
• the recipient 5 can be positioned on a table 6 or other suitable platform, and the array 30 can be positioned above the target area 1 of the recipient via the stand 25.
• the array can be positioned between about 1 and 8 inches from the target area of the recipient and an operator (not shown) can utilize the controller 40 to activate the array. Once activated, the optical emitters of the array can produce the optical output 35 described above that is sufficient to allow approximately 313.6 Lux to be delivered to the subcutaneous adipocytes of the target area for a period of about 1 to 8 minutes.
• the effective operating range of the device 20 for weight loss is between about 1 to 10 inches, and a maximum operating time of between 1 and 10 minutes, respectively.
• the device 20 can also be utilized for other therapeutic treatments such as collagen and elastin production, for example.
• results have been achieved at distances between the array 30 and the target area 1 of about 1 and 18 inches, and for operating times of between about 1 and 120 minutes, for example.
• FIG 8 illustrates an alternate embodiment of the device 20 wherein a plurality of arrays 30 and 30' function in unison to treat multiple target areas 1 and la of a recipient 5 simultaneously.
• array 30' can be constructed in an essentially identical manner as array 30 described above, and each of the arrays can be tethered 27 to a single controller 40.
• the device 20 can also function to treat multiple areas of a single recipient at one time.
• FIG. 9 illustrates yet another embodiment of the device 20, wherein the controller 40 and array 30 are integrated into a singular structure.
• the controller main body 41 and the array main body 41 are joined to create a unified main body 90 that houses the controller and array components as heretofore described.
• the device 20 can be connected to an external device 10 (in this instance a tablet pc) via an audio cable 11 in order to receive the audio signal.
• an external device 10 in this instance a tablet pc
• the device can operate in a self-service capacity.
• the user interfaces of the controller can be accessible to a recipient at all times during treatment. Such a feature can allow the
• the device will preferably be equipped with only the on/off switch, however any number of other user interfaces can also be provided.
• the advantages of the present invention may include, without limitation, the stimulation of biochemical processes of lipolysis and other desirable effects in the adipocyte, which could lead to reversals not only of obesity, but decrease unpleasant and harmful side effects of obesity, such as diabetes and high blood pressure, and heart attack.
• the benefits may also include the stimulation of production of collagen, elastin, leptin, and adiponectin.
• noninvasive, non-painful, and generally risk-free method is much more beneficial to the body than a surgical method of fat reduction.
• Many obese individuals at risk of diabetes and heart conditions are not surgical candidates; furthermore, surgical methods of localized fat reduction have not been shown to reduce the risk of heart disease, diabetes, or other weight-related medical conditions.
• one or more elements of the controllers 40 and 40' and the arrays 30 and 30' can each be constructed utilizing any number of known means of attachment such as, for example, screws, glue, compression fittings and welds, among others.
• various components may be described herein as including separate individual elements, other embodiments are contemplated wherein multiple individual components are formed together as one continuous element, either through manufacturing processes, such as welding, casting, or molding, or through the use of a singular piece of material milled or machined with the aforementioned components forming identifiable sections thereof.
• manufacturing processes such as welding, casting, or molding, or through the use of a singular piece of material milled or machined with the aforementioned components forming identifiable sections thereof.

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