System and method for reducing lipid content of adipocytes in a body

A system is provided for reducing lipid content of adipocytes in a body. The system includes an optical device configured to illuminate a region of the body at a selective peak wavelength and at a selective power density for a selective time period. The system also includes a controller connected to the optical device to determine the selective wavelength, the selective power density and the selective time period to stimulate lipolysis in the adipocytes. A system is also provided for reducing pain in the body. A method is also provided for reducing lipid content of adipocytes in the body.

FIELD OF THE INVENTION

The present invention relates to medical devices, and more particularly, to medical devices for reducing fat content in a body and improving physical appearance. Even more particularly, the present invention relates to medical devices using phototherapy to improve appearance of the human body by reduction of body fat content.

BACKGROUND OF THE INVENTION

To reduce fat in the human body, behavior modification has been a conventional method with minimal risk to the patient. However, behavior modification involves a high rate of recidivism and noncompliance where the patient frequently reverts back to his or her former eating and lifestyle patterns. Thus, long term success is only moderately successful. Furthermore, short term weight loss in patients is frequently followed by weight gain and thus results in a difficulty in remaining a normal and healthy weight. Additionally, pharmacological methods have been used to reduce body fat, which rely on reducing feelings of hunger or reducing absorption of nutrients. This method has also shown to have limited effectiveness, in addition to causing side effects.

Other conventional methods to reduce fat in the human body involve surgical methods such as liposuction (suction lipectomy) which are inherently risky and invasive by potentially damaging surrounding tissue, nerves, skin, as well as potentially causing pain, trauma and infection. Additionally, these surgical methods are typically only effective with localized subcutaneous adipose deposits.

Other recently-approved devices by the Food and Drug Administration (FDA) to reduce fat in the human body include devices utilizing cryogenics to freeze fat cells, after which the fat cells die and are metabolized by the body. These devices involve inherent drawbacks, such as delayed results, which may not be realized for up to four months, and an inherent risk of damage to surrounding tissue in a vicinity of the fat cells.

BRIEF DESCRIPTION OF THE INVENTION

In one embodiment of the present invention, a system is provided for reducing lipid content of adipocytes in a body. The system includes an optical device configured to illuminate a region of the body at a selective peak wavelength and at a selective power density for a selective time period. The system further includes a controller connected to the optical device to determine the selective wavelength, the selective power density and the selective time period to stimulate lipolysis in the adipocytes.

In another embodiment of the present invention, a system is provided for pain reduction in a body. The system includes a support to hold a region of the body and an array of LEDs configured to output a peak wavelength with a selective power density at the region of the body for a selective time period sufficient to reduce pain in the region of the body. The system also includes a stand to hold the array of LEDs at a selective distance above the region of the body. The system also includes a controller connected to the LEDs and the stand. The controller is configured to transmit a signal to the stand or the support to vary the selective distance of the LEDs above the region of the body and to modulate an output of the LEDs at a selective frequency. The controller is configured to modulate the output of the LEDs based on a transmission of an input signal to the LEDs at the selective frequency based on one of an internal modulation signal or an external modulation signal.

In another embodiment of the present invention, a method is provided for reducing lipid content of adipocytes in a body. The method begins by positioning a region of the body on a support. The method then involves determining a selective peak wavelength of radiation from an optical device to the region of the body to stimulate lipolysis in the adipocytes in the region of the body. The method then involves determining a selective power density of radiation at the region of the body to stimulate lipolysis in the adipocytes, including varying a selective distance between the optical device and the region of the body. The method then involves determining a selective time period to transmit the radiation from the optical device to the region of the body. The determining of the selective time period step is based on the step of varying the selective distance between the optical device and the region of the body. Then method then involves illuminating the region of the body with radiation from the optical device at the selective peak wavelength and with the selective power density at the region of the body for the selective time period to stimulate lipolysis in the adipocytes in the region of the body. The illuminating step includes modulating the radiation at a selective frequency.

DETAILED DESCRIPTION OF THE INVENTION

In describing particular features of different embodiments of the present invention, number references will be utilized in relation to the figures accompanying the specification. Similar or identical number references in different figures may be utilized to indicate similar or identical components among different embodiments of the present invention.

The inventor of the present invention recognized that conventional methods for reducing lipid content in adipocytes involved either delayed results (up to four months), possible damage to surrounding adipocyte tissue and/or were restricted to overweight (not obese) patients. Thus, the inventor developed a system and method for reducing lipid content in patients, irrespective of whether the patient is overweight or obese, in which results are achieved in a much shorter time span than the conventional methods and in which no damage is caused to surrounding adipocyte tissue or any other tissue. The inventor of the present invention developed the system which may cause one or more small pores to open in adipocytes for a short period, such as of approximately 48-72 hours, for example, during which lipid content is emptied and metabolized from the adipocytes. The liberated lipid content from the adipocytes is then drained by the lymphatic system and processed by the liver as part of the body's normal course of detoxification. The inventor of the present invention recognized that results in the system of the present invention were optimal in those individuals who limited fat intake during the treatment, minimized or avoided intake of alcohol, performed moderate exercise and stayed hydrated by drinking a sufficient quantity of water during the treatment. Although these factors may affect the degree of results for certain patients, they are not required factors in order for results to be obtained in patients.FIG. 1illustrates a system10for reducing lipid content of adipocytes12in a body14and/or for reducing pain in the body14. Although the system10will be discussed below, with reference to the effect of reducing lipid content of adipocytes12in the body14, the system10may have an additional benefit of reducing pain in the body14. Thus, the structural features of the system10discussed below, with reference to the effect of reducing lipid content of adipocytes12in the body14are restated herein with respect to the system10being used for the additional benefit of reducing pain in the body14. Indeed, the system10reduces the quantity of lipids in the adipocytes12without adverse effects to the adipocytes12, to the irradiated skin, or to the surrounding tissue. The system10stimulates various biochemical processes which include, but are not limited to, pain reduction, shortening of healing time, and scar reduction, as well as lipolysis and collagen and elastin stimulation. Additionally, collagen and elastin stimulation may complement the lipolysis, since weight loss may cause the skin to sag and create stretch marks. Collagen and elastin stimulation mitigate the instances of sagging skin and stretch marks due to the weight loss based on lipolysis. Upon reducing the lipid content from the adipocytes12, metabolism of the freed lipids may be needed for successful weight loss, and thus individuals who are unable to adequately metabolize lipids using normal bodily functions (i.e., liver), may not be suitable for treatment with the system10. However, even such individuals may still benefit from other advantages of the system10, as discussed below.

As illustrated inFIG. 1, the system10includes an optical device, such an as LED array15that is provided within a housing17, and is configured to illuminate a region18of the body14at a selective peak wavelength and at a selective power density for a selective time period, in order to stimulate lipolysis in adipocytes12at the region18of the body14. The region18of the body14is determined by the patient's desire to lose fat from the body14in that region18. Exemplary regions18of the body14may include, but are not limited to: breasts, the waist, the lower back, the upper thighs, and/or the neck, for example. As further illustrated inFIG. 1, the system10also includes a controller20that is connected to the housing17of the LED array15with a cable58. The controller20is used to determine the selective peak wavelength of the radiation from the LED array15, the selective power density of the radiation at the region18of the body14, and the selective time period to illuminate the region18of the body14, so that lipolysis is stimulated in adipocytes12at the region18of the body14. In an exemplary embodiment, the controller20determines the selective peak wavelength from a range of 630-660 nm; the controller20determines the selective power density from a range between 75-1500 mW/cm2; and the controller20determines the selective time period from a range between 5-120 minutes. One factor which determines which wavelength is selected by the controller20within the wavelength range of 630-660 nm is whether collagen and elastin stimulation, pain reduction or lipolysis is to be performed at the region18of the body14. For example, if lipolysis is to be performed at the region18of the body14, the controller20selects the peak wavelength from a narrower wavelength range, such as between 630-650 nm, for example. In another example, if collagen and elastin stimulation or pain reduction is to be performed at the region18of the body14, the controller20selects the peak wavelength from a broader wavelength range, such as 630-660 nm, for example. In an additional exemplary embodiment, the controller20determines a selective energy density of the radiation from the LED array15at the region18of the body14from a range between 4-82.5 J/cm2. Depending on whether the LED array15is being used to stimulate elastin and collagen, reduce pain or for lipolysis, the controller20is configured to select the appropriate energy density within the range. For example, the stimulation of collagen or reduction of pain in the region18of the body14has a lower energy density threshold than lipolysis and thus takes place at a smaller energy density than lipolysis. Thus, the controller20is configured to select a smaller energy density during the stimulation of collagen and a higher energy density from the above energy density range during lipolysis within the region18of the body14. In another exemplary embodiment, the selective time period may be determined within a range between 15-100 minutes. In another exemplary embodiment, the controller20determines the selective peak wavelength to be 635 nm, and the controller20determines the selective time period from a range between 5-40 minutes. In an additional exemplary embodiment, the controller20determines the selective wavelength, the selective power density and the selective time period in order to stimulate lipolysis in the adipocytes12of the region18of the body14where the body14has a body mass index (BMI) in excess of an obese BMI threshold. For example, the BMI of the body14is in excess of 30. However, the system10of the present invention is not limited to being used with a body having any specific BMI and may be used to stimulate lipolysis in adipocytes in a body having a BMI less than or greater than 30. The selective power density, determined within the above range of 75-1500 mW/cm2, is used to create a reaction in the adipocytes12and may vary in effect on each body14depending on a thickness of the adipocytes12in each body14. The selective power density in the above range is sufficient to stimulate lipolysis by encouraging an emptying of the adipocytes12into interstitial space, where the lipid content is metabolized using normal bodily processes.

Additionally, as illustrated inFIG. 1, the system10includes a support such as a table52to hold the body14, and an adjustable stand54to hold the LED array15at a selective distance50above the body14. In an exemplary embodiment, the stand54includes a swingable arm which can be raised or lowered manually and tightened in place, to adjust the selective distance50. However, the adjustable stand54may include a motor which is powered by a signal from the controller20, to adjustably move the LED array15up or down, and correspondingly adjust the selective distance50, for example. The controller20is connected to the adjustable stand54with the cable58, so that the controller20transmits the signal to the adjustable stand54to vary the selective distance50. When the controller20varies the selective distance50, the controller20correspondingly adjusts the selective time period, in order to deliver an equivalent amount of energy to the region18of the body14over the selective time period. Although the embodiment ofFIG. 1discusses the arrangement of the table52and the adjustable stand54, the embodiments of the present invention are not limited to this arrangement and may include a fixed stand and any type of support, including an adjustable support, to hold the patient, which receives a signal from the controller20, in order to move up or down, to vary the selective distance. Additionally, althoughFIG. 1illustrates that the table is used to hold all of the patient's body14, the embodiments of the present invention are not limited to this arrangement, and may feature any type of support which is configured to hold just the region18of the patient's body14that is subject to the treatment with the system10, for example.

In an exemplary embodiment, for each treatment with the system10, the user employs input features of the controller20to adjust the selective time period and the selective distance50, so that during the treatment the LED array15illuminates the region18of the body14at the selective distance50for the selective time period. The patient may undergo multiple treatments by the system10in one day, in which the same region18of the body14is treated by the system10or in which multiple regions of the body14are treated by the system, by moving either the stand54or the patient in between treatments. If the patient undergoes multiple treatments by the system10in one day, the system10may include a maximum total time period during which the patient can be treated during the day, to ensure that the patient's body has adequate time to metabolize the lipid content emptied from the adipocytes12during the total time period. Additionally, the system10may include a minimum rest period, between the days that the patient undergoes treatment for the maximum total time period. The minimum rest period should be long enough so that the body14has adequate time to metabolize the released lipid content from the adipocytes12during the treatment(s), but the minimum rest period should also be short enough so that the pores of the adipocytes12opened by the treatment are still open during a subsequent treatment. As previously discussed, the pores of the adipocytes12at the region18of the body14may be open for approximately 48-72 hours after treatment by the system10, for example. In an exemplary embodiment, the radiation from the LED array15causes the mitochondria in the nucleus of the adipocytes12to open transitory pores in the cell membranes of the adipocytes12. For example, the system10may limit the maximum total time period during which a patient can be treated during a day to 48 minutes. In another example, the system10may limit the maximum total time period that the patient can be treated to 48 minutes, and provide a minimum rest period of one day, so that the patient can undergo the 48 minute treatment period every other day, for example. For example, a patient may undergo 6 individual 8 minute treatments in one day, with one day rest period in between. In another example, the patient may undergo 3 individual 16 minute treatments in one day, with one day rest period in between. The maximum total time period and the minimum rest period may be stored in a memory of the controller20along with patient identifying information, and the controller20may feature an internal clock so that the controller20can track whether a specific patient is eligible for treatment, for example. Depending on what region18of the patient's body14is to be treated, multiple treatments in one day may or may not be necessary. For example, if a patient seeks to lose weight around a thigh region18of the body14, the system10may be used to perform multiple treatments on different portions of the thigh region18of the body14, where the patient rotates different portions of the thigh region of the body14to the LED array15in between each treatment, for example. In another example, if the patient seeks to lose weight from a lower back region of the body14, the system10may not need to perform multiple treatments on the lower back region.

In an exemplary embodiment, upon reducing the selective distance50, the controller20reduces the selective time period. In another exemplary embodiment, upon increasing the selective distance50, the controller20increases the selective time period. Thus, when the power density at the region18is lowered by raising of the LED array15away from the region18of the body14, the controller20may increase the selective time period for more optimal results and when the power density at the region18is raised by lowering the LED array15closer to the region18of the body14, the controller20may decrease the selective time period, for more optimal results. In an exemplary embodiment, the controller20adjusts the adjustable stand54so that the selective distance50is approximately 8 inches, and adjusts the selective time period to approximately 8 minutes for each treatment, for example. For this exemplary embodiment (selective distance is approximately 8 inches and the selective time period is approximately 8 minutes) the above-discussed maximum total time period of 48 minutes and minimum rest period of one day may also be used. In the exemplary embodiment, the LED array15is configured to collectively output 300 watts through the LEDs16at the selective distance50of approximately 8 inches, in order to establish a sufficient energy power density at the region18of the body14which stimulates lipolysis in the adipocytes12. In an exemplary embodiment, when the selective distance50is set at approximately 8 inches, the LED array15is configured to illuminate the region18(within the adipose tissue layer46) that spans an area of approximately 43.1 cm×53.3 cm, for example, in order to establish the sufficient energy power density at the region18to stimulate lipolysis in the adipocytes12. Thus, in the above exemplary embodiment, a patient may undergo multiple 8-minute long treatments, provided that the patient does not undergo more than 48 minutes of total treatment time, every other day, thus providing the patient's body with adequate time to metabolize the emptied lipid content from the adipocytes12. Indeed, the controller20maintains the selective distance50to be no greater than a maximum distance, since if the LED array15is raised too far above the region18of the body14, the LED array15illuminates the region18with an insufficient energy density for lipolysis of the adipocytes12. If a patient seeks to remove visceral fat from the region18of the body14, the controller20may adjust the selective distance50to be less than if a patient seeks to remove subcutaneous fat from the region18of the body14. In an exemplary embodiment, the selective distance50may be moved within a range of 1 inch to 18 inches, for example. However, the selective distance is not limited to this specific range and may be adjusted to a distance outside this range, provided that the LED array15effectively reduces the lipid content in the adipocytes at the region of the body.

FIG. 2illustrates the region18of the body14discussed above, including an epidermis layer42, a dermis layer44and an underlying adipose tissue layer46with the adipocytes12in which the system10is used to simulate lipolysis. As illustrated inFIG. 2, the radiation from the LED array15is configured to penetrate through the epidermis layer42, the dermis layer44and to the adipocytes12in the adipose tissue layer46at a depth range between 8-10 mm, for example. Lipolysis of the adipocytes12in the adipose tissue layer46occurs once the LED array15delivers a sufficient energy density (J/cm2) to the adipose tissue layer46at the region18of the body14. The lipolysis of the adipocytes12is specific to the adipose tissue layer46at the region18of the body14, but may be transmitted to other regions of the body14outside of the region18. However, this numeric depth range is not limiting and the system10may provide an LED array which is configured to penetrate a depth which is less or greater than this depth range, provided that the penetrated depth is sufficient to stimulate lipolysis in the adipocytes in the region of the body. In an exemplary embodiment, selection of the peak wavelength from the range between 630-660 nm is to stimulate natural intracellular photochemical processes which in turn reduce pain and stimulate the body's production of collagen and elastin. If the patient seeks to reduce pain at the region18of the body14(rather than remove fat through lipolysis), then the selective time period may be adjusted to a longer period than the selective time period used for lipolysis. For example, a selective time period used for pain reduction may be 20 minutes, which is longer than the above-discussed exemplary selective time period of 8 minutes that is used for lipolysis. The dermis layer44elasticity is due to the presence of elastin fibers. Thus, increasing collagen and elastin production will improve the skin's appearance so that it appears smoother, tighter and reduce fine lines and wrinkles. In addition, other advantages of using a selective peak wavelength in the range between 630-660 nm include diminishment of wrinkles and fine lines; improvement in skin tone and texture; refinement of large pores; lightening of age spots; lightening of dark under eye circles; improvement in overall evenness of skin tone; treatment of acne spots; enhancement of Adenosine triphosphate (ATP) production in the mitochondria, which provides more energy substrate for cellular healing and tissue recovery post injury; and decreasing inflammatory mediators in wounds and increasing endogenous endorphin release. However, the present invention is not limited to the use of a selective peak wavelength in this specific range or for these specific advantages, and may include selection of any selective peak wavelength, provided that the use of this selective peak wavelength reduces the lipid content of the adipocytes12at the body region18.

FIG. 3illustrates the housing17of the LED array15, which includes a rectangular grid of LEDs16. In the exemplary embodiment ofFIG. 2, the LED array15may include a rectangular grid of 144 LEDs, for example. The present invention is not limited to this specific LED array15, and may feature less or more than this specific number of LEDs or any non-rectangular grid of LEDs in an array that is used to illuminate the region18of the body14, provided that the number of LEDs used in the array is sufficient to illuminate the region18of the body14with sufficient power to cause the desired effect.

FIGS. 4-5illustrate the controller20of the system10. In addition to determining the selective peak wavelength, the selective power density and the selective time period of the radiation from the LED array15at the region18of the body14, the controller20modulates the radiation output from the LED array15at a selective frequency to further stimulate the lipolysis in the adipocytes12at the region18of the body14. As illustrated inFIG. 4, the controller20includes a switch22to select between internal modulation or external modulation to modulate the radiation output from the array15. Additionally, the switch22may be moved to an off position, to turn the controller20and the LED array15off. Modulation of the output of the LED array15is not required, but may enhance the removal of lipid content from the adipocytes. For example, if the LED array15is positioned at the selective distance50from the region18of the body14, so that the energy density at the region18of the body14exceeds the range needed for lipolysis, modulation of the output of the LED array15can reduce the energy density at the region18to be within the range need for lipolysis. Indeed, the controller20of the present invention is configured to modulate the output of the LED array15and to vary the selective distance50of the LED array15above the region18, so that the energy density at the region18is within the range required for lipolysis.

As illustrated inFIG. 5, when the switch22is used to select internal modulation the switch22transmits a signal to the timer60to initiate a countdown of the selective time period. The timer60then transmits a signal to the relay25, after which the relay25sends an input signal28to the LED array15, which is modulated based on an internal modulation signal at a predetermined modulation frequency. The relay25also transmits a signal to an hours meters61, which monitors the elapsed time that the relay25outputs the input signal28to the LED array15. As illustrated inFIG. 1, the controller20is connected to a power source59with a cable56. In an exemplary embodiment, the power source59transmits the input signal28, which is an AC (alternating current) signal to the relays25,26, so that the relays25,26can subsequently transmit the input signal28to the LED array15, subject to internal/external modulation. Additionally, the power source59transmits a DC (direct current) signal, to power the components of the controller20. For example, the input signal28from the power source59may be a 120V AC signal and the DC signal may be a 12V DC signal, to power the components of the controller20. The controller20may include a 4 A fuse, to protect the operator and the controller20in the event of an electrical problem of excessive current flow through the controller20. In an exemplary embodiment, the input signal28is modulated such that the input signal28is shut off during negative portions of the internal modulation signal and the input signal28is transmitted to the LED array15during positive portions of the internal modulation signal. When the switch22is used to select internal modulation, the external modulation of the input signal28(discussed below) is not active.

As illustrated inFIG. 5, when the switch22is used to select external modulation, an inlet32is provided to receive an external modulation signal24from an audio recorder74at the selective frequency. For example, the external modulation signal24may be a digital or analog sound signal from the audio recorder74, which transmits the external modulation signal24to the inlet32through a standard ⅜ inch mini-phone plug cable, for example. The inlet32passes the external modulation signal24to a half-wave rectifier34. As illustrated inFIG. 6, the half-wave rectifier34converts positive portions36of the external modulation signal24into positive portions of a DC signal38and blocks negative portions40of the external modulation signal24from the DC signal38, thereby resulting in the DC signal38with positive portions corresponding to the positive portions36of the external modulation signal24. As illustrated inFIG. 5, the half-wave rectifier34then transmits the DC signal38to a solid state relay26, which subsequently outputs the input signal28to the LED array15during the positive portions of the DC signal38and thereby blocking the input signal28to the LED array15during the negative portions40of the external modulation signal24. When the switch22is used to select external modulation, the internal modulation of the input signal28(discussed above) is not active.

As further illustrated inFIG. 4, the controller20includes a timer60to adjust the selective time period during which the relay25,26transmits the input signal28to the LED array15. Additionally, the controller20includes a start button62to start the timer60and start the transmission of the input signal28from the relay25,26to the LED array15for the selective time period. Additionally, the controller20includes a stop button64to stop the timer60and stop the transmission of the input signal28from the relay25,26to the LED array15.

When the switch22is used to select external modulation of the LED array15, the controller20is also provided with a speaker66to output a sound of the external modulation signal24received through the inlet32. Also, the controller20features a monitor68to control a volume of the sound of the external modulation signal24that is outputted through the speaker66. A different sounding audio output from the speaker66will result in the LED array15having a different modulation or fluency, resulting in varying photochemical and biochemical responses and outcomes at the cellular level. The system10provides maximum flexibility and variation in the modulation signal design and processing. The controller20also features an LED indicator70to show that the input signal28is transmitted to the LEDs16and a modulation indicator72to show a presence and a signal strength of the external modulation signal24received through the inlet32. In the exemplary embodiment ofFIG. 4, the modulator indicator72shows the signal strength based on the number of lights of the indicator72that are illuminated. However, this specific design is merely exemplary and any modulator indicator design may be provided, as long as it indicates the presence and signal strength of the external modulation signal24received through the inlet32.

The LED array15is connected to the controller20with the cable58and the controller20controls the array15via specific modulation patterns provided for decreasing the lipid content of adipocytes12without permanent or adverse effects on the adipocytes12and their surrounding tissues. In an exemplary embodiment, the LED array15, in conjunction with its modulation by the controller20, can be used to direct light at the epidermis42, dermis44and the underlying adipose tissue46by applying radiation of a dominant peak wavelength of 635 nm in order to affect specific cellular enzymatic processes, such as pain reduction, lipolysis, stimulation of production of collagen, elastin, leptin, and adiponectin. As previously discussed, the input signal28to the LED array15is modulated in accordance with a selective frequency which may be internally or externally modulated and may vary with respect to time. For example, when external modulation is used, the LED array15emits radiation when the external modulation signal24is positive and does not emit radiation when the external modulation signal24is at or below zero, thereby varying the fluency of the radiation from the LED array15. The selective frequency is detected with the rectifier34and the input signal28is transmitted by the high-speed, solid state relay26to the LED array15, so that the input signal28is on during the positive portions36of the external modulation signal24and the input signal28is off during the negative portions40of the external modulation signal24. However, this is merely an exemplary modulation design, and the present invention may use any other modulation design, such as the input signal28being on during negative portions of the modulation signal and being off during positive portions of the modulation signal or being on during a first cycle of the modulation signal and being off during a second cycle of the modulation signal, for example. Indeed, any modulation design may be used for the input signal28, provided that the LED array15output enhances the removal of lipid content from the adipocytes12. Table 1 below provides examples of various specific selective frequencies of the external modulation signal24:

The harmonic selective frequencies A-E in Table 1 above may be used for the external modulation signal24, since these selective frequencies may be particularly advantageous in regard to removal of lipid content from the adipocytes12during lipolysis and pain reduction when the region18of the body14is illuminated with the LED array15. In one example, each specific numerical harmonic frequency (which is approximately 128thorder harmonics of the base frequencies in Table 1) may be used for specific treatments, such as pain reduction (harmonic frequencies E and G) and lipolysis (harmonic frequencies A, B and F). However, although Table 1 provides specific numerical modulation frequencies for the external modulation signal24, these numerical frequencies are merely exemplary and the selective frequency of the external modulation signal24may be varied to be within +/−30% of these numerical frequencies in Table 1, for example. Furthermore, the selective frequency of the external modulation signal24used in the present invention may be any numerical frequency other than these specific numerical frequencies in Table 1, provided that the external modulation of the LED array15enhances the removal of lipid content from the adipocytes12.

FIGS. 7A and 7Billustrate an exemplary embodiment of a spectral plot and a chromaticity diagram of the LED array15. Table 2 provides sample data of this spectral plot and chromaticity diagram:

FIG. 8depicts a flowchart of a method100for reducing lipid content of adipocytes12in the body14. The method100is non-invasive and reduces fat and cellulite in a body14by applying optical energy to the selected region18of the body14. The effect of the method100is to reduce a circumference in the region18of the body14. The extent to which the circumference of the body14is reduced depends on each patient, based on such factors as age, metabolism, food and drink intake, and alcohol consumption. In an exemplary embodiment, the circumference of a waist of the body14may be reduced by 5.1 cm during one treatment session, for example. In an exemplary embodiment, the photonic energy of the radiation from the LEDs16is sufficient to reduce visceral fat deposits of obese patients as well as subcutaneous fat in subjects. As appreciated by one skilled in the art, subcutaneous fat is positioned underneath the skin layer, but over the muscle wall, whereas visceral fat is positioned behind the muscle wall, surrounding internal organs. The method100begins at101by positioning102the region18of the body14on the table52and determining104a selective peak wavelength of radiation from the LED array15to the region18of the body14to stimulate lipolysis in the adipocytes12in the region18of the body14. The method100also includes determining106a selective power density of radiation at the region18of the body14to stimulate lipolysis in the adipocytes12, including varying the selective distance50between the LED array15and the region18of the body14. The method100also includes determining108a selective time period to transmit the radiation from the LED array15to the region18of the body14, based on the varying of the selective distance50. The method100also involves illuminating110the region18of the body14with radiation from the LED array15at the selective peak wavelength and with the selective power density at the region18of the body14for the selective time period to stimulate lipolysis in the adipocytes12in the region18of the body14, where the illuminating110step involves modulating the radiation at a selective frequency, before the method ends at111.

The advantages of the present invention may include, without limitation, the stimulation of biochemical processes of lipolysis and other desirable effects in the adipocytes12, which may reduce obesity, and reduce harmful side effects of obesity, such as diabetes, high blood pressure, and heart attacks. Other benefits of the present invention may include pain reduction and the stimulation of production of collagen, elastin, leptin, and adiponectin, as well as the reduction of blood triglycerides as a side effect of lipolysis of the adipocytes. The system10may result in a reduction in lipid content of adipocytes12, which can reduce the BMI of obese individuals. Additionally, the system10may significantly reduce healthcare costs for those individuals who would otherwise require treatment for the typical side effects of obesity. In addition, the noninvasive and non-painful system10offers significant advantages over a surgical method of lipid reduction in the adipocytes12. Further, many obese individuals are not surgical candidates and thus would not have this alternative available as an option.

In one embodiment, the present invention is an optical device such as the LED array15that can be used to illuminate the skin and underlying subcutaneous fat deposits, causing a photochemical reaction that stimulates specific cellular processes, such as lipolysis and freeing of cellular triglycerides and a reduction of blood triglycerides as a side effect of lipolysis of the adipocytes, pain reduction, as well as stimulation of collagen and elastin production, among other beneficial effects. In one embodiment, an optical illumination device such as the LED array15may operate at a wavelength centered around the 635 nm wavelength. Lipolysis refers to the biochemical breakdown and release of stored fat from adipose tissue46. Lipolysis of triacylglycerol stores located in white adipose tissue results in the liberation of glycerol and nonesterified fatty acids that are released into the vasculature for use by other organs as energy substrates. Lipolysis rates are usually precisely regulated through hormonal and biochemical signals. These signals modulate the activity of lipolytic enzymes and accessory proteins, allowing for maximal responsiveness of adipose tissue to changes in energy requirements and availability. These signals modulate the activity of lipolytic enzymes and accessory proteins, allowing for maximal responsiveness of adipose tissue to changes in energy requirements and availability.

The system10may be a Light Stimulated Adipocyte Depletion (LSAD) device, and be used to stimulate biochemical signals to cause lipolysis irrespective of changes in energy requirements and availability. The system10may also affect systemic and local controls of enzymatic modulation over biochemical hydrolysis (lipolysis) and synthesis (lipogenesis) of triacylglycerol. Triacylglycerol, which is metabolically active, is typically hydrolyzed to release the fatty acids from the adipocytes12. This occurs on a continual basis, where stores are continually being hydrolyzed and resynthesized. Adipocytes12are typically found mostly in the abdominal cavity and subcutaneous tissue.

Leptin has a central role in the metabolism of adipocytes12. Leptin coordinates intricate biological processes through its receptors. Leptin deficiency or leptin resistance can result in obesity, diabetes, and infertility in humans. Leptin has broad effects on angiogenesis, blood pressure, bone mass, hematopoiesis, lymphoid organ homeostasis, reproduction, and T lymphocyte systems. Leptin circulating in the blood regulates energy intake and energy expenditure via, its control of appetite and metabolism. The level of circulating leptin is directly proportional to the total amount of adipocytes in the body. The system10may be used as an LSAD device to modulate the biochemistry of adipocytes to affect leptin production and therefore, facilitate fat reduction. According to the system10, light centered around the 635 nm wavelength, with sufficient Power Density (W/cm2), temporal characteristics, and Energy Density (fluence or J/cm2) according to LSAD, increases the amount of Leptin that is produced by the adipocytes12, since leptin production is a side effect of the lipolysis of the adipocytes12. This may be a valuable effect that assists in fat reduction and weight loss.

The system10may be used as a LSAD device to alter enzymatic processes at the membrane level to produce an acceleration of lipolysis. The system10alters cellular structures, the extra cellular matrix, transmembrane “integrin receptors,” and cytoskeletal structures; specifically the membrane of the adipocyte12, to allow lipids to leak to interstitial space and be metabolized by the body14. During the illumination of the region18of the body14with the LED array15, no significant heat or detrimental effects to the region18are produced.

The epidermis layer42ofFIG. 2is the outermost layer of the skin and forms the waterproof, protective wrap over the body14surface. The dermis layer44is the layer of skin beneath the epidermis42that consists of connective tissue. In an exemplary embodiment, collagen is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content, for example. The dermis layer44constitutes about 15 to 20% of the weight of the body14. At many different wavelengths of light, only a single tissue constituent (e.g., water or collagen) absorbs the energy from the light. Therefore, it is important that the controller20determine the selective peak wavelength so that it can be transferred through the dermis layer44to the subcutaneous adipose tissue46. Due to the characteristics of skin components, the distribution of optical radiation through the epidermis42and dermis44to the subcutaneous adipose tissue46is controlled by various factors including the selective time period of exposure, absorption and scattering properties of layers of skin on the body14, and the selective power density of the LED array15and the selective frequency used to modulate the LED array15. These factors are used by the controller20to determine proper energy penetration through the skin layers42,44,46to the subcutaneous adipocytes12at the subcutaneous adipose tissue46. Thus, optical absorption, refraction and scattering are factors considered by the controller20in determining the selective power density and selective energy density of the LED array15at the region18of the body14and/or at the subcutaneous adipose tissue46. Because the dermis44possesses significant amounts of collagen fibrils, a significant amount of optical scattering may occur at the dermis layer44. The scale and degree of light absorption in the skin is relative to the scattering that takes place during the radiation of the skin. The selective peak wavelength and the selective power density are determined by the controller20in order to safely augment a cell's existing biochemical and enzymatic processes.

Photons that enter skin tissue at the region18of the body14are scattered one or more times until they either escape or are absorbed. The Beer-Lambert Law is applied if absorption (rather than scattering) is dominant in the skin tissue. The Beer-Lambert law describes the logarithmic dependence between the transmission, T, of light through a substance and the product of the absorption coefficient of the substance, α, and the distance the light travels through the tissue (i.e., the path length), l. The spatial distribution of the absorbed radiation in a tissue from a known absorption coefficient of a particular wavelength can thereby be determined. If scattering prevails over absorption, then a stochastic analysis may be used to determine the selective power density of the absorbed radiation for particular wavelengths, such as those used in the system10. In an exemplary embodiment, the adipocytes12in the subcutaneous adipose tissue46begin at a depth of approximately 4 mm or greater into the skin at the region18of the body14, and may be deeper for some individuals or some body regions. In addition, the cellular structure of the skin at the region18of the body14may vary due to differences in individual chemistries, hydration of the skin, and existence of collagen fibrils of varying densities, lengths, and thicknesses. Therefore, various power densities of the LED array15of the system10may be applied to achieve desired results according to the present invention. In an exemplary embodiment, the output power of the LED array15will be of a level such that the power density (W/cm2) of the radiation at the region18of the body14will be sufficient to cause the optical energy that penetrates the dermis44to be of greater energy density and/or greater power density at the depth of the adipose tissue46than it is at the surface of the epidermis42.

The LED array15and/or the controller20may be provided with a power limiter to limit the dosage of applied illumination to any particular patient, for example. The selective power density and/or selective energy density at the region18of the body14and distribution at the adipose tissue46under the skin that is maintained with less energy and power and without any significant thermal rise to the dermal layer44. The system10provides:

1) The selective power density and/or energy density at the adipose tissue46is greater than the power density and/or energy density at the epidermis layer42at the region18of the body14;

2) The region18of the body14is based on the area of illumination of the LED array15and makes use of the effects of Optical Energy Tissue distribution phenomena to effect a reduction in lipid content of adipocytes12in adipose tissue46while also stimulating positive biochemical and photochemical effects in the epidermis42and dermis44layers.

The system10may utilize LSAD techniques that illuminate the region18of the body14with the LED array15at predetermined power densities and time periods that thermodynamically lower enzymatic transition states of necessary enzymes in the adipocytes12, via the absorption of optical energy at a selected wavelength of about 635 nm in the lipid bilayer, and in the lipid pool, hence stimulating positive biochemical processes in these cells. The system10parameters, including the selective peak wavelength (such as 635 nm, for example), an output power of the LED array15(in watts), and the selective time period (in minutes) to achieve the desired outcome. Additionally, the system10parameters include modulation parameters, including whether the system10will use external or internal modulation, for example, and the selective frequency of the modulation signal. These parameters, combined with the area of the region18of the body14at the treatment surface being selected, may determine the selective power density at the region18of the body14(and at the adipose tissue46) to reduce the lipid content of the adipocytes12.

Biochemical processes modulated by the system10of the present invention include but are not limited to lipolysis, lipogenesis, leptin production, and glucose absorption or metabolism. This can result in the reduction of cellular levels of triglycerides as well as a reduction of blood triglycerides, as a side effect of lipolysis of the adipocytes, in addition to reduced levels of low density lipoprotein (LDL), for example.

According to the first law of photochemistry, the Grotthuss-Draper law, in order for a photochemical reaction to take place, light is absorbed by a compound. Thus, if light of a particular wavelength is not absorbed by a skin layer, no photochemistry will occur, nor photobiological effects, no matter how long one irradiates the skin layer with that non-absorbed wavelength of light. Once a given photobiological response is observed at an absorbed wavelength, the controller20determines the optimum dose of the absorbed wavelength of light needed to produce the desired photobiological response. Upon determining the optimum dose of each absorbed wavelength, the controller20determines the relative effectiveness of different absorbed wavelengths of light at different power densities/energy densities, in order to cause the desired biological response, such as reduction of lipid content in the adipocytes12, for example. Enhanced lipolysis is the result of photochemical and/or photophysical changes produced by the absorption of the selective peak wavelength (determined by the controller20) at proper power densities and/or energy densities.

This written description uses examples to disclose embodiments of the invention, including the best mode, and also to enable any person skilled in the art to make and use the embodiments of the invention. The patentable scope of the embodiments of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.