The present invention relates to light stimulation systems and methods for elevating testosterone levels in male patients.
Light stimulation therapy, also known as photobiomodulation (PBM), has been known for many years. As early as 1939, Dr. Myerson measured circulating testosterone in men and exposed their various body parts to UV light. After five days, testosterone levels increased by 120 percent when the light was focused on the patient's chest. Testosterone levels increased by 200% after eight days of light exposure to the patient's genitals, which reportedly was due to a boost in the production of the cells that produce testosterone (Leydig cells). Myerson, A. “Influence of ultraviolet radiation on excretion of sex hormones in the male.” Endocrinology 1939; 25:7-12.
In recent years, many researchers have investigated photobiomodulation therapies, including studies using red and near-infrared light wavelengths, such as: Wunsch, A. et al. “A Controlled Trial to Determine the Efficacy of Red and Near-Infrared Light Treatment in Patient Satisfaction, Reduction of Fine Lines, Wrinkles, Skin Roughness, and Intradermal Collagen Density Increase” Photomed Laser Surg. 2014 Feb. 1; 32(2): 93-100.
Red light wavelengths are reported to stimulate the creation of ATP (adenosine triphosphate), which is involved with energy production and also boosts the activity of the Leydig cells in the testes. Such an effect may occur since red light wavelengths penetrate deeper into the skin than other visible light colors. When skin cells absorb such red light wavelengths, cell growth can greatly accelerate, which can result in collagen and elastin generation at an accelerated rate. For this major reason, therapies with red light wavelengths are frequently used to treat eczema, acne, psoriasis, and other skin disorders.
In 2016 meeting of the European College of Neuropsychopharmacology, a researcher reported on the results of a pilot trial in which 38 men with low libido were placed into one of two groups: one received bright light therapy from a light box and the other was exposed to a light box that had less bright light. The light boxes were of the type used to treat Seasonal Affective Disorder (SAD), a form of depression that responds well to such a light therapy. After two weeks of daily exposure for 30 minutes, the authors found that the testosterone levels of men who were exposed to bright light increased by 300 percent, and their libido increased by the same percentage. Fagiolini, A. “Lack of interest in sex successfully treated by exposure to bright light” European College of Neuropsychopharmacology (ECNP); Sep. 18, 2016.
The present disclosure includes methods and devices for light stimulation to a region of the body. For example, such light stimulation can enhance testosterone levels in a patient when the stimulation is applied to the patient's testes.
A method under the present disclosure includes positioning a wearable structure carrying light emitters proximate to testes of a patient, where the wearable structure carrying light emitters emits at least one selected wavelength between 400 nm and 850 nm; actuating the light emitters in a duty cycle consisting of an ON/OFF sequence wherein the ON interval totals at least 5 minutes in at least a 30 minute period; and providing an irradiance in the range of 20 mW/cm2 to 200 mW/cm2 to the patient's testes where such irradiance enhances testosterone levels in the patient.
The present disclosure also includes light stimulation systems comprising a structure carrying at least one light emitter configured to emit at least one selected wavelength between 400 nm and 850 nm, wherein the at least one light emitter is adapted for carrying in a wearable garment configured to position the at least one light emitter proximate to testes of a patient; and a controller configured to activate the at least one light emitter to provide a selected irradiance in a duty cycle consisting of an ON/OFF sequence wherein the ON interval totals at least 5 minutes per hour over at least a 2 hour period.
The light stimulation described herein can include irradiance ranges from 50 mW/cm2 to 150 mW/cm2 or from 80 mW/cm2 to 120 mW/cm2.
Variations of the method and systems described herein can employ light emitters that comprise LEDs carried in a substrate. Alternatively, or in combination, other light sources can be used. In additional variations, the light emitters comprise side-emitting optical fibers carried in a fabric. For example, side-emitting optical fibers can be detachably coupled to at least one LED. Any combination of light emitting devices can be combined in a device under the present disclosure.
In variations of the device, the fabric can be separate from the wearable structure. Alternatively, the fabric can be integrated in the wearable structure.
The methods and devices described herein can include a controller to modulate operating parameters of the light emitters. For example, actuating the light emitters includes using the controller to control the irradiance in a duty cycle consisting of an ON/OFF sequence wherein the ON intervals total at least 5 minutes over at least a 30 minute period.
In another variation, the methods and/or devices can include an ON/OFF sequence having an ON interval ranging from 1 millisecond to 30 minutes and an OFF interval ranging from 1 millisecond to 10 minutes.
Additional variations include a temperature sensor coupled to the structure. The controller can modulate operating parameters of the light emitters in response to signals from a temperature sensor. Such operating parameters can include (i) at least one selected wavelength, (ii) irradiance, and (iii) duty cycle.
In an additional variation, the methods and systems can further include connecting the light emitters to a wearable module carrying a controller and a power source.
The systems and methods described herein can include light emitters comprising an array of 2 to 200 LEDs. The array can be carried by a flexible substrate.
The methods and systems can further include a cooling mechanism configured to be carried by the wearable garment and comprising at least one of a Peltier element, a flat flexible polymer heat pipe and a heat sink element. In additional variations, the systems and methods include a sensing mechanism configured to be carried by the wearable garment and selected from the group of pulse oximeters, impedance sensors and capacitance sensors.
In yet an additional variation, the light emitters are spaced apart from a perimeter of the device by at least 5 mm.
The present invention will be more fully appreciated and understood from the following detailed description of the present invention when viewed in conjunction with the accompanying figures.
The following detailed description describes currently contemplated modes of carrying out the invention. The description is not limiting but is made for the purpose of illustrating the general principles of the invention.
The testes are the body's main source of male hormones such as testosterone, and light stimulation is adapted to increase testosterone levels. Referring to
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In a variation, the controller 125 carried by the system 100 includes algorithms for modulating operating parameters of the system 100, where the parameters consist of (i) at least one selected wavelength, (ii) irradiance, and (iii) duty cycle. The device 105 can carry a plurality of LEDs wherein the various LEDs have different wavelengths or alternatively the device can carry a plurality of LEDs that provide varied different wavelengths. The controller 125 further can selectively modulate the selected wavelengths over a treatment interval to thus provide a polychromatic photobiomodulation therapy. The controller 125 can also modulate the irradiance over the time of a treatment interval, wherein the varied irradiance can be within the range described above, e.g., an irradiance range from 20 mW/cm2 to 200 mW/cm2. In a variation, the controller 125 also can modulate the duty cycle, wherein the ON/OFF sequence includes an ON interval ranging from 1 millisecond to 30 minutes and an OFF interval ranging from 1 millisecond to 10 minutes
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In general, a light stimulation method corresponding to the invention comprises (i) providing a wearable structure carrying light emitters that emit at least one selected wavelength between 400 nm and 850 nm, wherein the light emitters are positioned in the wearable structure to be proximate to testes of a patient, (ii) actuating the light emitters in a duty cycle consisting of an ON/OFF sequence wherein the ON interval totals at least 5 minutes per hour over at least a 2 hour period, and (iii) providing an irradiance in the range of mW/cm2 to 200 mW/cm2 to the patient's testes to thereby enhance testosterone levels in the patient. Often, the method provides an irradiance ranging from 50 mW/cm2 to 150 mW/cm2 or from 80 mW/cm2 to 120 mW/cm2
In another variation, the system allows for recording of a patient's treatment in terms of operating parameters. In a typical form of treatment, the system is adapted for personal use under a physician's care wherein the stored data then can be reviewed by the physician for patient compliance with the treatment program. Typically, a patient will wear the garment and light stimulation device for treatments period which may be from 1 weeks to 6 months. In some variations, the light stimulation may be used indefinitely as a maintenance therapy to maintain testosterone levels at a selected level. As described above, the system can include a module for uploading the treatment data to the cloud 245 which then can be reviewed by the physician for compliance.
In another variation, the light stimulation systems 100 and 200 of
Referring to
In another variation, a light emitting device 105 or 205 as shown in
In another variation, the wearable device 105 or 205 of
Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
This application is a continuation of U.S. patent application Ser. No. 17/811,387, filed Jul. 8, 2022, which is a continuation of U.S. patent application Ser. No. 17/446,703, filed Sep. 1, 2021, now abandoned, which is a continuation of U.S. patent application Ser. No. 16/863,664, filed Apr. 30, 2020, now U.S. Pat. No. 11,110,295, the content of each of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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Parent | 17811387 | Jul 2022 | US |
Child | 18303913 | US | |
Parent | 17446703 | Sep 2021 | US |
Child | 17811387 | US | |
Parent | 16863664 | Apr 2020 | US |
Child | 17446703 | US |