WO2022246108A1

WO2022246108A1 - Health photobiomodulation device

Info

Publication number: WO2022246108A1
Application number: PCT/US2022/030103
Authority: WO
Inventors: Nicholas DETERS; Sergio ALEMAN
Original assignee: Goldwave Biotechnology
Priority date: 2021-05-19
Filing date: 2022-05-19
Publication date: 2022-11-24

Abstract

A health photobiomodulation device includes a light source and an interface configured to be associated with a body part (e.g., human breast(s)). The device has an ergonomic design which allows for self-administration and a means for calibration, thereby allowing a user to apply a specific and repeatable dosage of light to the surface of the body part being treated.

Description

HEALTH PHOTOBIOMODULATION DEVICE

[0001] This application claims priority to Provisional Application Serial No. 63/201 ,928, filed on May 19, 2021 , the entirety of which is hereby incorporated by reference.

BACKGROUND

[0002] The present disclosure relates to a health photobiomodulation device including a light source, an interface for association with a human body part (e.g., breast(s)), an ergonomic design which allows for self-administration and a means for calibration, allowing the user to apply a specific and repeatable dosage of light to the surface of the skin (e.g., nipple). It finds particular application in conjunction with maternal health and will be described with particular reference thereto. However, it is to be appreciated that the present disclosure is also amenable to other like applications.

[0003] Postpartum mothers often choose to breastfeed their baby, as there are a multitude of benefits to both the child and the mother. For the baby, breastfeeding lowers the risk of allergies, asthma, certain childhood cancers, type I and II diabetes, speech problems, orthodontic problems, among others. For the mother, breastfeeding lowers the risk of postpartum bleeding, urinary tract infections and anemia, among other things. Additionally, for the mother, breastfeeding promotes faster weight loss after birth, as the body must burn additional calories to produce and maintain milk supply.

[0004] When breastfeeding, if the baby is latching properly, the entire nipple should be deep inside the mouth. However, if not latched properly, or the baby is unable to take a deep enough mouthful of breast, the nipple often is compressed by the gums as they attempt to extract milk. This shallow attachment may cause the mother to suffer nipple trauma.

[0005] Nipple trauma is characterized by rupture of the skin that covers the nipple, with fissures, cracks and abrasion being the most common injuries. This is typically accompanied by local pain. Nipple trauma can also be caused by infection or vasospasm. [0006] Typically, mothers experience issues with nipple pain and damage within the first six weeks after childbirth. Up to 80% of mothers experience some type of nipple related pain due to breastfeeding within this timeframe. Nearly 60% report nipple damage or trauma. Other events, such as teething, may also cause these issues.

[0007] Unfortunately for mothers, the pain associated with nipple trauma often results in depression, stress, sleep disturbances and mastitis. Many mothers choose to cease breastfeeding due to these symptoms, a decision that also presents negative consequences for the baby.

[0008] There are currently no effective treatments or preventative options on the market today for nipple trauma injuries. Accordingly, there exists a need for a photobiomodulation device which overcomes the above-mentioned difficulties and others, while providing better overall results.

BRIEF DESCRIPTION

[0009] The present disclosure relates to a method for self-administering, calibrating, and delivering a specific and repeatable dosage of light to the surface of skin (e.g., a nipple).

[0010] In some embodiments, the systems and methods of the present disclosure are configured for treatment of the surfaces of both nipples simultaneously.

[0011] The systems and methods utilize a power source, which may be a DC power source (e.g., one or more batteries) or an AC power source. The power source provides power to a light source (e.g., a light-emitting diode).

[0012] The methods of the present disclosure may include calibrating the amount of light energy being exposed to the surface of the nipple over a period of time (i.e., the dosage).

[0013] The methods may also include communicating to the user the status and/or completion of a treatment.

[0014] The device may be fixed and secured, requiring the user to position the breast(s) and nipple against the device. Alternatively, the device may be mobile, or handheld, allowing the user to position it against the breast and nipple.

[0015] The device is capable of being operated by the user or “self-administered.” [0016] According to one aspect of the present disclosure, a method for calibrating the dosage of light to the surface of the nipple may include controlling the distance between the light source and nipple surface through use of mechanical adjustment. Reflectors and/or lensing may be used to appropriately direct the light to the desired location on and around the nipple.

[0017] Additionally, this device may offer thermal healing and pain relief benefits to the user due to proximity of the light source (e.g., LED) to the treatment surface.

[0018] Disclosed, in some embodiments, is a health photobiomodulation device including a cup configured to interface with a human breast; a light source configured to provide light through an opening in the cup to a nipple of the human breast; and a power source configured to provide power to the light source.

[0019] The device may further include a lens within the cup.

[0020] In some embodiments, the light source is a light-emitting diode (LED).

[0021] The light source may configured to emit light at a wavelength in a range of about 630 nm to about 660 nm.

[0022] In some embodiments, the power source includes a power cord or a receptacle for receiving at least one battery.

[0023] The cup may include at least one transparent or translucent portion (i.e., a viewing window).

[0024] In some embodiments, the device further includes a translating or removable light-shielding cover, and the device is configured to prevent the light source from being turned on when the light-shielding cover is not in place.

[0025] The device may further include a temperature sensor configured to measure a temperature of the nipple; and a controller configured to decrease a power of the light source when the temperature exceeds a predetermined threshold value.

[0026] In some embodiments, the device further includes at least one status indicator selected from the group consisting of an indicator light, a speaker, and a vibrator.

[0027] A distance between the light source and the nipple may be adjustable while the cup is coupled to the human breast.

[0028] In some embodiments, the device further includes a user input configured to a user to control light intensity from the light source and/or to control suction of the cup. [0029] The device may further include a handle. [0030] In some embodiments, the device includes an adhesive surface configured to secure the cup to the human breast.

[0031] Bras and breast pumps containing the health photobiomodulation device are also disclosed.

[0032] Disclosed, in other embodiments, is a health photobiomodulation device includeing: a first cup configured to interface with a first human breast; a second cup configured to interface with a second human breast; a first light source configured to provide light to at least one of a first nipple of the first human breast and a second nipple of the second human breast; and a power source configured to provide power to the light source.

[0033] In some embodiments, the device further includes a second light source; wherein the first light source is configured to provide light to the first nipple; and wherein the second light source is configured to provide light to the second nipple.

[0034] The device may include a stand having an adjustable height and configured to enable a user to use the device without hands.

[0035] Disclosed, in further embodiments, is a health photobiomodulation device including: a cup configured to interface with a human breast, the cup comprising a transparent or translucent window for viewing a nipple of the human breast; a lens within the cup; a graspable handle attached to the cup; and a light-emitting diode (LED) configured to provide light through the lens to the nipple.

[0036] The device may further include a user input on the handle; a receptacle within the handle for receiving at least one battery; and a controller within the handle configured to control an intensity of light at the nipple.

[0037] Still other aspects of the disclosure will become apparent upon a reading and understanding of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS [0038] The following is a brief description of the drawings, which are presented for the purposes of illustrating the exemplary embodiments disclosed herein and not for the purposes of limiting the same. Various features of the drawings discussed below are not necessarily drawn to scale. Dimensions of various features and elements in the drawings may be sized differently to illustrate more clearly various embodiments.

[0039] FIG. 1 is a perspective view of a nipple treatment device in accordance with some embodiments of the present disclosure.

[0040] FIG. 2 is a perspective view of another nipple treatment device including a user interface in accordance with some embodiments of the present disclosure.

[0041] FIG. 3 is a side view of a further nipple treatment device shaped for grasping between fingers in accordance with some embodiments of the present disclosure.

[0042] FIG. 4 is a side view of another nipple treatment device with a button for activating the device and/or creating suction in accordance with some embodiments of the present disclosure.

[0043] FIG. 5 is a perspective view of another nipple treatment device in a hand, the device being configured to click to communicate the device is latched and turned on in accordance with some embodiments of the present disclosure.

[0044] FIG. 6 is a perspective view of a nipple treatment device applied to a breast, the device including a trigger clamp for creating a vacuum in accordance with some embodiments of the present disclosure.

[0045] FIG. 7 is a side view of a nipple treatment device applied to a breast, the device being configured to generate suction when a suction area is pressed in accordance with some embodiments of the present disclosure.

[0046] FIG. 8 is a bottom perspective view of a nipple treatment device with an adhesive pad in accordance with some embodiments of the present disclosure.

[0047] FIG. 9 includes perspective and bottom views of a nipple treatment device with four adhesive tabs in accordance with some embodiments of the present disclosure. [0048] FIG. 10 includes multiple views of a nipple treatment device nested inside a bra in accordance with some embodiments of the present disclosure.

[0049] FIG. 11 is a perspective view of a nipple treatment device nested inside a bra, highlighting the connection between the device and bra in accordance with some embodiments of the present disclosure.

[0050] FIG. 12 includes multiple views of a nipple treatment device nested inside a bra in accordance with some embodiments of the present disclosure. [0051] FIG. 13 includes multiple views of a nipple treatment device with a rotatable element for adjusting the distance between the light source and the nipple in accordance with some embodiments of the present disclosure.

[0052] FIG. 14 is a perspective view of a nipple treatment device with a lever for securing the device in accordance with some embodiments of the present disclosure. [0053] FIG. 15 is a perspective view of a nipple treatment device with a push and pull lever adjustment for altering the distance from the nipple to the light source in accordance with some embodiments of the present disclosure.

[0054] FIG. 16 illustrates a nipple treatment device capable of treating both nipples simultaneously and including a support in accordance with some embodiments of the present disclosure.

[0055] FIG. 17 is a rear view of a nipple treatment device capable of treating both nipples simultaneously with a central storage portion in accordance with some embodiments of the present disclosure.

[0056] FIG. 18 is a front view of a nipple treatment device capable of treating both nipples simultaneously and focused on the treatment compartments in accordance with some embodiments of the present disclosure.

[0057] FIG. 19 is a front perspective view of a nipple treatment device capable of treating both nipples simultaneously and suitable for application to a woman’s waist in accordance with some embodiments of the present disclosure.

[0058] FIG. 20 is a rear perspective view of a nipple treatment device capable of treating both nipples simultaneously with a removable cover in accordance with some embodiments of the present disclosure.

[0059] FIG. 21 is a front perspective view of a handheld nipple treatment device capable of treating both nipples simultaneously in accordance with some embodiments of the present disclosure.

[0060] FIG. 22 is a top view of a nipple treatment device capable of treating both nipples simultaneously and having a thin connector bar in accordance with some embodiments of the present disclosure. [0061] FIG. 23 is a front perspective view of a nipple treatment device capable of treating both nipples simultaneously and having an adjustable bar in accordance with some embodiments of the present disclosure.

[0062] FIG. 24 illustrates multiple views of a portion of a nipple treatment device wherein the nipple treatment elements may be removed from a connecting bar for single action use or a distance therebetween may be adjusted in accordance with some embodiments of the present disclosure.

[0063] FIG. 25 is a perspective view of a nipple treatment device with a bent/curved display support such that a screen faces a user in accordance with some embodiments of the present disclosure.

[0064] FIG. 26 is a side view of the device of FIG. 25.

[0065] FIG. 27 includes multiple views of a nipple treatment device including a charging unit in accordance with some embodiments of the present disclosure.

[0066] FIG. 28 includes multiple views of a nipple treatment device wherein the light source housing is hingedly connected to the cup in accordance with some embodiments of the present disclosure.

[0067] FIG. 29 is a perspective view of a nipple treatment device with a digital notification element in accordance with some embodiments of the present disclosure. [0068] FIG. 30 is a perspective view of a nipple treatment device with a wand handle in accordance with some embodiments of the present disclosure.

[0069] FIG. 31 illustrates a handheld device integrated into a breast pump in accordance with some embodiments of the present disclosure.

[0070] FIG. 32 illustrates a handheld device that takes the place of a standard breast pump “cup” in accordance with some embodiments of the present disclosure.

[0071] FIG. 33 is a perspective view of another nipple treatment device in accordance with some embodiments of the present disclosure.

[0072] FIG. 34 is a side cross-sectional view of the device of FIG. 33.

DETAILED DESCRIPTION

[0073] The present disclosure may be understood more readily by reference to the following detailed description of desired embodiments included therein. In the following specification and the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings.

[0074] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent can be used in practice or testing of the present disclosure. The materials, methods, and articles disclosed herein are illustrative only and not intended to be limiting.

[0075] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0076] As used in the specification and in the claims, the term “comprising” may include the embodiments “consisting of and “consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases that require the presence of the named ingredients/steps and permit the presence of other ingredients/steps. However, such description should be construed as also describing compositions, mixtures, or processes as “consisting of and “consisting essentially of the enumerated ingredients/steps, which allows the presence of only the named ingredients/steps, along with any impurities that might result therefrom, and excludes other ingredients/steps. [0077] In the drawings, it should be understood that various elements are not labeled or not shown in certain drawings but may still be part of the depicted device. For example, light and power sources are omitted or unlabeled in various drawings. Additionally, it should be understood that various aspects of different drawings may be combined. It should further be understood that the light source may be housed in the handle, a separate housing, the cup, or some combination thereof. The handle, housing, etc. may also be omitted in some embodiments.

[0078] As used herein, an object “interfacing” with a body part is in direct physical contact with the body part or in close proximity (up to one inch away) thereto.

[0079] As used herein, the term “cup” may refer to a bell- or cup-shaped object configured to interface with a human breast. However, “cup” is not limited to these particular shapes and encompasses any shape that conforms to the human breast. [0080] Although some aspects of the disclosure refer to the nipple, it should be understood that the devices and methods of the present disclosure are also applicable to breast tissue more generally. Thus, it should be understood that these references to the nipple may alternatively refer to the nipple area (including the nipple and the immediately surrounding area - within one inch of the nipple) or breast tissue more generally. The breast tissue may also include internal anatomies of the breast, such as lobes, milk ducts, and blood/or vessels.

[0081] As used herein, a “light guide” is a device used to direct light from a light source to a target area.

[0082] The present disclosure relates to systems and methods for curing and/or preventing nipple trauma caused by nipple trauma in postpartum mothers. Additionally, the systems and methods can reduce pain cause by nipple trauma. One feature of this device is its ability to be self-administered by the patient, rather than by a professional. This gives the patient the ability to administer treatments more easily in a home setting, rather than frequently traveling to an office. To achieve this, the design may include one or more of the following:

• An ergonomic design with a treatment interface that matches the geometry of the female breast and nipple. This interface design will have adequate surface area contact around the perimeter, but no contact in the “centered” treatment area in order to provide comfort to the patient. The positioning interface will mimic the inside shape created by the hand when raised and palms facing inward towards the breast, allowing the user to comfortably hold the device against the breast for the purposes of selfadministration.

• A “wireless” design. More specifically, the device may not require a stand-alone power supply or light source, but instead, may use a battery and LED embedded within the envelope of the handheld device. These features will increase mobility and ease of use.

• The ability to communicate data and status of treatment to the user. Examples include “treatment in progress,” “time left in treatment (seconds)” and “treatment is complete”. This may be accomplished using audio feedback through an integrated speaker or unique vibrations that indicate various updates. Using non-visual methods for delivering updates will allow the user to keep her head in a more comfortable position for the duration of the treatment, rather than being required to look directly and the device.

[0083] An additional feature of this device is its ability to be calibrated by the user. This allows the device to deliver a specific and controlled dosage of light to the surface of the nipple. Using a single LED and reflector assembly, light will be focused and normal to the treatment area surface. Because nipple length varies by patient, the device must be calibrated by the user, so the appropriate dosage of light is achieved. This may be accomplished in one or more of the following ways:

• A mechanical means to adjust the distance between the light-emitting diode and nipple surface. The portion of the device that surrounds the nipple will have a transparent section that allows the user to see the “tip” of the nipple along with an indicator, such as etch marks or colored “zones,” which determines the type of adjustment to be made. Using a rotary component located and the base of the LED, turning clockwise will extend the LED forward, decreasing the distance between the LED and treatment area. Turning counterclockwise, the LED will retract, increasing the distance between the LED and treatment area.

• Adjusting intensity of the LED. The portion of the device that surrounds the nipple will have a transparent section that allows the user to see the “tip” of the nipple along with an indicator, such as etch marks or colored “zones,” which determines the type of adjustment to be made. Based on which etch mark or “zone” the tip of the nipple aligns with, a corresponding input, such as a physical button or dial, will be selected, which controls the current supplied to the LED, thus controlling its intensity.

• Adjusting the time duration of the treatment. The portion of the device that surrounds the nipple will have a transparent section that allows the user to see the “tip” of the nipple along with an indicator, such as etch marks or colored “zones,” which determines the type of adjustment to be made. Based on which etch mark or “zone” the tip of the nipple aligns with, a corresponding input, such as a physical button or dial, will be selected, which controls the timer of the controller, thus adding or subtracting time from treatment. [0084] An additional feature of this device includes the thermal benefits of the LED in close proximity to the treatment surface. This thermal therapy is in combination to the benefits of photobiomodulation.

[0085] An additional feature of this device includes its ability to be integrated into existing marketed breast pump technology. The breast pump may be the power source and user communication interface for the device. The optics of the device may also be built in the “cup” interface between the breast and pump, giving the patient the ability to self-administer treatment simultaneously while pumping breast milk.

[0086] Also disclosed are methods for mitigating risks associated with use of the device in close proximity to the body.

[0087] A method for protecting the human eye from being exposed to light emitted from the LED is also disclosed. In order to mitigate this risk, the design includes shielding which blocks the light from the user. This is accomplished by using a removable or translating cover, allowing the user to view the placement of the nipple inside the device for purposes of calibration, but still requiring the shielding component to be in place prior to treatment. The electronics of the device will not function until this shielding device is secured.

[0088] A method for preventing thermal injury to the surface of the skin is also disclosed. In order to mitigate this risk, the design includes the ability to measure the temperature at the surface of the treatment area. The electronic controls of the device will monitor this value and remove power from the LED in the event that temperature values rise above an established setpoint.

[0089] The light source may be configured to emit light at a particular wavelength or within a wavelength range. In some embodiments, the wavelength is adjustable. The light may be red light. In some embodiments, the wavelength is in the range of about 500 nm to about 999 nm, including from about 620 nm to about 750 nm and about 630 nm to about 660 nm. Other specific wavelengths or endpoints for ranges may include 510 nm, 520 nm, 530 nm, 540 nm, 550 nm, 560 nm, 570 nm, 580 nm, 590 nm, 600 nm, 610 nm,

640 nm, 650 nm, 670 nm, 680 nm, 690 nm, 700 nm, 710 nm, 720 nm, 730 nm, 740 nm,

760 nm, 770 nm, 780 nm, 790 nm, 800 nm, 810 nm, 820 nm, 830 nm, 840 nm, 850 nm,

860 nm, 870 nm, 880 nm, 890 nm, 900 nm, 910 nm, 920 nm, 930 nm, 940 nm, 950 nm, 960 nm, 970 nm, 980 nm, and 990 nm. All range combinations including any two of the specific wavelengths or endpoint values for ranges are contemplated herein.

[0090] FIGS. 1-15 and 28-30 depict various embodiments of a handheld device that interfaces with the breast using a conical or “bell” shaped design which may be referred to hereinafter as a “cup.” This cup may mimic the cup of a standard breast pump. In some embodiments, the cup comprises silicone. The cup may be entirely transparent or translucent or a portion thereof may be transparent or translucent. The light source (e.g., light-emitting diode or LED) may be centered on the device and facing the nipple, using a reflector or lens to project light onto the surface of the nipple. Data and status of a treatment may be communicated to the user through the use of audio or vibrations. Embodiments include both single and dual nipple treatment options. Although various depicted embodiments utilize a single LED or other light source, it should be understood that a plurality of such elements could be included.

[0091] In FIG. 1, the device 100 includes a cup 110 and a handle 120 with ribs 121 and a textured grip 122 for improved gripping.

[0092] FIG. 2 illustrates a device 200 that allows the user to view a screen 230 to communicate data, status and/or completion of a treatment. Although the depicted screen 230 is attached to the handle 220, it is also possible to attach the screen 230 to the cup 210 or a different element.

[0093] The device 300 of FIG. 3 allows for a distinctive grip between fingers. The grip position 311 is located between the cup 310 and handle 320.

[0094] FIGS. 4-7 illustrate embodiments which utilize suction to assist in holding the device in place on the breast. In FIG. 4, the device 400 includes a button 412 attached to the cup 410 and may generate suction against the chest area when pressed. The button 412 may generate suction and turn on the light source.

[0095] In FIG. 5, the device 500 is configured to click to communicate to a user that the device is latched and turned on. The sound may be generated from a mechanical “latching” wherein there is spring resistance until a “hook” component catches on a fixed ledge. The device may include an outer complete cup and an inner, topless cup.

[0096] In FIG. 6, the device 600 includes a curved handle 620 secured to the cup 610. The handle 620 includes a trigger 622 for removing air and creating a vacuum. [0097] In FIG. 7, the device 700 includes a suction area 712 adjacent to the cup 710 which may be pressed to provide suction. Alternatively, this may be provided on the handle 720.

[0098] FIGS. 8 and 9 illustrate embodiments which utilize an adhesive composition to assist in holding the device in place on the breast. In FIG. 8, the device 800 includes an adhesive pad 814 extending around at least a portion of the cup 810 which is secured to the handle 820.

[0099] In FIG. 9, the device 900 includes four adhesive areas 914 located around the cup. However, it is also contemplated that other numbers of adhesive areas may be utilized (e.g., 1 , 2, 3, 5, 6, 7, 8, 9, 10, or more).

[00100] FIGS. 10-12 illustrate embodiments in which the device integrates with a bra to assist in holding the device in place on the breast. In the device 1000 of FIG. 10, the light source (e.g., LED) 1040 screws in or is otherwise secured to the bra and the bra helps the cup (e.g., silicone attachment) 1010 remain in place.

[00101] In the device 1100 of FIG. 11 , a locking mechanism 1150 (which may lock with a 90-degree twist) releasably secures the cup 1110 to the bra.

[00102] In the device 1200 of FIG. 12, the device may be slid into the bra. The device may contain silicone.

[00103] FIGS. 13-15 illustrate devices in which the distance between the LED and a nipple surface can be adjusted, and thus calibrated, by the user. In the device 1300 of FIG. 13, a rotatable stopper 1365 between power source 1360 and cup 1310 is configured to spin to adjust the LED distance from the nipple.

[00104] In the device 1400 of FIG. 14, a lever 1421 secured to the handle 1420 controls how far the LED penetrates into the cup 1410 and thus the treatment distance. The device includes an LED and a cylindrical body with ridges. A housing includes bell cover and a sleeve with a lever. When the lever is pushed down, it locks between ridges on the cylindrical body.

[00105] In the device 1500 of FIG. 15, a push/pull lever attached to the handle 1520 adjusts the distance the light source 1540 extends into the cup 1510 and thus the treatment distance. [00106] FIGS. 16-20 depict devices in which the user can bring and position the breast and nipple into conical or “bell”-shaped cups. The devices may permit treatment of both nipples simultaneously. Each cup may be associated with its own light source or plurality of light sources. Alternatively, the cups may be associated with a common light source or plurality of light sources. Additionally, each cup may be associated with its own power source or both cups may be associated with a common power source. In FIG. 16, the device 1600 includes two cups 1610 interfacing with a housing 1680 which may be releasably or permanently affixed to a support structure 1670. The height of the housing 1680 may be adjusted via a setting on the support structure 1670. The support structure may be placed or otherwise secured to a table, a desk, etc.

[00107] In FIG. 17, a device 1700 is illustrated which includes a middle section for providing storage. For example, cleaning supplies may be stored in the middle section. [00108] The device 1800 of FIG. 18 includes two cups 1810 and the interface for the user is clearly shown.

[00109] The device 1900 of FIG. 19 is configured to conform to a user’s waist and/or thighs.

[00110] In the device 2000 of FIG. 20, the front cover 2090 (i.e., the portion that contacts the user) can be slid out or otherwise removed and easily cleaned and/or replaced. [00111] FIGS. 21-23 illustrate additional devices which allow the device to treat both nipples simultaneously. In the device 2100 of FIG. 21, the power source 2160 extends to an easily greppable handle 2120, each cup 2210 being associated with a light source 2240 powered by a power source 2260.

[00112] In the device 2300 of FIG. 23, the handle 2320 to which the cups 2310 are secured includes a mechanism 2325 for adjusting a distance therebetween.

[00113] In the device 2400 of FIG. 24, the treatment element including cup 2410 and light source 2440 can be moved along or removed from bar 2420 via adjustment (e.g., knob) 2426. Removal allows the device to be converted into a mobile or handheld unit. [00114] The device 2500 of FIGS. 25 and 26 is bent such that screen 2530 faces a user in the same direction as the cup 2510. The light source 2540 and the power source (e.g., wire or cord) 2560 are also visible. [00115] FIG. 27 illustrates a device 2600 with a charging unit 2695. In addition to charging a battery, the charging unit separates the treatment surface of the device 2600 from the surface it is placed on.

[00116] FIG. 28 illustrates a device 2700 wherein the handle 2740 is hinged relative to the cup 2710, thereby allowing space to be saved in a storage configuration.

[00117] FIG. 29 illustrates a device 2800 wherein the handle 2820 includes notification features (e.g., indicator lights 2826 and a temperature gauge 2827). These features may inform a user when the treatment operation is completed and/or if the baby is starting to get a fever. The cup 2810 and light source 2840 are also visible.

[00118] FIG. 30 illustrates a device 2900 wherein the cup 2910 is attached to a wand handle 2920.

[00119] FIG. 31 illustrates an embodiment of a handheld device 3001 which is integrated into a breast pump 3001. The device 3000 interfaces with the breast using a conical or “bell” shaped design. The light emitting diode (LED) is centered on the device and facing the nipple, using a reflector or lens to project light onto the surface of the nipple. The device is connected to the breast pump using a cable which also functions as the power source 3002. The breast pump also communicates data and treatment updates to the user. Alternatively, the device may be battery powered and connected to the breast pump through wireless means. A standard breast pump interface/bottle apparatus 3003 is also depicted. The device 3000 and apparatus 3003 may be connected to the power source 3002 at the same time in some embodiments. In other embodiments, the device 3000 and apparatus 3003 are configured such that only one is plugged into the power source 3002 at a time. It may be possible to apply the apparatus 3003 to one breast and the device 3000 to the other breast for simultaneous operation in some embodiments.

[00120] FIG. 32 illustrates an embodiment of a handheld device 3100 that takes the place of a standard breast pump “cup”. The device integrates lenses 3104 into the breast pump “cup” 3110, allowing light to enter from the side and re-direct towards the surface of the nipple. Light emitting diodes (LEDs) 3140 are mounted into an apparatus that attaches to the outside of the breast pump “cup.” This apparatus is detachable, allowing the “cup” and all other breast pump components to be sanitized. This apparatus may either be battery powered or powered by the breast pump using a cable. Data and status of treatment is communicated to the user through the use of audio or vibrations from the device, or wirelessly, through the breast pump interface. Dosage is controlled, or calibrated, by allowing the user to choose an appropriately sized cup, which will place the nipple surface in the desired location.

[00121] FIGS. 33 and 34 depict an embodiment of a handheld device 3200 that interfaces with the breast using a conical or “bell” shaped design 3210, mimicking that of a standard breast pump. The light emitting diode (LED) 3240 is centered on the device and facing the nipple, using a lens 3204 to project light onto the surface of the nipple. The distance between LED 3240, lens and beast interface allow minimum light dosage when nipple surface (treatment surface) is at breast interface and maximum light dosage when nipple surface is at the lens. These fixed mechanical geometries ensure acceptable range of dosage is always received, regardless of user anatomical variations. Data and status of a treatment may be communicated to the user through the use of audio or vibrations. The planes which receive minimum (at the breast interface) and maximum (at the lens) light dosages are shown in FIG. 34. Various components (e.g., battery, controller, etc.) ,ay be stored in the handle 3220.

[00122] This embodiment depicts a handheld device that interfaces with the breast using a “cup” design, mimicking that of a standard breast pump. The light emitting diode (LED) is centered on the device and facing the breast, using a lens to project light onto the breast tissue. Fixed mechanical geometries ensure acceptable range of dosage is always received, regardless of user anatomical variations.

[00123] Dosage values (measured in irradiance at surface of breast tissue):

• Minimum light dosage limit: 20 mW/cm²

• Maximum light dosage limit: 150 mW/cm²

[00124] Various aspects described above may be combined with aspects of one or more of US 2015/0112411 A1 to Beckman et al., US 2018/0289874 A1 to Wang, WO 2009/121158 A2 to Rodrigues de Araujo et al., and PI0905068-0 A2 to Texeira et al. These documents are incorporated by reference herein in their entireties.

[00125] The subject matter of the present disclosure has been described with reference to the preferred embodiments. Obviously, modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

CLAIMS:

1. A health photobiomodulation device comprising: a cup configured to interface with a human breast; a light source configured to provide light to breast tissue of the human breast; and a power source configured to provide power to the light source.

2. The health photobiomodulation device of claim 1 , further comprising: at least one of a lens, a light guide, or a reflector within the cup.

3. The health photobimodulation device of claim 1 , wherein the light source comprises a light-emitting diode (LED) or a laser.

4. The health photobiomodulation device of claim 1 , wherein the light source is configured to emit light at a wavelength in a range of about 600 nm to about 800 nm.

5. The health photobiomodulation device of claim 1 , wherein the power source comprises a power cord or a receptacle for receiving at least one battery.

6. The health photobiomodulation device of claim 1, wherein the cup comprises at least one transparent or translucent portion.

7. The health photobiomodulation device of claim 6, further comprising a translating or removable light-shielding cover, wherein the device is configured to prevent the light source from being turned on when the light-shielding cover is not in place.

8. The health photobiomodulation device of claim 1 , further comprising: a temperature sensor configured to measure a temperature of the breast tissue; and a controller configured to decrease a power of the light source when the temperature exceeds a predetermined threshold value.

9. The health photobiomodulation device of claim 1 , further comprising: at least one status indicator selected from the group consisting of an indicator light, a speaker, and a vibrator.

10. The health photobiomodulation device of claim 1, wherein a distance between the light source and the breast tissue is adjustable while the cup is coupled to the human breast.

11. The health photobiomodulation device of claim 1 , further comprising a user input configured to allow a user to control light intensity from the light source, to control treatment time, and/or to control suction of the cup.

12. The health photobiomodulation device of claim 1, further comprising a handle allowing for self-administration.

13. The health photobiomodulation device of claim 1, comprising an adhesive configured to secure the cup to the human breast.

14. A bra comprising the health photobiomodulation device of claim 1.

15. A breast pump comprising: a breastmilk receiving cup; a vacuum pump connected to the breastmilk receiving cup; and the health photobiomodulation device of claim 1, the health photobiomodulation device further comprising: a handle; and at least one of a lens, a light guide, or a reflector.

16. A health photobiomodulation device comprising: a first cup configured to interface with a first human breast; a second cup configured to interface with a second human breast; a first light source configured to provide light to at least one of a first nipple area of the first human breast and a second nipple area of the second human breast; and a power source configured to provide power to the light source.

17. The health photobiomodulation device of claim 16, further comprising: a second light source; wherein the first light source is configured to provide light to the first nipple area; and wherein the second light source is configured to provide light to the second nipple area.

18. The health photobiomodulation device of claim 16, a stand having an adjustable height and configured to enable a user to use the device without hands.

19. A health photobiomodulation device comprising: a cup configured to interface with a human breast, the cup comprising a transparent or translucent window for viewing breast tissue of the human breast; a lens, a light guide, or a reflector within the cup; a graspable handle attached to the cup; and a light-emitting diode (LED) configured to provide light through the lens to the breast tissue.

20. The health photobiomodulation device of claim 19, further comprising: a user input on the handle; a receptacle within the handle for receiving at least one battery; and a controller within the handle configured to control an intensity of light at the breast tissue.