Phototherapy device for the treatment of dermatological disorders of the scalp - Patent Application 20070122997

Abstract

A phototherapy device for treating dermatological disorders of the scalp is provided. An exemplary device includes a flexible printed circuit board (FPCB) supporting at least one light-emitting device having an emitter height. The FPCB includes a plurality of interconnected panels and a flexion region defined within and between at least some of the interconnected panels, allowing the FPCB to be configured in a concave shape to cover at least a portion of the patient's scalp. At least one optically transmissive layer near the FPCB is configured to transmit (e.g., be incoherent with) the optical radiation generated by the at least one light-emitting device. At least one standoff is configured to be disposed between the FPCB and the patient's scalp, the at least one standoff including a standoff height greater than the emitter height.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE

[0001] This disclosure relates to devices and methods for the phototherapeutic treatment of localized dermatological disorders of the scalp, such as androgenetic alopecia, acne, psoriasis, dermatitis, and other conditions. [Background technology]

[0002] Androgenetic alopecia is a common form of hair loss in both men and women. In men, this condition is also known as "male pattern baldness" or male pattern baldness. This form of hair loss affects an estimated 60 million men in the United States alone. While the risk factors contributing to this condition are still being studied, researchers have determined that androgenetic alopecia is related to hormones called androgens, and in particular, an androgen called dihydrotestosterone. Increased levels of androgens in hair follicles can lead to shorter hair growth cycles and the growth of shorter, thinner hair. Most men consider baldness an undesirable and distressing experience. While baldness due to androgenetic alopecia is less common in women than in men, the psychological impact of hair loss tends to be much greater for women. Although androgenetic alopecia is not the primary cause of hair loss in most women, female hair loss is reported to affect approximately 20 million women in the United States.

[0003]

[0003] Early hair loss can be delayed or ameliorated with medication. FDA-approved medications include minoxidil and finasteride. Other treatment options include tretinoin in combination with minoxidil, ketoconazole shampoo, and spironolactone. Advanced cases of hair loss may be resistant to or may not respond to medication. Many patients choose to undergo surgical hair transplantation.

[0004]

[0004] Various phototherapy devices have been developed to address androgenetic alopecia. The term "phototherapy" refers to the therapeutic use of light. Not necessarily intended to treat hair loss, various phototherapies (including, for example, low-level light therapy (LLLT) and photodynamic therapy (PDT)) have been publicly reported or claimed to provide various health-related medical benefits, including, but not limited to, treating skin or tissue inflammation, promoting tissue or skin healing or rejuvenation, enhancing wound healing, pain management, reducing wrinkles, scars, stretch marks, varicose veins, and spider veins, elevating mood, treating bacterial infections, treating hyperbilirubinemia, and treating various tumor and non-tumor diseases or disorders.

[0005]

[0005] Various mechanisms by which phototherapy has been suggested to provide therapeutic benefits include increasing circulation (e.g., by increasing the formation of new capillaries), stimulating collagen production, stimulating adenosine triphosphate (ATP) release, enhancing porphyrin production, reducing nervous system tissue excitability, stimulating fibroblast activity, increasing phagocytosis, inducing a thermal effect, stimulating tissue granulation and connective tissue protrusion, reducing inflammation, and stimulating acetylcholine release. Phototherapy has also been suggested to stimulate cells to produce nitric oxide. Various biological functions attributed to nitric oxide include its role as a signaling messenger, cytotoxin, antiapoptotic agent, antioxidant, and regulator of microcirculation. Nitric oxide is recognized to relax vascular smooth muscle, dilate blood vessels, inhibit platelet aggregation, and modulate T cell-mediated immune responses. Nitric oxide is produced by multiple cell types in the skin and is formed by the conversion of the amino acid L-arginine to L-citrulline and nitric oxide, mediated by the enzymatic action of nitric oxide synthase (NOS).

[0006]

[0006] One example of a commercially available phototherapy device aimed at addressing hair loss is the iGrow® Laser Hair Rejuvenation System (Apira Science, Boca Raton, Florida, USA), which embodies a rigid helmet (resembling a bicycle helmet in appearance) that utilizes a combination of red laser diodes and light-emitting diodes operating at 655 nm ± 5 nm. Another example of a commercially available phototherapy device aimed at addressing hair loss is the Theradome™ LH80 Pro Helmet (resembling a bicycle helmet in appearance) that utilizes 80 lasers with a peak wavelength of 678 nm (Theradome, Inc., Pleasanton, California, USA). Yet another example of a commercially available phototherapy device aimed at addressing hair loss is the Capillus® Laser Cap (Capillus LLC, Miami, Florida, USA), which embodies a rigid cap insert with 272 laser diodes operating at 650 nm that is positioned to fit under a conventional head covering, such as a baseball cap, headscarf, or beanie. Other commercially available phototherapy devices aimed at addressing hair loss include laser combs such as the Hairmax® Laser Comb (Lexington Int., LLC, Boca Raton, Florida, USA). Various Hairmax® Laser Combs utilize 7-12 laser modules operating at 655 nm ± 10 nm.

[0007]

[0007] Existing phototherapy devices have limitations that affect their practicality. Rigid helmet-type phototherapy devices can be uncomfortable and unsightly for many users, and such devices can be cumbersome to manufacture. Providing substantially uniform and / or uninterrupted coverage across the area to be treated can also be difficult with conventional phototherapy helmets, caps, and combs (e.g., because they require user movement and compliance). Heat management can also be a concern with conventional phototherapy helmets and caps.

[0008]

[0008] The art continues to seek improved phototherapy devices that can provide desirable illumination characteristics and overcome the challenges associated with conventional phototherapy devices. Summary of the Invention [Means for solving the problem]

[0009]

[0009] Aspects of the present disclosure relate to wearable devices for delivering light energy to a patient's scalp, as well as methods of making and using such devices.

[0010] In a first aspect, the present disclosure relates to a phototherapy device for delivering optical radiation (e.g., light energy) to a patient's scalp, the device including a flexible printed circuit board (FPCB), at least one optically transmissive layer (e.g., an encapsulant or lens), and a plurality of standoffs. The FPCB includes a proximal surface supporting at least one light-emitting device having an emitter height above the proximal surface, and the FPCB includes a plurality of interconnected panels and a plurality of bend regions defined within and between at least some of the plurality of interconnected panels to enable the FPCB to provide a concave shape for covering at least a portion of the patient's top head. The at least one optically transmissive layer is disposed near the FPCB and configured to transmit at least a portion of the optical radiation generated by the at least one light-emitting device. The plurality of standoffs are configured to be disposed between the FPCB and the patient's scalp, and at least some of the plurality of standoffs include a standoff height that exceeds the emitter height.

[0010]

[0011] In certain embodiments, the light therapy device further includes a driver circuit configured to excite the at least one light emitting device to generate light radiation, hi certain embodiments, the at least one light emitting device includes a plurality of light emitting devices.

[0011]

[0012] In certain embodiments, the light therapy device further includes a molded member having a generally concave interior positioned to receive the FPCB. In certain embodiments, the light therapy device further includes a fabric cover positioned to cover the FPCB. In certain embodiments, the FPCB is positioned to accommodate outward expansion and inward contraction to allow the multiple standoffs to contact the patient's scalp. In certain embodiments, the light therapy device further includes a fabric cap positioned near a distal surface of the FPCB, the fabric cap defining an aperture configured to receive an electronics housing containing at least a portion of the driver circuitry.

[0012]

[0013] In certain embodiments, the light therapy device further includes an energy storage device electrically coupled to the driver circuit, hi certain embodiments, the energy storage device comprises a battery, the battery being held by a battery holder coupled to the electronics housing.

[0013]

[0014] In certain embodiments, the light therapy device further includes a power supply circuit arranged to provide at least one regulated power signal for use by at least one of the microcontrollers of the light therapy device or the at least one light-emitting device, wherein upon detection of a designated number of uses of the light therapy device, the light therapy device is instructed to prevent further operation of the light therapy device. In certain embodiments, the light therapy device is configured to generate a disabling signal adapted to irreversibly disable the power supply circuit. In certain embodiments, the power supply circuit includes at least one fusible link arranged in electrical communication with the at least one light-emitting device, and the disabling signal is adapted to open the at least one fusible link to prevent current from being supplied to the at least one light-emitting device.

[0014]

[0015] In certain embodiments, the at least one light emitting device comprises a non-coherent light emitting device. In certain embodiments, the at least one light emitting device provides a fluence of at least 1 joule per square centimeter when excited to emit light. In certain embodiments, the at least one light emitting device comprises a first array of light emitting devices arranged to generate light having a first peak wavelength and a second array of light emitting devices arranged to generate light having a second peak wavelength, the second peak wavelength differing from the first peak wavelength by at least 20 nm.

[0015]

[0016] In certain embodiments, the first peak wavelength and the second peak wavelength are selected from one of the following combinations (a) to (f): (a) the first peak wavelength is in the range of 615 nm to 635 nm, and the second peak wavelength is in the range of 650 nm to 670 nm; (b) the first peak wavelength is in the range of 520 nm to 540 nm, and the second peak wavelength is in the range of 650 nm to 670 nm; or (c) the first peak wavelength is in the range of 410 nm to 430 nm. , and the second peak wavelength is in the range of 620 nm to 640 nm, (d) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 650 nm to 670 nm, (e) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 495 nm to 515 nm, or (f) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 520 nm to 540 nm.

[0016]

[0017] In certain embodiments, the at least one light emitting device comprises a first array of light emitting devices arranged to generate light having a first peak wavelength and a second array of light emitting devices arranged to generate light having a second peak wavelength, the second peak wavelength differing from the first peak wavelength by at least 50 nm.

[0017]

[0018] In certain embodiments, the first array of light-emitting devices provides a spectral output having a first peak wavelength value and a first full-width half-maximum value, where the first peak wavelength value minus half of the first full-width half-maximum value is greater than 400 nm, and the second array of light-emitting devices provides a spectral output having a second peak wavelength value and a second full-width half-maximum value, where the second peak wavelength value minus half of the second full-width half-maximum value is greater than 450 nm.

[0018]

[0019] In certain embodiments, the phototherapy device further includes a proximity sensor positioned to detect a condition indicative of placement of the phototherapy device near the patient's scalp, and at least one of initiating, terminating, or modifying operation of the at least one light-emitting device is responsive to an output signal of the proximity sensor.

[0019]

[0020] In certain embodiments, the phototherapy device further includes a temperature sensor positioned to sense a temperature condition at or near a portion of the phototherapy device, and at least one of initiation of operation, deviation from operation, or termination of operation of the at least one light-emitting device is responsive to an output signal of the temperature sensor.

[0020]

[0021] In certain embodiments, the phototherapy device further includes (a) a user-perceptible visible signaling element arranged to generate a visible signal, and / or (b) a user-perceptible audible signaling element arranged to generate an audible signal, wherein the visible and / or audible signal is indicative of the operating status of the phototherapy device, the state of charge of the phototherapy device, or the number of operating cycles of the phototherapy device.

[0021]

[0022] In certain embodiments, the plurality of standoffs are integral with at least one optically transmissive layer. In certain embodiments, the plurality of standoffs are attached to at least one optically transmissive layer.

[0022]

[0023] In certain embodiments, the phototherapy device is embodied in a wearable cap that is positioned to be worn on the patient's head, the outermost surface of the wearable cap comprising a fabric covering.

[0023]

[0024] In certain embodiments, a distance from a proximal end of at least some of the plurality of standoffs to a proximal surface of the FPCB exceeds a thickness of the at least one optically transmissive layer. In certain embodiments, the plurality of standoffs are positioned between the FPCB and the at least one optically transmissive layer. In certain embodiments, the at least one optically transmissive layer comprises a flexible lenticular lens.

[0024]

[0025] In certain embodiments, a method for treating at least one dermatological disorder includes placing a phototherapy device on a patient's head and exciting at least one light-emitting device to direct light radiation onto at least a portion of the patient's scalp.

[0025]

[0026] In another aspect, the present disclosure relates to a phototherapy device for delivering optical radiation to a patient's scalp. The phototherapy device includes a flexible substrate including a proximal surface supporting at least one array of light-emitting devices and an optically transparent layer configured to transmit at least a portion of the optical radiation generated by the at least one array of light-emitting devices. The device also includes a plurality of standoffs positioned between the flexible substrate and the patient's scalp. The device further includes an energy storage element, a driver circuit disposed in electrical communication with the energy storage element and configured to drive the at least one array of light-emitting devices, and a fabric cover disposed over the flexible substrate. The flexible substrate and the fabric cover are disposed to accommodate outward expansion and inward contraction to allow the phototherapy device to be adjustably fitted to the patient's head.

[0026]

[0027] In certain embodiments, a distance from a proximal end of at least some of the plurality of standoffs to a proximal surface of the flexible substrate exceeds a thickness of the optically transmissive layer. In certain embodiments, the plurality of standoffs are positioned between the flexible substrate and the optically transmissive layer. In certain embodiments, the optically transmissive layer comprises a flexible lenticular lens.

[0027]

[0028] In certain embodiments, the flexible substrate comprises a plurality of interconnected panels and a plurality of flex regions defined within and between at least some of the plurality of interconnected panels.

[0028]

[0029] In certain embodiments, the flexible substrate comprises a flexible printed circuit board (FPCB). In certain embodiments, a light-emitting device of at least one array of light-emitting devices comprises an emitter height, and the phototherapy device comprises a plurality of standoffs disposed on the FPCB and / or the light-transmissive layer and raised relative to the proximal surface, at least some of the plurality of standoffs comprising a standoff height that exceeds the emitter height.

[0029]

[0030] In certain embodiments, air gaps are provided between portions of adjacent panels of the plurality of interconnected panels to accommodate outward expansion and inward contraction and to allow dissipation of heat generated by at least one array of light emitting devices.

[0030]

[0031] In certain embodiments, the phototherapy device further includes a cloth cap defining an aperture configured to receive an electronics housing containing at least a portion of the driver circuit, hi certain embodiments, the energy storage element comprises a battery, the battery being held by a battery holder fixed to or pivotally coupled to the electronics housing.

[0031]

[0032] In certain embodiments, upon detection of a designated number of uses of the phototherapy device, the phototherapy device is configured to generate a disabling signal adapted to reversibly disable the phototherapy device to prevent further operation of the phototherapy device, hi certain embodiments, the disabling signal comprises a voltage spike and / or a current spike.

[0032]

[0033] In certain embodiments, the phototherapy device further includes a power supply circuit arranged to provide at least one regulated power signal for use by the microcontroller of the phototherapy device and / or the at least one light-emitting device, and the disabling signal is sent to prevent further operation of the phototherapy device.

[0033]

[0034] In certain embodiments, the phototherapy device further includes at least one fusible link disposed in electrical communication with the at least one array of light-emitting devices, and the disable signal is adapted to open the at least one fusible link to prevent current from being supplied to the at least one array of light-emitting devices.

[0034]

[0035] In certain embodiments, the at least one array of light emitting devices comprises non-coherent solid state light emitting devices. In certain embodiments, the at least one array of solid state light emitting devices provides a fluence of at least 1 joule per square centimeter. In certain embodiments, the at least one array of solid state light emitting devices comprises a first array of solid state light emitting devices arranged to produce light having a first peak wavelength and a second array of solid state light emitting devices arranged to produce light having a second peak wavelength, the second peak wavelength differing from the first peak wavelength by at least 20 nm.

[0035]

[0036] In certain embodiments, the first peak wavelength and the second peak wavelength are selected from one of the following combinations (a) to (f): (a) the first peak wavelength is in the range of 615 nm to 635 nm, and the second peak wavelength is in the range of 650 nm to 670 nm; (b) the first peak wavelength is in the range of 520 nm to 540 nm, and the second peak wavelength is in the range of 650 nm to 670 nm; or (c) the first peak wavelength is in the range of 410 nm to 430 nm. , and the second peak wavelength is in the range of 620 nm to 640 nm, (d) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 650 nm to 670 nm, (e) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 495 nm to 515 nm, or (f) the first peak wavelength is in the range of 410 nm to 430 nm and the second peak wavelength is in the range of 520 nm to 540 nm.

[0036]

[0037] In certain embodiments, the at least one array of solid state light emitting devices comprises a first array of solid state light emitting devices arranged to produce light having a first peak wavelength and a second array of solid state light emitting devices arranged to produce light having a second peak wavelength, the second peak wavelength differing from the first peak wavelength by at least 50 nm.

[0037]

[0038] In certain embodiments, the first array of solid state light emitting devices provides a spectral output having a first peak wavelength value and a first full width half maximum value, where the first peak wavelength value minus half the first full width half maximum value is greater than 400 nm, and the second array of solid state light emitting devices provides a spectral output having a second peak wavelength value and a second full width half maximum value, where the second peak wavelength value minus half the second full width half maximum value is greater than 450 nm.

[0038]

[0039] In certain embodiments, the phototherapy device further includes an optical sensor positioned to detect a condition indicative of placement of the phototherapy device near the patient's scalp, and wherein the initiation, termination, or modification of operation of the at least one array of light-emitting devices is responsive to an output signal of the optical sensor.

[0039]

[0040] In certain embodiments, the phototherapy device further includes a temperature sensor positioned to sense temperature conditions at or near a portion of the phototherapy device, and wherein the initiation of operation, modification of operation, and / or termination of operation of the at least one array of light-emitting devices is responsive to an output signal of the temperature sensor.

[0040]

[0041] In certain embodiments, the phototherapy device further includes (a) a user-perceptible visible signaling element arranged to generate a visible signal, and / or (b) a user-perceptible audible signaling element arranged to generate an audible signal, wherein the visible and / or audible signal is indicative of the operating status of the phototherapy device, the state of charge of the phototherapy device, or the number of operating cycles of the phototherapy device.

[0041]

[0042] In certain embodiments, the phototherapy device further includes (a) a user-perceptible visible signaling element arranged to generate a visible signal, and / or (b) a user-perceptible audible signaling element arranged to generate an audible signal, wherein the visible and / or audible signal is indicative of the number of operating cycles of the phototherapy device.

[0042]

[0043] In certain embodiments, the phototherapy device is embodied in a wearable cap that is positioned to be worn on the patient's head, the outermost surface of the wearable cap comprising a fabric covering.

[0043]

[0044] In certain embodiments, a method for treating at least one dermatological disorder includes placing a phototherapy device on a patient's head and exciting at least one array of light-emitting devices to direct light energy to at least a portion of the patient's scalp.

[0044]

[0045] In another aspect, the present disclosure relates to a method for treating at least one dermatological disorder, the method comprising the steps of placing a phototherapy device as disclosed herein on a patient's head and exciting at least one array of light-emitting devices to direct light energy to at least a portion of the patient's scalp.

[0045]

[0046] In another aspect, the present disclosure relates to a phototherapy device for delivering optical radiation to a patient's scalp. The device includes a flexible lens having a proximal lens surface and a distal lens surface, a flexible printed circuit board (FPCB) including at least one light-emitting device on its proximal surface, and a plurality of standoffs positioned between the distal lens surface and the FPCB to maintain a minimum distance between the at least one light-emitting device and the distal lens surface. The phototherapy device is configured to transmit optical radiation generated by the at least one light-emitting device through the flexible lens to the patient's scalp.

[0046]

[0047] In certain embodiments, the distance from the proximal end of each standoff of the plurality of standoffs to the proximal surface of the flexible lens exceeds the thickness of the flexible lens. In certain embodiments, the optically transmissive layer comprises a flexible lenticular lens.

[0047]

[0048] In certain embodiments, the light therapy device further includes a communication module configured to electrically communicate with an electronic device external to the light therapy device.

[0049] In certain embodiments, the light emission of the at least one light-emitting device is in the range of about 410 nm to 455 nm. In certain embodiments, the light emission of the at least one light-emitting device is in the range of about 620 nm to 700 nm, or 620 nm to 900 nm. In certain embodiments, the light emission is configured to treat or prevent hair loss in a patient.

[0048]

[0050] In certain embodiments, a method for treating at least one dermatological disorder includes placing a phototherapy device on a patient's head and exciting at least one light-emitting device to deliver light radiation to at least a portion of the patient's scalp.

[0049]

[0051] In certain embodiments, the light therapy device further includes a driver circuit configured to excite the at least one light emitting device to generate light radiation, hi certain embodiments, the at least one light emitting device includes a plurality of light emitting devices.

[0050]

[0052] In certain embodiments, the phototherapy device further includes a cloth cap, the FPCB positioned between the cloth cap and the flexible lens, the FPCB comprising an expansion joint to allow adjustment of an opening circumference of the cloth cap. In certain embodiments, the cloth cap defines an aperture configured to receive an electronics housing containing at least a portion of the driver circuit. In certain embodiments, the FPCB is arranged to accommodate outward expansion and inward contraction.

[0051]

[0053] In certain embodiments, the light therapy device further includes an energy storage device electrically coupled to the driver circuit, the energy storage device comprising a battery, the battery held by a battery holder coupled to the electronics housing.

[0052]

[0054] In certain embodiments, the phototherapy device further includes a power supply circuit arranged to provide at least one regulated power signal for use by at least one of the microcontrollers of the phototherapy device or the at least one light-emitting device, and the disabling signal is adapted to reversibly disable the power supply circuit.

[0053]

[0055] In certain embodiments, the standoffs are integral with the flexible lens. In certain embodiments, the standoffs are attached to the flexible lens.

[0054]

[0056] In certain embodiments, a phototherapy device includes a substrate comprising a plurality of interconnected panels, a plurality of flexion regions defined within and between multiple panels of the plurality of interconnected panels.

[0055]

[0057] In certain embodiments, upon detection of a designated number of uses of the phototherapy device, the phototherapy device is configured to generate a disabling signal adapted to reversibly disable the phototherapy device to prevent further operation of the phototherapy device, hi certain embodiments, the disabling signal comprises a voltage spike and / or a current spike.

[0056]

[0058] In certain embodiments, the phototherapy device further includes at least one fusible link disposed in electrical communication with at least one light-emitting device (e.g., at least one array of light-emitting devices), and the disable signal is adapted to open the at least one fusible link to prevent current from being supplied to the at least one light-emitting device.

[0057]

[0059] In certain embodiments, the phototherapy device further includes an optical sensor positioned to detect a condition indicative of placement of the phototherapy device near the patient's scalp, and at least one of initiating, terminating, or modifying operation of the at least one light-emitting device (e.g., at least one array of light-emitting devices) is responsive to an output signal of the optical sensor.

[0058]

[0060] In certain embodiments, the phototherapy device further includes a temperature sensor positioned to sense temperature conditions at or near a portion of the phototherapy device, and at least one of initiating operation, modifying operation, or terminating operation of at least one light-emitting device (e.g., at least one array of light-emitting devices) is responsive to an output signal of the temperature sensor.

[0059]

[0061] In certain embodiments, the flexible lens comprises a flexible lenticular lens. In certain embodiments, the plurality of standoffs are integrally attached to the flexible lenticular lens. In certain embodiments, the flexible lens and FPCB are adjustable in size and / or shape to accommodate various head sizes. In certain embodiments, the flexible lenticular lens and the plurality of standoffs are formed by molding.

[0060]

[0062] In another aspect, the present disclosure relates to a phototherapy device for delivering light energy to a patient's scalp. The phototherapy device includes a cloth cap, a flexible lenticular lens including a plurality of standoffs extending from a distal surface thereof, and a flexible printed circuit board (FPCB) positioned between the flexible lenticular lens and the cloth cap, the FPCB including a plurality of interconnected panels defining a recess, and at least one light-emitting device disposed on a proximal surface of the FPCB and configured to generate incoherent light. The plurality of standoffs are configured to maintain a minimum distance separation between the at least one light-emitting device and the distal surface of the flexible lenticular lens. The phototherapy device is configured to be worn on a patient's head to cover at least a portion of the patient's crown so as to transmit at least a portion of the incoherent light generated by the at least one light-emitting device for application to the patient's scalp. In another aspect, the present disclosure relates to a method for delivering light energy to a patient's scalp. The method includes the steps of positioning a phototherapy device on a patient's head, the phototherapy device including a flexible lens including a distal lens surface, a flexible printed circuit board (FPCB) at least partially covering the flexible lens and supporting at least one light emitting device, and a plurality of standoffs positioned between the distal lens surface and the FPCB to maintain a minimum distance between the at least one light emitting device and the distal lens surface; adjusting the size and / or shape of the phototherapy device to fit the patient's head; generating light radiation from the at least one light emitting device attached to the FPCB; and transmitting at least a portion of the generated light radiation through at least one optically transparent portion of the flexible lens and directed against the patient's scalp.

[0061]

[0063] In another aspect, the present disclosure relates to a method of assembling a phototherapy device, the method including the steps of: disposing a flexible printed circuit board (FPCB) over at least a portion of a flexible lens, the FPCB including at least one light emitting device mounted thereon, wherein a plurality of standoffs are positioned between the distal lens surface and the FPCB to maintain a minimum distance between the at least one light emitting device and the distal lens surface; and disposing a cloth cap over at least a portion of the FPCB with the FPCB secured between the cloth cap and the flexible lens.

[0062]

[0064] In another aspect, the present disclosure relates to a capacitor comprising: a first flexible circuit board element comprising a first conductive material layer and a first dielectric material layer, a second flexible circuit board element comprising a second conductive material layer and a second dielectric material layer, and at least one solid spacer coupled between the first and second flexible circuit board elements.

[0063]

[0065] In certain embodiments, the at least one solid spacer has a dielectric constant value in the range of about 2 to about 5. In certain embodiments, the at least one solid spacer is adhered between the first flexible circuit board element and the second flexible circuit board element.

[0064]

[0066] In certain embodiments, the first flexible circuit board element comprises a continuous extension of the second flexible circuit board element with a bent back region disposed between the first flexible circuit board element and the second flexible circuit board element, hi certain embodiments, the first conductive material layer has a greater lateral extent than the second conductive material layer.

[0065]

[0067] In certain embodiments, the at least one solid spacer, the first dielectric layer, and the second dielectric layer maintain a distance between the first conductive layer and the second conductive layer within a range of about 0.2 mm to about 2 mm, and in certain embodiments, this distance is within a range of about 0.3 mm to about 1.9 mm.

[0066]

[0068] In certain embodiments, the proximity sensor comprises a capacitor.

[0069] In other embodiments, any of the foregoing embodiments and / or various separate embodiments and features as described herein may be combined to further advantage. Any of the various features and elements as disclosed herein may be combined with one or more other disclosed features and elements, unless otherwise indicated herein.

[0067]

[0070] Other aspects, features, and embodiments of the present invention will become more fully apparent from the ensuing disclosure and appended claims. [Brief explanation of the drawings]

[0068] [Figure 1] FIG. 1 is an exploded view of a light-emitting device embodied in a wearable cap for delivering light radiation to a patient's scalp, the device comprising a plurality of light emitters and standoffs supported by an FPCB arranged in a concave configuration, a concave molding member configured to receive the FPCB and to support a battery and control module, and a fabric cover arranged to cover the support member and flexible substrate. [Figure 2A] 2 is a top perspective view of the concave molding member assembled together with the control module (with battery) of FIG. 1; FIG. [Figure 2B] FIG. 2B is a top plan view of the concave molding member and control module of FIG. 2A. [Figure 2C] FIG. 2C is a front view of the concave molding member and control module of FIGS. 2A and 2B. [Figure 2D]FIG. 2D is a left side view of the concave molding member and control module of FIGS. 2A to 2C. [Figure 2E] FIG. 2E is a bottom perspective view of the concave molding member and control module of FIGS. 2A to 2D. [Figure 2F] FIG. 2C is a bottom plan view of the concave molding member and control module (with battery) of FIGS. 2A-2E. [Figure 3A] 2 is a bottom plan view of the FPCB illustrated in FIG. 1 with a light emitter and standoffs disposed thereon, prior to shaping the FPCB into a concave configuration. [Figure 3B] 3B is a bottom plan view of the FPCB of FIG. 3A with electrical traces and emitter mounting areas disposed thereon, prior to attachment of the light emitters and formation of the standoffs, and prior to molding of the FPCB. [Figure 3C] 3C is a cross-sectional view of the FPCB of FIGS. 3A and 3B from below, showing the electrical traces along the top side of the FPCB. FIG. [Figure 3D] FIG. 3D is a bottom plan view of the FPCB profile of FIGS. 3A-3C, showing the bending region and bending angle useful for shaping the FPCB into a concave shape to fit around a user's scalp. [Figure 3E] FIG. 3E is a top perspective view of the FPCB of FIG. 3D after a bending or molding step to form a concave shape suitable for fitting around a user's scalp. [Figure 3F] For ease of illustration, FIG. 3F is a bottom plan view of the molded FPCB of FIG. 3E without the presence of emitters, traces, emitter mounting regions, or standoffs. [Figure 3G] FIG. 3C is a left side view of the molded FPCB of FIGS. 3E and 3F. [Figure 3H] FIG. 3C is a top front perspective view of the molded FPCB of FIGS. 3E-3G. [Figure 4A] 2 is a top perspective view of the assembled light emitting device of FIG. 1. [Figure 4B] FIG. 4B is a top plan view of the assembled light-emitting device of FIG. 4A. [Figure 4C] FIG. 4C is a front view of the assembled light-emitting device of FIGS. 4A and 4B. [Figure 4D] FIG. 4D is a left side view of the assembled light emitting device of FIGS. 4A-4C. [Figure 5A] FIG. 4E is a front view of the assembled light-emitting device of FIGS. 4A-4D superimposed on a modeled human head. [Figure 5B] 5B is a side view of a portion of the light emitting device of FIGS. 1, 4A-4D, and 5A, omitting the concave molding member and fabric cover. FIG. [Figure 6] 1 is a schematic diagram of a fabric cover including an adjustable closure positioned to allow adjustment of the opening circumference of the fabric cover. [Figure 7A] 1 is a cross-sectional side view of a portion of a first light emitting device including a standoff having an upwardly curved circular configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 7B] FIG. 10 is a cross-sectional side view of a portion of a second light emitting device including standoffs having a rounded tower configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 7C] FIG. 10 is a cross-sectional side view of a portion of a third light emitting device including a standoff having a conical tower configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 7D] FIG. 10 is a cross-sectional side view of a portion of a fourth light emitting device including a standoff having a recessed cone configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 7E] FIG. 10 is a cross-sectional side view of a portion of a fifth light emitting device including a standoff having a flat-topped cone configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 7F] FIG. 10 is a cross-sectional side view of a portion of a sixth light emitting device including standoffs with a circular configuration extending from an encapsulated FPCB that supports multiple light emitting elements. [Figure 8] 1 is a schematic diagram illustrating the interconnections between components of a light-emitting device for delivering light energy to a patient's scalp, according to one embodiment. [Figure 9]FIG. 1 is a schematic diagram depicting interfaces between hardware drivers, functional components, and software applications suitable for operating a light-emitting device for delivering light energy to a patient's scalp, according to one embodiment. [Figure 10A] FIG. 1 is a top perspective view of a light-emitting device for phototherapy embodied in a wearable cap for delivering light energy to a patient's scalp, according to one embodiment, the light therapy device including a flexible cap, a flexible printed circuit board (FPCB) with at least one light-emitting device (LED), a flexible lenticular lens, and a plurality of standoffs. [Figure 10B] FIG. 10B is a bottom perspective view of the phototherapy device of FIG. 10A. [Figure 10C] FIG. 10C is a right side view of the phototherapy device of FIGS. 10A and 10B. [Figure 10D] FIG. 1D is a bottom plan view of the phototherapy device of FIGS. 10A-10C. [Figure 10E] FIG. 1C is an exploded view of the phototherapy device of FIGS. 10A-10D. [Figure 11A] FIG. 10F is a rear view of the flexible printed circuit board (FPCB) assembly shown in FIG. 10E, including a panel subassembly and an electronics subassembly. [Figure 11B] 11B is a cross-sectional side view of the FPCB assembly of FIG. 11A taken along section line AA illustrated in FIG. 11A. [Figure 11C] FIG. 11C is an exploded view of the FPCB assembly of FIGS. 11A and 11B. [Figure 12A] FIG. 11B is a bottom perspective view of the panel subassembly of FIG. 11A in a bent configuration with bends formed between the various panels to form concave surfaces. [Figure 12B] FIG. 12B is a bottom plan view of the panel subassembly of FIG. 12A in a bent configuration. [Figure 12C] 12C is a cross-sectional side view of the panel subassembly of FIGS. 12A and 12B in a bent configuration, taken along section line CC illustrated in FIG. 12B. [Figure 12D]Top plan view of the panel sub-assembly of FIGS. 12A-12C in a flat configuration with illustration of the inter-panel flexure region. [Figure 12E] Bottom plan view of the panel sub-assembly of FIGS. 12A-12D in a flat configuration. [Figure 12F] Cross-sectional view of a flexible printed circuit board (FPCB) incorporating elements for fabricating a capacitor prior to folding of the FPCB and adhesion of the capacitor element. [Figure 12G] Cross-sectional view (taken along cut line B-B of FIG. 12F) of a capacitor fabricated from the FPCB and elements shown in FIG. 12F, including flexible printed circuit board elements and intervening spacer elements. [Figure 12H] Circuit diagram of a proximity sensor including an integrated circuit chip and a capacitor according to FIG. 12G. [Figure 13A] FIG. 13A is a front view of a patient wearing the phototherapy device according to FIGS. 10A-10E. [Figure 13B] FIG. 13B is a side cross-sectional view of the patient and phototherapy device of FIG. 13A, taken along cut line B-B illustrated in FIG. 13A. [Figure 14A] Upper perspective view of a package including the phototherapy device according to FIGS. 10A-10E. [Figure 14B] Exploded perspective view of the package and phototherapy device of FIG. 14A after removal of the upper cover from the lower lid of the package. [Figure 14C] Exploded assembly view of a package with the phototherapy device of FIGS. 14A and 14B, according to one embodiment. [Figure 14D] Side cross-sectional view of the packaged phototherapy device of FIGS. 14A-14C. [Figure 15A] Upper perspective view of the charging base portion of the packaged phototherapy device of FIGS. 14A-14D. [Figure 15B] Lower perspective view of the charging base of FIG. 15A. [Figure 15C] Side view of the charging base of FIGS. 15A and 15B. [Figure 15D] FIG. 15D is a top plan view of the charging base of FIGS. 15A to 15C. [Figure 16A] FIG. 16A illustrates an exemplary method for providing combination therapy that includes administering a hair growth agent and shining light onto the treatment area after the hair growth agent has been administered. [Figure 16B] FIG. 16B illustrates another exemplary method for providing combination therapy, which includes shining light onto the treatment area simultaneously with or immediately following the step of administering a hair growth agent. [Figure 17] FIG. 1 is a side cross-sectional view of a patient wearing a phototherapy device configured to provide both a hair growth agent and light therapy to the patient's scalp. [Figure 18] FIG. 1 is a side cross-sectional view of a patient wearing a delivery device configured to provide a hair growth agent separately from light therapy. [Figure 19A] FIG. 19A is a partial side view of another delivery device configured to separately deliver a hair growth agent to the scalp before light therapy is delivered. [Figure 19B] FIG. 19B is an end view of the delivery device of FIG. 19A. DETAILED DESCRIPTION OF THE INVENTION

[0069]

[0133] The embodiments set forth below represent the information necessary to enable those skilled in the art to practice the embodiments and to illustrate the best mode of practicing the embodiments. Upon reading the following description in light of the accompanying drawings, those skilled in the art will understand the concepts of the present disclosure and will recognize applications of these concepts not specifically addressed herein. It is understood that these concepts and applications fall within the scope of the present disclosure and the appended claims.

[0070]

[0134] Terms such as first, second, etc. may be used herein to describe various elements, but it should be understood that these elements should not necessarily be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element, without departing from the scope of the present disclosure. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0071]

[0135] It should also be understood that when an element is referred to as being "connected" or "coupled" to another element, it may be directly connected or coupled to the other element, or there may be intervening elements. Conversely, when an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present.

[0072]

[0136] It should be understood that the terms "upper," "lower," "bottom," "middle," "middle," "top," and the like may be used herein to describe various elements, but these elements should not necessarily be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first element may be referred to as an "upper" element, and similarly, a second element may be referred to as an "upper" element, depending on the relative orientation of these elements, without departing from the scope of the present disclosure.

[0073]

[0137] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "comprise," "comprising," "include," and / or "including," when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0074]

[0138] Unless otherwise specified, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It is further understood that terms used herein should be interpreted as having a meaning consistent with their meaning in the context of the present specification and the related art, and should not be interpreted in an idealized or overly formal sense, except as otherwise expressly defined herein.

[0075]

[0139] Aspects of the present disclosure relate to wearable devices for delivering light energy to a patient's scalp, as well as methods of making and using such devices.

[0140] Various embodiments disclosed herein include a flexible printed circuit board (FPCB) that supports at least one light-emitting device. In certain embodiments, the FPCB can include a polyimide-containing layer and at least one layer of copper or another conductive material. In certain embodiments, a light-transmitting layer (e.g., an encapsulant or lens) can be disposed to cover and / or be in contact with at least a portion of the FPCB and any light emitters supported thereon. A preferred encapsulant material is silicone, which can be applied by any suitable means, such as molding, dipping, spraying, dispensing, printing, or the like. In certain embodiments, substantially all surfaces (e.g., front and back) of the FPCB can be coated with the encapsulant material. In certain embodiments, the total thickness of the encapsulated flexible LED, including the embedded light emitters, can be in the range of 1 mm to 5 mm, or in the range of 1 mm to 3 mm, excluding standoffs. In certain embodiments, the FPCB comprises a flexible polymeric membrane, polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), polyetherimide (PEI), fluoropolymer (FEP), copolymers, and the like.

[0076]

[0141] In certain embodiments, the at least one standoff is configured to be positioned between the FPCB and the patient's scalp, the at least one standoff comprising a standoff height that exceeds a height of the emitter supported by the FPCB. Preferably, the at least one standoff comprises an optically transparent material, such as silicone, PET, PET-G, or the like.

[0077]

[0142] In certain embodiments, forming an encapsulated FPCB with standoffs may include defining electrical traces on the FPCB, mounting, forming, or otherwise affixing one or more light emitting devices onto the FPCB to form standoffs or standoff portions, encapsulating various structures including the light emitting device, the FPCB, and optionally encapsulating the standoffs or standoff portions. In certain embodiments, the order of the foregoing steps may be changed, and in certain embodiments, at least some of the standoffs may be partially or entirely free of encapsulant.

[0078]

[0143] In certain embodiments, the standoff or standoff portion may be molded, positioned, formed, printed, adhered, or otherwise applied to the outer surface of the FPCB prior to encapsulation, and the standoff or standoff portion may then be partially or completely encapsulated along with one or more light-emitting elements and one or more portions of the FPCB.

[0079]

[0144] In certain embodiments, the standoffs or standoff portions can be placed, formed, printed, adhered, or otherwise applied to the exterior surface of the FPCB after the FPCB and light emitting device are encapsulated.

[0080]

[0145] In certain embodiments, the standoffs or standoff portions may be formed simultaneously with the encapsulation process, such as by molding, printing, spraying, or other deposition methods.

[0081]

[0146] In certain embodiments, a crosslinkable material may be selectively applied or formed along regions of the FPCB, and such material may be activated by suitable means (e.g., heat, photon energy, chemical activation, or the like) to form standoffs or standoff portions, whether before, during, or after the sealing step.

[0082]

[0147] In certain embodiments, the standoff height, standoff shape, light emitting element spacing, and light element optical distribution may be selected to enable adjacent light emitting elements to provide overlapping beam patterns on the patient's scalp.

[0083]

[0148] In certain embodiments, an array of a plurality of standoffs may be formed on, in, or over the encapsulant material. In certain embodiments, each standoff in the array has substantially the same size, shape, and / or durometer. In other embodiments, different standoffs in the array may have different sizes, shapes, and / or durometers.

[0084]

[0149] In certain embodiments, one or more standoffs may include a shape and / or material suitable for providing light focusing, diffusing, and / or scattering utility. In certain embodiments, one or more standoffs may include one or more wavelength converting materials (e.g., phosphors, quantum dots, fluorophores, or the like) to provide wavelength converting utility. In certain embodiments, one or more standoffs may include a shape and / or material suitable for providing light reflecting utility.

[0085]

[0150] In certain embodiments, the one or more standoffs may be positioned away from the one or more light-emitting elements, while in other embodiments, the one or more standoffs may be intentionally placed on or over the one or more light-emitting elements, where the standoffs serve to transmit, shape, and / or otherwise influence light received from the one or more light-emitting elements.

[0086]

[0151] Various types of light-emitting elements may be used with a phototherapy device to deliver light energy to a patient's scalp. In certain embodiments, the radiation of the phototherapy device may consist of incoherent light (e.g., characteristic of light-emitting diode radiation). In certain embodiments, the radiation of the phototherapy device may consist of coherent light (e.g., characteristic of laser radiation). In certain embodiments, the radiation of the phototherapy device may include a combination of coherent and incoherent light. In certain embodiments, the phototherapy device does not have any laser diodes positioned to direct light onto the patient's scalp.

[0087]

[0152] In certain embodiments, a phototherapy device for delivering light energy to a patient's scalp may include one or more solid-state light-emitting devices. Examples of solid-state light-emitting devices include (but are not limited to) light-emitting diodes, lasers, thin-film electroluminescent devices, powdered electroluminescent devices, magnetic-field-induced polymer electroluminescent devices, and polymer light-emitting electrochemical cells.

[0088]

[0153] In certain embodiments, multiple emitters of different peak wavelengths (e.g., having peak wavelengths that differ by at least about 10 nm, at least about 20 nm, at least about 30 nm, at least about 50 nm, at least about 75 nm, at least about 100 nm, or another threshold value specified herein) may be provided.

[0089]

[0154] In certain embodiments, light of different peak wavelengths may be generated by different emitters contained within a single (e.g., solid-state) emitter package, and close spacing between adjacent emitters may result in natural color mixing. In certain embodiments, one or more arrays of light-emitting devices may be provided. In certain embodiments, a first array of light-emitting devices may be configured to provide light of a first peak wavelength, and a second array of light-emitting devices may be configured to provide light of a second peak wavelength. In certain embodiments, an array of multi-emitter packages may be provided, and emitters within a single package may provide the same or different peak wavelengths. In certain embodiments, an array of solid-state emitter packages may embody a package further including a second, third, third, and / or fifth solid-state emitter, such that a single array of solid-state emitter packages may embody two, three, four, or five arrays of solid-state emitters, each array arranged to generate radiation at a different peak wavelength.

[0090]

[0155] In certain embodiments, a phototherapy device for delivering light energy to a patient's scalp may include one or more light-emitting devices without a wavelength-converting material. In other embodiments, the one or more light-emitting devices may be positioned to stimulate a wavelength-converting material, such as a fluorescent material, a fluorescent dye material, a quantum dot material, or a fluorophore material.

[0091]

[0156] In certain embodiments, the one or more light emitting devices may be arranged to provide substantially monochromatic light. In certain embodiments, the one or more light emitting devices may include a spectral output having a full width at half maximum value of less than 25 nm (or less than 20 nm, or less than 15 nm, or in the range of 5 nm to 25 nm, or in the range of 10 nm to 25 nm, or in the range of 15 nm to 25 nm).

[0092]

[0157] In certain embodiments, the one or more light emitting devices may be configured to provide radiation having a peak wavelength in the range of 400 nm to 900 nm, or in the range of 500 nm to 900 nm, or in the range of 500 nm to 800 nm, or in the range of 600 nm to 700 nm, or in the range of 620 nm to 670 nm.

[0093]

[0158] In certain embodiments, at least one light-emitting device may be configured to provide radiation having a peak wavelength within the range of 620 nm to 645 nm (or 615 nm to 635 nm), and at least one light-emitting device may be configured to provide radiation having a peak wavelength within the range of 645 nm to 670 nm (or 650 nm to 670 nm). In certain embodiments, at least one first light-emitting device may be configured to provide radiation having a peak wavelength of approximately 630 nm, and at least one second light-emitting device may be configured to provide radiation having a peak wavelength of approximately 660 nm. Such wavelengths may be useful for providing an anti-inflammatory effect and / or promoting vasodilation. The anti-inflammatory effect may be useful for promoting wound healing, reducing acne scars, promoting facial beauty, and / or treating atopic dermatitis and other topical dermatological disorders. Vasodilation may also be beneficial for treating androgenetic alopecia or other topical dermatological disorders.

[0094]

[0159] In certain embodiments, at least one light-emitting device (or multiple light-emitting devices) can be configured to produce light in a wavelength range and flux that can alter the presence, concentration, or growth of bacteria or other microorganisms in or on living mammalian tissue that receives the light. UV light and near-UV light (e.g., having a peak wavelength between 400 nm and 435 nm, or more preferably between 410 nm and 430 nm) can particularly affect microbial growth. The effect on microbial growth can depend on the wavelength range and the dose. In certain embodiments, the emitted light is (e.g., <9 mW / cm 2to produce a bacteriostatic effect (e.g., using pulsed light with a radiant flux of 9 mW / cm 2 ~17mW / cm 2 to produce a germicidal effect (e.g., using substantially steady-state light having a radiant flux in the range of 18 mW / cm 2 ~60mW / cm 2 In the range of 17mW / cm 2 In certain embodiments, radiation within the near-UV range (e.g., 400 nm to 420 nm, or 410 nm to 420 nm) can also affect microbial growth (whether in the bacteriostatic, bactericidal, or antibacterial ranges) for applications such as wound healing, acne scar reduction, or atopic dermatitis treatment.

[0095]

[0160] In certain embodiments, at least one light-emitting device (or multiple light-emitting devices) can be configured to produce light in a wavelength range and flux that can trigger the release of nitric oxide from endogenous stores (e.g., at least one of nitrosoglutathione, nitrosoalbumin, nitrosohemoglobin, nitrosothiols, nitrosamines, and metal nitrosyl complexes). In certain embodiments, light having a peak wavelength within the ranges of 400 nm to 435 nm, or 410 nm to 430 nm, or 430 nm to 490 nm, or 510 nm to 550 nm, or 520 nm to 540 nm can be used for this purpose.

[0096]

[0161] In certain embodiments, light having peak wavelengths of one, two, three, or more of the following values ​​may be used: about 415 nm, about 505 nm, 530 nm, about 630 nm, and / or 660 nm.

[0097]

[0162] In certain embodiments, any suitable combination of peak wavelengths disclosed herein may be used in combination for a desired therapeutic effect (e.g., vasodilation, inflammation reduction, enzymes, nitric oxide production, nitric oxide release, and antimicrobial function). In certain embodiments, wavelength combinations may be provided during the same time window, during overlapping but non-simultaneous time windows, or during non-overlapping time windows.

[0098]

[0163] In certain embodiments, the at least one first light emitter and the at least one second light emitter (which may be embodied in a first array of light emitters and a second array of light emitters) may be arranged to provide different peak wavelengths selected from one of the following combinations (a) to (f): (a) the first peak wavelength is in the range of 620 nm to 640 nm (or 615 nm to 635 nm) and the second peak wavelength is in the range of 650 nm to 670 nm; (b) the first peak wavelength is in the range of 520 nm to 540 nm and the second peak wavelength is in the range of 650 nm to 670 nm; (c) the first peak wavelength is in the range of 400 nm to 400 nm; (d) the first peak wavelength is in the range of 400 nm to 420 nm (or 410 nm to 430 nm) and the second peak wavelength is in the range of 650 nm to 670 nm; (e) the first peak wavelength is in the range of 400 nm to 420 nm (or 410 nm to 430 nm) and the second peak wavelength is in the range of 495 nm to 515 nm; and (f) the first peak wavelength is in the range of 400 nm to 420 nm (or 410 nm to 430 nm) and the second peak wavelength is in the range of 520 nm to 540 nm.

[0099]

[0164] In certain embodiments, the first array of light emitting devices provides a spectral output having a first peak wavelength value and a first full width half maximum value, the first peak wavelength value minus half the first full width half maximum value being greater than 400 nm. Additionally, the second array of light emitting devices provides a spectral output having a second peak wavelength value and a second full width half maximum value, the second peak wavelength value minus half the second full width half maximum value being greater than 450 nm.

[0100]

[0165] In certain embodiments, the one or more light emitting devices, when excited to emit light, can provide a fluence of at least 1 joule per square centimeter, at least 3 joules per square centimeter, or at least 5 joules per square centimeter. In certain embodiments, the one or more light emitting devices can provide a fluence of 5 mW / cm 2 ~60mW / cm 2 The radiant flux may be in the range of .

[0101]

[0166] In certain embodiments, the one or more light emitting devices may be arranged to provide a substantially steady state of light, hi certain embodiments, the one or more light emitting devices may be arranged to provide multiple discrete pulses of light.

[0102]

[0167] In certain embodiments, a device for delivering light energy to a patient's scalp may include an FPCB having multiple interconnected panels and multiple flex regions defined therein to allow the FPCB to provide a concave shape for covering at least a portion of the patient's scalp. In certain embodiments, openings are provided between adjacent panel portions to allow for heat and fluid (e.g., sweat) transport. In certain embodiments, a fabric cover may be disposed to cover the FPCB, and the fabric cover is preferably breathable to allow for heat transport and fluid transport (e.g., sweat evaporation). In certain embodiments, the fabric cover may include an adjustable closure disposed to allow the opening circumference of the fabric cover to be adjusted. When the FPCB is contained within the fabric cover, adjustment of the closure may selectively compress a portion of the FPCB, thus allowing the opening circumference of the FPCB to be adjusted. In certain embodiments, the FPCB and fabric cover are disposed to accommodate outward expansion and inward contraction to allow the standoffs of the FPCB to contact the patient's scalp.

[0103]

[0168] In certain embodiments, a flexible molded member having a generally concave interior can be positioned to receive the FPCB. In certain embodiments, the flexible molded member can be provided between the FPCB and the fabric cover. In certain embodiments, the FPCB and molded member can be positioned to accommodate outward expansion and inward contraction to allow the standoffs to contact the patient's scalp.

[0104]

[0169] In certain embodiments, the flexible molding member includes a central frame and a plurality of ribs attached to the frame. The plurality of ribs may include at least one front rib, at least one rear rib, and at least two cross ribs, each rib of the plurality of ribs projecting generally outward from the central frame to define an outer portion of a generally concave interior. In certain embodiments, the fabric cover may include a plurality of pockets positioned to receive the plurality of ribs to hold the fabric cover in a position that completely covers the flexible molding member and the FPCB. In certain embodiments, the fabric cover comprises the outermost surface of a wearable cap that is positioned to be worn on the patient's head.

[0105]

[0170] In certain embodiments, the flexible molding member may include, in addition to the plurality of ribs, a plurality of curved panels projecting generally outward and downward from the central frame to substantially conform to a portion of the crown, with each curved panel of the plurality of curved panels being disposed between two different ribs of the plurality of ribs. In certain embodiments, air gaps may be provided between adjacent portions of the ribs and curved panels to accommodate outward expansion and inward contraction and to allow dissipation of heat generated by at least one light-emitting device associated with an FPCB held within the flexible molding member. In certain embodiments, the flexible molding member may be fabricated from a suitable polymeric material.

[0106]

[0171] In certain embodiments, the central frame of the flexible molded member includes a hole or opening configured to receive the electronics housing. In certain embodiments, the electronics housing may include a driver circuit (or at least a portion of a driver circuit) configured to energize at least one light-emitting device for incidence of light on the patient's scalp. In certain embodiments, the electronics housing may include one or more user interfaces, sensory interfaces, charging interfaces, data interfaces, signal inputs, signal outputs, and / or display elements. In certain embodiments, an energy storage device (e.g., a battery) may be held by a battery holder pivotally (or otherwise movably) coupled to the electronics housing. Such a movable coupling may allow relative movement between the battery holder and the electronics housing, allowing the phototherapy device to accommodate a variety of patients with different head sizes and shapes.

[0107]

[0172] In certain embodiments, the operation of a device as disclosed herein may be in response to one or more signals generated by one or more sensors or other elements. Various types of sensors are contemplated, such as temperature sensors, light sensors, image sensors, proximity sensors, pressure sensors, chemical sensors, biosensors, accelerometers, humidity sensors, oximeters, current sensors, voltage sensors, and the like. Other elements that may affect the incidence of light and / or the operation of a device as disclosed herein include timers, cycle counters, manual controls, wireless transmitters and / or receivers (which may be embodied in transceivers), laptop or tablet computers, mobile phones, or other portable digital devices. Wired and / or wireless communication between a device as disclosed herein and one or more signal-generating or signal-receiving elements may be provided.

[0108]

[0173] In certain embodiments, a light-emitting device as disclosed herein may be configured to prevent unauthorized use beyond an authorized number of treatment cycles. In certain embodiments, the number of treatment cycles for the device may be incremented and stored in a counter or other memory element. In certain embodiments, operation of the device may be reversibly or irreversibly disabled when the number of treatment cycles reaches a predetermined limit. In certain embodiments, when the number of treatment cycles reaches a predetermined limit, a signal may be communicated to the user to notify them that the prescribed limit on the number of treatment cycles has been reached, and the user may be prompted to either (i) purchase a new device or component thereof, or (ii) purchase the ability to continue using the device for a specified number of additional cycles or for a specified additional time period. In certain embodiments, one or more signals regarding cycle use and / or allowing the user to purchase additional use may be communicated via wired or wireless means. In certain embodiments, the user may download an application for use on a personal computer, tablet computer, mobile phone, or another portable digital device, which application may provide cycle use information and / or allow the user to purchase additional cycles or additional use time to continue using the device.

[0109]

[0174] In certain embodiments, upon detection of a designated number of uses of the device, the light emitting device is configured to generate a disable signal adapted to reversibly disable the device to prevent further operation of the device. In certain embodiments, the disable signal may include at least one of a voltage spike and a current spike arranged to damage at least one circuit element. In certain embodiments, the light emitting device includes a power supply circuit arranged to provide at least one regulated power signal for use by the device and / or the microcontroller of the at least one light emitting device, and the disable signal may be adapted to reversibly disable at least one element of the power supply circuit. In certain embodiments, at least one fusible link may be placed in electrical communication with the at least one light emitting device, and the disable signal may be adapted to open the at least one fusible link to prevent current from being supplied to the at least one light emitting device. In certain embodiments, the at least one fusible link may be placed in electrical communication with at least one light emitter and / or light emitter driver circuit.

[0110]

[0175] In certain embodiments, the incidence of light on biological tissue and / or the operation of a device as disclosed herein may be responsive to one or more temperature signals. For example, a temperature condition may be sensed on or near the FPCB, at least one signal indicative of the temperature condition may be generated, and operation of the device to deliver light energy to the patient's scalp may be controlled in response to the at least one signal. Such control may include initiating operation of the light-emitting element, deviating (or changing) operation, or terminating operation. In certain embodiments, thermal foldback protection may be provided at a threshold temperature (e.g., >42 degrees Celsius) to prevent the user from suffering burns or discomfort. In certain embodiments, thermal foldback protection may trigger the light-emitting device to terminate operation, reduce current, or change operating state in response to receiving a signal indicative of an over-temperature condition.

[0111]

[0176] In certain embodiments, a proximity sensor is placed near a portion of the FPCB to determine when the FPCB is near the surface to be illuminated (e.g., the scalp) and may be used for patient safety by reducing the flux when not near the surface.

[0112]

[0177] In certain embodiments, the device for delivering light energy to the patient's scalp may include a user-perceptible visual signaling element (e.g., one or more lights, LED displays, alphanumeric displays, mobile apps, or the like) arranged to generate a visible signal, and / or a user-perceptible audible signaling element (e.g., a speaker, buzzer, alarm generator, or the like) arranged to generate an audible signal. In certain embodiments, at least one of the visible and audible signals indicates the operating state or charging state of the device. In certain embodiments, at least one of the visible and audible signals indicates the number of operating cycles of the device.

[0113]

[0178] In certain embodiments, a device for delivering light energy to a patient's scalp as disclosed herein may include a memory element for storing information indicative of one or more sensor signals. Such information may be used to detect device use, assess patient status, assess patient improvement, and evaluate device functionality. In certain embodiments, information indicative of one or more sensor signals may be transmitted via wired or wireless means (e.g., via Bluetooth, WiFi, Zigbee, or another suitable protocol) to a mobile phone, computer, data logging device, or another suitable device, which may optionally be connected to a local network, wide area network, telephone network, or other communications network. In certain embodiments, a data port (e.g., micro USB or other type) may be provided to allow for the extraction or recall of information contained in the memory.

[0114]

[0179] Details of an exemplary device for delivering light energy to a patient's scalp are described hereinafter.

[0180] FIG. 1 is an exploded view of a light-emitting device 5 embodied in a wearable cap for delivering light energy to a patient's scalp. The device 5 includes multiple light emitters and standoffs supported by an FPCB 10 including multiple interconnected panels 12A-12F (e.g., multiple interconnected elements) arranged in a concave configuration. A concave molding member 30 (including a frame 31, ribs 32A-32D, and curved panels 34A-34D) is configured to receive the FPCB 10. A fabric cover 60 is configured to cover the concave molding member 30 and the FPCB 10 contained therein. A battery 50 and a battery holder 51 are disposed between the FPCB 10 and the concave molding member 30. An electronics housing 40 is positioned to be received within an opening 31A defined in the frame 31 of the concave molding member 30. Pivot coupling elements 41A, 51A (e.g., cylindrical tabs) are disposed to pivotally couple the battery holder 51 to the electronics housing 40. The electronics board 41 is insertable into the electronics housing 40, which is closed by the cover 42. Disposed on the electronics board 41 are a cycle counter 43, control buttons 44, a charging / data port 45, and a status light 46. The various elements associated with the electronics housing 40 and the electronics board 41 may generally be referred to as a "control module." A window 42A defined in the cover 42 provides access to the cycle counter 43, control buttons 44, charging / data port 45, and status light 46. The fabric cover 60 includes a fabric body portion 61 and a plurality of interior pockets 62A-62D positioned to receive portions of the ribbing 32A-32D. An opening 68 in the top of the fabric cover 60 is positioned to receive the cover 42.

[0115]

[0181] Further views of the concave molding member 30, electronics housing 40, and battery holder 51 are provided in FIGS. 2A-2F. FIG. 2A is a top perspective view, FIG. 2B is a top plan view, FIG. 2C is a front view, FIG. 2D is a left side view, FIG. 2E is a bottom perspective view, and FIG. 2F is a bottom plan view. As shown in FIG. 2A, the ribs 32A-32D and the curved panels 34A-34D project generally outward and downward from the frame 31. The curved panels 34A-34D preferably do not extend downward as far as the ribs 32A-32D. The top plan view provided in FIG. 2B shows that the concave molding member 30 has a generally elliptical shape when viewed from above. In certain embodiments, the ribs 32A-32D, the curved panels 34A-34D, and the frame 31 can be fabricated from one or more pieces of metal by a suitable method, such as molding. As shown in Figures 2B-2D, air gaps 33A1-33D2 are provided between adjacent portions of the ribs 32A-32D and curved panels 34A-34D to accommodate outward expansion and inward contraction and to allow for heat and / or fluid transport (e.g., evaporation of sweat). The cover 42 may be substantially flush or nearly flush with the upper edge of the center frame 31. As shown in Figures 2C and 2D, the front rib 32A may be shorter than the cross ribs 32B, 32D, and the rear rib 32C.

[0116]

[0182] As shown in FIGS. 2E and 2F, the electronics housing 40 may include central holes 40A, 40B to accommodate fasteners (not shown) for receiving the FPCB 10. The electronics housing 40 further includes corner holes 40C positioned to accommodate additional fasteners (not shown) for attaching the cover 42 to the electronics housing 40. The pivotal connection between the battery holder 51 and the electronics housing 40 via the pivotal connection element 51A is shown in FIG. 2E. As shown in FIGS. 2E and 2F, the battery holder 51 is positioned generally below the rear rib 32C and the two rear curved panels 34B, 34C, and the battery 50 has a thin, low-profile shape. In one embodiment, the battery 50 is a flexible battery preferably providing at least 3.7 V and at least 1000 mAh.

[0117]

[0183] Various views of FPCB 10, or portions thereof, in a flat configuration are shown in Figures 3A-3D.

[0184] FIG. 3A is a bottom plan view of FPCB 10 with light emitter 20 and standoffs 25 disposed thereon. FPCB 10 includes polyimide substrate 11, inner surface 11A, and outer surface 11B (shown in FIGS. 1, 3E, 3G, and 3H). Preferably, FPCB 10 is encapsulated along its front and back surfaces with a suitable optically transparent material, such as PETG or silicone (not shown). In one embodiment, light emitter 20 includes a total of 280 light-emitting diodes arranged as 56 strings of five LEDs, with a string voltage of 11 V, a power limit of 5 mA, and a power consumption of 3.08 Watts. FIG. 3A illustrates 36 standoffs 25 extending from inner surface 11A of FPCB 10. FPCB 10 includes six interconnected panels 12A-12F, which are connected to each other via narrowed tab regions 13B-13F. Air gaps 14A-14F are provided between the various panels 12A-12F, and such air gaps 14A-14F (widened near narrowed tab regions 13B-13F) are useful for permitting heat and / or fluid transport (e.g., sweat evaporation) between the panels 12A-12F. As shown in FIG. 3A , holes 15A, 15B are defined through FPCB 10 for receiving fasteners (not shown) for coupling FPCB 10 to corresponding holes 40A, 40B defined in electronics housing 40. An additional opening 15C may be provided for sensor communication between a proximity sensor (e.g., a photosensor) and the interior of FPCB 10 when molded into a concave configuration.

[0118]

[0185] FIG. 3B is a bottom plan view of substrate 11 of FPCB 10, showing electrical traces 17 and emitter mounting areas 18 disposed thereon, before attachment of light emitters and formation of standoffs, and before shaping substrate 11 into a concave configuration. As shown in FIG. 3B, each emitter mounting area 18 includes two anodes and two cathodes to enable attachment of a multi-LED solid-state emitter package including LEDs with different peak wavelengths. The presence of multiple anodes and cathodes in each emitter mounting area 18 allows LEDs with different peak wavelengths to be controlled differently. FIG. 3C is a cross-sectional view of FPCB 10 from below (e.g., as if substrate 11 were transparent), showing electrical traces 16 along the top side of substrate 11.

[0119]

[0186] FIG. 3D is a bottom plan view of the FPCB 10 profile, showing the bend regions and bend angles useful for molding the substrate 11 into a concave shape to fit around a user's scalp. As shown in FIG. 3D, bend regions are provided between each of the panels 12A-12F, with each panel 12A-12F including additional bend regions. The first panel 12A includes two longitudinal bend regions as well as corner bend regions. The second panel 12B includes five bend regions. The third and fourth panels 12C and 12D each include one bend region. The fifth panel 12E and the sixth panel 12F each include four bend regions.

[0120]

[0187] 3E-3H provide various views of FPCB 10 in a concave configuration, including an upper perspective view (FIG. 3E), a lower plan view (FIG. 3F), a left side view (FIG. 3G), and an upper front perspective view (FIG. 3H). FIGS. 3E, 3G, and 3H show outer surface 11B of molded FPCB 10, while FIG. 3F shows inner surface 11A. As is evident from the concave shapes depicted in FIGS. 3E-3H, first panel 12A is configured to cover the user's cranial protuberance, second panel 12B is configured to cover a portion of the user's forehead, third and fourth panels 12C, 12D are configured to cover the user's temples, and fifth and sixth panels 12E, 12F are positioned to cover a rear portion of the user's head.

[0121]

[0188] 4A-4D provide various views of the assembled device 5 of FIG. 1, including a top perspective view (FIG. 4A), a top plan view (FIG. 4B), a front view (FIG. 4C), and a left side view (FIG. 4D). Most of the exterior surface of device 5 includes a fabric cover 60, with the uppermost exterior surface embodying cover 42 for electronics housing 40. Fabric cover 60 includes a fabric body portion 61 and a plurality of (internal) pockets 62A-62D positioned to receive portions of ribbing 32A-32D.

[0122]

[0189] FIG. 5A is a front view of the assembled lighting device of FIGS. 4A-4D superimposed on a modeled human head. As shown in FIG. 5A, device 5 is embodied in a cap with a lower edge between the user's forehead and hairline and above the user's ears. FIG. 5B is a side view of a portion of the lighting device of FIGS. 1, 4A-4D, and 5A, with the concave molding and fabric cover omitted to show the intended placement of FPCB 10, electronics housing 40, cover 42, battery holder 51, and battery 50 relative to the user's head. As shown in FIG. 5B, FPCB 10 fits snugly over at least a portion of the patient's crown.

[0123]

[0190] 6 is a schematic diagram of a fabric cover member 60A including an adjustable closure including portions 68A, 68B positioned to allow adjustment of the opening circumference of the fabric cover member 60A. In certain embodiments, the adjustable closure may include hook-and-loop fasteners, a snap closure, a selectively operable compression fit, or a fabric edge that can be tied to form a knot.

[0124]

[0191] 7A-7F illustrate cross-sectional views of portions of flexible light-emitting devices each including standoffs extending from an encapsulated FPCB that supports multiple light-emitting elements, the standoffs in each case having different shapes and volumes.

[0125]

[0192] 7A is a side cross-sectional view of a portion of a first light emitting device including a standoff 25A having an upwardly curved circular configuration extending from an FPCB 10 that supports multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25A. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25A has a volume of 22.42 cubic millimeters.

[0126]

[0193] 7B is a side cross-sectional view of a portion of a second light emitting device including a standoff 25B having a rounded tower configuration extending from the FPCB 10 supporting multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25B. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25B has a volume of 34.89 cubic millimeters.

[0127]

[0194] 7C is a side cross-sectional view of a portion of a third light emitting device including a standoff 25C having a conical tower configuration extending from the FPCB 10 supporting multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25C. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25C has a volume of 35.5 cubic millimeters.

[0128]

[0195] 7D is a side cross-sectional view of a portion of a fourth light emitting device including a standoff 25D with a recessed cone configuration extending from the FPCB 10 that supports multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25D. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25D has a volume of 62.89 cubic millimeters.

[0129]

[0196] 7E is a side cross-sectional view of a portion of a fifth light emitting device including a standoff 25E having a flat-topped conical configuration extending from the FPCB 10 supporting multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25E. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25E has a volume of 77.31 cubic millimeters.

[0130]

[0197] 7F is a side cross-sectional view of a portion of a fifth light emitting device including a standoff 25F having a circular configuration extending from an FPCB 10 that supports multiple light emitters 20. The emissions of the multiple light emitters 20 overlap on the standoff 25F. Both the inner and outer surfaces 11A, 11B of the FPCB 10 are coated with an encapsulant material 19A, 19B. The standoff 25F has a volume of 92.82 cubic millimeters.

[0131]

[0198] As shown in Figures 7A-7F, a variety of standoff shapes and sizes can be used depending on considerations such as user comfort, material volume, and light interaction and / or light blocking characteristics.

[0132]

[0199] 8 is a schematic diagram illustrating the interconnections between components of a light-emitting device for delivering light energy to a patient's scalp, according to one embodiment. The microcontroller 102 is arranged to receive power from a battery 122 (nominal 3.7 V) via a 5 V voltage boost circuit 112. The microcontroller 102 may be arranged to control a charging integrated circuit 114 arranged between a micro USB connector 116 and the battery 122, which may be used to receive current to charge the battery 122. In certain embodiments, the micro USB connector 116 may be used to communicate data and / or instructions to or from the microcontroller 102 and / or associated memory. The microcontroller 102 is also arranged to control a 12 V boost circuit 118 to increase the voltage to one or more LED arrays 120. The microcontroller 102 further controls one or more LED driver circuits 110 arranged to drive the one or more LED arrays 120. The microcontroller 102 is also arranged to receive inputs from the user input buttons 104, the temperature sensor 124, and the proximity sensor 126 (including the infrared LEDs 128). The microcontroller 102 is further arranged to provide output signals to the LCD display 106 and the buzzer 108. Certain components are located externally to the controller FPCB, as indicated by the vertical dashed lines in FIG. 8 . During operation of the lighting device, a user may press the button 104 to initiate operation. If the proximity sensor 126 detects that the device has been placed on the user's head, the microcontroller 102 may trigger one or more LED driver circuits 110 to energize one or more LED arrays 120. The temperature during operation is monitored by the temperature sensor 124. If an over-temperature condition is detected, the microcontroller 102 may take appropriate action to reduce the current supplied by the one or more LED driver circuits 110 to the one or more LED arrays 120. Operation may continue until a timer (e.g., internal to the microcontroller 102) automatically terminates the operation.One or more indicator LEDs (not shown) may provide a visual signal indicating the charge status of the battery 122. Audible signals for the start or end of operation may be provided by a buzzer 108 or suitable speaker. Information regarding the usage cycle, usage time, or any other parameter may be displayed by the LCD display 106.

[0133]

[0200] 9 is a schematic diagram depicting interfaces between hardware drivers, functional components, and software applications suitable for operating a light-emitting device for delivering light energy to a patient's scalp, according to one embodiment. Application execution functionality 103, including timers and counters 107, may be implemented by one or more integrated circuits (such as the microcontroller 102 illustrated in FIG. 8). The hardware drivers 105 may be used to interface with various input and output elements, such as one or more LED arrays 120, a speaker or buzzer 108, an LCD display 106, a temperature sensor 124, user input buttons 104 (e.g., push buttons), indicator LEDs 109, and an optical sensor 126.

[0134]

[0201]

[0013] Figures 10A-10E illustrate a phototherapy device for delivering light energy to a patient's scalp according to another embodiment. More specifically, Figure 10A is a top perspective view, Figure 10B is a bottom perspective view, Figure 10C is a right side view, Figure 10D is a bottom plan view, and Figure 10E is an exploded view of the phototherapy device. As discussed in more detail below, the phototherapy device 210 may include a flexible cap 212, a flexible printed circuit board (FPCB) assembly 214, a flexible lenticular lens 216, a plurality of standoffs 218a, 218b, foam pads 220a, 220b, and a binding edge 221 (shown in Figures 13A and 13B).

[0135]

[0202] The flexible cap 212 may comprise one or more different fabrics or materials (e.g., cotton, open or closed cell polyethylene foam, polyester, rayon, etc.) and may be formed in a variety of different shapes and sizes depending on the patient's head dimensions. In certain embodiments, the flexible cap 212 comprises a stretchable material to accommodate various head sizes. The flexible cap 212 includes a proximal surface 222 (e.g., which may be variously described as a bottom surface, lower surface, inner surface, or surface near the patient) and a distal surface 224 (e.g., which may be variously described as a top surface, upper surface, outer surface, or surface away from the patient). The flexible cap 212 forms a concave surface 226 generally sized and shaped to receive an upper portion of the patient's head and may include a rear extension 228 configured to cover a lower, rear portion of the patient's head (e.g., near the nape of the neck, rear hairline, occipital protuberance, etc.). Near the rear extension 228 (but toward the center of the flexible cap 212), the flexible cap 212 may include bent bows (e.g., left bent bow 229a and right bent bow 229b) that allow the rear extension 228 to bend outward more easily to accommodate various head sizes.

[0136]

[0203] In certain embodiments, flexible cap 212 may include a sealing plug 232 that removably attaches to and covers electronic connection port 230 on flexible cap 212. Electronic connection port 230 is mechanically attached to an electronics receptacle 234 that is disposed on flexible cap 212. Sealing plug 232 covers electronic connection port 230 and protects it from damage when not in use. Electronics receptacle 234 may be configured to receive electronics subassembly 250 (shown in FIGS. 11A and 11B and discussed in more detail below) of FPCB assembly 214 and provide mechanical stability to electronics subassembly 250. For example, electronics receptacle 234 may be mechanically attached to and secured to electronics subassembly 250 to prevent relative movement therebetween. Electronic connection port 230 (together with electronics receptacle 234) may provide mechanical and / or electronic connectivity between electronics subassembly 250 and an electronic device (e.g., a computer, smartphone, etc.) or electronic connector (e.g., a power cord, USB cord, etc.) outside of light therapy device 210 for receiving power and / or electronic data (e.g., operating parameters). In certain embodiments, wireless communication may be provided between light therapy device 210 and an electronic device. In certain embodiments, a battery operably coupled to FPCB assembly 214 may be inductively charged (e.g., wirelessly charged).

[0137]

[0204] The FPCB assembly 214 (discussed in more detail below) includes a proximal surface 236 (which may be variously referred to as a bottom surface, lower surface, inner surface, inner side, or surface near the patient) and a distal surface 237 (which may be variously referred to as a top surface, upper surface, outer surface, outer side, or surface away from the patient). The FPCB assembly 214 forms a concave surface 238 generally sized and shaped to receive at least an upper portion of the patient's head and may include a rear extension 239 configured to cover a lower, rear portion of the patient's head (e.g., near the nape of the neck, rear hairline, occipital protuberance, etc.). The proximal surface 236 includes at least one light-emitting device (e.g., an LED) and may also include multiple LED devices configured to generate radiation having one or more peak wavelengths (e.g., red and / or blue LEDs), as discussed in more detail above.

[0138]

[0205] The flexible lenticular lens 216 includes a proximal surface 252 (e.g., an inner surface, an inner side, a surface near the patient) and a distal surface 254 (e.g., an outer surface, an outer side, a surface away from the patient). The flexible lenticular lens 216 forms a concave surface 256 that is generally sized and shaped to the patient's head and may include a posterior extension 258 configured to cover a lower portion of the back of the patient's head (e.g., the nape of the neck, the posterior hairline, the occipital protuberance, and / or nearby). Near the posterior extension 258 (but toward the center of the flexible lenticular lens 216), the flexible lenticular lens 216 may include bending bows 259 a and 259 b, which allow the posterior extension 258 to more easily bend outward to accommodate various head sizes. The flexible lenticular lens 216 may be molded and may have a thickness of approximately 0.02 inches to 0.06 inches (e.g., approximately 0.033 inches) and a lens density ranging from about 10 to about 80 lenses per inch, or about 20 to about 60 lenses per inch, or about 30 to about 50 lenses per inch, or about 40 lenses per inch (LPI), although other dimensions may also be used. Depending on the material used, if the flexible lenticular lens 216 has a thickness less than about 0.02 inches, it may result in undesirable shrinkage or wrinkling, and if the flexible lenticular lens 216 has a thickness greater than 0.02 inches, it may be insufficiently flexible or stretchy to accommodate different patient head sizes.

[0139]

[0206] In certain embodiments, the flexible lenticular lens 216 may include pad recesses 260 along the outer periphery of the flexible lenticular lens 216 to receive the foam pads 220a, 220b (so that the foam pads 220a, 220b contact the flexible lenticular lens proximal surface 252). In this manner, the pad recesses 260 and the foam pads 220a, 220b may generally complement each other in size and / or shape. In certain embodiments, the pad recesses 260 and the foam pads 220a, 220b may be configured to extend along the entire outer periphery of the flexible lenticular lens 216 or a portion thereof. The foam pads 220a, 220b provide an added layer of comfort and a compressible layer for improved fit to the patient's head. In certain embodiments, the foam pads 220a, 220b may be removably attached (e.g., by Velcro®) to the flexible lenticular lens proximal surface 252, such that the foam pads 220a, 220b may be washable and / or replaceable.

[0140]

[0207] FPCB assembly 214 is positioned between flexible cap 212 and flexible lenticular lens 216. More specifically, FPCB assembly 214 is positioned within flexible cap concave surface 226 such that FPCB assembly distal surface 237 is near flexible cap proximal surface 222. Flexible lenticular lens 216 is positioned within FPCB assembly concave surface 238 such that flexible lenticular lens distal surface 254 is positioned near FPCB assembly proximal surface 236. In this manner, when flexible cap 212, FPCB assembly 214, and flexible lenticular lens 216 are assembled together, the concave surfaces and their outer peripheries are generally aligned with one another. In the same manner, flexible cap concave surface 226, FPCB concave surface 238, and flexible lenticular lens concave surface 256 are all generally aligned with one another, flexible cap rear extension 228, FPCB assembly rear extension 239, and flexible lenticular lens rear extension 258 are all generally aligned with one another, and flexible cap bending arcs 229a, 229b and flexible lenticular lens bending arcs 259 are generally aligned with one another. Binding edge clips 221 (shown in FIG. 13B) may be positioned along the outer periphery of flexible cap 212, FPCB assembly 214, and flexible lenticular lens 216 to secure them together (e.g., binding edge clips 221 are biased inward).

[0141]

[0208] The plurality of standoffs 218a, 218b may include a top standoff 218a positioned on or along the flexible lenticular lens 216 and side standoffs 218b positioned on or along the sides of the flexible lenticular lens 216. Each standoff 218a, 218b includes a proximal end 262 and a distal end 264. The standoffs 218a, 218b are positioned between the flexible lenticular lens 216 and the FPCB assembly 214. In certain embodiments, the standoffs 218a, 218b may be attached to the flexible lenticular lens 216 (e.g., by adhesive) or may be integrally formed therewith (e.g., by co-molding the standoffs 218a, 218b with the flexible lenticular lens 216). More specifically, for each standoff 218a, 218b, standoff proximal end 262 contacts (and extends from) flexible lenticular lens distal surface 254, and standoff distal end 264 may contact FPCB assembly proximal surface 236 such that the distance between FPCB assembly proximal surface 236 and flexible lenticular lens distal surface 254 is equal to or less than the height of standoff 218a, 218b. The height of standoff 218a, 218b may be greater than the height of the LED (of the plurality of LEDs) to prevent flexible lenticular lens distal surface 254 from contacting the LED (and / or any of the plurality of LEDs). Standoffs 218a, 218b maintain a minimum distance between flexible lenticular lens distal surface 254 and FPCB assembly proximal surface 236, as described in more detail below.

[0142]

[0209] 11A-11C are diagrams of FPCB assembly 214. More specifically, FIG. 11A is a rear view, FIG. 11B is a side cross-sectional view, and FIG. 11C is an exploded view of FPCB assembly 214. FPCB assembly 214 includes panel subassembly 240 (e.g., multiple interconnected FPCB panels or elements) and electronics subassembly 250. Electronics subassembly 250 is attached to panel subassembly 240 by mount 266, which also houses electronic circuitry therein. Mount 266 includes multiple attachments extending from its bottom surface, including tabs 268a, 268b, engagement prongs 270, threaded rod 272, prong receptacle 274, and the like. Mount 266 also includes electronics port 27 extending therethrough. In certain embodiments, electronics port 275 may be embodied in an electronics connector, providing mechanical and electronic communication (described in more detail below) between an external electronics device or connector and electronics subassembly 250.

[0143]

[0210] Electronics subassembly 250 also includes an O-ring 276 positioned around electronics port 275 on the bottom surface of mount 266. Electronics subassembly 250 further includes a control printed circuit board (PCB) 278 that includes driver circuitry for controlling the operation of panel subassembly 240 (and the LEDs mounted thereon). Control PCB 278 includes multiple attachments, including screw holes 280 and prong holes 282. Screw holes 280 receive screws 284 therethrough that extend into mount threaded rods 272, thereby attaching control PCB 278 to the bottom of mount 266 (although any other suitable fasteners or attachment means may be used). Tab 268b and / or its opposite ridge 269 further secure control PCB 278 to mount 266 by preventing lateral movement of control PCB 278 relative to mount 266 (tab 268b may also be inserted into a groove or hole in panel subassembly 240).

[0144]

[0211] The electronics port 275 is aligned with the connector circuitry of the control PCB 278 and the flexible cap electronics receptacle 234 (shown in FIG. 10E) to provide electronic and / or mechanical access of the PCB electronics connector to an external electronic device (e.g., a computer, a smartphone, etc.) or electronic connector (e.g., a power cord, a USB cord, etc.) for receiving power and / or electronic communications (e.g., instructions, software updates, operating parameters, operating data, and the like).

[0145]

[0212] Electronics subassembly 250 further includes a battery 286 attached to the bottom surface of mount 266 by a battery attachment 288 (e.g., an adhesive film, a mechanical element, etc.). FPCB locking pad 290 is positioned on FPCB assembly proximal face 236 and aligned with FPCB snap lock 292. FPCB snap lock 292 includes engagement prongs 294 (e.g., outwardly biased) that extend through slot 304 in panel subassembly 240, through control PCB prong holes 282, and through mount prong receptacle 274, thereby securing panel subassembly 240, control PCB 278, and mount 266 together. Thus, control PCB 278 and battery 286 are positioned adjacent to one another and together contact (or are positioned near) FPCB assembly distal face 237.

[0146]

[0213] 12A-12E illustrate a panel subassembly (also illustrated in FIGS. 11A-11C. More specifically, FIG. 12A is a bottom perspective view of the panel subassembly in a bent configuration, FIG. 12B is a bottom plan view of the panel subassembly in a bent configuration, FIG. 12C is a side cross-sectional view of the panel subassembly, FIG. 12D is a top plan view of the panel subassembly in a flat and fully extended configuration with the bent region illustrated, and FIG. 12E is a bottom plan view of the panel subassembly in a flat and fully extended configuration.

[0147]

[0214] Panel subassembly 240 includes multiple interconnected FPC board panels that can bend and move relative to one another (e.g., along reduced width regions or using hinge-like structures) to form various dihedral angles. Panel subassembly 240 includes a body portion 300 (e.g., one or more body panels) with a stiffener area 302 positioned between two through-slots 304. Through-slots 304 receive FPC snap-lock engagement prongs 294 (shown in FIGS. 11A-11C and discussed above) and are aligned with electronics subassembly control PCB prong holes 282 and electronics subassembly mounting prong receptacles 274, as described above.

[0148]

[0215] Body portion 300 includes a plurality of radially extending portions (eg, a series of interconnected panels) positioned generally circumferentially around the outer periphery of body portion 300 . More specifically, the main body portion 300 includes a front extension 306, a rear extension 324 (extending opposite the front extension 306), a left extension 328a (positioned between and to the left of the front extension 306 and the rear extension 324), a right extension 328b (positioned between and to the right of the front extension 306 and the rear extension 324), a left front extension 332a (positioned between the front extension 306 and the left extension 328a), a left rear extension 338a (positioned between the rear extension 324 and the left extension 328a), a right front extension 332b (positioned between the front extension 306 and the right extension 328b), and a right rear extension 338b (positioned between the rear extension 324 and the right extension 328b). Each extension may include one or more panels separated by a bending region to allow bending or other relative movement therebetween (e.g., forming various dihedral angles).

[0149]

[0216] Front extension 306 is attached to main body portion 300 at a proximal end, and its distal end (opposite the proximal end) includes a reinforcement section 308 and a capacitive touch-active pad 322. Reinforcement section 308 is provided on distal surface 237 (e.g., the top surface), and capacitive touch-active pad 322 is provided on proximal surface 236 (e.g., the bottom surface), with reinforcement section 308 and capacitive touch-active pad 322 facing each other but aligned with each other. Front extension 306 further includes left flap 312a attached to the left side of the distal end of front extension 306 and right flap 312b attached to the right side of the distal end of front extension 306.

[0150]

[0217] A capacitive tab 316 is attached to the distal end of the front extension 306 by a neck 318. The capacitive tab 316 includes a stiffener section 320 on the distal surface 237 and a signal guard 310 on the proximal surface 236, with the stiffener section 320 and the signal guard 310 disposed opposite each other but aligned with each other. The capacitive tab 316 can be bent outward by the neck 318 so that the capacitive tab stiffener section 320 and the front extension stiffener section 308 contact each other. In such a configuration, the capacitive tab stiffener section 320, signal guard 310, front extension stiffener section 308, and front extension capacitive touch-active pad 322 are aligned with each other. In an alternative embodiment, the capacitive tab 316 can be bent inward by the neck 318. In such a configuration, the extension reinforcement area 308 and the capacitive tab reinforcement area 320 may be disposed along the proximal surface, the front extension 306 may include a signal guard on the distal surface, and the capacitive tab 316 may include a capacitive touch active pad on the distal surface.

[0151]

[0218] Rear extension 324 is attached to main body 300 at its proximal end and includes left and right flaps 326a, 326b at its distal end. Left extension 328a is attached to main body 300 at its proximal end and includes front flap 330a at its distal end. Right extension 328b is attached to main body 300 at its proximal end and includes front flap 330b at its distal end. Left front extension 332a is attached to main body 300 at its proximal end and includes front and rear flaps 334a, 336a at its distal end. Left rear extension 338a is attached to main body 300 at its proximal end and includes rear flap 340a at its distal end. Right front extension 332b is attached to main body 300 at its proximal end and includes front and rear flaps 334b, 336b at its distal end. Right rear extension 338b is attached to main body portion 300 at its proximal end and includes a rear flap 340b at its distal end.

[0152]

[0219] The extensions and flaps may each include one or more panels and / or bend regions 352a, 352b. More specifically, as shown in FIG. 12D , the extensions and flaps may each include one or more horizontal bend regions 352a (e.g., bends perpendicular to the radius of the main body portion 300). At least a portion of each extension may be connected to at least a portion of the respective flap by a vertical bend region 352b (bends along the radius of the main body portion 300). The bend regions 352a, 352b allow the panel subassembly 240 to conform to the shape of the patient's head (e.g., the vertical bend region 352b allows the panel subassembly 240 to conform to the circumference of the patient's head). The flaps may be attached to their respective extensions along all or a portion of the sides of the flap.

[0153]

[0220] Panel subassembly 240 includes a plurality of ingress prevention regions 350 a, 350 b on its proximal surface 236. When FPCB assembly 214 and flexible lenticular lens 216 are assembled together, ingress prevention regions 350 a, 350 b generally align with (and are larger than) distal ends 264 of the plurality of standoffs 218 a, 218 b to protect the circuitry of panel subassembly 240 and to prevent standoffs 218 a, 218 b from contacting light emitters attached to panel assembly 240. More specifically, top ingress prevention region 350 a aligns with and contacts top standoff 218 a, and side ingress prevention region 350 b aligns with and contacts side standoff 218 b. In certain embodiments, panel subassembly 240 may include an encapsulant layer.

[0154]

[0221] 12F-12H illustrate a capacitor. More specifically, FIG. 12F is a cross-sectional view of a flexible printed circuit board (FPCB) incorporating elements for fabricating a capacitor, prior to folding the FPCB (in the direction of curved arrow C, along fold line AA) and bonding the capacitor elements. FIG. 12F illustrates a copper layer 305C disposed between a cover layer 305A and a carrier (e.g., polyimide) layer 305B of an FPCB 306 (which may be embodied in a front extension panel), with capacitive touch active pads 322 and signal guards 310 further attached to the FPCB 306 (preferably over a first surface of the carrier layer 305B and in electrical communication with traces formed by the copper layer 305A). A front extension stiffener area 308 and a capacitive tab stiffener area 320 are provided along a second surface of the carrier layer 305B near the signal guards 310 and the capacitive touch active pads 322, respectively. Adhesive (or double-sided adhesive tape) 325 is disposed along one or more of the stiffener sections 308, 320 to provide a non-conductive bond therebetween when the FPCB is folded along fold line AA in the direction of curved arrow C. FIG. 12G is a cross-sectional view of the FPCB 306 shown in FIG. 12F and a capacitor 353 fabricated from the elements after folding of the FPCB 306 and bonding of the stiffener sections (or spacer elements) 308, 320 together. In certain embodiments, the portion of the FPCB 306 extending forward of fold line AA may embody a capacitive tab 316 that is continuous with the remainder of the FPCB 306. In other embodiments, the capacitive tab 316 may embody a second FPCB panel that is discontinuous with the FPCB 306.

[0155]

[0222] In certain embodiments, the capacitor 353 shown in FIG. 12G comprises a front extension 306 (which may be embodied in a front extension panel, a first FPCB panel, a first FPCB element, etc.), a front extension stiffener area 308 (e.g., a first stiffener area), a front extension capacitive touch-active pad 322 (e.g., a capacitive pad), a carrier layer 305B (which may be embodied in a capacitive tab 316 or a capacitive tab panel, a second FPCB panel, a second FPCB element, etc.), a capacitive tab stiffener area 320 (e.g., a second stiffener area), a signal guard 310 (e.g., a signal ground hatch), and an adhesive (or double-sided adhesive tape) 325 positioned between the front extension stiffener area 308 and the capacitive tab stiffener area 320. The front extension stiffener area 308, the capacitive tab stiffener area 320, and the adhesive (or double-sided adhesive tape) 325 provide a non-conductive separation between the front extension capacitive touch active pad 322 and the signal guard 310. As shown in FIG. 12G , the carrier layer 305B (e.g., 0.1-1.5 mm thick), the front extension stiffener area 308 (e.g., 0.25-2.5 mm thick), the capacitive tab stiffener area 320 (e.g., 0.25-2.5 mm thick), and the adhesive (or double-sided adhesive tape) 325 (e.g., 0.01-0.25 mm) together define a distance (e.g., a predetermined distance, d in Equation 1 below) between the front extension capacitive touch active pad 322 and the signal guard 310 that corresponds to a predetermined capacitance value, such as that shown below.

[0156]

number

[0223] In Equation 1, L is the length of the conductive element, W is the width of the conductive element, and E rwhere σ is the dielectric constant and d is the dielectric thickness between the conductive elements. In one embodiment, the length is about 3.0 cm, the width is about 2.0 cm, and the thickness is about 0.75-1.00 mm. This provides a capacitance for the capacitor 353 of about 25-33 pF. In certain embodiments, the signal guard 310 may have a lateral dimension (e.g., width) that exceeds the lateral dimension of the front extension capacitive touch active pad 322 by 20%-40%. The first and second FPCB panels may comprise polyimide, and the first and second stiffener regions may have a dielectric constant of 2.5-5 (e.g., 4-4.5).

[0157]

[0224] It should be noted that a single stiffener may be used in place of two stiffeners. For example, the front extension stiffener region 308 may be doubled in thickness so that the capacitive tab stiffener region 320 is not needed. The stiffeners (e.g., non-conductive spacers) may be any non-conductive material (e.g., foam, PCB, etc.) and may be attached to their respective FPCB components by fasteners or adhesives (e.g., glue, tape, etc.). The adhesive 325 may be applied to at least a portion of the front extension stiffener region 308 and / or the capacitive tab stiffener region 320. Additionally, any type of adhesive 325 may be used (e.g., double-sided tape, glue, etc.), and other types of attachments, such as fasteners (e.g., screws, nails, etc.), may be used other than the adhesive 325. In such circumstances, the adhesive 325 may be omitted.

[0158]

[0225] In certain embodiments, the capacitor 353 may be used as a proximity sensor (e.g., a capacitive sensor) such that the light therapy device 210 can determine whether the light therapy device 210 is near the patient's forehead by changes in capacitance and / or voltage (e.g., due to interaction with an electric field near the patient's skin). In certain embodiments, the patient's skin may change the capacitance (and resulting voltage) from close proximity without requiring contact with the capacitor 353.

[0159]

[0226] The panel of the panel subassembly 240, as a flex circuit, is very thin (e.g., about 0.10 mm or less). This thickness is generally too thin to provide adequate capacitance values ​​for a proximity sensor because the capacitance is quite high. Therefore, folding the capacitive tab 316 aligns the signal guard 310 with the front extension capacitive touch-active pad 322, and a minimum distance between them is maintained by the front extension stiffener area 308, the capacitive tab stiffener area 320, and / or the adhesive 325, which preferably embody a dielectric material. Thus, a larger distance is created between these two conductive plates (e.g., the signal guard 310 and the front extension capacitive touch-active pad 322), modifying the capacitance value. Optionally, the capacitance value may be further adjusted by adding a layer of material (e.g., double-sided adhesive tape 325) between the two plates (e.g., signal guard 310 and front extension capacitive touch-active pad 322), with such additional material preferably acting as a dielectric.

[0160]

[0227] In certain embodiments, the capacitor 353 provides direction sensing functionality such that only the capacitance of the front extension capacitive touch-active pad 322 is altered by the proximity of skin thereto. In certain embodiments, the signal guard 310 may be configured to be driven with an opposite polarity to that of the front extension capacitive touch-active pad 322, and the signal guard 310 may be larger in size than the front extension capacitive touch-active pad 322 so that it extends beyond the margins of the front extension capacitive touch-active pad 322. This ensures that the proximity of skin to the signal guard 310 does not change the capacitance of the front extension capacitive touch-active pad 322. In other words, the front extension capacitive touch-active pad 322 is configured to detect capacitance changes (due to skin proximity) arising from inside the light therapy device 210, and the signal guard 310 prevents detection of spurious proximity signals (e.g., from capacitance changes arising from sources outside the light therapy device 210). This prevents the patient from triggering operation of the light therapy device 210 by touching the outside of the light therapy device 210 (e.g., capacitive tab 316). The light therapy device 210 is triggered only from wearing the light therapy device 210 (e.g., because the patient's skin modifies the capacitance of the capacitor 353). The front extension signal guard 310 may be patterned with copper (e.g., hatch, mesh, etc.) to form a Faraday cage to insulate the front extension capacitive touch-active pad 322, which may include a continuous (e.g., solid copper) conductive surface.

[0161]

[0228] FIG. 12H shows a circuit 354 for the capacitor 353 (or proximity sensor). The circuit 354 includes a capacitive touch controller 355 (e.g., a microcontroller), which may be an integrated circuit (IC). The circuit 354 may be connected to the front extension capacitive touch active pad 322, the signal guard 310, and a power circuit 356 (including a positive power supply voltage and ground). Additionally, the circuit 354 may be connected to one or more data sources 357 (e.g., a serial data line (SDA), a serial clock line (SCL), etc.) and an interrupt 358 (INT). When the interrupt 358 is triggered, the interrupt 358 sends a signal to the motherboard to bring the motherboard from a sleep state (e.g., to save power) to an active state. In the active state, the motherboard may check wireless (e.g., Bluetooth) signals and / or electrical connections, check accounts (e.g., status), and / or enable operation of the phototherapy device 210. In particular embodiments, circuitry 354 may remain continuously active and provide feedback to the controller such that interrupt 358 is triggered when voltage and / or capacitance exceeds a predetermined value (e.g., 12-50 pF), such as resulting from a change in capacitance of capacitor 353. In particular embodiments, the sensitivity threshold may be adjusted by capacitive touch controller 355.

[0162]

[0229] 13A and 13B illustrate a patient wearing and using the light therapy device 210 of FIGS. 10A-10. More specifically, FIG. 13A is a front view of a patient wearing the light therapy device 210, and FIG. 13B is a side cross-sectional view of a patient wearing the light therapy device 210. As shown, the front of the light therapy device 210 is positioned over the patient's eyes, and the back of the light therapy device 210 (e.g., the rear extension) extends along the lower back of the head, such that the front and rear lower edges of the light therapy device 210 are at two different heights when in use. This allows the light therapy device 210 to increase its coverage area to cover desired hair-producing areas of the patient's 360 scalp. As discussed above, the flexible cap 212, FPCB assembly 214, and flexible lenticular lens 216 may be adjustable in size and shape (e.g., the circumference may vary) to accommodate different users. For example, the inner circumference may vary from 54 cm to 64 cm.

[0163]

[0230] During use, the LEDs of the phototherapy device 210 provide therapeutic light radiation to the scalp 362 of the patient 360. More specifically, the LEDs mounted on the FPCB assembly proximal face 236 transmit light through the flexible lenticular lens 216, which defocuses the light radiation to increase the uniform distribution of the light radiation across the patient's scalp 362. In certain embodiments, a flexible lenticular lens 216 is used, although other light-transmitting materials or layers, including a diffuser, may be used. The flexible lenticular lens 216 is preferably positioned a predetermined distance from the LEDs for optimal light radiation distribution and performance (e.g., avoiding positioning the LEDs too far or too close to the flexible lenticular lens 216) and to maintain a safe distance between the patient's scalp 362 and the LEDs (e.g., from heat generated by the LEDs). This distance (e.g., 3.5 mm between the LED and the flexible lenticular lens 216 in a particular embodiment) is maintained by a plurality of standoffs 218a, 218b, where gravity naturally urges the FPCB assembly 214 toward the flexible lenticular lens 216, and the plurality of standoffs 218a, 218b contact the FPCB assembly 214 to maintain a minimum distance therebetween (for LED protection, optical optimization, and / or thermal isolation from the patient's scalp).

[0164]

[0231] In certain embodiments, the LEDs may provide one or more peak wavelengths (e.g., red light emission and / or blue light emission), such as between about 620 nm and 660 nm and / or between 660 nm and 670 nm. For example, the plurality of LEDs may include LEDs producing peak wavelengths of about 420 nm and 620 nm, or 420 nm and 660 nm, or 420 nm, 625 nm, and 660 nm.

[0165]

[0232] 14A-14D are diagrams of a package and a phototherapy device. More specifically, FIG. 14A is a top perspective view of a package including a phototherapy device. FIG. 14B is an exploded perspective view of the package and phototherapy device after removal of the top cover from the bottom cover (the top cover is transparent for illustration purposes). FIG. 14C is an exploded view of the package with the phototherapy device of FIGS. 14A and 14B (the top cover is transparent for illustration purposes). FIG. 14D is a side cross-sectional view of the packaged phototherapy device. The packaged device 400 includes a top cover 402, a bottom cover 404, a charging base 406 therebetween, and an accessory box 408 positioned between the bottom cover 404 and the charging base 406, with the phototherapy device 410 positioned on the charging base 406 between the charging base 406 and the top cover 402.

[0166]

[0233] The top cover 402 may be provided in a variety of shapes and sizes. In certain embodiments, the top cover 402 may include an upper wall 412 having a sidewall 416 extending downward from its periphery. In certain embodiments, the sidewall may include a cord hole punch 418 to receive an electronic connector therethrough for connection to the light therapy device 410. In certain embodiments, the top cover 402 may include one or more locating flaps 420 located near (but slightly away from) the opening in the top cover 402 to provide sufficient clearance to receive a portion of the bottom lid 404. The locating flaps 420 help stabilize the light therapy device 410 and prevent its lateral movement. In certain embodiments, the top cover 402 may include an insert 422 having a lower wall 424 and a sidewall 426 extending upward from its periphery. The insert 422 includes a clearance hole 428 approximately in its center for receiving a portion of the top of the light therapy device 410. The top cover insert 422 thus prevents lateral movement of the light therapy device 410 and secures the light therapy device 410 between the insert 422 and the charging base 406.

[0167]

[0234] The bottom cover 404 may be provided in a variety of shapes and sizes. The bottom cover 404 may include a bottom wall 430 having a sidewall 432 extending upward from its periphery. In certain embodiments, the bottom cover 404 may include an insert 434 having a bottom wall 436, an outer wall 438 along its outer periphery, and an inner wall 440 along its inner periphery, defining an internal bore 442 (extending through the bottom wall 436). In certain embodiments, the insert outer wall 438 may be taller than the bottom cover sidewall 432, such that the insert outer wall 438 contacts the inside of the top cover sidewall 416 (to frictionally secure the top cover 402 thereto and prevent lateral movement therebetween). The bottom cover insert inner wall 440 may receive the accessory box 408 therein (to frictionally secure the accessory box 408 thereto and prevent lateral movement therebetween). The accessory box 408 may include a headliner pack, a USB cable, an AC adapter, and the like.

[0168]

[0235] 15A-15D are diagrams of the charging base 406. More specifically, FIG. 15A is a top perspective view of the charging base of the packaged phototherapy device, FIG. 15B is a bottom perspective view of the charging base, FIG. 15C is a side view of the charging base, and FIG. 15D is a top plan view of the charging base. The charging base 406 may include a base 444 that is complementary in shape to the shape of the bottom lid insert outer wall 438 (to frictionally secure the charging base 406 thereto and to prevent lateral movement therebetween). In certain embodiments, the charging base 406 may include a notch 446 on the front edge of the base 444 to facilitate removal of the charging base 406 from the bottom lid 404 (shown in FIGS. 14A-14D and discussed above). In certain embodiments, the charging base 406 may include one or more feet 448 extending from the bottom surface of the charging base 406. The feet 448 may be integrally formed with the base 444 or may be attached thereto.

[0169]

[0236] The base 444 has a contoured top 452 (e.g., a convex top) that generally conforms to the shape of the proximal surface of the light therapy device 410, and the base 444 may include a lip 450 that generally conforms to the outer periphery of the light therapy device 410. Thus, the contoured top 452 and lip 450 of the charging base 406 stabilize the light therapy device 410 when placed thereon. Additionally, the contoured top 452 receives the accessory box 408 within an interior defined by the contoured top 452. The charging base 406 may be used to hold the light therapy device 410 when it is not in use and / or is charging, thereby supporting the light therapy device 410 in a protective manner and preventing its shape from being distorted. In certain embodiments, the charging base 406 may provide wireless inductive charging of the light therapy device 410 through the contoured top 452 when the light therapy device 410 is positioned thereon.

[0170]

[0237] Various types of phototherapy devices for delivering light energy to a patient's treatment area are described above. Such phototherapy devices may be provided alone or integrated with other therapies for the treatment and / or prevention of hair loss. In this manner, the phototherapy devices described herein may be well suited to forming part of a combination therapy in the treatment and / or prevention of hair loss. An exemplary combination therapy includes the application of one or more hair growth agents in conjunction with the application of light to a common treatment area. In various embodiments, the hair growth agent may be administered prior to and / or simultaneously with the light treatment. In certain applications, the hair growth agent may provide additive benefits to the light treatment in certain embodiments. In other applications, the hair growth agent and the light treatment may provide synergistic benefits, thereby promoting a multiplier effect for enhanced treatment and / or prevention of hair loss.

[0171]

[0238] As described herein, hair growth agents may include, in addition to light, platelet-rich plasma, hyaluronic acid, minoxidil, amino acids such as arginine, finasteride, tretinoin, ketoconazole, or spironolactone, and other substances associated with nitric oxide release. Delivery of such hair growth agents includes application by one or more of local injection, topical application, and / or systemic delivery via oral and / or intravenous delivery.

[0172]

[0239] 16A and 16B depict an exemplary method for providing a combination therapy including both a hair growth agent and light therapy for the treatment and / or prevention of hair loss. In FIG. 16A, a first step 454 involves administering a hair growth agent to a treatment area of ​​mammalian tissue, followed by a second step 456 of applying light having a first peak wavelength to the treatment area. In certain embodiments, the first peak wavelength may include any of the wavelengths or wavelength ranges described above, including, for example, the 600 nm to 700 nm range. An optional third step 458, as indicated by the dashed line in FIG. 16A, may include administering a photosynthesizing agent or photoactivatable agent to the treatment area prior to applying light to the treatment area. The photosynthesizing agent may be applied simultaneously with the hair growth agent or as an intermediate step between application of the hair growth agent in the first step 454 and the light therapy in the second step 456.

[0173]

[0240] The time period or delay between the first step 454 and the second step 456 can be determined based on the type of hair growth agent being applied to enhance the effectiveness of the agent on the tissue. By way of example, a time delay of at least 5 minutes, or at least 10 minutes, or at least 15 minutes can provide sufficient time for certain hair growth agents, such as those applied topically, to effectively engage the tissue. In certain embodiments, the second step 456 can be performed within a time window of the first step 454, such as within 5 hours, within 1 hour, or within 30 minutes. As such, the second step 456 can be performed within a range from any of the above time delay values ​​(e.g., 5 minutes, 10 minutes, 15 minutes) to any of the above time windows (e.g., 30 minutes, 1 hour, 5 hours).

[0174]

[0241] 16B illustrates a method similar to that of FIG. 16A, except that a hair growth agent may be administered simultaneously with or immediately following the light treatment. In this manner, a first step 454 and a second step 456 may be performed simultaneously or immediately following, such as in less than five minutes. Additionally, an optional third step 458 may also be performed simultaneously with or immediately following the first step 454 and the second step 456.

[0175]

[0242] FIG. 17 is a side cross-sectional view of a patient wearing a phototherapy device 460 configured to provide both a hair growth agent and light therapy to the patient's scalp. The phototherapy device 460 may embody any of the phototherapy devices described above with respect to FIGS. 1-15D , with the additional feature of being able to administer a hair growth agent to a treatment area, in this case, the patient's scalp. As illustrated, a structure 462 of the phototherapy device 460 is generally illustrated in FIG. 17 . The structure 462 may incorporate any of the features described above with respect to FIGS. 1-15D , including, but not limited to, one or more of the features of the phototherapy device 5 of FIG. 1 and / or the phototherapy device 210 of FIG. 10E . For purposes of illustration, a light-emitting device 464, such as an LED, is generally illustrated in FIG. 17 along with the structure 462 in a position that directs light toward the patient's scalp. Light from the light-emitting device 464 may impinge directly on the scalp or may pass through one or more elements associated with the structure 462, such as the lens or lenticular lens 216 illustrated above with respect to FIG. 10E. In FIG. 17, the phototherapy device 460 may further include an applicator structure 466 configured to administer one or more hair growth agents to or within the surface of the scalp. The one or more hair growth agents may be stored within a reservoir in the structure 462, and the applicator structure 466 may embody a dispensing needle or tip through which the one or more hair growth agents exit the phototherapy device 460. In certain embodiments, the applicator structure 466 may embody a needle that penetrates the surface of the scalp for delivery of a localized injection of the hair growth agent. In this manner, the phototherapy device 460 may be configured to administer the hair growth agent simultaneously with the light, or the phototherapy device 460 may be configured to provide light within a time delay and time window as described above with respect to FIG. 16A.

[0176]

[0243] 18 is a side cross-sectional view of a patient wearing a delivery device 468 configured to provide a hair growth agent separately from light therapy. In this manner, structure 470 of device 468 may not include features associated with providing light therapy as described above. Rather, structure 470 may include a reservoir containing a hair growth agent and applicator structure 466 described above. Thus, the patient may first fit device 468 to their scalp for delivery of the hair growth agent, followed by light therapy delivered by any of the light therapy devices described above with respect to FIGS. 1-15D.

[0177]

[0244] 19A and 19B are side and end views of another delivery device 472 configured to separately deliver a hair growth agent to the scalp before light therapy is delivered by any of the phototherapy devices described above with respect to FIGS. 1-15D. FIG. 19A is a side view of delivery device 472, and FIG. 19B is an end view of delivery device 472. Device 472 may include a central structure 474 and a rotating structure 476 configured to rotate about central structure 474. A portion of central structure 474 spaced from rotating structure 476 may form a handle for device delivery 472. For illustrative purposes, only a small portion of applicator structure 466 is illustrated in FIG. 19A. As best illustrated in FIG. 19B, applicator structure 466 may be radially disposed about rotating structure 476. One or more hair growth agents may be contained within delivery device 472, such as within a reservoir of rotating structure 476. In this regard, the delivery device 472 may be configured to locally apply a hair growth agent for delivery of a local infusion of the hair growth agent upon rotation in the patient's tissue before light therapy is provided by a separate device.

[0178]

[0245] Those skilled in the art will recognize improvements and modifications to the preferred embodiments of the present disclosure, and all such improvements and modifications are considered within the scope of the concepts described herein and the claims that follow.

Claims

1. 1. A method for delivering light radiation to stimulate hair growth, comprising: applying a hair growth agent to a treatment area of ​​mammalian tissue; after applying the hair growth agent to the treatment area, applying light having a first peak wavelength in the range of 600 nanometers (nm) to 700 nm to the treatment area; A method comprising:

2. 10. The method of claim 1, wherein the hair growth agent comprises one or more of hyaluronic acid, arginine, minoxidil, finasteride, tretinoin, ketoconazole, or spironolactone.

3. The method of claim 1 , wherein the hair growth agent comprises platelet-rich plasma.

4. 10. The method of claim 1, wherein the step of applying the hair growth agent comprises the step of administering a local injection of the hair growth agent through the surface of the treatment area.

5. 5. The method of claim 4, wherein the step of performing the local injection includes rotating a delivery device having radially arranged needles along the treatment area to inject the hair growth agent through the surface of the treatment area.

6. 5. The method of claim 4, wherein the treatment area includes the scalp, and wherein the step of performing the local injection includes placing a cap having a needle over the treatment area to inject the hair growth agent through the surface of the treatment area.

7. 10. The method of claim 1, wherein applying the hair growth agent comprises topically applying the hair growth agent along the surface of the treatment area.

8. 10. The method of claim 1, further comprising the step of applying a photosynthesizing agent to the treatment area prior to applying the light to the treatment area.

9. The method of claim 8 , wherein the photosynthesizing agent is applied simultaneously with the hair growth agent.

10. 10. The method of claim 1, wherein the step of providing the hair growth agent comprises systemic delivery of the hair growth agent.

11. 10. The method of claim 1, wherein the step of applying light to the treatment area is performed within 5 hours of applying the hair growth agent.

12. 12. The method of claim 11, wherein the step of applying light to the treatment area occurs after a delay of at least 5 minutes after administering the hair growth agent.

13. 10. The method of claim 1, wherein the step of applying light to the treatment area is performed within 5 minutes to 1 hour of applying the hair growth agent.

14. 12. The method of claim 11, wherein the step of applying light to the treatment area is performed simultaneously with the step of applying the hair growth agent.

15. The step of applying the light having the first peak wavelength to the treatment area comprises: providing a light therapy device comprising a flexible substrate having a proximal surface and a distal surface opposite the proximal surface, the proximal surface supporting an array of light emitting devices configured to generate the light having the first peak wavelength; placing the phototherapy device near the treatment area; electrically activating the array of light emitting devices; The method of claim 1 , comprising:

16. 16. The method of claim 15, wherein the light therapy device comprises a driver circuit and a proximity sensor on the flexible substrate, the proximity sensor configured to trigger the driver circuit to at least one of start, stop, or modify operation of the array of light emitting devices.

17. The method of claim 16 , wherein the proximity sensor is a capacitive sensor.

18. 16. The method of claim 15, wherein the phototherapy device comprises a reservoir for storing the hair growth agent.

19. 10. The method of claim 1, further comprising the step of applying light having a second peak wavelength to the treatment area after applying the hair growth agent to the treatment area, wherein the second peak wavelength differs from the first peak wavelength by at least 20 nm.

20. 20. The method of claim 19, wherein the first peak wavelength is in a range of 615 nm to 635 nm and the second peak wavelength is in a range of 650 nm to 670 nm.

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