Light-emitting headband for scalp stimulation

Abstract

The present invention relates to a headband for photobiostimulation of the scalp comprising: a plurality of diode lasers each configured to radiate with a power of (5) to (75) mW in a bandwidth associated with a therapeutic window, controlled by at least one driver, each diode laser comprising a dissipation system; a casing including a plurality of modules each configured to house a diode laser, each of the modules having a damping system configured to act on a diode laser by extending it distally from the casing; and the plurality of diode lasers being arranged in the modules of the casing such that they are oriented and configured to be in contact with the user's head by retracting at least one diode laser.

Description

[0001] Light-emitting headband for scalp stimulation

[0002] Technical field of the invention

[0003] The present invention is in the field of helmet or headband-type devices for scalp stimulation by light emission.

[0004] Background of the invention

[0005] Hair loss is a common condition that affects a significant portion of the global population, with varying degrees of severity. One of the most serious forms of hair loss is alopecia, a disorder characterized by the partial or complete absence of hair from areas of the body where hair is typically present. Alopecia can manifest in various forms, including androgenetic alopecia (male and female pattern baldness), alopecia areata, and scarring alopecia, among others.

[0006] The exact causes of alopecia are diverse and may include genetic factors, hormonal imbalances, autoimmune responses, and environmental influences. Androgenetic alopecia, for instance, is often attributed to the effects of androgens (male hormones) on hair follicles, while alopecia areata is believed to be an autoimmune condition in which the body's immune system mistakenly attacks hair follicles. Regardless of the underlying cause, alopecia can significantly impact individuals’ self-esteem, leading to psychological and social consequences.

[0007] Over the years, numerous cosmetic and therapeutic methods have been developed to address hair loss and promote hair regrowth. These methods vary in their approach and efficacy, with some focusing on stimulating hair follicles, while others aim to alter the biochemical processes involved in hair growth.

[0008] Topical treatments, hair growth serums and shampoos are the most common products for preventing hair loss. These products typically contain vitamins, botanicals, or peptides intended to nourish the scalp and strengthen existing hair.

[0009] On the other hand, pharmacological treatments such as finasteride are commonly prescribed to treat androgenetic alopecia by blocking the action of dihydrotestosterone (DHT), a hormone responsible for follicular miniaturization. The use of these therapies has shown promising results in slowing or halting hair loss.

[0010] Despite the array of available treatments, there remains a need for more effective, non- invasive solutions with fewer side effects, as many of the current treatments can be costly or come with adverse effects.

[0011] Low-level laser / light therapy (LLLT), also known as photobiomodulation or photobiostimulation, is a known method for preventing hair loss and stimulate hair growth for both men and women. Those devices are used to stimulate hair follicles, purportedly improving hair density and thickness by enhancing cellular activity within the scalp. A number of devices are now commercially available for home use that are relatively simple and inexpensive, especially compared to conventional medical treatments and hair transplant surgery.

[0012] Photobiostimulation of the scalp has been described as a therapy for alopecia Dodd EM, Winter MA, Hordinsky MK, Sadick NS, Farah RS. Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. J Cosmet Laser Ther. 2018 Jun;20(3): 159-167.

[0013] However, photobioestimulation of the scalp also improves the hair growth in healthy subjects Kim TH, Kim NJ, Youn JL Evaluation of wavelength-dependent hair growth effects on low-level laser therapy: an experimental animal study. Lasers Med Sci. 2015 Aug;30(6): 1703-9.

[0014] LLLT is usually applied by means of light-emitting helmets or headbands. These devices typically use LEDs or laser diodes to emit light that stimulates the cells responsible for hair growth.

[0015] Document US11383097 describes a headband-type device with LEDs or low-level laser diodes or a combination thereof in a plurality of arrays that are mounted on the headband between a plurality of teeth that comb the hair, reducing the amount of energy that scatters the hair.

[0016] Document US10112058 describes a helmet-type device that is fitted with 40 to 80 near infrared (NIR) laser diodes mounted on a flexible printed circuit board with a particular shape to follow the concavity of the skull and a number of openings for diode dissipation.

[0017] Document WO 2021 / 068278 A1 describes a light-emitting device for transcranial light regulation that emits low-power red light or near-infrared light to a user's head with a power level of 1-500 mW and wavelength of 600-1100 nm used to stimulate the user's brain. The device includes a light source part, a light-transmitting layer with multiple light guides that contact the scalp, an elastic member for device-level flexibility, and a heat dissipation layer fixed in the housing. However, this device is directed to transcranial brain stimulation rather than scalp photobiostimulation, uses a single device-level heat dissipation layer rather than individual dissipation systems for each light source, employs light guides as intermediary contact elements rather than direct light source contact with the scalp, and does not disclose a modular casing architecture with individual modules housing individual light sources each with their own integrated dissipation systems.

[0018] However, these devices have the drawback of having a very large number of low-power laser diodes or LEDs. Moreover, these devices have the drawback of keeping the laser diodes / LEDs at a fixed distance from the scalp since the diodes are mounted on printed circuit boards that do not follow the exact contour of the head. In addition, these devices tend to overheat due to the simultaneous activation of a large number of low-power laser diodes connected to a printed circuit board without a dissipation system. Overheating causes the power of the laser diode to be reduced and may even change the bandwidth of the radiation. Finally, the use of very low-level laser diodes / LEDs means that distance, light scattering and the presence of attenuating elements such as the hair itself, prevent the light energy from reaching the tissue of interest in a constant manner and in specific therapeutic ranges.

[0019] Description of the invention

[0020] The present invention proposes a solution to the above problems in the form of a headband for photobiostimulation of the scalp to deliver an energy density of 1 to 10 J / cm2comprising: a plurality of diode lasers each configured to radiate with a power of 5 to 75 mW in a bandwidth associated with a therapeutic window, controlled by a base plate, each diode laser comprising a dissipation system; a casing comprising a plurality of modules each configured to house a diode laser, each of the modules having a damping system configured to act on a diode laser by extending it distally from the casing; and the plurality of diode lasers being arranged in the modules of the casing such that they are oriented and configured to be in contact with the user’s head by retracting at least one diode laser.

[0021] In the context of the invention, a diode laser is an element comprising at least one laser diode together with a dissipation system. Throughout the text, where the technical features of a diode laser relating to energy radiation are mentioned, it is understood that these technical features correspond to the laser diode it comprises.

[0022] It is known that to achieve a photobiostimulation effect on scalp tissue, an energy density of 1 to 10 J / cm2, more preferably 2 to 6 J / cm2, more preferably 2.5 J / cm2or / and 5 J / cm2, should be provided to the scalp.

[0023] In total, the energy density provided to the scalp, in joules divided per square centimetre, is equal to the radiated power of the diode laser, measured in watts, multiplied by the number of diode lasers, multiplied by the time in seconds of application and divided by the area of application, in cm2.

[0024] The distribution of the energy delivered to the tissue may vary locally, however, for the calculation of the delivered energy, it is assumed that the power radiated by the diode lasers is radiated and distributed uniformly.

[0025] A therapeutic window is defined as a bandwidth range associated with low-level laser / light therapy (LLLT). These windows are known in the prior art and correspond to the combination of different optical energy absorbance windows in tissues. The main elements that make up the optical windows of tissues are water, melanin and haemoglobin. A person skilled in the art will be able to select the bandwidth of a diode laser depending on the skin type and application of LLLT therapy. The term “therapeutic window” refers to a defined range or bandwidth that induces a biological effect, without implying whether this range is intended for therapeutic use or not. In the context of photobiostimulation of the scalp, it is known that the main therapeutic window corresponds to the red and near-infrared (R&NIR) region corresponding to a bandwidth range of 620-950 nm. Other therapeutic windows at 1100-1350 nm and 1600- 1870 nm are known.

[0026] Laser diodes are classified according to the power of the light they can radiate. In the field of photobiostimulation for the scalp, laser diodes with a maximum power of 1 to 5 mW are common. These laser diodes have a small size, making them suitable for use in large numbers. Typically, these laser diodes are mounted on printed circuit boards as shown in document US10112058. This configuration has the drawback of difficult dissipation of the heat produced by the laser diodes.

[0027] The temperature increase of a diode laser above its ideal temperature causes the actual radiated power of the diode laser to be reduced compared to its nominal radiated power. In addition, the bandwidth of the emitted radiation may also vary due to the increase in temperature, reducing the effectiveness of the treatment.

[0028] However, in a first inventive aspect, the applicant makes surprising use of higher radiated power laser diodes. The use of higher power laser diodes reduces the photobiostimulation time and the number of laser diodes needed to reach the threshold energy density of at least 1 J / cm2associated with photobiostimulation.

[0029] Given that higher power laser diodes produce more heat, each diode laser must have its own heat dissipation system. This means that higher power laser diodes cannot be integrated into printed circuit boards as is usual for devices with lower power laser diodes. The inventive configuration of the diode lasers reduces the risk of heating the device for photobiostimulation.

[0030] In a preferred embodiment, the invention uses diode lasers each configured to radiate with a power of 5 to 75 mW. More preferably 7 to 50 mW, more preferably 10 to 25 mW, more preferably 15 to 20 mW.

[0031] It should be noted that the actual power at which a diode laser radiates may differ from its nominal power. This is because environmental conditions can alter the power of a diode laser. However, a person skilled in the art will be able to select a diode laser with a given nominal radiated power to radiate an actual power under the expected device operating conditions.

[0032] In a second inventive aspect, the headband comprises a plurality of modules that are integrated into a casing, each configured to house a diode laser comprising its dissipation system.

[0033] Not only do these modules allow larger diode lasers with dissipation systems to be housed, but their particular distribution and construction allow even better dissipation of the heat produced by the diode lasers.

[0034] According to a preferred embodiment, the headband has 4 to 14 diode lasers, more preferably 6 to 12 diode lasers, more preferably 6 to 8 diode lasers housed in respective modules.

[0035] In a third inventive aspect, each housing module comprises a damping system that extends the corresponding diode laser distally from the casing in the headband so that, in the position of use on the user’s head, the diode lasers are in contact with the user’s head, regardless of the shape of the user’s skull, with each diode laser in its module retracting a certain distance by actuating the respective damping systems.

[0036] The three inventive aspects described above are combined in a synergistic and inventive manner to solve the problems identified in the prior art.

[0037] In a preferred embodiment, the plurality of diode lasers comprises respective lenses. The lenses allow the radiation emitted by the laser diodes to be collimated, causing it to be distributed over a predetermined area and with a specific energy distribution.

[0038] In a preferred embodiment, the headband further comprises a support member configured to be fixed to the user’s head, the support member being attached at two opposite ends to the casing through rotating means comprising pivoting connections, so as to allow a circular movement of the casing around the user’s head from a frontal area to an occipital area and from the occipital area to the frontal area. In a preferred embodiment, the rotating means comprise a motor configured to drive the circular movement of the casing relative to the support member.

[0039] In a preferred embodiment, the elastic elements are elastic return springs.

[0040] In a preferred embodiment, each damping system comprises at least two elastic elements attached to an end of a diode laser and to an anchor point of the casing.

[0041] In a preferred embodiment, the casing comprises a first injection-moulded plastic part and a second injection-moulded plastic part facing each other and which can be coupled by coupling means.

[0042] In a preferred embodiment, the coupling means consist of a snap-on system provided with projections protruding from an inner side of the first (and / or second) part, which can be fitted into holes provided on the inner edge of the second part and / or first part.

[0043] With respect to another aspect related to the invention, a method for photobiostimulation of the scalp is disclosed, characterised in that it comprises the steps of: placing the headband according to any of the preceding claims on the user’s head such that the diodes of the headband are in contact with the user’s head, establishing a number of areas on the user’s head to be photobiostimulated, photobiostimulating an area with at least one diode laser with a power of 5 to 75 mW for 5 to 20 seconds, moving the casing in a pivoting circular movement from two opposite ends of the casing around the user’s head from one area to another area.

[0044] In a variant of the method, the step of photobiostimulating an area with at least one diode laser is performed with the plurality of diode lasers in an alternating manner.

[0045] In a variant of the method, the step of photobiostimulating an area with at least one diode laser is performed with the plurality of diode lasers together.

[0046] With respect to another aspect related to the invention, the headband is used for the treatment of alopecia. Brief description of the drawings

[0047] Figure 1 Figure 1 shows the headband for photobiostimulation of the scalp according to the first embodiment.

[0048] Figure 2 Figure 2 shows a coronal view of the headband in which the damping system is activated.

[0049] Figure 3 Figure 3 shows a module 11 in detail.

[0050] Figure 4 Figure 4 shows a section of the casing corresponding to a module 11 for a diode laser 40 together with said diode laser 40.

[0051] Figure 5 Figure 5 shows a detail view of a diode laser 40.

[0052] Figure 6 Figure 6 shows two of the facing parts making up the casing 10.

[0053] Figure 7 Figure 7 shows the motorised attachment of the casing and the support member according to a second embodiment.

[0054] Detailed description of an exemplary embodiment

[0055] In the following detailed description, numerous specific details are set forth in the form of examples to provide a thorough understanding of the relevant teachings. However, it will be apparent to those skilled in the art that the present teachings can be implemented without such details.

[0056] Figure 1 exemplifies a headband 100 for photobiostimulation of the scalp according to the present invention. In the example, the headband consists of a casing 10 made of three injection-moulded plastic parts facing each other. The front casing 10a and the rear casing 10b are attached to one another by screwing, while the upper part 10c is snapped on to the other two. In the example, six diode lasers 40 are also shown protruding from the casing 10.

[0057] Figure 2 shows the headband 100 of Figure 1 without the front casing 10a. Three drivers 60 can also be seen in the figure. These drivers control the diode lasers 40 and the execution of the photobiostimulation procedure. Figure 2 shows the six diode lasers 40 collapsed in their respective modules 11 and the damping system 20 activated.

[0058] Figure 3 shows a detail view of a module 11 , a diode laser 40 and the respective damping system 20. In the example, the damping system comprises two elastic return springs 21a, 21 b attached at an end to respective ends of the diode laser 43a, 43b and at the other end to respective anchors in the casing 13a, 13b. In the rest position, the springs 21a, 21 b will cause the diode laser 40 to protrude from the casing.

[0059] Figure 4 shows a module 11 housing a diode laser 40 in detail. In the example, the module is formed by attaching the front casing 10a and the rear casing 10b to one another. The housing of the module 11 for the diode laser 40 consists of a number of plastic reinforcements in the form of ribs that serve three functions: to encapsulate the diode lasers 40, to promote the dissipation of the heat produced by the diode lasers 40, and to reinforce the structure of the casing 10. It is also possible to see that the end of the diode laser 43 allows the connection and routing of electrical cables.

[0060] Figure 5 shows an example of a diode laser 40. In the example, the diode laser comprises an end 43 with corresponding anchors 43a, 43b, a laser diode 41 , a lens 42, a dissipation system 44 and a protection window 45.

[0061] The light emitted by the laser diode 41 is collimated by an aspherical lens 42 with a focal length of 10 mm. The lens also includes an absorbing circular aperture that vignettes the beam so that the typically elliptical and Gaussian emission of the internal photodiode 41 is configured in a circular output of 3 mm in diameter and with a homogeneous power distribution.

[0062] The diode laser 40 is connected to a driver 60 which allows it to be controlled at constant emitting power. This is achieved by reading the signal of its laser diode 41 and regulating the current with a closed loop. Each diode laser 40 is adjusted according to its emitted power, so that the circuit absorbs any differences due to manufacturing tolerances of both the diode lasers 40 and the different electronic components.

[0063] In the example, the diode used allows up to 35 mW to be emitted in a 1x3 pm emitter with 10°x60° divergence. It is adjusted below its maximum operating point so as to deliver, after the optical system, 18 mW over an area 3 mm in diameter with a residual divergence of <0.6 mrad. The dissipation system 44 comprises an aluminium and brass body that allows the operation of the diode laser 40 below the maximum temperature point and they help to keep the temperature of the internal photodiode 41 below 60°C. In the example, in addition, the diode laser 40 is fitted with a protection window 45 comprising a replaceable POM plastic part which prevents direct contact of the diode laser 40 with the user’s head and facilitates cleaning and replacement.

[0064] Figure 6 shows the front casing 10a and the rear casing 10b.

[0065] Figure 7 shows another example of a headband 100 for photobiostimulation of the scalp in which the upper casing 10c is attached to a support member 30 at opposite ends 12a, 12b. The attachment between the support member 30 and the casing 10 is of a pivoting type and has a motor that drives the circular movement of the casing 10 around the user’s head from a frontal area to an occipital area and from the occipital area to the frontal area.

[0066] Example of use

[0067] The headband 100 is placed on the user’s head by adjusting the support member around the user’s head and causing the damping systems of each diode laser 40 to activate due to the contact of the user’s head with the diode lasers 40, placing each of them in contact with the user’s head.

[0068] When the power button is pressed, the headband 100 is activated and each diode laser 40 emits for 10 to 20 seconds at a power of 18 mW to deliver 2.5 to 5 J / cm2. At the end of the photobiostimulation of the area, the headband advances by means of the motor drive in the direction of the occipital part of the user’s head until it reaches the next biostimulation area, the modules always being in permanent contact with the user’s scalp, so that the existing hair is displaced by each of the modules. In the next position, each 18 mW diode emits again for 10 to 20 seconds to deliver 2.5 to 5 J / cm2. The process is repeated successively until all marked areas of the user’s head are covered.

Claims

CLAIMS1. A headband (100) for photobiostimulation of the scalp to deliver an energy density of 1 to 10 J / cm2, characterised in that it comprises: a plurality of diode lasers (40) each configured to radiate with a power of 5 to 75 mW in a bandwidth associated with a therapeutic window, controlled by at least one driver (60), each diode laser (40) comprising a dissipation system (44); a casing (10) comprising a plurality of modules (11) each configured to house a diode laser (40), each of the modules (11) having a damping system (20) configured to act on a diode laser (40) by extending it distally from the casing; and the plurality of diode lasers (40) being arranged in the modules (11) of the casing (10) such that they are oriented and configured to be in contact with the user’s head by retracting at least one diode laser (40).

2. The headband (100) of claim 1 , characterised in that the plurality of diode lasers (40) comprises respective lenses (42).

3. The headband (100) of claim 1 or 2, characterised in that it comprises a support member (30) configured to be fixed to the user’s head, the support member (30) being attached at two opposite ends to the casing (12a, 12b) through rotating means (31) comprising pivoting connections, so as to allow a circular movement of the casing (10) around the user’s head from a frontal area to an occipital area and from the occipital area to the frontal area.

4. The headband (100) of the preceding claim, characterised in that the rotating means (31) comprise a motor configured to drive the circular movement of the casing relative to the support member (30).

5. The headband (100) of any of the preceding claims, characterised in that each damping system (20) comprises at least two elastic elements (21a, 21 b) attached to an end of a diode laser (43a, 43b) and to an anchor point of the casing (13a, 13b).

6. The headband (100) according to any of the preceding claims, characterised in that theelastic elements (21a, 21 b) are elastic return springs.

7. The headband (100) according to any of the preceding claims, wherein the casing comprises a first injection-moulded plastic part (10a) and a second injection-moulded plastic part (10b) facing each other and which can be coupled by coupling means.

8. The headband (100) according to claim 7, characterised in that the coupling means consist of a snap-on system provided with projections protruding from an inner side of the first part (10a) and / or second part (10b), which can be fitted into holes provided on the inner edge of the second part and / or first part.

9. The headband (100) according to any of the preceding claims, characterised in that the therapeutic window is a bandwidth range of 620-950 nm.

10. The headband (100) according to any of the preceding claims, characterised in that the diode lasers emit radiation in a red or near-infrared bandwidth.11 . A method for photobiostimulation of the scalp, characterised in that it comprises the steps of: placing the headband (100) according to any of the preceding claims on the user’s head such that the diodes (40) of the headband (100) are in contact with the user’s head, establishing a number of areas on the user’s head to be photobiostimulated, photobiostimulating an area with at least one diode laser (40) with a power of 5 to 75 mW for 5 to 20 seconds, moving the casing (10) in a pivoting circular movement from two opposite ends of the casing (12a, 12b) around the user’s head from one area to another area.

12. The method for photobiostimulation of the scalp of claim 11 , characterised in that the step of photobiostimulating an area with at least one diode laser (40) is performed with the plurality of diode lasers (40) in an alternating manner.

13. The method for photobiostimulation of the scalp of claim 11 , characterised in that the step of photobiostimulating an area with at least one diode laser (40) is performed with the plurality of diode lasers (40) together.

14. The headband (100) according to claims 1-10 for use in the treatment of alopecia.

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