WO2019006528A1 - Led helmet with diode light guide for the scalp - Google Patents

Led helmet with diode light guide for the scalp Download PDF

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Publication number
WO2019006528A1
WO2019006528A1 PCT/BR2018/050209 BR2018050209W WO2019006528A1 WO 2019006528 A1 WO2019006528 A1 WO 2019006528A1 BR 2018050209 W BR2018050209 W BR 2018050209W WO 2019006528 A1 WO2019006528 A1 WO 2019006528A1
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WIPO (PCT)
Prior art keywords
light
helmet
led
scalp
characterized
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PCT/BR2018/050209
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French (fr)
Portuguese (pt)
Inventor
Alvaro Pereira DE OLIVEIRA
Original Assignee
De Oliveira Alvaro Pereira
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Publication date
Priority to BRBR1020170146316 priority Critical
Priority to BR102017014631-6A priority patent/BR102017014631A2/en
Priority to BR132018010728 priority
Priority to BRBR1320180107282 priority
Application filed by De Oliveira Alvaro Pereira filed Critical De Oliveira Alvaro Pereira
Publication of WO2019006528A1 publication Critical patent/WO2019006528A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05BELECTRIC HEATING; ELECTRIC LIGHTING NOT OTHERWISE PROVIDED FOR
    • H05B1/00Details of electric heating devices

Abstract

The invention relates to an LED helmet (1) with a light carrier (6) from the diode to the scalp, comprising an enveloping element (3) having openings for the introduction of spicules (4) which act as transmitters. of light from the diode to the scalp. The spicules (4) coated with a metallic material (5) and resinated (5) direct the passage of light, thereby forming light carriers (6) which are retractable thanks to the flexible foam (7) filling the space between the wrapping element (3) and the shell (8) of the LED helmet. Externally, the shell (8) envelops the foam (7). On the side of the LED headset is the button (2) that turns the device on / off.

Description

 LED HELMET WITH LEATHER DIODE CONVERTER FOR LEATHER

 HAIRY

APPLICATION FIELD

 The present application relates to a helmet internally provided with light transporters ensuring the effective delivery of light from the diode directly to the scalp and providing efficiency in the delivery of radiant exposure directly into the hair follicle and, consequently, in hair treatment. The light emitting diodes (LEDs) are structured in the shape of light transmitting spicules.

 Thus, the present invention relates to a helmet with spikes which can be coated by both a metallic and a resinstock.

 The spike material is considered a good light transmitter and in this case will carry the light from the diode to the scalp transposing structures such as the hair. The spike does not allow the light to escape laterally by directing the transport of diode light directly to the scalp.

 Structures such as hair can absorb light with wavelengths in the range of the electromagnetic spectrum in the region of visible and / or infrared light and cause the energy of the device arriving in the scalp, more specifically in the hair follicle, to be smaller than necessary to effectively produce the photobiomodulation phenomenon.

STATE OF THE TECHNIQUE

 [005] Currently, it is possible to find in the market some devices aimed at the implementation of such characteristics in the scalp. However, none of the devices cited in the patent defending institutions is similar to the LED light-carrying diode-to-scalp light helmet.

Among the documents found in the Prior Art, we can cite US7722656B1, published on 05/25/2010 which describes a device and method for hair growth stimulation (Device and Method for Stimulating Hair Growth) comprising one or more sources (less than 1,000 mW) in the infrared spectrum from 2500 nm to about 10,000 nm and power of about 500 mW. This device features diodes arranged at fixed spacings around the scalp that move following periodic cycles within a certain period of time. It is a rotational application method following a pattern of dispersion of the diode in certain areas at least once during the periodic cycle. Despite the versatility of treatments that can be performed by this equipment, it does not present contact of the light source to the scalp which ends up not guaranteeing the effective dose of the device to the hair follicle since other structures can absorb part of the energy of the light emitter. Moreover, it is made of laser and the periodic cycles do not guarantee to reach the entire region of the scalp as in the case of the five regions most affected by alopecia.

 As regards document ES2522165T3, published 11/13/2014, it is a portable phototherapy device for treating the scalp allowing "hands-fred" during the application. The device features a head support with light sources, springs to fit the device into a variety of head shapes and a controller.This device claims to be easy to use, has specific treatment schedules ranging for men or women ranging from about 20 to 25 minutes in length and promises to cover specific areas However, as in the previous case, it does not present contact of the light source to the scalp which ends up not guaranteeing the effective radiant exposure of the device since structures such as the hair, will absorb part of the energy of the emitter light and still presents about 30 light emitters, which is considered an amount that can not be homogeneous during the irr process treatment and also reach the five regions most affected by alopecia.

 Another device, JP2006116088A, issued 05/05/2006, is to be a laser apparatus capable of irradiating on the surface of the skin. It is said to be simple in configuration and has the ability to provide different types of contact by distancing or approaching the lenses of the laser and thereby controlling the radiant exposure in the tissue in a shorter time of use. Because it consists of laser and lenses, this device tends to present a high cost and it is not possible to irradiate homogeneously throughout the scalp in order to treat the 5 regions most affected by alopecia.

Already the document KR20080025989A published on 03/24/2008 refers to an equipment for hair growth with infrared formed by a main body in the form of a helmet, a cover of silicone, several diodes allocated in this layer of silicone with length of between 650 ~ 890 nm in projections simulating the acupuncture points, a power supply, a controller with LCD display panel and a switch. Like the previous device, it also does not radiate homogenously throughout the scalp in order to treat the 5 regions most affected by alopecia. In addition to not mentioning the application time and not providing efficacy in the transport of light directly into the hair follicle. It is worth mentioning that the silicone tends to yellow according to the time of use, which ends up blocking part of the light to be irradiated.

As to the light conveyor, devices have been found as in the case of US12456750 published on 12/23/2010 and which describes a visible light conveyor composed of supports for other devices as in the case of road lighting lamps. Such a device is composed of resin that allows the light to be attenuated and transmitted. This device is not applied to medicine besides being composed of resin, and therefore does not similar to ght transported n // 'described herein.

 We may also cite GB 222,963, issued 10/13/1924 and which describes a hair treatment apparatus which comprises a carton having an aperture for insertion of the user's head. Inside the box of the equipment is provided an ozone generator by electric discharge of high tension and colored lamps for the treatment of the hair (blue and red). The equipment comprises a rectangular box with the lower front cut out. The hairs are thrown over a slanted wall. An induction coil within a housing is attached to electrodes that project into the housing. Electrically heated filaments, red and blue lamps are provided, each of which is connected via an independent switch, a fan, a door and a thermometer. Despite the versatility of treatments that can be performed by this equipment, it has a large dimension, which makes it incompatible with domestic use.

Within the scope of employing an object of smaller size, and therefore easily obtainable and used by the user, the state of the art provides, as described in CN1398650, published on 02/26/2003, a hairbrush with red LEDs to promote improved blood circulation, hair growth and less itching. In the same sense, PI 0704946-3 discloses an LED brush for treatment of hair phototherapy. The purpose of this is to use a light-emitting diode brush for hair phototherapy treatment, such as baldness, loss of color and hydration, with a view to improve the well-being of life and health of individuals. The apparatus is composed of a module 10 centimeters wide, 20 centimeters long, and 5 centimeters high. In the extreme module of the application there is a small brush, where are located 10 LEDs in the red colors, with wavelength of 650 nm, and blue, with wavelength of 405 nm. The device also features a power button, and power from internal lithium batteries. The user should turn on the appliance and brush or comb the hair, scouring the entire scalp. The treatment of each session is defined by the person himself, and the use is recommended for at least 15 minutes daily. Such a device depends on the motor ability and does not guarantee effectiveness in the homogeneous delivery of the effective irradiating exposure to provide photobiomodulation directly in the hair follicle.

 Another similar solution is described in PI 0802844-3, which comprises a flat and ultrasonic LED or hairbrush or brush for the treatment of phototherapy and ultrasonic hair, such as moisturizing, color loss and softener, with a view to improving the well-being of life and health of individuals. The apparatus is composed of a module 20 centimeters wide, 10 centimeters long, and a cable 10 centimeters long, 5 centimeters high. In the application module there are two small plates, where on one side are located 20 red and blue high brightness LEDs with a wavelength of 630 nm and 405 nm respectively. At the other end, the ultrasound plate is positioned, which stimulate water molecules and stimulate hair strands.

 [014] Another solution, which eliminates the need for "manipulation" by the user, is to use hats and caps, which are placed on the user's head and removed at the end of treatment. In this regard, JP 8092810, published 04/04/1996, describes a cap intended for children to generate contour effect through an inner camera of red light reflecting fabric. In this no citation is made to capillary properties.

[015] Finally, there are also described in the art three other very similar solutions which allude to the use of caps in capillary treatments. Of these, JP 2002 129424, published 09/05/2002, refers to a hat intended to promote the revitalization of weak roots by virtue of the constant use of hats and caps; the hat is red and allows the passage of the IV rays, besides being indicated for the treatment of alopecia areata which is not has guaranteed cases of cure effectiveness, since alopecia areata is an autoimmune disease. JP 2006 037318, published 09/02/2006, refers to a hat that allows only the passage of light rays in the red spectrum; in this, the rays reach the scalp and activate the roots, stimulating the capillary growth. Finally, WO 2008/069154, published 06/26/2008, describes a hat that allows penetration of the red and near-infrared light rays, and which is intended to promote hair growth and reduce the ills of cerebral vascular origin.

 Although the above solutions are effectively portable and easy to use, all of them present a common problem, namely lack of control over the exposure time of the scalp to the proposed treatment or even of not making the delivery available from the device to the scalp. Besides that in cases that lack time control, it becomes quite complicated to perform the treatment, since these devices must move throughout the user's head. Thus, one area may be much more radiated than another, which leads to inconsistent results. In addition, it is debatable that a user spend 15 minutes in a row combing his hair, day after day, however light the device.

OBJECTS OF THE INVENTION

 In order to eliminate possible 'light barriers' such as hair and ensure that all diode energy effectively reaches the hair follicle, it is necessary that the light is transported to the contact surface of the scalp and, thus ensuring that radiant exposure provides the necessary photobiomodulation to stimulate the follicle. Hair is composed of melanin, and melanin is a type of chromophore that absorbs light at the wavelengths in the electromagnetic spectrum range in the visible and / or infrared light region. Therefore, it is interesting to apply light from the diode directly to the scalp to have direct action on the follicle and prevent absorption by the hair melanin.

[018] According to the above summaries, the mentioned processes do not have similarity with the object of the present patent application of "LED HELMET WITH CARRIER OF DIODE TO CABELUDE LEATHER", reason why we consider that there are no technical impediments nor legal to obtain the requested privilege. The object of the present patent solves handling problems by users allowing efficiency in the delivery of light from the LED to the scalp reaching both the 5 regions most affected by hair loss and capillary as in the case of people with a lot of hair, mainly women who are in the early stage of alopecia or hair loss - since, in these cases, only the helmet is fitted, adjusting it on the head to deliver the light directly on the hair's scalp patient and nothing more. The spicules fit in the head because they are retractile and still contribute by being able to deliver the light directly to the scalp, as they act as a picker of the hair strands, removing them and reaching the capillary follicle with the radiant exposure necessary for the photobiomodulation and , consequently for the hair treatment accelerating the growth and making the hair stronger and healthier.

 SUMMARY OF THE INVENTION

 The device now proposed comprises a helmet-shaped body (1) composed of an outer hull (8) and an inner ring (3). Its interior is filled with flexible foam (7). The function of the foam, in addition to acting as a shock absorber against falls, causes the spikes (4) to be retractable thus providing comfort by using the LED helmet (1) with light conveyor (6) from the diode to the scalp . On the side of the LED helmet (1) is located the button (2) that turns the device on / off.

 The spikes (4) which are covered laterally by a metallized structure (5) have the light blocked laterally in order to bar and direct the passage of light, said structure engaging around the spike (4) forming the thereby ensuring efficacy in the delivery of light only in the part that is in contact with the scalp, ie at the tip of the spike (4).

 The sprue assembly 4 and resilient material 9 forms the light conveyor 6 which directs delivery of the light at an angle that may range from 10 ° to 80 °, wherein said resinous material coats ) to the spike (4).

DESCRIPTION OF THE FIGURES

 The object of the present invention will be better understood in the light of the detailed description which follows by way of example, but not by way of limitation, taken from the attached drawings.

 Figure 1: Perspective view of the LED helmet.

Figure 2: Side perspective view of the LED helmet focusing on the power button located on the right side insert. Figure 3: Top perspective view of the hoop with holes to allocate the light conveyors.

 Figure 4A: Front view of spike covered with metallic material.

 Figure 4B: Frontal view of the resin spike.

 Figure 5: Bottom perspective view of the metal and resin spike.

 Figure 6: Top view of the resin spike and cut in section A-A of the same.

 Figure 7: Bottom perspective view of the flexible foam in which it fills the gap between the rim and the helmet of the LED helmet.

 Figure 8: Exploded perspective view of the helmet.

DETAILED DESCRIPTION OF THE INVENTION

 [023] The light-carrying LED helmet is a device in which it uses the principle of Low Levei Light Therapy (LLL T or photobiomodulation). This device offers safe and effective treatment. The effects can be noticed in a few applications, as it acts directly on local microcirculation stimulus providing several benefits: it aids in inflammatory processes, contributes to the reduction of edema and reduction of pain, accelerates the wound healing process, helps in tissue repair and accelerates hair growth.

 The object of the present invention solves handling problems by the users allowing effective delivery of light from the LED to the scalp reaching both the 5 regions most affected by alopecia and hair loss as in the case of people with a lot of hair mainly , women who are in the early stage of alopecia or hair loss - since in these cases, just put the LED helmet fitting on the head to deliver light straight into the patient's scalp and nothing else. The spicules fit on the head because they are retractable, and still contribute by being able to deliver the light directly on the scalp, as they act as a picker of the hair strands, removing them and reaching the hair follicle with the radiant exposure required for the effect of photobiomodulation and, consequently, for capillary treatment.

[025] In general, the wavelengths in the range of the electromagnetic spectrum in the region of visible and / or infrared light show interaction at the cellular level stimulating analgesia, anti-inflammatory and cicatrizing actions. Light in the red and / or infrared region of the spectrum (cytochrome c oxidase), releasing NO (nitric oxide) into the bloodstream (considered an excellent vasodilator) stimulating the production of adenosine triphosphate (ATP) (energy for the cell) and Oxygen Reactive Species - ROS (a major marker for gene transcription and cell growth factors).

 [026] This device has light emitted from transmitting spicules that directly reach the scalp and are able to encompass the five regions most affected by Androgenetic Alopecia because they are homogeneously distributed in the inner part of the LED helmet, that is, it can reach the apex region, frontal region, central region and lateral regions. LED sources have low power and wavelengths in the range of the electromagnetic spectrum in the region of visible and / or infrared light.

 [027] The operating principle of the LED helmet with light diode transporter for the scalp is to be able to carry the light homogeneously in every area to be treated with the least possible loss of light (be it losses through absorption by other structures or through the loss of physical phenomena such as reflection, refraction and scattering), which makes a delivery more efficient, guaranteeing the success and reliability of the treatment.

[028] Thinking of avoiding that external structures absorb part of the energy necessary to the capillary stimulus, as the material of the spike is considered a great light transmitter due to the greater diffusion of light and transparency as well as high durability and guarantee against yellow, in this helmet of LED light transmitters from the diode to the scalp are retractable spikes to be able to fit across the surface of the scalp and thus provide a non-invasive and efficient treatment even in the case of people with enough hair and who are having hair problems.

 [029] In the case of the metal-coated spike, the latter coats the spike laterally, as the metal will not let the light escape laterally through the spike assisting and directing the transport of light from the diode directly to the scalp.

[030] For light transmitters with resinous material, the resin plays the role of not letting light escape through the sides of the spike, further increasing the efficiency of light delivery directly into the hair follicle since the spike material is structured a way that angularly directs the beam of light. This is why, in this case, there is no of a structure surrounding the spatter to bar side light, as the present light conveyor has a light emitting angle in the range of 10 ° to 80 °, preferably 25 ° to 60 °, and most preferably 30 °. In addition, the resin used is a biocompatible resin for encapsulating the spike.

 [031] As for the material used to manufacture the thermal helmet, studies have been made of engineering polymers, synthetic fibers or injected plastic such as Acrylonitrile Butadiene Styrene (ABS) that offer excellent physical, chemical and processability properties. They are materials that have excellent combinations of properties, especially in case of high impact resistance and yellowing depending on the formulation. These are commercially interesting materials for various fields of application such as automotive, home appliances, safety and aesthetic items due to good interfacial interaction allowing various types of painting and metallization.

 Accordingly, the subject of the present application, the LED helmet (1) with light conveyor (6) of the diode for the scalp, comprises a ring (3) for allocating the metal (5) or resinous spicules (9) which act as light transmitters from the diode to the scalp. More specifically, said ring (3) has about 190 to 230 holes for allocating the spikes (4).

 The spike (4) is covered by metallised (5) or resins (9) forming the light conveyor (6) in which they are retractable due to the flexible foam (7) and in which it fills the space between the rim (3) and the helmet (8) of the LED helmet and behaves as a natural shock absorber of the spikes (4) making them retractable and able to fit into various head shapes.

Additionally, the LED helmet 1 externally comprises a hull 8 surrounding the flexible foam 7, ensuring the device good impact resistance and provides great visual appearance. Said hull 8 further comprises, on the side of the LED helmet, the button which switches the device on / off (2). The LED helmet can present a cable connected to a voltage transformer 110 ~ 220VAC 9 ~ 12VDC, be powered via mains and / or battery to be fixed on the inside of the helmet possibly being able to be between the hull and the rim.

[035] Phototherapy has the principle of inducing photobiological processes in cells. Low-intensity monochromatic light, when present at specific wavelengths, acts on chromophores to generate specific cellular responses and has been used to aid in the treatment for example, to stimulate hair growth in the case of baldness, loss of color and hydration of the hair, improve the appearance and appearance of the scalp as in the case of assisting the treatment of seborrheic dermatitis (dandruff), with improving the well-being of life and health of individuals.

 [036] With regard to hair treatments intended to improve hair quality, it is known that wavelengths in the electromagnetic spectrum range in the visible and / or infrared light region have mainly cicatricial, microcirculatory stimulant and analgesic properties. Such properties have been widely used, for example, in the treatment of alopecia as well as complement in treatments of other scalp disorders such as telogen effluvium (hair loss), some cases of alopecia areata and traction, folliculitis, psoriasis among other pathologies inflammatory effects of the region.

DESCRIPTION OF PRIVATE ACHIEVEMENTS

[037] In a non-limiting manner, one of the scopes of the present application is a capillary photobiomodulation device (LED helmet) which is carried out by both metal-coated and resin-coated spicules and provides about 1.0 J / cm 2 to 10.0 J / cm 2 of radiant exposure, and is comprised of direct light scalp transporters which enhance the effect of hair treatment such as for the aid of inflammatory processes of the scalp, accelerating hair growth making the most nourished, healthy, shiny and bulky hair and potentializing the delivery of topical drugs by the drug delivery action, through the homogeneous irradiation of light within the electromagnetic spectrum in the region of visible and / or infrared light throughout the area to be treated, which is portable, easy to use, can be used in any place as well as in the case of beauty salon, dermatological clinics, aesthetic center and / or even home use. In addition to these benefits, the present invention is also effective against telogen effluvium (hair loss) and some cases of seborrheic dermatitis (dandruff) and psoriasis.

 [038] To verify that the spicules covered with resin material do not have allergenic properties, three (3) tests were done:

EVALUATION ASSESSMENT OF CYTOXICITY POTENTIAL

[039] This assay aimed to evaluate the cytotoxic potential of the PTH LED sample on cells in vivo, in this specific case, cells from the V-79 lineage were used. [040] To this end, this test complied with the following conditions:

 Negative Control: DMEM Culture Medium + 10% Bovine Fetal Serum and 1% Penicillin / Streptomycin.

 Extraction control: Culture medium DMEM + 10% Bovine Fetal Serum and 1% Penicillin / Streptomycin maintained in a Schott bottle at 37 ° C for 24 hours.

 Positive control: Extraction performed in culture medium DMEM + 10% Bovine Fetal Serum and 1% Penicillin / Streptomycin of the Latex product (extraction performed for 24 hours at 37 ° C).

[041] The procedure for performing the test was as follows:

[042] Fibroblasts from the V-79 cell line were cultured in 96-well cell culture plates and incubated for a 24-hour period to form the cell monolayer. After this period, the culture medium was replaced by a new medium containing the treatments (n = 6) and the positive controls (n = 6), negative (n = 12) and extraction (n = 12). The sample concentrations used for the treatment were 100%, 50%, 25% and 12.5%, where they were incubated for 24 hours. At the end of the exposure period, the culture medium with the treatments was discarded and 50 μΙ of the MTT solution ((3- (4,5-dimethylthiazolyl-2) -2,5-diphenyltetrazolium bromide) was added to each well , the cells were incubated for 2 hours, then the MTT solution was discarded, and 100 μl of Isopropanol was added to each well and the plate was kept under stirring for 5 minutes. The absorbance of the samples was measured at a wavelength of 570 nm (reference wavelength 650 nm).

 [043] Samples that show reduction of cell viability greater than 30% in relation to the negative control were considered cytotoxic.

[044] Table 1 below summarizes the result of this assay.

Table 1: Cell viability (%) of the mean percentages of the replicates of the negative and positive controls and concentrations of the PTH LED sample.

Figure imgf000014_0001

 [045] Table 1 shows a reduction in cell viability of less than 30% in relation to the negative control at all concentrations of the PTH LED sample (12.5%, 25%, 50% and 100%).

 [046] Figure 9 shows the reduction of cell viability of the LED sample

PTH at concentrations of 100%, 50%, 25% and 12.5% after exposure of 24 hours.

 [047] In this way, it is concluded that the PTH LED sample did not present toxic effect to the V-79 cell line, therefore, it was not considered toxic.

 SKIN IRRITATION TEST

 [048] This test aimed to obtain information about the irritating or corrosive effects of exposure to the PTH LED product on the skin of rabbits of the species Oryctolagus cuniculus.

[049] The conditions for this test were:

 Average Temperature: 23.0 ° C.

 Average Relative Humidity: 76.1%.

 Photoperiod: 12 hours of light and 12 hours of darkness.

 Number and sex: 3 male rabbits.

[050] For this assay the animals were trichotomized approximately 24 hours prior to assay in the dorsal region on both sides of the spine, making up an area of approximately 6 cm x 12 cm. The sample was weighed in the proportion 0.2 g to 1.0 mL of demineralized water and subjected to extraction in a water bath at 37 ° C for 72 hours and applied (0.5 mL) in two application areas on the back of each animal. The treated areas were covered with a semi-occlusive dressing of porous gauze and non-irritating plaster. The exposure lasted for 4 hours, after which the sample was removed using demineralized water. The contralateral region was treated with 0.5 mL of demineralized water subjected to the same extraction conditions and was used as test control; the animals were weighed before exposure and at the end of the trial and evaluated at 1h, 24h, 48h, and 72h after dressing was removed for edema and erythema. The degree of skin irritation was evaluated according to the Draize method.

 [051] At the end of the test, the samples were classified into one of the following categories: non-irritating, slightly irritating, moderately irritating or severely irritant, according to ISO10993: 10. In addition to observations on dermal irritation, to assess local and / or systemic toxic effects.

 [052] After the test, the animals showed no signs of skin irritation during the evaluations. Due to the absence of signs of skin irritation, the test was completed in 72h for all animals evaluated. According to table 2 below, it can be verified that animal 3 presented weight loss unrelated to the sample, since it did not show clinical signs during the test. The primary irritation index (IIP) of the sample was determined as 0.0. Table 2: Clinical follow-up, initial and final body weight, and weight difference of the tested animals.

Figure imgf000015_0001

 [053] From table 3 below, it can be seen that there were no signs of edema and erythema in the animals tested.

Table 3: Evaluation for edema and erythema of the PTH LED sample.

Figure imgf000016_0002

Figure imgf000016_0001

 [054] Thus, it is concluded that, according to the test conditions, the PTH LED sample was classified as non-irritant in accordance with ISSO10993: 10.

SENSITIZATION CUTANEOUS - LOCAL LYMPHONOD TEST

 [055] The local lymph node assay (LLNA) is intended to identify substances that have the capacity to cause dermal sensitization. This essay aims to obtain information about the sensitizing effects of the PTH LED sample, based on the information that the sensitizing sample induces proliferation of lymphocytes in the lymph node near the field of application.

[056] The conditions for performing this test were:

 Average temperature: 21.5 ° C.

 Average Relative Humidity: 77.6%.

 Photoperiod: 12 hours of light / 12 hours of dark.

 Species: Mus musculus

Lineage: CBA / J. Age at beginning of trial: 8 weeks.

 Number and sex: 15 animals (females and males).

Selected dose

 [057] According to ISO Standard 10993-12, 2012, the sample was extracted at 37 ° C ± 72 hours with olive oil at the ratio of 0.2 g of sample to 1 ml of the vehicle. To this extract was added acetone (4: 1 acetone: olive oil) and 25 μl was applied to the back of each ear of a group of 5 mice (3 males and 2 females).

 [058] In addition, a negative control group was conducted using 5 mice (5 males) treated with vehicle alone, and a positive control group, using 5 mice (males) treated with α-hexylcinnamaldehyde diluted in acetone vehicle : olive oil (4: 1 v / v) at 25% concentration.

Positive control

 [059] The sensitivity and reliability of the experimental technique are evaluated using a-hexylcinnamaldehyde (CAS No. 101-86-0). According to OECD 442B (2010), a positive response in the sensitization test is considered using the LLNA method when at least the response obtained has an Stimulation Index> 1.6. In the positive control test the mice (male and female) are treated with α-hexylcinnamaldehyde diluted in acetone: olive oil (4: 1 v / v) at 25% concentration.

Procedures

 [060] On the day of start of the trial (day 1), the animals were individually identified in the caudal region and weighed. The following application protocol was then used:

 [061] Day 1: topical application of 25 μΙ of the sample on the back of each ear of the animals or negative and positive controls.

 [062] Day 2: same procedure as day 1.

 [063] Day 3: same procedure as day 1.

 [064] Day 4: no treatment.

 [065] Day 5: 0.5 ml_ (5 mg / animal) application of the BrdU (Bromodeoxyuridine) solution (10 mg / ml) intraperitoneally in all animals.

[066] Day 6: weighing of animals, recording of clinical signs and record of erythema grade of auricular pavilion; euthanasia of animals and removal of atrial lymph nodes to buffered saline (PBS). Subsequently, necropsy of these animals was performed.

 Lymph node processing

 [067] Lymph nodes were submitted to mechanical disaggregation to obtain cell suspension; after that step, the BrdU incorporated into the cells was measured by ELISA (enzyme-linked immunosorbent assay) using the commercial kit (Roche Applied Sciences, Germany).

Anti-BrdU ELISA Assay

 [068] The cell suspension was added to the wells of a tri-plane flat bottom microplate; after the fixation and denaturation steps, the anti-BrdU antibody was added and incubated for 90 minutes; subsequently, the anti-BrdU antibody was removed by washing and the substrate solution was added for production of the chromogen. The measurement was performed on the ELISA reader, with 370 nm being the emission wavelength and 492 nm the reference wavelength. Calculations

 [069] BrdU binding index and stimulation index (SI) were calculated by the following equations:

BrdU binding index = (ABS and m37o - ABS pbs at 37o) - (ABS re f 492 - ABS pbs re f492)

 At where:

em = emission wavelength (370 nm)

ref = reference wavelength (492 nm) stimulation index (SI) = BrdU binding index of each tested animal

 BrdU binding index of the control animal

The BrdU binding index of the negative control should have an absorbance between 0.1 and 0.2 and the result to be considered positive should present SI> 1.6.

 Results

 [071] The initial and final weights of the animals of the negative and positive, and experimental control groups are shown in Table 4 below.

Table 4 - Initial individual body weight (PI) and final (PF) and weight variation (PF-PI) of the animals from the positive and negative control groups, and experimental group treated with PTH LED.

Figure imgf000019_0001

 [072] All animals evaluated showed a change in body weight within physiological variability.

 [073] Clinical observations (grade of erythema) of animals from the control and experimental groups are presented in Table 5 below.

Table 5 - Clinical observations (grade of erythema) of the animals of the negative and positive control groups, and of the experimental group treated with PTH LED.

Figure imgf000020_0001

[074] None of the animals tested in the experimental and negative control groups showed clinical signs or signs of local irritation during exposure. In the animals of the positive control group, light erythema was observed.

[075] The results obtained in the ELISA reader for each animal are shown in Table 6 (mean replicates). Table 6 - Results obtained by the ELISA test

Figure imgf000021_0001

 [076] According to these results, it was possible to verify that the negative control had an absorbance between 0.1 and 0.2 within the expected value for the negative control. The positive control presented the Stimulation Index (SI) equal to 3.29, obtaining a positive response according to OECD 442B (2010).

 [077] The results obtained for the PTH LED sample indicate a Stimulation Index of 1.51.

[078] In this way, it was concluded that, according to the conditions of the test, the PTH LED sample was classified as non-sensitizing.

 [079] All three tests performed were performed according to ABNT NBR ISO / IEC 17025: 2005.

Claims

REINDIVICATIONS
 An LED helmet (1) with light transporter (6) of the diode for the scalp, comprising a ring (3) with holes, wherein said holes allocate the spikes (4) acting as light transmitters of the diode for the scalp directing the passage of light, said helmet being characterized in that said spikes (4) are:
 - Covered by a metallized structure (5) that bars and directs the passage of light, wherein said structure (5) fits around the spirals (4) and forms the light conveyor (6); or
 Covered by a resin material (9), said material (9) encircles the spikes (4) and forms the light conveyor (6).
 An LED helmet (1) according to claim 1, characterized in that the light is homogeneously carried throughout the scalp area by intensifying the effect of the capillary treatment through the metallized (5) or resinated (9) spurs forming the conveyor of light (6) homogeneously radiating light within the electromagnetic spectrum in the region of visible and / or infrared light.
 LED helmet (1) according to claims 1 and 2, characterized in that the spatula covered with metallic material (5) bars and directs the passage of light, said structure (5) fits around the spikes (4), forming the light conveyor and emitting the light.
 The LED helmet (1) according to claims 1 and 2, characterized in that the spatula covered with resinous material (9) carries the light at an angle ranging from 10 ° to 80 °, preferably from 25 ° to 60 ° And more preferably 30 °.
 An LED helmet (1) with a light diode (6) for the scalp diode, according to claim 1, characterized in that said ring (3) has about 190 to 230 holes for allocating the spikes (4) .
LED helmet (1) according to claim 1, characterized in that the spike assembly (4) and metallized structure or resin material (5) form the light conveyor (6) in which it is retractable due to flexible foam ( 7) which fills the space between the rim (3) and the hull (8) of the LED helmet (1).
An LED helmet (1) according to claim 1, characterized in that it externally comprises a hull (8) surrounding the flexible foam (7), and further comprising on the side of the therapeutic helmet the button (2) on / off the device.
An LED helmet (1) according to claim 1 and 5, characterized in that it has a cable connected to a voltage transformer 110 ~ 220VAC 9 ~ 12V C D and is supplied via mains and / or battery to be fixed on the inside of the helmet, located between the hull (8) and the rim (3).
 LED helmet (1) according to claim 1, characterized in that it is made from synthetic fibers or injected plastic, such as Acrylonitrile Butadiene Styrene (ABS).
 A method for emitting light and cellular interaction as defined by the LED helmet of claim 1, characterized by the following steps:
 a) interaction of wavelengths in the range of the electromagnetic spectrum in the region of visible and / or infrared light;
 b) direct action of light in the red and / or infrared region of the electromagnetic spectrum in the mitochondria, more specifically acting on the IV complex of the respiratory chain (cytochrome c oxidase);
 c) release of nitric oxide (NO) into the bloodstream;
 d) stimulation of the production of Adenosine Triphosphate (ATP) and Oxygen Reactive Species (ROS).
Use of the LED cap helmet (1) for capillary photobiomodulation according to claims 1, 2 and 8, characterized in that the device provides about 1.0 J / cm 2 to 10.0 J / cm 2 of radiant exposure and intensify the effect on inflammatory processes of the scalp, such as telogen effluvium, seborrheic dermatitis, psoriasis; analgesia actions; healing; stimulation of hair growth; hydration of wires; improves the appearance and appearance of the scalp; and potentiation of the delivery of topical drugs by the drug delivery action, through the homogeneous irradiation of light within the electromagnetic spectrum in the region of visible and / or infrared light throughout the area to be treated.
Use of the LED cap helmet (1) for capillary photobiomodulation, according to claim 1, 2, 8 and 11, characterized in that it is for the treatment of inflammatory processes of the scalp, such as telogen effluvium, seborrheic dermatitis, psoriasis; analgesia actions; healing; stimulation of hair growth; hydration of wires; improves the appearance and appearance of the scalp.
 Use of the capillary photobiomodulation device according to claims 3 and 9, characterized in that it is portable, easy to use and can be used in any place as well as in the case of beauty salon, dermatological clinics, aesthetic center and / or even home use.
PCT/BR2018/050209 2017-07-06 2018-06-26 Led helmet with diode light guide for the scalp WO2019006528A1 (en)

Priority Applications (4)

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BRBR1020170146316 2017-07-06
BR102017014631-6A BR102017014631A2 (en) 2017-07-06 2017-07-06 led helmet with LED light carrier to the scalp
BR132018010728 2018-05-25
BRBR1320180107282 2018-05-25

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