Intraoral phototherapy device with LEDs for the treatment of palate and oral mucosa lesions.

Abstract

A phototherapy device consisting of small, 3W LEDs (light emitting diodes) with red (625–740 nm) or blue (440–485 nm) colors, arranged in an anatomical plate for the oral cavity in a semi-elliptical shape, covered by a protective silicone sheath, which can be used in the treatment of extensive lesions in the palate and oral mucosa, such as oral mucositis in patients undergoing radiotherapy and chemotherapy, and oral candidiasis, such as prosthetic stomatitis.

Description

1 / 5 Descriptive Report of the Invention Patent for "INTRAORAL PHOTOTHERAPY DEVICE WITH LEDs FOR THE TREATMENT OF PALATE AND ORAL MUCOSA LESIONS" [001 The present invention falls within the field of phototherapeutic devices applied to the health area, more specifically Dentistry and Medicine, referring to a device consisting of light-emitting diodes (LEDs), adapted to the oral cavity, intended for the treatment of lesions of the palate and oral mucosa.

[002] In Dentistry, there are several known lesions in the oral cavity that require phototherapy treatment. This device can be used in the treatment of extensive lesions in the palate and oral mucosa.

[003] Cancer patients undergoing treatments such as chemotherapy and head and neck radiotherapy may experience oral side effects such as oral mucositis, with at least 75% of those receiving high doses developing this condition at some point during treatment (RILEY 2017, Leung 2007). During radiotherapy and after chemotherapy, the basal cells of the epithelium become unable to adequately replace the cells lost by the treatment. Exfoliation, resulting in epithelial atrophy and consequent mucosal collapse. This process results from direct effects on DNA and indirect effects through myelosuppression and compromised immune function in the patient. Clinically, oral mucositis presents in a mild form with erythematous atrophic lesions or in a severe form with ulcerative lesions that penetrate the submucosa. Due to the severity of the pain, oral mucositis affects oral physiological functions and the patient's quality of life, causing difficulties in drinking, eating, swallowing, and speaking. Its evolution is complex, as it is influenced by other complications such as xerostomia, dysgeusia, odynophagia, and opportunistic infections such as candidiasis (FREITAS, 2014).

[004] Candidiasis is a generic term that includes a group of mucous membrane and skin diseases with a common etiological agent of the genus. The main pathogen involved in the development of oral candidiasis is the species Candida albicans. Clinically, the oral manifestations of candidiasis are variable, with numerous forms of expression observed, the acute pseudomembranous form, popularly known as thrush, being the most common. The lesions are characterized by white plaques or nodules of variable consistency, and their borders may be... Petition 870260044600, dated 12 / 05 / 2026, page 18 / 25 2 / 5 r erythematous. They may be asymptomatic or there may be complaints of pain or burning (MANGUEIRA et al., 2010).

[005] Another quite common oral mucosal lesion is prosthetic stomatitis, the most frequent being related to users of complete dentures, affecting one in three patients (EMAMI et al., 2014). The use of complete dentures made of acrylic resin makes them a favorable site for colonization by microorganisms, due to their porosity and possible surface roughness. The biofilm formed on the surface of the prosthesis, consisting particularly of Candida, can be considered a risk factor for the development of prosthetic stomatitis, and may be associated with other factors such as trauma caused by poorly fitting prostheses, inadequate hygiene and nighttime use of the prostheses (EMAMI et al., 2014). Prosthetic stomatitis is a chronic inflammatory disease characterized by the presence of hyperemia and edema, sometimes accompanied by hemorrhagic petechiae.The clinical symptoms of this disease may include pain, irritation, and salivation disorders (YILENGTAY et al., 2014).

[006] There are several agents to prevent and treat these conditions, among them we can mention cytoprotective agents, growth factors, vitamin E, metabolic supplements, antibiotics, antimicrobials, lubricating agents, anti-inflammatories (such as benzydamine and L-glutamine), cryotherapy, mouthwashes, topical anesthetics, antioxidants (such as amifostine). N-acetylcysteine), gene therapy and, more recently, phototherapies with LASER and LED and photodynamic therapy, which have been widely used (FREITAS, 2014).

[007] Phototherapy consists of a treatment based on the interaction of electromagnetic light radiation with biological tissues. Phototherapy employs LASERs and LEDs, which are devices capable of emitting light (with a specific wavelength) that stimulates mitochondrial oxidative metabolism – through interaction with cytochrome c oxidase – accelerating cellular and tissue repair processes and stimulating cell proliferation, as well as collagen production, important factors for the healing process (Freitas 2014). A systematic review conducted by Bensadoun and Nair in 2012 showed how phototherapy is effective in the treatment of oral mucositis, based on several studies, including randomized clinical trials. The review identified 33 articles. Petition 870260044600, dated 12 / 05 / 2026, page 19 / 25 3 / 5 r Relevant studies that underwent meta-analysis showed that phototherapy reduces the risk, duration, and severity of oral mucositis, in addition to its pain-relieving effect.

[008] Antimicrobial photodynamic therapy (aPDT) involves combining the action of a photosensitizing dye with a light source, LASER or LED, in order to induce cell necrosis and microbial death. The action occurs when the photosensitizing substance stains a target cell, absorbs photons from the light source, and its electrons become excited, resulting in a first reaction with the production of superoxide, hydroxyl radicals, and free radicals. In the presence of molecular oxygen, a second reaction occurs, in which the photosensitizer transfers energy to itself when it returns to its natural state, forming short-lived and highly reactive molecules, such as singlet oxygen (O2). All these products oxidize biological molecules, such as mitochondrial proteins, altering their structure and activity, and denature proteins and lipids. membrane and modify the structure of cellular DNA. Due to this mechanism of action, it is very unlikely that a microorganism will develop resistance to this type of therapy (ALLISON et al., 2013; λ* r (DE FREITAS et al., 2017). The systematic literature review conducted by Javed et al. in 2014 showed that TFDa has antimicrobial effects against oral Candida, based on studies, including clinical trials and in vitro assays, being an effective treatment alternative for prosthetic stomatitis and oral candidiasis.

[009] Existing LASER and LED light devices for these therapies have tips that irradiate the tissue in a focused manner, thus a small area is irradiated with each application. For the treatment of extensive lesions, applications are necessary at various points in the tissue, which requires a long irradiation time, ranging from 3 to 30 minutes, making the treatment clinically unfeasible (JAVED et al., 2014, BENSADOUN & NAIR, 2012). rr

[010] Another disadvantage of current devices is the use of very low output power (less than 1W), because to achieve the desired energy density in the target tissue, it requires r Long application period at each point. For the treatment of oral mucositis, the energy density is... 2222... The desired concentration in the tissue should be at least 4 J / cm², and for the treatment of prosthetic stomatitis, 7.5 J / cm² (JAVED et al., 2014).

[011] Some authors argue that LED represents an alternative therapeutic approach to r Laser light has several advantages. LED light has less collimation, therefore the area irradiated by an LED tip is 25 times larger than... Petition 870260044600, dated 12 / 05 / 2026, p. 20 / 25 4 / 5 r Unlike lasers, LEDs allow for a larger area to be irradiated in each application, reducing the number of application points needed for treatment. The light emitted by LEDs has a wider spectral band than lasers, reaching a greater number of chromophores, which can aid in the healing of lesions (FREITAS, 2014).

[012] Thus, there is clinical interest in the development of a device that enables the application of light to large areas, such as the entire palate region of the patient in a single application, allowing irradiation with the desired energy density (dosimetry) in the target tissue, in a short application period. r

[013] The device that implements the solution presented in this patent application is composed of 9 LEDs with a power of 3 W each and a diameter of 5.6 mm, in red (625 - 740 nm) or blue (440 - 485 nm) colors, which are devices that emit one of the highest luminous fluxes compared to others in their category. The encapsulation of the LEDs has been optimized for use with power integrated circuits, supporting higher temperatures, and they are pre-fixed in primary heat sinks to facilitate assembly in the final application. r tu

[014] Other features of the invention are: - 9 LEDs arranged on a blank printed circuit board in the shape of a semi-ellipse. - Anatomical printed circuit board format for the oral cavity. rr - Activation is done through an external 9V power source with an electrical current of 500mA. Current limitation for each LED is achieved through a resistor. - Each LED consumes 27 mA using a 330 Ohm resistor with a 3W rating. - The plate is covered with a protective silicone membrane to prevent saliva penetration and keep the LEDs exposed, allowing for maximum light exposure. - Controlled output power. Controlled radiation time. Petition 870260044600, dated 12 / 05 / 2026, page 21 / 25 5 / 5 rr

[015] The main advantage of this device is that it allows irradiation of a wide area in the oral cavity, r both on the palate and on the mucosa, in a faster way, making it possible to carry out phototherapy treatments. r tu

[016] The following description and the associated figures, all given by way of non-limiting example, will make the invention clear.

[017] Figure 1 represents a front view of the device with dimensions of 43.49 mm at the base and 57.78 mm in height, with 9 LEDs of 5.6 mm diameter each arranged on the printed circuit board.

[018] Figure 2 represents, in cross-section, the virgin printed circuit board with a thickness of 1.60 mm, the assembled printed circuit board with a thickness of 7.06 mm and the device covered with the silicone protective membrane with a thickness of 7.91 mm.

[019] Figure 3 represents a perspective view of the device. r

[020] There is currently no technology, either in articles or in patent databases, with complete similarity to the device, which is the subject of this patent application. r

[021] The constructive variables of the present invention may revolve around the different distances of the LEDs arranged on the printed circuit board. In the increase or decrease in the number of LEDs and in the colors of the LEDs used. Petition 870260044600, dated 12 / 05 / 2026, p. 22 / 25

Claims

1 / 1 CLAIMS 1. Phototherapy device with LEDs adapted to the oral cavity for the treatment of palate and oral mucosa lesions, characterized by comprising a semi-elliptical plate, anatomically shaped to the oral cavity, containing a plurality of LEDs distributed on its active surface, each LED with a power of approximately 3 W, selected from the red (625-740 nm) or blue (440-485 nm) spectral bands, configured to promote the simultaneous irradiation of extensive areas of the oral mucosa, in order to provide high energy density to the tissue in a reduced application time.

2. Device, according to claim 1, characterized by comprising 9 (nine) LEDs distributed on the surface of the board.

3. Device according to claim 1 or 2, characterized in that the LEDs have a nominal power of approximately 3 W each and an approximate diameter of 5.6 mm.

4. Device, according to any of the preceding claims, characterized by being powered by an external source of approximately 9 V and an electric current of approximately 500 mA, with individual current limitation by means of resistors.

5. A device, according to any of the preceding claims, characterized by having a protective silicone membrane, configured to prevent the penetration of saliva, while simultaneously maintaining the exposure of the LEDs for light emission.

6. Device, according to any of the preceding claims, characterized by comprising means of controlling the output power and irradiation time, intended for the phototherapeutic treatment of oral mucositis, oral candidiasis and prosthetic stomatitis in an individualized manner for each patient. Petition 870260044600, dated 12 / 05 / 2026, pp. 23 / 25

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