Device for treating snoring and apnea

Abstract

The present invention relates to a dental device for treating snoring and apnea (1) which is made using a 3D digital model and 3D printers and is composed of an upper plate (4) and a lower plate (6) that are joined by interlocking mechanisms (8, 9) that limit the opening of the mouth, optimizing the results of the treatment for snoring and apnea. The device is an apparatus for bringing the lower jaw forward that does not contain metal elements incorporated into the design of the apparatus, making manufacture easier and cheaper, as well as making the device more hygienic. Additionally, the forward movement of the lower jaw (7) is not achieved using screws or metal wires, but rather by sequentially and incrementally changing the plates, thus increasing the caliber of the airways, wherein the forward movement results from changes in the positioning of the interlocking mechanisms (8, 9).

Description

“DEVICE FOR TREATMENT OF SNORING AND APNEA” FIELD OF INVENTION

[0001] The present invention relates to a dental device that meets the needs of human beings. More specifically, the present invention features a dental device designed to treat patients suffering from sleep apnea and snoring. The device is designed to improve breathing and reduce these problems when used during sleep. Use of the device can be beneficial for those suffering from these conditions, significantly improving their life expectancy and quality of life. BACKGROUND OF THE INVENTION

[0002] Sleep-disordered breathing, most often consisting of snoring and sleep apnea, represents a serious health problem that can negatively impact the life expectancy and quality of life of those affected. Although the conventional treatment for these disorders is the use of a continuous positive airway pressure (CPAP) device, poor adherence to CPAP can limit its therapeutic effectiveness. On the other hand, intraoral mandibular advancement devices have proven to be an effective alternative to CPAP.

[0003] Mandibular advancement devices currently available on the market have significant limitations. These include manufacturing complexity and high cost, as they require multiple clinical visits and hours of laboratory work by a technician. Furthermore, they cause patient discomfort due to the device's bulkiness and pose hygiene challenges. These devices have limited optimal hygiene, as they consist of several metal components attached to the body of the device, which is typically made of resin or plastic. The recesses and joints are difficult to clean.

[0004] The present invention also provides better hygiene of the device by having a smooth surface design, without the addition of metal components such as screws, clamps, springs and others.

[0005] The mandibular advancement device presented in this patent is used only during sleep and maintains the lower jaw in an advanced position. It is constructed entirely through 3D printing using industrial design programs. The device's design and printing process is quick, reducing costs, making the treatment of sleep apnea and snoring more affordable than existing options.

[0006] Advantageously, the computer-generated design allows the device to have the smallest possible volume, making it more comfortable by putting less pressure on the tongue, cheeks, teeth and lips, increasing treatment adherence.

[0007] Additionally, the device's innovative design incorporates an element that increases comfort when using the device. The device's insertion axis on the teeth diverges from the axis of mouth opening movement during relaxation, creating an innovative device retention mechanism without the need for metal clasps or pressure from the device on the teeth to maintain stability. When the patient opens their mouth with a slight projection of the lower jaw, the device easily disengages from the teeth. However, when the lower jaw is relaxed, the device remains firmly attached to the teeth, keeping the mouth slightly open but preventing involuntary mouth opening during sleep.

[0008] Patent databases were searched for intraoral devices that treat snoring and apnea, but none of the patents found had the same characteristics and advantages as the technology product presented here.

[0009] The North American patent US 5003994 A presents an oral appliance to improve breathing, reduce or eliminate snoring and prevent sleep apnea composed of a rigid structure with an upper tray and a lower stop that keeps the lower jaw advanced and slightly open. The device presented in this patent does not allow adjustments to the position of the lower jaw.

[0010] U.S. patent 5868138 A describes a mandibular advancement device that allows precise adjustments to the magnitude of lower jaw advancement. This device consists of three metal plates connected to each other by a screwed metal connection system, allowing the main components of the device to articulate.

[0011] Brazilian patent application PI 0006726 1 A2 presents an intraoral device for treating snoring and obstructive sleep apnea comprising a removable upper body fitted to the upper jaw and incorporating a support surface inclined downwards and backwards in relation to the bite plane; a removable lower body fitted to the lower jaw and incorporating a stop surface inclined upwards and forwards in relation to the bite plane and which is seated against a respective support surface; and a pair of elastic means between them, providing a position close to that of a "closed bite".

[0012] Brazilian patent application PI 0503601 1 A2 refers to a device configured by two acrylic plates, upper and lower encapsulated, covering the upper and lower teeth in their occlusal third, interconnected by stabilizing arches, each one with an orthopedic screw, intended for the treatment of disorders resulting from snoring and apnea during sleep.

[0013] Utility model patent MU 8500840 0 U2 describes an intraoral device used in the treatment of primary snoring and obstructive sleep apnea and hypopnea syndrome in adults, consisting of two separate parts, one upper and one lower, each constructed with circumferential orthodontic wire retaining and opposing clasps around all upper and lower dental elements and the covering An occlusal device made of self-curing acrylic resin. On the sides are closed springs and orthodontic loops. The two parts are articulated by intermaxillary elastics that are attached to the springs and orthodontic loops adapted to the region of the upper canines and lower molars, respectively, which are responsible for the lower jaw advancement mechanism of this device.

[0014] Utility model patent application MU 8500324 7 U2 shows an intraoral device for treating patients with snoring and obstructive sleep apnea / hypopnea, composed of two self-curing acrylic resin plates that have retention clips, sliding tracks, opening guides, bayonets and telescopic tubes, thus providing latero-protrusive movements with control of progressive mandibular advancement.

[0015] Utility model patent application MU 8603012 4 U2 presents a mandibular repositioning device made of two upper and lower polystyrene plates, vacuum-molded to the anatomical shape of the teeth and soft tissues, and two helical springs made of stainless steel wire with acrylic resin portions to form the union between the stainless wire springs and the upper and lower polystyrene plates.

[0016] Brazilian patent PI 0901217 6 C8 discloses a snoring and apnea inhibiting orthosis comprising a main body made of acetate, formed by two parts, one for the upper jaw and the other for the lower jaw, where the parts are joined by a system of wires with two or more helicoids that run inside metal tubes and applied to both sides of the constituent parts, allowing frontal, lateral and vertical displacement of the lower part in relation to the upper part.

[0017] Utility model patent application MU 8800799 5 U2 describes a device for treating snoring and sleep apnea consisting of two upper and lower vacuum-molded, encapsulated plates, which cover the upper and lower teeth in their occlusal third, interconnected by dorsal arches, with one of their ends joined to a telescopic tube, and also having, installed in the lower region of each dorsal arch, a "Gurin" type screw.

[0018] Patent application BR 112012009115 8 A2 discloses an apparatus consisting of maxillary plates joined by a front screw housed in a polygonal cylindrical casing that has an upper displacement ring that serves as a guide for bars that provide a sliding movement between the jaws.

[0019] Patent BR 1 12014004653 0 B1 discloses an intraoral mandibular advancement device comprising two upper and lower “trays” and sliding adjustment blocks on their sides that are coupled to locking channels to reposition the lower jaw forward.

[0020] Patent BR 20 2013 000979 8 U2 presents an intraoral system for preventing snoring and obstructive sleep apnea by means of two independent plates attached to the teeth of the upper and lower jaws, which are connected to each other by a clamp made of a metal wire for orthodontic use. Said clamp passes through the region of the front teeth through a capillary tube whose function is to lock the position of the lower jaw forward of its relaxed anatomical position.

[0021] Patent BR 1 1 2015 029484 7 B1 describes an incrementally adjustable lower jaw advancement device for the prevention and treatment of snoring and apnea. It consists of two horseshoes molded to the teeth and articulated with each other through mechanical or resilient joints in the region of the back teeth. The device is prefabricated and made from thermoplastic material molded directly to the user's teeth.

[0022] Patent BR 10 2015 032038 8 B1 presents an intraoral device composed of an upper and a lower plate Made entirely of a resin material that can be made flexible by heating. The plates have metal retaining clips on the teeth and are connected to each other by metal clamps that enable the device to be activated. When generated, the clamps advance the lower jaw.

[0023] Utility model patent BR 20 2016 004886 4 Y1 discloses an intraoral device for treating snoring and obstructive sleep apnea. It consists of two acetate plates molded to the shape of the upper and lower dental arches and connected by an orthodontic steel wire that fits into a telescopic tube in the upper dental arch. When in the mouth, the assembly forces the lower jaw forward.

[0024] Patent BR 1 1 2019 000267 7 B1 presents a dental device that limits tongue movement, consisting of a support that is attached to the teeth made of resin material and to said component is attached a mechanism for restricting the positioning of the tongue, the structure of which is made of metallic material in the shape of a handle.

[0025] Patent application BR 10 2017 015024 0 A2 discloses a customized device characterized by having, internally to the thermopolymerizable acrylic, a metal bar composed of nickel chrome or cobalt chrome, containing expanders at its ends, positioned in the region of the lower premolars and elevation present in the region of the upper molars.

[0026] Utility model patent BR 20 2016 004886 4 Y1 describes a device consisting of an upper and lower acetate plate, both pressed in a vacuum laminator. The plates are fitted with acrylic occlusal tracks, and the plates are joined together on the outside of the right and left dental arches using expansion screws and an orthodontic archwire arm fitted and fixed to a telescopic tube.

[0027] Patent application BR 1 1 2020 024392 2 A2 discloses a mandibular advancement system that requires the surgical installation of four plates fixed to the upper and lower jaws with screws. These plates, in turn, anchor springs that protrude the jaw anteriorly.

[0028] Utility model patent application BR 20 2020 021047 0 U2 presents a system that includes orthodontic aligners with tabs that promote advancement of the lower jaw when the patient forces the lower jaw to close. When the patient opens their mouth, the lower jaw returns to its original anatomical position.

[0029] Patent application BR 10 2022 003251 3 A2 describes an appliance consisting of an upper arch tray, a lower arch tray, and an intermediate arch tray. The upper arch tray is pivotally connected to the intermediate arch tray so as to rotate with the user's upper set of teeth. The lower arch tray is adapted to move with the user's lower set of teeth in a horizontal direction relative to the upper and intermediate arch trays. BRIEF DESCRIPTION OF THE INVENTION

[0030] Lower jaw projection device for treating snoring and other sleep-related breathing disorders (1), characterized by being composed of two components (4,6) that are sequentially exchanged, composed of upper (4) and lower (5) plates, and that are articulated by a fitting mechanism (8,9) in the form of couplings, in which the upper plate has a fitting tab (8) and the lower plate (5) has a fitting tab (9) that are fitted together forming a joint, in which the device (1) is attached to the teeth by retainers (10), the device (1) being manufactured by means of additive manufacturing or subtractive manufacturing from a 3D digital model.

[0031] In another embodiment of the invention, the lower jaw projection device for treating snoring and other sleep-disordered breathing (1), according to claim 1, characterized in that the upper (4) and lower (5) plates are periodically exchanged. to establish incremental advancements of the lower jaw in order to achieve adequate advancement of the lower jaw (7) that can overcome respiratory events.

[0032] In yet another embodiment of the invention, the lower jaw projection device for treating snoring and other sleep-disordered breathing (1), according to claims 1 and 2, characterized in that the exchanges of the upper (4) and lower (5) plates can specify a sequence of tooth movements so that orthodontic treatment can be performed in conjunction with the treatment of the respiratory disorder.

[0033] In another embodiment of the invention, the lower jaw projection device for treating snoring and other sleep-related breathing disorders (1), according to claims 1 to 3, characterized by having a connection mechanism (8,9) between the upper (4) and lower (5) plates in a snap-fit ​​format, which does not allow the patient to open their mouth completely during sleep, thus optimizing the treatment of the breathing disorder.

[0034] In one embodiment of the present invention, the lower jaw projection device for treating snoring and other sleep-related breathing disorders (1), according to claims 1 to 4, characterized by retention mechanisms (10) for teeth with various shapes and described in the present patent application, which are intended to not overload a restoration or supporting tooth of the upper or lower plate in an inadequate manner, leading to damage to the dentition.

[0035] Another embodiment of the present invention, according to claims 1 to 5, the lower jaw projection device for treating snoring and other sleep-related breathing disorders (1) can be coupled to orthodontic aligners for correcting the position of the teeth, meaning that in this way the two types of devices, namely the one for treating snoring and apnea and the device for correcting teeth, can be used simultaneously during the night. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1. In A, item (2) pointed to by the arrow shows an airway closure event—an obstructive apnea—occurring. In B, item (3), one can see the increase in airway space caused by the use of the mandibular advancement device (1).

[0037] Figure 2. The mandibular advancement device (1) is made up of two independent components (4, 6), but articulated with each other during use, the two being together, constituting a single functional piece. The upper portion (4) of the device (1) fits over the upper teeth (5), while the lower portion (6) fits over the lower teeth (7).

[0038] Figure 3. Device (1) is shown here in anterior (A) and lateral (B and C) views. The independent components (4) and (6) in views A and B have snap-on tabs (8,9) that are disjointed. When device (1) is worn by the patient, the snap-on tabs (8,9) of components (4) and (6) are snapped together and worn as shown in C and constitute device (1).

[0039] Figure 4. Components (4) and (6) can receive retainers (10) to increase the retention of elements (4) and (6) to their respective dental arches. The retainers (10) can be made in different shapes according to need or convenience.

[0040] Figure 5. The mandibular advancement device (1) requires incremental activations that correspond to progressive advancements of the lower jaw. These advancements, highlighted by the dotted arrows in the posterior region of the device (1), are necessary to ensure maximum effect on airway opening. These advancements are obtained by replacing component (4) or (6), with these components varying in their construction to allow for advancements, the position of the snap-on tab elements (8) and / or (9).

[0041] Figure 6. Components (4) and (6) are inserted, respectively, on the upper (5) and lower (7) teeth with axes of insertion drawn in a computer program that are represented by solid line arrows. The insertion axes of (4) and (6) have an angle with the mouth opening axis shown by the dotted arrows and are not orthogonal to the occlusal plane highlighted by the right angles drawn here. The existence of the angle between the insertion axis of the components and the mouth opening axis provides retention of the device (1) in place, preventing the patient from fully opening the mouth when relaxed. The position with the teeth engaged in the device (1) is the one that allows the respiratory functional gains provided by the device (1).

[0042] Figure 7. The mandibular advancement device (1), consisting of independent components (4, 6), can be used directly on the teeth (5 and 7) or on orthodontic aligners intended for the correction of the patients' teeth (11 and 12), the latter not being the object of the present invention. The aligners fit over the dental arches (5 and 7) and the components (4 and 6) fit over them, allowing the treatment of snoring and apnea simultaneously with the orthodontic treatment of the position of the teeth with aligners. DESCRIPTION OF THE INVENTION

[0043] The mandibular advancement device for the treatment of snoring, apnea, and other sleep-related breathing disorders described in this patent is constructed using additive or subtraction 3D printing techniques. The device is composed of upper (4) and lower components (6) that fit respectively into the upper (5) and lower dental arches (7) forming the functional element (1). The functional element (1) can also be fitted over aligners that correct the position of the teeth, allowing the correction of the alignment of the teeth simultaneously with the treatment of apnea and snoring.

[0044] The device (1) shown in the drawings embraces almost all the teeth of the upper and lower arches, and uses the teeth or Orthodontic aligners are used as retention to keep the lower jaw projected forward. This projection is how the device delivers therapeutic results by bringing the tongue and soft palate forward, increasing the caliber of the airway during use.

[0045] It is important for patient treatment to achieve effective lower jaw advancement, which requires progressive advancement of the lower jaw over a few months. This advancement is done gradually to provide the patient with flexibility in the articulation of the lower jaw with the skull base. Therefore, replacements of components (4) or (6) are necessary, with variations in the positioning of the snap-on tab elements (8) or (9), as shown in Figure 5. Each new element implements an additional level of advancement.

[0046] The upper (4) and lower (6) components are articulated with each other by means of the upper (8) and lower (9) projections (fitting tabs) that act as a system of opposing hands, configuring the union of the components (4) and (6) in the functional element (1). The mandibular advancement device (1), which is the reason for the present patent, is fitted in the way in which it is used in the mouth in figure 1 B, in figure 3 C, in figure 4 C, and in figure 5.

[0047] The articulation of components (8) and (9) prevents the mouth from opening and becomes a functional advantage that the device (1) provides in relation to other devices, as opening the mouth hinders the advancement of the lower jaw and the effect of the therapy.

[0048] In order for the patient's mouth to remain almost completely closed, without the device (1) coming loose during the patient's sleep, a design element of the device (1) is incorporated which is configured by the divergence of the insertion axis of the components (4) and (6) from the axis described by the lower jaw when it is opened, that is, when the patient opens the mouth. This angulation provided during the fitting of the elements (8) and (9) retains the device (1) in place.

[0049] The device is used continuously throughout the patient's life only during sleep, and does not correct apnea, acting physically in the same way that glasses do to improve vision. EXAMPLES OF EMBODIMENTS OF THE INVENTION

[0050] The present mandibular advancement device was used in a series of patients treated by the patent applicant. The patients had sleep-disordered breathing and were diagnosed and monitored with polysomnography, which is the gold standard for diagnosing and monitoring patients with sleep-disordered breathing in the medical field.

[0051] The variable presented in the table is the oxygen desaturation index (ODI), and represents the number of drops in blood oxygen concentration per hour of sleep for each patient with and without the mandibular advancement device constant in this patent.

[0052] The treatment results presented in Table 1 reveal a significant improvement in the ODI of the treated patients. The mean ODI without the device was 22.9 ± 10.5 (mean ± standard deviation) and fell to 5.5 ± 2.8 (mean ± standard deviation), and the difference between “without the device” and “with the device” was statistically significant (p < 0.0001). Table 1 - Oxygen desaturation index of 17 patients with and without the device for treating snoring and apnea. IDO Pacie - SC nte in the device with the device 2 15 8 3 39 7 4 8 0 5 11 3 6 16 2 7 33 8 8 11 2 9 45 9 10 32 8 11 29 5 12 18 3 13 23 4 14 27 6 15 14 7 16 16 9 17 25 8

[0053] The average advancement of the lower jaw with the device of the present patent was 5.3 mm, and was achieved with a median of two upper or lower component exchanges.

[0054] Having revealed some preferred and alternative examples of execution of the present invention, it is clear that none of the examples provided is limitative to the scope of protection of the present invention, which is defined and limited solely by the attached claims framework and the claims contained therein.

Claims

CLAIMS 1. Device for treating snoring and apnea (1) characterized by being manufactured by means of additive manufacturing or subtractive manufacturing from a 3D digital model with 3D printers, and composed of upper (4) and lower (6) plates that are articulated by fitting mechanisms (8,9), which limit the opening of the mouth, optimizing the result of the treatment of snoring and apnea.

2. Device for treating snoring and apnea (1), according to claim 1, characterized in that the upper (4) and lower (6) plates are exchanged sequentially to establish incremental advancements of the lower jaw in order to achieve adequate advancement of the lower jaw to overcome apneas and snoring (7), with the advancements deriving from variations in the positioning of the fitting mechanisms (8,9).

3. Device for treating snoring and apnea (1), according to claims 1 and 2, characterized by the fact that the device (1) is fixed to the teeth by means of an insertion axis diverging from the mouth opening axis and by retainers (10).

4. Device for treating snoring and apnea (1), according to claims 1 to 3, characterized in that the upper (4) and lower (5) plate exchanges can fit over orthodontic aligners for tooth movement.

5. Device for treating snoring and apnea (1), according to claims 1 to 3, characterized by having a connection mechanism (8,9) between the upper (4) and lower (5) plates in a snap-fit ​​format, which does not allow the patient to open their mouth completely during sleep, thus optimizing the treatment of the respiratory disorder.

6. Device for treating snoring and apnea (1), according to claims 1 to 4, characterized by retention mechanisms (10) for teeth with various shapes and described in the present patent application, which are intended to not overload a restoration or tooth. Inadequate upper or lower plate support leading to damage to the teeth.

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