Mouthpiece for improving symptoms of sleep apnea syndrome

Abstract

To provide a mouthpiece for ameliorating symptoms of a sleep apnea syndrome, the mouthpiece being small-sized and providing little discomfort when being attached.SOLUTION: A mouthpiece has a front wall part formed integrally on a front face of a lower jaw piece with which a lower jaw dentition is to be covered, the front wall part having a height reaching at least a tip of an upper jaw dentition and extending in right and left directions from its center part along the upper jaw dentition. When a patient attaches the mouthpiece to his / her oral cavity, a front face and a back face of the front wall part abut on an inner side of a lip and the upper jaw dentition, respectively, which makes a lower jaw be moved forward with respect to an upper jaw and be fixed.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a mouthpiece for improving the symptoms of sleep apnea syndrome.

Background Art

[0002] Sleep apnea syndrome is a disease in which the upper airway becomes narrow or is temporarily blocked mainly during sleep, resulting in apnea or hypopnea, which prevents good-quality sleep, leading to daytime sleepiness and decreased concentration, etc., and also the amount of oxygen in the body tends to be insufficient during sleep, which may cause complications such as myocardial infarction and stroke.

[0003] As a method for improving the symptoms of sleep apnea syndrome, the most popular treatment method currently in Europe, the United States, and Japan is CPAP therapy (continuous positive airway pressure therapy). Its principle is to continuously send air into the airway to keep the airway open in order to prevent apnea during sleep. The CPAP device improves the symptoms by having the patient wear a mask on the face and forcibly sending air into the patient's airway through an air tube connected to the device. On the other hand, for the patient, there is a sense of discomfort in wearing the mask on the face, and the device requires a motor for driving the fan and a power supply unit, so it is a large-scale device and also costly. Therefore, it is said that there are not a few patients who drop out of this treatment method.

[0004] On the other hand, devices that are inserted into the mouth during sleep are known as devices that are less uncomfortable and less expensive than CPAP devices in improving the symptoms of sleep apnea syndrome. For example, based on a treatment method that keeps the upper airway wide open by fixing the lower jaw in a position further forward than the upper jaw, preventing snoring and apnea, examples of mouthpieces for fixing the upper and lower jaws in such positions are disclosed in Patent Documents 1 and 2. The mouthpieces disclosed in these documents consist of an upper jaw mouthpiece and a lower jaw mouthpiece, and the lower jaw is moved and fixed further forward than the upper jaw by adjusting the occlusal parts of both mouthpieces or by adjusting the member that connects the two mouthpieces.

[0005] Although these oral devices place less burden on the patient than CPAP devices, they have drawbacks: the stress they place on the upper and lower jaws significantly restricts movement, which carries the risk of them becoming dislodged (or being removed unconsciously) during sleep; the devices themselves are somewhat large for portability; and they are relatively expensive to manufacture.

[0006] In contrast, Patent Document 3 discloses a small mouthpiece for treating sleep apnea syndrome, comprising an upper piece positioned between the maxillary teeth and the lip, a lower piece attached to the mandibular teeth, and an adjusting member for adjusting the relative position of the lower piece to the upper piece. This small mouthpiece achieves miniaturization by combining a mouthpiece that covers the mandibular teeth with an upper piece, which is a plate-like member that covers only the outer surface of the maxillary teeth. However, due to the presence of the adjusting member that protrudes forward from the device, the overall miniaturization of the device is not significant. Furthermore, although it is not necessary to cover both the upper and lower teeth with a mouthpiece, the lower jaw is fixed forward relative to the upper jaw by abutting the plate-like upper piece against the maxillary anterior teeth, which may place a heavy burden on the maxillary anterior teeth, and the fit may not necessarily be good. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Patent No. 3589456 [Patent Document 2] Patent No. 6157583 [Patent Document 3] Patent No. 6719265 [Overview of the project] [Problems that the invention aims to solve]

[0008] The present invention aims to provide a small mouthpiece that causes minimal discomfort when worn, for improving the symptoms of sleep apnea syndrome. [Means for solving the problem]

[0009] The mouthpiece for improving the symptoms of sleep apnea syndrome according to the present invention has an anterior wall integrally formed on the front surface of the mandibular piece that is placed over the mandibular teeth. This anterior wall extends from the center along the maxillary teeth on both sides and is at least as far as the tip of the maxillary teeth. When the patient wears the mouthpiece in their mouth, the front surface of the anterior wall contacts the inside of the lips and the back surface contacts the maxillary teeth, thereby moving and fixing the mandible forward relative to the maxilla. This keeps the upper airway wide and prevents snoring and apnea.

[0010] It is more desirable that the aforementioned anterior wall portion be formed along the maxillary dentition, extending from the center to at least the third tooth on each side. This is because it reduces the burden on the maxillary dentition.

[0011] Furthermore, it is more effective if the back and bottom surfaces of the anterior wall are molded to reflect the impression of the surface and occlusal surface of the maxillary dentition and the bite between the maxilla and mandible, as this reduces the discomfort and stress experienced by the patient when the maxillary dentition comes into contact with the anterior wall.

[0012] The aforementioned mandibular aligner should preferably be fitted over the teeth from the center of the mandibular arch to at least the sixth tooth on each side. This is because it prevents it from easily coming loose during sleep. [Effects of the Invention]

[0013] The mouthpiece according to the present invention provides the following effects: • It is worn only on the lower jaw and does not fix the upper jaw, resulting in less discomfort. • It does not significantly restrict the movement of the lower jaw, resulting in less stress. • The mouthpiece is small overall, making it easy to carry around. • There is less risk of it coming off (being taken off) unconsciously while sleeping. • It can be manufactured at a relatively low cost. [Brief explanation of the drawing]

[0014] [Figure 1] This is a perspective view of a mouthpiece according to an embodiment. [Figure 2] This is a side view of a mouthpiece according to an embodiment. [Figure 3] This is a perspective view showing the maxillary model, mandibular model, and bite. [Figure 4] This figure shows an example of creating a mouthpiece model using an articulator. [Modes for carrying out the invention]

[0015] Hereinafter, with reference to the drawings, an embodiment of the mouthpiece for improving the symptoms of sleep apnea syndrome according to the present invention will be described. Figure 1 is a perspective view of the mouthpiece 1 according to this embodiment, and Figure 2 is a cross-sectional view showing the mouthpiece 1 cut vertically through the center of the U-shape.

[0016] As shown in FIGS. 1 and 2, the mouthpiece 1 is integrally formed with a front wall portion 3 at the upper front of a substantially U-shaped lower molding piece 2 that fits into the lower dental arch, with a height reaching at least the tip of the upper dental arch and extending left and right along the upper dental arch from the center. Considering the burden on the upper dental arch when the patient wears the mouthpiece 1 (if the number of teeth in contact with the inner side of the front wall portion 3 is small, the burden on the teeth increases and there may be pain), it is formed along the dental arch from the center of the upper dental arch to at least the third tooth on both the left and right sides.

[0017] The lower molding piece 2 is a hollow body formed with a concave portion 2a for fitting the dental arch based on the shape of the molded lower dental arch in order to cover the lower dental arch. The lower molding piece 2 does not necessarily need to cover the entire lower dental arch, but it is desirable to cover at least a sufficient portion of the lower dental arch (for example, the dental arch from the center of the lower dental arch to at least the sixth tooth on both the left and right sides) so that it does not easily come off during sleep.

[0018] When the patient wears the mouthpiece 1 in the oral cavity, the front surface 3a of the front wall portion 3 abuts against the inner side of the lip, and the back surface 3b of the front wall portion 3 abuts against the upper dental arch, thereby enabling the lower jaw to move forward by the thickness of the front wall portion 3 with respect to the upper jaw. The back surface 3b and the bottom surface 3c of the front wall portion 3 are molded so as to take a mold of the occlusion between the upper dental arch and the upper and lower jaws and reflect the impression of the surface and the occlusal surface of the upper dental arch, reducing the discomfort and stress of the patient when the upper dental arch abuts against the back surface 3b of the front wall portion 3.

[0019] The material of the mouthpiece 1 can be a resin that conforms to the shape of the lower jaw and has appropriate hardness and softness, such as polyester, urethane, epoxy, polystyrene (PS), polycarbonate (PC), polyvinyl chloride (PVC), nylon, silicone, etc. It is often made of a transparent material, but it does not necessarily have to be transparent.

[0020] Next, an example of the process for manufacturing the mouthpiece 1 will be described while referring to FIGS. 3 and 4.

[0021] • Take impressions (molds) of the upper and lower jaws, and use them to create the upper jaw model 5 and the lower jaw model 6. To create the maxillary model 5 and mandibular model 6, one method is to take impressions of the maxilla and mandible using impression material, pour plaster into the molds, and remove them after they harden. Alternatively, the impression data can be acquired as three-dimensional digital data using an optical scanner (intraoral scanner), and the maxillary model 5 and mandibular model 6 can be produced using a 3D printer based on the acquired data.

[0022] • Take a bite (occlusion) of 7. For example, a wax material for acquiring the bite is applied along the lower teeth, and with the patient's lower jaw moved forward, the upper and lower jaws are brought into contact to acquire an impression of the bite on the wax material. In addition to wax, silicone or other materials can also be used to acquire the bite. When acquiring the bite, the degree to which the patient's lower jaw should be moved forward is somewhere between the state in which the upper and lower jaws are at rest and the state in which the lower jaw is moved as far forward as possible. If the lower jaw is moved too far forward, it will cause pain, and if the degree of forward movement is too small, the effect of improving sleep apnea will not be achieved. When the lower jaw drops during sleep and closes the airway, breathing is possible if there is even about 5 mm of space, so it will be necessary to move it forward by 5 mm or more, but it is not possible to make a uniform judgment as it depends on the patient's physique and oral condition, so the lower jaw will be moved forward "to the extent that sufficient space is secured in the airway for breathing".

[0023] Next, the bite is reproduced using an articulator. An articulator is a device that uses a model of teeth to reproduce the bite state of a patient's teeth and the movement of the jaw joint. Figure 4 shows an example of creating a model of a mouthpiece using an articulator 10. First, the maxillary model 5 is attached to the top of the articulator 10, the bite 7 is positioned to match the maxillary model 5, and then the mandibular model 6 is positioned to match the bite 7, and the mandibular model 6 is attached to the articulator. This reproduces the state when the patient acquires their bite (i.e., a bite with the mandible moved forward). Next, the bite 7 is removed, and the shape of the mouthpiece is fabricated on the model using wax. Figure 4 shows the completed state after removing the bite 7 and fabricating a wax model 11 of the mouthpiece using wax in the gap between the maxillary model 5 and the mandibular model 6 and on their front surfaces.

[0024] There are various methods for creating the mouthpiece 1 from the wax model 11 of the mouthpiece formed from wax as described above, and these methods differ depending on the material of the mouthpiece 1. For example, the finished wax model 11 is embedded in an investment material (such as plaster), then the wax is melted by immersing it in hot water, and the material for the mouthpiece 1 is poured into the resulting space to create the mouthpiece 1.

[0025] The completed mouthpiece 1 is then fitted by the patient and adjusted within the patient's oral cavity. The manufacturing process for mouthpiece 1 described above is just one example; various other methods can be used, and the process will differ depending on the material of the mouthpiece. On the other hand, mouthpiece 1 according to the present invention is characterized by its shape, and its effect is not affected by the manufacturing process.

[0026] The mouthpiece 1 according to this embodiment is worn only on the lower jaw and does not fix the upper jaw. Therefore, compared to a configuration that combines mouthpieces for the lower and upper jaws, it causes less discomfort when worn and does not significantly restrict the movement of the lower jaw, thus reducing stress on the patient while wearing it. As a result, the risk of the mouthpiece coming off unconsciously (or being removed unconsciously) during sleep can be reduced.

[0027] Furthermore, the area where the upper teeth are positioned is molded to reflect the shape of the upper teeth, thus reducing stress on the upper teeth.

[0028] Furthermore, because Mouthpiece 1 is small in overall size and relatively lightweight, it is easy to carry. Also, it requires less material to manufacture, making it relatively inexpensive to produce. [Explanation of Symbols]

[0029] 1. Mouthpiece 2. Mandibular molding piece 3 Front wall 5 Upper jaw model 6 Lower jaw model 7 bytes 10 Articulator 11. Wax model of the mouthpiece

Claims

1. A molded mandibular piece for improving symptoms of sleep apnea syndrome, in which the upper part of the mandibular piece fitted into the mandibular dentition has a height that reaches at least to the tip of the maxillary dentition, and on the left and right sides, only the anterior wall portion that extends from the center along the maxillary dentition is integrally formed on the upper front surface of the mandibular piece, and the maxilla is not fixed.

2. The anterior wall portion is formed along the upper jaw dentition, extending from the center to at least the third tooth on each side, as described in claim 1 for the mandibular molded piece for improving symptoms of sleep apnea syndrome.

3. The mandibular molded piece for improving symptoms of sleep apnea syndrome according to claim 1, wherein the back and bottom surfaces of the anterior wall portion are molded to reflect the impression of the surface and occlusal surface of the maxillary dentition.

4. The mandibular molded piece described in claim 1 is fitted to the teeth from the center of the mandibular dentition to at least the sixth teeth on both sides, for the improvement of symptoms of sleep apnea syndrome.

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