Extracorporeal training device for ameliorating sleep apnea

Abstract

To solve the problem that performance of conventional training is not good.SOLUTION: An extracorporeal training method for ameliorating sleep apnea includes: creating a first oral model by scanning the oral cavity of a user; obtaining an extracorporeal training device by selecting an articulator body according to the first oral model, molding a plurality of first customized type electrode sheets, and assembling the plurality of first customized type electrode sheets in the articulator body again; the user's clenching the extracorporeal training device in the non-sleeping time of the user and giving electric stimulation to the top face and two sides of the tongue by the plurality of first customized type electrode sheets; creating a second oral model by scanning the oral cavity of the user again after an elapse of a training period; and comparing the first oral model and the second oral model for remaking the customized type electrode sheets timely.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an external training method and device for improving sleep apnea, and more particularly to an external training method and device for improving sleep apnea used during non-sleep periods. [Background technology]

[0002] According to a survey by the World Health Organization (WHO), there are approximately 1 billion adults (aged 30-69) suffering from obstructive sleep apnea (OSA) worldwide. Among them, approximately 42 million people in the United States suffer from sleep apnea, and one in five adults suffer from mild sleep apnea, while one in 15 suffer from moderate to severe sleep apnea. In addition, according to statistics from the Taiwan Society of Sleep Medicine (TSSM), approximately 450,000 people in Taiwan suffer from sleep quality affected by sleep apnea.

[0003] The main causes of sleep apnea are congenital or obesity-related airway narrowing, or insufficient muscle tone in the airway due to aging, which can lead to respiratory obstruction. There are three types of obstruction that cause sleep apnea: nasal obstruction, soft palate obstruction, and tongue base obstruction. Nearly 70% of patients, or about 650 million people worldwide, have tongue base obstruction, which is the largest group of obstructive patients, and at least 300,000 people in Taiwan have the same condition. Tongue base obstruction is strongly associated with reduced activity of the upper airway muscles and reduced activation of the sublingual muscles. Patients with sleep apnea not only affect the quality of sleep of those around them by snoring, but also cause problems such as daytime sleepiness and reduced concentration, as the quality of the patient's own sleep deteriorates. In severe cases, sudden death may occur due to cessation of breathing during sleep.

[0004] However, there is currently no medicine that can treat sleep apnea, and the commonly known methods for improving sleep apnea are as follows: (1) Intraoral anti-snoring device. It is applied to patients with mild to moderate sleep apnea. However, the intraoral anti-snoring device disturbs the patient's sleep due to the foreign body sensation in the mouth. (2) Appliance therapy. By wearing a continuous positive airway pressure (CPAP) machine on the face during sleep, air can be continuously injected into the airway to open it. However, CPAP machines are bulky and expensive, and many pipelines are placed around the user's head during use, which affects the comfort and quality of sleep. (3) Surgical treatment. The airway is widened by cutting the uvula or tonsils, or surgery is performed to implant an electrical stimulation device, which electrically stimulates the sublingual muscles and other upper airway muscles during sleep to increase the tone of the upper airway muscles. For patients with moderate to severe sleep apnea who are unable to receive or continue CPAP therapy, a treatment called an implanted electrical stimulation device may be considered. However, this treatment requires the device to be implanted in the body through surgery, which not only carries the risk of infection during surgery, but also requires surgical removal and re-implantation if the device breaks down, and electrical stimulation during sleep can affect the quality of sleep. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 8,428,725 Summary of the Invention [Problem to be solved by the invention]

[0006] Although the above-mentioned conventional improvement methods are all used while the user is sleeping, in recent years, a sleep apnea training device that is used when not sleeping has become known, and the user can train to recover muscle tone by electrically stimulating the sublingual muscles simply by placing the articulator in the mouth, effectively avoiding the risks of implant surgery and discomfort during sleep. However, the specifications of the articulator are uniform, and clinically it has been found that a very high percentage of users do not accurately electrically stimulate the sides and top of the tongue while using the device, and therefore the effect of the training is far lower than expected.

[0007] Based on the above-mentioned problems, the above-mentioned conventional methods for improving sleep apnea need to be further improved.

[0008] In order to solve the above problems, the first object of the present invention is to provide an external training method for improving sleep apnea, which allows a user to accurately train the sublingual muscles and recover muscle tone by customizing the electrode sheet of an articulator.

[0009] A second object of the present invention is to provide an external training method for improving sleep apnea, which can accurately recommend the next re-examination time.

[0010] The third object of the present invention is to provide an external training device for improving sleep apnea, which is obtained by the above-mentioned method.

[0011] A fourth object of the present invention is to provide an external training device for improving sleep apnea, which is convenient to use and carry. [Means for solving the problem]

[0012] The terms of direction or approximate terms used throughout the specification of the present invention, such as "front," "rear," "left," "right," "upper (top)," "lower (bottom)," "inner," "outer," "side," etc., mainly indicate directions in the accompanying drawings, and each term of direction or approximate terms is intended to aid in the explanation and understanding of each embodiment of the present invention, and is not intended to limit the present invention.

[0013] The use of the numerals "one" or "one piece" in the description of parts and members throughout the specification of the present invention is merely for convenience and to provide the ordinary meaning within the scope of the present invention, and should be read as including one or at least one in the present invention, and the concept of a line segment also includes multiple situations, unless clearly otherwise intended.

[0014] In the present specification, the terms "connection", "combination" or "assembly" and other similar terms mainly include those in which the members can be separated without being destroyed even after being connected, or those in which the members cannot be separated after being connected, which can be selected by a person skilled in the art according to the materials of the members to be connected or the requirements of the assembly.

[0015] The external training method for improving sleep apnea of ​​the present invention includes: making a first oral cavity model by scanning a user's oral cavity; selecting an articulator body according to the first oral cavity model, molding a plurality of first customized electrode sheets, and assembling the plurality of first customized electrode sheets to the articulator body to obtain an external training device; having the user bite the external training device during a non-sleep period, and training the muscular endurance of the user's sublingual muscles by electrically stimulating the upper and both sides of the tongue with the plurality of first customized electrode sheets; after a training period, making a second oral cavity model by scanning the user's oral cavity again; comparing the first oral cavity model with the second oral cavity model; and if the image overlap rate of the first oral cavity model and the second oral cavity model is lower than 80%, making a plurality of second customized electrode sheets according to the second oral cavity model, and assembling the plurality of second customized electrode sheets to the articulator body instead of the plurality of first customized electrode sheets.

[0016] As a result, the external training method for improving sleep apnea of ​​the present invention can more accurately stimulate the sublingual muscles of the user with a customized electrode sheet, train the muscle endurance of the sublingual muscles, and support the user in recovering the original tension of the sublingual muscles, thereby improving the condition in which the tongue sinks and blocks the airway during sleep, thereby improving the symptoms of sleep apnea. In addition, by periodically visiting the patient for a follow-up visit to check the morphology of muscle changes in the sublingual muscles and replacing the customized electrode sheet that is newly customized according to the current muscle morphology in a timely manner, it is ensured that the user can train the sublingual muscles with effective electrical stimulation over the long term, and the effects of the training can be more reliably improved, thereby improving the symptoms of sleep apnea more efficiently than conventional methods.

[0017] In addition, when the image overlap rate of the first and second oral cavity models is lower than 80% and equal to or higher than 70%, a recommended re-examination time is set, and the recommended re-examination time is approximately equal to the training period. In this way, by accurately recommending a timely re-examination to the user and replacing the customized electrode sheet, the effect of the training can be improved and the user's time can be saved.

[0018] In addition, when the image overlap rate of the first and second oral cavity models is lower than 70%, a recommended re-examination time may be set, and the recommended re-examination time may be shorter than the training period. In this way, by accurately recommending a timely re-examination to the user and replacing the customized electrode sheet, the effect of the training can be improved and the user's time can be saved.

[0019] In addition, the recommended re-examination time may be shorter than two-thirds of the training period and longer than half of the training period. In this way, the effect of the training can be improved and the user's time can be saved by accurately recommending a timely re-examination to the user and replacing the customized electrode sheet.

[0020] In addition, when the image overlap rate between the first and second oral cavity models is 80% or more, a recommended re-examination time is set, and the recommended re-examination time is shorter than the training period. In this way, by accurately recommending a timely re-examination to the user and replacing the customized electrode sheet, the effect of the training can be improved and the user's time can be saved.

[0021] In addition, the recommended re-examination time is shorter than half the duration of the training and longer than one-third of the duration of the training. In this way, by accurately recommending a timely re-examination to the user and replacing the customized electrode sheet, the effect of the training can be improved and the user's time can be saved.

[0022] Furthermore, the external training device for improving sleep apnea of ​​the present invention includes an articulator body, a plurality of customized electrode sheets, and an electrical stimulation module, the articulator body has a mouthpiece part and an exposed part, the mouthpiece part has a plurality of connecting parts, the plurality of customized electrode sheets are customized and molded according to a user's oral model, and are detachably assembled and connected to the plurality of connecting parts, and the electrical stimulation module is disposed in the articulator body, electrically connected to the plurality of customized electrode sheets, and used to generate electrical stimulation signals to the plurality of customized electrode sheets, thereby training the muscular endurance of the user's sublingual muscles. In this way, the above-mentioned sublingual muscles can be accurately trained to improve the training results, and the external training device can be formed in a small and compact form as a whole, making it convenient to use and carry.

[0023] In addition, the multiple customized electrode sheets are divided into an over-the-tongue type and a tongue-side type, the over-the-tongue type customized electrode sheet is formed in a thin sheet shape and is coupled to the lower surface of the mouthpiece part, the tongue-side customized electrode sheet has a protrusion, the protrusion is detachably coupled to a corresponding coupling part and protrudes from the lower surface of the mouthpiece part, a tooth contact surface is formed on the outside of the protrusion, and an electrical conductive part is formed on the inside of the protrusion. In this way, it is possible to accurately electrically stimulate the upper and both sides of the tongue with a simple structure, and it is also possible to improve the convenience of manufacturing, replacement, and assembly.

[0024] In addition, the tooth contact surface is formed to have an outer shape that matches the inside of the lower dentition of the user according to the oral cavity model. In this way, it is possible to increase the degree of contact when contacting the lower dentition of the user, and also to support accurate positioning of the mouthpiece part in the oral cavity of the user.

[0025] In addition, the electrical stimulation module has at least one power source and one control unit disposed in the exposed portion of the articulator body, the power source is electrically connected to the multiple customized electrode sheets and the control unit, and the control unit can control the electrical stimulation signal emitted to the customized electrode sheets. In this way, the structure of the external training device can be simplified and the weight can be reduced.

[0026] In addition, the control unit is coupled to a smart device and adjusts the stimulation intensity and / or frequency of the electrical stimulation signal through the APP interface of the smart device, so that the user can adjust the effect of the electrical stimulation at any time according to their needs and comfort, and improve the training effect and the comfort of the treatment.

[0027] The voltage adjustment range of the electrical stimulation signal is 0 to 100 V, the current adjustment range is 0 to 30 mA, the wave (pulse) width adjustment range is 5 to 500 ms, and the frequency adjustment range is 1 to 80 Hz. In this way, the user can start, adjust, pause, or stop the electrical stimulation according to needs, which increases the convenience of operation and ensures the safety of use and the effectiveness of training. [Brief description of the drawings]

[0028] [Figure 1] 2 is a flow chart of the steps of the method of the present invention. [Diagram 2] FIG. 2 is an exploded perspective view of an embodiment of the present invention. [Diagram 3] FIG. [Figure 4] FIG. 2 is a schematic diagram of the coupling connection between the apparatus of the present invention and a smart device. BEST MODE FOR CARRYING OUT THEINVENTION

[0029] In order to make the above and other objects, features and advantages of the present invention more clear and understandable, the present invention will be described in detail with reference to the following embodiments with reference to the drawings. In addition, the same reference numerals in different drawings are regarded as the same, and the description thereof will be omitted.

[0030] As shown in FIGS. 1 and 2, the external training method for improving sleep apnea of ​​the present invention includes the following steps.

[0031] In step S1 of the initial model making, a first oral cavity model is made by scanning the oral cavity of the user. The user goes to a sleep medical center, and after a sleep test or evaluation by a clinician, if the obstruction type of the sleep apnea belongs to tongue base obstruction, an image of the inside of the oral cavity of the user can be obtained by equipment such as a computed tomography device or an oral cavity scanning device, and a three-dimensional oral cavity model (i.e., a first oral cavity model) is constructed by medical software.

[0032] In step S2 of customizing the external training device, an articulator body 1 is selected according to the first oral cavity model, a plurality of first customized electrode sheets 2 are molded, and the plurality of first customized electrode sheets 2 are assembled to the articulator body 1 to obtain an external training device T. The articulator body 1 is substantially Y-shaped and has a substantially V-shaped mouthpiece part 1a and a substantially I-shaped exposed part 1b, and the mouthpiece part 1a and the exposed part 1b may be integrally formed. When used, the mouthpiece part 1a can be inserted into the mouth of a user, and the exposed part 1b is exposed and not included in the mouth (as shown in FIG. 3). The articulator body 1 may be divided into sizes such as S, M, and L according to the maximum width of the mouthpiece part 1a. When used for the first time, an articulator body 1 having an appropriate width of the mouthpiece part 1a can be selected according to the first oral cavity model of the user.

[0033] The lower surface 11 of the mouthpiece part 1a may have a plurality of coupling parts 12, which can be used to detachably couple the plurality of first customized electrode sheets 2. In this embodiment, the plurality of first customized electrode sheets 2 can be divided into two types, a tongue type 2a and a tongue side type 2b, and the first customized electrode sheet 2 of the tongue type 2a can be formed in a thin sheet shape and can be molded into shapes and sizes corresponding to different assembly positions according to the tongue side F1 (also refer to FIG. 3) of the first oral cavity model. The first customized electrode sheet 2 of the tongue side type 2b can be formed in a three-dimensional shape, for example, and may have a protrusion 21, which is detachably coupled to the corresponding coupling part 12 and protrudes from the lower surface 11 of the mouthpiece part 1a. Furthermore, a tooth contact surface 22 may be formed on the outer side of the protrusion 21, so that the tooth contact surface 22 can abut against the inner side of the lower dentition of the user. In addition, the tooth contact surface 22 may be formed into an outer shape that matches the inside of the lower dentition of the user according to the first oral cavity model, thereby increasing the degree of adhesion when contacting the lower dentition of the user and supporting accurate placement of the mouthpiece part 1a in the oral cavity of the user. The first customized electrode sheet 2 of the lingual type 2b may further have an electrically conductive part 23 formed on the inside of the protrusion 21.

[0034] The above-mentioned multiple customized first electrode sheets 2 may be assembled by aligning them with the multiple connecting parts 12 of the mouthpiece part 1a. In this embodiment, the first customized electrode sheets 2 of one tongue type 2a may be assembled and connected to both ends near the V-shaped opening of the mouthpiece part 1a. Furthermore, between the part where the mouthpiece part 1a and the exposed part 1b are connected and the first customized electrode sheets 2 of the two tongue types 2a, one first customized electrode sheet 2 of the tongue type 2b may be assembled, and the tooth contact surface 22 of the first customized electrode sheet 2 of the two tongue types 2b may be directed outward toward the inside of the lower dentition of the user, and the electrical conductive part 23 of the first customized electrode sheet 2 of the two tongue types 2b may be directed inward toward both the left and right sides of the user's tongue.

[0035] In addition, the external training device T further includes an electrical stimulation module 3 arranged in the articulator body 1, and the electrical stimulation module 3 can emit an electrical stimulation signal having a predetermined voltage, current, frequency and pulse time to the customized electrode sheets coupled to the multiple coupling parts 12 by control. In this embodiment, the electrical stimulation module 3 may include at least one power source 31 and one control unit 32 arranged in the exposed part 1b of the articulator body 1, and can be electrically connected to the power source 31 when the multiple first customized electrode sheets 2 are assembled to the articulator body 1. The power source 31 may be electrically connected to the control unit 32, thereby providing a power source for the operation of the control unit 32. The control unit 32 can control the electrical stimulation signal emitted to the customized electrode sheets coupled to the multiple coupling parts 12. 4, the control unit 32 can be coupled to a smart device E, such as a mobile phone, tablet, or smart watch, so that the user can perform personalized settings through the APP interface of the smart device E according to needs and comfort, and adjust the stimulation intensity and / or frequency of the above-mentioned electrical stimulation signal to enhance the training effect and training experience. For example, the voltage adjustment range may be 0-100V, the current adjustment range may be 0-30mA, the amplitude adjustment range may be 5-500ms, and the frequency adjustment range may be 1-80Hz. This allows the user to start, adjust, pause, or stop the electrical stimulation according to needs.

[0036] As shown in Figures 1 and 3, in training step S3, the user bites the external training device T during a non-sleep period, and the multiple first customized electrode sheets 2 provide electrical stimulation to the upper and both sides of the tongue to train the muscular endurance of the user's sublingual muscles M.

[0037] In detail, when training, the user can put the mouthpiece part 1a of the articulator main body 1 into the mouth during the non-sleep period, and the tooth contact surface 22 of the first customized electrode sheet 2 of the lingual type 2b can be abutted against the inside of the lower dentition of the user, and the electrical conductive part 23 can be roughly aligned with both the left and right sides F2 of the user's tongue. At this time, the first customized electrode sheet 2 of the supra-lingual type 2a can be roughly aligned with the upper surface F1 of the user's tongue. In this way, the electrical stimulation module 3 can provide electrical stimulation signals to the multiple first customized electrode sheets 2, and the first customized electrode sheet 2 of the supra-lingual type 2a can electrically stimulate the upper surface F1 of the tongue, and the first customized electrode sheet 2 of the lingual type 2b can electrically stimulate the left and right sides F2 of the tongue, respectively, thereby training the user's sublingual muscle group M and recovering its muscle endurance.

[0038] In the tracking model making step S4, after the training period, the user's oral cavity is scanned again to make a second oral cavity model. After the user's sublingual muscles M are trained with electrical stimulation for a certain period of time, the muscles of the sublingual muscles M become stronger. At this time, the muscles of the sublingual muscles M may become larger, smaller or shifted, so when the training step S3 is performed, the first customized electrode sheets 2 cannot provide electrical stimulation to the sublingual muscles M according to the planned position, which affects the effect of the training. To this end, the training period can be set, for example, one month, that is, the user should perform the training step S3 every day and visit the hospital again for a follow-up examination after the training period is completed, at which time the user's oral cavity is scanned again to make the second oral cavity model.

[0039] In update step S5, the first oral cavity model is compared with the second oral cavity model. If the image overlap rate of the first oral cavity model and the second oral cavity model is lower than 80%, a plurality of second customized electrode sheets are molded according to the second oral cavity model, and the plurality of second customized electrode sheets are assembled to the articulator body 1 instead of the plurality of first customized electrode sheets 2.

[0040] In detail, by comparing the image overlap rate of the first oral cavity model and the second oral cavity model, the muscular change morphology of the user's sublingual muscles M after the training period can be known. If the image overlap rate is lower than 80%, it indicates that the muscular morphology has already changed obviously, and the original customized multiple first customized electrode sheets 2 may soon not provide electrical stimulation to the sublingual muscles M according to the planned position, so it is necessary to customize multiple second customized electrode sheets according to the second oral cavity model again. After the multiple second customized electrode sheets are molded, the multiple first customized electrode sheets 2 originally assembled on the articulator body 1 can be removed, and then the corresponding multiple second customized electrode sheets are attached, so that the updated device can be adapted to the current muscular morphology of the user's sublingual muscles M, and the electrical stimulation can be accurately provided to the sublingual muscles M according to the planned position and the effect of the training can be ensured.

[0041] In addition, if the image overlap rate of the first and second oral cavity models is lower than 80% and not less than 70%, it indicates that the timing of the re-examination is appropriate, and the next time the patient can visit the hospital for a re-examination according to the same period. That is, a recommended re-examination time can be set, and the recommended re-examination time is approximately equal to the training period. On the other hand, if the image overlap rate of the first and second oral cavity models is lower than 70%, it indicates that the timing of the re-examination is too late, and the currently used first customized electrode sheets 2 cannot accurately stimulate the user's sublingual muscle group M from a certain point in time, so that after updating and replacing with the second customized electrode sheets molded according to the second oral cavity model, the recommended re-examination time should be shorter than the training period, and preferably shorter than about two-thirds of the training period and longer than about half of the training period. For example, if the training period for training the sublingual muscles M using the first customized electrode sheets 2 last time is one month, and the training period after replacing with the second customized electrode sheets should be shorter than one month, the next recommended re-examination time should be shorter than one month, preferably about 10 to 20 days after the first customized electrode sheets 2 are replaced. Furthermore, the image overlap rate between the oral cavity model produced by the next scanning and the second oral cavity model is expected to be lower than 80% and higher than 70%.

[0042] Furthermore, if the image overlap rate of the first and second oral cavity models is 80% or more, it indicates that the multiple customized electrode sheets currently combined with the articulator body 1 can still accurately perform electrical stimulation on the user's sublingual muscles M, so the timing of visiting the hospital for a re-examination is a little too early, and the multiple customized electrode sheets are still applicable and do not need to be replaced, so the training of the user's sublingual muscles M can be continued without interruption (it takes about several days to make the corresponding customized electrode sheets according to a new oral cavity model each time), and the user can visit the hospital again for a re-examination after a certain period of time has elapsed. That is, the recommended re-examination time can be shorter than the training period, and is preferably shorter than about half the training period and longer than about one-third the training period. The recommended re-examination time can be determined by the image overlap rate, and the higher the image overlap rate, the longer the recommended re-examination time. For example, the training period for training the sublingual muscles M using the plurality of first customized electrode sheets 2 last time is assumed to be one month, and if the user visits the hospital again after training for one month and the image overlap rate between the first and second oral cavity models is 80% or more, the user continues to use the plurality of first customized electrode sheets 2 to continue training the sublingual muscles M. The user should then visit the hospital again within one month for a follow-up examination, preferably after about 10 to 15 days, and at this time, it is checked whether the image overlap rate between the oral cavity model produced by scanning again and the first oral cavity model is already lower than 80%, thereby determining whether a new customized electrode sheet needs to be produced and replaced.

[0043] As a result, the external training method for improving sleep apnea of ​​the present invention can more accurately stimulate the sublingual muscles of the user with a customized electrode sheet, train the muscle endurance of the sublingual muscles, and support the user in recovering the original tension of the sublingual muscles, thereby improving the situation in which the tongue sinks and blocks the airway during sleep, thereby improving the symptoms of sleep apnea. In addition, by periodically reviewing the patient's condition and checking the morphology of muscle changes in the sublingual muscles, and replacing the customized electrode sheet with a new one customized to match the current muscle morphology in a timely manner, the user can be ensured to train the sublingual muscles with effective electrical stimulation over the long term, thereby making the training effect more certain and improving the symptoms of sleep apnea more efficiently than conventional methods.

[0044] In summary, the in vitro training method and device for improving sleep apnea according to the present invention have the following advantages: (1) Excellent training effect. The present invention customizes the shape of the electrode sheet of a dedicated articulator according to the oral cavity model of each user, and furthermore, the customized electrode sheet is replaced in a timely manner according to the current muscle shape. Compared with the conventional articulator, the present invention allows each user to accurately train the sublingual muscles and recover muscle tone, so that good training results can be ensured. (2) Recommendation of appropriate timing for re-examination. The present invention compares the image overlap rate of the oral cavity model, and can accurately recommend the time of the next re-examination according to the muscle training status of each user, thereby reducing the user's unnecessary hospital visits and helping to build a good relationship between doctor and patient. (3) No effect on sleep quality. Since the electrical stimulation of the present invention is performed during non-sleep periods, it does not cause discomfort during sleep and does not affect the user's sleep quality. (4) Increased motivation for continued use. Since the user can selectively choose a time and place convenient for daily life to receive electrical stimulation training, the convenience and comfort of the user's training can be effectively improved, and the motivation of the user to continue using the device can be increased. (5) No risk of surgery. The external training method of the present invention is non-invasive and does not require the implantation of a corresponding device through surgery, so that the risks and inconveniences caused by the surgical procedure can be avoided, and the training burden on the user can be greatly reduced. (6) Easy to use and carry. The external training device of the present invention is compact in size and very easy to carry. Compared with the continuous positive pressure ventilator (CPAP), which can only be used near the device and has multiple belts and tubes around the user's head, which can cause problems such as tube marks on the user's face, the external training device of the present invention allows the user to walk around freely and does not have the problem of multiple belts and tubes in the conventional CPAP, so that the present invention is easy to use and greatly increases comfort. (7) Reduced capital investment costs.Compared with conventional improvement methods such as surgery or expensive continuous positive pressure ventilation, the external training device of the present invention has a low capital investment cost, allowing more medical institutions and clinics to provide corresponding training services, and users themselves can purchase a dedicated external training device at a low cost to perform electrical stimulation training anytime and anywhere. In addition, the external training device of the present invention has a simple structure, which can improve maintenance efficiency and reduce maintenance costs. (8) Saving time or labor costs. The use of the external training method or device of the present invention can eliminate the time and recovery period required for surgery and reduce the need for surgery or training services by medical professionals, thereby saving time and labor costs.

[0045] Although the present invention has been described using the above-mentioned relatively good examples, the present invention is not limited to the above-mentioned examples, and even if a person familiar with this technology makes various changes or modifications to the above-mentioned examples, they still belong to the technical scope protected by the present invention, so the scope of protection of the present invention should naturally include modifications within the meaning and equivalent scope described in the attached claims. In addition, if the above-mentioned multiple examples can be combined, the present invention includes embodiments by any combination. [Explanation of symbols]

[0046] 1…Articulator body 1a…Mouthpiece section 1b...Exposed part 11…Bottom surface 12...Joining part 2…First customized electrode sheet 2a…Supralingual type 2b…lingual type 21… Convex part 22…Tooth contact surface 23...Electrical conductive part 3. Electrical stimulation module 31…Power supply 32…Control unit E: Smart device F1…Upper surface of tongue F2…Lingual surface M: Sublingual muscles S1: First model making step S2…Steps for customizing external training equipment S3…Training Steps S4…Tracking model making steps S5…Update steps T…External training device

Claims

1. Creating a first oral model by scanning the oral cavity of a user; Selecting an articulator body according to the first oral cavity model, forming a plurality of first customized electrode sheets, and assembling the plurality of first customized electrode sheets to the articulator body to obtain an extracorporeal training device; A user bites the external training device during a non-sleep period, and electrically stimulates the upper and both sides of the tongue with the first customized electrode sheets to train the muscle endurance of the user's sublingual muscles; After the training period, scanning the user's mouth again to create a second mouth model; and comparing the first oral cavity model with the second oral cavity model; and if an image overlap rate between the first oral cavity model and the second oral cavity model is lower than 80%, molding a plurality of second customized electrode sheets according to the second oral cavity model, and assembling the plurality of second customized electrode sheets to the articulator body in place of the plurality of first customized electrode sheets.

2. 2. The external training method for improving sleep apnea according to claim 1, wherein when an image overlap rate between the first oral cavity model and the second oral cavity model is lower than 80% and is equal to or higher than 70%, a recommended re-examination time is set, and the recommended re-examination time is equal to a period of the training.

3. 2. The external training method for improving sleep apnea according to claim 1, wherein when an image overlap rate between the first oral cavity model and the second oral cavity model is lower than 70%, a recommended re-examination time is set, and the recommended re-examination time is shorter than a period of the training.

4. 4. The external training method for improving sleep apnea according to claim 3, wherein the recommended re-examination time is shorter than two-thirds of the training period and longer than half of the training period.

5. 2. The external training method for improving sleep apnea according to claim 1, wherein when an image overlap rate between the first oral cavity model and the second oral cavity model is 80% or more, a recommended re-examination time is set, and the recommended re-examination time is shorter than a period of the training.

6. 6. The external training method for improving sleep apnea according to claim 5, wherein the recommended re-examination time is shorter than half the period of the training and longer than one-third the period of the training.

7. The present invention includes an articulator body, a plurality of customized electrode sheets, and an electrical stimulation module, the articulator body has a mouthpiece portion and an exposed portion, the mouthpiece portion has a plurality of connecting portions, The plurality of customized electrode sheets are customized and molded according to a user's oral cavity model, and are detachably assembled and coupled to the plurality of coupling parts, respectively; The electrical stimulation module is disposed within the articulator body, electrically connected to the plurality of customized electrode sheets, and used to emit electrical stimulation signals to the plurality of customized electrode sheets, thereby training the muscle endurance of the user's sublingual muscles, thereby providing an external training device for improving sleep apnea.

8. The external training device for improving sleep apnea as described in claim 7, characterized in that the multiple customized electrode sheets are divided into over-the-tongue type and lingual type, the over-the-tongue type customized electrode sheet is formed in a thin sheet shape and is attached to the lower surface of the mouthpiece part, the lingual type customized electrode sheet has a convex portion, the convex portion is detachably attached to a corresponding connecting portion and protrudes from the lower surface of the mouthpiece part, a teeth contact surface is formed on the outside of the convex portion, and an electrical conductive portion is formed on the inside of the convex portion.

9. The external training device for improving sleep apnea according to claim 8, wherein the tooth contact surface is formed to have an outer shape that matches the inside of the lower dentition of the user according to the oral cavity model.

10. The external training device for improving sleep apnea as described in claim 7, characterized in that the electrical stimulation module has at least one power source and one control unit arranged in the exposed portion of the articulator body, the power source is electrically connected to the multiple customized electrode sheets and the control unit, and the control unit can control the electrical stimulation signal emitted to the customized electrode sheets.

11. The external training device for improving sleep apnea as claimed in claim 10, characterized in that the control unit is coupled to a smart device and adjusts the stimulation intensity and / or frequency of the electrical stimulation signal through an APP interface of the smart device.

12. The external training device for improving sleep apnea as described in claim 11, characterized in that the voltage adjustment range of the electrical stimulation signal is 0 to 100 V, the current adjustment range is 0 to 30 mA, the amplitude adjustment range is 5 to 500 ms, and the frequency adjustment range is 1 to 80 Hz.

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