Extracorporeal training device for genioglossus muscle strength

Abstract

To solve problems associated with conventional methods for training for the sleep apnea syndrome, such as risks associated with surgical procedures and discomfort during sleep.SOLUTION: Provided is an extracorporeal training method for a genioglossus muscle strength, comprising: applying an electrode patch of an extracorporeal training device to a region below a user's chin during non-sleep periods; receiving an electrical stimulation signal from an electrical stimulation module via the electrode patch; and transcutaneously electrically stimulating the user's genioglossus muscle to enhance its muscular endurance. Also disclosed is a device for implementing the method.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a method and device for external muscle strength training, and more particularly to a method and device for external training of genioglossus muscle strength to be 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 airway muscle tone 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, belong to the tongue base obstruction group, 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 decreased activity of the upper airway muscles and decreased activation of the genioglossus muscle. Patients with sleep apnea not only affect the quality of sleep of the people next to them by snoring, but also cause problems such as daytime sleepiness and decreased concentration, as the quality of the patients' own sleep is also deteriorated. In severe cases, sudden death may occur due to cessation of breathing during sleep. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,428,725 Summary of the Invention [Problem to be solved by the invention]

[0005] 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, 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 while sleeping, air can be continuously injected into the airway to open it. However, CPAP machines are bulky and expensive. (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 genioglossus muscle and other upper airway muscles while sleeping to increase the tone of the upper airway muscles. For patients with moderate to severe sleep apnea who have difficulty receiving or continuing CPAP therapy, a treatment called implantation of an electrical stimulation device is considered. However, the above treatments require the device to be surgically implanted in the body, which not only carries the risk of infection during surgery, but also requires surgical removal and re-implantation if the device breaks down. Furthermore, administering electrical stimulation while sleeping can affect the quality of sleep.

[0006] Based on the above-mentioned problems, the conventional methods for improving sleep apnea need to be further improved.

[0007] In order to solve the above problems, a first object of the present invention is to provide an external training method for genioglossus muscle strength, which can train the genioglossus muscle to recover muscle tone by percutaneously stimulating it with electrical stimulation during non-sleep periods, thereby eliminating the risk of implantation surgery and reducing discomfort during sleep periods.

[0008] A second object of the present invention is to provide an external genioglossus muscle strength training device capable of carrying out the above-mentioned method.

[0009] A third object of the present invention is to provide an external training device for genioglossus muscle strength which is easy to carry and maintain. [Means for solving the problem]

[0010] 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.

[0011] 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.

[0012] 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.

[0013] The external training method for genioglossus muscle strength of the present invention includes attaching an electrode patch of an external training device under the chin of a user during a non-sleep period, receiving an electrical stimulation signal from an electrical stimulation module via the electrode patch, and transcutaneously electrically stimulating the genioglossus muscle of the user to enhance its muscular endurance, wherein the electrical stimulation signal has a voltage range of 1 to 100 V, a current range of 1 to 30 mA, a pulse width range of 1 to 500 ms, and a frequency range of 1 to 80 Hz.

[0014] As a result, the external training method for genioglossus muscle strength uses percutaneous electrical stimulation to stimulate the genioglossus muscle during non-sleep periods to train it to recover muscle tone, thereby eliminating the risks associated with implant-type surgery and reducing discomfort during sleep periods, resulting in no risk of surgery and no impact on sleep quality. In addition, the user can choose a time and place convenient for daily life to receive electrical stimulation training, effectively improving the convenience and comfort of the user's training, increasing the user's motivation to continue using the device, and improving the results of the training.

[0015] The time interval for carrying out the external training method is once a day, preferably not exceeding one hour per time.

[0016] The external training method should be performed multiple times each day, with at least one hour between each training session.

[0017] Furthermore, the external training device for genioglossus muscle strength of the present invention includes an electrode patch and an electrical stimulation module, the electrode patch has a body surface adhesive surface and an assembly surface opposite to each other, the body surface adhesive surface is used to attach under the user's chin to align with the user's genioglossus muscle, and the electrical stimulation module is disposed on the assembly surface, electrically connected to the electrode patch, and used to generate an electrical stimulation signal to the electrode patch so as to transcutaneously electrically stimulate the genioglossus muscle of the user. In this way, not only can the above-mentioned external training method be performed to improve sleep apnea, but the electrical stimulation module of the external training device can be in direct contact with the electrode patch without any electric wire between them, so that the entire device can be made more compact and simpler, and it is more convenient to use, carry and maintain.

[0018] In addition, the adhesive surface on the body surface has a function of being repeatedly attachable and detachable, so that the user can repeatedly use the same set of electrode patches, thereby improving the efficiency of material usage.

[0019] In addition, the assembly surface of the electrode patch has at least one first electrical connection, the electrical stimulation module has a shell, at least one power source is disposed in the shell, at least one second electrical connection is electrically connected to the power source and exposed to the outside of the shell, the electrical stimulation module is detachably assembled and coupled to the electrode patch, the shell covers a part of the assembly surface, and the second electrical connection is electrically connected to the first electrical connection, thus improving the convenience of replacing the electrode patch.

[0020] In addition, the electrical stimulation module has a control unit disposed in the shell, the power source is electrically connected to the control unit, and the control unit can control the electrical stimulation signal emitted to the electrode patch. In this way, the structure of the external training device can be simplified.

[0021] 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 effect and comfort of the training.

[0022] The voltage adjustment range of the electrical stimulation signal is 0 to 100 V, the current adjustment range is 0 to 30 mA, the pulse width adjustment range is 1 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]

[0023] [Figure 1] FIG. 1 is a schematic diagram of the use 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] Schematic diagram of the coupling connection between the apparatus of the present invention and a smart device. [Figure 4] FIG. BEST MODE FOR CARRYING OUT THEINVENTION

[0024] 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.

[0025] As shown in FIG. 1, the external training method for genioglossus muscle strength of the present invention includes the following steps. During a non-sleep period, an electrode patch 1 of an external training device T is attached under the chin of a user, and the electrode patch 1 receives an electrical stimulation signal from an electrical stimulation module 2 to percutaneously stimulate the genioglossus muscle M of the user to increase its muscle endurance. The voltage range of the electrical stimulation signal is 1-100V, the current range is 1-30mA, the pulse width range is 1-500ms, and the frequency range is 1-80Hz. These parameters are adjusted according to the doctor's professional judgment and evaluation of the patient's condition, and can be adjusted according to the patient's personal needs (e.g., the thickness of the genioglossus muscle and the resistance value of the feedback of the electrical stimulation). In this way, the genioglossus muscle can be effectively and safely trained.

[0026] As a result, the external training method of the present invention trains the muscular endurance of the user's genioglossus muscle M by externally applying percutaneous electrical stimulation during a non-sleep period, for example, 30 minutes before sleep, and also trains the supporting force of the genioglossus muscle M to restore the original tension of the genioglossus muscle M, thereby improving the situation in which the tongue sinks and blocks the airway during sleep, thereby improving the symptoms of sleep apnea. In addition, the time interval for carrying out the external training method is preferably once a day, and each time preferably does not exceed one hour. If the external training method must be carried out several times a day, each training session must be separated by at least one hour.

[0027] 2 shows an embodiment of an external training device T for sleep apnea that performs the above-mentioned external training method. The external training device T includes an electrode patch 1 and an electrical stimulation module 2, and the electrical stimulation module 2 is electrically connected to the electrode patch 1.

[0028] As shown in Figs. 1 and 2, the electrode patch 1 has good electrical conductivity and flexibility, so that it can be ensured that the electrode patch 1 is firmly attached to the user's skin and is not easily peeled off. That is, the electrode patch 1 has a body surface adhesive surface 1a, which is used to attach the electrode patch 1 under the user's chin, and can keep the electrode patch 1 aligned with the user's genioglossus muscle M. In addition, the body surface adhesive surface 1a preferably has a function of being repeatedly attached and peeled off, so that the user can repeatedly use the same set of electrode patches 1, thereby improving the efficiency of material use. The electrode patch 1 may have at least one electrical conductive part 11 arranged on the body surface adhesive surface 1a, which is in contact with the user's skin and can provide electrical stimulation to the user from outside the body.

[0029] The electrical stimulation module 2 is electrically connected to the electrode patch 1, and generates an electrical stimulation signal with a predetermined voltage, current, frequency and pulse time to the electrode patch 1 under control, thereby electrically stimulating the genioglossus muscle M of the user from outside the body through the electrode patch 1. The present invention is not limited to a form of electrical connection between the electrical stimulation module 2 and the electrode patch 1. That is, the electrical stimulation module 2 can be electrically connected to the electrode patch 1 by several electric wires, or as shown in the drawings of this embodiment, the electrode patch 1 has an assembly surface 1b, the assembly surface 1b is formed to face the body surface adhesive surface 1a, and can be used to assemble and position the electrical stimulation module 2. In this way, the electrical stimulation module 2 arranged on the assembly surface 1b directly contacts the electrode patch 1 to form an electrical connection, and there is no need to install electric wires between the electrical stimulation module 2 and the electrode patch 1 to form an electrical connection, so that the entire external training device T is more compact, simple, and convenient to use and carry.

[0030] In addition, the electrical stimulation module 2 is preferably detachably assembled and coupled to the assembly surface 1b of the electrode patch 1. This makes it easy to replace the electrode patch 1 when it is damaged, broken, or the viscosity of the body surface adhesive surface 1a is reduced. For example, the assembly surface 1b of the electrode patch 1 has at least one first electrical connection part 12, the electrical stimulation module 2 has a shell 21, at least one power source 22 is disposed in the shell 21, and at least one second electrical connection part 23 is exposed outside the shell 21 while electrically connecting with the power source 22, and the electrical stimulation module 2 can be quickly assembled and coupled to the electrode patch 1, for example, by magnetic coupling, the shell 21 covers a part of the assembly surface 1b, and the second electrical connection part 23 is electrically connected with the first electrical connection part 12. The power source 22 in the electrical stimulation module 2 can be replaced, or the power source 22 can be charged by a charging part 24, or the power source 22 can be charged by wireless charging, but this is not limited in the present invention.

[0031] As shown in FIGS. 2 and 3, the electrical stimulation module 2 may further include a control unit 25 disposed in the shell 21, and the power source 22 may be electrically connected to the control unit 25 to provide a power source for the operation of the control unit 25. The electrical stimulation module 2 may also include a switch 26 disposed in the shell 21. The switch 26 is used to control the state of the power source 22 supplying power to the control unit 25. The control unit 25 can control the electrical stimulation signal emitted to the electrode patch 1, and can also be coupled to a smart device E such as a mobile phone, tablet, or smart watch, so that the user can adjust the stimulation intensity and / or frequency of the above-mentioned electrical stimulation signal through the APP interface of the smart device E according to their needs and comfort, thereby enhancing the effect of training and the experience of training. For example, the voltage adjustment range may be 0 to 100V, the current adjustment range may be 0 to 30mA, the pulse width adjustment range may be 1 to 500ms, and the frequency adjustment range may be 1 to 80Hz. This allows the user to start, adjust, pause or stop electrical stimulation according to their needs.

[0032] As shown in Figs. 2, 3 and 4, the user can use the external training device T of this embodiment during the non-sleep period. When using the device, first, the electrode patch 1 is attached under the chin with the body surface adhesive surface 1a, and the shell 21 of the electrical stimulation module 2 is coupled to the assembly surface 1b of the electrode patch 1. Then, the switch 26 is pressed to start the electrical stimulation module 2, thereby directly starting the electrical stimulation. Alternatively, the electrical stimulation module 2 can be put into a standby state, and the user can start, pause, or set the time for electrical stimulation through the APP interface of the smart device E. As a result, the electrical stimulation of the present invention is performed during the non-sleep period, so that it does not affect the quality of the user's sleep, and the user can selectively choose a time and place convenient for daily life to receive electrical stimulation training, which effectively improves the convenience and comfort of the user's training and increases the user's motivation to continue using the device. In addition, since the external training method of the present invention is non-invasive, there is no need to implant a corresponding device through surgery, which can avoid the risks and inconveniences caused by the surgical procedure, and at the same time, can greatly reduce the burden of training on the user.

[0033] In summary, the external training method and device for genioglossus muscle strength of the present invention have the following advantages: (1) No effect on sleep quality. The electrical stimulation of the present invention is performed during non-sleep periods, so it does not cause discomfort during sleep and does not affect the user's sleep quality. (2) Increased willingness to continue using the device. The user can choose a time and place convenient for daily life to receive the electrical stimulation training, which effectively improves the convenience and comfort of the training for the user and increases the user's willingness to continue using the device. (3) No risk of surgery. The external training method of the present invention is non-invasive, so there is no need to implant a corresponding device through surgery, which avoids the risks and inconveniences brought about during surgery and greatly reduces the training burden on the user. (4) Easy to use and carry. The external training device of the present invention is compact in size and very easy to carry. Compared with a 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 using multiple belts and tubes in the conventional CPAP, so the present invention is easy to use and significantly increases comfort. (5) Reduction in capital investment costs. Compared with conventional training methods such as surgery and expensive continuous positive pressure ventilators, the external training device of the present invention has low capital investment costs, 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 conduct electrical stimulation training anytime and anywhere. In addition, the external training device of the present invention has a simple structure, which can increase the efficiency of maintenance and reduce maintenance costs. (6) 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.

[0034] 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]

[0035] 1. Electrode patch 1a…Body surface adhesive surface 1b…Assembly surface 11...Electrical conductive part 12...First electrical connection part 2. Electrical stimulation module 21. Shell 22…Power supply 23...Second electrical connection part 24...Charging part 25…Control unit 26…Switch E: Smart device M...Genioglossus muscle T…External training device

Claims

1. and attaching an electrode patch of the external training device under the chin of the user during a non-sleep period, receiving an electrical stimulation signal from an electrical stimulation module through the electrode patch, and electrically stimulating the genioglossus muscle of the user percutaneously to enhance its muscle endurance; The electrical stimulation signal has a voltage range of 1 to 100 V, a current range of 1 to 30 mA, a pulse width range of 1 to 500 ms, and a frequency range of 1 to 80 Hz.

2. 2. The method for externally training genioglossus muscle strength according to claim 1, wherein the time interval for performing the external training method is once a day, and each time does not exceed one hour.

3. 2. The method for externally training genioglossus muscle strength according to claim 1, wherein the external training method is performed multiple times per day, and each training session is separated by at least one hour.

4. an electrode patch; and an electrical stimulation module; The electrode patch has opposing body surface adhesive surfaces and assembly surfaces, the body surface adhesive surface is used to attach under a user's chin and align with the user's genioglossus muscle, and the electrical stimulation module is disposed on the assembly surface, electrically connected to the electrode patch, and used to emit an electrical stimulation signal to the electrode patch so as to transcutaneously electrically stimulate the genioglossus muscle of the user to stimulate its muscle endurance.

5. 5. An external genioglossus muscle strength training device according to claim 4, wherein said body surface adhesive surface has a function of being repeatedly attached and peeled off.

6. 5. The external genioglossus muscle strength training device according to claim 4, characterized in that the assembly surface of the electrode patch has at least one first electrical connection portion, the electrical stimulation module has a shell, at least one power source is disposed in the shell, at least one second electrical connection portion is electrically connected to the power source and exposed to the outside of the shell, the electrical stimulation module is removably assembled and coupled to the electrode patch, the shell covers a portion of the assembly surface, and the second electrical connection portion and the first electrical connection portion are electrically connected.

7. 7. The external genioglossus muscle strength training device according to claim 6, wherein the electrical stimulation module has a control unit disposed within the shell, the power source is electrically connected to the control unit, and the control unit is capable of controlling the electrical stimulation signal emitted to the electrode patch.

8. The external genioglossus muscle strength training device according to claim 7, wherein 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.

9. 9. The external genioglossus muscle strength training device according to claim 8, wherein the voltage adjustment range of the electrical stimulation signal is 0 to 100 V, the current adjustment range is 0 to 30 mA, the pulse width adjustment range is 1 to 500 ms, and the frequency adjustment range is 1 to 80 Hz.

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