TWI868831B - An in vitro training device for genioglossus muscle strength - Google Patents

Abstract

An in vitro training device for genioglossus muscle strength, which is used to solve the problems that the conventional training methods for sleep apnea have surgical risks or cause discomfort during sleep. The in vitro training device for genioglossus muscle strength includes: an electrode patch having a body adhesive surface and an assembly surface, with the body adhesive surface being designed to be attached under a user’s chin to align with the user’s genioglossus muscle; and an electrical stimulation module located on the assembly surface and electrically connected to the electrode patch is used to send electrical stimulation signals to the electrode patch, which then provides transcutaneous electrical stimulation to enhance the muscle endurance of the user’s genioglossus muscle.

Description

In vitro training device for occipital glossal muscle strength

The present invention relates to an in vitro muscle strength training device, in particular to an in vitro muscle strength training device for the occipital glossal muscle used during non-sleep periods.

According to a survey by the World Health Organization (WHO), there are about 1 billion adults (aged 30-69) suffering from obstructive sleep apnea (OSA) worldwide. Among them, there are about 42 million sleep apnea patients in the United States, and one in five adults suffers from mild sleep apnea, while one in fifteen adults suffers from moderate to severe sleep apnea. In addition, according to statistics from the Taiwan Society of Sleep Medicine (TSSM), about 450,000 people in Taiwan have sleep apnea that affects their sleep quality.

The main causes of sleep apnea are congenital or obesity causing narrow airways, or the lack of muscle tension in the airways after aging, which makes them prone to collapse, causing respiratory obstruction. The types of obstruction that cause sleep apnea include nasal obstruction, soft palate and oral obstruction, and tongue root obstruction. Nearly 70% of patients suffer from tongue root obstruction, with about 650 million people worldwide, the largest group of obstructive patients. At least 300,000 people in Taiwan have the same condition. Tongue root obstruction is strongly related to reduced upper airway muscle drive and weakened activation of the occlusal glossal muscle. Sleep apnea patients not only affect the sleep quality of the person next to them with snoring, but also cause poor sleep quality for the patients themselves, leading to daytime sleepiness and reduced concentration. In severe cases, they may die suddenly due to interrupted breathing during sleep.

However, there is no drug that can be used to train patients with sleep apnea. The known training methods for sleep apnea include: (1) oral snoring device: suitable for patients with mild to moderate sleep apnea, but oral snoring device will make it difficult for patients to fall asleep due to the foreign body sensation in the mouth. (2) Equipment training: such as wearing a continuous positive airway pressure (CPAP) device during sleep to continuously inject air into the respiratory tract to open it, but the CPAP equipment is bulky and expensive. (3) Surgical training: such as cutting the uvula or tonsils to expand the airway, or surgically implanting an electrical stimulation device to stimulate the occlusal glossal muscle and other upper airway muscles during sleep to increase the tension of the upper airway muscles; if patients with moderate to severe sleep apnea find it difficult to accept or adhere to CPAP training, they may consider implanting an electrical stimulation device for training. However, it requires surgical implantation into the human body, which not only carries the risk of infection, but also requires surgical removal and re-implantation when the device fails. In addition, electrical stimulation during sleep will also affect the patient's sleep quality.

In view of this, the known methods for improving sleep apnea still need to be improved.

In order to solve the above problems, the purpose of the present invention is to provide an extracorporeal training device for the occlusal glossal muscle strength, which can use transcutaneous electrical stimulation to stimulate the occlusal glossal muscle during the non-sleep period to train and restore muscle tension, thereby eliminating the surgical risks of implantation and the discomfort during sleep.

Another object of the present invention is to provide an in vitro training device for the occipital glossal muscle strength, which is easy to carry and maintain.

The directions or similar terms described in the present invention, such as "front", "rear", "left", "right", "upper", "lower", "inner", "outer", "side", etc., are mainly for reference to the directions of the attached drawings. Each direction or similar terms are only used to assist in the description and understanding of the various embodiments of the present invention, and are not used to limit the present invention.

The quantifiers "one" or "a" used in the components and parts described throughout the present invention are only for the convenience of use and to provide a general meaning of the scope of the present invention; in the present invention, they should be interpreted as including one or at least one, and the single concept also includes the plural case, unless it is obvious that it means otherwise.

The similar terms such as "combination", "assembly" or "assembly" mentioned in the present invention mainly include the connection that can be separated without damaging the components, or the connection that makes the components inseparable, which can be selected by those with ordinary knowledge in the field according to the materials of the components to be connected or the assembly requirements.

The in vitro training device for the lipoglossal muscle strength of the present invention comprises: an electrode patch having a body surface adhesive surface and an assembly surface opposite to each other, the body surface adhesive surface being used to be attached to the user's chin to face the lipoglossal muscle of the user; and an electrical stimulation module being located on the assembly surface and electrically connected to the electrode patch to send an electrical stimulation signal to the electrode patch to transcutaneously electrically stimulate the lipoglossal muscle endurance of the user.

Accordingly, the in vitro training device for the occlusal glossal muscle strength of the present invention can use transcutaneous electrical stimulation to stimulate the occlusal glossal muscle during the non-sleep period to train and restore muscle tension, eliminating the surgical risks of implantation and the discomfort during sleep, and has the effects of no surgical risks and no impact on sleep quality. Furthermore, users can choose to perform electrical stimulation training at any convenient time and place in daily life, which can effectively improve the user's training convenience and comfort, thereby improving the user's willingness to continue using and the training effect; in addition, the electrical stimulation module of the in vitro training device can also be directly connected to the electrode patch, and there is no wire between the two, which can make the overall device more compact and simple, and more convenient to use, carry and maintain.

The surface of the body adhesive preferably has the function of being removable and reapplied. In this way, the user can reuse the same set of electrode patches, which has the effect of improving the efficiency of material use.

The assembly surface of the electrode patch may have at least one first electrical connection part, the electrical stimulation module may have an outer shell, at least one power source may be located in the outer shell, at least one second electrical connection part may be electrically connected to the power source and may be exposed outside the outer shell, the electrical stimulation module is preferably detachably assembled and combined with the electrode patch, the outer shell may cover a part of the assembly surface, and the second electrical connection part may be electrically connected to the first electrical connection part. In this way, the convenience of replacing the electrode patch is improved.

The electrical stimulation module may have a control unit located in the housing, the power source may be electrically connected to the control unit, and the control unit may control the electrical stimulation signal sent to the electrode patch. In this way, the structure of the in vitro training device is simplified.

The control unit can be coupled to a smart device, and the stimulation intensity and/or frequency of the electrical stimulation signal can be adjusted through the APP interface of the smart device. In this way, the user can adjust the electrical stimulation effect at any time according to needs and comfort, which has the effect of improving training effectiveness and training comfort experience.

The voltage adjustment range of the electrical stimulation signal can be 0~100V, the current adjustment range can be 0~30mA, the pulse width adjustment range can be 1~500ms, and the frequency adjustment range can be 1~80Hz. In this way, users can start, adjust, pause or stop electrical stimulation as needed, which has the effect of improving operational convenience and ensuring safety and training effectiveness.

1: Electrode patch

1a: Body surface adhesive surface

1b: Assembly surface

11:Electrical conduction unit

12: First electrical connection part

2:Electrical stimulation module

21: Shell

22: Power supply

23: Second electrical connection part

24: Charging unit

25: Control unit

26: Switch

E: Smart devices

M: Oligoglossus muscle

T: In vitro training device

[Figure 1] Schematic diagram of the use of the method of the present invention.

[Figure 2] An exploded perspective view of a preferred embodiment of the device of the present invention.

[Figure 3] Schematic diagram of the coupling between the device of the present invention and a smart device.

[Figure 4] A diagram showing the use of the present invention.

In order to make the above and other purposes, features and advantages of the present invention more clearly understood, the following specifically cites the preferred embodiments of the present invention and provides a detailed description in conjunction with the attached drawings; in addition, the same symbols in different drawings are considered the same and their descriptions will be omitted.

Referring to FIG. 1, the present invention provides an in vitro training method for lipoglossal muscle strength, which includes: during non-sleep period, an electrode patch 1 of an in vitro training device T is attached to the lower chin of the user, and the electrode patch 1 receives an electrical stimulation signal from an electrical stimulation module 2 to transcutaneously stimulate the muscle endurance of the user's lipoglossal muscle M. The electrical stimulation signal has a voltage range of about 1-100V, a current range of about 1-30mA, a pulse width range of about 1-500ms, and a frequency range of about 1-80Hz. These parameters will be adjusted by the doctor based on his professional judgment and assessment of the patient's condition. For example, they can be adjusted according to the patient's individual needs (such as the thickness of the occipital muscle or the resistance value of its feedback after electrical stimulation). In this way, the occipital muscle can be trained effectively and safely.

Accordingly, the in vitro training method of the present invention can train the muscle endurance of the user's occlusal ligament M through transcutaneous electrical stimulation during non-sleep periods, such as 30 minutes before bedtime, to train the support strength of the occlusal ligament M, reproduce the original tension of the occlusal ligament M, improve the situation of tongue sinking and blocking the airway during sleep, and thus improve the symptoms of sleep apnea. The best time to perform the in vitro training method is once a day, and each time is preferably no more than one hour; if the in vitro training method needs to be repeated within a day, the interval between each training must be at least one hour.

Please refer to Figure 2, which is a preferred embodiment of an in vitro training device T for improving sleep apnea that can implement the above-mentioned in vitro training method, comprising an electrode patch 1 and an electrical stimulation module 2, and the electrical stimulation module 2 is electrically connected to the electrode patch 1.

Please refer to Figures 1 and 2. The electrode patch 1 has good conductivity and softness, which can ensure that the electrode patch 1 can be firmly attached to the user's skin and is not easy to fall off. That is, the electrode patch 1 has a body surface adhesive surface 1a, which is used to be attached under the user's chin, so that the electrode patch 1 can maintain the occlusal glossal muscle M located on the user; wherein, the body surface adhesive surface 1a preferably has a repetitive tearing function, so that the user can reuse the same set of electrode patches 1, thereby improving the efficiency of material use. The electrode patch 1 can have at least one electrically conductive part 11 located on the body surface adhesive surface 1a, so that the electrically conductive part 11 can contact the user's skin and electrically stimulate the user from outside the body.

The electrical stimulation module 2 is electrically connected to the electrode patch 1, and can be controlled to send an electrical stimulation signal of a predetermined voltage, current, frequency and pulse time to the electrode patch 1, thereby percutaneously electrically stimulating the muscle endurance of the user's chooglossal muscle M from outside the body through the electrode patch 1. The present invention does not limit the type of electrical connection of the electrical stimulation module 2 to the electrode patch 1; that is, the electrical stimulation module 2 can be electrically connected to the electrode patch 1 through a plurality of wires, or as shown in the diagram of this embodiment, the electrode patch 1 can have an assembly surface 1b, which is opposite to the body surface adhesive surface 1a and is used for assembly and positioning of the electrical stimulation module 2. In this way, the electrical stimulation module 2 located on the assembly surface 1b can be directly connected to the electrode patch 1 to form an electrical connection, so that there is no need to set up wires between the electrical stimulation module 2 and the electrode patch 1 to form an electrical connection, which can make the extracorporeal training device T more compact and simple as a whole, and more convenient to use and carry.

The electrical stimulation module 2 is preferably detachably assembled and coupled to the assembly surface 1b of the electrode patch 1, so as to replace the electrode patch 1 that is damaged, faulty, or has a decreased viscosity on the body surface adhesive surface 1a. For example, the assembly surface 1b of the electrode patch 1 may have at least one first electrical connection portion 12, and the electrical stimulation module 2 may have a housing 21, at least one power source 22 is located in the housing 21, and at least one second electrical connection portion 23 is electrically connected to the power source 22 and exposed outside the housing 21. The electrical stimulation module 2 may be quickly assembled and coupled to the electrode patch 1, for example, by magnetic attraction, so that the housing 21 covers a portion of the assembly surface 1b, and the second electrical connection portion 23 is electrically connected to the first electrical connection portion 12. The electrical stimulation module 2 can replace the power source 22, or have a charging unit 24 to charge the power source 22, or use a wireless charging method to charge the power source 22, and the present invention is not limited to this.

As shown in Figures 2 and 3, the electrical stimulation module 2 may also have a control unit 25 located in the housing 21, and the power source 22 may also be electrically connected to the control unit 25 to provide the control unit 25 with working power. In addition, the electrical stimulation module 2 may also have a switch 26 disposed in the housing 21, and used to control the power supply state of the power source 22 to the control unit 25. The control unit 25 may control the electrical stimulation signal sent to the electrode patch 1, and may also be coupled to a smart device E such as a mobile phone, tablet or smart watch, so that the user can perform personalized settings according to needs and comfort through the APP interface of the smart device E, and adjust the stimulation intensity and/or frequency of the aforementioned electrical stimulation signal, so as to improve the training effect and training experience. For example, the voltage can be adjusted from 0 to 100V, the current can be adjusted from 0 to 30mA, the pulse width can be adjusted from 1 to 500ms, and the frequency can be adjusted from 1 to 80Hz; accordingly, users can start, adjust, pause or stop electrical stimulation as needed.

Please refer to Figures 2 to 4. The user can use the in vitro training device T of this embodiment during non-sleeping periods. When using it, the electrode patch 1 can be first attached to the lower chin with the body surface adhesive surface 1a, and the outer shell 21 of the electrical stimulation module 2 can be combined with the assembly surface 1b of the electrode patch 1, and then the switch 26 can be pressed to start the electrical stimulation module 2 to directly start electrical stimulation; or the electrical stimulation module 2 can be put into standby mode, and then the start, pause or setting of the electrical stimulation time can be controlled through the APP interface of the smart device E. Accordingly, since the electrical stimulation of the present invention is not performed during sleep, it will not affect the user's sleep quality. The user can also choose to perform electrical stimulation training at any convenient time in daily life, which can effectively improve the user's training convenience and comfort, thereby increasing the user's willingness to continue using it. Furthermore, the in vitro training method of the present invention is non-invasive and does not require surgery to implant a corresponding device, which can avoid the risks and inconveniences brought about by the surgical process. At the same time, it can also greatly reduce the user's training burden.

In summary, the in vitro training method and device for the occlusal glossal muscle strength of the present invention have the following advantages: (1) Does not affect sleep quality: The electrical stimulation of the present invention is not performed during sleep, so it will not cause discomfort during sleep and affect the user's sleep quality. (2) Improves willingness to continue using: Users can choose to perform electrical stimulation training at any convenient time and place in their daily lives, which can effectively improve the user's training convenience and comfort, thereby increasing the user's willingness to continue using. (3) No surgical risk: The in vitro training method of the present invention is non-invasive and does not require surgery to implant a corresponding device. It can avoid the risks and inconveniences brought about by the surgical process, and at the same time greatly reduce the user's training burden. (4) Easy to use and carry: The in vitro training device of the present invention is compact and very easy to carry. Compared with a continuous positive airway pressure (CPAP) device that can only be used near the device and has multiple straps and tubes around the user's head, which often leaves pressure marks on the user's face, the in vitro training device of the present invention allows the user to move around freely and does not need to be aware of the problem of using multiple straps and tubes for a continuous positive airway pressure device. It is easy to use and the comfort level is greatly improved. (5) Reduce equipment investment costs: Compared with traditional training methods that require surgery or the use of expensive continuous positive airway pressure (CPAP) devices, the in vitro training device of the present invention has a lower equipment investment cost, allowing more medical institutions and clinics to provide corresponding training services. Even users can easily afford to purchase their own in vitro training devices to perform electrical stimulation training anytime and anywhere. Furthermore, the in vitro training device of the present invention is simple in structure and has the effects of improving maintenance efficiency and reducing maintenance costs. (6) Save time or labor costs: The use of the in vitro training method or device of the present invention does not require surgical time and recovery period, and can also reduce the need for medical professionals to perform surgery or training services, thereby saving time and labor costs.

Although the present invention has been disclosed using the above preferred embodiments, they are not intended to limit the present invention. Any person skilled in the art may make various changes and modifications to the above embodiments without departing from the spirit and scope of the present invention, and these changes and modifications are still within the technical scope protected by the present invention. Therefore, the protection scope of the present invention shall include all changes within the meaning and equivalent scope recorded in the attached patent application scope.

1: Electrode patch

1a: Body surface adhesive surface

1b: Assembly surface

11:Electrical conduction unit

12: First electrical connection part

2:Electrical stimulation module

21: Shell

22: Power supply

23: Second electrical connection part

24: Charging unit

25: Control unit

26: Switch

T: In vitro training device

Claims (6)

An extracorporeal training device for lipoglossal muscle strength comprises: an electrode patch having a body surface adhesive surface and an assembly surface opposite to each other, the body surface adhesive surface being used to be attached to the lower chin of a user to face the lipoglossal muscle of the user; and an electrical stimulation module being located on the assembly surface and electrically connected to the electrode patch to send an electrical stimulation signal to the electrode patch to transcutaneously electrically stimulate the lipoglossal muscle of the user to improve its muscle endurance. As in claim 1, the in vitro training device for the occlusal glossal muscle strength, wherein the body surface adhesive surface has the function of being able to be repeatedly torn off and pasted. As in claim 1, the in vitro training device for lipoglossal muscle strength, wherein the assembly surface of the electrode patch has at least one first electrical connection portion, the electrical stimulation module has an outer shell, at least one power source is located in the outer shell, at least one second electrical connection portion is electrically connected to the power source and exposed outside the outer shell, the electrical stimulation module is detachably assembled and combined with the electrode patch, the outer shell covers a part of the assembly surface, and the second electrical connection portion is electrically connected to the first electrical connection portion. As in claim 3, the in vitro training device for the occlusal glossal muscle strength, wherein the electrical stimulation module has a control unit located in the outer shell, the power source is electrically connected to the control unit, and the control unit can control the electrical stimulation signal sent to the electrode patch. As in claim 4, the in vitro training device for lipoglossal muscle strength, wherein the control unit is coupled to a smart device to adjust the stimulation intensity and/or frequency of the electrical stimulation signal through the APP interface of the smart device. For example, the in vitro training device for lipoglossal muscle strength of claim 5, wherein the voltage adjustment range of the electrical stimulation signal is 0~100V, the current adjustment range is 0~30mA, the pulse width adjustment range is 1~500ms, and the frequency adjustment range is 1~80Hz.

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