Tongue sleeve device and method for operating same

Abstract

The present invention relates to a tongue sleeve device for electrically stimulating hypoglossal nerves, comprising: an outer housing configured to have an inner cavity and an opening into which a tongue extends; the inner shell is arranged in the inner cavity of the outer shell and is connected with the outer shell, so that the inner shell divides the inner cavity of the outer shell into a closed first accommodating cavity between the outer shell and the inner shell and a second accommodating cavity which is used for accommodating the tongue part and can be communicated with the outside through the opening; the stimulation circuit is provided with a power source, a controller and an electrode terminal which are electrically connected with one another, the power source and the controller are arranged in the first containing cavity, the electrode terminal is arranged on the inner shell, at least the stimulation face of the electrode terminal is exposed in the second containing cavity, and the inner shell is at least partially made of a shape memory polymer. An actuating device is arranged in the first containing cavity and can enable the inner shell to change between a contraction state and an expansion state. The invention also relates to a method for operating the tongue sleeve device.

Description

Technical Field

[0001] The present invention relates to the field of medical devices and nerve regulation technology, in particular to a tongue cuff device for electrically stimulating the hypoglossal nerve and a method for operating the tongue cuff device. Background Art

[0002] Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurring complete or partial upper airway obstruction during sleep, resulting in interrupted or shallow breathing. This condition can lead to poor sleep quality at night and daytime sleepiness, and in severe cases, may increase the risk of cardiovascular disease. Currently, continuous positive airway pressure (CPAP) therapy is one of the standard treatments for OSA, but due to patient compliance issues, there is a growing demand for alternative treatments.

[0003] In recent years, neurostimulation technology has been studied as an emerging treatment for OSA. In particular, electrical stimulation of the hypoglossal nerve has shown potential efficacy. By stimulating the hypoglossal nerve, it activates the tongue muscles, preventing the tongue from falling back during sleep and thus maintaining upper airway patency.

[0004] Existing devices for electrically stimulating the hypoglossal nerve typically include a stimulation terminal that extends into the oral cavity during operation and a control terminal that remains outside the oral cavity. To facilitate cleaning of the device, the stimulation terminal and the control terminal are typically constructed to be detachable and connected via an interface. This design requires additional connectors, such as interfaces, resulting in a cumbersome and costly structure. Furthermore, the device requires the user's mouth to be partially open to allow the stimulation terminal and the control terminal to connect, which can cause discomfort when worn.

[0005] Therefore, miniaturization of such devices, especially their complete placement in the oral cavity, has been a long-standing research direction. However, the space in the oral cavity is very limited, and arranging all electronic components in a small space and effectively packaging them has been a long-standing challenge.

[0006] Furthermore, because oral structures vary from user to user, the fit of the electrode terminals used for electrical stimulation on the tongue can vary between users using the same device. When the electrode terminals don't effectively adhere to the tongue, the electrical stimulation effect is weakened or even eliminated. Therefore, ensuring the proper fit of the electrode terminals on the tongue is a pressing issue. Summary of the Invention

[0007] Therefore, in order to solve the above problems, according to one aspect of the present invention, a tongue sleeve device for electrically stimulating the hypoglossal nerve is proposed, the tongue sleeve device comprising: an external shell, the external shell being configured to have an inner cavity and an opening for the tongue to extend into; an internal shell, the internal shell being arranged in the inner cavity of the external shell and connected to the external shell, so that the internal shell divides the inner cavity of the external shell into a closed first accommodating cavity between the external shell and the internal shell and a second accommodating cavity for accommodating the tongue and capable of communicating with the outside world through the opening; and a stimulation circuit, the stimulation circuit having a power supply, a controller and electrode terminals electrically connected to each other, the power supply and the controller being arranged in the first accommodating cavity, the electrode terminals being arranged on the internal shell and exposed in the second accommodating cavity with at least their stimulation surfaces, wherein the internal shell is at least partially made of a shape memory polymer, and an actuator is arranged in the first accommodating cavity, the actuator being capable of changing the internal shell between a contracted state and an expanded state.

[0008] Because the inner shell is made of a shape-memory polymer and can change between a contracted state and an expanded state under the action of an actuator, the tongue cover device can be placed in the mouth in a smaller volume in the contracted state, and in the expanded state, the stimulation surface of the electrode terminal is effectively attached to the tongue. When the electrode terminal is attached to the tongue due to the expansion of the inner shell, the tongue is also wrapped by the expanded inner shell, thereby limiting the relative movement between the tongue and the tongue cover device. For example, the wrap-around tongue cover design controls the relative displacement between the tongue and the tongue cover device within a range of ±10mm. This ensures that the electrode terminal will not change the stimulation point due to conscious or unconscious tongue movement of the user during operation, thereby continuously acting on the same stimulation point, achieving a basically consistent stimulation effect.

[0009] On the one hand, the deformable internal shell brings excellent adaptability to adapt to the tongue structure of various users. On the other hand, it can effectively utilize the volume of the inner cavity of the external shell, so that only a smaller external shell is needed to accommodate all electronic components while leaving enough space for accommodating the tongue.

[0010] Preferably, the actuating device and the inner housing are integrated into a multi-layer composite structure comprising an outer layer made of medical rubber, a middle layer made of a thermotropic SMP film, and an inner layer made of a heating element, wherein the heating element is the actuating device. This structure enables a highly integrated structure within the tongue-enclosing device, resulting in a compact structure and ease of manufacture.

[0011] More preferably, the heating element may be a resistance wire, which is made of, for example, a nickel-chromium alloy wire with a diameter of 40-60 μm and arranged in a serpentine shape to ensure uniform heating and avoid local overheating.

[0012] Alternatively, the heating element may be a flexible electric heating film, which is printed with carbon nanotube or silver nanowire conductive ink, for example, with a thickness of less than or equal to 0.1 mm and a power consumption of less than or equal to 0.5 W.

[0013] Preferably, the tongue cover device further includes a temperature control system comprising a temperature sensor for detecting the temperature of the intermediate layer or the inner layer and a temperature control circuit for adjusting the power of the heating element. More preferably, the temperature control system comprises a PID temperature control circuit with an integrated temperature sensor. The temperature sensor may be an NTC thermistor with an accuracy of up to ±1°C.

[0014] Preferably, the tongue cover device further includes a wireless communication module, through which the controller, the actuator, and / or the temperature control circuit communicate with an external device. Thus, a user can manipulate the controller, the actuator, and / or the temperature control circuit via the external device, including activating / deactivating the actuator, activating or deactivating the stimulation circuit, and setting related parameters.

[0015] Preferably, the thermotropic SMP film is made of polyurethane and has a thickness in the range of 0.2 mm to 0.5 mm, and the power of the heating element is in the range of 0.1 W to 0.5 W. This allows the inner shell to achieve an appropriate amount of deformation, and the heating and deformation process to be controlled within, for example, 60 seconds, thereby shortening user waiting time to an acceptable range and providing an excellent user experience.

[0016] Preferably, the outer shell is made of silicone with a hardness of 70A-100A. The hard outer shell can provide overall support for the tongue cover device and is used to install electronic components such as a power supply and a controller.

[0017] Preferably, the outer shell and the inner shell are formed by secondary injection molding, that is, the outer shell and the inner shell are injection molded separately, and then the two are heated again to form an integral body, thereby achieving particularly good sealing performance for the first accommodating cavity between the outer shell and the inner shell.

[0018] Preferably, the power supply and the controller are arranged on the inner side of the outer housing and spaced apart from the inner housing. Alternatively or additionally, the first accommodating chamber is filled with a gas, particularly nitrogen or an inert gas. This prevents the electronic components in the first accommodating chamber from being squeezed and damaged.

[0019] According to another aspect of the present invention, a method for operating the above-mentioned tongue cover device is provided, the method comprising: step S1, placing the tongue cover device into the mouth, allowing the tongue to enter the second accommodating cavity through the opening of the external shell; step S2, starting the actuator to change the internal shell from the contracted state to the expanded state; step S3, starting the stimulation circuit, and applying a stimulation current to the electrode terminal through the controller; step S4, turning off the actuator; and step S5, removing the tongue cover device.

[0020] As a result, the electrode terminals within the tongue cover device can adapt to different users' oral structures, particularly tongue sizes, and ensure that the stimulation surface of the electrode terminals fits well with the tongue surface, thereby achieving a good stimulation effect. After the actuator is turned off and the internal housing is at least partially retracted, the user can remove the tongue cover device without having to wait for the internal housing to fully return to its retracted state.

[0021] Preferably, the tongue glove device further comprises a wireless communication module, wherein the tongue glove device is connected to an external device via the wireless communication module, and steps S2, S3, and / or S4 are performed by the external device. This type of control is particularly advantageous when the first receiving cavity containing the electronic components is sealed.

[0022] Preferably, after the actuating device is activated, step S3 is automatically executed after a first predetermined time has passed.

[0023] Preferably, after the stimulation circuit is activated, step S4 is automatically executed after a second predetermined time has passed.

[0024] Preferably, after the actuator is turned off, the stimulation circuit is automatically turned off after a third predetermined time has passed, and then step S5 is performed. The actuator can be turned off manually by the user through an external device, or it can be turned off automatically before the stimulation circuit is turned off.

[0025] By setting the above-mentioned predetermined time by the user or the manufacturer, the user can obtain a smooth usage experience, a gradually weakening and comfortable electrical stimulation experience, and can easily remove the actuator without waiting after feeling the disappearance of the electrical stimulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] To better understand the above and other objects, features, advantages, and functions of the present invention, reference may be made to the preferred embodiments shown in the accompanying drawings. Like reference numerals in the accompanying drawings refer to like components. Those skilled in the art should understand that the accompanying drawings are intended to illustrate preferred embodiments of the present invention by way of illustration and are not intended to limit the scope of the present invention. The components in the drawings are not drawn to scale.

[0027] Figure 1 A perspective view of the tongue cover device of the present invention is shown;

[0028] Figure 2 Shown Figure 1 A cross-sectional view of the tongue cover device is shown taken along line AA;

[0029] Figure 3 Shown Figure 1 A cross-sectional view of the tongue cover device shown is taken along line BB and then along line CC;

[0030] Figure 4 shows the integrated structure of the inner housing and the actuating device; and

[0031] Figure 5 A flow chart illustrating a method for operating the tongue cover device of the present invention is shown. DETAILED DESCRIPTION

[0032] Now referring to the accompanying drawings, the specific embodiments of the present invention will be described in detail. What is described here is only the preferred embodiment of the present invention. Those skilled in the art can think of other ways to implement the present invention based on the preferred embodiment, and the other ways also fall within the scope of the present invention.

[0033] In this document, the terms "upper", "lower", "front" and "back" all refer to the directions corresponding to when a user normally wears the tongue cover device.

[0034] Figures 1 to 3 The tongue cover device 1 of the present invention is shown, and includes an outer shell 100, an inner shell 200, and a stimulation circuit. The outer shell 100 is configured to have an inner cavity 110 and an opening 120 for the tongue to extend into. The inner shell 200 is arranged in the inner cavity 110 of the outer shell 100 and connected to the outer shell 100, particularly, connected to the opening 120 of the outer shell 100, so that the inner shell 200 divides the inner cavity 110 of the outer shell 100 into a first closed accommodating cavity 112 between the outer shell 100 and the inner shell 200 and a second accommodating cavity 114 for accommodating the tongue and capable of communicating with the outside through the opening 120.

[0035] The outer shell 100 can be made of silicone with a hardness of 70A-100A to provide an overall support structure for the tongue cover. The size of the outer shell 100 is designed to be accommodated in the mouth and to provide sufficient space for accommodating the tongue and the stimulation circuit that provides electrical stimulation.

[0036] Reference Figure 3The stimulation circuit has a power supply 310, a controller 320 and an electrode terminal 330 electrically connected to each other, wherein the power supply 310 and the controller 320 are both arranged in the first accommodating cavity 112, and the electrode terminal 330 is arranged on the internal shell 200 and is exposed in the second accommodating cavity 114 with at least its stimulation surface.

[0037] The power supply 310 can be a small-capacity wirelessly rechargeable battery, the capacity of which is preferably sufficient to ensure one to two stimulation operations, thereby effectively reducing the battery volume. In addition to providing the energy required for electrical stimulation to the electrode terminals 330, the power supply 310 can also provide energy for the actuator and other electronic components of the tongue cover device 1. The controller 320 can be constructed as a flexible circuit board, which has a small size and is easy to install. The power supply 310 and the controller 320 are preferably arranged on the inner side of the outer shell 100 and spaced apart from the inner shell 200 to obtain good support and avoid being squeezed.

[0038] Reference Figure 2 The electrode terminals 330 are preferably arranged on the upper surface and two side portions of the internal housing 200, with three rows and one column of electrode terminals arranged on each side portion, and three rows and three columns of electrode terminals arranged on the upper surface, thereby providing appropriate stimulation sites for different users. In one example, the multiple electrode terminals 330 are arranged in a programmable matrix, and the controller 320 can selectively activate one or more of the multiple electrode terminals 330 to adapt the stimulation site to different users.

[0039] The inner housing 200 is at least partially made of a shape memory polymer (SMP), such as an SMP film. An actuator is disposed within the first accommodating cavity 112, capable of shifting the inner housing 200 between a contracted state and an expanded state. Shape memory polymers are a type of functional polymer material that can be given a certain shape (i.e., an initial state) under certain conditions, resulting in the contracted state of the inner housing 200. When external conditions change, the shape changes accordingly and stabilizes, shifting the inner housing 200 to an expanded state. When the external conditions that caused the deformation disappear, the shape returns to its initial state, returning the inner housing 200 to a contracted state.

[0040] The deformable inner housing 200 can better utilize the space within the inner cavity of the outer housing 100, specifically, the space in the first accommodating cavity 112 and the second accommodating cavity 114. Specifically, during the expansion of the inner housing 200, the shape memory polymer displaces space in both the first accommodating cavity 112 and the second accommodating cavity 114. This displaced space is balanced by the contours of the tongue and the arrangement of the electronic components, thereby preventing excessive compression of the electronic components while ensuring a close fit between the inner housing 200, particularly the stimulation surface of the electrode terminal 330 on the inner housing 200, and the tongue.

[0041] When the electrode terminal 330 is attached to the tongue due to the expansion of the internal housing 200, the tongue is also encased by the expanded internal housing 200, thereby limiting the relative movement between the tongue and the tongue cover device 1. For example, the expanded internal housing 200 can control the relative displacement between the tongue and the tongue cover device 1 within a range of ±10mm. As a result, in the working state, the electrode terminal 330 will not change the stimulation point due to the user's conscious or unconscious tongue movement, thereby continuously acting on the same stimulation point, achieving a basically consistent stimulation effect.

[0042] exist Figure 3 It is shown that the first accommodating cavity 112 between the internal shell 200 and the external shell 100 in the contracted state not only accommodates the electronic components of the stimulation circuit, but is also filled with a certain amount of gas, such as nitrogen or inert gas. On the one hand, it can provide stronger and more uniform internal pressure support when the internal shell 200 reaches the expanded state, further preventing the electronic components from being damaged by excessive squeezing, and on the other hand, it can also prevent the oxidation of the electronic components.

[0043] Because the outer shell 100 and the inner shell 200 are made of different materials, they can be manufactured through two-shot injection molding, that is, the outer shell 100 and the inner shell 200 are injection molded separately, and then the two are heated again to form an integral body. The tongue cover device 1 thus manufactured has excellent sealing performance in the first receiving cavity 112 between the outer shell 100 and the inner shell 200, and in particular, it has both airtightness and liquid-tightness.

[0044] In this case, in order to control the tongue cover device 1, especially the controller 320 and the actuator, a wireless communication module, such as a Bluetooth module, can be set in the first accommodating cavity 112. The tongue cover device 1, especially the controller 320 and the actuator can be connected to an external device, such as a mobile phone, through the wireless communication module so as to be controlled by the external device, such as starting or shutting down the actuator, starting or shutting down the stimulation circuit, setting relevant parameters, etc.

[0045] exist Figure 4 In the illustrated embodiment, the actuator and inner housing 200 are integrated into a multi-layer composite structure. This multi-layer composite structure includes: an outer layer 210 made of medical rubber, which protects the inner structure and provides a flexible feel and biocompatibility for the user; an intermediate layer 220 made of a thermotropic SMP film (e.g., polyurethane), which enables the inner housing 200, and in particular the multi-layer composite structure, to change between a contracted state and an expanded state; and an inner layer 230 made of a heating element. The heating element, which serves as the actuator, can drive the thermotropic SMP film between a contracted state and an expanded state by changing the temperature of the intermediate layer 220. Here, the heating element is configured as a resistance wire 235. The resistance wire 235 can be made of, for example, a nickel-chromium alloy wire with a diameter of 40-60 μm and arranged in a serpentine pattern to ensure uniform heating and avoid local overheating.

[0046] In this case, the tongue cover device 1 may further include a temperature control system 400 having a PID temperature control circuit integrated with a temperature sensor. The temperature sensor is, for example, an NTC thermistor, which is used to detect the temperature of the middle layer 220 or the inner layer 230 with an accuracy of ±1°C.

[0047] Therefore, during use, the user can first heat the inner layer 230 and the middle layer 220 using the heating element. At a transition temperature of, for example, 38°C, the middle layer 220, i.e., the thermotropic SMP film, begins to expand from a contracted state and gradually transitions to an expanded state. During this process, the temperature sensor of the temperature control system 400 continuously monitors the temperature of, for example, the middle layer 220 and feeds the temperature signal back to the PID temperature control circuit. The PID temperature control circuit adjusts the power of the heating element based on the temperature signal, effectively regulating the temperature of the middle layer 220. Specifically, if the temperature sensor detects a temperature exceeding, for example, 45°C, it can directly cut off the power to the heating element to prevent excessive heat from burning the user or damaging components.

[0048] Depending on the power of the heating element, the material and thickness of the thermotropic SMP film, and other factors, the heating and expansion process can take anywhere from a few seconds to a few minutes, eliminating the need for the user to wait for extended periods of time while the inner housing 200, particularly the stimulation surface of the electrode terminal 330, is securely attached to the tongue. Preferably, the power of the heating element is controlled within the range of 0.1W to 0.5W, and the thickness of the polyurethane thermotropic SMP film is controlled within the range of 0.2mm to 0.5mm. This allows the inner housing 200 to achieve an appropriate deformation and keeps the heating and deformation process within a reasonable range, for example, 60 seconds or less. In one example, the time required for the heating element to raise the temperature to 38°C and for the thermotropic SMP film to reach its expanded state is 50±5 seconds. This minimizes user waiting time and provides a relatively smooth user experience.

[0049] The stimulation circuit is then activated, and a stimulation current is applied to the electrode terminals 330 via the controller 320 to stimulate the corresponding tongue muscles of the user, such as the genioglossus muscle. This stimulation of the tongue muscles can prevent the tongue from falling back during sleep, thereby maintaining an open upper airway and treating obstructive sleep apnea.

[0050] To remove the tongue cover device 1, the power supply to the heating element can be cut off, allowing the temperature of the inner shell 200, especially the intermediate layer 220, to naturally drop. When the temperature drops below the transition temperature, for example, 38°C, the thermotropic SMP film begins to contract from its expanded state. Once contracted to a certain degree, the tongue cover device 1 can be removed. Alternatively, the user can manually press the tongue cover device 1 or apply external force using tongue movements to remove it more quickly.

[0051] Alternatively, the heating element may be constructed as a flexible electric heating film, which may be printed with carbon nanotube or silver nanowire conductive ink, with a thickness of less than or equal to 0.1 mm and a power consumption of less than or equal to 0.5 W.

[0052] In other embodiments, the shape memory polymer in the inner housing 200 can be an electro-, photo-, or chemically responsive SMP film, and the actuating device can be configured as a device that provides an electrical signal, a light signal, or a chemical reactant. These actuating devices can effectively provide an actuation signal that is not affected by the human body.

[0053] Figure 5 A flow chart showing a method for operating the tongue cover device 1 of the present invention is shown.

[0054] In step S1, the user places the tongue cover device 1 into the mouth, allowing the tongue to pass through the opening 120 of the outer shell 100 and enter the second accommodating cavity 114. At this time, the inner shell 200 and the electrode terminal 330 may only partially abut against the tongue.

[0055] In step S2, the user can activate the actuator via the wireless communication module using an external device, causing the internal housing 200 to transition from a contracted state to an expanded state. This state transition may last from a few seconds to a few minutes. However, in practice, since conditions such as the power of the heating element and the material and thickness of the thermotropic SMP film are preset during the design process, the state transition process is generally stable. Therefore, after a first predetermined time, the internal housing 200 can be considered to have completed the state transition. Therefore, after this first predetermined time, the process can automatically proceed to the next step S3. The first predetermined time can also be adjusted by the user through operation of the external device. Of course, the user can also actively operate the external device to proceed to step S3.

[0056] In step S3, the stimulation circuit is activated, and a stimulation current is applied to the electrode terminals 330 via the controller 320. The stimulation time, or treatment time, of the tongue cover device 1 is typically the same for the same user. This time can be preset by the user through an external device. Therefore, the process automatically proceeds to step S4 after the preset second predetermined time. Alternatively, the user can initiate the process by actively operating an external device.

[0057] In step S4, the actuator is deactivated, causing the inner housing 200 to at least partially transition from an expanded state to a contracted state. The stimulation circuit can be deactivated simultaneously or after a third predetermined time, for example, 5-20 seconds. When the stimulation circuit is deactivated with a delay, as the inner housing 200 gradually returns to the contracted state, at least a portion of the electrode terminals 330 gradually separate from the tongue surface, causing the user to experience a gradual weakening of the electrical stimulation, which eventually disappears as the stimulation circuit is deactivated. At this point, the inner housing 200 is also at least partially separated from the tongue surface, making removal of the tongue cover device 1 easier. This allows the user to experience a better electrical stimulation experience without requiring additional waiting time to remove the tongue cover device 1. The third predetermined time can be adjusted by the user using an external device or set by the manufacturer during the production process. Alternatively, the user can set the stimulation duration of the stimulation circuit using an external device. The actuator is then automatically deactivated a third predetermined time before the stimulation duration expires, and the stimulation circuit is automatically deactivated upon the expiration of the stimulation duration, resulting in a particularly smooth user experience.

[0058] Finally, in step S5 , the user actively removes the tongue cover device 1 , especially after feeling that the electrical stimulation disappears.

[0059] The above description of various embodiments of the present invention is provided for the purpose of description to one of ordinary skill in the relevant art. It is not intended to exclude or limit the present invention to a single disclosed embodiment. As above, a person of ordinary skill in the art will understand the various substitutions and variations of the present invention. Therefore, although some alternative embodiments are specifically described, a person of ordinary skill in the art will understand or relatively easily develop other embodiments. The present invention is intended to include all substitutions, modifications and variations of the present invention described herein, as well as other embodiments that fall within the spirit and scope of the present invention described above.

[0060] Reference Signs List

[0061] 1. Tongue-covering device

[0062] 100 External housing

[0063] 110 Lumen

[0064] 112 first accommodating chamber

[0065] 114 Second accommodating chamber

[0066] 120 Opening

[0067] 200 inner shell

[0068] 210 outer layer

[0069] 220 middle layer

[0070] 230 inner layer

[0071] 235 resistance wire

[0072] 310 Power Supply

[0073] 320 controller

[0074] 330 electrode terminal

[0075] 400 temperature control system

Claims

1. A tongue sheath device for electrically stimulating the hypoglossal nerve, the tongue sheath device comprising: an outer shell, the outer shell being configured to have an inner cavity and an opening for the tongue to extend into; an inner shell, the inner shell being arranged in the inner cavity of the outer shell and connected to the outer shell, so that the inner shell divides the inner cavity of the outer shell into a first closed accommodating cavity between the outer shell and the inner shell and a second accommodating cavity for accommodating the tongue and capable of communicating with the outside through the opening; as well as a stimulation circuit having a power supply, a controller, and electrode terminals electrically connected to each other, the power supply and the controller being arranged in the first accommodating cavity, the electrode terminals being arranged on the inner housing and at least with their stimulation surfaces exposed in the second accommodating cavity, The inner shell is at least partially made of a shape memory polymer, and an actuating device is arranged in the first accommodating cavity, and the actuating device can change the inner shell between a contracted state and an expanded state.

2. The tongue cover device according to claim 1, wherein: The actuating device and the inner shell are integrated into a multi-layer composite structure, which includes an outer layer made of medical rubber, a middle layer made of thermotropic SMP film, and an inner layer made of a heating element, wherein the heating element is the actuating device.

3. The tongue cover device according to claim 2, wherein: The heating element is a resistance wire or a flexible electric heating film.

4. The tongue cover device according to claim 2 or 3, wherein: The tongue cover device further comprises a temperature control system having a temperature sensor for detecting the temperature of the middle layer or the inner layer and a temperature control circuit for adjusting the power of the heating element.

5. The tongue cover device according to claim 4, wherein: The temperature control system has a PID temperature control circuit integrated with a temperature sensor.

6. The tongue cover device according to claim 4, wherein: The tongue cover device further includes a wireless communication module, and the controller, the actuating device and / or the temperature control circuit are communicatively connected with an external device via the wireless communication module.

7. The tongue cover device according to claim 2, wherein: The material of the thermotropic SMP film is polyurethane, the thickness of which is in the range of 0.2 mm to 0.5 mm, and the power of the heating element is in the range of 0.1 W to 0.5 W.

8. The tongue cover device according to claim 1, wherein: The outer shell is made of silicone with a hardness of 70A-100A.

9. The tongue cover device according to claim 1, wherein: The outer shell and the inner shell are molded by two injection molding.

10. The tongue cover device according to claim 1, wherein: The power supply and the controller are arranged on an inner side of the outer housing and are spaced apart from the inner housing.

11. The tongue cover device according to claim 1, wherein: The first accommodating chamber is filled with gas.

12. The tongue cover device according to claim 11, wherein: The gas is nitrogen or an inert gas.

13. A method for operating a tongue cover device according to any one of claims 1 to 12, the method comprising: Step S1, placing the tongue cover device into the mouth, so that the tongue portion enters the second accommodating cavity through the opening of the outer shell; Step S2, starting the actuating device to change the inner shell from the contracted state to the expanded state; Step S3, starting the stimulation circuit and applying a stimulation current to the electrode terminals through the controller; Step S4, closing the actuating device; as well as Step S5: removing the tongue cover device.

14. The method according to claim 13, wherein The tongue cover device further includes a wireless communication module, and the tongue cover device is connected to an external device through the wireless communication module, and steps S2, S3 and / or S4 are performed by the external device.

15. The method according to claim 13, wherein After the actuating device is activated, step S3 is automatically executed after a first predetermined time has passed.

16. The method according to claim 13, wherein After the stimulation circuit is activated, step S4 is automatically executed after a second predetermined time has passed.

17. The method according to claim 13, wherein: After the actuating device is turned off, the stimulation circuit is automatically turned off after a third predetermined time has passed, and then step S5 is executed.

Images