Mouthpiece device for electrically stimulating the hypoglossal nerve

Abstract

The utility model relates to a tongue cap device for electrically stimulating hypoglossal nerve, include: external casing, it is configured to have inner chamber and the opening for the tongue department to extend into, internal casing, it is arranged in the inner chamber of external casing and is connected with external casing, so that internal casing will the inner chamber of external casing divide into the closed first accommodating cavity between external casing and internal casing and the second accommodating cavity for accommodating the tongue department, can pass through the opening and communicate with the outside, and stimulating circuit has the power, controller and electrode terminal that electrically connected with one another, the power and controller are arranged in the first accommodating cavity, and the electrode terminal is arranged on internal casing and is at least with its stimulating face exposed in the second accommodating cavity, wherein, internal casing is made at least partially by shape memory polymer, and is arranged in the first accommodating cavity with actuating device, and the actuating device can make internal casing change between the shrinkage state and the inflation state.

Description

Technical Field

[0001] This utility model relates to the field of medical devices and neuromodulation technology, and in particular to a tongue sleeve device for electrically stimulating the hypoglossal nerve. Background Technology

[0002] Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent complete or partial obstruction of the upper airway during sleep, leading to interrupted or shallow breathing. This condition causes 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, the need for alternative treatments is increasing.

[0003] In recent years, neurostimulation technology has been studied as an emerging treatment for obstructive sleep apnea (OSA). In particular, hypoglossal nerve electrical stimulation has shown potential effectiveness by stimulating the hypoglossal nerve to activate the tongue muscles, preventing the tongue from falling back during sleep and thus maintaining the patency of the upper airway.

[0004] Existing devices for electrically stimulating the hypoglossal nerve typically consist of a stimulation end that inserts into the oral cavity during operation and a control end that remains outside the oral cavity. For ease of cleaning, the stimulation and control ends are usually detachable and connected via an interface. This design requires additional connectors, such as interfaces, resulting in a bulky and costly structure. Furthermore, it requires the user to partially open their mouth to allow the stimulation and control ends to connect, leading to discomfort.

[0005] Therefore, miniaturization of such devices, especially their complete placement within the oral cavity, has been a long-standing research direction. However, the space within the oral cavity is extremely limited, and arranging all electronic components and effectively encapsulating them within this confined space has been a persistent challenge.

[0006] Furthermore, because users' oral structures vary, the fit between the electrode terminals used for electrical stimulation and the tongue will differ when different users use the same device. When the electrode terminals cannot fit effectively with the tongue, the effect of electrical stimulation will be weakened or even disappear. Therefore, ensuring a proper fit between the electrode terminals and the tongue is one of the problems that urgently needs to be solved. Utility Model Content

[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 outer shell configured to have an inner cavity and an opening for the tongue to extend into; an inner shell disposed in the inner cavity of the outer shell and connected to the outer shell, such that the inner shell divides the inner cavity of the outer shell into a closed first receiving cavity between the outer shell and the inner shell and a second receiving cavity for receiving the tongue and capable of communicating with the outside through the opening; and a stimulation circuit having a power supply, a controller and electrode terminals electrically connected to each other, the power supply and the controller being disposed in the first receiving cavity, the electrode terminals being disposed on the inner shell and exposed at least with their stimulation surfaces in the second receiving cavity, wherein the inner shell is at least partially made of a shape memory polymer, and an actuation device is disposed in the first receiving cavity, the actuation device being capable of changing the inner shell between a contracted state and an expanded state.

[0008] Because the inner shell is made of shape memory polymer and can change between a contracted and expanded state under the action of the actuation device, the tongue sleeve device can be inserted into the oral cavity with a small volume in the contracted state, and ensures effective contact between the stimulation surface of the electrode terminals and the tongue in the expanded state. When the electrode terminals are in contact with the tongue due to the expansion of the inner shell, the tongue is also simultaneously wrapped by the expanded inner shell, thereby restricting the relative movement between the tongue and the tongue sleeve device. For example, the relative displacement between the tongue and the tongue sleeve device is controlled within ±10mm through the wrap-around tongue sleeve design, so that the electrode terminals will not change the stimulation point due to the user's conscious or unconscious tongue movements during operation, thus continuously acting on the same stimulation point and achieving a basically consistent stimulation effect.

[0009] The deformable inner shell provides excellent adaptability to accommodate various users' tongue structures, while also effectively utilizing the volume of the outer shell's cavity. This allows for the inclusion of all electronic components in a smaller outer shell while leaving sufficient space for the tongue.

[0010] Preferably, the actuation device is integrated with the inner housing as a multi-layer composite structure, comprising an outer layer made of medical-grade rubber, an intermediate layer made of a thermotropic SMP film, and an inner layer made of a heating element, wherein the heating element is the actuation device. This structure enables a high degree of integration within the tongue sleeve device, resulting in a compact structure that is easy to manufacture.

[0011] More preferably, the heating element can be a resistance wire, for example made of 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.

[0012] Alternatively, the heating element may be a flexible electrothermal film, for example, printed with conductive ink from carbon nanotubes or silver nanowires, 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 sleeve device further includes a temperature control system, which has a temperature sensor for detecting the temperature of the intermediate layer or inner layer and a temperature control circuit for adjusting the power of the heating element. More preferably, the temperature control system has a PID temperature control circuit with an integrated temperature sensor. The temperature sensor can be an NTC thermistor with an accuracy of ±1℃.

[0014] Preferably, the tongue device further includes a wireless communication module, through which the controller, the actuator, and / or the temperature control circuit are communicatively connected to an external device. Thus, the user can control the controller, actuator, and / or temperature control circuit via an external device, including activating / deactivating the actuator, activating / deactivating the stimulation circuit, and setting relevant parameters.

[0015] Preferably, the thermally induced SMP film is made of polyurethane with a thickness ranging from 0.2 mm to 0.5 mm, and the power of the heating element is ranging from 0.1 W to 0.5 W. This allows the inner casing to achieve a suitable amount of deformation and controls the heating and deformation process within, for example, 60 seconds, thereby reducing the user's waiting time to an acceptable range and resulting in an excellent user experience.

[0016] Preferably, the outer housing is made of silicone with a hardness of 70A-100A. The rigid outer housing provides overall support for the tongue device and is used to install electronic components such as power supplies and controllers.

[0017] Preferably, the outer shell and the inner shell are formed by two-stage injection molding, that is, the outer shell and the inner shell are injection molded separately, and then the two are heated a second time to form a single integral shape. This can provide particularly good sealing performance for the first receiving 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 receiving cavity is filled with gas, particularly nitrogen or an inert gas. This prevents the electronic components within the first receiving cavity from being compressed and damaged. Attached Figure Description

[0019] To better understand the above and other objects, features, advantages, and functions of this utility model, reference can be made to the preferred embodiments shown in the accompanying drawings. The same reference numerals in the drawings refer to the same parts. Those skilled in the art should understand that the drawings are intended to schematically illustrate the preferred embodiments of this utility model and do not limit the scope of this utility model in any way; the parts in the drawings are not drawn to scale.

[0020] Figure 1 A perspective view of the tongue sleeve device of this utility model is shown;

[0021] Figure 2 It shows Figure 1 The sectional view of the tongue device shown is taken along line AA;

[0022] Figure 3 It shows Figure 1 The sectional view shown is taken along line BB and then along line CC.

[0023] Figure 4 The integrated structure of the internal housing and the actuation device is shown; and

[0024] Figure 5 A flowchart is shown for a method of operating the tongue device of this invention. Detailed Implementation

[0025] Now, with reference to the accompanying drawings, specific embodiments of the present invention will be described in detail. The embodiments described herein are merely preferred embodiments of the present invention; those skilled in the art can conceive of other ways to implement the present invention based on these preferred embodiments, and such other ways also fall within the scope of the present invention.

[0026] In this article, the terms "upper", "lower", "front", and "back" all refer to the positions corresponding to when the user is wearing the tongue cover device normally.

[0027] Figures 1 to 3 The present invention discloses a tongue sleeve device 1, which includes an outer housing 100, an inner housing 200, and a stimulation circuit. The outer housing 100 is configured to have an inner cavity 110 and an opening 120 for the tongue to extend into. The inner housing 200 is disposed in the inner cavity 110 of the outer housing 100 and connected to the outer housing 100, and specifically, is connected to the opening 120 of the outer housing 100, such that the inner housing 200 divides the inner cavity 110 of the outer housing 100 into a closed first receiving cavity 112 between the outer housing 100 and the inner housing 200, and a second receiving cavity 114 for receiving the tongue and communicating with the outside through the opening 120.

[0028] The outer shell 100 can be made of silicone with a hardness of 70A-100A, thus providing an overall support structure for the tongue sheath. The outer shell 100 is sized to fit within the oral cavity and provide sufficient space to accommodate the tongue and provide stimulation circuitry for electrical stimulation.

[0029] Reference Figure 3 The stimulation circuit has a power supply 310, a controller 320 and an electrode terminal 330 that are electrically connected to each other. The power supply 310 and the controller 320 are both arranged in the first receiving cavity 112, and the electrode terminal 330 is arranged on the inner housing 200 and is exposed in the second receiving cavity 114 at least with its stimulation surface.

[0030] The power supply 310 can be a small-capacity wirelessly rechargeable battery, preferably with a capacity sufficient for one to two stimulation sessions, thus effectively reducing battery size. In addition to providing energy for the electrical stimulation of the electrode terminals 330, the power supply 310 can also provide energy for the actuation device of the tongue sleeve device 1 and other electronic components. 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 controller 320 are preferably arranged on the inner side of the outer housing 100 and spaced apart from the inner housing 200, thereby obtaining good support and avoiding compression.

[0031] Reference Figure 2 The electrode terminals 330 are preferably arranged on the upper surface and two sides of the inner housing 200, with three rows and one column of electrode terminals arranged on each of the two sides and three rows and three columns of electrode terminals arranged on the upper surface, thereby providing suitable stimulation sites for different users. In one example, 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 to the stimulation sites of different users.

[0032] The inner shell 200 is at least partially made of a shape memory polymer (SMP), such as an SMP film, and an actuation device is arranged in the first receiving cavity 112, which enables the inner shell 200 to change between a contracted state and an expanded state. Shape memory polymers are a class of functional polymer materials that can be endowed with a certain shape, i.e., an initial state, under certain conditions, thereby giving the inner shell 200 a contracted state; when external conditions change, it can correspondingly change its shape and fix it, thereby causing the inner shell 200 to transition to an expanded state; when the external conditions that caused its deformation disappear, it can restore its shape to the initial state, thereby causing the inner shell 200 to return to a contracted state.

[0033] The deformable inner shell 200 can better utilize the space within the inner cavity of the outer shell 100, that is, to make reasonable use of the spaces of the first receiving cavity 112 and the second receiving cavity 114. Specifically, during the expansion of the inner shell 200, the shape memory polymer occupies space in both the first receiving cavity 112 and the second receiving cavity 114. This occupancy is balanced by the constraints of the tongue contour and the arrangement of electronic components, thereby avoiding excessive compression of the electronic components and ensuring that the stimulation surface of the inner shell 200, especially the electrode terminals 330 on the inner shell 200, fits tightly against the tongue.

[0034] When the electrode terminal 330 comes into contact with the tongue due to the expansion of the inner housing 200, the tongue is also simultaneously enveloped by the expanded inner housing 200, thus restricting the relative movement between the tongue and the tongue sleeve device 1. For example, the relative displacement between the tongue and the tongue sleeve device 1 can be controlled within ±10mm by the expanded inner housing 200. Therefore, in the working state, the electrode terminal 330 will not change the stimulation point due to the user's conscious or unconscious tongue movements, thus continuously acting on the same stimulation point to achieve a basically consistent stimulation effect.

[0035] exist Figure 3 The first receiving cavity 112 between the inner housing 200 and the outer housing 100 in the contracted state not only houses the electronic components of the stimulating circuit, but is also filled with a certain amount of gas, such as nitrogen or inert gas. This provides stronger and more uniform internal pressure support when the inner housing 200 reaches the expanded state, further preventing the electronic components from being damaged by excessive compression. On the other hand, it also prevents the oxidation of the electronic components.

[0036] Since the outer shell 100 and the inner shell 200 are made of different materials, they can be manufactured by secondary injection molding, i.e., the outer shell 100 and the inner shell 200 are injection molded separately, and then the two are heated and molded together as a single unit. The tongue device 1 thus manufactured has excellent sealing performance in the first receiving cavity 112 between the outer shell 100 and the inner shell 200, especially with both airtightness and liquid tightness.

[0037] In this case, in order to control the tongue device 1, especially the controller 320 and the actuator, a wireless communication module, such as a Bluetooth module, can be provided in the first receiving cavity 112. The tongue device 1, especially the controller 320 and the actuator, can communicate with an external device, such as a mobile phone, through the wireless communication module so as to control them through the external device, such as starting or stopping the actuator, starting or stopping the stimulation circuit, setting relevant parameters, etc.

[0038] exist Figure 4 In the illustrated embodiment, the actuation device is integrated with the inner housing 200 into a multi-layered composite structure. This multi-layered composite structure includes: an outer layer 210 made of medical-grade rubber, which provides protection for the internal structure and offers a flexible feel and biocompatibility for the user; an intermediate layer 220 made of a thermotropic SMP film (e.g., polyurethane), which allows the inner housing 200, and particularly the multi-layered composite structure, to change between a contracted and expanded state; and an inner layer 230 made of a heating element, which is the actuation device, capable of driving the thermotropic SMP film to change between a contracted and expanded state by altering the temperature of the intermediate layer 220. Here, the heating element is constructed as a resistance wire 235, which can be made of, for example, a nichrome alloy wire with a diameter of 40-60 μm and arranged in a serpentine pattern to ensure uniform heating and avoid localized overheating.

[0039] In this configuration, the tongue sleeve device 1 may also include a temperature control system 400, which has a PID temperature control circuit with an integrated temperature sensor. The temperature sensor is, for example, an NTC thermistor, used to detect the temperature of the intermediate layer 220 or the inner layer 230, with an accuracy of ±1°C.

[0040] Therefore, during use, the user can first heat up the inner layer 230 and the intermediate layer 220 using the heating element. The intermediate layer 220, i.e., the thermotropic SMP film, begins to expand from a contracted state at the transition temperature, for example, 38°C, and gradually transitions to an expanded state. During this process, the temperature sensor of the temperature control system 400 continuously monitors, for example, the temperature of the intermediate 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 according to the temperature signal, thereby effectively regulating the temperature of the intermediate layer 220. In particular, when the temperature sensor detects that the temperature exceeds, for example, 45°C, the power supply to the heating element can be directly cut off to prevent the user from being burned by excessively high temperatures or damage to the components.

[0041] Depending on factors such as the power of the heating element, the material and thickness of the thermotropic SMP film, the heating and expansion processes can occur within a few seconds to a few minutes, thus achieving close contact between the stimulation surface of the inner housing 200, and especially the electrode terminals 330 on the inner housing 200, and the tongue without requiring excessive user waiting time. Preferably, controlling the power of the heating element to within the range of 0.1W to 0.5W and the thickness of the thermotropic SMP film formed of polyurethane to within the range of 0.2mm to 0.5mm allows the inner housing 200 to achieve a suitable amount of deformation and keeps the heating and deformation processes within a reasonable range, for example, less than or equal to 60 seconds. In one example, the time required to raise the temperature to 38°C using the heating element and allow the thermotropic SMP film to reach its expanded state is 50±5 seconds. This compresses the user's waiting time to an acceptable range, resulting in a relatively smooth user experience.

[0042] Then, the stimulation circuit is activated, and a stimulating current is applied to the electrode terminal 330 via the controller 320 to stimulate the user's corresponding tongue muscles, such as the genioglossus muscle. By stimulating the tongue muscles, the tongue can be prevented from falling back during sleep, thereby keeping the upper airway open and achieving the effect of treating obstructive sleep apnea.

[0043] To remove the tongue sleeve device 1, the power supply to the heating element can be cut off, allowing the temperature of the inner housing 200, especially the intermediate layer 220, to drop naturally. When the temperature drops below the transition temperature, for example, 38°C, the thermotropic SMP film begins to contract from its expanded state. Once it has contracted to a certain extent, the tongue sleeve device 1 can be removed. Alternatively, the user can manually press the tongue sleeve device 1 or apply external force using tongue movement to remove it more quickly.

[0044] Alternatively, the heating element can be constructed as a flexible electrothermal film, which can be printed from 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.

[0045] In other embodiments, the shape memory polymer in the inner housing 200 may be an electro-, photo-, or chemi-sensitive SMP film, and the actuation device is configured to provide a corresponding electrical signal, optical signal, or chemical reactant. These actuation devices can effectively provide actuation signals unaffected by the human body.

[0046] Figure 5 A flowchart is shown of a method for operating the tongue device 1 of this invention.

[0047] In step S1, the user places the tongue sleeve device 1 into the mouth, allowing the tongue to enter the second receiving cavity 114 through the opening 120 of the outer housing 100. At this time, the inner housing 200 and the electrode terminals 330 may only partially abut the tongue.

[0048] In step S2, the user can use an external device to activate the actuator via a wireless communication module, causing the inner casing 200 to change from a contracted state to an expanded state. This state transition may last from a few seconds to a few minutes, but in practice, since the power of the heating element, the material and thickness of the thermotropic SMP film are preset during the design process, the state transition process is usually stable. Therefore, the inner casing 200 can be considered to have completed the state transition after a first predetermined time. Thus, 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 operating the external device. Of course, the user can also actively operate the external device to proceed to step S3.

[0049] In step S3, the stimulation circuit is activated, and a stimulation current is applied to the electrode terminal 330 via the controller 320. For the same user, the stimulation time, or treatment time, of the tongue sleeve device 1 is usually the same, and this time can be preset by the user through operation of an external device. Therefore, after the preset second predetermined time, the process can automatically proceed to the next step S4. Alternatively, the user can actively operate the external device to proceed to step S4.

[0050] In step S4, the actuation device is turned off, causing the inner housing 200 to at least partially change from an expanded state to a contracted state. The stimulation circuit can be turned off simultaneously, or it can be turned off after a third predetermined time, for example, a delay of 5-20 seconds. When the stimulation circuit is turned off with a delay, as the inner housing 200 gradually returns to the contracted state, at least some of the electrode terminals 330 will gradually detach from the tongue surface, so that the user feels the electrical stimulation gradually weakening, and finally disappearing as the stimulation circuit is turned off. At this time, the inner housing 200 has also at least partially detached from the tongue surface, making the removal of the tongue cover device 1 simpler. Thus, the user can obtain a better electrical stimulation experience and no longer needs an additional waiting time to remove the tongue cover device 1. The third predetermined time can be adjusted by the user through operating an external device, or it can be set by the manufacturer during the production process. Alternatively, the user can also set the stimulation duration of the stimulation circuit through operating an external device, and then automatically turn off the actuation device before the third predetermined time before the stimulation duration is reached, and automatically turn off the stimulation circuit when the stimulation duration is reached, thereby obtaining a particularly smooth user experience.

[0051] Finally, in step S5, especially after the electrical stimulation disappears, the user actively removes the tongue cover device 1.

[0052] The above description of various embodiments of this utility model is provided for the purpose of description to a person of ordinary skill in the art. It is not intended to exclude or limit the utility model to a single disclosed embodiment. As stated above, a person of ordinary skill in the art will understand that various alternatives and variations of this utility model exist. Therefore, although some alternative embodiments have been specifically described, a person of ordinary skill in the art will understand or relatively easily develop other embodiments. This utility model is intended to include all alternatives, modifications, and variations of the utility model described herein, as well as other embodiments falling within the spirit and scope of the utility model described above.

[0053] List of reference numerals

[0054] 1. Tongue sheath device

[0055] 100 Outer casing

[0056] 110 Inner cavity

[0057] 112 First Receiving Chamber

[0058] 114 Second Reception Chamber

[0059] 120 opening

[0060] 200 Internal casing

[0061] 210 Outer layer

[0062] 220 Intermediate Layer

[0063] 230 Inner Layer

[0064] 235 resistance wire

[0065] 310 power supply

[0066] 320 controller

[0067] 330 electrode terminals

[0068] 400 temperature control system

Claims

1. A tongue-shaped device for electrically stimulating the hypoglossal nerve, characterized in that, The tongue-sheath device includes: An outer housing, the outer housing being configured to have an inner cavity and an opening for the tongue to extend into; An inner housing, disposed within and connected to the inner cavity of the outer housing, such that the inner housing divides the inner cavity of the outer housing into a closed first receiving cavity between the outer housing and the inner housing, and a second receiving cavity for receiving the tongue and capable of communicating with the outside through the opening; and The stimulation circuit includes a power supply, a controller, and electrode terminals electrically connected to each other. The power supply and the controller are arranged in a first receiving cavity, and the electrode terminals are arranged on the inner housing and exposed at least their stimulation surfaces in a second receiving cavity. The inner shell is at least partially made of a shape memory polymer, and an actuation device is arranged in the first receiving cavity, the actuation device being capable of changing the inner shell between a contracted state and an expanded state.

2. The tongue-sheath device according to claim 1, characterized in that, The actuation device is integrated with the inner housing as a multi-layer composite structure, which includes an outer layer made of medical rubber, an intermediate layer made of thermotropic SMP film, and an inner layer made of heating element, wherein the heating element is the actuation device.

3. The tongue-sheath device according to claim 2, characterized in that, The heating element is a resistance wire or a flexible electric heating film.

4. The tongue-sheath device according to claim 2 or 3, characterized in that, The tongue device also includes a temperature control system, which has a temperature sensor for detecting the temperature of the intermediate layer or inner layer and a temperature control circuit for adjusting the power of the heating element.

5. The tongue-sheath device according to claim 4, characterized in that, The temperature control system has a PID temperature control circuit with an integrated temperature sensor.

6. The tongue-sheath device according to claim 4, characterized in that, The tongue device also includes a wireless communication module, through which the controller, the actuation device, and / or the temperature control circuit are connected to an external device.

7. The tongue-sheath device according to claim 2, characterized in that, The thermally induced 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.

8. The tongue-sheath device according to claim 1, characterized in that, The outer shell is made of silicone with a hardness of 70A-100A.

9. The tongue-sheath device according to claim 1, characterized in that, The outer shell and the inner shell are formed by secondary injection molding.

10. The tongue-sheath device according to claim 1, characterized in that, The power supply and the controller are arranged on the inner side of the outer housing and spaced apart from the inner housing.

11. The tongue-sheath device according to claim 1, characterized in that, The first cavity is filled with gas.

12. The tongue-sheath device according to claim 11, characterized in that, The gas is nitrogen or an inert gas.

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