Mouthpiece device for electrically stimulating the hypoglossal nerve

Abstract

The utility model relates to a tongue cap device for electrically stimulating hypoglossal nerve, the tongue cap device includes tongue cap body, electrode terminal and electrode circuit, wherein, the tongue cap body has the base part for being in contact with the dorsum of the tongue of continuous extension and two side parts of the angle extension with the base part on both sides, the base part and each side part in the two side parts are evenly arranged with the electrode terminal, the electrode circuit is at least partially arranged in the tongue cap body and is electrically connected with the electrode terminal.

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 and a method for operating the tongue sleeve device. 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] However, existing devices for electrically stimulating the hypoglossal nerve are typically fixed in the mouth via braces, lacking structures to restrict tongue movement. Therefore, wearers may consciously or unconsciously move their tongues during stimulation, preventing the same nerve points from being electrically stimulated. Furthermore, effective stimulation points vary from wearer to wearer, resulting in different stimulation effects from the same point to different individuals. Therefore, there is an urgent need for a device with consistent and / or universal applicability for electrically stimulating the hypoglossal nerve. Utility Model Content

[0005] Therefore, in order to at least partially 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 includes a tongue sleeve body, electrode terminals, and an electrode circuit. The tongue sleeve body has a continuously extending base for contacting the dorsal surface of the tongue and two side portions extending at an angle to the base on both sides of the base. The electrode terminals are arranged on the base and each of the two side portions. The electrode circuit is at least partially arranged in the tongue sleeve body and electrically connected to the electrode terminals.

[0006] Therefore, the tongue sleeve body can provide comprehensive restraint to the back and sides of the tongue through its continuously extending base and two sides, preventing tongue movement during stimulation and thus ensuring consistent stimulation points. By providing multiple electrode terminals on the continuously extending base and sides, the wearer can also activate the appropriate electrode terminals for stimulation and deactivate the less effective ones, thereby improving the effectiveness of stimulation and the utilization rate of electrical energy.

[0007] Preferably, the electrode terminals arranged on the base form at least two columns of a first electrode terminal array, and the electrode terminals arranged on each of the two sides form at least one column of a second electrode terminal array. The electrode terminal array provides more electrode terminals for the wearer to selectively activate, thereby increasing the coverage of the stimulation points targeted by the electrode terminals.

[0008] The essence of electrical stimulation of the hypoglossal nerve lies in providing a change in transmembrane potential, meaning that the excitation of nerve cells depends on changes in transmembrane voltage. In the resting state, there is a potential difference of approximately -70mV across the cell membrane (negative inside, positive outside). When external electrical stimulation creates a sufficient voltage gradient (electric field) across the cell membrane, it triggers the opening of ion channels, allowing ions to flow across the membrane and depolarizing the membrane potential. Voltage (electric field) determines whether depolarization can be initiated, while the amount of charge determines the duration and intensity of depolarization.

[0009] Therefore, on the one hand, a higher density of electrode terminals in the electrode terminal array provides more and more precise stimulation points to choose from, requiring the stimulation surface and spacing of the electrode terminals to be as small as possible. On the other hand, the area of ​​the stimulation surface of the electrode terminals cannot be too small, because the area of ​​the stimulation surface of the electrode terminals determines the amount of charge passing through per unit time. Too small an area leads to insufficient depolarization intensity, failing to produce a sufficient stimulation effect. In addition, the spacing between adjacent electrode terminals cannot be too small, as too small a spacing will make the installation and wiring of the electrode terminals difficult.

[0010] For the reasons stated above, the applicant proposes a compromise arrangement for the electrode terminal array, wherein the area of ​​the stimulation surface of the electrode terminals is greater than or equal to 60 mm². 2 And / or the spacing between adjacent electrode terminals in the electrode terminal array is greater than or equal to 5 mm.

[0011] Preferably, the electrode circuit includes a power supply, a controller, and wires, wherein the power supply and the controller are electrically connected to the electrode terminals via the wires.

[0012] Preferably, the electrode circuit further includes a storage unit, which is capable of storing the position information of the electrode terminals, and the controller is capable of selectively activating the corresponding electrode terminals in the electrode terminals according to the position information.

[0013] Preferably, the electrode circuit further includes a wireless communication unit, which enables the electrode circuit to communicate with an external device. The external device can be a smart mobile device, such as a mobile phone, which can provide peripheral operation capabilities for the tongue-covering device via, for example, a dedicated app, thereby significantly reducing the number of buttons that need to be set on the tongue-covering device.

[0014] Preferably, the tongue cover device further includes an extension located outside the wearer's mouth when the tongue cover device is worn, and the power supply and the controller are located within the extension. The extension provides additional volume for housing the power supply and the controller, thereby minimizing the space occupied by the tongue cover body and allowing the wearer to wear it comfortably.

[0015] Preferably, the extension has a first extension and a second extension that are separable from each other. The first extension is integrally constructed with the tongue body, and the second extension is electrically connected to the first extension via an interface. The power supply and the controller are located in the second extension. This structure makes cleaning the tongue body particularly convenient, and there is no need to worry about water damage to the internal circuitry during cleaning.

[0016] Preferably, the base is an isosceles trapezoid, and / or the tongue body is wedge-shaped. This shape makes the tongue body generally taper from back to front. Thus, the wearer's tongue can be easily inserted into the tongue body through the relatively loose entrance formed by the base and sides, and engage and be positioned in the appropriate location.

[0017] Preferably, each of the two sides has a bend at its lower end, away from the base, for engaging the lower edge of the tongue. Alternatively or additionally, the tongue cover body also has a bottom, which connects to the lower ends of the two sides, away from the base, such that the base, the sides, and the bottom form a receiving cavity for accommodating the tongue. The bends and / or the bottom allow the tongue cover body to be better secured to the wearer's tongue, thereby optimizing the positioning of the stimulation point.

[0018] Preferably, the bottom extends from the front end of the lower end portion, thereby forming a clearance portion at the rear end of the lower end portion. The clearance portion can effectively avoid the frenulum of the tongue, allowing the tongue sleeve body to better engage with the entire tongue, thereby enabling the electrode terminals to make full contact with the tongue surface associated with the genioglossus muscle. 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 first embodiment of the tongue sheath device of this utility model is shown;

[0021] Figure 2 It shows Figure 1 A top view of the tongue-shaped device shown;

[0022] Figure 3 It shows Figure 1 A schematic diagram of the electrode circuit of the tongue sleeve device shown;

[0023] Figure 4 A perspective view of a second embodiment of the tongue sheath device of this utility model is shown;

[0024] Figure 5 It shows Figure 4 The front view of the tongue sleeve device shown;

[0025] Figure 6 A flowchart illustrating the operation method of the tongue-shaped device is shown;

[0026] Figure 7 The initial interface of the tongue device in selection mode is shown; and

[0027] Figure 8 The final interface of the tongue device in selection mode is shown. Detailed Implementation

[0028] 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.

[0029] In this article, the terms "upper", "lower", "front", and "back" all refer to the positions corresponding to the wearer's normal wearing of the tongue cover device.

[0030] Figures 1 to 3 The first embodiment of the tongue sleeve device 1 of the present invention is shown. The tongue sleeve device 1 includes a tongue sleeve body 100, an electrode terminal 200 and an electrode circuit 300.

[0031] like Figure 1As shown, the tongue body 100 has a continuously extending base 110 for contacting the back of the tongue and two side portions 120 located on both sides of the base 110, each side portion 120 extending at an angle to the base 110. Here, the angle between the base 110 and the side portions 120 is approximately 90°. In other embodiments, this angle can be in the range of 60° to 150°. A rounded transition may be used between the base 110 and the side portions 120. The base 110 and the side portions 120 have approximately equal thicknesses.

[0032] like Figure 2 As shown, the continuously extending base 110 is approximately an isosceles trapezoid, and the side portion 120 is located at the two legs of this isosceles trapezoid. Figure 3 As shown, the entire tongue sleeve body 100 is roughly wedge-shaped, that is, it tapers from back to front. As a result, the tongue can be easily inserted into the tongue sleeve body 100 through the tongue inlet formed by the base 110 and the side 120, and engage with and be positioned in the tongue sleeve body 100 at the appropriate location.

[0033] The tongue cover body 100 can be made of an elastic material, such as medical rubber. This allows for good biocompatibility, excellent insulation, and adaptability to different wearers' tongue sizes. In this case, the angle between the base 110 and the side 120 can have a deformation amount of, for example, 10° to 30°.

[0034] Electrode terminals 200 are arranged on each of the base 110 and the two side portions 120. Here, two electrode terminals 200 are arranged at the rear end of the base 110, and one electrode terminal 200 is arranged at the rear end of each side portion 120. The electrode terminals 200 can be made of conductive materials, such as metal or conductive plastic. The electrode terminals 200 are positioned with their stimulation surfaces in contact with nerve target points on the human tongue to provide, for example, a voltage of approximately 70 mV to the nerve target points for stimulation.

[0035] Each of the two side portions 120 may have a bent portion 122 at its lower end 121 away from the base 110. This bent portion 122 extends inward relative to the side portion 120 in cross-section to engage the lower edge of the tongue, thereby allowing the tongue sleeve body 100 to at least partially cover the wearer's tongue. This prevents the wearer's tongue from easily moving within the tongue sleeve body 100, thus preventing easy misalignment of the contact point between the electrode terminal 200 and the stimulation point of the tongue sleeve body 100, and ensuring the consistency of the electrical stimulation point. The bent portion 122 may extend along the entire lower end 121 of the side portion 120.

[0036] Replace the bend 122, or as Figure 1Additionally, the tongue sleeve body 100 may have a bottom 130 connecting the lower ends 121 of the two sides 120 away from the base 110, such that the base 110, sides 120, and bottom 130 form a receiving cavity for accommodating the tongue. The bottom 130 may extend over a portion or the entire lower end 121 of the sides 120. When the bottom 130 extends over a portion of the lower end 121 of the sides 120, it preferably extends at the front end of the lower end 121, thereby forming a clearance 140 at the rear end of the lower end 121 to effectively avoid the frenulum, allowing the tongue sleeve body 100 to better engage with the entire tongue, and in particular, allowing the electrode terminals 200 to contact the tongue surface associated with the genioglossus muscle.

[0037] A rounded transition may be used between the side portion 120 and the bent portion 122 and / or the bottom portion 130.

[0038] Reference Figure 3 The diagram schematically illustrates the electrode circuit 300 of the tongue sleeve device 1. Here, the electrode circuit 300 includes a power supply 310, a control circuit 320, and wires 330. The power supply 310 and control circuit 320 are arranged in an extension 400 outside the tongue sleeve body 100, which, during use, is located outside the wearer's mouth. Thus, the extension 400 can be made of a rigid material, such as plastic. The wires 330 are at least partially arranged in the tongue sleeve body 100, particularly in the base 110 and side 120, and are electrically connected to the electrode terminals 200.

[0039] The extension 400 is preferably constructed as a separate structure, for example, divided into a first extension 410 and a second extension 420, wherein the first extension 410 is integrally constructed with the tongue cover body 100. The first extension 410 and the second extension 420 are connected via an interface 340. The interface 340 is preferably a magnetic interface. The power supply 310 and the control circuit 320 are preferably arranged in the second extension 420. The separate structure of the extension 400 makes cleaning the tongue cover body 100 particularly easy.

[0040] In this configuration, the tongue sleeve body 100 is electrically connected via interface 340 to the power supply 310 and control circuit 320 in the second extension 420. The control circuit 320 controls the output voltage and / or current, supplying it via wires 330 to electrode terminals 200 on the base 110 and sides 120 of the tongue sleeve body 100. The electrode terminals 200 contact the surface of the wearer's tongue, thereby transmitting electrical stimulation to various nerve points on the wearer's tongue. The tongue muscles are then activated by periodically stimulating the hypoglossal nerve, preventing the tongue from falling back during sleep and thus maintaining the patency of the upper airway.

[0041] Figure 4 and Figure 5A second embodiment of the tongue sleeve device 1 of the present invention is shown, wherein the second extension 420 is not shown. This embodiment differs from the previous embodiment in that a plurality of electrode terminals 200 are arranged on each of the base 110 and the two side portions 120, and these electronic terminals 200 form electrode terminal arrays 210, 220 in particular.

[0042] In this embodiment, an electrode terminal array 210 arranged in two columns (i.e., along the longitudinal direction, or the front-to-back direction) and three rows (i.e., along the transverse direction) is arranged at the rear end of the base 110, and an electrode terminal array 220 arranged in one column and three rows is arranged at the rear end of each side 120. Of course, more columns and / or two or more rows of electrode terminal arrays can be arranged on each of the base 110 and each of the two side 120s. Each electrode terminal 200 in these electrode terminal arrays 210 and 220 corresponds to a different stimulation point.

[0043] The stimulation surface of the electrode terminal 200 can have various shapes such as circular, rectangular, polygonal, and oblong, and its area is preferably greater than or equal to 60 mm². 2 Furthermore, the spacing between adjacent electrode terminals 200 is preferably greater than or equal to 5 mm.

[0044] In this embodiment, the control circuit 320 can selectively activate corresponding electrode terminals among these electrode terminals 200. For this purpose, the tongue sleeve device 1 can switch between a selection mode and an operating mode. When the tongue sleeve device 1 is in selection mode, the electrode terminals 200 are activated sequentially, and when the wearer feels effective stimulation, they can select and record the currently activated electrode terminal 200 via a selector. When the tongue sleeve device 1 is in operating mode, all selected electrode terminals 200 are activated.

[0045] For this purpose, the electrode circuit 300 may also include a storage unit capable of storing position information of the electrode terminal 200, particularly one or more sets of position information related to the selected electrode terminal 200, so that the tongue sleeve device 1 can operate in one or more operating modes and enable the electrode terminal 200 at the corresponding position.

[0046] Switching between selection modes and operating modes, as well as operating the selector, can be achieved via various buttons provided on the extension 400, or via other external devices. When operated using an external device, such as a mobile phone, the electrode circuit 300 may also include a wireless communication unit, through which the electrode circuit 300 communicates with the external device.

[0047] Figures 6 to 8The flowchart, initial interface, and final interface of the operation method for selectively activating the electrode terminals in the selection mode of the tongue device 1 are shown respectively.

[0048] In this embodiment, a first electrode terminal array 210 with 3 rows and 3 columns is provided on the base 110, which is in Figure 7 The display is located in the center; a second electrode terminal array 220 with 3 rows and 2 columns is provided on the side 120, which is in Figure 7 The first electrode terminal array 210 and the second electrode terminal array 220 are separated by a dashed line. Figure 7 The lower part displays operation buttons: "Confirm" and "Next". The names of these buttons are for illustrative purposes only; their functions will be explained in the following steps.

[0049] like Figure 6 As shown, in step S1, the wearer enters the selection mode by operating the button on the tongue sleeve device 1 or the external device connected to it.

[0050] Next, in step S2, at least one electrode terminal in the tongue sleeve device 1 is activated. For example, the upper left electrode terminal, marked as half black and half white, is activated first, which may also be indicated to the wearer in the actual display, for example, by flashing. The electrode terminal can be activated at a predetermined frequency, predetermined voltage, and predetermined time for a predetermined period of time, so that the wearer can evaluate its stimulation effect under the same conditions. The predetermined frequency, predetermined voltage, and predetermined time can be set in an external device, such as a mobile phone, before entering the selection mode.

[0051] Then, in step S3, the wearer assesses the stimulation effect through tactile feedback and selects whether to select the electrode terminal. If the wearer approves of the stimulation effect, they can click the "Confirm" button to record the position of the electrode terminal; if the wearer does not approve of the stimulation effect, they can click the "Next" button, and the position of the electrode terminal will not be recorded.

[0052] Once the "Confirm" or "Next" button is clicked, the selection is complete, and the process proceeds to step S4 to determine whether all electrode terminals have been activated sequentially or the evaluation is finished. If any electrode terminals remain unactivated, the process returns to step S2, activating at least one electrode terminal that was not activated in this selection mode, allowing the wearer to further evaluate its stimulation effect, and steps S2 to S4 are repeated.

[0053] If all electrode terminals have been evaluated, proceed to step S5 to store the position information of all selected electrode terminals. Figure 8As shown, an image of the selected electrode terminals is ultimately generated, where, for example, the black electrode terminals are the selected / recorded electrode terminals. This image and / or the location information of the selected / recorded electrode terminals it represents are stored in a storage unit.

[0054] Finally, in step S6, the control circuit 320 activates the corresponding electrode terminals in the operating mode using the stored position information, while other unactivated electrode terminals are not powered. This allows for adaptation of stimulation points to different wearers, enabling the activation of the electrode terminal 200 corresponding to the most effective stimulation point and improving energy utilization.

[0055] Advantageously, the storage unit can also be located in an external device, such as a mobile phone, that communicates with the tongue sleeve device 1. Thus, when the wearer replaces tongue sleeve devices of the same or even different types, as long as this location information in the storage unit can be shared between the tongue sleeve devices, the appropriate electrode terminals can be selected for electrical stimulation via communication with the external device without repeating the above method.

[0056] After making the selection, step S7 can be executed to enter the working mode. In the working mode, the corresponding electrode terminal selected in the selection mode is activated for working time with working frequency and working voltage. The working frequency, working voltage, and working time can be set in an external device, such as a mobile phone, before entering the working mode.

[0057] 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.

[0058] List of reference numerals

[0059] 1. Tongue sleeve device

[0060] 100 tongue sleeve body

[0061] 110 base

[0062] 120 side

[0063] 121 lower end

[0064] 122 bend

[0065] 130 bottom

[0066] 140 Avoidance Section

[0067] 200 electrode terminals

[0068] 210 First Electrode Terminal Array

[0069] 220 Second Electrode Terminal Array

[0070] 300 electrode circuit

[0071] 310 power supply

[0072] 320 control circuit

[0073] 330 wire

[0074] 340 interface

[0075] 400 extension

[0076] 410 First Extension

[0077] 420 Second Extension

Claims

1. A tongue sleeve device for electrically stimulating the hypoglossal nerve, the tongue sleeve device comprising a tongue sleeve body, electrode terminals, and electrode circuitry, characterized in that, The tongue sleeve body has a continuously extending base for contacting the back of the tongue and two side portions extending at an angle to the base on both sides of the base. The electrode terminals are arranged on the base and each of the two side portions. The electrode circuit is at least partially arranged in the tongue sleeve body and electrically connected to the electrode terminals.

2. The tongue-sheath device according to claim 1, characterized in that, The electrode terminals arranged on the base form at least two columns of a first electrode terminal array, and the electrode terminals arranged on each of the two sides form at least one column of a second electrode terminal array.

3. The tongue-sheath device according to claim 2, characterized in that, The area of ​​the stimulation surface of the electrode terminal is greater than or equal to 60 mm². 2 The spacing between adjacent electrode terminals is greater than or equal to 5 mm.

4. The tongue-sheath device according to claim 1, characterized in that, The electrode circuit includes a power supply, a controller, and wires, and the power supply and the controller are electrically connected to the electrode terminals through the wires.

5. The tongue-sheath device according to claim 4, characterized in that, The electrode circuit also includes a storage unit that can store the position information of the electrode terminals, enabling the controller to selectively activate the corresponding electrode terminals based on the position information.

6. The tongue-sheath device according to claim 4, characterized in that, The electrode circuit also includes a wireless communication unit, which enables the electrode circuit to communicate with external devices.

7. The tongue-sheath device according to claim 4, characterized in that, The tongue cover device further includes an extension that is located outside the wearer's mouth when the tongue cover device is worn, and the power supply and the controller are located in the extension.

8. The tongue-sheath device according to claim 7, characterized in that, The extension has a first extension and a second extension that are separable from each other. The first extension is integrally constructed with the tongue body. The second extension is electrically connected to the first extension via an interface. The power supply and the controller are located in the second extension.

9. The tongue-sheath device according to claim 1, characterized in that, The base is an isosceles trapezoid, and / or the tongue body is wedge-shaped.

10. The tongue-sheath device according to claim 1, characterized in that, The two sides each have a bent portion at the lower end away from the base for engaging the lower edge of the tongue.

11. The tongue-sheath device according to claim 1, characterized in that, The tongue body also has a bottom, which connects to the lower ends of the two sides away from the base, such that the base, the sides and the bottom form a receiving cavity for accommodating the tongue.

12. The tongue-sheath device according to claim 11, characterized in that, The bottom extends at the front end of the lower end, thereby forming a clearance portion at the rear end of the lower end.

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