Tongue muscle stimulator and preparation method thereof

Abstract

The invention discloses a tongue muscle stimulator and a preparation method of the tongue muscle stimulator, the tongue muscle stimulator is provided with a first structural section located on the front side and a second structural section located on the rear side, the tongue muscle stimulator comprises a bridge arm located on the first structural section, and the rear side of the bridge arm is provided with two end parts which are oppositely arranged; the positioning part is located on the second structural section and connected to the end of the corresponding side of the bridge arm, and the positioning part is used for being in positioning fit with corresponding tissue in the oral cavity; the capsule body is located on the second structural section and connected with the positioning part, the capsule body is of an elastic structure capable of integrally deforming, the capsule body is provided with a smooth peripheral surface, and at least one part of the peripheral surface is a combination surface; and the electrode is fixed on the combination surface and is used for performing electrical stimulation on a preset part. Through structure optimization of the tongue muscle stimulator, the position and the fitting condition of the electrode relative to the preset part can be adaptively adjusted, the wearing comfort is improved, and the user experience is improved.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a tongue muscle stimulator and a method for preparing the tongue muscle stimulator. Background Art

[0002] Obstructive sleep apnea-hypopnea syndrome (OSAHS), clinical manifestations include snoring, apnea and daytime sleepiness during sleep, and the direct cause is upper airway obstruction. There are many indirect causes, such as upper airway stenosis caused by various physiological or pathological reasons; another example is the partial or complete collapse of the upper airway due to the reduced regulatory function of the nervous system on the upper airway muscles and tongue muscles during sleep. If the upper airway is completely blocked, it will cause apnea.

[0003] In view of the upper airway obstruction caused by the reduced regulation function of the nervous system, technicians in this field try to achieve tongue extension by electrically stimulating the corresponding nerves or muscles to prevent it from blocking the upper airway. The genioglossus muscle controlled by the hypoglossal nerve is electrically stimulated by an oroglossal muscle stimulator to train the muscle tension of the tongue and alleviate the upper airway obstruction.

[0004] The tongue muscle stimulator in the prior art has a general stimulation effect and poor wearing comfort, which leads to poor compliance of patients and affects the use effect. In addition, the improvement of the tongue muscle stimulator is limited by the production process, and the prior art cannot meet the performance optimization of the tongue muscle stimulator. Summary of the invention

[0005] The present application provides a tongue muscle stimulator that can adaptively adjust the position and fit of electrodes relative to a predetermined part, thereby improving wearing comfort and enhancing user experience.

[0006] The present application discloses a tongue muscle stimulator, which has a first structural section located at the front side and a second structural section located at the rear side. The tongue muscle stimulator comprises: A bridge arm, located in the first structural section, the rear side of the bridge arm having two ends arranged opposite to each other; A positioning portion, located at the second structural segment and connected to the end portion of the corresponding side of the bridge arm, the positioning portion being used to position and cooperate with a corresponding tissue in the oral cavity; A capsule body, located in the second structural section and connected to the positioning portion, the capsule body is an elastic structure that can be deformed as a whole, the capsule body has a smooth outer peripheral surface, and at least a portion of the outer peripheral surface is a bonding surface; The electrode is fixed to the combination surface and is used to electrically stimulate a predetermined part.

[0007] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0008] In one embodiment, in the bonding surface, the area where the electrode is located is the first area, the capsule has an initial shape without being pressed, and in the initial shape, the first area has a tendency to bulge outward relative to the surrounding area.

[0009] In one embodiment, when the capsule is under pressure, the first region changes its convexity accordingly, and the electrode is sheet-shaped and changes accordingly with the first region.

[0010] In one embodiment, the first region changes its convexity in the following manner: Compared with the initial shape, it is further concave into the capsule; or further protrudes outward from the capsule compared to the initial shape; Or the degree to which a shape changes its flatness compared to its initial shape.

[0011] In one embodiment, the capsule has a front side and a rear side opposite to each other, and the shape gradually expands from the front side to the rear side; The rear side of the capsule is spherical.

[0012] In one embodiment, the top side of the capsule is used to place the tongue, and the electrode is located on the inner side of the capsule; Along the direction from the front side to the back side of the capsule, the length ratio of the electrode to the capsule is (0.35-0.85):1.

[0013] In one embodiment, the capsule is a solid structure, or the capsule has a cavity inside, and the cavity is connected as a whole or includes a plurality of sub-cavities isolated from each other.

[0014] In one embodiment, the positioning portion has a top side and a bottom side opposite to each other, and the bottom side has a tooth-engaging groove; The tooth slot has two opposite slot walls, and the capsule is connected to the bottom side of one of the slot walls; The positioning portion has an inner side and an outer side opposite to each other, and the capsule is located at the bottom side of the positioning portion and further extends toward the inner side of the positioning portion.

[0015] In one embodiment, the top side of the capsule body has a flat area, the flat area has a reserved opening and a splicing part that closes the opening, and the splicing part and other parts of the capsule body are separately molded and connected to form an integrated structure.

[0016] In one embodiment, the capsule gradually converges in shape from the electrode toward the positioning portion to form a splicing portion, and the splicing portion is provided with an opening connected to the capsule, and the opening is closed synchronously during the connection between the splicing portion and the positioning portion.

[0017] The present application also provides a method for preparing the tongue muscle stimulator, comprising preparing the capsule, the positioning portion and the bridge arm in any order and connecting them accordingly; The preparation of the capsule comprises: Providing a first mold with a mold cavity, and placing the electrode into a predetermined position of the mold cavity; suspending a mold core in the mold cavity; Pouring a material into the mold cavity, and demolding the material after solidification to obtain a capsule with an opening, wherein the opening corresponds to a removal path of the mold core; The opening is closed to obtain a capsule with the electrode.

[0018] In one embodiment, closing the opening specifically includes: A support sheet is fixed on the inner side of the opening, wherein the support sheet and the inner edge of the opening form a to-be-filled area; Filling material is placed into the area to be filled to close the opening.

[0019] In one embodiment, closing the opening specifically includes: providing a second mold; The capsule with the opening is placed in contact with the second mold with the opening facing downward, and the second mold and the inner edge of the opening form a to-be-filled area; Filling material is placed into the area to be filled to close the opening.

[0020] In one embodiment, the capsule with the opening has two opposite sides, the opening is at a first side, and the other side is a second side; When placing the filling material into the area to be filled, the second side is penetrated by an injection device until the filling material is delivered to the area to be filled; the second side is pre-formed with an opening, or an opening is formed accordingly when the injection device penetrates; After the filling material is conveyed to the area to be filled, the opening is closed.

[0021] In one embodiment, the opening is a slit or an opening and is located on a side of the capsule body facing the positioning portion, and the opening is closed when the capsule body and the positioning portion are combined.

[0022] The technical solution in the present application can adaptively adjust the position and fit of the electrode relative to the predetermined part through structural optimization of the tongue muscle stimulator, thereby improving wearing comfort and enhancing user experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the conventional technology, the drawings required for use in the embodiments or the conventional technology descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 This is a schematic diagram of the structure of a tongue muscle stimulator in one embodiment of the present application; Figure 2 for Figure 1 Schematic diagram of the middle tongue muscle stimulator from a top view; Figure 3 for Figure 2 Schematic diagram of the cross section at AA; Figure 4 for Figure 2 Schematic diagram of the cross section at BB; Figure 5 for Figure 1 Schematic diagram of the middle tongue muscle stimulator from a side view; Figure 6 for Figure 1 Schematic diagram of the middle tongue muscle stimulator from a bottom-up perspective; Figure 7 Schematic diagram of the pressure sensor setup for the tongue muscle stimulator; Figure 8 This is a schematic diagram of electrodes and wires of a tongue muscle stimulator; Fig. 9 This is a schematic diagram of preparing a tongue muscle stimulator in one embodiment of the present application; Fig.10 This is a schematic diagram of preparing a tongue muscle stimulator in another embodiment of the present application; Fig.11 This is a schematic diagram of preparing a tongue muscle stimulator in another embodiment of the present application.

[0025] The reference numerals of the components are as follows: 100, positioning portion; 110, tooth slot; 111, buccal side wall; 112, lingual side wall; 200, capsule; 210, cavity; 220, opening; 230, support sheet; 240, closing member; 250, opening; 300, electrode; 310, wire; 400, bridge arm; 410, incisor positioning groove; 420, extension arm; 430, interface assembly; 500. Pressure sensor. DETAILED DESCRIPTION

[0026] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0027] It should be noted that when a component is referred to as being "fixed to" or "disposed on" another component, it may be directly on the other component or there may also be a central component. When a component is considered to be "connected to" another component, it may be directly connected to the other component or there may be a central component at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in the specification of this application are for illustrative purposes only and do not represent the only implementation method.

[0028] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0029] In the present application, unless otherwise clearly specified and limited, a first feature being “above” or “below” a second feature may mean that the first feature is directly in contact with the second feature, or the first feature and the second feature are indirectly in contact through an intermediate medium. Moreover, a first feature being “above”, “above”, or “above” a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level (or in a state of use, or from a certain perspective of the attached figure) than the second feature. A first feature being “below”, “below”, or “below” a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level (or in a state of use, or from a certain perspective of the attached figure) than the second feature.

[0030] Unless otherwise defined, all technical and scientific terms used in the specification of this application have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used in the specification of this application includes any and all combinations of one or more related listed items.

[0031] In order to overcome the problems of general stimulation effect and poor wearing comfort of tongue muscle stimulators in the prior art, see Figure 1 to Figure 8 One embodiment of the present application discloses a tongue muscle stimulator, which has a first structural section located at the front side and a second structural section located at the rear side, and specifically includes: The bridge arm 400 is located in the first structural section, and the rear side of the bridge arm 400 has two ends arranged opposite to each other; The positioning portion 100 is located in the second structural section and connected to the end of the corresponding side of the bridge arm 400, and is used for positioning and cooperating with the corresponding tissue in the oral cavity; The capsule 200 is connected to the positioning part 100. The capsule 200 is an elastic structure that can be deformed as a whole. The capsule 200 has a smooth outer peripheral surface, and at least a part of the outer peripheral surface is a bonding surface that can be deformed adaptively with the shape change of the capsule 200. The electrode 300 is fixed to the bonding surface and is used to electrically stimulate a predetermined part.

[0032] The electrical stimulation effect of the tongue muscle stimulator is related to the impedance value of the electrode 300. The impedance value is affected by the size of the electrode 300 and the degree of fit with the predetermined part, especially the contact area between the electrode 300 and the predetermined part. When the contact area of ​​the electrode 300 changes due to tongue movement, especially when the contact area becomes smaller, the electrical stimulation output parameters set based on the original impedance value may cause a tingling sensation to the wearer. Therefore, the capsule 200 with an elastic structure in the present application can adaptively adjust the position and fit of the electrode 300 relative to the predetermined part during the activity of the oral muscles and tongue muscles, thereby improving wearing comfort and user experience.

[0033] The tongue muscle stimulator needs to be worn in the oral cavity when in use. The tongue muscle stimulator can be divided into the part located in the oral cavity as the intraoral section (for example, the Figure 5 The arc apex of the middle extension arm 420 is the right part of the dividing line) and the outer section (for example, the attached Figure 5 The arc vertex of the middle extension arm 420 is the left part of the dividing line). The capsule 200 is located in the intraoral section. The length of the capsule 200 accounts for 25% to 60% of the total length of the intraoral section. Further, in the mesiodistal direction, the length of the capsule 200 is approximately equal to 2 to 5 teeth. The capsule 200 has a rounded appearance as a whole to improve the foreign body sensation, such as a spherical, ellipsoidal, teardrop-shaped, etc.

[0034] For the specific configuration of the capsule 200, see Figure 2~Figure 5 In the embodiment shown, the capsule 200 as a whole is an elastic structure that changes shape after being pressed, and the joint surface adapts to the shape change of the capsule to fit the predetermined part. In addition to the movement in the spatial position, the joint surface can further provide adjustment of the fitting plane to optimize the fitting of the electrode 300 and the predetermined part. In the joint surface, the area where the electrode 300 is located is the first area, and the capsule 200 has an initial shape without being pressed (see Figure 4 ), the first area has a tendency to bulge outward relative to the surrounding area in the initial shape. Correspondingly, when the capsule 200 is pressed, the first area changes its bulge degree accordingly, and the electrode 300 is sheet-shaped and changes accordingly with the first area. The change in the bulge degree of the first area can be specifically reflected as follows: Compared with the initial shape, it is further recessed into the capsule 200; or further protrudes outward from the capsule 200 compared to the initial shape; Or the degree to which a shape changes in its flatness compared to its initial shape.

[0035] The first region changing its flatness and the first region further becoming concave / convex can be implemented at the same time.

[0036] The specific part of the capsule 200 that is pressed can be the first area, or other areas of the capsule 200, such as any surface of the capsule 200 except the first area. In terms of specific form, the capsule 200 is block-shaped and has a smooth outer peripheral surface. The capsule 200 has a front side and a rear side that are opposite to each other, and the shape gradually expands from the front side to the rear side, and the rear side of the capsule 200 is spherical.

[0037] See also Figure 2 In the embodiment, the front side of the capsule 200 is toward the lip side of the oral cavity, and the rear side of the capsule 200 is toward the throat side of the oral cavity. In the direction from the lip side to the throat side, the outer edge of the capsule 200 gradually expands outward. The rear side of the capsule 200 further extends beyond the positioning portion 100. From the muscle state of the genioglossus muscle, the genioglossus muscle is distributed in a fan shape, and the genioglossus muscle closer to the throat side is stronger. The further extension of the capsule 200 delivers the electrode 300 to the vicinity of the genioglossus muscle and close to the throat side, so that the genioglossus muscle generates muscle tension to prevent the tongue root from falling back.

[0038] In order to realize the elastic structure, the sac 200 can be made of elastic material and be a solid structure. The scheme shown in the figure can also be adopted, in which the sac 200 has a cavity 210 inside. The cavity 210 is filled with a compressible and / or incompressible fluid. Further, the sac 200 is an airbag. The cavity 210 is connected as a whole. Further, the cavity 210 can also include a plurality of sub-cavities isolated from each other. The airbag as a whole is in the form of a drooping drop with one end reduced and the other end expanded, wherein the smaller end points to the lip side and the larger end points to the throat side.

[0039] The edge of the airbag converges and connects to the edge of the positioning part 100 and the two transition smoothly. The airbag is closed and does not exchange substances with the outside world. Only the fluid enclosed in the airbag responds to external pressure changes to adjust the fit between the outer peripheral surface of the airbag and the target tissue.

[0040] The capsule 200 also includes a flat area at the top, which smoothly transitions to the surrounding area. When the tongue muscle stimulator is worn in the oral cavity, the flat area fits the lower surface of the tongue. A splicing portion is provided in the flat area, and the splicing portion and other parts of the capsule 200 are formed separately and connected to form an integral structure. The splicing portion is slightly smaller than the overall area of ​​the flat area, for example, the splicing portion accounts for 60% to 95% of the overall area of ​​the flat area.

[0041] In another embodiment, the cavity 210 gradually narrows in the direction from the electrode 300 to the positioning portion 100, and the side wall of the cavity 210 forms a joint portion at the narrowed portion, and the joint portion is provided with an opening connected to the cavity 210, such as a slit or an opening, and the opening is located on the side of the capsule 200 facing the positioning portion 100. During the preparation process, the opening can be sealed first, and then the joint portion is connected to the positioning portion 100, or the opening can be closed simultaneously during the process of connecting the joint portion to the positioning portion 100.

[0042] The capsule 200 is provided to provide a better working effect for the electrode 300. The capsule 200 is located in a small gap between the teeth and the tongue, and the capsule 200 will deform according to the force applied, ensuring that the electrode 300 is closely matched with the genioglossus muscle. The capsule 200 has a top surface for resting the tongue, and the electrode 300 is located on the inner side of the capsule 200. The tongue, the lower jaw, and the teeth surround and wrap the capsule 200 and realize the positioning of the capsule 200. During the wearing process, the capsule 200 can rebound or contract according to the size of the space formed by the tongue, the lower jaw, and the teeth, to ensure that the electrode 300 can still closely match the predetermined part (such as the genioglossus muscle mentioned above) when the muscles in the oral cavity move, so as to avoid the impedance change between the electrode 300 and the predetermined part exceeding expectations.

[0043] For the dimensions of the electrode 300, see Figure 3In the left-right direction of the figure, the ratio between the length D1 of the electrode 300 and the length D2 of the capsule 200 ranges from 0.35 to 0.85; in one embodiment, the length D1 of the electrode 300 ranges from 5 mm to 20 mm, and the length D2 of the capsule 200 ranges from 10 mm to 25 mm.

[0044] See also Figure 4 In the vertical direction of the figure, the ratio between the height H1 of the electrode 300 and the height H2 of the capsule 200 ranges from 0.25 to 0.75. The thickness of the electrode 300 matches the wall thickness of the capsule 200. Figure 8 The electrode 300 is embedded in the side wall of the capsule 200, and the outer surface is flush with the outer surface of the capsule 200 (ie, the outer surface of the first region).

[0045] In order to provide a sufficient positioning effect to the capsule 200 as an elastic structure, the positioning portion 100 has a higher strength relative to the capsule 200. The higher strength is specifically manifested as a smaller elastic coefficient and / or a larger yield strength and / or a larger hardness. When the capsule 200 is subjected to an external force, the capsule 200 deforms earlier or to a greater extent than the positioning portion 100. This can be achieved specifically through the structural difference between the two, for example, the capsule 200 has a cavity 210 and the bridge arm 400 is a solid setting; it can also be achieved through the material difference between the two. In one embodiment, the positioning portion 100 and the capsule 200 are polymer materials of different components. Specifically, the polymer material is silica gel, plastic, or a composite material with inorganic materials added.

[0046] For the specific configuration of the positioning portion 100, see Figure 2~Figure 5 In the embodiment shown, the positioning portion 100 has a top side and a bottom side opposite to each other, and the bottom side has a tooth-engaging groove 110. In this embodiment, the corresponding tissue that cooperates with the positioning portion 100 is tooth tissue. The tooth-engaging groove 110 has two opposite groove walls, and the capsule 200 is connected to the bottom side of one of the groove walls. Figure 4 The tooth slot 110 corresponds to the molar area, especially the lower molar area, and the two opposite groove walls of the tooth slot 110 are respectively the buccal side wall 111 and the lingual side wall 112, and the capsule 200 is connected to the bottom side of the lingual side wall 112. The positioning portion 100 has an inner side and an outer side opposite to each other, and the capsule 200 is located at the bottom side of the positioning portion 100 and further extends to the inner side of the positioning portion 100.

[0047] In terms of the overall shape of the tongue muscle stimulator, there are two positioning parts 100, the inner sides of the two positioning parts 100 are opposite to each other, each positioning part 100 is configured with a capsule 200 and an electrode 300, and a bridge arm 400 is connected between the two positioning parts 100. The relative parts of the two capsules 200 gradually approach from the front to the back. The bridge arm 400 is connected to the outside of the two positioning parts 100 and extends along the trend of tooth arrangement. That is, the bridge arm 400 is C-shaped. The bridge arm 400 and the positioning part 100 constitute a braces structure to improve the positioning effect of the positioning part 100. Furthermore, the bridge arm 400 is provided with an incisor positioning groove 410.

[0048] The electrode 300 of the tongue muscle stimulator requires a corresponding control device to realize energy delivery. Referring to one embodiment, the tongue muscle stimulator also includes a control device (not shown), and the control device is connected to the electrode 300 through a wire 310 to realize circuit connection, which is used to drive the electrode 300 to perform electrical stimulation and / or detect corresponding signals through the electrode 300. In this embodiment, the electrode 300 realizes energy output and signal acquisition functions in different working states, and different working states are switched according to preset cycles, or switched in response to preset conditions.

[0049] The wire 310 of the electrode 300 may be embedded in one or more of the bridge arm 400 , the positioning portion 100 or the capsule 200 to avoid being exposed in the oral cavity and causing a foreign body sensation.

[0050] The control device can be built-in and installed in the tongue muscle stimulator. For example, the control device is built into the positioning part 100 and / or the bridge arm 400 of the tongue muscle stimulator. This setting can simplify the layout, and the user has less foreign body sensation when wearing the tongue muscle stimulator, and has good adaptability. Figure 6 as well as Figure 8 The control device is externally mounted, and the tongue muscle stimulator is further provided with an interface component 430, through which the control device is connected to the electrode 300. This configuration provides a more adequate design space for the control device. The interface component 430 may be in the form of a magnetic contact, etc., to facilitate the wearer to quickly connect or separate the control device. The interface component 430 may be disposed on the bridge arm 400 and adjacent to the incisor positioning groove 410.

[0051] The bridge arm 400 may further include an extension arm 420, and an interface assembly 430 is disposed on the extension arm 420. The extension arm 420 extends out of the oral cavity from the bridge arm 400 away from the incisor positioning groove 410, and the interface assembly 430 is disposed on the end of the extension arm 420 located outside the oral cavity. The connection between the extension arm 420 and the bridge arm 400 is aligned with the incisor positioning groove 410. The end of the extension arm 420 located outside the oral cavity extends downward. The extension trend of the extension arm 420 can cooperate with the lips, provide a positioning effect while avoiding the nose area, and optimize the layout of the connection assembly.

[0052] When the tongue muscle stimulator is worn in the oral cavity, the electrode 300 is attached to the predetermined position after the capsule 200 is adaptively adjusted, and the control device measures the impedance value between the electrode 300 and the predetermined position, and adjusts the electrical stimulation output parameters according to the impedance value, such as frequency, pulse width, amplitude, etc. The goal of the electrical stimulation output parameters is to achieve the stimulation effect while avoiding discomfort to the wearer, avoiding tingling, affecting sleep, etc.

[0053] For further information, see Figure 7 The tongue muscle stimulator may further include a pressure sensor 500, which is fixed to the capsule 200 and is used to detect and feed back a pressure signal to the control device. The pressure sensor 500 can detect the pressure change of the capsule 200. For example, when the tongue moves, the capsule 200 rebounds or contracts adaptively, and the pressure sensor 500 can sense the above changes, thereby providing a decision-making basis for the control device to adjust the electrical stimulation parameters, which can further improve the accuracy of electrical stimulation and improve the user experience.

[0054] The pressure sensor 500 can directly detect the contact pressure between the capsule 200 and the predetermined part (such as the genioglossus muscle mentioned above), or can indirectly detect the indicators of other parts of the capsule 200 to convert the contact situation between the capsule 200 and the predetermined part. For example, the pressure sensor 500 is arranged on the outer surface of the capsule 200 except the first area or the inner surface of the cavity 210 of the capsule 200 or the side wall interlayer of the capsule 200. The pressure sensor 500 can detect the deformation degree of the corresponding surface or the pressure change in the inner cavity of the capsule 200 to convert the contact situation between the capsule 200 and the predetermined part. Further, the pressure sensor 500 is a thin film piezoelectric sensor. In the figure, the pressure sensor 500 is arranged on the bottom surface or the top surface of the capsule 200. Each positioning part 100 is provided with a pressure sensor 500.

[0055] The present application improves the fit between the electrode 300 and the predetermined part by deforming the capsule 200. In particular, during the activity of the oral muscles and tongue muscles, the tongue muscle stimulator can adaptively adjust the relative position and spatial form of the electrode 300. In conjunction with the impedance monitoring and pressure monitoring of the control device, it can effectively improve the wearing comfort and enhance the user experience.

[0056] In order to overcome the process limitations of the prior art for optimizing the tongue muscle stimulator, an embodiment of the present application discloses a method for preparing a tongue muscle stimulator, which is used to prepare the tongue muscle stimulator of any of the above embodiments. The method for preparing the tongue muscle stimulator of this embodiment includes forming a capsule 200, a positioning portion 100, and a bridge arm 400 in any order and connecting them according to the positional relationship of the above embodiments. Any order can be understood as preparing the three one by one, or preparing multiple at the same time.

[0057] The preparation of the capsule 200 includes: Providing a first mold with a mold cavity, and placing the electrode 300 at a predetermined position of the mold cavity; suspending a mold core in the mold cavity; Pour the material into the mold cavity, and demould after the material is solidified and formed, to obtain a capsule 200 with an opening, wherein the opening corresponds to a removal path of the mold core; The opening is closed to obtain the capsule 200 with the electrode 300 .

[0058] In this embodiment, the mold can adopt a split structure to facilitate the placement of the electrode 300 and the demolding of the capsule 200. Since the capsule 200 is a hollow structure, a mold core is required as a placeholder and support. The mold core itself can be integral or split. The suspended mold core is understood as the approximate positional relationship of the mold core in the mold cavity, and does not strictly limit the mold core to have no connection with the inner wall of the mold cavity. The mold core can be placed in the mold cavity and keep the position stable through external connectors before closing the mold, and can even be connected to the first mold through an opening or other parts.

[0059] The capsule 200 is provided with an opening to facilitate the taking and placing of the mold core. During demoulding, the mold core is separated from the capsule 200 through the opening. The size of the opening can be set according to the size of the mold core and the elasticity of the capsule 200. As far as the capsule 200 is concerned, the position of the opening is not strictly limited, but it is preferably set in the flat area on the top side, or in a position that is convenient for closing operations.

[0060] In addition, before the electrode 300 is placed in the mold cavity, the wire 310 can be welded by a suitable process, such as laser welding, and then the electrode 300 can be placed in the mold cavity together with the wire 310. In one embodiment, the end of the wire 310 away from the electrode 300 is welded with an interface component 430, and the interface component 430 can be in the form of a magnetic spring contact. The electrode 300, the wire 310 and the interface component 430 are wrapped with materials to achieve embedded installation and avoid exposure of components.

[0061] When demoulding, the mold cavity is opened first, and then the capsule 200 with the opening is separated from the mold core. The size of the mold core and the mold cavity determines the side wall thickness of the capsule 200.

[0062] There are many ways to close the opening, see Fig. 9 In the first embodiment shown, closing the opening 220 specifically includes: A support sheet 230 is fixed on the inner side of the opening 220, and the support sheet 230 and the inner edge of the opening 220 form a waiting area for filling; Filling material is placed into the area to be filled to close the opening 220 .

[0063] The side edges of the support sheet 230 and the opening 220 can be arranged to be connected to each other by an adapting structure, or can be arranged to be connected by bonding, welding, fusion, etc. For example, when the support sheet 230 is fixed on the inner side of the opening 220, glue is first applied to the edge of the support sheet 230 and / or the inner side of the opening 220, and then the support sheet 230 is placed in the corresponding position and fixed by bonding. The filling material can be pre-formed to obtain a sheet-shaped closing component 240, and then the closing component 240 and the opening 220 are connected by an adhesive. The filling material can also be formed in the area to be filled, and the connection with the opening 220 is achieved by the bonding effect of the filling material itself.

[0064] The support sheet 230 can be set as a sealed membrane to prevent the filling material from passing through the support sheet 230 and entering the cavity 210 inside the capsule 200. This solution is particularly suitable for working conditions where the filling material is formed in the area to be filled and the filling material has high fluidity. Of course, it can also be applied to other working conditions mentioned below.

[0065] The support sheet 230 can also be configured as a mesh membrane or a support frame to facilitate the connection between the support sheet 230 and the capsule 200 with the opening 220. This solution is applicable to the following working conditions: A) the filling material is pre-formed into a closing part 240, and the fluidity of the adhesive between the closing part 240 and the opening 220 is low; B) The filling material is formed in the area to be filled and has low fluidity.

[0066] In addition to preventing the filling material and adhesive from entering the capsule when the opening is closed, the support sheet 230 can also provide a reinforcing structure during the bonding process. After bonding, the support sheet 230, the opening 220 and the filling material are connected to form an integral structure, thereby preventing the local strength of the capsule from decreasing due to the opening 220.

[0067] For ways to close the opening, please refer to Fig.10 In the second embodiment shown, closing the opening 220 specifically includes: providing a second mold; The capsule with the opening 220 is placed in contact with the second mold with the opening 220 facing downward, and the second mold and the inner edge of the opening 220 form a filling area; The capsule 200 with the opening 220 has two opposite sides, the opening 220 is on the first side and the other side is the second side; when the filling material is placed into the area to be filled, an injection device is used to penetrate the second side until the filling material is transported to the area to be filled and the opening 220 is closed.

[0068] The second side may be pre-formed with an opening 250, or the opening 250 may be formed accordingly when the injection device penetrates. Since the size of the opening 250 is small, it may be directly closed by a material that is the same material as the capsule 200 or mutually compatible. The first side corresponds to the top surface of the capsule 200, and the second side corresponds to the bottom surface of the capsule 200. When the capsule 200 is matched with the second mold, in the direction of gravity, the opening 220 is located below the capsule 200, and the filling material can be kept in the area to be filled under the action of gravity and the opening 220 is closed after solidification.

[0069] The capsule 200, the positioning part 100 and the bridge arm 400 can be made of the same material or different materials. For example, the material strength of each part of the capsule 200, the bridge arm 400 and the positioning part 100 gradually increases. Higher strength is specifically manifested as a smaller elastic coefficient and / or a larger yield strength and / or a larger hardness. Different strengths can be achieved by using different component ratios of the same type of material or different types of materials, and each part is cast and cured in stages to form an integrated structure; it can also be achieved by casting the same type and component of materials at the same time and then adding reinforcing or weakening materials in different parts; it can also be achieved by changing the size of the mold cavity to form different mechanical structures. The above schemes can be implemented separately or in combination. In one embodiment, the capsule 200, the bridge arm 400 and the positioning part 100 are cast using a polymer material, and the polymer material is silica gel, plastic or a composite material with inorganic materials added.

[0070] refer to Fig.11 In the third embodiment, the opening 220 can be closed when the capsule 200 is combined with adjacent components. For example, the electrode 300 and the capsule 200 form a first structure in advance, and the opening 220 is not yet closed. The opening 220 can be a slit or an opening. Since the capsule 200 is adjacent to the positioning part 100, the positioning part 100 can be combined with the capsule 200 and the opening 220 can be closed when the positioning part 100 is formed, and then the wire 310 is connected to the electrode 300. This embodiment closes the opening by combining the capsule 200 with the positioning part 100, which can reduce the process and improve the production efficiency.

[0071] For another example, at least one of the positioning portion 100 and the bridge arm 400 and the wire 310 are pre-formed into a second structure, and then the first structure is connected to the corresponding position of the second structure. Since the opening 220 is located at the connection position, the opening 220 can be closed in the process, and then the wire 310 and the electrode 300 are connected. This embodiment makes molding and assembly more flexible.

[0072] The preparation method of the present application can quickly prepare the capsule 200 through the cooperation of the mold core and the first mold. Other components can be placed or connected as needed during the preparation process, which provides an optimization space for the tongue muscle stimulator while ensuring production efficiency. The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same accompanying drawing, it can be regarded that the accompanying drawing also discloses the combination examples of the various embodiments involved.

[0073] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of patent protection of the present application shall be subject to the attached claims.

Claims

1. A tongue muscle stimulator, comprising a first structural section located at the front side and a second structural section located at the rear side, It is characterized in that The tongue muscle stimulator comprises: A bridge arm, located in the first structural section, the rear side of the bridge arm having two ends arranged opposite to each other; A positioning portion, located at the second structural segment and connected to the end portion of the corresponding side of the bridge arm, the positioning portion being used to position and cooperate with a corresponding tissue in the oral cavity; A capsule body, located in the second structural section and connected to the positioning portion, the capsule body is an elastic structure that can be deformed as a whole, the capsule body has a smooth outer peripheral surface, and at least a portion of the outer peripheral surface is a bonding surface; The electrode is fixed to the combination surface and is used to electrically stimulate a predetermined part.

2. The tongue muscle stimulator according to claim 1, It is characterized in that In the combination surface, the area where the electrode is located is the first area, the capsule has an initial shape without being pressed, and in the initial shape, the first area has a tendency to bulge outward relative to the surrounding area; When the capsule is under pressure, the first region changes its convexity accordingly, and the electrode is sheet-shaped and changes accordingly with the first region.

3. The tongue muscle stimulator according to claim 2, It is characterized in that The first region changes its convexity in the following manner: Compared with the initial shape, it is further concave into the capsule; or further protrudes outward from the capsule compared to the initial shape; Or the degree to which a shape changes its flatness compared to its initial shape.

4. The tongue muscle stimulator according to claim 1, It is characterized in that The capsule has a front side and a rear side opposite to each other, and the shape gradually expands from the front side to the rear side; The rear side of the capsule is in a spherical crown shape.

5. The tongue muscle stimulator according to claim 4, It is characterized in that The top side of the capsule is used to place the tongue, and the electrode is located inside the capsule; Along the direction from the front side to the back side of the capsule, the length ratio of the electrode to the capsule is (0.35-0.85):

1.

6. The tongue muscle stimulator according to claim 1, It is characterized in that The capsule is a solid structure, or the capsule has a cavity inside, and the cavity is connected as a whole or includes a plurality of sub-cavities isolated from each other.

7. The tongue muscle stimulator according to claim 1, It is characterized in that The positioning portion has a top side and a bottom side opposite to each other, and the bottom side is provided with a tooth slot; the tooth slot has two opposite slot walls, and the capsule is connected to the bottom side of one of the slot walls; The positioning portion has an inner side and an outer side opposite to each other, and the capsule is located at the bottom side of the positioning portion and further extends toward the inner side of the positioning portion.

8. The tongue muscle stimulator according to claim 1, It is characterized in that The top side of the capsule body is provided with a flat area, the flat area is provided with a reserved opening and a splicing part for closing the opening, and the splicing part and other parts of the capsule body are formed separately and connected to form an integral structure.

9. The tongue muscle stimulator according to claim 1, It is characterized in that The capsule gradually shrinks in shape from the electrode toward the positioning portion to form a splicing portion, and the splicing portion is reserved with an opening communicating with the capsule. The opening is closed synchronously during the connection between the splicing portion and the positioning portion.

10. A method for preparing a tongue muscle stimulator according to any one of claims 1 to 9, It is characterized in that The method comprises preparing the capsule, the positioning portion and the bridge arm in any order and connecting them accordingly; The preparation of the capsule comprises: Providing a first mold with a mold cavity, and placing the electrode into a predetermined position of the mold cavity; suspending a mold core in the mold cavity; Pouring a material into the mold cavity, and demolding the material after solidification to obtain a capsule with an opening, wherein the opening corresponds to a removal path of the mold core; The opening is closed to obtain a capsule with the electrode.

11. The method for preparing the tongue muscle stimulator according to claim 10, It is characterized in that When closing the opening, it specifically includes: A support sheet is fixed on the inner side of the opening, wherein the support sheet and the inner edge of the opening form a to-be-filled area; Filling material is placed into the area to be filled to close the opening.

12. The method for preparing the tongue muscle stimulator according to claim 10, It is characterized in that When closing the opening, it specifically includes: providing a second mold; The capsule with the opening is placed in contact with the second mold with the opening facing downward, and the second mold and the inner edge of the opening form a to-be-filled area; Filling material is placed into the area to be filled to close the opening.

13. The method for preparing the tongue muscle stimulator according to claim 12, It is characterized in that The capsule with the opening has two opposite sides, the opening is at a first side and the other side is a second side; When placing the filling material into the area to be filled, the second side is penetrated by an injection device until the filling material is delivered to the area to be filled; the second side is pre-formed with an opening, or an opening is formed accordingly when the injection device penetrates; After the filling material is conveyed to the area to be filled, the opening is closed.

14. The method for preparing the tongue muscle stimulator according to claim 10, It is characterized in that The opening is a slit or an opening and is located at a side of the capsule body facing the positioning portion. The opening is closed when the capsule body and the positioning portion are combined.

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