Tongue retraction device

Abstract

The application relates to a tongue traction device, which comprises a tongue implant, a traction wire, a traction mechanism and an adjusting mechanism. The tongue implant is used for implanting a patient's tongue body, and one end of the traction wire is connected with the tongue implant. The traction mechanism is used for implanting a patient's mandibular chin part, and the traction mechanism comprises a first shell and a winding shaft rotatably arranged in the first shell. The winding shaft is connected with the traction wire. The adjusting mechanism is used for driving the winding shaft to rotate relative to the first shell, so that the winding shaft winds or releases the traction wire. The tongue traction device can adjust the tightness of tongue traction after operation, and improves the postoperative curative effect.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a tongue traction device. Background Technology

[0002] OSAHS (Obstructive sleep apnea-hypopnea syndrome) is a sleep-disordered breathing disease characterized by snoring, apnea, intermittent hypoxemia, and disrupted sleep structure, caused by upper airway collapse and obstruction during sleep. OSAHS can lead to damage to multiple organs, including the cardiovascular and endocrine systems. It is an independent risk factor and underlying cause of various systemic diseases such as hypertension, coronary heart disease, diabetes, and stroke, and is closely related to sudden death during sleep.

[0003] The primary cause of OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome) is the collapse of the soft tissues in the palatopharynx and glossopharynx due to mucosal hyperplasia of the soft palate, hypertrophy and posterior displacement of the tongue, or decreased neuromuscular regulation during sleep, leading to airway narrowing or obstruction. While many treatments exist for OSAHS, most are not ideal and involve large incisions. Exploring more minimally invasive and effective surgical methods is a crucial research topic in sleep medicine. Tongue base traction is a relatively minimally invasive treatment; however, among related techniques, the instruments used are complex, resulting in larger surgical incisions and difficulty in adjusting the tightness of the traction post-operatively, leading to poor treatment outcomes. Summary of the Invention

[0004] Therefore, it is necessary to provide a tongue traction device that has a simple structure and can adjust the tightness of tongue traction as needed, resulting in better treatment effects.

[0005] A tongue traction device, comprising:

[0006] A tongue implant for implantation into the tongue;

[0007] A traction wire, one end of which is connected to the tongue implant;

[0008] A traction mechanism, comprising a first housing and a take-up shaft rotatably disposed within the first housing, the take-up shaft being connected to the traction line; and

[0009] An adjustment mechanism is provided to drive the take-up shaft to rotate so that the take-up shaft can wind up or release the traction line.

[0010] The technical solution will be further explained below:

[0011] In one embodiment, the take-up shaft includes:

[0012] A rotating shaft, one end of which has a slot extending axially and radially through both sides of the rotating shaft, wherein the end of the traction wire away from the tongue implant is connected to the slot; and

[0013] A fastening sleeve is detachably connected to one end of the rotating shaft that has the slot.

[0014] In one embodiment, the first housing is provided with an open receiving groove, the take-up shaft is movably disposed in the receiving groove, the end of the take-up shaft near the opening is provided with a first mating part, the adjustment mechanism includes a screwdriver, one end of the screwdriver is provided with a second mating part, the second mating part can pass through the opening and be detachably connected with the first mating part, rotating the screwdriver can drive the take-up shaft to rotate.

[0015] In one embodiment, one of the first mating portion and the second mating portion has a mating groove for the other to be inserted into, the groove wall has an internal thread, and the other has an external thread that matches the internal thread.

[0016] In one embodiment, the winding shaft is provided with a first anti-reverse tooth, and the receiving groove is provided with a second anti-reverse tooth that matches the first anti-reverse tooth. The winding shaft has a unidirectional rotation state when the first anti-reverse tooth and the second anti-reverse tooth are engaged, and a bidirectional rotation state when the first anti-reverse tooth and the second anti-reverse tooth are separated. The screwdriver can drive the winding shaft to move axially so that the winding shaft can switch between the unidirectional rotation state and the bidirectional rotation state.

[0017] In one embodiment, the pulling mechanism further includes an internal magnetron disk and a first transmission assembly. The internal magnetron disk is rotatably disposed in the first housing and has a first magnet. The first transmission assembly connects the internal magnetron disk to the take-up shaft and is used to drive the take-up shaft to rotate when the internal magnetron disk rotates. The adjusting mechanism includes a surface magnetron disk and has a second magnet that can attract the first magnet. Rotating the surface magnetron disk can drive the internal magnetron disk to rotate.

[0018] In one embodiment, the first transmission component includes:

[0019] A first output shaft passes through the center of the internal magnetron disk and can rotate synchronously with the internal magnetron disk. A first gear is connected to the first output shaft.

[0020] The second gear meshes with the first gear.

[0021] A first worm gear, which is coaxially arranged with the second gear; and

[0022] A first worm gear is connected to the winding shaft and meshes with the first worm.

[0023] In one embodiment, the adjustment mechanism includes:

[0024] The motor, which is disposed within the first housing; and

[0025] The second transmission assembly connects the motor shaft to the take-up shaft, so as to drive the take-up shaft to rotate when the motor shaft rotates.

[0026] In one embodiment, the second transmission component includes:

[0027] An output gear, which is connected to the shaft of the motor;

[0028] The third gear meshes with the output gear;

[0029] The fourth gear meshes with the third gear;

[0030] A second worm gear, which is coaxially arranged with the fourth gear; and

[0031] The second worm gear is connected to the winding shaft and meshes with the second worm.

[0032] In one embodiment, the tongue-pulling device further includes an in vivo control mechanism, the in vivo control mechanism comprising:

[0033] Second shell;

[0034] A battery, disposed within the second housing, electrically connected to the motor; and

[0035] The control module is electrically connected to both the battery and the motor, and is used to control the operating state of the motor.

[0036] In one embodiment, the in vivo control mechanism further includes a communication module disposed in the second housing and electrically connected to the control module. The tongue traction device also includes an external remote controller wirelessly connected to the communication module. The external remote controller is used to send control signals to the control module so that the control module controls the working state of the motor.

[0037] In one embodiment, the in vivo control mechanism further includes a non-contact charging module disposed within the second housing and electrically connected to the battery; the tongue traction device further includes an external charging device capable of electromagnetic induction with the non-contact charging module to charge the battery.

[0038] In one embodiment, the in vivo regulation mechanism further includes a monitoring module disposed in the second housing and electrically connected to the control module. The monitoring module is used to monitor the physiological information of the target and control the working state of the motor according to the physiological information.

[0039] In one embodiment, the tongue-pulling device further includes a pressure sensor connected to the traction line, the pressure sensor being used to obtain the tension of the traction line; and / or,

[0040] The tongue traction device further includes a blood oxygen saturation sensor, which is used to acquire the target's blood oxygen saturation signal; and / or,

[0041] The tongue-pulling device further includes a snoring sensor, which is used to acquire the snoring signal of the target; and / or,

[0042] The tongue-pulling device further includes an electrocardiogram (ECG) sensor, which is used to acquire the target's ECG signal; and / or,

[0043] The tongue-pulling device further includes a body position sensor, which is used to acquire the target's body position signal; and / or,

[0044] The tongue traction device also includes a thoracic pressure sensor, which is used to acquire the thoracic pressure signal of the target.

[0045] In one embodiment, the tongue traction device further includes an electrical stimulation mechanism, the electrical stimulation mechanism comprising:

[0046] Electrodes, said electrodes for implantation into the genioglossus muscle or hypoglossal nerve; and

[0047] An electrical stimulation module is electrically connected to the electrodes and is used to control the electrodes to release electrical stimulation.

[0048] In one embodiment, the first housing has a mounting hole for inserting a fastener to secure the first housing; and / or, the first housing has a sealed channel for the pull wire to pass through.

[0049] In one embodiment, there are multiple tongue implants for spaced-out implantation into the tongue, each tongue implant is connected to a traction wire, and the end of all the traction wires away from the tongue implant is connected to the take-up shaft.

[0050] In clinical use, the aforementioned tongue traction device involves making a small incision in the skin of the mandible and chin. Using specialized surgical instruments, a tongue implant with a traction wire is inserted into the midline of the patient's tongue, near the dorsum and root of the tongue, under the submucosa. The traction mechanism is then implanted into the mandible and chin. The other end of the traction wire connecting the tongue implant is connected to the winding shaft of the traction mechanism, thus tractioning the tongue, widening the posterior airway space, and ensuring smooth breathing during sleep. Furthermore, by rotatably housing the winding shaft within the first housing, an adjustment mechanism drives the winding shaft to rotate. During postoperative follow-up, if the therapeutic effect is not as expected, the winding shaft can be rotated relative to the first housing by the adjustment mechanism to wind up or release the traction wire, adjusting the tightness of the tongue traction and thus improving postoperative efficacy. Attached Figure Description

[0051] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute an undue limitation of this application.

[0052] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0053] Furthermore, the accompanying drawings are not drawn to a 1:1 scale, and the relative dimensions of the various components are shown as examples only and not necessarily to scale. In the accompanying drawings:

[0054] Figure 1 This is a schematic diagram of the tongue-pulling device in the first embodiment.

[0055] Figure 2 for Figure 1 The diagram shows the structural structure of the traction mechanism of the tongue traction device.

[0056] Figure 3 for Figure 2 The exploded view of the tongue-pulling mechanism shown is shown.

[0057] Figure 4 This is a schematic diagram illustrating the interaction between the take-up shaft and the pull line in one embodiment.

[0058] Figure 5This is a schematic diagram of the screwdriver component according to one embodiment.

[0059] Figure 6 This is a schematic diagram of the structure of the first anti-reverse tooth and the second anti-reverse tooth in one embodiment.

[0060] Figure 7 This is a schematic diagram of the tongue-pulling device in the second embodiment.

[0061] Figure 8 for Figure 7 The diagram shows the structural structure of the traction mechanism of the tongue traction device.

[0062] Figure 9 for Figure 8 The side view of the traction mechanism shown.

[0063] Figure 10 for Figure 7 The diagram shows the structural structure of the adjustment mechanism of the tongue-pulling device.

[0064] Figure 11 for Figure 10 The side view of the adjustment structure shown.

[0065] Figure 12 This is a schematic diagram of the tongue-pulling device in the third embodiment.

[0066] Figure 13 for Figure 12 The diagram shows the structural structure of the traction mechanism of the tongue traction device.

[0067] Figure 14 for Figure 13 The side view of the traction mechanism shown.

[0068] Explanation of reference numerals in the attached figures:

[0069] 10. Tongue implant; 20. Traction mechanism; 21. First housing; 211. Receiving groove; 212. Second anti-reverse gear; 213. Mounting hole; 22. Rewinding shaft; 221. Rotating shaft; 2211. Slot; 2212. First mating part; 2213. Mating groove; 2214. First anti-reverse gear; 222. Fastening sleeve; 23. Internal magnetron; 231. First magnet; 241. First output shaft; 242. First gear; 243. Second gear; 244. First worm; 245. First worm wheel; 25. Electric 261. Output gear; 262. Third gear; 263. Fourth gear; 264. Second worm; 265. Second worm wheel; 30. Traction line; 31. Snap-fit ​​part; 40. Adjustment mechanism; 41. Screwdriver part; 411. Second mating part; 412. Handle; 42. Surface magnetic control plate; 421. Second magnet; 423. Knob; 43. Internal control mechanism; 431. Second housing; 50. External remote control; 61. Electrode; 62. Connecting line; 71. Pressure sensor; 91. Tongue; 92. Chin. Detailed Implementation

[0070] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0071] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0072] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0073] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0074] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0075] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0076] Specifically, one embodiment of this application provides a tongue traction device for traction of the tongue body 91 to treat OSAHS. See also... Figure 1 as well as Figure 2One embodiment of the tongue traction device includes a tongue implant 10, a traction wire 30, a traction mechanism 20, and an adjustment mechanism 40. The tongue implant 10 is implanted into the patient's tongue 91, and one end of the traction wire 30 is connected to the tongue implant 10. The traction mechanism 20 is implanted into the patient's mandibular chin 92, and includes a first housing 21 and a winding shaft 22 rotatably disposed in the first housing 21, the winding shaft 22 being connected to the traction wire 30. The adjustment mechanism 40 is used to drive the winding shaft 22 to rotate relative to the first housing 21, so that the winding shaft 22 winds up or releases the traction wire 30.

[0077] Specifically, in clinical use, the aforementioned tongue traction device involves implanting the tongue implant 10, connected to a traction wire 30, into the patient's tongue 91, and implanting the traction mechanism 20 into the patient's mandible 92. By connecting the other end of the traction wire 30 to the winding shaft 22 of the traction mechanism 20, traction can be applied to the tongue 91, widening the posterior airway space and ensuring smooth breathing during sleep. Furthermore, by rotatably housing the winding shaft 22 within the first housing 21, and allowing the adjustment mechanism 40 to drive the winding shaft 22 to rotate, if the postoperative follow-up examination reveals that the therapeutic effect is not as expected, the adjustment mechanism 40 can drive the winding shaft 22 to rotate relative to the first housing 21, causing the winding shaft 22 to wind up or release the traction wire 30, thus adjusting the tightness of the tongue traction and improving postoperative efficacy.

[0078] See Figure 3 as well as Figure 4 Optionally, in one embodiment, a slot 2211 is provided at one end of the rotating shaft 221. The slot 2211 extends axially along the rotating shaft 221 and passes through both sides of the rotating shaft 221 radially. The end of the traction wire 30 away from the tongue implant 10 is connected to the slot 2211. Preferably, in one embodiment, the rotating shaft 221 is made of a non-toxic and corrosion-resistant metal material, such as pure titanium. The outer diameter of the rotating shaft 221 is 2.5 mm to 3.5 mm, and the width of the slot 2211 matches the diameter of the traction wire 30. Preferably, the width of the slot 2211 is 0.3 mm to 0.5 mm.

[0079] Optionally, see Figure 4 In one embodiment, the end of the traction wire 30 away from the tongue implant 10 is provided with a snap-fit ​​member 31. The size of the snap-fit ​​member 31 is larger than the width of the slot 2211, so that the end of the traction wire 30 away from the tongue implant 10 can be fixed in the slot 2211 by snapping the snap-fit ​​member 31 into the slot 2211. Furthermore, the outer peripheral surface of the rotating shaft 221 is provided with a V-shaped groove that communicates with the slot 2211, and the snap-fit ​​member 31 can be accommodated in the V-shaped groove.

[0080] See Figure 3Optionally, in one embodiment, the take-up shaft 22 further includes a fastening sleeve 222, which is detachably connected to one end of the rotating shaft 221 that has a slot 2211. The fastening sleeve 222 is used to close the opening of the slot 2211 and can reduce the width of the slot 2211, thereby preventing the traction wire 30 from coming out of the opening of the slot 2211.

[0081] See Figure 2 Optionally, in one embodiment, the first housing 21 has mounting holes 213 for inserting fasteners to fix the first housing 21 to the patient's mandible chin 92. Preferably, there are multiple mounting holes 213, such as 2-4, spaced apart along the edge of the first housing 21, thereby improving the fixation effect. Further, the first housing 21 also has a sealed channel (not shown) for the traction wire 30 to pass through, so that the traction wire 30 can pass through the sealed channel into the first housing 21 to connect to the take-up shaft 22. Preferably, the sealed channel and the traction wire 30 are sealed together to prevent bodily fluids from entering the first housing 21. Preferably, the first housing 21 is made of a non-toxic and corrosion-resistant metal material, such as pure titanium.

[0082] See also Figure 1 In one embodiment, there are multiple tongue implants 10, which are used to implant into the tongue body 91 at intervals. Each tongue implant 10 is connected to a traction wire 30, and the end of all traction wires 30 away from the tongue implant 10 is connected to a retractor 22. For example, the number of tongue implants 10 can be 2-5, thereby making the force on the tongue body 91 more even and improving the treatment effect.

[0083] It is worth noting that there are many ways in which the adjusting mechanism 40 drives the take-up shaft 22 to rotate; for example, see [link to example]. Figures 2 to 3 In the first embodiment, the first housing 21 is provided with an open receiving groove 211, specifically, the receiving groove 211 has a cylindrical structure. A take-up shaft 22 is movably disposed in the receiving groove 211, and a first mating portion 2212 is provided at one end of the take-up shaft 22 near the opening. See also Figure 5 The adjustment mechanism 40 includes a screwdriver 41. One end of the screwdriver 41 is provided with a second mating part 411. The second mating part 411 can pass through the opening and be detachably connected to the first mating part 2212. Rotating the screwdriver 41 can drive the winding shaft 22 to rotate synchronously, thereby adjusting the tension of the traction line 30.

[0084] Furthermore, when the tension of the traction line 30 needs to be adjusted postoperatively, a minimally invasive incision is made in the skin of the patient's chin 92. The second mating part 411 of the screwdriver 41 is then inserted through the minimally invasive incision into the skin of the chin 92 and connected to the first mating part 2212 of the take-up shaft 22. By rotating the screwdriver 41, the take-up shaft 22 can be rotated clockwise or counterclockwise, thereby adjusting the tension of the traction line 30. The entire adjustment operation is simple, minimally invasive to the patient, and because the minimally invasive incision is small and located outside the mouth, mucosal damage and infection can be avoided.

[0085] Optionally, in one embodiment, one of the first mating portion 2212 and the second mating portion 411 has a mating groove 2213 for the other to be inserted into. The groove wall of the mating groove 2213 has an internal thread, and the other has an external thread that matches the internal thread. For example, in this embodiment, the first mating portion 2212 has a mating groove 2213 for the second mating portion 411 to be inserted into, and the groove wall of the mating groove 2213 has an internal thread. See also Figure 5 The second mating part 411 has an external thread that matches the internal thread. Thus, by inserting the second mating part 411 into the mating groove 2213 and engaging the external thread with the internal thread, the screwdriver 41 and the take-up shaft 22 can be connected. Rotating the screwdriver 41 then drives the take-up shaft 22 to rotate synchronously. Preferably, the mating groove 2213 is a tapered groove, and the second mating part 411 of the screwdriver 41 has a tapered structure that matches the mating groove 2213, making it easier for the second mating part 411 to be inserted into the mating groove 2213. Understandably, in other embodiments, the mating groove 2213 can also be formed in the second mating part 411. Correspondingly, the first mating part 2212 has an external thread that matches the internal thread of the mating groove 2213, thus also enabling the screwdriver 41 to drive the take-up shaft 22 to rotate.

[0086] See Figure 3 as well as Figure 6 In one embodiment, the take-up shaft 22 is provided with a first anti-reverse tooth 2214, and a second anti-reverse tooth 212 matching the first anti-reverse tooth 2214 is provided in the receiving groove 211. The take-up shaft 22 has a unidirectional rotation state and a bidirectional rotation state. Specifically, when the first anti-reverse tooth 2214 and the second anti-reverse tooth 212 are engaged, the take-up shaft 22 is in a unidirectional rotation state. At this time, the take-up shaft 22 can only rotate in one direction, for example, it can only rotate forward to tighten the traction line 30, and reverse rotation is restricted. When the first anti-reverse tooth 2214 and the second anti-reverse tooth 212 are separated, the take-up shaft 22 is in a bidirectional rotation state. At this time, the take-up shaft 22 can rotate freely in both directions. Further, the screwdriver 41 can drive the take-up shaft 22 to move axially, thereby causing the first anti-reverse tooth 2214 to engage or disengage with the second anti-reverse tooth 212, and thus allowing the take-up shaft 22 to switch between a unidirectional rotation state and a bidirectional rotation state.

[0087] Specifically, when it is necessary to tighten the traction line 30, the screwdriver 41 presses against the take-up shaft 22, causing the first anti-reverse tooth 2214 of the take-up shaft 22 to engage with the second anti-reverse tooth 212 in the receiving groove 211. At this time, the screwdriver 41 drives the take-up shaft 22 to rotate forward to tighten the traction line 30. At this time, the reverse rotation of the take-up shaft 22 is restricted. After the adjustment is completed and the screwdriver 41 separates from the take-up shaft 22, the take-up shaft 22 cannot rotate in reverse, thereby avoiding the already tightened traction line 30 from loosening again due to the reverse rotation of the take-up shaft 22. When it is necessary to loosen the traction line 30, the take-up shaft 22 is pulled out by the screwdriver 41, so that the first anti-reverse tooth 2214 of the take-up shaft 22 separates from the second anti-reverse tooth 212 in the receiving groove 211. At this time, the take-up shaft 22 can rotate freely in both directions. The traction line 30 can be loosened by driving the take-up shaft 22 to reverse by the screwdriver 41. After the traction line 30 is adjusted to the appropriate tension, the take-up shaft 22 is pressed by the screwdriver 41, so that the first anti-reverse tooth 2214 of the take-up shaft 22 engages with the second anti-reverse tooth 212 in the receiving groove 211, which can restrict the rotation of the take-up shaft 22 and fix the tension of the traction line 30 at this time.

[0088] See Figure 5 Optionally, the screwdriver 41 is provided with a handle 412 at the end away from the second mating part 411. The handle 412 is used by the operator to grip, thereby making it easier to operate.

[0089] See Figures 7 to 9 In the second embodiment, the pulling mechanism 20 further includes an internal magnetron 23 and a first transmission assembly. The internal magnetron 23 is rotatably disposed in the first housing 21, and a first magnet 231 is provided on the internal magnetron 23. The first transmission assembly connects the internal magnetron 23 and the take-up shaft 22, and is used to drive the take-up shaft 22 to rotate when the internal magnetron 23 rotates. See also Figures 10 to 11 The adjustment mechanism 40 includes a surface magnetocontrol disk 42, which is provided with a second magnet 421 that can attract the first magnet 231. Rotating the surface magnetocontrol disk 42 can drive the internal magnetocontrol disk 23 to rotate.

[0090] Thus, by placing the surface magnetic control plate 42 close to the patient's chin 92, the first magnet 231 and the second magnet 421 attract each other. Rotating the surface magnetic control plate 42 then drives the internal magnetic control plate 23 to rotate, which in turn drives the winding shaft 22 to rotate, tightening or loosening the traction wire 30. In this embodiment, controlling the rotation of the winding shaft 22 through magnetic attraction avoids the need for postoperative incisions on the patient, achieving non-invasive adjustment of the tightness of tongue traction, reducing patient pain, and minimizing the risk of infection.

[0091] Preferably, there are multiple first magnets 231, such as 2-4, arranged at intervals along the circumference of the internal magnetic control disk 23 at its edge. Further, the diameter of the internal magnetic control disk 23 is 15-20 mm. Correspondingly, there are also multiple second magnets 421, such as 2-4, arranged at intervals along the circumference of the surface magnetic control disk 42 at its edge. Preferably, the diameter of the surface magnetic control disk 42 is 15-20 mm. Further, a knob 423 is connected to the center of the surface magnetic control disk 42; manually or electrically rotating the knob 423 can rotate the surface magnetic control disk 42.

[0092] Further, see also Figure 8 as well as Figure 9 The first transmission assembly includes a first output shaft 241, a first gear 242, a second gear 243, a first worm 244, and a first worm wheel 245. The first output shaft 241 passes through the center of the internal magnetron 23 and rotates synchronously with it. The first output shaft 241 is connected to the first gear 242. The second gear 243 meshes with the first gear 242. The first worm 244 is coaxially arranged with the second gear 243. The first worm wheel 245 is connected to the winding shaft 22 and meshes with the first worm 244.

[0093] Thus, by rotating the surface magnetic control disk 42, the internal magnetic control disk 23 is driven to rotate, which in turn drives the first output shaft 241 and the first gear 242 to rotate synchronously. The first gear 242 drives the second gear 243 and the first worm 244 to rotate synchronously. The first worm 244 then drives the winding shaft 22 to rotate through the first worm wheel 245, thereby adjusting the tension of the traction line 30.

[0094] See Figures 12 to 14 In the third embodiment, the adjustment mechanism 40 includes a motor 25 and a second transmission assembly. The motor 25 is housed within the first housing 21. The second transmission assembly connects the shaft of the motor 25 to the take-up shaft 22, so that the take-up shaft 22 rotates when the shaft of the motor 25 rotates. Thus, by driving the take-up shaft 22 to rotate via the motor 25, the tension of the traction line 30 can be adjusted non-invasively.

[0095] Further, see Figure 13 as well as Figure 14The second transmission assembly includes an output gear 261, a third gear 262, a fourth gear 263, a second worm 264, and a second worm wheel 265. The output gear 261 is connected to the shaft of the motor 25. The third gear 262 meshes with the output gear 261. The fourth gear 263 meshes with the third gear 262. The second worm 264 is coaxially arranged with the fourth gear 263. The second worm wheel 265 is connected to the take-up shaft 22 and meshes with the second worm 264. Thus, the motor 25 drives the output gear 261 to rotate, which in turn drives the third gear 262 to rotate. The third gear 262 then drives the fourth gear 263 and the second worm 264 to rotate synchronously. The second worm 264, through the second worm wheel 265, drives the take-up shaft 22 to rotate, thereby adjusting the tension of the traction line 30.

[0096] See Figure 12 Furthermore, the tongue traction device also includes an internal control mechanism 43, which can be implanted subcutaneously in the patient's chest and is used to control the motor 25. Specifically, the internal control mechanism 43 includes a second housing 431, a battery, and a control module. The second housing 431 is implanted subcutaneously in the patient's chest and is made of a non-toxic, corrosion-resistant metal material, such as pure titanium. The battery is located inside the second housing 431 and is electrically connected to the motor 25 via a connecting wire 62 to supply power to the motor 25. The control module is electrically connected to both the battery and the motor 25 and is used to control the operating state of the motor 25. Specifically, the control module controls the operating state of the motor 25 by controlling the current output from the battery, wherein the operating states of the motor 25 include, but are not limited to, forward rotation, reverse rotation, start / stop, acceleration, deceleration, and intermittent operation.

[0097] See Figure 12 The internal control mechanism 43 also includes a communication module, which is located in the second housing 431 and electrically connected to the control module. The tongue-pulling device also includes an external remote controller 50, which is wirelessly connected to the communication module, for example, via WiFi, Bluetooth, or radio frequency communication. The external remote controller 50 is used to send control signals to the control module, so that the control module controls the working state of the motor 25. In this way, the motor 25 can be remotely controlled to drive the winding shaft 22 to rotate in both directions, thereby controlling the tightness of the tongue pull and improving ease of use.

[0098] Optionally, the in-body control mechanism 43 also includes a contactless charging module, which is disposed within the second housing 431 and electrically connected to the battery. The tongue traction device also includes an external charging device, which is capable of electromagnetic induction with the contactless charging module and is used to charge the battery. By cooperating with the contactless charging module, the external charging device can achieve non-invasive battery charging.

[0099] See Figure 12 The internal regulation mechanism 43 also includes a monitoring module, which is located in the second housing 431 and electrically connected to the control module. The monitoring module monitors the patient's physiological information and controls the operation of the motor 25 based on this information. Specifically, the physiological information includes, but is not limited to, data signals such as blood oxygen saturation, snoring signals, electrocardiogram signals, body position signals, and intrathoracic pressure signals. Furthermore, the monitoring module can also upload the patient's physiological signals to a designated server, such as a sleep medicine center, via a wireless network. The sleep medicine center can then monitor the patient's physiological signals in real time and adjust the tongue traction device accordingly. By monitoring the patient's physiological signals in real time, the tongue traction device can be dynamically adjusted, further improving the therapeutic effect.

[0100] Optionally, in one embodiment, the tongue traction device further includes a blood oxygen saturation sensor (not shown) for acquiring the patient's blood oxygen saturation signal. Preferably, the blood oxygen saturation sensor may be implanted subcutaneously in the patient's chest and electrically connected to the monitoring module.

[0101] In one embodiment, the tongue traction device further includes a snoring sensor (not shown) for acquiring snoring signals from the patient, such as snoring volume and frequency. Preferably, the snoring sensor can be implanted subcutaneously in the patient's chest and electrically connected to the monitoring module.

[0102] In one embodiment, the tongue traction device further includes an electrocardiogram (ECG) sensor (not shown) for acquiring the patient's electrocardiogram (ECG) signal. Preferably, the ECG sensor is implanted subcutaneously in the patient's chest and electrically connected to the monitoring module.

[0103] In one embodiment, the tongue traction device further includes a position sensor (not shown) for acquiring the patient's positional signals, such as monitoring whether the patient is currently lying on their side or supine. Preferably, the position sensor can be implanted subcutaneously in the patient's chest and electrically connected to the monitoring module.

[0104] In one embodiment, the tongue traction device further includes a thoracic pressure sensor (not shown) for acquiring the patient's thoracic pressure signal. Preferably, the thoracic pressure sensor is implanted subcutaneously in the patient's chest and electrically connected to the monitoring module.

[0105] Furthermore, the sealed housings of the blood oxygen saturation sensor, snoring sensor, electrocardiogram sensor, body position sensor, chest pressure sensor, and their connecting wires are all made of non-toxic and corrosion-resistant medical silicone or Teflon materials.

[0106] Further, see Figure 4The tongue traction device also includes a pressure sensor 71, which is connected to the traction line 30. The pressure sensor 71 is used to obtain the tension of the traction line 30. Preferably, the pressure sensor 71 is electrically connected to the motor 25 and the control module. The control module can also dynamically adjust the working state of the motor 25 according to the tension of the traction line 30 detected by the pressure sensor 71, thereby improving the control accuracy.

[0107] See Figure 12 In one embodiment, the in vivo regulation mechanism 43 further includes an electrical stimulation mechanism, which includes an electrode 61 and an electrical stimulation module. The electrode 61 is used for implantation into the genioglossus muscle or the hypoglossal nerve. The electrical stimulation module is electrically connected to the electrode 61 and is used to control the electrode 61 to release electrical stimulation. Further, in this embodiment, the electrical stimulation module is disposed in the second housing 431, and the electrical stimulation module is connected to the battery and the electrode 61 through a low-frequency generating circuit. By controlling the electrode 61 to release electrical stimulation, the genioglossus muscle or the hypoglossal nerve can be stimulated, thereby causing the muscles around the electrode 61 to contract, thus widening the posterior airway space and improving the therapeutic effect. Preferably, there are multiple electrodes 61, which are spaced apart. Further, the electrode 61 is bipolar or multipolar, and its shape can be spherical, sheet-like, or sleeve-like.

[0108] Another embodiment of this application provides a method for treating OSAHS using the tongue traction device of any of the above embodiments. Specifically, taking an OSAHS case mainly characterized by narrowing of the glossopharyngeal plane due to tongue hypertrophy, relaxation, and posterior displacement as an example, the method includes the following steps:

[0109] The procedure can be performed under local infiltration anesthesia, using bilateral lingual nerve block combined with infiltration anesthesia at the ablation site. A fine needle is inserted approximately 1 cm into the oral mucosa inside the mandibular third molar, or approximately 1.5 cm into the corresponding area on the mandibular border outside the mouth, and 2.5 ml of 2% lidocaine is injected bilaterally. Then, a long, thin needle is inserted into the midline of the 92-degree lower border of the mandible, and 5-8 ml of 1% lidocaine + saline + epinephrine is injected in a fan-shaped pattern along the midline into the root and dorsum of the tongue. Separately, 5-10 ml of 1% lidocaine + saline is drawn into a 5-10 ml syringe and connected to the proximal end of the injection needle in the handle of the radiofrequency ablation electrode. This is then placed into the injection device's fixation chamber, the handle's transparent cover is closed, and the movable push plate connected to the syringe plunger is pushed. Medication should flow from the working end of the radiofrequency ablation electrode.

[0110] A 1cm incision is made along the midline of the 92° lower border of the chin, reaching the chin bone. The chin bone surface is exposed using a dissector. A fan-shaped surgical approach, approximately 2-3cm deep, is then created along the midline of the geniohyoid and geniohyoid muscles at the lower border of the chin using hemostatic forceps. An oral gag is placed, and the tongue tip is pulled out of the mouth. The surgeon inserts their left index finger into the patient's mouth, palpating the circumferential papillae and foramen cecum along the midline of the tongue's dorsum. Holding the radiofrequency ablation electrode connected to the main unit (ablation set to level 5) in the right hand, the needle is inserted along the midline of the lower border of the chin. While initiating ablation and slowly advancing the needle towards the tip of the left index finger, the surgeon simultaneously pushes the movable pressure plate connected to the syringe plunger to inject 1% lidocaine + saline solution until the needle tip feels close to the tip of the left index finger. The purpose of injecting 1% lidocaine + saline solution is to improve the efficiency of low-temperature plasma radiofrequency ablation, prevent adhesion, and achieve hemostasis and analgesia. Remove the ablation electrode, leaving the detachable puncture cannula.

[0111] Insert the tongue implant 10 into the cannula and use the pusher to push the tongue implant 10 into the tongue tissue near the tip of the left index finger. Remove the puncture cannula and pusher, leaving the traction suture 30 in place. Withdraw the left index finger tip approximately 15mm, and use the radiofrequency ablation electrode to puncture and ablate again, then push in the tongue implant 10. Repeat this process until 3-5 tongue implants 10 are implanted in a fan shape along the midline of the tongue. Then pull all the traction sutures 30 out of the surgical incision. Fix the tail end of the traction suture 30 to the winding shaft 22 of the traction mechanism 20, and adjust the tension of the traction sutures 30. Fix the traction mechanism 20 to the chin of the mandible with titanium screws.

[0112] Properly stop the bleeding, place a drainage patch if necessary, suture the incision, and the surgery is complete.

[0113] Post-operatively, patients are instructed to have regular follow-up examinations and polysomnography. Three to six months post-surgery, the tongue implant 10 integrates tightly with the scar tissue within the tongue, allowing it to withstand significant tension. At this point, the tongue traction tightness can be further adjusted using the adjustment mechanism 40 to increase the tension, widen the posterior airway space, and enhance the therapeutic effect.

[0114] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are 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.

[0115] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A tongue-pulling device, characterized in that, include: A tongue implant for implantation into the tongue; A traction wire, one end of which is connected to the tongue implant; A traction mechanism, comprising a first housing and a take-up shaft rotatably disposed in the first housing, the take-up shaft being connected to the traction line; as well as An adjustment mechanism is provided to drive the take-up shaft to rotate, so that the take-up shaft can wind up or release the traction line. The traction mechanism further includes an internal magnetron control disk and a first transmission assembly. The internal magnetron control disk is rotatably disposed in the first housing and has a first magnet. The first transmission assembly connects the internal magnetron control disk and the take-up shaft. The first transmission assembly is used to drive the take-up shaft to rotate when the internal magnetron control disk rotates. The adjustment mechanism includes a surface magnetron control disk and has a second magnet that can attract the first magnet. Rotating the surface magnetron control disk can drive the internal magnetron control disk to rotate.

2. The tongue-pulling device according to claim 1, characterized in that, The take-up shaft includes: A rotating shaft, one end of which has a slot extending axially and penetrating both sides of the rotating shaft radially, wherein the end of the traction wire away from the tongue implant is connected to the slot; and, A fastening sleeve is detachably connected to one end of the rotating shaft that has the slot.

3. The tongue-pulling device according to claim 1, characterized in that, The first housing is provided with an open receiving groove, in which the take-up shaft is movably disposed.

4. The tongue-pulling device according to claim 3, characterized in that, The winding shaft is provided with a first anti-reverse tooth, and the receiving groove is provided with a second anti-reverse tooth that matches the first anti-reverse tooth. The winding shaft has a unidirectional rotation state when the first anti-reverse tooth and the second anti-reverse tooth are engaged, and a bidirectional rotation state when the first anti-reverse tooth and the second anti-reverse tooth are separated.

5. The tongue-pulling device according to claim 1, characterized in that, The tongue-pulling device further includes a pressure sensor connected to the traction line, the pressure sensor being used to obtain the tension of the traction line; and / or The tongue traction device further includes a blood oxygen saturation sensor, which is used to acquire the target's blood oxygen saturation signal; and / or, The tongue-pulling device further includes a snoring sensor, which is used to acquire the snoring signal of the target; and / or, The tongue-pulling device further includes an electrocardiogram (ECG) sensor, which is used to acquire the target's ECG signal; and / or, The tongue-pulling device further includes a body position sensor, which is used to acquire the target's body position signal; and / or, The tongue traction device also includes a thoracic pressure sensor, which is used to acquire the thoracic pressure signal of the target.

6. The tongue-pulling device according to any one of claims 1-5, characterized in that, The tongue traction device further includes an electrical stimulation mechanism, which includes: Electrodes, said electrodes for implantation into the genioglossus muscle or hypoglossal nerve; and An electrical stimulation module is electrically connected to the electrodes and is used to control the electrodes to release electrical stimulation.

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