A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction

Abstract

The present invention discloses a wearable electrical stimulation treatment device for promoting periodontal tissue remodeling, comprising a brace, wherein an electrode portion is provided at the gum contact portion of the brace, and a piezoelectric portion is provided at the tooth surface contact portion of the brace, wherein the electrode portion and the piezoelectric portion are connected via a metal wire embedded inside the brace. The invention provides a wearable electrical stimulation treatment device for promoting periodontal tissue remodeling, which can not only achieve maintenance treatment for periodontitis patients, but also accelerate orthodontic tooth movement. The present invention has high sensitivity during use, good stability and stretchability, and is low in price, simple to operate, safe and non-toxic. Patients can treat themselves at home, and it is easy to achieve large-scale industrial production, and is suitable for the field of scalable biomedical electronics.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical equipment, and in particular to a wearable electrical stimulation treatment device for promoting periodontal tissue reconstruction. Background Art

[0002] Periodontal tissues include gums, alveolar bones and periodontal ligaments, which play an important role in the fixation, support and nutrition of teeth. Healthy periodontal tissues are the prerequisite for oral dental, restorative and orthodontic treatment. However, according to the results of the 2019 Global Burden of Disease Study, approximately 1.087 billion people in the world suffer from periodontitis, and the abnormal periodontal tissue remodeling such as gingival recession and alveolar bone absorption caused by it greatly increases the risk during oral treatment. Therefore, how to maintain the health of periodontal tissues and promote periodontal tissue remodeling to increase the safety of oral treatment is a difficult problem that needs to be solved urgently.

[0003] The existence of electric current or potential in bone and periosteum plays an important role in maintaining bone mass and volume. In recent years, some scholars have found that bioelectric factors coordinate the creation and repair of in vivo structures through ion channels and endogenous electrical signals on cell membranes. Among them, electrical stimulation provides an appropriate physiological environment to simulate endogenous electric fields to manipulate transmembrane potentials to regulate cell growth, differentiation and cell function, thereby affecting the body's bone metabolism. With the continuous understanding of electrical stimulation and periodontal tissue remodeling, domestic and foreign scholars have found that electromagnetic treatments such as electric current, magnetic field and electromagnetic waves can accelerate the synthesis and secretion of bone remodeling-related factors by enhancing the phosphorylation activity of cell enzymes, thereby accelerating tooth movement. In addition, pulsed electromagnetic fields can induce induced currents in alveolar bones through electromagnetic field changes, which can promote bone remodeling on the one hand, and assist in killing periodontal pathogens on the other hand by promoting drug penetration. It can be seen that electrical stimulation has played an important role in many oral treatment fields such as orthodontics and periodontal treatment by promoting periodontal tissue remodeling. However, due to the complex oral environment, it is at the starting point of the digestive tract and respiratory tract, and is close to brain tissue, so the development of convenient, comfortable and safe medical devices is a major trend in future development.

[0004] With the advent of the era of smart medicine, it is imperative to develop new green, high-performance wearable excitation medical devices. However, traditional wearable devices have poor scalability, are difficult to get rid of batteries and other charging devices, require additional power drives, have short working life, and are relatively expensive. In addition, existing wearable devices have poor stability during wearing, and achieving electrical stimulation therapy to accelerate periodontal tissue reconstruction are all problems that need to be solved urgently. Summary of the invention

[0005] The purpose of the present invention is to provide a wearable electrical stimulation therapeutic device with a simple structure, safety and non-toxicity, simple preparation process, and easy large-scale industrial production. During use, it can promote the reconstruction of periodontal tissue, thereby achieving maintenance treatment of periodontitis and accelerating orthodontic tooth movement.

[0006] The present invention is implemented through the following technical solutions: A wearable electrical stimulation treatment device for promoting periodontal tissue reconstruction, comprising a brace, wherein the gum contact part of the brace is provided with an electrode layer structure, and the tooth surface contact part of the brace is provided with a piezoelectric layer structure, and the electrode layer structure and the piezoelectric layer structure are connected by a metal interconnection line embedded in the brace. The brace is a full-mouth brace, which is divided into a maxillary brace and a mandibular brace, and the upper and lower teeth are respectively bitten into the maxillary brace and the mandibular brace. The brace is made of a hot-pressed film material, and the hot-pressed film material includes but is not limited to polyethylene terephthalate, polyethylene terephthalate-polyethylene glycol, thermoplastic polyurethane, polycarbonate, polypropylene material and ethylene vinyl acetate.

[0007] The working principle of this technical solution is to integrate the wearable electrical stimulation treatment device with a personalized customized brace. When in use, the subject puts the wearable electrical stimulation treatment device in the mouth and fits it tightly with the teeth, gums and other parts. When the subject's upper and lower teeth bite, or when a slight vibration occurs, the piezoelectric layer structure will output a voltage, and this voltage will be transmitted to the electrode layer structure through the interconnecting wires to form an electric field, thereby electrically stimulating the gums and alveolar bones. Electrical stimulation can promote the osteogenic differentiation of periodontal ligament stem cells, and enhance osteoblast proliferation, adhesion, mineralized nodule formation and extracellular matrix protein synthesis, thereby maintaining periodontal stability, inhibiting the absorption of alveolar bone and periodontal soft tissue, promoting periodontal tissue regeneration and accelerating tooth movement.

[0008] In order to better implement the present invention, further, the electrode layer structure includes interdigital electrodes, the interdigital electrodes are coated with a first silicone film layer, and the first silicone film layer is coated with a first flexible packaging layer. The main function of the interdigital electrodes is to form an electric field, the function of the first silicone film layer is to protect the interdigital electrodes to prevent leakage or erosion by saliva, and the function of the first flexible packaging layer is to prevent adverse effects on the human oral cavity in addition to protection.

[0009] In order to better realize the present invention, further, the interdigital electrode is composed of six serpentine polyimide line arrays or six serpentine transparent indium tin metal oxide ITO electrodes, and the surfaces of the six serpentine polyimide lines or the six serpentine transparent indium tin metal oxide ITO electrodes are all provided with a gold nanoparticle layer. The specific manufacturing process of the interdigital electrode composed of six serpentine polyimide line arrays is: on a polyimide board, six serpentine polyimide lines are obtained by mechanical engraving or laser cutting. The polyimide lines themselves are not conductive and cannot be used as electrodes. Therefore, gold nanoparticles need to be sputtered on their surface to form a gold nanoparticle layer to make it conductive. Among them, the mechanical engraving machine used in the mechanical engraving method includes a conveyor belt type or a rotary mechanical engraving machine; the cutting machine used in the laser cutting method includes a Delong ultraviolet nanosecond laser processing system, Silhouette Cameo, Silhouette Portrait or Senfeng fiber laser cutting machine, etc. In addition, compared with the ordinary serpentine structure, the serpentine line array structure has greater ductility and extremely high fault tolerance, which effectively improves the mechanical and electrical stability.

[0010] In order to better implement the present invention, further, the interdigital electrodes are composed of six serpentine transparent indium tin metal oxide ITO electrodes.

[0011] In order to better implement the present invention, further, the serpentine polyimide line has a thickness of 0.1 nm to 10 μm, a width of 10 μm to 2 mm, a spacing between adjacent polyimide lines of 50 μm to 2 mm, and a thickness of the gold nanoparticle layer of 200 nm.

[0012] In order to better realize the present invention, further, the piezoelectric layer structure includes a piezoelectric material layer, the surface of the piezoelectric material layer is coated with a metal layer matching its shape and structure, the metal layer is coated with a second silicone film layer on the outside, the second silicone film layer is coated with a second flexible packaging layer on the outside, and the second flexible packaging layer has a pyramid-shaped microstructure. The piezoelectric material layer is to generate current when subjected to pressure, while the metal layer is used as a conductor to transmit current, and the first silicone film layer is used to protect the interdigital electrodes to prevent leakage or erosion by saliva. Among them, in addition to having the same protective function and oral protection function as the first flexible packaging layer, the second flexible packaging layer needs to have better ductility because it is squeezed by teeth, so the second flexible packaging layer has a pyramid-shaped microstructure, and the preparation process of the second flexible packaging layer is: a triangular structure with a bottom side length of 10μm is obtained by laser direct writing on a Si / SiO2 sheet, and then the flexible film material is poured onto the Si / SiO2 sheet, and a second flexible packaging layer with a triangular microstructure configuration is obtained by transfer technology.

[0013] In order to better realize the present invention, further, the piezoelectric material layer is composed of a number of rectangular electrode blocks arranged in a point array, and the adjacent rectangular electrode blocks are connected by serpentine wires, and the rectangular electrode blocks and the serpentine wires together form an island bridge structure, and the side length of the rectangular electrode block and the diameter of the serpentine wire are both 1000μm, and the curvature of the serpentine wire is 230°. The piezoelectric material layer uses rectangular electrode blocks and serpentine wires to form an island bridge structure. Compared with the ordinary serpentine structure, this structure has greater ductility and extremely high fault tolerance, and effectively improves the mechanical and electrical stability. By exploring the side lengths and serpentine wire diameters of rectangular electrode blocks of different sizes, and outputting voltage through interdigitated electrodes, it is finally determined that when the side length of the rectangular electrode block and the diameter of the serpentine wire are both 1000μm, the piezoelectric material layer has the best output voltage value, thereby achieving a better electrical stimulation effect to promote periodontal tissue reconstruction and accelerate orthodontic tooth movement.

[0014] In order to better realize the present invention, further, the material of the piezoelectric material layer is at least one of an organic piezoelectric material, a piezoelectric crystal, a piezoelectric ceramic, and a piezoelectric electret film, and the thickness of the voltage material layer is 10 μm to 500 μm. The specific material of the piezoelectric material layer can be polyvinylidene fluoride (PVDF), lead zirconate titanate (PZT) or barium titanate (BTO), etc.

[0015] In order to better implement the present invention, further, the material of the metal layer is a conductive metal; the thickness of the metal layer is 0.1nm-50μm. The specific material of the metal layer is aluminum.

[0016] In order to better realize the present invention, further, the materials of the first flexible encapsulation layer and the second flexible encapsulation layer are both polymer cured products with a Young's modulus of 10kPa to 100MPa, and the thickness is 0.01μm to 1000μm. The specific material of the first flexible encapsulation layer can be PDMS (polydimethylsiloxane), ecoflex (aliphatic aromatic silicon-free copolyester), silicone, PU (polyurethane) or 3M Tegaderm (transparent dressing), etc. The specific material of the second flexible encapsulation layer can be PDMS (polydimethylsiloxane), ecoflex (aliphatic aromatic random copolyester), etc.

[0017] In order to better implement the present invention, further, the metal interconnection line is made of a conductive material, the line width of the metal interconnection line is 10 μm to 2 mm, and the conductive material is a conductive metal or a conductive adhesive. The material of the metal interconnection line is preferably copper.

[0018] In order to better implement the present invention, further, a power interface is provided on the outside of the front end of the braces, and the power interface has a built-in wire connected to the piezoelectric layer structure. The power interface can provide an electric field for stimulating gums to the electrode layer structure through an external power supply, and the voltage provided by the external power supply is the same as the voltage generated by the piezoelectric layer structure.

[0019] In order to better realize the present invention, further, the external power supply is a battery or a wireless charger, and the wireless charger includes a shell, and a circuit rectifier board and a wireless transmission coil connected by copper-core wires are arranged in the shell, and the circuit rectifier board is also connected to a magnetic interface fixed on the shell, and the magnetic interface can be connected to the power interface outside the front end of the braces through a magnetic power line, and the power interface provides voltage to the electrode layer structure, thereby forming an electric field to stimulate the gums.

[0020] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0021] (1) The invention realizes efficient mechanical energy-electrical energy conversion for micro-vibration and slight bite by patterning piezoelectric film and designing pressure-sensitive microstructures, and integrates them into personalized braces in combination with flexible stretchable electrodes, thereby getting rid of the self-driven electric field generated by traditional batteries and achieving the ultimate goal;

[0022] (2) The interdigitated electrodes and piezoelectric materials in the invention adopt a serpentine line array structure and an island bridge structure. Compared with the ordinary serpentine structure, the structure has greater ductility and extremely high fault tolerance, effectively improving the mechanical and electrical stability;

[0023] (3) The wearable electrical stimulation treatment device for promoting periodontal tissue reconstruction provided by the present invention has high sensitivity during use, good stability and stretchability, can effectively solve problems such as periodontal disease, is inexpensive, safe and non-toxic, and can be used to treat diseases of various human organs through electrical stimulation. During use, by promoting periodontal tissue reconstruction, it can not only achieve maintenance treatment of periodontitis, but also accelerate orthodontic tooth movement, and is suitable for the field of scalable biomedical electronics;

[0024] (4) A wearable electrical stimulation treatment device for promoting periodontal tissue reconstruction provided by the present invention is also provided with a power supply interface, which can power the electrode layer structure through an external battery or wireless charger, so that it can generate an electric field that can treat periodontitis or accelerate orthodontic tooth movement. In this way, when the piezoelectric layer structure cannot provide voltage to the electrode layer structure due to damage or other reasons, the electrode layer structure can be powered by an external power supply to perform normal work and realize the treatment process;

[0025] (5) The wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction provided by the present invention has a simple structure, a simple preparation process, a low production cost, is easy to realize large-scale industrial production, has a long working life, a relatively high output voltage, and is well stabilized during wearing. It is also easy to operate and can be safely operated by patients themselves. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments with reference to the following drawings:

[0027] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0028] Figure 2 An exploded view of the electrode layer structure in the present invention;

[0029] Figure 3 Schematic diagram of the planar structure of the interdigitated electrode in the present invention;

[0030] Figure 4 An exploded view of the piezoelectric layer structure of the present invention;

[0031] Figure 5 is a schematic diagram of the planar structure of the piezoelectric material layer in the present invention;

[0032] Figure 6 It is a schematic diagram of a planar junction of a piezoelectric material layer formed by electrode blocks with different side lengths in the present invention;

[0033] Figure 7 This is a diagram comparing the output voltages of the piezoelectric material layer formed by electrode blocks with different side lengths in the present invention;

[0034] Figure 8 This is a diagram showing the voltage output of the wearable electrical stimulation therapeutic device at different frequencies in the present invention;

[0035] Fig. 9 This is a long-term stability test diagram of the wearable electrical stimulation therapeutic device in the present invention;

[0036] Fig.10 This is a comparison chart of the stability test of the wearable electrical stimulation treatment device for human body and the machine stability test in the present invention;

[0037] Fig.11 A bar graph comparing the daily cell proliferation abilities of the experimental group and the control group in the present invention;

[0038] Fig.12 The micro-CT images of young mice in control group 1 and experimental group 1 of the present invention;

[0039] Fig.13It is a statistical diagram of young mice in control group 1 and experimental group 1 of the present invention;

[0040] Fig.14 The micro-CT images of the senescent mice in the control group 2 and the experimental group 2 in the present invention;

[0041] Fig.15 It is a statistical chart of the aging mice in the control group 2 and the experimental group 2 of the present invention;

[0042] Fig.16 It is a schematic diagram of some structures in the present invention.

[0043] Among them: 1—tooth braces, 2—electrode layer structure, 21—interdigital electrodes, 22—first silicone film layer, 23—first flexible packaging layer, 3—piezoelectric layer structure, 31—piezoelectric material layer, 311—electrode block, 322—snake line, 32—metal layer, 33—second silicone film layer, 34—second flexible packaging layer, 4—metal interconnection line, 5—power interface, 6—wireless charger, 61—housing, 62—copper core wire, 63—circuit rectifier board, 64—wireless transmission coil, 65—magnetic interface, 7—magnetic power cord. DETAILED DESCRIPTION

[0044] In order to make the purpose, process conditions and advantages of the present invention more clearly understood, the present invention is further described in detail in conjunction with the following embodiments, but the embodiments of the present invention are not limited thereto. Without departing from the above-mentioned technical ideas of the present invention, various substitutions and changes are made according to the common technical knowledge and customary means in the field, which should all be included in the scope of the present invention. The specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0045] Embodiment 1:

[0046] This embodiment provides a wearable electrical stimulation treatment device that promotes periodontal tissue reconstruction, the structure of which is as follows: Figure 1 As shown, it includes a brace 1, wherein an electrode layer structure 2 is provided at the gum contact portion of the brace 1, and a piezoelectric layer structure 3 is provided at the tooth surface contact portion of the brace 2, and the electrode layer structure 2 and the piezoelectric layer structure 3 are connected via a metal interconnection line 4 embedded in the brace 1.

[0047] The specific structure of the electrode layer structure 2 is as follows: Figure 2 As shown, it comprises interdigital electrodes 21 , the outer portion of the interdigital electrodes 21 is coated with a first silicone film layer 22 , and the outer portion of the first silicone film layer 22 is coated with a first flexible packaging layer 23 .

[0048] The specific structure of the interdigital electrode 21 is as follows: Figure 3As shown, the interdigital electrode 21 is composed of an array of six serpentine polyimide lines, and a gold nanoparticle layer is arranged on the surface of the six serpentine polyimide lines. The serpentine polyimide lines have a thickness of 0.1nm to 10μm, a width of 10μm to 2mm, a spacing between adjacent polyimide lines of 50μm to 2mm, and a thickness of the gold nanoparticle layer of 200nm.

[0049] The specific structure of the piezoelectric layer structure 3 is as follows: Figure 4 As shown, it includes a piezoelectric material layer 31, the surface of the piezoelectric material layer 31 is coated with a metal layer 32 whose shape and structure match the piezoelectric material layer 31, the outside of the metal layer 32 is coated with a second silicone film layer 33, the outside of the second silicone film layer 33 is coated with a second flexible packaging layer 34, and the second flexible packaging layer 34 has a pyramid-shaped microstructure.

[0050] The specific structure of the piezoelectric material layer 31 is as follows: Figure 5 As shown, it is composed of a number of rectangular electrode blocks 311 arranged in a point array, and adjacent rectangular electrode blocks 311 are connected by serpentine lines 312. The rectangular electrode blocks 311 and the serpentine lines 312 together form an island bridge structure. The side length of the rectangular electrode block 312 and the diameter of the serpentine line 312 are both 1000μm, and the curvature of the serpentine line 312 is 230°.

[0051] Embodiment 2:

[0052] Based on the above embodiments, this embodiment further defines the material of each structure and corresponding parameters, such as thickness, etc. Specifically, it includes:

[0053] The material of the piezoelectric material layer 31 is at least one of organic piezoelectric material, piezoelectric crystal, piezoelectric ceramic, and piezoelectric electret film, and the thickness of the piezoelectric material layer 31 is 10 μm to 500 μm. The specific material of the piezoelectric material layer 31 can be polyvinylidene fluoride PVDF, lead zirconate titanate PZT, or barium titanate BTO.

[0054] The material of the metal layer 32 is a conductive metal, and the thickness of the metal layer 32 is 0.1 nm to 50 μm. The specific material of the metal layer 32 is aluminum.

[0055] The first silicone film layer 22 and the second silicone film layer 33 both play a protective role to prevent the internal coated components from being corroded by saliva or the internal components from leaking electricity. Therefore, the material of the first silicone film layer 22 and the second silicone film layer 33 is PU (polyurethane).

[0056] The materials of the first flexible encapsulation layer 23 and the second flexible encapsulation layer 34 are both polymer solids with a Young's modulus of 10kPa to 100MPa, and the thickness is 0.01μm to 1000μm. The specific material of the first flexible encapsulation layer can be PDMS polydimethylsiloxane, ecoflex aliphatic aromatic silicon-free copolyester, silicone, PU polyurethane or 3MTegaderm transparent dressing, etc. The specific material of the second flexible encapsulation layer can be PDMS polydimethylsiloxane, ecoflex aliphatic aromatic random copolyester, etc. The above materials have good biocompatibility and flexibility, can be attached to human skin for a long time, and do not cause adverse effects on the oral environment.

[0057] The metal interconnection line 4 is made of conductive material, the line width of the metal interconnection line 4 is 10 μm to 2 mm, and the conductive material is conductive metal or conductive glue. The material of the metal interconnection line 4 is preferably copper. The rest of this embodiment is the same as the above embodiment and will not be repeated here.

[0058] Embodiment 3:

[0059] In order to verify the influence of the side lengths of the electrode blocks 311 of different sizes in the piezoelectric material layer 31 on the generated voltage, the electrode blocks 311 with side lengths of 800 μm, 900 μm, 1000 μm, 1200 μm and 1500 μm are selected to form the piezoelectric material layer 31 with an island bridge structure. Figure 6 shown.

[0060] The prepared different piezoelectric material layers 31 were subjected to simulated tooth pressure tests to test their voltage outputs under the same pressure, the same time, and the same frequency. The results are shown in FIG. Figure 7 shown.

[0061] according to Figure 7 It can be seen from the content that all piezoelectric material layers 31 can generate stable voltage output. When the side length of the electrode block 311 is 1000μm, all piezoelectric materials can be activated to maximize the voltage output, which can ensure that the material has the best output performance and lay the foundation for the subsequent electrical stimulation to accelerate orthodontic movement of teeth.

[0062] Embodiment 4:

[0063] This embodiment further verifies the voltage output of the wearable electrical stimulation therapeutic device at different frequencies. The parameters of different frequencies of the stretching machine in the laboratory are used to simulate the frequency when the human body bites food. The specific frequencies are 0.3Hz, 0.5Hz, 1Hz, 2Hz, 3Hz, and 5Hz, respectively. The voltage output under the same pressure is tested. The specific situation is as follows: Figure 8 shown.

[0064] according to Figure 8 As shown in the figure, regardless of the frequency, the output voltage is basically around 2V, which has no significant impact on the device. It can be found that as long as the upper and lower teeth of the subject vibrate slightly, an electric field can be formed to achieve the effect of electrical stimulation therapy.

[0065] Embodiment 5:

[0066] In order to verify the long-term stability of the wearable electrical stimulation therapeutic device in the present invention, this embodiment is tested. The specific operation is: the device is subjected to a piezoelectric test for 1200 cycles using a stretching machine. The test results are as follows: Fig. 9 As shown,

[0067] according to Fig. 9 It can be seen that after 1200 piezoelectric tests, the piezoelectric output can be maintained at about 3V, with basically no significant deviation. It can be seen that the wearable electrical stimulation therapeutic device described in the present invention has a long working life and high stability.

[0068] Embodiment 6:

[0069] In order to verify the difference between the stability of the wearable electrical stimulation treatment device for human body and the stability of the machine, this embodiment performs a piezoelectric test on it, as follows:

[0070] The device was placed on a commercial tooth model and the piezoelectric performance was tested multiple times when the teeth were biting. The results were compared with the biting output when the device was worn by the human body. Fig.10 shown.

[0071] according to Fig.10 It can be seen that, whether compared with piezoelectric output or multiple time cycles, the stability of the wearable electrical stimulation therapeutic device for the human body is consistent with the stability of the machine. This proves that the wearable electrical stimulation therapeutic device described in the present invention has good stability performance and is not easily affected by the external environment.

[0072] Embodiment 9:

[0073] In order to verify the biocompatibility of the wearable electrical stimulation therapeutic device described in the present invention, the following tests were performed in this embodiment:

[0074] Experimental group: The wearable electrical stimulation therapeutic device described in the present invention was placed in a culture dish with periodontal ligament cells for culture.

[0075] Control group: periodontal ligament cells were cultured in ordinary culture dishes.

[0076] By comparing the cell proliferation ability of the experimental group and the control group, the test was continued for three days and the comparison results were recorded every day. Fig.11 shown.

[0077] according to Fig.11It can be seen that the test results of the proliferation ability of periodontal ligament cells in the experimental group and the control group were P>0.05, and the difference was not statistically significant. This proves that the wearable electrical stimulation treatment device described in the present invention has good biocompatibility.

[0078] Embodiment 10:

[0079] In order to verify that the wearable electrical stimulation treatment device of the present invention can accelerate orthodontic tooth movement, the following experiments are conducted:

[0080] (1) Experimental subjects

[0081] 10 young Sprague Dawley male rats, 60 days old, with identical growth and development conditions; 10 old Sprague Dawley male rats, 480 days old, with identical growth and development conditions.

[0082] (2) Experimental groups

[0083] Control group 1: Five young mice were randomly selected and tension springs were installed on their teeth to apply force to their teeth to cause tooth movement (TM);

[0084] Control group 2: Randomly select 5 aged mice and install tension springs on their teeth to apply force to their teeth to make them move (Tooth movement, TM);

[0085] Experimental group 1: In addition to installing tension springs on the teeth for added traction, the other 5 young mice were given the wearable electrical stimulation therapeutic device of the present invention for electrical stimulation (TM+ES);

[0086] Experimental group 2: In addition to installing tension springs on the teeth of the other 5 aged mice for added traction, they were also given the wearable electrical stimulation therapeutic device of the present invention for electrical stimulation (TM+ES).

[0087] (3) Experimental process:

[0088] The control group 1, the control group 2, the experimental group 1, and the experimental group 2 were observed for 18 days, and the teeth of each group of rats were scanned by micro-CT at the beginning of the experiment, the 5th day, the 11th day, and the 18th day to calculate the tooth movement distance.

[0089] (4) Experimental results

[0090] according to Fig.12 , Fig.13It can be seen that in young mice, the tooth movement speed of experimental group 1 (TM+ES) was significantly accelerated, and the tooth movement distance of experimental group 1 increased by 63.07% compared with that of control group 1 (TM) on day 5. On day 18, the tooth movement distance of experimental group 1 was about 207um more than that of control group 1 on average.

[0091] according to Fig.14 , Fig.15 It can be seen that among the aged mice, the teeth of the control group 2 (TM) hardly moved, while the teeth of the experimental group 2 moved slightly. On the 18th day, the tooth movement distance of the experimental group 2 increased by 346.09% compared with that of the control group 2.

[0092] (5) Experimental conclusion

[0093] according to Fig.12 , Fig.13 , Fig.14 and Fig.15 It can be seen that the tooth movement speed of young mice or old mice wearing the wearable electrical stimulation treatment device described in the present invention is significantly increased, which proves that the wearable electrical stimulation treatment device described in the present invention can accelerate orthodontic tooth movement.

[0094] Embodiment 11:

[0095] Based on the above embodiment, this embodiment further defines the specific structure of the interdigital electrode 21, and the interdigital electrode 21 is composed of six transparent indium tin metal oxide ITO electrodes in a serpentine shape. The indium tin metal oxide ITO electrode can exert the same technical effect as the polyimide line with a gold nanoparticle layer on the surface, and other materials or structures of the interdigital electrode 21 that can exert the same technical effect as the polyimide line with a gold nanoparticle layer on the surface can also be selected. The rest of this embodiment is the same as the above embodiment, and will not be repeated here.

[0096] Embodiment 12:

[0097] Based on the above embodiments, this embodiment further defines the structure of the mouthpiece 1, such as Fig.16 As shown, the front end of the braces 1 is also provided with a power interface 5, and the power interface 5 has a built-in wire connected to the piezoelectric layer structure 3. The power interface 5 can provide an electric field for stimulating the gums to the electrode layer structure 2 through an external power source, and the voltage provided by the external power source is the same as the voltage generated by the piezoelectric layer structure 3. The power interface 5 is added so that the external power source can also provide power to realize the generation of a pulsed electric field by the electrode layer structure 2. The other parts of this embodiment are the same as the above embodiment and will not be repeated here.

[0098] Embodiment 13:

[0099] Based on the above embodiment, this embodiment further limits the external power source to a wireless charger 6, such as Fig.16 As shown, the wireless charger 6 includes a housing 61, in which a circuit rectifier 63 and a wireless transmission coil 64 connected by a copper core wire 62 are arranged. The circuit rectifier 63 is also connected to a magnetic interface 65 fixed to the housing 61. The magnetic interface 65 can be connected to the power interface 5 outside the front end of the braces 1 through a magnetic power line 7, and the electrode layer structure 2 is provided with voltage through the power interface 5, thereby forming an electric field to stimulate the gums. The wireless charger 6 can receive energy through the wireless transmission coil 64, and integrate the received energy through the circuit rectifier 63 and output it to the magnetic interface 65 through the copper core wire 62. The magnetic interface 65 is connected to the power interface 5 on the jacket 1 through the magnetic power line 7, and the electrode layer structure 2 provides power. The other parts of this embodiment are the same as the above embodiment, and will not be repeated here.

[0100] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction, characterized in that: The invention comprises a dental brace (1), wherein an electrode layer structure (2) is arranged at a gum contact position of the dental brace (1), and a piezoelectric layer structure (3) is arranged at a tooth surface contact position of the dental brace (2), wherein the electrode layer structure (2) and the piezoelectric layer structure (3) are connected via a metal interconnection line (4) embedded in the dental brace (1); the electrode layer structure (2) comprises an interdigitated electrode (21), wherein the interdigitated electrode (21) is externally coated with a first silicone film layer (22), and the first silicone film layer (22) is externally coated with a first flexible packaging layer (23); the piezoelectric layer structure (3) comprises a piezoelectric material layer (31), wherein the surface of the piezoelectric material layer (31) is coated with a metal layer (32) having a shape and structure matching the piezoelectric material layer, wherein the metal layer (32) is externally coated with a second silicone film layer (33), and the second silicone film layer (33) is externally coated with a second flexible packaging layer (34), wherein the second flexible packaging layer (34) has a microstructure of a pyramid configuration.

2. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The interdigital electrode (21) is composed of an array of six serpentine polyimide lines, and a gold nanoparticle layer is provided on the surface of the six serpentine polyimide lines.

3. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 2, characterized in that: The serpentine polyimide lines have a thickness of 0.1 nm to 10 μm and a width of 10 μm to 2 mm. The spacing between adjacent polyimide lines is 50 μm to 2 mm. The thickness of the gold nanoparticle layer is 200 nm.

4. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The interdigitated electrodes (21) are composed of six snake-shaped transparent indium tin metal oxide (ITO) electrodes.

5. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The piezoelectric material layer (31) is composed of a plurality of rectangular electrode blocks (311) arranged in a dot array, adjacent rectangular electrode blocks (311) are connected by serpentine lines (312), the rectangular electrode blocks (311) and the serpentine lines (312) together form an island bridge structure, the side length of the rectangular electrode block (312) and the diameter of the serpentine line (312) are both 1000 μm, and the curvature of the serpentine line (312) is 230°.

6. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The material of the piezoelectric material layer (31) is at least one of an organic piezoelectric material, a piezoelectric crystal, a piezoelectric ceramic, and a piezoelectric electret film, and the thickness of the piezoelectric material layer (31) is 10 μm to 500 μm.

7. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The material of the metal layer (32) is a conductive metal; the thickness of the metal layer (32) is 0.1 nm to 50 μm.

8. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The materials of the first flexible encapsulation layer (23) and the second flexible encapsulation layer (34) are both polymer cured products with a Young's modulus of 10 kPa to 100 MPa, and the thicknesses are both 0.01 μm to 1000 μm.

9. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The metal interconnection line (4) is made of a conductive material, the line width of the metal interconnection line (4) is 10 μm to 2 mm, and the conductive material is a conductive metal or a conductive glue.

10. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 1, characterized in that: The front end of the dental brace (1) is also provided with a power interface (5), the power interface (5) having a built-in wire connected to the piezoelectric layer structure (3), and the power interface (5) can provide an electric field for stimulating the gums to the electrode layer structure (2) through an external power source, and the voltage provided by the external power source is the same as the voltage generated by the piezoelectric layer structure (3).

11. A wearable electrical stimulation therapeutic device for promoting periodontal tissue reconstruction according to claim 10, characterized in that: The external power source is a battery or a wireless charger (6). The wireless charger (6) comprises a housing (61). A circuit rectifier (63) and a wireless transmission coil (64) connected via a copper core wire (62) are arranged inside the housing (61). The circuit rectifier (63) is connected to a magnetic interface (65) fixed to the housing (61). The magnetic interface (65) can be connected to a power interface (5) outside the front end of the dental brace (1) via a magnetic power line (7). A voltage is provided to the electrode layer structure (2) via the power interface (5), thereby forming an electric field for stimulating the gums.

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