Auricular point electrical stimulation smoking cessation instrument based on auricle scanning and 3D printing and use method

Abstract

The invention discloses an auricular point electrical stimulation smoking cessation instrument based on auricle scanning and 3D printing and a use method, and the instrument can fit the ear shape of an individual, enables electrodes or stimulation salient points to accurately correspond to acupoints, achieves the precise positioning and standardized operation of electrical stimulation, simulates the'qi gaining 'effect of acupuncture, enhances the abstinence symptom relieving and desire inhibiting effects, and improves the smoking cessation efficiency. The wearing duration, the stimulation frequency and the compliance are monitored in real time, and objective and quantitative data are provided for doctors. The ear clip comprises a three-dimensional scanning and individual modeling module, a 3D printing individualized ear clip main body, an electrical stimulation control module and a signal output and control unit.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine acupuncture, wearable medical devices, and 3D printing, and particularly relates to an auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing and a use method of the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing. BACKGROUND

[0002] Smoking is seriously harmful to human health and can cause cardiovascular diseases, respiratory diseases, decreased immunity, bone problems, reproductive system damage, digestive system diseases, skin problems, and also affects the nervous system. In addition, smoking also damages the nervous system, causing memory loss, intelligence decline, and other problems. At the same time, the harm of secondhand smoke to the surrounding people cannot be ignored, and long-term inhalation of secondhand smoke also increases the risk of various diseases.

[0003] In summary, the harm of smoking is everywhere and far-reaching and lasting. For the health of oneself and the surrounding people, smoking cessation is a must and an urgent task. At present, the methods for smoking cessation include: using nicotine replacement therapy, trying non-nicotine drug assistance, and diverting attention by means of exercise and interest.

[0004] There are many acupoints corresponding to the ear, and some people have developed auricular point stimulation principles to quit smoking. The existing auricular point stimulation devices are mainly of a general structure, such as mechanical ear clips, electrode patches, or ear pressure beans, and their design is based on an average auricle model. Therefore, they cannot adapt to individual anatomical differences, auricular point smoking cessation treatment operation relies on manual experience, acupoint positioning is not accurate, stimulation parameters are uncontrollable, the curative effect has poor repeatability, patient compliance is low, and it is difficult to realize standardized, quantified, and individualized treatment. SUMMARY

[0005] To overcome the defects of the prior art, the technical problem to be solved by the present application is to provide an auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing, which can fit the ear type of an individual, so that the electrodes or stimulation protrusions can accurately correspond to the acupoints, realize accurate positioning and standardized operation of electric stimulation, simulate the "qi" effect of acupuncture, enhance the relief of withdrawal symptoms and craving suppression effect, and monitor the wearing time, stimulation frequency, and compliance in real time to provide objective and quantitative data for doctors.

[0006] The technical scheme of the present application is that the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing comprises: a three-dimensional scanning and individual modeling module, which collects three-dimensional morphological data of the auricle of a subject by means of structured light scanning or high-precision photogrammetry, positions the acupoints of Shenmen, Feishu, and Jiaoyin on the auricle model according to standard auricular point anatomical coordinates, and generates a three-dimensional auricle data file containing acupoint coordinates; 3D printing individualized ear clip body, which is designed with three-point positioning structure according to three-dimensional auricle data file; the ear clip body is prepared by 3D printing technology using medical grade biocompatible material; an electrode mounting hole is reserved on the inner side of the ear clip body, so that the center of the electrode is aligned with the target acupoint coordinate; The electric stimulation control module (3) comprises a micro electrode group, a constant current stimulation circuit, a pulse control chip and a rechargeable micro power supply, each electrode corresponds to a corresponding acupoint, the pulse control chip receives the set stimulation parameters, generates periodic or continuous stimulation through the constant current stimulation circuit, and the rechargeable micro power supply supplies power for the constant current stimulation circuit and the pulse control chip. The signal output and control unit (4) outputs periodic or continuous stimulation to the electrode and controls the stimulation parameters.

[0007] The beneficial technical effects of the present application are as follows: (1) Precise acupoint selection and individual matching The present application obtains the auricle shape data of the subject by three-dimensional scanning technology, automatically positions the key acupoints such as Shenmen, lung and sympathetic nervous system according to the auricular acupoint standard anatomical coordinates, and customizes the individualized ear clip structure by combining the 3D printing technology, so that the spatial deviation between the center of the electrode and the target acupoint is controlled within 1 mm, the stimulation accuracy is significantly improved, and the problems of large error and strong operator dependence of traditional manual acupoint selection are overcome.

[0008] (2) Standardization and repeatability The smoking cessation device adopts a fixed three-point positioning structure (auricle, ear wheel and ear boat contact surface), and can realize stable and repeated stimulation position among different time and different operators. The standardized structure design and controllable electric stimulation parameters enable the auricular point therapy to be transformed from an empirical operation into a quantifiable, replicable and standardized treatment mode.

[0009] (3) Controllable electric stimulation and enhanced efficacy The built-in micro electric stimulation module can output low-frequency pulse current, and the frequency, intensity and waveform can be preset or adjusted, so as to accurately simulate the "qi" effect of acupuncture, continuously stimulate the nerve endings of the auricular point, improve the withdrawal symptoms such as anxiety and insomnia, and improve the success rate of smoking cessation. Compared with the traditional mechanical stimulation or pressing of the ear bean, the stimulation intensity is stable, and the treatment effect is more persistent.

[0010] (4) Intelligent monitoring and improved compliance The Bluetooth or NFC communication module can record the wearing time, stimulation times and current intensity, realize the compliance monitoring and efficacy evaluation. The doctor can remotely view the data through the mobile terminal, and timely adjust the treatment scheme, so as to significantly improve the active participation and follow-up compliance of the patient.

[0011] (5) Comfortable, safe and reliable wearing The ear clip body is made of medical-grade biocompatible material by 3D printing, has light structure, good adhesion, and no obvious discomfort in long-term wearing. The electric stimulation current is in a safe range, and will not cause skin damage or pain, and is suitable for clinical and home use.

[0012] (6) High clinical transformation potential The application has simple structure and is easy to mass-produce, and can be used in combination with existing smoking cessation clinics, community health centers or mobile health platforms. By realizing the digitization and standardization of traditional Chinese medicine ear acupuncture therapy, a new technical path and intelligent product scheme are provided for acupuncture smoking cessation.

[0013] A use method of the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing is also provided, which comprises the following steps: (1) The three-dimensional morphological data of the auricle of a subject is collected by using a structured light scanning or high-precision photogrammetry method; the Shenmen, lung and sympathetic points are positioned on the auricle model according to the standard auricular point anatomical coordinates; and a three-dimensional auricle data file containing the point coordinates is generated; (2) The auricle clip body with a three-point positioning structure is designed according to the three-dimensional auricle data file; the auricle clip body is prepared by using a 3D printing technology and medical-grade biocompatible material; and the electrode mounting hole is reserved on the inner side of the auricle clip body, so that the center of the electrode is aligned with the target point coordinates; (3) The electric stimulation control module, signal output and control unit, communication and recording module are installed on the outer side of the auricle clip body; (4) When the subject wears it, the electrodes are aligned with the Shenmen, lung and sympathetic points; and the device outputs a set pulse current to perform low-frequency electric stimulation on the points. BRIEF DESCRIPTION OF DRAWINGS

[0014] Figure 1 Fig. 1 is a structural schematic diagram of the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing according to the present application.

[0015] Figure 2 Fig. 2 is a flowchart of the use method of the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing according to the present application. DETAILED DESCRIPTION

[0016] In order for those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should belong to the scope of protection of the present application.

[0017] It is to be understood that the terminology "includes", "has", "holds", "contains" and related terminology used herein in the specification and in the claims is used in the sense of "including but not limited to", "having at least" and the like, and is not to be interpreted as limiting.

[0018] As shown in the drawings, Figure 1 The auricular point electrostimulation smoking cessation instrument based on auricle scanning and 3D printing comprises: a three-dimensional scanning and individual modeling module which collects three-dimensional morphological data of auricles of a subject by using structured light scanning or high-precision photogrammetry, positions auricular points of Shenmen, lung and sympathetic according to standard auricular point anatomical coordinates on an auricle model, and generates a three-dimensional auricle data file containing auricular point coordinates; a 3D-printed individualized ear clip main body which designs an ear clip main body 1 with a three-point positioning structure according to the three-dimensional auricle data file, prepares the ear clip main body by using 3D printing technology and medical-grade biocompatible materials, and reserves an electrode mounting hole 2 on the inner side of the ear clip main body to align the center of the electrode 6 with the target auricular point coordinates; an electrostimulation control module 3 which comprises a micro electrode group, a constant current stimulation circuit, a pulse control chip and a rechargeable micro power supply, each electrode corresponds to a corresponding auricular point one by one, the pulse control chip receives set stimulation parameters, generates periodic or continuous stimulation through the constant current stimulation circuit, and the rechargeable micro power supply supplies power to the constant current stimulation circuit and the pulse control chip; a signal output and control unit 4 which outputs periodic or continuous stimulation to the electrode and controls stimulation parameters.

[0019] The present application has the following beneficial technical effects: (1) Precise point selection and individual matching The present application acquires auricle morphological data of a subject by using three-dimensional scanning technology, automatically positions key auricular points such as Shenmen, lung and sympathetic according to standard auricular point anatomical coordinates, customizes individualized ear clip structures by using 3D printing technology, controls the spatial deviation of the center of the electrode from the target auricular point within 1 mm, significantly improves stimulation accuracy, and overcomes the problems of large errors in traditional manual point selection and strong dependence on operators.

[0020] (2) Standardization and repeatability The smoking cessation instrument adopts a fixed three-point positioning structure (auricle, antihelix and concha contact surface), can realize stable and repeatable stimulation positions at different times and between different operators, and makes auricular point therapy transform from an empirical operation into a quantifiable, replicable and standardized treatment mode by virtue of the standardized structure design and controllable electrostimulation parameters.

[0021] (3) Controllable electrostimulation and enhanced efficacy The built-in micro electric stimulation module can output low-frequency pulse current, and the frequency, intensity and waveform can be pre-set or adjusted. The effect of "qi" of acupuncture is simulated, the nerve endings of auricular points are continuously stimulated, and the withdrawal symptoms such as anxiety and insomnia are improved, so that the success rate of smoking cessation is improved. Compared with traditional mechanical stimulation or pressing of ear beans, the stimulation intensity is stable, and the curative effect is more persistent.

[0022] (4) Intelligent monitoring and compliance improvement The Bluetooth or NFC communication module can record the wearing time, stimulation frequency and current intensity, realize compliance monitoring and curative effect evaluation. The doctor can remotely view the data through the mobile terminal, and timely adjust the treatment scheme, so that the active participation and follow-up compliance of the patient are significantly improved.

[0023] (5) Comfortable, safe and reliable The ear clip main body is made of medical grade biocompatible material and is 3D printed, which is light in structure and good in adhesion, and there is no obvious discomfort in long-term wearing. The electric stimulation current is in a safe range and will not cause skin damage or pain, and is suitable for clinical and family use.

[0024] (6) High clinical transformation potential The structure is simple and easy to mass produce, and can be combined with existing smoking cessation clinics, community health centers or mobile health platforms for popularization and use. By realizing the digitization and standardization of traditional Chinese medicine auricular point therapy, a new technical path and intelligent product scheme for acupuncture smoking cessation are provided.

[0025] Preferably, the smoking cessation instrument further comprises a communication and recording module 5, which is provided with a micro Bluetooth module or an NFC unit, connected with a mobile terminal App, and performs stimulation parameter setting, data acquisition and compliance monitoring; records the wearing time, stimulation frequency and current intensity information.

[0026] Preferably, the smoking cessation instrument further comprises a fixing and wearing module, which adopts a flexible clamping or magnetic attraction structure, and the outer side of the clamping body is provided with a direction mark or a calibration mark line to assist the patient in positioning correctly.

[0027] Preferably, the position of the three-point positioning structure comprises: the ear screen, the opposite helix and the ear concha contact surface.

[0028] Preferably, the constant current stimulation circuit outputs pulse current, and the frequency is 1-100 Hz and the intensity is 0.1-2.0 mA.

[0029] Preferably, the electrode is made of flexible conductive material and is coated with medical silicone.

[0030] Preferably, the center of the electrode is aligned with the target acupoint coordinates, and the deviation is less than or equal to 1 mm.

[0031] Preferably, the ear clip main body is made of medical PLA or flexible resin.

[0032] Preferably, the electric stimulation control module is mounted on the outside of the ear clip body, and the electric stimulation control module is connected with the three electrodes through wires to form independent control circuits, respectively outputting electric stimulation signals with different parameters to realize single or multiple acupoint linkage stimulation; the stimulation modes include continuous wave, intermittent wave and gradual wave modes, and the electric stimulation control module has an overcurrent protection circuit and a voltage abnormality power-off circuit.

[0033] As shown in Figure 2 A use method of the auricular point electric stimulation smoking cessation instrument based on auricle scanning and 3D printing is also provided, which includes the following steps: (1) The three-dimensional morphological data of the auricle of a subject is collected by using a structured light scanning or high-precision photogrammetry method; the Shenmen, lung and sympathetic acupoints are positioned on the auricle model according to standard auricular point anatomical coordinates; and a three-dimensional auricle data file containing acupoint coordinates is generated; (2) The auricle clip body with a three-point positioning structure is designed according to the three-dimensional auricle data file; the auricle clip body is prepared by using a 3D printing technology and a medical-grade biocompatible material; and electrode mounting holes are reserved on the inner side of the auricle clip body to align the centers of the electrodes with the target acupoint coordinates; (3) The electric stimulation control module, signal output and control unit, and communication and recording module are installed on the outer side of the auricle clip body; (4) When the subject wears the auricle clip, the electrodes are aligned with the Shenmen, lung and sympathetic acupoints; and the device outputs a set pulse current to perform low-frequency electric stimulation on the acupoints.

[0034] The above is only a preferred embodiment of the present application, and does not limit the present application in any form. Any simple modification, equivalent change and modification made according to the technical essence of the present application to the above embodiment still falls within the protection scope of the technical solution of the present application.

Claims

1. An ear acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing, characterized in that: It includes: The 3D scanning and individual modeling module uses structured light scanning or high-precision photogrammetry to acquire 3D morphological data of the subject's auricle; it locates the acupoints Shenmen, Lung, and Sympathetic on the auricle model according to standard auricular anatomical coordinates; and generates a 3D auricle data file containing the coordinates of the acupoints. The 3D-printed individualized ear clip body is designed with a three-point positioning structure based on the three-dimensional auricle data file (1); the ear clip body is prepared using medical-grade biocompatible materials through 3D printing technology; an electrode mounting hole (2) is reserved on the inner side of the ear clip body so that the center of the electrode (6) is aligned with the coordinates of the target acupoint; The electrical stimulation control module (3) includes a micro electrode group, a constant current stimulation circuit, a pulse control chip and a rechargeable micro power supply. Each electrode corresponds to a corresponding acupoint. The pulse control chip receives the set stimulation parameters and generates periodic or continuous stimulation through the constant current stimulation circuit. The rechargeable micro power supply powers the constant current stimulation circuit and the pulse control chip. The signal output and control unit (4) outputs periodic or continuous stimulation to the electrodes and controls the stimulation parameters.

2. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 1, characterized in that: The smoking cessation device also includes a communication and recording module (5), which is equipped with a miniature Bluetooth module or NFC unit to connect to a mobile app to perform stimulation parameter setting, data collection and compliance monitoring; and to record information such as wearing time, stimulation frequency and current intensity.

3. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 2, characterized in that: The smoking cessation device also includes a fixation and wearing module, which uses a flexible clamping or magnetic structure. The outside of the clamp is equipped with directional markings or calibration lines to help patients position themselves correctly.

4. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 3, characterized in that: The positions of the three-point positioning structure include: the tragus, the antihelix, and the contact surface of the conchae.

5. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 4, characterized in that: The constant current stimulation circuit outputs a pulse current with a frequency of 1–100 Hz and an intensity of 0.1–2.0 mA.

6. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 5, characterized in that: The electrode is made of flexible conductive material and covered with medical-grade silicone.

7. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 6, characterized in that: The center of the electrode is aligned with the coordinates of the target acupoint, with a deviation of less than or equal to 1 mm.

8. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 7, characterized in that: The ear clip body is made of medical-grade PLA or flexible resin.

9. The auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 8, characterized in that: The electrical stimulation control module (3) is installed on the outside of the ear clip body. The electrical stimulation control module is connected to the three electrodes through wires to form an independent control circuit, and outputs electrical stimulation signals with different parameters to realize single or multiple acupoint linkage stimulation. The stimulation modes include continuous wave, intermittent wave and gradual wave modes. The electrical stimulation control module has an overcurrent protection circuit and a voltage abnormality power-off circuit.

10. The method of using the auricular acupoint electrical stimulation smoking cessation device based on auricular scanning and 3D printing according to claim 1, characterized in that: It includes the following steps: (1) Three-dimensional morphological data of the subject’s auricle were collected by structured light scanning or high-precision photogrammetry; the acupoints of Shenmen, Lung and Sympathetic were located on the auricle model according to the standard auricular acupoint anatomical coordinates; and a three-dimensional auricle data file containing the coordinates of the acupoints was generated. (2) Based on the three-dimensional auricle data file, design an ear clip body with a three-point positioning structure; use medical-grade biocompatible materials to prepare the ear clip body using 3D printing technology; reserve electrode mounting holes on the inner side of the ear clip body so that the center of the electrode is aligned with the coordinates of the target acupoint; (3) Install an electrical stimulation control module, a signal output and control unit, and a communication and recording module on the outside of the ear clip body; (4) When the subject wears the device, the electrodes are aligned with the Shenmen, Lung, and Sympathetic acupoints; the device outputs a set pulse current to perform low-frequency electrical stimulation on the acupoints.

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