Portable percutaneous acupoint electrical stimulation sleep promoting instrument and use method thereof

Abstract

The invention provides a portable percutaneous acupoint electrical stimulation sleep promoting instrument, and aims to improve sleep quality and relieve postoperative pain. The device comprises a box body, a cover body, an electrical stimulation device, a control device and a storage battery. The electrical stimulation device can be adsorbed in the box body to be charged and stored through the design of a magnetic attraction groove and a charging contact, the electrical stimulation device is fixed to the Shenmen acupoint, the hypnotic acupoint, the Sanyinjiao acupoint and the Zusanli acupoint through hydrogel pasting pieces when the electrical stimulation device is used, and the stimulation intensity and time are accurately regulated and controlled through the control device. Clinical tests show that the device can remarkably prolong the total sleep time of the postoperative patient, reduce the postoperative pain score and shorten the hospitalization time, and is simple and convenient to operate, safe and painless. According to the invention, a modern electronic technology and a traditional Chinese medicine acupoint theory are combined, and an efficient and portable solution is provided for sleep disorder and postoperative pain management.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a portable transcutaneous acupoint electrical stimulation sleep promoting device and a method of using the same. Background Art

[0002] With the accelerated pace of modern life, sleep disorders have become a common health problem. Sleep disorders not only affect the quality of life of individuals, but also cause multiple harms to the body. For example, it can significantly reduce brain efficiency, leading to fatigue, emotional instability, and inattention. Long-term sleep disorders can also reduce the function of the digestive system, reduce the body's energy supply, weaken the brain's memory of new things, reduce the body's immunity, and increase susceptibility to disease. In addition, during the perioperative period, decreased sleep quality can also increase the incidence of postoperative complications, such as postoperative fatigue, cardiovascular events, and increased pain sensitivity.

[0003] In order to improve sleep quality, existing home sleep devices mainly use head-mounted devices to stimulate the brain or massage the eyes to help patients fall asleep. Although these devices have a sleep-inducing effect to a certain extent, the effect is often limited for patients with severe sleep disorders. The main reason is that the mechanism of action of these devices is relatively simple and cannot fundamentally solve the complex causes of sleep disorders. For example, head-mounted sleep devices mainly use sound or physical vibrations to induce sleep, but they are not ideal for insomnia caused by anxiety, pain or other physiological problems. In addition, these devices are usually large in size, inconvenient to wear, and easily shifted or fell off due to head movement during sleep, affecting the user experience.

[0004] In recent years, acupuncture has been shown to effectively alleviate sleep disorders and improve insomnia in cancer patients. Transcutaneous Electrical Acupoint Stimulation (TEAS), as an improved acupuncture treatment technique, combines the advantages of traditional Chinese acupuncture theory with modern electrical stimulation technology. TEAS uses non-invasive electrical stimulation to add perceptible pulse stimulation to the surface of acupuncture points on the human body, thereby producing a therapeutic effect similar to acupuncture. Compared with traditional acupuncture and electroacupuncture, TEAS does not directly pierce the skin, reducing the risk of infection. It also has the advantages of being painless, simple to operate, safe and stable, making it more easily accepted by patients.

[0005] However, existing TEAS devices still have shortcomings in terms of portability and ease of use. Most devices require complex wiring, which is not only inconvenient to use but also prone to detachment due to pulling during sleep. Summary of the Invention

[0006] The present invention aims to provide a portable transcutaneous acupoint electrical stimulation sleep-promoting device to solve the problems of large size, inconvenience in use and limited effect of the existing equipment.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solutions: A portable transcutaneous acupoint electrical stimulation sleep-promoting device, comprising a box body, a cover body hingedly connected to the top of the box body, a number of connecting platforms fixedly connected to the inner side walls of the box body, a connecting plate hingedly connected to the front ends of the several connecting platforms, a number of fixing grooves opened at the top of the fixing plate, a magnetic block and a charging contact fixedly connected to the bottom wall of the fixing groove, an electrical stimulation device arranged in the fixing groove, the electrical stimulation device comprising a shell, an electrode sheet fixedly connected in the middle of the top of the shell, a hydrogel adhesive sheet fixedly connected around the top of the shell, a magnetic groove cooperated with the magnetic block opened at the bottom of the shell, a charging contact cooperated with the charging contact opened at the bottom of the shell, a display screen arranged at the front end of the box body, a battery 1 and a control device arranged in the box body, a battery 2 and a functional device arranged in the shell, the control device comprising a controller, a pulse generator, a button, and a Bluetooth transmitter, the functional device comprising a Bluetooth receiver and a control chip.

[0008] Preferably, a bayonet is provided at the top end of the box body, and a buckle that cooperates with the bayonet is provided at the bottom end of the cover body.

[0009] Preferably, a handle is fixedly connected to the top of the connecting plate.

[0010] A method of treating sleep by using a portable transcutaneous electrical acupoint stimulation device comprises the following steps:

[0011] Step 1: Open the box and take out multiple electrical stimulation devices;

[0012] Step 2: Align the electrodes of multiple electrical stimulation devices to the Shenmen, Anmian, Sanyinjiao, and Zusanli acupoints of the human body respectively;

[0013] Step 3: Adhere the electrical stimulation device to the human skin through the hydrogel adhesive patch;

[0014] Step 4: Start the control device in the box body, and send a control signal to the electrical stimulation device through the control device, so that the electrical stimulation device performs transcutaneous electrical stimulation on the acupuncture points;

[0015] Step 5: After a certain period of stimulation, the control device automatically stops the electrical stimulation.

[0016] The principle and beneficial effects of this technical solution:

[0017] This device combines modern electronic technology with traditional Chinese medicine acupuncture theory to achieve precise electrical stimulation of specific acupoints, thereby improving sleep quality. The device utilizes magnetic connection and Bluetooth wireless communication technology, eliminating the cumbersome wiring issues associated with traditional devices. During use, patients no longer need to worry about the device falling off or the wiring being pulled due to physical activity, ensuring stable and comfortable use.

[0018] The electrostimulation device is compact and, thanks to its magnetic slots and charging contacts, can be conveniently attached to the device for charging and storage. Furthermore, the device's functionality is simple, requiring minimal power, and the battery's manageable weight ensures it won't fall out during sleep. A hydrogel adhesive patch secures the device to the body, ensuring it's not only skin-friendly but also re-adhesive with a simple wash if it becomes less sticky, extending its lifespan.

[0019] This device uses a control unit to precisely regulate electrical stimulation. The control unit, which includes a controller, pulse generator, buttons, and a Bluetooth transmitter, can adjust stimulation intensity, duration, and efficiency based on the patient's needs. Different buttons correspond to several independently adjustable levels, such as low, medium, and high frequencies. Patients can adjust stimulation intensity using these buttons. Different levels correspond to different pulse frequencies, meaning different stimulation intensities and durations, to achieve the optimal therapeutic effect. The device also has an automatic stop function, ensuring it automatically shuts off after a certain period of stimulation to avoid overstimulation.

[0020] In existing electrical stimulation therapy, therapeutic effects are typically achieved by stimulating numerous acupoints, such as the Four Gods Needle Points, Shenting, Yintang, Hegu, Taichong, Sanyinjiao, Shenmen, Zusanli, Shendao, and Zhaohai. However, extensive clinical validation has shown that precisely stimulating a specific combination of Shenmen, Anmian, Sanyinjiao, and Zusanli can significantly improve sleep quality. Compared to other complex combinations, this approach is more targeted and effective in terms of therapeutic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic diagram of the structure of a portable transcutaneous electrical acupoint stimulation sleep-promoting device provided by an embodiment of the present invention;

[0022] Figure 2 A schematic diagram of the structure of an electrical stimulation device of a portable transcutaneous acupoint electrical stimulation sleep-promoting device provided by an embodiment of the present invention;

[0023] In the figure: 1. Box body; 2. Cover body; 3. Connecting platform; 4. Connecting plate; 5. Fixing slot; 6. Magnetic block; 7. Charging contact; 8. Electric stimulation device; 9. Shell; 10. Electrode sheet; 11. Hydrogel adhesive sheet; 12. Magnetic slot; 13. Charging contact; 14. Display screen; 15. Button; 16. Bayonet; 17. Buckle; 18. Handle. DETAILED DESCRIPTION

[0024] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments:

[0025] Example:

[0026] 1. Device design and function

[0027] 1. Device structure

[0028] like Figure 1 - Figure 2 As shown, a portable transcutaneous electrical acupoint stimulation sleep-promoting device includes a box body, a cover body hinged on the top of the box body, a bayonet is provided on the top of the box body, and a buckle is provided on the bottom of the cover body to cooperate with the bayonet to ensure the cover is closed. Several connecting platforms are fixedly connected to the inner side walls of the box body, and the front ends of the several connecting platforms are hinged with connecting plates. Several fixing grooves are opened on the top of the fixing plate, and the bottom walls of the fixing grooves are fixedly connected with magnetic blocks and charging contacts. An electric stimulation device is arranged in the fixing groove, and a handle is provided on the top of the connecting plate to facilitate users to take the electric stimulation device of the next layer. Ten electric stimulation devices can complete the use of this solution. This embodiment is designed to have five electric stimulation devices on one layer, and two layers are designed. When more electric stimulation devices are needed, more layers can be designed according to needs. At this time, the connecting platform is stepped to ensure that the upper connecting platform will not form an obstacle when the fixing plate is lifted. A display screen is provided at the front end of the box body, and a tutorial is set in the display screen. When the electric stimulation device is picked up, the recommended use area of ​​the device is played, and the specific location of the acupoint is displayed in text. For example, it is shown that Zusanli is located on the outside of the calf, 3 inches below Dubi, and on the line connecting Dubi and Jiexi, which is convenient for guiding acupoint positioning.

[0029] The electrostimulation device includes a housing with an electrode pad fixedly attached to the center of the top of the housing for contacting acupuncture points on the human body. Hydrogel adhesive patches are fixedly attached around the top of the housing to secure the electrode pad to the skin. The bottom of the housing has a magnetic groove that mates with a magnetic block, and charging contacts that mate with charging contacts to secure and charge the electrostimulation device. The housing contains a first battery and a control device, while the housing contains a second battery and a functional device, including a Bluetooth receiver and a control chip.

[0030] The control unit, located inside the box, includes a controller, pulse generator, buttons, and a Bluetooth transmitter. These components allow the user to adjust the intensity, duration, and efficiency of the electrostimulation. The control unit uses a Bluetooth transmitter. The Bluetooth transmitter and the Bluetooth receiver inside the housing can be replaced with other wireless devices, similar to the lower-cost Star Flash connection, to send control signals to the electrostimulation device for remote control.

[0031] 2. Features

[0032] The main function of this invention is to improve sleep quality by electrically stimulating specific acupuncture points. Its working principle is based on transcutaneous electrical acupoint stimulation (TEAS), a non-invasive treatment method that combines traditional Chinese medicine acupuncture theory with modern electrical stimulation technology. TEAS applies perceptible pulses to the surface of acupuncture points on the body, producing therapeutic effects similar to acupuncture while avoiding the pain and infection risks associated with acupuncture.

[0033] 2. Acupoint Selection and Clinical Verification

[0034] The present invention has undergone extensive clinical validation in selecting acupoints, ultimately identifying Shenmen, Anmian, Sanyinjiao, and Zusanli as the primary acupoints for stimulation. These acupoints are believed in Traditional Chinese Medicine to have calming effects, aiding sleep, and regulating body functions. The specific effects of these acupoints are as follows:

[0035] Shenmen acupoint (HT7): It is the original acupoint of the Heart Meridian. The heart governs blood vessels and the mind. Stimulating this acupoint can benefit the heart, calm the mind, and promote blood circulation.

[0036] Anmian Point (HN0): Combined with Shenmen Point and Sanyinjiao Point, it is mainly used to treat insomnia.

[0037] Sanyinjiao Point (SP6): It is the point where the three Yin meridians of Qi and blood meet, and has the effect of calming the mind and promoting sleep.

[0038] Zusanli acupoint (ST36): "If you want peace of mind, keep the Zusanli acupoint moist." Stimulating this acupoint can regulate the body's immunity and strengthen the body's resistance and eliminate pathogenic factors.

[0039] To validate the effectiveness of the present invention in improving sleep quality, a study was conducted on 110 elderly lung cancer patients with postoperative cognitive dysfunction. The results showed that compared with the control group (Sham-TEAS group), patients who received acupoint stimulation using the present invention experienced significantly improved sleep scores on the first, seventh, and 30th days after surgery, demonstrating that the device can effectively improve patients' sleep quality after surgery.

[0040] 3. Clinical Trial Results

[0041] 1. Baseline indicators

[0042] Before the experiment began, a statistical analysis of baseline parameters was performed for the two groups (TEAS group and Sham-TEAS group), including age, BMI, total sleep duration before surgery, preoperative RCSQ score, and preoperative PSQI score. As shown in Table 4, there were no significant differences between the two groups in these parameters (P>0.05), indicating that the two groups were comparable at the beginning of the experiment.

[0043] Table 1 Baseline indicators

[0044]

[0045] 2. Total sleep time (TST)

[0046] As shown in Table 2, on the first and second days after surgery, the total sleep duration of patients in the TEAS group was significantly longer than that in the Sham-TEAS group (P < 0.001). This indicates that the present invention can significantly improve patients' sleep quality in the early postoperative period.

[0047] Table 2 Total sleep time (TST) on the first and second days after surgery

[0048]

[0049] 3. Secondary outcome measures

[0050] As shown in Table 3, on the first and second days after surgery, the Richards Campbell (RCSQ) scores of patients in the TEAS group were significantly higher than those in the Sham-TEAS group (P < 0.001), indicating that patients in the TEAS group had better sleep quality. Furthermore, the incidence of nausea and vomiting in the TEAS group was lower than that in the Sham-TEAS group on the first day after surgery (P = 0.045), while there was no significant difference in the incidence of nausea and vomiting between the two groups on the second day after surgery (P = 0.896). On the first, second, and 30th days after surgery, the surgical quality recovery scores of patients in the TEAS group were significantly higher than those in the Sham-TEAS group (P < 0.001). On the 30th day after surgery, the Pittsburgh Sleep Quality Index (PSQI) scores of patients in the TEAS group were significantly lower than those in the Sham-TEAS group (P < 0.001), indicating that patients in the TEAS group had better long-term sleep quality. Regarding the length of postoperative hospital stay, the TEAS group had a significantly shorter hospital stay than the Sham-TEAS group (P < 0.001), indicating that the present invention helps accelerate postoperative recovery and shorten hospital stay.

[0051] Table 3 shows the secondary outcome indicators

[0052]

[0053] 4. Postoperative NRS pain score

[0054] As shown in Table 4 , the resting NRS pain scores and coughing NRS pain scores in the TEAS group were lower than those in the Sham-TEAS group on days 1 and 2 after surgery ( P < 0.001).

[0055] Table 4 Postoperative NRS pain scores

[0056]

[0057] In summary, stimulating the four acupoints in combination can relieve pain, calm the mind, and help sleep. The device is effective in treatment.

[0058] The above is only an embodiment of the present invention, and common knowledge such as the specific technical solutions or characteristics in the solution is not described in detail here. For those skilled in the art, without departing from the technical solution of the present invention, several variations and improvements can be made, which should also be regarded as the scope of protection of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the description can be used to interpret the content of the claims.

Claims

1. A portable transcutaneous electrical acupoint stimulation sleep-promoting device, characterized by: It includes a box body, the top of the box body is hinged with a cover body, the inner side walls of the box body are fixedly connected to a number of connecting platforms, the front ends of the several connecting platforms are hinged with connecting plates, the top of the fixing plate is provided with a number of fixing grooves, the bottom walls of the fixing grooves are fixedly connected with magnetic blocks and charging contacts, an electric stimulation device is arranged in the fixing groove, the electric stimulation device includes a shell, an electrode sheet is fixedly connected to the center of the top of the shell, hydrogel adhesive sheets are fixedly connected around the top of the shell, a magnetic groove is opened at the bottom of the shell for cooperating with the magnetic block, and charging contacts are opened at the bottom of the shell for cooperating with the charging contacts, a display screen is arranged at the front end of the box body, a battery 1 and a control device are arranged in the box body, a battery 2 and a functional device are arranged in the shell, the control device includes a controller, a pulse generator, a button, and a Bluetooth transmitter, and the functional device includes a Bluetooth receiver and a control chip.

2. The portable transcutaneous electrical acupoint stimulation sleep-promoting device according to claim 1, characterized in that: The top end of the box body is provided with a bayonet, and the bottom end of the cover body is provided with a buckle that cooperates with the bayonet.

3. The portable transcutaneous electrical acupoint stimulation sleep-promoting device according to claim 1, characterized in that: A handle is fixedly connected to the top of the connecting plate.

4. A therapeutic method of the portable transcutaneous acupoint electrical stimulation sleep promoting device according to claim 1, characterized in that: The following steps are involved: Step 1: Open the box and take out multiple electrical stimulation devices; Step 2: Align the electrodes of multiple electrical stimulation devices to the Shenmen, Anmian, Sanyinjiao, and Zusanli acupoints of the human body respectively; Step 3: Adhere the electrical stimulation device to the human skin through the hydrogel adhesive patch; Step 4: Start the control device in the box body, and send a control signal to the electrical stimulation device through the control device, so that the electrical stimulation device performs transcutaneous electrical stimulation on the acupuncture points; Step 5: After a certain period of stimulation, the control device automatically stops the electrical stimulation.

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