CN-121971803-A - Vagus nerve stimulation device and preparation method thereof

Abstract

The application relates to a vagus nerve stimulation device and a preparation method thereof. The vagus nerve stimulation device is suitable for being placed at the neck of a human body to stimulate the cervical vagus nerve and comprises an electric stimulation unit, a thermal therapy unit and a hard basal shell. The electric stimulation unit comprises a pulse generation module and an electrode electrically connected with the pulse generation module, the thermal therapy unit is used for generating heat to act on the neck of a human body, and the hard base shell is used for installing the electrode and the thermal therapy unit. The hard basal shell bears the electrode and the heat treatment unit, and is arranged on the neck of a human body, so that the electrode contacts with the skin of the neck to output an electric stimulation signal to stimulate the vagus nerve of the neck, and the heat treatment unit heats the electrode or the skin of the neck. The vagus nerve stimulation device provided by the application improves the treatment effect and the use experience through the cooperation of the thermal therapy and the electric stimulation therapy.

Inventors

• ZHANG TIANYI
• SUN SHENGYANG
• FANG XIAO
• HU JUNLI
• LV SHUHUI
• SUN CHANG

Assignees

• 杭州演化医疗设备有限公司

Dates

Publication Date

20260505

Application Date

20260208

Claims (20)

1. 1. A vagus nerve stimulation device adapted to be placed at the neck of a human body to stimulate the cervical vagus nerve, the vagus nerve stimulation device comprising: the electric stimulation unit comprises a pulse generation module and an electrode electrically connected with the pulse generation module; a thermal therapy unit for generating heat; a hard base shell for mounting the electrode and the thermal therapy unit; the hard basal shell bears the electrode and the heat treatment unit, and is arranged on the neck of a human body, so that the electrode contacts with the skin of the neck to output an electric stimulation signal to stimulate the vagus nerve of the neck, and the heat treatment unit heats the electrode or the skin of the neck.
2. 2. The vagus nerve stimulation device of claim 1, wherein the thermal therapy unit comprises an electrical heat generating element.
3. 3. The vagus nerve stimulation device of claim 2, wherein the electrical heating element comprises one or more of a heater wire, a PTC heating element, a semiconductor heating sheet, and an electrothermal film.
4. 4. The vagus nerve stimulation device of claim 1, wherein the thermal therapy unit comprises a chemically reactive heat generating element.
5. 5. The vagus nerve stimulation device of claim 4, wherein the chemically reactive heat generating component comprises a substance capable of an exothermic chemical reaction upon exposure to air.
6. 6. The vagus nerve stimulation device of claim 1, wherein the thermal therapy unit is a phase change material heat generating element comprising a phase change material capable of releasing heat during phase change.
7. 7. The vagus nerve stimulation device of claim 1, wherein the rigid base shell is a metal piece or a rigid plastic piece.
8. 8. The vagus nerve stimulation device of claim 1, wherein the rigid base housing is provided with an electrode mounting slot, and the electrode is disposed within the electrode mounting slot.
9. 9. The vagus nerve stimulation device of any one of claims 1 to 8, wherein the electrode is a metal electrode.
10. 10. The vagus nerve stimulation device of claim 8, further comprising an adhesive layer disposed on the rigid base shell for adhering to the cervical skin.
11. 11. The vagus nerve stimulation device of claim 10, wherein the rigid base shell is provided with an adhesive layer mounting groove, and the adhesive layer is disposed within the adhesive layer mounting groove.
12. 12. The vagus nerve stimulation device of claim 11, wherein the electrode mounting grooves and the adhesive layer mounting grooves are located on one surface of the hard base shell, which contacts the neck of the human body, two electrode mounting grooves are located at two ends of the hard base shell respectively, and the adhesive layer mounting grooves are located between the two electrode mounting grooves.
13. 13. The vagus nerve stimulation device of any one of claims 1 to 8, wherein the electrode has an adhesive property to adhere the rigid basal shell to the skin of the neck.
14. 14. The vagus nerve stimulation device of claim 13, wherein the electrode is a conductive gel or a conductive double sided adhesive tape.
15. 15. The vagus nerve stimulation device of claim 13, wherein a conductive enhancement layer is further disposed between the electrode and the rigid base shell, the conductive enhancement layer being electrically connected to the electrode.
16. 16. The vagus nerve stimulation device of claim 15, wherein the conductivity enhancing layer comprises a graphite film or a metal film.
17. 17. The vagus nerve stimulation device of any one of claims 1-8, wherein the pulse generation module comprises a circuit board.
18. 18. The vagus nerve stimulation device of claim 17, wherein the rigid base shell has an inner side that faces the skin of the neck and an outer side that faces away from the skin of the neck in use, the electrode is located on the inner side of the rigid base shell, the circuit board is located on the outer side of the rigid base shell, and the two are electrically connected by a conductive portion that passes through the rigid base shell.
19. 19. The vagus nerve stimulation device of claim 18, wherein the conductive portion is a wire or a conductive terminal.
20. 20. The vagus nerve stimulation device of claim 17, wherein the pulse generation module further comprises a protective housing for protecting the circuit board.

Description

Vagus nerve stimulation device and preparation method thereof Technical Field The application relates to the technical field of nerve stimulation devices, in particular to a vagus nerve stimulation device and a preparation method thereof. Background The vagus nerve is used as brain nerve with wide distribution and complex functions in human body, and has important regulating and controlling effects on cardiovascular, digestive, respiratory, immune, emotion regulating and other systems. At present, percutaneous vagal nerve electric stimulation has become an important physical treatment means for treating various diseases such as epilepsy, depression, anxiety, migraine, chronic pain, inflammatory diseases and the like. However, single transdermal electrical stimulation techniques have a therapeutic bottleneck in practical applications. The electric stimulation mainly plays a role in electrophysiological modulation of nerve fibers, and the effect is limited by individual anatomical difference, difficulty in optimizing stimulation parameters, nerve adaptability and other factors to a certain extent. For some patients or some complex diseases, the therapeutic effect achieved by the pure electrical stimulation is effective, and the clinical improvement requirement of a deeper level or a quicker speed is difficult to meet. In view of this, a new technical solution is necessary to overcome the drawbacks of the prior art. Disclosure of Invention Based on the above, the application provides a vagus nerve stimulation device and a preparation method thereof, wherein the vagus nerve stimulation device improves treatment effect and use experience through cooperation of thermal therapy and electric stimulation therapy. The application adopts the following technical scheme that the vagus nerve stimulation device is suitable for being placed at the neck of a human body to stimulate the cervical vagus nerve, and comprises the following components: the electric stimulation unit comprises a pulse generation module and an electrode electrically connected with the pulse generation module; a thermal therapy unit for generating heat; a hard base shell for mounting the electrode and the thermal therapy unit; the hard basal shell bears the electrode and the heat treatment unit, and is arranged on the neck of a human body, so that the electrode contacts with the skin of the neck to output an electric stimulation signal to stimulate the vagus nerve of the neck, and the heat treatment unit heats the electrode or the skin of the neck. In some of these embodiments, the thermal therapy unit comprises an electrical heat generating element. In some embodiments, the electrical heat generating element comprises one or more of a heat generating wire, a PTC heating element, a semiconductor heat generating sheet, and an electrothermal film. In some of these embodiments, the thermal therapy unit comprises a chemically reactive heat generating element. In some of these embodiments, the chemical reaction heat generating element comprises a substance capable of undergoing an exothermic chemical reaction when exposed to air. In some of these embodiments, the thermal therapy unit is a phase change material heat generating element comprising a phase change material capable of releasing heat during a phase change. In some of these embodiments, the rigid base shell is a metal piece or a rigid plastic piece. In some embodiments, the hard base shell is provided with an electrode mounting groove, and the electrode is arranged in the electrode mounting groove. In some of these embodiments, the electrode is a metal electrode. In some of these embodiments, the vagal nerve stimulation device further comprises an adhesive layer disposed on the rigid base shell for adhering to the neck skin. In some embodiments, the hard base shell is provided with an adhesive layer mounting groove, and the adhesive layer is arranged in the adhesive layer mounting groove. In some embodiments, the electrode mounting grooves and the adhesive layer mounting grooves are all positioned on one surface of the hard base shell, which is in contact with the neck of a human body, two electrode mounting grooves are respectively positioned at two ends of the hard base shell, and the adhesive layer mounting grooves are positioned between the two electrode mounting grooves. In some of these embodiments, the electrode has an adhesive property to adhere the rigid base shell to the neck skin as an adhesive layer. In some of these embodiments, the electrode is a conductive gel or a conductive double sided tape. In some embodiments, a conductive enhancement layer is further disposed between the electrode and the rigid base shell, and the conductive enhancement layer is electrically connected to the electrode. In some of these embodiments, the conductivity enhancing layer comprises a graphite film or a metal film. In some of these embodiments, the pulse generation module comprises a circuit board. In