Portable vagus nerve stimulation treatment equipment and use method thereof

Abstract

The invention provides a portable vagus nerve stimulation treatment device and a use method thereof, and the device comprises an ear stimulation assembly which is used for stimulating the vagus nerve of the ear of a patient; the acquisition module is used for acquiring the intensity of a sympathetic nerve signal of the patient; and the host is used for controlling stimulation parameters of the ear stimulation assembly according to the intensity of the sympathetic nerve signal. The ear sympathetic nerves of a patient can be stimulated through the device, and then the patient is treated.

Description

Technical Field

[0001] This application belongs to the field of wearable medical devices, and in particular relates to a portable vagus nerve stimulation therapy device and its method of use. Background Technology

[0002] Cardiovascular diseases have become a major factor seriously endangering human health in modern society. Various arrhythmias, such as atrial fibrillation and premature ventricular contractions, are extremely common in clinical practice. The incidence of myocardial infarction is constantly increasing, and the age of onset for myocardial infarction is showing a trend towards younger ages. Arrhythmias following myocardial infarction and heart failure can often worsen the disease and even cause sudden death. Although there are currently PCI surgery, radiofrequency ablation surgery, and various drugs for treating arrhythmias and delaying ventricular remodeling available in clinical practice, each has its limitations.

[0003] Vagus nerve stimulation (VNS) has been used to treat cardiovascular diseases for nearly a century, initially for the prevention and treatment of malignant ventricular arrhythmias following myocardial infarction. With further research, VNS has been found to have protective effects against myocardial ischemia-reperfusion injury and heart failure. Recent studies have revealed that VNS may exert its protective effects on cardiovascular diseases through mechanisms such as reducing inflammatory responses and oxidative stress, improving endothelial cell function, and inhibiting sympathetic nerve activation. However, related VNS treatments require surgical implantation of a neck stimulator, a procedure that is not only expensive but also carries risks such as bleeding, infection, and nerve damage, limiting its widespread application. Therefore, designing a low-cost, safe, and effective vagus nerve stimulator is a pressing issue that needs to be addressed. Summary of the Invention

[0004] In view of this, this application provides a portable vagus nerve stimulation therapy device and its method of use, which aims to stimulate the vagus nerve in the ear of patients in a low-cost, safe and effective manner.

[0005] In a first aspect, this application provides a portable vagus nerve stimulation therapy device, comprising: Ear stimulation component, used to stimulate the vagus nerve in the patient's ear; The acquisition module is used to acquire the intensity of the patient's sympathetic nerve signals; The main unit is used to control the stimulation parameters of the ear stimulation component based on the intensity of sympathetic nerve signals.

[0006] Optionally, the ear stimulation component: Used for electrical, magnetic, or ultrasonic stimulation of the vagus nerve in the ear.

[0007] Optionally, the ear stimulation component includes: The main body, and several electrodes disposed on the main body.

[0008] Optionally, the electrode includes: First electrode and second electrode; the first electrode is disposed on the side of the main body near the patient's ear, and the second electrode is disposed on the top of the main body via a flexible mounting rod.

[0009] Optionally, the acquisition module includes a plurality of patch electrodes.

[0010] Optionally, a clamping part is provided on the side of the host.

[0011] Optionally, the ear stimulation component is wired or wirelessly connected to the host.

[0012] Secondly, this application provides a method of using a portable vagus nerve stimulation therapy device, including: Stimulating the vagus nerve in the patient's ear; To obtain the intensity of the patient's sympathetic nerve signals; The stimulation parameters of the vagus nerve in the ear are adjusted according to the intensity of the sympathetic nerve signal.

[0013] Optionally, the stimulation parameters include stimulation frequency and stimulation intensity.

[0014] Optionally, if the intensity of the sympathetic nerve signal does not reach a preset value, the stimulation frequency and stimulation intensity are increased until the intensity of the sympathetic nerve signal reaches the preset value.

[0015] The beneficial effects of the technical solution provided in this application include: The ear stimulation component stimulates the vagus nerve in the ear, and then the host and acquisition module detect the sympathetic nerve signals. Based on the intensity of the sympathetic nerve signals, it is determined whether the stimulation of the vagus nerve in the ear is effective. Then, based on the judgment result, the stimulation intensity, stimulation frequency and other parameters of the ear stimulation component are adjusted to achieve the preset effect of vagus nerve stimulation, so as to improve cardiovascular diseases such as arrhythmia. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of the host and acquisition module provided in an embodiment of this application; Figure 2 This is a schematic diagram of the structure of the host and the acquisition module provided in another embodiment of this application; Figure 3 This is a schematic diagram of the structure of an ear stimulation component provided in an embodiment of this application; Figure 4 This is a schematic diagram of the structure of an ear stimulation component provided in another embodiment of this application; Figure 5 This is a schematic diagram of the structure of an ear stimulation component provided in another embodiment of this application; Figure 6 This is a schematic diagram showing the placement position of the patch electrode according to an embodiment of this application; Figure 7 A flowchart illustrating the method of using a portable vagus nerve stimulation therapy device provided in an embodiment of this application.

[0018] The attached figures are labeled as follows: 11: Ear stimulation component; 111: Main body; 112: First electrode; 113: Second electrode; 114: Flexible mounting rod; 115: First charging electrode; 116: Second charging electrode; 12: Acquisition module; 121: Surface mount electrode; 122: Connecting wire; 13: Main unit; 131: Clamping part. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0020] See Figures 1 to 5 This application provides a portable vagus nerve stimulation therapy device, comprising: Ear stimulation component 11 is used to stimulate the vagus nerve in the patient's ear. Acquisition module 12 is used to acquire the patient's sympathetic nerve signals; The host unit 13 is used to control the stimulation parameters of the ear stimulation component according to the intensity of the sympathetic nerve signal.

[0021] In some examples, the ear stimulation component 11: Used for electrical, magnetic, or ultrasonic stimulation of the vagus nerve in the ear.

[0022] In some examples, the ear stimulation component 11 includes: The main body 111, and several electrodes disposed on the main body 111.

[0023] In some examples, the body 111 is shaped like an earphone.

[0024] In some examples, the ear stimulation component 11 is positioned in both the patient's left and right ears. For an example of the ear stimulation component 11 positioned in the left ear, please refer to [link to example]. Figure 3 Please refer to the ear stimulation component 11 located in the right ear. Figure 4 .

[0025] In some examples, the electrode includes: A first electrode 112 and a second electrode 113; the first electrode 112 is disposed on the side of the main body 111 near the patient's ear, and the second electrode 113 is disposed on the top of the main body 111 via a flexible mounting rod 114.

[0026] One of the stimulation electrodes on the ear stimulation assembly can be mounted on a flexible mounting rod, and the contact position of the second electrode can be finely adjusted by bending the flexible mounting rod.

[0027] In some examples, the first and second electrodes are positioned to correspond to the vagus nerve distribution area in the patient's ear. For instance, the first and second electrodes are positioned to correspond to the area of ​​the cymba conchae in the patient's ear.

[0028] In some examples, the ear stimulation assembly 11 includes a power source (not shown) and a first charging electrode 115 and a second charging electrode 116 for charging the power source.

[0029] In some examples, the acquisition module 12 includes a plurality of patch electrodes 121.

[0030] In some examples, the number of patch electrodes 121 is six. This allows for the simultaneous measurement of the patient's electrocardiogram (ECG) signals via chest leads using six patch electrodes, enabling early warning of cardiac events based on these signals (alarm warnings of acute cardiac problems such as arrhythmias or myocardial infarction based on abnormal ECG signals). Alternatively, using only five patch electrodes can acquire the intensity of the patient's sympathetic nerve signals.

[0031] See Figure 6 The diagram shows the specific placement of the five patch electrodes 121 when measuring the intensity of sympathetic nerve signals.

[0032] Specifically, a patch electrode Ch 1+ is placed in the black area of ​​the left clavicle, a patch electrode Ch 1- is placed in the white area of ​​the right clavicle, a patch electrode Ch 2- is placed in the red area below the right clavicle, a patch electrode Ch 2+ is placed in the left lumbar region, and a patch electrode Ch0 is placed in the right lumbar region.

[0033] In some examples, the patch electrode 121 is connected to the host 13 via a connecting wire 122.

[0034] In one embodiment, a storage and charging slot for the ear stimulation component can be provided on the surface of the host 13.

[0035] In some examples, the main unit 13 has a clamping part 131 on its side. By providing the clamping part on the main unit, the main unit can be secured to a collar or other location for easy carrying.

[0036] In some examples, the ear stimulation component 11 is wired or wirelessly connected to the host 13.

[0037] The working principle of the treatment device is as follows: the ear stimulation component stimulates the vagus nerve in the ear, and the host and patch electrodes detect the sympathetic nerve signals. The intensity of the sympathetic nerve signals determines whether the stimulation of the vagus nerve in the ear has achieved the desired effect. Based on the determination result, the stimulation intensity, stimulation frequency and other parameters of the ear stimulation component are adjusted to achieve closed-loop control.

[0038] Specifically, when the host detects that the sympathetic nerve signal has not reached the set threshold, it means that the ear stimulation component is not stimulating the vagus nerve in the ear. In this case, the stimulation intensity or frequency of the ear stimulation component can be increased to achieve the preset effect of stimulating the vagus nerve, thereby improving cardiovascular diseases such as arrhythmia.

[0039] Figure 7 A flowchart illustrating the method of using the portable vagus nerve stimulation therapy device provided in one embodiment of this application. See also... Figure 7 ,include: S101 stimulates the vagus nerve in the patient's ear.

[0040] Among them, the vagus nerve in the patient's ear is stimulated by an ear stimulation component.

[0041] S102, obtains the intensity of the patient's sympathetic nerve signals.

[0042] The method involves using several patch electrodes to acquire the intensity of the patient's sympathetic nerve signals and / or the patient's electrocardiogram signals.

[0043] S103 adjusts the stimulation parameters of the vagus nerve in the ear according to the intensity of the sympathetic nerve signal.

[0044] In some examples, the stimulation parameters include stimulation frequency and stimulation intensity.

[0045] In some examples, when the intensity of the sympathetic nerve signal does not reach a preset value, the stimulation frequency and intensity are increased until the sympathetic nerve signal reaches the preset value.

[0046] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A portable vagus nerve stimulation therapy device, characterized in that, include: Ear stimulation component, used to stimulate the vagus nerve in the patient's ear; The acquisition module is used to acquire the intensity of the patient's sympathetic nerve signals; The main unit is used to control the stimulation parameters of the ear stimulation component based on the intensity of sympathetic nerve signals.

2. The portable vagus nerve stimulation therapy device according to claim 1, characterized in that, The ear stimulation component: Used for electrical, magnetic, or ultrasonic stimulation of the vagus nerve in the ear.

3. The portable vagus nerve stimulation therapy device according to claim 1, characterized in that, The ear stimulation component includes: The main body, and several electrodes disposed on the main body.

4. The portable vagus nerve stimulation therapy device according to claim 3, characterized in that, The electrode includes: First electrode and second electrode; the first electrode is disposed on the side of the main body near the patient's ear, and the second electrode is disposed on the top of the main body via a flexible mounting rod.

5. The portable vagus nerve stimulation therapy device according to claim 1, characterized in that, The acquisition module includes several patch electrodes.

6. The portable vagus nerve stimulation therapy device according to claim 1, characterized in that, The main unit has a clamping part on its side.

7. The portable vagus nerve stimulation therapy device according to claim 1, characterized in that, The ear stimulation component is connected to the host computer via wired or wireless connection.

8. A method of using a portable vagus nerve stimulation therapy device, characterized in that, include: Stimulate the vagus nerve in the patient's ear; To obtain the intensity of the patient's sympathetic nerve signals; The stimulation parameters of the vagus nerve in the ear are adjusted according to the intensity of the sympathetic nerve signal.

9. The method of using the portable vagus nerve stimulation therapy device according to claim 8, characterized in that, The stimulation parameters include stimulation frequency and stimulation intensity.

10. The method of using the portable vagus nerve stimulation therapy device according to claim 8, characterized in that, If the intensity of the sympathetic nerve signal does not reach the preset value, the stimulation frequency and intensity are increased until the intensity of the sympathetic nerve signal reaches the preset value.

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