Nasal electrical stimulation device, system and method

Abstract

The present application relates to the technical field of nasal stimulation, and particularly relates to a nasal electrical stimulation device, system and method, wherein the nasal electrical stimulation device comprises a patch body; a first electrode group and a second electrode group electrically connected, the first electrode group and the second electrode group are symmetrically arranged relative to the central axis of the patch body, and a switch piece is arranged on a passage between the first electrode group and the second electrode group; a pressure sensor is arranged on the patch body, the pressure sensor is provided with 2n, n is an integer greater than or equal to 1, and the plurality of pressure sensors are symmetrically arranged relative to the central axis of the patch body. The patch-type flexible pressure sensor is symmetrically arranged, the change of the pressure of alae nasi can be collected without being inserted into the nasal cavity, and the foreign body sensation is completely eliminated. The traditional rod structure is abandoned, the electrode group, the sensor and the processing unit are integrated on the flexible patch, and the miniaturization and light weight of the device are realized. Through the symmetric electrode group and the multi-switch design, the stimulation mode can be flexibly switched.

Description

Technical Field

[0001] This invention relates to the field of electrical stimulation technology, and in particular to a nasal electrical stimulation device, system and method. Background Technology

[0002] Existing rhinitis treatment devices have significant limitations in terms of measurement methods, portability, and treatment adaptability. Traditional devices involve invasive measurements, resulting in poor comfort. Traditional rhinitis information collection devices use a rod structure with built-in pressure sensors. Relying on the rod-insertion pressure sensor to collect nasal cavity data can easily cause discomfort such as foreign body sensation and nasal mucosal irritation, leading to poor user compliance, and are particularly unsuitable for children and sensitive individuals.

[0003] The rod-like structure makes the device complex, preventing miniaturization and integration, and limiting its use in scenarios such as commuting. The limited form factor and the rod-like acquisition structure hinder portability, restricting its application and preventing anytime, anywhere treatment.

[0004] Furthermore, existing electrical stimulation modes are limited and cannot provide targeted stimulation to the nose. Electrical stimulation often employs fixed parameters and bilateral synchronous output, which cannot provide targeted stimulation to the nose, easily leading to overstimulation or undertreatment. These shortcomings result in significant deficiencies in the current equipment regarding personalized treatment, user experience, and clinical applicability. Summary of the Invention

[0005] In this section, as well as in the abstract and title of this application, some simplifications or omissions may be made to avoid obscuring the purpose of this section, the abstract, and the title of this application, and such simplifications or omissions shall not be used to limit the scope of the invention.

[0006] To address the shortcomings of existing technologies, one objective of this invention is to provide a nasal electrical stimulation device, comprising: a patch body; a first electrode group disposed on the patch body; a second electrode group disposed on the patch body, the first electrode group and the second electrode group being electrically connected, the first electrode group and the second electrode group being symmetrically arranged with respect to the central axis of the patch body, a switch being provided in the passage between the first electrode group and the second electrode group; and pressure sensors disposed on the patch body, wherein there are 2n pressure sensors, where n is an integer ≥ 1, and the plurality of pressure sensors are symmetrically arranged with respect to the central axis of the patch body.

[0007] In a preferred embodiment of the nasal electrical stimulation device of the present invention, the first electrode group includes a first positive electrode and a first negative electrode that are electrically connected, and a first switch is provided in the passage between the first positive electrode and the first negative electrode; the second electrode group includes a second positive electrode and a second negative electrode that are electrically connected, and a second switch is provided in the passage between the second positive electrode and the second negative electrode.

[0008] In a preferred embodiment of the nasal electrical stimulation device of the present invention, the first positive electrode and the second negative electrode are electrically connected, and a third switch is provided in the path between the first positive electrode and the second negative electrode; the second positive electrode and the first negative electrode are electrically connected, and a fourth switch is provided in the path between the second positive electrode and the first negative electrode.

[0009] Another objective of this invention is to provide a nasal electrical stimulation system, comprising: an electrode module for electrically stimulating nasal tissue; the electrode module having a built-in constant current source unit; a pressure sensor for acquiring pressure data in the nasal alar region and generating pressure measurements; a bioimpedance measurement unit for acquiring bioimpedance data of nasal tissue and generating impedance measurements, the constant current source unit being electrically connected to the bioimpedance measurement unit; and a processing unit for constructing a measurement vector from the pressure and impedance measurements, and generating a predicted state vector for the current moment based on a preset state transition matrix onto the state vector of the previous moment, and generating a prediction error covariance; further, calculating a Kalman gain based on the prediction error covariance, the observation matrix, and the measurement noise covariance, correcting the predicted state vector according to the Kalman gain and the measurement vector, and generating a current optimal state vector characterizing the patency of the nasal cavity; and the processing unit being electrically connected to the constant current source unit; and the electrode module adjusting the output electrical stimulation parameters according to the current optimal state vector.

[0010] As a preferred embodiment of the nasal electrical stimulation system of the present invention, the state vector includes a nasal patency index and a rate of change of the nasal patency index.

[0011] As a preferred embodiment of the nasal electrical stimulation system of the present invention, the system further includes: the processing unit applying the observation matrix to the predicted state vector and generating a predicted measurement vector; calculating the residual between the measurement vector and the predicted measurement vector; multiplying the Kalman gain by the residual and adding the result to the predicted state vector to obtain the current optimal state vector; The processing unit is further configured to: update the prediction error covariance for the prediction step at the next time step; the processing unit determines the electrical stimulation parameters based on the nasal patency index in the current optimal state vector through a preset stimulation strategy mapping table.

[0012] Another objective of this invention is to provide a nasal electrical stimulation method, comprising: acquiring pressure data of the nasal alar region and bioimpedance data of nasal tissue, and constructing a measurement vector; executing a prediction step of a Kalman filter algorithm, applying a state transition matrix to the state vector at the previous moment to generate a predicted state vector at the current moment; executing an update step of a Kalman filter algorithm, calculating the Kalman gain, correcting the predicted state vector according to the measurement vector, and generating a current optimal state vector characterizing the patency of the user's nasal cavity; and adjusting electrical stimulation parameters based on the current optimal state vector.

[0013] As a preferred embodiment of the nasal electrical stimulation method of the present invention, the method comprises: calculating the Kalman gain based on the prediction error covariance, the observation matrix, and the measurement noise covariance; calculating the residual between the measurement vector and the predicted state vector after transformation by the observation matrix; and correcting the predicted state vector according to the Kalman gain and the residual.

[0014] As a preferred embodiment of the nasal electrical stimulation method of the present invention, the following steps are performed: update the error covariance, repeat the above steps, and perform closed-loop control at the next time step.

[0015] As a preferred embodiment of the nasal electrical stimulation method of the present invention, the nasal patency index in the current optimal state vector is compared with a preset threshold, and the corresponding electrical stimulation parameters are selected according to the comparison result.

[0016] The beneficial effects of this invention are as follows: It employs a symmetrical layout of a patch-type flexible pressure sensor, allowing for the acquisition of nasal pressure changes without insertion into the nasal cavity, completely eliminating the feeling of a foreign object and improving wearing comfort and user compliance. Abandoning the traditional rod structure, the electrode assembly, sensor, and processing unit are integrated into a flexible patch, achieving miniaturization and lightweight design, suitable for daily wear and use in various scenarios. Through a symmetrical electrode assembly and multi-switch design, it allows for flexible switching between unilateral non-cross-nasal, bilateral independent, and cross-nasal stimulation modes. Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the nasal electrical stimulation method of the present invention.

[0019] Figure 2 This is a structural diagram of the nasal electrical stimulation method of the present invention.

[0020] Figure 3This is a diagram showing the assembly of components in the nasal electrical stimulation method of the present invention.

[0021] Figure 4 This is a cross-sectional view of the components of the nasal electrical stimulation method of the present invention. Detailed Implementation

[0022] To make the objectives, features, and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0023] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0024] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places in this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that is mutually exclusive with other embodiments.

[0025] Example 1

[0026] Reference Figure 1 This embodiment is the first embodiment of the invention, providing a nasal stimulation device. The device includes a patch body 101, a first electrode group 102, a second electrode group 103, and multiple pressure sensors 105.

[0027] Specifically, the patch body 101 is the base of the entire device, and its shape and material are designed to adhere comfortably and securely to the user's nose, for example, using medical-grade flexible silicone or non-woven fabric. The first electrode group 102 and the second electrode group 103 are electrically connected and disposed on the patch body 101. To accommodate the symmetrical structure of the nose, the first electrode group 102 and the second electrode group 103 are symmetrically arranged with respect to the central axis of the patch body 101, corresponding to the left and right sides of the user's nose, respectively. A switch 104 is provided in the electrical path between the first electrode group 102 and the second electrode group 103, and the switch 104 is used to control the on / off state between the two sides of the first electrode group 102 and the second electrode group 103.

[0028] Pressure sensors 105 are also disposed on the patch body 101, and their function is to monitor and collect minute changes in skin pressure in the user's nasal region caused by breathing airflow. To comprehensively and accurately capture these signals, the number of pressure sensors 105 is 2^n, where n is an integer ≥ 1. These multiple pressure sensors 105 are also symmetrically distributed with respect to the central axis of the patch body 101; for example, n sensors are placed at the corresponding positions on the left nasal wing and n sensors are placed at the corresponding positions on the right nasal wing, thereby enabling symmetrical monitoring of ventilation in both nasal cavities.

[0029] Example 2

[0030] Reference Figures 1-3 This embodiment is the second embodiment of the present invention, and this embodiment is based on embodiment 1.

[0031] Specifically, the first electrode group 102 contains a first positive electrode 102a and a first negative electrode 102b, which are connected by an electrical path, and a first switch 102c is provided on the path. Similarly, the second electrode group 103 contains a second positive electrode 103a and a second negative electrode 103b, which are also connected by an electrical path, and a second switch 103c is provided on the path.

[0032] By controlling the on / off state of the first switch 102c and the second switch 103c, the first electrode group 102 and the second electrode group 103 can be independently controlled to form an independent stimulation circuit. For example, when the first switch 102c is closed, current can flow between the first positive electrode 102a and the first negative electrode 102b, providing precise non-transnasal stimulation to acupoints on one side of the nose (such as Yingxiang and Shangyingxiang acupoints). This independent control method enhances the flexibility of the stimulation mode, allowing for targeted treatment of more severe unilateral nasal congestion, thus improving the specificity of the treatment.

[0033] Preferably, the switching element 104 is specifically configured as a third switch 104a and a fourth switch 104b. Specifically, the first positive electrode 102a in the first electrode group 102 is electrically connected to the second negative electrode 103b in the second electrode group 103, and the third switch 104a is disposed in the path between them. Simultaneously, the second positive electrode 103a in the second electrode group 103 is electrically connected to the first negative electrode 102b in the first electrode group 102, and the fourth switch 104b is disposed in the path between them.

[0034] This cross-connection design enables the device to perform cross-nasal stimulation. When the third switch 104a and the fourth switch 104b are closed (while the first switch 102c and the second switch 103c are open), current can flow from the positive electrode on one nostril to the negative electrode on the other, forming a stimulation circuit across the bridge of the nose. This cross-nasal stimulation mode can simultaneously act on acupoints around the nose on both sides, producing a wider and deeper stimulation effect, which can improve bilateral nasal congestion or overall nasal microcirculation. By combining and controlling the first switch 102c, the second switch 103c, the third switch 104a, and the fourth switch 104b, the nasal stimulation device can flexibly switch or combine various stimulation modes such as left-side single-circuit, right-side single-circuit, and cross-nasal cross-circuit to adapt to different treatment needs.

[0035] Example 3

[0036] Reference Figures 1-4 This embodiment provides a nasal electrical stimulation system, including an electrode module 200, a pressure sensor 105, a bioimpedance measurement unit 300, and a processing unit 400. The core of this embodiment lies in how the processing unit 400 uses a Kalman filter algorithm to process the sensor data to achieve intelligent control. The Kalman filter algorithm is existing technology; this embodiment describes how to use the Kalman filter algorithm to process the sensor data.

[0037] Specifically, electrode module 200 is used to apply electrical stimulation to nasal tissue, and its specific structure can be referred to the first electrode group 102 and the second electrode group 103 described in embodiments 1 and 2. Pressure sensor 105 is used to collect pressure data in the nasal alar region and generate pressure measurement values. Bioimpedance measurement unit 300 is used to collect bioimpedance data of nasal tissue and generate impedance measurement values. In a preferred embodiment, bioimpedance measurement unit 300 reuses the first electrode group 102 and the second electrode group 103 in electrode module 200. By applying a probe current and measuring the voltage between the electrodes, it calculates, for example, the bioimpedance of facial tissue between the two electrodes of the first electrode group 102 according to Ohm's law (Z=V / I). It is worth noting that during a rhinitis attack (nasal congestion), the nasal mucosa becomes congested and edematous, and tissue fluid increases, causing changes in the conductivity of the tissue in this area, thereby causing changes in bioimpedance values. Therefore, bioimpedance is a key indicator that can directly reflect the physiological state of the nasal mucosa.

[0038] Preferably, the present invention can integrate a constant current source unit 201 (such as using an LM317 chip) within the electrode module 200. The constant current source unit 201 is existing technology and will not be described in detail. The core function of the constant current source unit 201 is to maintain a constant output current through negative feedback adjustment when the nasal skin impedance fluctuates, avoiding unstable treatment effects or skin discomfort caused by fluctuating stimulation intensity. For example, the adjustable constant current function is implemented through a processing unit 400 and a digital-to-analog converter module. The processing unit 400 outputs digital instructions based on the nasal patency index, and the digital-to-analog converter module converts these into corresponding voltage signals to control the reference voltage of the constant current source, thereby achieving continuous adjustment within the range of 0.1~2mA (0.1mA step) to adapt to the treatment needs of different degrees of inflammation.

[0039] When the bioimpedance measurement unit 300 detects a change in the impedance of the nasal tissue (e.g., from 30Ω to 45Ω), the processing unit 400 adjusts the output voltage (U=I×R) in real time through the feedback signal of the constant current source to ensure that the current value remains at a set constant value (e.g., 1mA) and the fluctuation is controlled within ±0.05mA.

[0040] In coordination with the stimulation mode, during unilateral non-transnasal stimulation, the constant current value is fixed at the current optimal value (e.g., when the left nasal obstruction is severe, the left electrode group outputs a constant current of 1.8mA); during transnasal stimulation, the current is dynamically distributed according to the difference in patency between the two sides (e.g., when the left index is 20% and the right index is 50%, the left pathway has a constant current of 1.6mA and the right pathway has a constant current of 1.0mA).

[0041] Preferably, the processing unit 400 is responsible for controlling the entire nasal electrical stimulation system. First, the received pressure and impedance measurements are combined to form a measurement vector. Next, the processing unit 400 executes a Kalman filter algorithm to estimate the true patency of the nasal cavity through a two-step process. The first step is prediction: based on a preset state transition matrix and the state vector from the previous moment, the processing unit 400 generates a predicted state vector for the current moment, and simultaneously generates a prediction error covariance. The second step is updating: based on the prediction error covariance generated in the prediction step, a preset observation matrix, and a preset measurement noise covariance, the processing unit 400 calculates the Kalman gain. Finally, the predicted state vector is corrected using the Kalman gain and the current measurement vector, thereby generating a current optimal state vector that most accurately represents the patency of the nasal cavity. The electrode module 200 then adjusts its output electrical stimulation parameters in real time according to this current optimal state vector output by the processing unit 400.

[0042] To more comprehensively describe the nasal cavity condition, the state vector in this embodiment is defined as containing two pieces of information: the nasal patency index and the rate of change of this index. The nasal patency index is a quantitative indicator (e.g., 0-100%) that represents the severity of nasal congestion. The rate of change of the nasal patency index describes whether the nasal congestion is worsening, improving, or remaining stable.

[0043] To implement the Kalman filter update step, the specific calculation process of the processing unit 400 is as follows: First, the processing unit 400 applies the observation matrix to the previously obtained predicted state vector to generate a predicted measurement vector. Then, it calculates the difference between the actual measurement vector and this predicted measurement vector; this difference is called the residual. Next, the processing unit 400 multiplies the calculated Kalman gain by this residual and adds the result to the initial predicted state vector. Through this correction, the current optimal state vector is obtained. After completing one update, the processing unit 400 also updates the prediction error covariance to prepare for the prediction step at the next moment. After obtaining the current optimal state vector, the processing unit 400 extracts the nasal patency index and refers to a preset stimulation strategy mapping table to finally determine the electrical stimulation parameters to be output. For example, the mapping table can specify: when the patency index is below 30%, high-intensity stimulation is used; when the index is between 30% and 70%, medium-intensity stimulation is used; when the index is above 70%, the intensity is reduced or stimulation is paused.

[0044] Example 4

[0045] Reference Figures 1-4 This embodiment is the fourth embodiment of the invention. This embodiment provides a nasal electrical stimulation method corresponding to the system in Embodiment 3. The core of this method is the application of the Kalman filter algorithm, and its specific steps are as follows: First, pressure data from the nasal alar region is acquired using pressure sensor 105, and bioimpedance data from the nasal tissue is acquired using bioimpedance measurement unit 300. These two sets of data are combined to form a measurement vector. Next, the prediction step of the Kalman filter algorithm is executed. Specifically, a preset state transition matrix is ​​applied to the state vector from the previous moment to generate the predicted state vector for the current moment. Following this, the update step of the Kalman filter algorithm is executed. The core of this step is to calculate the Kalman gain and correct the predicted state vector based on the actual measurement vector, ultimately generating an optimal state vector that characterizes the user's nasal patency. Finally, based on this optimal state vector, the method dynamically adjusts the electrical stimulation parameters output to the electrodes.

[0046] In the update step, the calculation of the Kalman gain is based on three key preset parameters: prediction error covariance, observation matrix, and measurement noise covariance. After calculating the Kalman gain, the residual between the actual measurement vector and the predicted state vector transformed by the observation matrix is ​​further calculated. Finally, based on the calculated Kalman gain and this residual, the predicted state vector is finally corrected to obtain the optimal solution.

[0047] This method is a continuous closed-loop control process. After one calculation cycle (one prediction and update), the method updates the error covariance value, then immediately enters the next calculation cycle with the latest state vector and error covariance, repeating the above steps of acquisition, prediction, update, and adjustment. This uninterrupted loop enables the system to track the dynamic changes in the nasal cavity state in real time and perform immediate feedback adjustments, achieving truly intelligent closed-loop control.

[0048] In the specific step of adjusting the electrical stimulation parameters, the nasal patency index extracted from the current optimal state vector is compared with one or more preset thresholds. For example, two thresholds, T1 and T2 (e.g., 30% and 70%), are set. If the index is below T1, it is determined to be severe nasal obstruction, and high-intensity electrical stimulation parameters are selected; if the index is between T1 and T2, it is determined to be moderate nasal obstruction, and medium-intensity parameters are selected; if the index is above T2, it is determined to be patent, and low-intensity or zero-intensity (pause) parameters are selected. In this way, continuous state assessment is converted into discrete or segmented control commands to drive the electrode module to work.

[0049] To facilitate understanding of the technical solution of this invention, its working process is briefly described below: The user attaches the patch body, which includes a symmetrical first electrode group 102, a second electrode group 103, and a pressure sensor 105, to the nose. After the nasal electrical stimulation system is activated, the pressure sensor 105 and the bioimpedance measurement unit 300 (using the reused first electrode group 102 and second electrode group 103) begin synchronously acquiring pressure and impedance data. The processing unit 400 receives this sensor data and performs fusion processing using a Kalman filter algorithm. This algorithm accurately estimates the user's real-time nasal patency index through continuous prediction-update loops. Finally, based on this index, and by consulting a built-in stimulation strategy table, the stimulation intensity, frequency, and mode (such as non-transnasal or transnasal modes) of the electrode output are automatically and in real-time adjusted, thereby achieving personalized and efficient closed-loop treatment of rhinitis symptoms while ensuring comfort and safety.

[0050] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A nasal stimulation device, characterized in that: include, Patch body (101); The first electrode group (102) is disposed on the patch body (101); The second electrode group (103) is disposed on the patch body (101). The first electrode group (102) and the second electrode group (103) are electrically connected and are symmetrically arranged with respect to the central axis of the patch body (101). A switch (104) is provided on the passage between the first electrode group (102) and the second electrode group (103). A pressure sensor (105) is disposed on the patch body (101). There are 2n pressure sensors (105), where n is an integer ≥1. The multiple pressure sensors (105) are symmetrically arranged with respect to the central axis of the patch body (101).

2. The nasal stimulation device as described in claim 1, characterized in that: The first electrode group (102) includes a first positive electrode (102a) and a first negative electrode (102b) that are electrically connected, and a first switch (102c) is provided in the passage between the first positive electrode (102a) and the first negative electrode (102b). The second electrode group (103) includes a second positive electrode (103a) and a second negative electrode (103b) that are electrically connected, and a second switch (103c) is provided in the passage between the second positive electrode (103a) and the second negative electrode (103b).

3. The nasal stimulation device as described in claim 2, characterized in that: The first positive electrode (102a) and the second negative electrode (103b) are electrically connected, and a third switch (104a) is provided in the passage between the first positive electrode (102a) and the second negative electrode (103b); the second positive electrode (103a) and the first negative electrode (102b) are electrically connected, and a fourth switch (104b) is provided in the passage between the second positive electrode (103a) and the first negative electrode (102b).

4. A nasal electrical stimulation system, characterized in that: include, Electrode module (200) for electrical stimulation of nasal tissue, wherein the electrode module (200) has a built-in constant current source unit (201). A pressure sensor (105) is used to collect pressure data in the nasal region and generate pressure measurements. A bioimpedance measurement unit (300) is used to collect bioimpedance data of nasal tissue and generate impedance measurement values. The constant current source unit (201) is electrically connected to the bioimpedance measurement unit (300). The processing unit (400) is used to construct a measurement vector from the pressure measurement value and the impedance measurement value, and to generate the predicted state vector at the current moment based on the preset state transition matrix onto the state vector at the previous moment, and to generate the prediction error covariance; it also calculates the Kalman gain based on the prediction error covariance, the observation matrix and the measurement noise covariance, and corrects the predicted state vector according to the Kalman gain and the measurement vector to generate the current optimal state vector characterizing the patency of the nasal cavity; and the processing unit (400) is electrically connected to the constant current source unit (201); The electrode module (200) adjusts the output electrical stimulation parameters according to the current optimal state vector.

5. The nasal electrical stimulation system as described in claim 4, characterized in that: The state vector includes the nasal patency index and the rate of change of the nasal patency index.

6. The nasal electrical stimulation system as described in claim 4, characterized in that: The processing unit (400) also applies the observation matrix to the predicted state vector and generates a predicted measurement vector; calculates the residual between the measurement vector and the predicted measurement vector; multiplies the Kalman gain with the residual and adds the result to the predicted state vector to obtain the current optimal state vector. The processing unit (400) is also configured to update the prediction error covariance for the prediction step at the next time step; The processing unit (400) determines the electrical stimulation parameters based on the nasal patency index in the current optimal state vector through a preset stimulation strategy mapping table.

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