Non-implantable medical device and system with electrode insertion detection and management

Abstract

The application provides a non-implanted medical device and system, wherein the non-implanted medical device comprises a device main body and an electrode, and is characterized in that the device main body comprises a controller, a stimulation circuit and a detection circuit, the controller is electrically connected with the stimulation circuit and the detection circuit; wherein the electrode is detachably connected with the device main body; when the electrode is inserted into the device main body, the electrode is electrically connected with the stimulation circuit and the detection circuit, and the detection circuit outputs a first electric signal; when the electrode is disconnected with the device main body, the detection circuit outputs a second electric signal different from the first electric signal.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and more specifically, relates to a non-implantable medical device and system with electrode insertion detection and management. Background Technology

[0002] In today's medical field, electrode stimulation has become an effective treatment method. Electrode stimulation devices can be further divided into implantable and non-implantable electrode stimulation devices, depending on whether they are implanted into the patient's body. Compared to implantable electrode stimulation devices, which require surgical implantation of electrodes into the target nerve region, non-implantable electrode stimulation devices are increasingly valued by medical institutions and patients due to several advantages. These advantages include: (1) avoiding the risks of infection and rejection associated with implantation surgery; (2) flexibility and reversibility, such as dynamic adjustment of electrode position; (3) adaptability to individualized treatment; and (4) lower overall cost.

[0003] As an application of non-implantable electrode stimulation devices, tongue muscle electrical stimulation devices have been investigated for the treatment of obstructive sleep apnea (OSA). OSA is a common sleep disorder characterized by recurrent complete or partial obstruction of the upper airway during sleep, leading to interrupted or shallow breathing. It is associated with a variety of chronic diseases, including coronary heart disease, hypertension, arrhythmias, type II diabetes, cerebrovascular disease, and cognitive impairment. Tongue muscle electrical stimulation has shown potential effectiveness in activating the tongue muscles by stimulating them to prevent the tongue from falling back during sleep, thereby maintaining the opening of the upper airway. For example, the prior art provides a device for training oral muscles, comprising a mouthpiece having at least one electrode device associated with the mouthpiece, with circuitry operatively connected to the electrode device, wherein the device is configured to provide electrical stimulation to one or more oral muscles (e.g., tongue muscles and optionally palatine muscles) via the inner membrane of the mouth (e.g., oral mucosa) through at least one electrode device during use.

[0004] In these types of non-implantable electrode stimulation devices, the electrodes are used to apply electrical stimulation to the treatment site, making them a crucial component. Electrode malfunction or disconnection can lead to incomplete treatment or even render the device unusable. Detecting electrode insertion and managing its lifespan in non-implantable electrode stimulation devices can improve maintenance efficiency, extend the device's lifespan, and reduce overall costs. Utility Model Content

[0005] According to a first aspect of this application, a non-implantable medical device is provided, comprising a device body and electrodes, characterized in that the device body includes a controller, a stimulation circuit, and a detection circuit, the controller being electrically connected to the stimulation circuit and the detection circuit; wherein the electrodes are detachably connected to the device body; when the electrodes are inserted into the device body, the electrodes are electrically connected to the stimulation circuit and the detection circuit, and the detection circuit outputs a first electrical signal; when the electrodes are disconnected from the device body, the detection circuit outputs a second electrical signal different from the first electrical signal.

[0006] According to an embodiment of this application, the detection circuit includes a voltage excitation source, one end of which is grounded, and the other end of which is connected to the controller via a resistor; the first electrical signal and the second electrical signal output by the detection circuit are voltage signals.

[0007] According to an embodiment of this application, the electrode includes a matching resistor. When the electrode is inserted into the device body, one end of the matching resistor is connected to the detection circuit, and the other end of the matching resistor is grounded, forming a voltage divider circuit.

[0008] According to an embodiment of this application, the detection circuit is part of the stimulation circuit.

[0009] According to an embodiment of this application, the electrode includes a storage unit, and the controller includes a communication interface module. When the electrode is inserted into the device body, the communication interface module is connected to the storage unit.

[0010] According to an embodiment of this application, the storage unit pre-stores electrode life parameters, including the electrode manufacturing date and rated usage time, and the main body of the device includes a timing circuit for recording the actual energization time of the electrode.

[0011] According to a second aspect of this application, a non-implantable medical system is provided, characterized in that the non-implantable medical system includes: the aforementioned non-implantable medical device; and an electronic device, wherein the electronic device is connected to the non-implantable medical device via a physical communication interface; the electronic device includes a parameter configuration module and a data receiving module.

[0012] According to an embodiment of this application, the electronic device includes a display unit configured to display information associated with electrode insertion detection of the non-implantable medical device.

[0013] According to an embodiment of this application, the electrical stimulation waveform parameters of the stimulation circuit of the non-implantable medical device are set by the parameter configuration module.

[0014] According to an embodiment of this application, it further includes a cloud device that communicates with the electronic device, and a data synchronization channel is established between the data transceiver module of the electronic device and the cloud device.

[0015] Compared with existing technologies, this application achieves a non-implantable medical device with electrode insertion detection and management functions through the above technical solution. Electrode insertion and disconnection detection improves the safety of the medical device and enhances the user experience. Furthermore, by managing the electrodes, such as through lifespan management, issues like electrode aging can be detected promptly, allowing for timely replacement, ensuring treatment effectiveness, improving the maintenance efficiency of the medical device, and reducing overall costs. Attached Figure Description

[0016] This application will now be described by way of example and with reference to the accompanying drawings, wherein:

[0017] Figure 1 This is a schematic diagram of the treatment system involved in the embodiments of this application.

[0018] Figure 2 This is a basic structural block diagram of the non-implantable medical device involved in the embodiments of this application.

[0019] Figure 3 This is a schematic diagram of electrode insertion detection for the non-implantable medical device of this application.

[0020] Figure 4 This is a schematic diagram of one embodiment of the circuit structure for electrode insertion detection according to this application. Detailed Implementation

[0021] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of the present application, and not all embodiments. Furthermore, all other embodiments obtained by those skilled in the art based on the embodiments of the present application without creative effort are within the scope of protection of the present application.

[0022] Figure 1This is a schematic diagram of the treatment system 100 according to an embodiment of this application. As shown, the non-implantable medical device 1 can communicate wirelessly or wiredly with the electronic device 2, receiving data or instructions from the electronic device 2 and transmitting treatment-related data to the electronic device 2. The non-implantable medical device 1 may be, for example, a tongue muscle stimulator device for treating obstructive sleep apnea, and the electronic device 2 may be an electronic device such as a smartphone, tablet, or desktop computer. Wireless communication may include near-field communication (NFC), Bluetooth, Wi-Fi, mobile networks, etc. Wired communication connections may include common wired networks, such as fiber optic or other optical networks, cable networks, power lines, etc.

[0023] Computer programs, such as applications specifically developed for the non-implantable medical device 1, can run on electronic device 2. Screenshots 3 and 4 show the application's user interface. Through the user interface, the user can operate the non-implantable medical device 1, such as setting parameters and performing treatment operations.

[0024] System 100 may also include a cloud device 5. This cloud device 5, for example, is a server device capable of establishing a data synchronization channel with the electronic device 2 via a network port, receiving and storing data from the electronic device 2, and transmitting data and instructions to the electronic device 2. At least some of the computations performed by the electronic device 2 can be conducted on the cloud device 5. For example, in situations requiring high computing power, the electronic device 2 can send data to the cloud device 5, which will then perform the computation and return the results to the electronic device 2. The electronic device 2 can also upload and store data on the cloud device 5, which can be accessed by other terminals 6. Of course, other terminals 6 can also send data and instructions to the electronic device 2 via the cloud device 5, thereby performing related operations on the non-implantable medical device 1. Doctors and device manufacturers with access permissions can use other terminals 6 to understand the patient's treatment plan, treatment progress, and other relevant information, and can also retrieve and study the patient's physical parameters.

[0025] It is understood that, in order to achieve the above functions, the electronic device includes hardware and / or software modules that perform the respective functions. Based on the algorithmic steps of the examples described in conjunction with the embodiments disclosed herein, this application can be implemented in hardware or a combination of hardware and computer software. Whether a function is performed by hardware or by computer software driving hardware depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application in conjunction with the embodiments, but such implementation should not be considered beyond the scope of this application.

[0026] Figure 2 This is a basic structural block diagram of the non-implantable medical device 1 involved in the embodiments of this application. Figure 2 As shown, the non-implantable medical device 1 involved in this application includes a sensor module 11, a controller 13, a stimulation circuit 15, an electrode interface 17, and an electrode array 21. Optionally, it may also include a communication module 19.

[0027] Sensor module 11 may include one or more sensors with detection functions. For example, it may include electrodes for acquiring electrophysiological signals, such as electromyographic (EMG) signals. To detect the user's oral cavity movements, a motion sensor may be included to acquire the oral cavity movement waveform. Sensor module 11 may also include a respiratory detection device for acquiring the user's respiratory signals. In addition, a microphone may be included to acquire sounds near the user's mouth. Furthermore, a pressure sensor for detecting airway pressure may also be included. Of course, the sensors described herein are not limited to any specific form as long as they can detect relevant parameters, and more or fewer sensors may be included as needed, as long as the predetermined function can be achieved. Of course, those skilled in the art should understand that in order to obtain the corresponding digital signals, other auxiliary devices may also be required, such as EMG signal acquisition circuits, analog-to-digital converters, etc., which are not listed here.

[0028] The controller 13 generates control signals based on the detection data from the sensor module 11. The controller 13 can be any computing device with logic computing capabilities, such as a microcontroller unit (MCU), digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc. Obviously, the specific type of the controller 13 does not constitute a limitation on the technical content of this application.

[0029] The stimulation circuit 15 generates an electrical stimulation waveform signal based on a control signal from the controller 13. The stimulation circuit 15 may include a boost module to provide sufficient stimulation output voltage. Furthermore, the stimulation circuit 15 may operate in a constant voltage, constant current, or constant charge output mode to adapt to different treatment needs. Additionally, the stimulation circuit may include an impedance measurement module for measuring the impedance of the load. The impedance measurement results can be used to determine whether the user is wearing the stimulator correctly, whether the electrodes are functioning properly, and so on.

[0030] The non-implantable medical device 1 of this application can communicate with the electronic device 2 via the communication module 19, receiving data or instructions from the electronic device 2, and transmitting treatment-related data to the electronic device 2. The electronic device 2 includes a parameter configuration module and a data transceiver module. The electrical stimulation waveform parameters of the stimulation circuit 15 of the non-implantable medical device 1 can be set by the parameter configuration module of the electronic device 2.

[0031] The electrode array 21 includes one or more electrodes, which can be distributed symmetrically or asymmetrically. Different treatment modes and effects can be produced depending on the electrode distribution. The electrodes can be replaced by the user as needed. That is, the electrodes are detachably connected to the main body of the device.

[0032] Electrode interface 17 is the connection interface between the electrodes in electrode array 21 and the main body of non-implantable medical device 1. This connection can include physical connection, electrical connection, and signal connection. Therefore, electrode interface 17 can be broadly defined as a connection device for physical or electrical connection, or a communication device for signal connection.

[0033] Figure 3 This is a schematic diagram of the electrode insertion detection structure of the non-implantable medical device of this application. Figure 3 As shown, the main body of the device includes a controller I / O module 131, a controller communication interface module 133, and a detection circuit 12. The controller I / O module 131 and the controller communication interface module 133 can be part of the controller 13. The detection circuit 12 can be an independent circuit or part of the stimulation circuit 15. On the other hand, the electrodes include a matching circuit 211 and a storage unit 213. The detection circuit 12 is electrically connected to the matching circuit 211. The controller I / O module 131 is connected to the detection circuit 12 and receives electrical signals from the detection circuit 12. Of course, those skilled in the art should understand that in some embodiments, other modules such as analog-to-digital converters may be needed to transmit electrical signals between the detection circuit 12 and the controller I / O module 131; these are omitted here for simplicity. A data channel is established between the controller communication interface module 133 and the electrode storage unit 213.

[0034] Figure 4 This is a schematic diagram of one embodiment of the circuit structure for electrode insertion detection according to this application. Figure 4 As shown, by configuring a pull-up resistor R1 on the controller IO module 131, the level of the detection port of the controller IO module 131 is pulled up to a high level, that is, the first electrical signal with a high level at the detection point P. Figure 4As shown, the controller I / O module 131 is connected to the detection point P of the circuit. On the electrode device, the matching circuit 211 includes a grounded matching resistor R2. Due to the presence of the grounded matching resistor R2, when the electrode is inserted, as shown, it is equivalent to a switch being closed, and resistor R2 is connected to the detection point P of the detection circuit 12, thereby forming a voltage divider circuit. Those skilled in the art will understand that when the electrode is inserted, the voltage level at the detection point P is related to the voltage level of the voltage excitation source and the magnitudes of resistors R1 and R2. Clearly, at this time, the voltage level (second electrical signal) at the detection point P is lower than the first electrical signal. This provides the controller I / O module 131 with a transition from a high level to a low level, which is captured by the controller I / O module 131. Thus, the controller detects the insertion of the electrode by the change between the first and second electrical signals of the detection circuit 12. Similarly, a change in voltage level also occurs when the electrode is disconnected from the device body, and the controller detects the electrode disconnection by the change in the electrical signal at the detection point P. By detecting the electrode connection status in real time, stimulation can be stopped immediately when the electrode falls off (detection point voltage jump), avoiding ineffective output that could damage human tissue.

[0035] After the electrode is inserted, the controller communication interface module 133 connects to the electrode storage unit 213. The controller 13 calls the controller communication interface module 133 to read data from the electrode storage unit 213 or write data to the electrode storage unit 213. For example, the data includes the electrode specifications, manufacturing time, etc. In addition, the controller can also record the electrode usage time, and manage the electrode's lifespan based on this data. On the other hand, when the device does not detect electrode insertion, it will alarm that the electrode is not inserted or has fallen off, and treatment should be stopped immediately. If the electrode is not inserted for a long time, such as more than 5 minutes, the medical device will enter a sleep state and operate in an ultra-low power mode. In one example of this application, the storage unit 213 pre-stores the electrode manufacturing date and rated usage time. The controller's built-in timing circuit automatically accumulates the actual usage time when the electrode is powered on, and triggers an alarm when the actual usage time exceeds the rated value. By coordinating the pre-stored electrode lifespan parameters and the hardware timing circuit, electrode lifespan monitoring can be achieved without software calculations, which can reduce the controller's computational load and improve response reliability.

[0036] When electrode life management indicates that an electrode is nearing its lifespan limit, or when impedance measurement results show an electrode malfunction, requiring the replacement of one or more electrodes to maintain optimal performance, the device can remind the user to replace the electrode or have it serviced by a professional. For example, the device can provide such reminders through voice prompts, text prompts, or flashing warning lights. Furthermore, it can be integrated with electronic device 2, which can then provide such reminders through voice prompts, text prompts, or user interface prompts. For instance, electronic device 2 can display information related to electrode insertion detection to the user through an app's user interface.

[0037] Through the above technical solutions, this application realizes a non-implantable medical device with electrode insertion detection and management functions. Electrode insertion and disconnection detection improves the safety of the medical device and enhances the user experience. Furthermore, by managing the electrodes, such as through lifespan management, issues like electrode aging can be detected promptly, allowing for timely replacement, ensuring treatment effectiveness, improving the maintenance efficiency of the medical device, and reducing overall costs.

[0038] This embodiment can divide the electronic device into functional modules based on the above example. For example, each function can be divided into its own functional modules, or two or more functions can be integrated into one processing module. The integrated modules can be implemented in hardware or software. It should be noted that the module division in this embodiment is illustrative and only represents one logical functional division; other division methods may be used in actual implementation.

[0039] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A non-implantable medical device, comprising a device body and electrodes, characterized in that, The main body of the device includes a controller, a stimulation circuit, and a detection circuit, wherein the controller is electrically connected to the stimulation circuit and the detection circuit. The electrode is detachably connected to the main body of the device; When the electrode is inserted into the main body of the device, the electrode is electrically connected to the stimulation circuit and the detection circuit, and the detection circuit outputs a first electrical signal; When the electrode is disconnected from the device body, the detection circuit outputs a second electrical signal that is different from the first electrical signal.

2. The non-implantable medical device as described in claim 1, characterized in that, The detection circuit includes a voltage excitation source, one end of which is grounded, and the other end of which is connected to the controller via a resistor; The first and second electrical signals output by the detection circuit are voltage signals.

3. The non-implantable medical device as described in claim 2, characterized in that, The electrode includes a matching resistor. When the electrode is inserted into the device body, one end of the matching resistor is connected to the detection circuit, and the other end of the matching resistor is grounded, forming a voltage divider circuit.

4. The non-implantable medical device as described in any one of claims 1-3, characterized in that, The detection circuit is part of the stimulation circuit.

5. The non-implantable medical device as described in any one of claims 1-3, characterized in that, The electrode includes a storage unit, and the controller includes a communication interface module. When the electrode is inserted into the main body of the device, the communication interface module is connected to the storage unit.

6. The non-implantable medical device as described in claim 5, characterized in that, The storage unit pre-stores electrode life parameters, including the electrode manufacturing date and rated usage time. The main body of the device includes a timing circuit for recording the actual energization time of the electrode.

7. A non-implantable medical system, characterized in that, The non-implantable medical system includes: The non-implantable medical device as described in any one of claims 1-6; and An electronic device, wherein the electronic device is connected to the non-implantable medical device via a physical communication interface; The electronic device includes a parameter configuration module and a data receiving module.

8. The non-implantable medical system as described in claim 7, characterized in that, The electronic device includes a display unit configured to display information associated with electrode insertion detection of the non-implantable medical device.

9. The non-implantable medical system as described in claim 7, characterized in that, The electrical stimulation waveform parameters of the stimulation circuit of the non-implantable medical device are set by the parameter configuration module.

10. The non-implantable medical system as described in claim 7, characterized in that, It also includes a cloud device that communicates with the electronic device, and a data synchronization channel is established between the data transceiver module of the electronic device and the cloud device.

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