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

Abstract

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

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular, relates to a non-implantable medical device and system with electrode insertion detection and management. Background Art

[0002] In today's medical field, treatment through electrode stimulation has become an effective treatment method. Among them, electrode stimulation devices can be divided into implantable electrode stimulation devices and non-implantable electrode stimulation devices according to whether the device is implanted in the patient's body. Compared with implantable electrode stimulation devices that require surgical implantation of electrodes into the target nerve area, non-implantable electrode stimulation devices have several advantages and are increasingly valued by medical institutions and patients. These advantages include: (1) avoiding the risk of infection and rejection during implantation surgery; (2) flexibility and reversibility such as dynamic adjustment of electrode position; (3) adaptation to individualized treatment; (4) low overall cost, etc.

[0003] As an application of non-implantable electrode stimulation devices, tongue muscle electrical stimulation devices have been studied for the treatment of obstructive sleep apnea (OSA). Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent complete or partial upper airway obstruction during sleep, resulting in interrupted or shallow breathing. It is associated with a variety of chronic diseases, including coronary heart disease, hypertension, arrhythmias, type 2 diabetes, cerebrovascular disease, and cognitive impairment. Tongue muscle electrical stimulation has shown potential to activate the tongue muscles by stimulating them, preventing the tongue from falling back during sleep, and thus maintaining upper airway patency. 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, and a circuit operably connected to the electrode device. The device is configured to provide electrical stimulation to one or more oral muscles (e.g., the tongue muscles and optionally the palatal muscles) via the at least one electrode device through the inner membrane of the mouth (e.g., the oral mucosa) during use.

[0004] In non-implantable electrode stimulation devices, electrodes are used to apply electrical stimulation to the treatment area and are therefore a crucial component. Electrode failure or disconnection can result in incomplete treatment or complete device unavailability. Being able to detect electrode insertion and manage the lifespan of non-implantable electrode stimulation devices would improve device maintenance, increase their useful lifespan, and reduce overall costs. Summary of the Invention

[0005] According to the first aspect of the present application, a non-implantable medical device is provided, comprising a device body and an electrode, characterized in that the device body comprises a controller, a stimulation circuit and a detection circuit, and the controller is electrically connected to the stimulation circuit and the detection circuit; wherein the electrode is detachably connected to the device body; when the electrode is inserted into the device body, 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 different from the first electrical signal.

[0006] According to an embodiment of the present 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 the present 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 to form a voltage divider circuit.

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

[0009] According to an embodiment of the present 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 the present application, the storage unit pre-stores electrode life parameters, including the electrode manufacturing date and rated usage time, and the device body includes a timing circuit for recording the actual power-on time of the electrode.

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

[0012] According to an embodiment of the present 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 the present 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 the present application, a cloud device that communicates with the electronic device is further included, and a data synchronization channel is established between the data transceiver module of the electronic device and the cloud device.

[0015] Compared to the prior art, the present application implements a non-implantable medical device with electrode insertion detection and management capabilities through the above technical solutions. Electrode insertion and disconnection detection can improve the safety of medical devices and enhance the user experience. Furthermore, electrode management, such as lifespan management, can promptly identify problems such as electrode aging, allowing for timely replacement to ensure treatment effectiveness, improve maintenance efficiency of medical devices, and reduce overall costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present application will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0017] Figure 1 It is a schematic diagram of a treatment system involved in an embodiment of the present application.

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

[0019] Figure 3 Schematic diagram of electrode insertion detection of the non-implantable medical device of the present application.

[0020] Figure 4 This is a schematic diagram of an embodiment of a circuit structure for electrode insertion detection of the present application. DETAILED DESCRIPTION

[0021] In order to enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Moreover, based on the embodiments in the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0022] Figure 1is a schematic diagram of a treatment system 100 involved in an embodiment of the present application. As shown in the figure, the non-implantable medical device 1 is capable of wireless or wired communication 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 can be, for example, a tongue muscle stimulator device for treating obstructive sleep apnea, and the electronic device 2 can be an electronic device such as a smart phone, a tablet computer, or a desktop computer. The wireless communication can be near field communication (NFC), Bluetooth, WIFI, a mobile network, etc. The wired communication connection can include common wired networks, such as optical fibers or other optical networks, cable networks, power lines, etc.

[0023] A computer program, such as an application specifically developed for the non-implantable medical device 1, can be run on the electronic device 2. Screenshots 3 and 4 illustrate the user interface of the application. Through the user interface, the user can operate the non-implantable medical device 1, such as setting parameters and performing treatment operations.

[0024] The system 100 may also include a cloud device 5. The cloud device 5 is, for example, a server device that can establish a data synchronization channel with the electronic device through a network port, receive and store data from the electronic device 2, and transmit data and instructions to the electronic device 2. At least a portion of the calculations of the electronic device 2 can be performed on the cloud device 5. For example, when the computing power requirement is high, the electronic device 2 can send data to the cloud device 5, and the cloud device 5 performs the calculation and returns the result to the electronic device 2. The electronic device 2 can also upload and store data on the cloud device 5, and the data can be accessed by other terminals 6. Of course, other terminals 6 can also send data and instructions to the electronic device 2 through the cloud device 5, thereby performing related operations on the non-implantable medical device 1. Doctors and equipment manufacturers with access rights can use other terminals 6 to understand the patient's treatment plan, treatment progress and other related information, and can also retrieve and study the patient's physical parameters.

[0025] It is understandable that in order to implement the above functions, the electronic device includes hardware and / or software modules that perform the corresponding functions. In combination with the algorithm steps of each example described in the embodiments disclosed herein, the present application can be implemented in the form of hardware or a combination of hardware and computer software. Whether a function is executed in a hardware or computer software driven hardware manner 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 combination with the embodiments, but such implementation should not be considered to be beyond the scope of this application.

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

[0027] The sensor module 11 may include one or more sensors with detection functions. For example, it may include electrodes for collecting electrophysiological signals. The electrophysiological signals are, for example, electromyographic signals. In order to detect the user's oral movements, a motion sensor may be included to collect the oral movement waveform. The sensor module 11 may also include a breathing detection device for collecting the user's breathing signals. In addition, the microphone can collect the sound near the user's mouth. Furthermore, it may also include a pressure sensor for detecting the respiratory airway pressure, etc. Of course, the sensors described herein are not limited to specific forms as long as they can detect relevant parameters. In addition, more or fewer sensors may be included as needed, as long as the predetermined functions 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 need to be included, such as electromyographic signal acquisition circuits, analog-to-digital conversion devices, etc., which are not listed here one by one.

[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 logical computing capabilities, such as a microcontroller unit (MCU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a 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 according to the control signal from the controller 13. The stimulation circuit 15 may include a boost module for providing sufficient stimulation output voltage. In addition, the stimulation circuit 15 may operate in a constant voltage, constant current, or constant charge output mode to adapt to different treatment needs. In addition, the stimulation circuit may also 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 working properly, etc.

[0030] The non-implantable medical device 1 of the present application can communicate with the electronic device 2 via the communication module 19, receive data or instructions from the electronic device 2, and transmit treatment-related data to the electronic device 2. The electronic device 2 includes a parameter configuration module and a data transceiver module, and 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 electrode distributions can produce different treatment modes and therapeutic effects. The electrodes can be replaced by the user as needed. In other words, the electrodes are detachably connected to the device body.

[0032] The electrode interface 17 is the connection interface between the electrodes in the electrode array 21 and the device body of the non-implantable medical device 1. This connection can include physical connection, electrical connection, and signal connection. Therefore, the 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 FIG. 1 is a schematic diagram of the electrode insertion detection structure of the non-implantable medical device of the present application. Figure 3 As shown, the device body includes a controller IO module 131, a controller communication interface module 133 and a detection circuit 12. Among them, the controller IO 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 it can also be part of the stimulation circuit 15. On the other hand, the electrode includes a matching circuit 211 and a storage unit 213. The detection circuit 12 is electrically connected to the matching circuit 211. The controller IO module 131 is connected to the detection circuit 12 to receive the electrical signal of the detection circuit 12. Of course, those skilled in the art should understand that in some embodiments, in order to transmit electrical signals between the detection circuit 12 and the controller IO module 131, other modules such as analog-to-digital conversion may be required, which 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 FIG. 1 is a schematic diagram of an embodiment of a circuit structure for electrode insertion detection of the present application. Figure 4 As shown, by configuring the pull-up resistor R1 for 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 of the high level at the detection point P. Figure 4As shown, the controller IO 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 in the figure, the switch is closed, and resistor R2 is connected to the detection point P of the detection circuit 12, thus forming a voltage divider circuit. Those skilled in the art will understand that when the electrode is inserted, the voltage level at detection point P is related to the voltage level of the voltage excitation source and the magnitude of resistors R1 and R2. Obviously, at this time, the voltage level at detection point P (the second electrical signal) is lower than the first electrical signal. This provides the controller IO module 131 with a transition from a high level to a low level, which is captured by the controller IO module 131. The controller then detects electrode insertion by detecting changes between the first and second electrical signals of the circuit 12. Similarly, when the electrode is disconnected from the device body, a voltage level change also occurs. The controller detects electrode disconnection by detecting changes in the electrical signal at detection point P. By real-time monitoring of the electrode connection status, stimulation can be immediately stopped when the electrode is disconnected (the voltage at the detection point jumps), preventing ineffective output from damaging human tissue.

[0035] After the electrode is inserted, the controller communication interface module 133 connects to the electrode's storage unit 213. The controller 13 calls the controller communication interface module 133 to read data from or write data to the electrode storage unit 213. For example, this data may include electrode specifications and manufacturing date. Furthermore, the controller can also record the electrode's usage time and other information, and use this data to manage the electrode's lifespan. On the other hand, if the device fails to detect electrode insertion, it will issue an alarm indicating that the electrode is not inserted or has fallen off, and treatment should be stopped immediately. If the electrode is not inserted for an extended period of time, for example, more than 5 minutes, the medical device will enter a sleep state and operate in an ultra-low power mode. In one example of the present application, the storage unit 213 pre-stores the electrode's manufacturing date and rated usage time. A built-in timing circuit in the controller automatically accumulates the actual usage time when the electrode is powered on, triggering an alarm when the actual usage time exceeds the rated value. By combining pre-stored electrode lifespan parameters with the hardware timing circuit, electrode lifespan monitoring can be achieved without the need for software calculations, reducing the controller's computational load and improving response reliability.

[0036] When the electrode life management prompts that the electrode is approaching its life limit or when the impedance measurement results show that the electrode is abnormal, one or more electrodes need to be replaced to maintain optimal performance. At this time, the device can remind the user to replace the electrode or hand it over to a professional for repair. For example, the device can make such a reminder through voice prompts, text prompts, or flashing warning lights. In addition, it can also be combined with the electronic device 2, and the electronic device 2 can make such a reminder through voice prompts, text prompts, user interface prompts, etc. For example, the electronic device 2 can display information related to the insertion detection of the electrode to the user through the user interface of the APP.

[0037] Through the above technical solutions, this application realizes a non-implantable medical device with electrode insertion detection and management functions. By detecting electrode insertion and disconnection, the safety of medical devices can be improved, enhancing the user experience. Furthermore, by managing electrodes, such as lifespan management, problems such as electrode aging can be promptly detected, allowing for timely replacement to ensure treatment effectiveness, improve maintenance efficiency of medical devices, and reduce overall costs.

[0038] In this embodiment, the electronic device can be divided into functional modules based on the above examples. For example, each functional module can be divided according to its function, or two or more functions can be integrated into a single processing module. The above integrated modules can be implemented in the form of hardware or software. It should be noted that the module division in this embodiment is illustrative and is only a logical functional division. In actual implementation, other division methods may be used.

[0039] The above is only a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or replacements that can be easily thought of by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. In the absence of mutual contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples. These modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of each embodiment of the present application.

Claims

1. A non-implantable medical device comprising a device body and an electrode, characterized in that: The device body includes a controller, a stimulation circuit and a detection circuit, and the controller is electrically connected to the stimulation circuit and the detection circuit; Wherein, the electrode is detachably connected to the device body; When the electrode is inserted into the device body, 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 electric signal different from the first electric signal.

2. The non-implantable medical device according to claim 1, wherein: The detection circuit includes a voltage excitation source, one end of the voltage excitation source is grounded, and the other end of the voltage excitation source 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.

3. The non-implantable medical device according to claim 2, wherein: 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 to form a voltage divider circuit.

4. The non-implantable medical device according to any one of claims 1 to 3, wherein: The detection circuit is part of the stimulation circuit.

5. The non-implantable medical device according to any one of claims 1 to 3, wherein: 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.

6. The non-implantable medical device according to claim 5, wherein: The storage unit pre-stores electrode life parameters, including the electrode manufacturing date and rated usage time. The device body includes a timing circuit for recording the actual power-on time of the electrode.

7. A non-implantable medical system, characterized in that: The non-implantable medical system comprises: The non-implantable medical device according to any one of claims 1 to 6; and an electronic device 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 according to claim 7, wherein: 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 according to claim 7, wherein: 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 according to claim 7, wherein: 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.

Images