Implantable medical devices and systems and methods for triggering storage thereof

Abstract

The present invention discloses an implantable medical device and system and a method for triggering storage thereof. The implantable medical device system includes an implantable medical device, an external device, and a magnet. When the patient feels uncomfortable, the magnet is brought close to the implantable medical device to generate a magnetic field, and a cardiac event is triggered and stored according to the method for triggering storage of the implantable medical device and system. The implantable medical device can transmit the cardiac event to the external device. The implantable medical device and system of the present invention utilize an external magnet to activate the implantable medical device to store cardiac events, and have the advantage of small volume. In addition, the method for triggering storage of the implantable medical device and system of the present invention can prevent accidental triggering and improve the reliability of monitoring.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an implantable medical device and system and a method for triggering and storing thereof. Background Art

[0002] An Insertable Cardiac Monitor (ICM) is implanted inside the human body (subcutaneous chest), mainly for detecting R-wave signals inside the human body, and judging and storing cardiac events according to the detected R-wave signals. Cardiac events include atrial fibrillation, atrial flutter, premature atrial contractions, ventricular tachycardia, ventricular fibrillation, asystole, bradycardia, etc., as well as accidental injury events such as syncope and falls of patients caused by the above cardiac events.

[0003] Since the ICM is a ultra-low power consumption device, the internal storage space thereof is limited. In order to save storage space, the ICM adopts a cyclic recording method, that is, new cardiac events will overwrite old cardiac events, and the old cardiac events will be deleted from the memory. In order to enable the ICM to record cardiac events in time after a patient has a cardiac event, the ICMs on the market are equipped with triggers for patients. After the trigger is triggered, the ICM permanently stores the R-wave signals and parameters for a period of time before the trigger moment and the R-wave signals and parameters for a period of time after the trigger moment, so as to prevent this cardiac event from being overwritten by new cardiac events.

[0004] The trigger of the prior art triggers the ICM through near-field magnetic communication. This triggering method requires an internal coil in the ICM. However, the internal coil will limit the reduction of the volume of the ICM, and the internal coil is not easy to be integrated with the circuit board inside the ICM, increasing the complexity of manufacturing and assembling the ICM. Summary of the Invention

[0005] To solve the above problems, the present invention provides a small-sized implantable medical device and system and a method for triggering and storing thereof, which activates the implantable medical device to store cardiac events by using an external magnet, does not require an internal coil, and can transmit cardiac events to an external device through a communication module of the implantable medical device. The present invention takes an implantable cardiac monitor as an example to illustrate the technical solution. However, the technical solution of the present invention can also be used for implantable pacemakers, cardiac defibrillators, resynchronization therapy defibrillators, nerve stimulators, etc.

[0006] To achieve the above object, the technical solution of the present invention is as follows:

[0007] An implantable medical device includes a processor, a memory, a timer, a magnetic sensor, a vibration sensor, an electrocardiogram (ECG) module, and a communication module. The processor is respectively connected to the memory, the timer, the magnetic sensor, the vibration sensor, the ECG module, and the communication module. The ECG module is electrically connected to a first electrode and a second electrode. When the magnetic sensor detects that the magnetic field strength is greater than a trigger threshold, it controls the timer to start timing.

[0008] In a specific embodiment, the timer is respectively connected to the magnetic sensor, the vibration sensor, and the communication module.

[0009] The ECG module includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module. The analog-to-digital conversion module converts the analog signals output by the first electrode and the second electrode into digital signals, which are filtered by the filtering unit module and amplified by the amplifying unit module, and then output to the processor for processing.

[0010] In a specific embodiment, an implantable medical device system includes the above implantable medical device, and further includes an external device and a magnet. When the magnet approaches the implantable medical device, it generates a magnetic field. The external device communicates with the implantable medical device and a remote server, and the external device generates a vibration signal.

[0011] In another specific embodiment, an implantable medical device system includes the above implantable medical device, and further includes the external device. The magnet is located in the vibration module of the external device. The magnet is an eccentric magnet. The vibration module of the external device includes a drive motor, an eccentric wheel structure, a drive module of the drive motor, and an encoder connected to the drive module. The eccentric wheel structure includes the magnet, and the magnet is driven by the drive motor.

[0012] A method for triggering storage in an implantable medical device and system includes,

[0013] When the patient feels discomfort, bring the magnet close to the implantable medical device;

[0014] When the magnetic sensor detects that the magnetic field strength is greater than the trigger threshold, set the timing time of the timer to a first timing time and start timing;

[0015] After the first timing time ends, the timer is reset and a reset signal is output.

[0016] In the first specific embodiment, the method for the implantable medical device and system to trigger storage further includes that the magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor, and the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory. The trigger signal includes the reset signal or the level signal.

[0017] In the second specific embodiment, the method for the implantable medical device and system to trigger storage further includes setting a third timing time. Within the third timing time, the vibration sensor detects a vibration signal sent by the external device. When the vibration signal contains an external excitation signal, the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory. The trigger signal includes the reset signal or the external excitation signal.

[0018] In the third specific embodiment, the method for the implantable medical device and system to trigger storage further includes that the magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor. A third timing time is set. Within the third timing time, the vibration sensor detects a vibration signal sent by the external device. When the vibration signal contains the external excitation signal, the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory. The trigger signal includes the reset signal or the level signal or the external excitation signal.

[0019] The method for the implantable medical device and system to trigger storage further includes that the processor activates the communication module and sends the cardiac events to the external device through the communication module; or the cardiac events are first stored in the memory until the cardiac events are uploaded to the external device.

[0020] The corresponding time period is from 6 minutes before the occurrence time of the trigger signal to 1 minute after the occurrence time of the trigger signal.

[0021] The method for the implantable medical device and system to trigger storage includes:

[0022] When the patient feels discomfort, bring the magnet close to the implantable medical device;

[0023] When the magnetic sensor detects that the magnetic field intensity is greater than the trigger threshold, set the first timing time and the second timing time through the timer. The first timing time is less than the second timing time, and start timing;

[0024] After the end of the first timing period, the timer outputs a reset signal, restarts the timing of the first timing period, and detects the reset signal.

[0025] In the first specific embodiment, the method for triggering storage in the above-mentioned implantable medical device and system further includes that when at least two reset signals can be detected within the second timing period, the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal.

[0026] In the second specific embodiment, the method for triggering storage in the above-mentioned implantable medical device and system further includes that when at least two reset signals can be detected within the second timing period, a third timing period is set. Within the third timing period, the vibration sensor detects the vibration signal sent by the external device. When the vibration signal contains the external excitation signal, the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal or the external excitation signal.

[0027] In the third specific embodiment, the method for triggering storage in the above-mentioned implantable medical device and system further includes that the magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor, sets the third timing period. Within the third timing period, the vibration sensor detects the vibration signal sent by the external device. When the vibration signal contains the external excitation signal, the processor stores the cardiac events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal or the level signal or the external excitation signal.

[0028] The method for triggering storage in the above-mentioned implantable medical device and system further includes that the processor activates the communication module and sends the cardiac events to the external device through the communication module; or the cardiac events are first stored in the memory until the cardiac events are uploaded to the external device.

[0029] The corresponding time period is from 6 minutes before the occurrence time of the trigger signal to 1 minute after the occurrence time of the trigger signal.

[0030] Advantageous effects: The implantable medical device and system of the present invention utilize an external magnet to activate the implantable medical device to store cardiac events, without the need for an internal coil, having the advantage of small size, and the magnet is convenient to carry and has a simple structure. The external device can be implemented with a smartphone, a smartwatch, etc. In addition, by setting a first timing time, a second timing time, detecting the magnetic field intensity, and detecting the vibration signal, false trigger signals can be further excluded, preventing the recording of invalid electrocardiogram signals and improving the reliability of monitoring.

[0031] To make the above features and advantages of the invention more obvious and understandable, specific embodiments are hereinafter given and described in detail in conjunction with the accompanying drawings as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 Schematic diagram of the implantable medical system of the present invention.

[0033] Figure 2 Block diagram of the first specific embodiment of the implantable medical device of the present invention.

[0034] Figure 3 Schematic diagram of the storage structure of the implantable medical device of the present invention.

[0035] Figure 4 Schematic diagram of the communication between the communication module and the external device in the implantable medical system of the present invention.

[0036] Figure 5 Block diagram of the second specific embodiment of the implantable medical device of the present invention.

[0037] Figure 6 Flowchart of the first specific embodiment of the method for triggering storage in the implantable medical device and system of the present invention.

[0038] Figure 7 Flowchart of the second specific embodiment of the method for triggering storage in the implantable medical device and system of the present invention.

[0039] Figure 8 Flowchart of the third specific embodiment of the method for triggering storage in the implantable medical device and system of the present invention.

[0040] Figure 9 Flowchart of the fourth specific embodiment of the method for triggering storage in the implantable medical device and system of the present invention.

[0041] Figure 10 Another specific embodiment of the implantable medical system of the present invention.

[0042] In the drawings, like reference numerals refer to the same elements. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0043] To make the objectives and technical solutions of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions of the embodiments of the present invention in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the described embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present invention.

[0044] Figure 1 This is a schematic diagram of the implantable medical device system of the present invention. As Figure 1 shown, the implantable medical device system includes an implantable medical device 100 implanted in a human body 400, an external device 200, and a magnet 300. The implantable medical device 100 includes a housing 110. A first electrode 130 is located on the surface of the head 120 of the implantable medical device. The first electrode 130 is electrically connected to a feedthrough structure within the head 120 of the implantable medical device, and the feedthrough structure is electrically connected to the first end of the housing 110. A second electrode 140 is located on the surface of the second end of the housing 110, and the second electrode 140 is electrically connected to the housing 110. The head 120 of the implantable medical device can be made of a biocompatible and wireless electromagnetic signal-passing material such as silicone that allows electromagnetic signals to pass through. The surface of the housing 110 is insulated. A passivation process can be used to make the surface of the housing 110 non-conductive. The first electrode 130 and the second electrode 140 are not insulated.

[0045] The function of the magnet 300 is to generate a magnetic field when it approaches the implantable medical device 100. The external device 200 communicates with the implantable medical device 100 and receives the cardiac events stored in the implantable medical device 100 through wireless communication. At the same time, the external device 200 can also communicate with a remote server, thereby providing the latest information to the remote server. The external device 200 includes handheld devices such as smartphones and personal digital assistants, and also includes dedicated devices such as home monitors, mobile medical devices, and programmers. The cardiac events refer to electrocardiogram signals corresponding to abnormal heart rates of patients, such as electrocardiogram signals corresponding to atrial fibrillation, atrial flutter, asystole, bradycardia, tachy-brady syndrome, ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, etc.

[0046] Figure 2 This is a schematic diagram showing the structure of the first specific embodiment of the internal circuit components of the implantable medical device 100. As Figure 2 shown, the implantable medical device 100 includes a processor 111, and the processor 111 is respectively connected to a memory 112, a timer 113, a magnetic sensor 114, a vibration sensor 115, an electrocardiogram module 116, and a communication module 117.

[0047] The electrocardiogram module 116 is electrically connected to the first electrode 130 and the second electrode 140. The electrocardiogram module 116 includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module. The analog-to-digital conversion module converts the analog signals output by the first electrode 130 and the second electrode 140 into digital signals. After being filtered by the filtering unit module and amplified by the amplifying unit module, the signals are output to the processor 111 for processing.

[0048] The vibration sensor 115 is used to detect the vibration signal emitted by the external device 200, and the vibration signal includes an external excitation signal. The magnetic sensor 114 is used to detect the magnetic field strength B. When the patient holds the magnet 300 close to the implantable medical device 100 and the detected magnetic field strength B continuously exceeds the set trigger threshold B S When, optionally, the trigger threshold B S can be 13 Oersteds, the magnetic sensor 114 generates a continuous level signal and outputs it to the processor 111. After receiving the level signal output by the magnetic sensor 114, the processor 111 wakes up the timer 113 to start timing, and the timing time is the first timing time T1. The first timing time T1 of the timer 113 is set by the processor 111. Optionally, the first timing time T1 of the timer 113 can be set to 0.1 - 15 seconds. When the timer 113 finishes timing, the timer 113 generates a reset signal and outputs it to the processor 111, and the processor 111 performs subsequent operations. Setting the timing time of the timer 113 is to ensure that the level signal output by the magnetic sensor 114 is actively triggered by the patient rather than accidentally triggered by the external environment. The timer 113 reduces the possibility of false triggering and can avoid the problem of increased system power consumption caused by the magnetic sensor 114 being abnormally and frequently triggered by the external environment.

[0049] When the processor 111 does not receive the reset signal of the timer 113, the processor 111 stores the collected heart events in a cyclic recording manner, and the new heart events will overwrite the heart events at a certain historical time point; when the processor 111 receives a trigger signal, it stores the heart events within the corresponding time period t S in the memory 112 in a permanent recording manner. Please refer to Figure 3 , Figure 3 for the storage structure schematic diagram of the implantable medical device 100, and the corresponding time period t Sis the time between time t0 and time t2. Time t0 is 6 minutes before the occurrence time t1 of the trigger signal, and time t2 is 1 minute after the occurrence time t1 of the trigger signal. Exemplarily, the heart beat interval of the patient at the trigger time is 240 ms, and the heart rate of the patient is 250 bpm. This is the ventricular tachycardia heart rate, and the patient can feel obvious discomfort in the body. Therefore, the patient uses the magnet 300 to trigger the implantable medical device 100 to record a cardiac event. The implantable medical device 100 records the heart beat intervals and QRS wave signals between 6 minutes before the trigger signal and 1 minute after the trigger signal in the memory 112 in a permanent recording manner. Storing cardiac events in a permanent recording manner can facilitate users or doctors to view the cardiac events at any time in the future.

[0050] The memory 112 stores cardiac events and also stores a computer program for diagnosing cardiac events. The processor 111 calls the computer program for diagnosing cardiac events to classify the cardiac events. In addition, the processor 111 can transmit the cardiac events stored in the memory 112 to the external device 200.

[0051] The processor 111 also calls an anti-mis-triggering program. In a specific embodiment, the anti-mis-triggering program includes monitoring the number of times the reset signal appears within a second timing time T2, which is set by the processor 111. When the reset signal is detected at least twice within the second timing time T2, the cardiac event is stored. More specifically, the time when the first reset signal appears is t S1 and the time when the second reset signal appears is t S2 . When t S2 -t S1 ≤T2, it is considered that the reset signal appears 2 times within the second timing time T2. In another specific embodiment, the anti-mis-triggering program includes monitoring the number of times the reset signal appears within a second timing time T2, which is set by the processor 111. When the reset signal is detected at least three times within the second timing time T2, the cardiac event is stored. More specifically, the time when the first reset signal appears is t S1 and the time when the second reset signal appears is t S2 and the time when the third reset signal appears is t S3 . When (t S3 -t S2 )+(t S2 -t S1) If it is less than or equal to T2, it is considered that the reset signal appears 3 times within the second timing time T2. Monitoring the number of times the reset signal is detected within a certain period of time can reduce the possibility of false triggering. When in use, the patient can shake the position of the magnet 300 near the implantable medical device 100 to activate the storage.

[0052] The communication module 117 has the function of communicating with the external device 200 and can send the cardiac events stored in the memory 112 to the external device 200. Figure 4 A schematic diagram of the communication between the communication module 117 and the external device 200 is shown. When the timer 113 finishes timing, the processor 111 activates the communication module 117, connects to the external device 200 through the communication module 117, and sends a first message M1 to the external device 200. The first message M1 is used to display a prompt message on the external device 200 indicating that the storage function of the implantable medical device 100 is activated, so as to facilitate the user to clearly understand the status of the implantable medical device 100. After the processor 111 finishes storing the cardiac event in the memory 112, the processor 111 sends a second message M2 to the external device 200 through the communication module 117. The second message M2 is used to display a prompt message indicating that the storage is completed on the external device 200. Optionally, the second message M2 further includes the storage space size of the cardiac event. The processor 111 also sends a third message M3 to the external device 200 through the communication module 117. The third message M3 includes the cardiac event, and the external device 200 receives the third message M3 and stores it. At the same time, the external device 200 can transmit the received first message M1, second message M2, and third message M3 to the cloud for further analysis. In a preferred embodiment, the communication module includes a Bluetooth device, and the external device 200 is a smart phone.

[0053] Figure 5 A block diagram showing a second specific embodiment of the implantable medical device 100 is shown. As Figure 5 shown, the implantable medical device 100 includes a processor 111, and the processor 111 is respectively connected to a memory 112, a timer 113, a magnetic sensor 114, a vibration sensor 115, an electrocardiogram module 116, and a communication module 117. The electrocardiogram module 116 is electrically connected to the first electrode 130 and the second electrode 140. The timer 113 is respectively connected to the magnetic sensor 114, the vibration sensor 115, and the communication module 117.

[0054] The electrocardiogram module 116 is electrically connected to the first electrode 130 and the second electrode 140. The electrocardiogram module 116 includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module. The analog-to-digital conversion module converts the analog signals output by the first electrode 130 and the second electrode 140 into digital signals. After being filtered by the filtering unit module and amplified by the amplifying unit module, the signals are output to the processor 111 for processing.

[0055] When the magnetic field intensity B detected by the magnetic sensor 114 continuously exceeds the set trigger threshold B S the magnetic sensor 114 generates a continuous level signal and outputs it to the timer 113, and the timer 113 starts timing. After the timer 113 finishes timing, the timer 113 outputs a reset signal to the vibration sensor 115 and the communication module 117, and sends a signal to the processor 111 to wake up the vibration sensor 115, the communication module 117, and the processor 111 to work.

[0056] Optionally, the timer 113 and the processor 111 can be replaced by a single device. The processor 111 includes the timer 113 and an execution unit. The processor 111 includes a timer wake-up port that wakes up the timer 113 after receiving a signal; the timer 113 includes a signal output port that outputs a reset signal to the input port of the execution unit.

[0057] Figure 6 This is a flowchart of the first specific embodiment of the method for triggering storage of the implantable medical device and system of the present invention. As Figure 6 shown,

[0058] Step S100, when the patient feels unwell, bring the magnet 300 close to the implantable medical device 100.

[0059] Step S101, the magnetic sensor 114 detects the magnetic field intensity B.

[0060] Step S102, determine whether the magnetic field intensity B is greater than the trigger threshold B S When the magnetic field intensity B is not greater than the trigger threshold B S the magnetic field intensity B is regarded as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field intensity B is greater than the trigger threshold B S proceed to step S103.

[0061] Step S103, set the timing time of the timer 113 to the first timing time T1 and start timing.

[0062] Step S104, after the timing of the timer 113 ends, the timer 113 is reset and outputs a reset signal. Meanwhile, the magnetic sensor 114 detects the magnetic field strength B.

[0063] Step S105, determine whether the magnetic field strength B is greater than the trigger threshold B S When the magnetic field strength B is not greater than the trigger threshold B S the magnetic field strength B is considered an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S the magnetic sensor 114 outputs a level signal to the processor 113, and step S106 is performed.

[0064] Step S106, the processor 113 stores the cardiac events within the corresponding time period T of the trigger signal S in the memory 112. The trigger signal includes the reset signal output by the timer 113 or the level signal output by the magnetic sensor 114.

[0065] Step S107, optionally, the processor 111 activates the communication module 117 and sends the cardiac events to the external device 200 through the communication module 117. Alternatively, the cardiac events are first stored in the memory 112 until the cardiac events are uploaded to the external device 200.

[0066] In this specific embodiment, detecting the magnetic field strength B while the timer 113 is reset can exclude false trigger signals and prevent recording invalid cardiac events.

[0067] Figure 7 This is a flowchart of the second specific embodiment of the method for triggering and storing an implantable medical device and system according to the present invention. As Figure 7 shown,

[0068] Step S200, when the patient feels unwell, bring the magnet 300 close to the implantable medical device 100.

[0069] Step S201, the magnetic sensor 114 detects the magnetic field strength B.

[0070] Step S202, determine whether the magnetic field strength B is greater than the trigger threshold B S When the magnetic field strength B is not greater than the trigger threshold B S the magnetic field strength B is considered an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S step S203 is performed.

[0071] Step S203: Set the timing time of the timer 113 to the first timing time T1 and start timing.

[0072] Step S204: After the timer 113 finishes timing, the timer 113 is reset and a reset signal is output. At the same time, the magnetic sensor 114 detects the magnetic field strength B.

[0073] Step S205: Determine whether the magnetic field strength B is greater than the trigger threshold B S When the magnetic field strength B is not greater than the trigger threshold B S the magnetic field strength B is regarded as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S the magnetic sensor 114 outputs a level signal to the processor 113, and step S206 is performed.

[0074] Step S206: Set the third timing time T3. Within the third timing time T3, the vibration sensor 115 detects a vibration signal, and the vibration signal is emitted by the external device 200.

[0075] Step S207: Determine whether the vibration signal contains an external excitation signal. When the vibration signal does not contain an external excitation signal, the vibration signal is regarded as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the vibration signal contains an external excitation signal, step S208 is performed.

[0076] Step S208: The processor 113 stores the cardiac events within the time period T S corresponding to the trigger signal in the memory 112. The trigger signal includes the reset signal output by the timer 113, the level signal output by the magnetic sensor 114, or the external excitation signal emitted by the external device 200.

[0077] Step S209: Optionally, the processor 111 activates the communication module 117 and sends the cardiac events to the external device 200 through the communication module 117. Alternatively, the cardiac events are first stored in the memory 112 until the cardiac events are uploaded to the external device 200.

[0078] In this specific embodiment, after the reset signal is output in step S204, the vibration sensor 115 in step S206 can directly detect the vibration signal, and then continue with step S207 until step S209. When the magnetic field strength B is detected to be greater than the trigger threshold B while the timer 113 is reset SIn this case, by detecting whether the vibration signal detected by the vibration sensor 115 contains an external excitation signal, false trigger signals can be further excluded to prevent the recording of invalid cardiac events.

[0079] Figure 8 This is a flowchart of the third specific embodiment of the method for triggering storage of the implantable medical device and system of the present invention. As Figure 8 shown,

[0080] Step S300, when the patient feels unwell, bring the magnet 300 close to the implantable medical device 100.

[0081] Step S301, the magnetic sensor 114 detects the magnetic field strength B.

[0082] Step S302, determine whether the magnetic field strength B is greater than the trigger threshold B S , when the magnetic field strength B is not greater than the trigger threshold B S , consider the magnetic field strength B as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S , perform step S303.

[0083] Step S303, set a first timing time T1 and a second timing time T2 through the timer 113, and the first timing time T1 is less than the second timing time T2, and start timing.

[0084] Step S304, after the first timing time T1 of the timer 113 ends, the timer 113 outputs a reset signal and restarts the timing of the first timing time T1; detect the reset signal.

[0085] Step S305, determine whether at least two reset signals can be detected within the second timing time T2. When at least two reset signals cannot be detected within the second timing time T2, consider the reset signal as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when at least two reset signals can be detected within the second timing time T2, perform step S306.

[0086] Step S306, the processor 113 stores the cardiac events within the time period T S corresponding to the trigger signal into the memory 112, and the trigger signal includes the reset signal output by the timer 113.

[0087] Step S307. Optionally, the processor 111 activates the communication module 117 to send a heart event to the external device 200 through the communication module 117. Alternatively, the heart event is first stored in the memory 112 until it is uploaded to the external device 200.

[0088] In this specific embodiment, by detecting whether there are more than two reset signals of the timer 113 with a timing time of T1 within the second timing time T2, false trigger signals can be further excluded to prevent the recording of invalid electrocardiogram signals.

[0089] Figure 9 This is a flowchart of the fourth specific embodiment of the method for triggering storage of the implantable medical device and system of the present invention. As Figure 9 shown,

[0090] Step S400. When the patient feels unwell, the magnet 300 is brought close to the implantable medical device 100.

[0091] Step S401. The magnetic sensor 114 detects the magnetic field strength B.

[0092] Step S402. Determine whether the magnetic field strength B is greater than the trigger threshold B S , when the magnetic field strength B is not greater than the trigger threshold B S , the magnetic field strength B is considered an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S , step S403 is performed.

[0093] Step S403. Design a first timing time T1 and a second timing time T2 through the timer 113, where the first timing time T1 is less than the second timing time T2, and start timing.

[0094] Step S404. After the first timing time T1 of the timer 113 ends, the timer 113 outputs a reset signal and restarts the timing of the first timing time T1; detect the reset signal.

[0095] Step S405. Determine whether at least two reset signals can be detected within the second timing time T2. When at least two reset signals cannot be detected within the second timing time T2, the reset signal is considered an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when at least two reset signals can be detected within the second timing time T2, step S406 is performed.

[0096] Step S406. The magnetic sensor 114 detects the magnetic field strength B;

[0097] Step S407, determine whether the magnetic field strength B is greater than the trigger threshold B S When the magnetic field strength B is not greater than the trigger threshold B S the magnetic field strength B is regarded as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the magnetic field strength B is greater than the trigger threshold B S the magnetic sensor 114 outputs a level signal to the processor 113, and step S408 is performed.

[0098] Step S408, set the third timing time T3. Within the third timing time T3, the vibration sensor 115 detects a vibration signal, and the vibration signal is sent by the external device 200.

[0099] Step S409, determine whether the vibration signal contains an external excitation signal. When the vibration signal does not contain an external excitation signal, the vibration signal is regarded as an invalid signal, and the implantable medical device 100 does not respond to the invalid signal; when the vibration signal contains an external excitation signal, step S410 is performed.

[0100] Step S410, the processor 113 stores the cardiac events within the time period T corresponding to the trigger signal S into the memory 112. The trigger signal includes the reset signal output by the timer 113, the level signal output by the magnetic sensor 114, or the external excitation signal sent by the external device 200.

[0101] Step S411, optionally, the processor 111 activates the communication module 117 and sends the cardiac events to the external device 200 through the communication module 117. Alternatively, the cardiac events are first stored in the memory 112 until the cardiac events are uploaded to the external device 200.

[0102] In this specific embodiment, after detecting two reset signals in step S405, the vibration sensor 115 in step S408 directly detects the vibration signal, and then continues with step S409 until step S411. By detecting whether there are at least two reset signals of the timer 113 with a timing time of T1 within the second timing time T2, detecting whether the magnetic field strength B is greater than the trigger threshold B S and detecting whether the vibration signal of the external device 200 contains an external excitation signal, false trigger signals can be further excluded, preventing the recording of invalid electrocardiogram signals.

[0103] In another specific embodiment of the implantable medical device system of the present invention, the external device and the magnet can be combined. Such asFigure 10 As shown, the magnet 214 is located in the vibration module 210 of the external device. The magnet 214 is an eccentric magnet. The vibration module 210 of the external device includes a drive motor (not shown in the figure), an eccentric wheel structure 211, a drive module 212 of the drive motor, and an encoder 213 connected to the drive module. The eccentric wheel structure 211 includes the magnet 214. The magnet 214 is driven by the drive motor. When the eccentric wheel structure 211 rotates to the first position 215, the magnet 214 generates a magnetic field strength B greater than the trigger threshold B S At this time, the encoder 213 controls the magnet 214 to stay at the first position 215 for a time greater than the first timing time T1. The encoder 213 controls the vibration module 210 to generate a vibration signal. The drive motor rotates at a set vibration frequency or is encoded according to the program of the encoder 213. The vibration signal includes a trigger signal. When the implantable medical device 100 monitors the trigger signal, it stores the heart events corresponding to the time period t S during which the magnetic field strength B is greater than the trigger threshold B S inside.

[0104] Although the present invention has been disclosed as above by way of embodiments, it is not intended to limit the present invention. Any person with ordinary knowledge in the technical field to which the present invention pertains may make some modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to that defined by the appended patent application scope.

Claims

1. An implantable medical device, characterized in that, It includes a processor, a memory, a timer, a magnetic sensor, a vibration sensor, an electrocardiogram module, and a communication module. The processor is respectively connected to the memory, the timer, the magnetic sensor, the vibration sensor, the electrocardiogram module, and the communication module. The electrocardiogram module is electrically connected to a first electrode and a second electrode. When the magnetic sensor detects that the magnetic field intensity is greater than the trigger threshold, it controls the timer to start timing. After the timer finishes timing, it outputs a reset signal to the processor to wake up the processor for subsequent operations; the first timing time and the second timing time are designed through the timer. After the first timing time ends, the timer outputs a reset signal. If at least two reset signals can be detected within the second timing time, a third timing time is set. Within the third timing time, the vibration sensor detects vibration signals.

2. The implantable medical device according to claim 1, characterized in that, The timer is respectively connected to the magnetic sensor, the vibration sensor, and the communication module.

3. The implantable medical device according to claim 1, characterized in that, The electrocardiogram module includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module. The analog-to-digital conversion module converts the analog signals output by the first electrode and the second electrode into digital signals, which are output to the processor for processing after being filtered by the filtering unit module and amplified by the amplifying unit module.

4. An implantable medical device system, characterized in that, It includes the implantable medical device as described in claim 1, and further includes an external device and a magnet. When the magnet approaches the implantable medical device, it generates a magnetic field. The external device communicates with the implantable medical device and a remote server, and the external device generates vibration signals.

5. An implantable medical device system, characterized in that, It includes the implantable medical device as described in claim 1, and further includes an external device. The magnet is located in the vibration module of the external device. The magnet is an eccentric magnet. The vibration module of the external device includes a drive motor, an eccentric wheel structure, a drive module of the drive motor, and an encoder connected to the drive module. The eccentric wheel structure includes the magnet, and the magnet is driven by the drive motor.

6. The method for triggering storage of the implantable medical device and system as described in claim 4 above, characterized in that, Includes When the patient feels discomfort, bring the magnet close to the implantable medical device. When the magnetic sensor detects that the magnetic field intensity is greater than the trigger threshold, set the timing time of the timer to the first timing time and start timing. After the first timing time ends, the timer resets and outputs a reset signal.

7. The method for triggering storage of the implantable medical device and system according to claim 6, wherein, Also includes The magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor, and the processor stores the heart events within the corresponding time period of the trigger signal into the memory. The trigger signal includes the reset signal or the level signal.

8. The method for triggering storage of the implantable medical device and system as claimed in claim 6, wherein Also includes Set the third timing time. Within the third timing time, the vibration sensor detects vibration signals. The vibration signals are emitted by the external device. When the vibration signals contain an external excitation signal, the processor stores the heart events within the corresponding time period of the trigger signal into the memory. The trigger signal includes the reset signal or the external excitation signal.

9. The method for triggering storage of the implantable medical device and system according to claim 6, characterized in that, Also includes The magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor, and a third timing time is set. During the third timing time, the vibration sensor detects a vibration signal, which is emitted by the external device. When the vibration signal contains an external excitation signal, the processor stores the heart events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal or the level signal or the external excitation signal.

10. The method for implantable medical device and system trigger storage according to any one of claims 7-9, characterized in that, It further includes that the processor activates the communication module and sends the heart events to the external device through the communication module; or the heart events are first stored in the memory until the heart events are uploaded to the external device.

11. The method for triggering storage of the implantable medical device and system according to any one of claims 7-9, characterized in that, The corresponding time period is from 6 minutes before the occurrence time of the trigger signal to 1 minute after the occurrence time of the trigger signal.

12. The method for triggering storage of the implantable medical device and system as described in claim 4 above, characterized in that, Including, When the patient feels unwell, the magnet is brought close to the implantable medical device. When the magnetic sensor detects that the magnetic field intensity is greater than the trigger threshold, the timer sets a first timing time and a second timing time, the first timing time is less than the second timing time, and the timing is started. After the first timing time ends, the timer outputs a reset signal and restarts the timing of the first timing time to detect the reset signal.

13. The method for triggering storage of the implantable medical device and system according to claim 12, wherein It further includes, When at least two reset signals can be detected within the second timing time, the processor stores the heart events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal.

14. The method for triggering storage of the implantable medical device and system according to claim 12, wherein It further includes, When at least two reset signals can be detected within the second timing time, a third timing time is set. During the third timing time, the vibration sensor detects the vibration signal, which is emitted by the external device. When the vibration signal contains an external excitation signal, the processor stores the heart events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal or the external excitation signal.

15. The method for triggering storage of the implantable medical device and system as claimed in claim 12, wherein It further includes, The magnetic sensor detects the magnetic field intensity. When the magnetic field intensity is greater than the trigger threshold, the magnetic sensor outputs a level signal to the processor, and a third timing time is set. During the third timing time, the vibration sensor detects the vibration signal, which is emitted by the external device. When the vibration signal contains an external excitation signal, the processor stores the heart events within the corresponding time period of the trigger signal into the memory, and the trigger signal includes the reset signal or the level signal or the external excitation signal.

16. The method for triggering storage of the implantable medical device and system according to any one of claims 13-15, characterized in that, It further includes that the processor activates the communication module and sends the heart events to the external device through the communication module; or the heart events are first stored in the memory until the heart events are uploaded to the external device.

17. The method for triggering storage of the implantable medical device and system according to any one of claims 13-15, characterized in that, The corresponding time period is from 6 minutes before the occurrence time of the trigger signal to 1 minute after the occurrence time of the trigger signal.

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