CN115363532B - Implantable medical device and system and method for triggering storage thereof - Google Patents
Implantable medical device and system and method for triggering storage thereofInfo
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- CN115363532B CN115363532B CN202211006822.1A CN202211006822A CN115363532B CN 115363532 B CN115363532 B CN 115363532B CN 202211006822 A CN202211006822 A CN 202211006822A CN 115363532 B CN115363532 B CN 115363532B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
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- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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Abstract
本发明公开了植入式医疗设备和系统及其触发存储的方法，所述植入式医疗设备系统包括植入式医疗设备、外部设备和磁体，患者感到不适时，将所述磁体靠近所述植入式医疗设备产生磁场，根据植入式医疗设备和系统触发存储的方法触发存储心脏事件，所述植入式医疗设备可将心脏事件传输给所述外部设备。本发明的植入式医疗设备和系统利用外部的磁体激活所述植入式医疗设备存储心脏事件，具有体积小的优点，此外，本发明的植入式医疗设备和系统触发存储的方法能够防误触，提高了监测的可靠性。
The present invention discloses an implantable medical device and system, and a method for triggering and storing such devices. The implantable medical device system includes an implantable medical device, an external device, and a magnet. When a patient experiences discomfort, the magnet is brought close to the implantable medical device to generate a magnetic field. The implantable medical device and system trigger and store cardiac events according to the method. The implantable medical device can then transmit the cardiac events 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 thus have the advantage of being compact. Furthermore, the method for triggering and storing such devices can prevent accidental touches, thereby improving monitoring reliability.
Description
Technical Field
The present invention relates to the field of medical devices, and more particularly, to an implantable medical device and system and a method for triggering storage thereof.
Background
An implantable cardiac monitor (Insertable Cardiac Monitor, abbreviated as ICM) is implanted within the body (subcutaneous chest), and is configured to detect R-wave signals within the body and to determine and store cardiac events based on the detected R-wave signals. Cardiac events include atrial fibrillation, atrial flutter, atrial premature beat, ventricular tachycardia, ventricular fibrillation, asystole, bradycardia, etc., and unexpected injury events such as syncope, fall, etc. of the patient due to the above-mentioned cardiac events.
Since the ICM is an ultra low power device, its internal memory space is limited. To save memory, the ICM uses a circular recording, i.e. new cardiac events will overwrite old cardiac events, which will be deleted from memory. In order to record a cardiac event in time after the cardiac event occurs in a patient, the ICM on the market is provided with a trigger for the patient, and after the trigger is triggered, the ICM permanently stores the R-wave signal and parameters for a period of time before the trigger time and the R-wave signal and parameters for a period of time after the trigger time, so as to prevent the cardiac event from being covered by a new cardiac event.
The trigger in the prior art triggers the ICM through near field magnetic communication, and the trigger mode needs to be provided with a coil in the ICM, however, the ICM is limited to be reduced in size by the built-in coil, and the built-in coil is not easy to integrate with a circuit board in the ICM, so that the complexity of ICM manufacturing and assembly is increased.
Disclosure of Invention
In order to solve the above problems, the present invention provides an implantable medical device and system with small volume and a method for triggering and storing the same, which uses an external magnet to activate the implantable medical device to store cardiac events, does not need a built-in coil, and can transmit the cardiac events to an external device through a communication module of the implantable medical device. The invention is described with respect to an implantable cardiac monitor, however, the invention may also be used with implantable pacemakers, defibrillators, re-synchronized therapy defibrillators, neurostimulators, and the like.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
the implantable medical device comprises a processor, a memory, a timer, a magnetic sensor, a vibration sensor, an electrocardio module and a communication module, wherein the processor is respectively connected with the memory, the timer, the magnetic sensor, the vibration sensor, the electrocardio module and the communication module, the electrocardio module is electrically connected with a first electrode and a second electrode, and when the magnetic sensor detects that the magnetic field intensity is greater than a trigger threshold value, the timer is controlled to start timing.
In a specific embodiment, the timer is connected to the magnetic sensor, the vibration sensor and the communication module, respectively.
The electrocardio module comprises a filtering unit module, an amplifying unit module and an analog-to-digital conversion module, wherein the analog-to-digital conversion module converts analog signals output by the first electrode and the second electrode into digital signals, and the digital signals are filtered by the filtering unit module and amplified by the amplifying unit module and then output to the processor for processing.
In a specific embodiment, the implantable medical device system comprises the implantable medical device, an external device and a magnet, wherein the magnet generates a magnetic field when being close to the implantable medical device, the external device is communicated with the implantable medical device and a remote server, and the external device generates a vibration signal.
In another specific embodiment, the implantable medical device system comprises the implantable medical device, and further comprises the external device, wherein the magnet is located in a vibration module of the external device, the magnet is an eccentric magnet, the vibration module of the external device comprises a driving motor, an eccentric wheel structure, a driving module of the driving motor, and an encoder connected with the driving module, the eccentric wheel structure comprises the magnet, and the magnet is driven by the driving motor.
Methods of implantable medical devices and systems for triggering storage, including,
The patient is inconvenienced by bringing the magnet in close proximity to the implantable medical device;
when the magnetic sensor detects that the magnetic field intensity is larger than a trigger threshold, setting the timing time of the timer to be first timing time, and starting timing;
And after the first timing time is over, the timer is reset, and a reset signal is output.
In a first specific embodiment, the method for triggering and storing an implantable medical device and a system as described above further includes that the magnetic sensor detects a magnetic field strength, and when the magnetic field strength is greater than the triggering threshold, the magnetic sensor outputs a level signal to the processor, and the processor stores a cardiac event in a time period corresponding to a triggering signal into the memory, where the triggering signal includes the reset signal or the level signal.
In a second specific embodiment, the method for triggering and storing an implantable medical device and a system further includes setting a third timing time, in which the vibration sensor detects a vibration signal, the vibration signal is sent by the external device, and when the vibration signal includes an external excitation signal, the processor stores a cardiac event in a time period corresponding to the triggering signal into the memory, and the triggering signal includes the reset signal or the external excitation signal.
In a third specific embodiment, the method for triggering and storing an implantable medical device and a system as described above further includes that the magnetic sensor detects a magnetic field strength, the magnetic sensor outputs a level signal to the processor when the magnetic field strength is greater than the triggering threshold, a third timing time is set, the vibration sensor detects a vibration signal during the third timing time, the vibration signal is sent by the external device, and when the vibration signal includes the external excitation signal, the processor stores a cardiac event in a time period corresponding to the triggering signal into the memory, and the triggering signal includes the reset signal or the level signal or the external excitation signal.
The method for triggering and storing the implantable medical device and the implantable medical system further comprises the steps that the processor activates the communication module, and the cardiac event is sent to the external device through the communication module, or the cardiac event is stored in the memory first until the cardiac event is uploaded to the external device.
The corresponding time period is from 6 minutes before the trigger signal generation time to 1 minute after the trigger signal generation time.
Methods of implantable medical devices and systems for triggering storage, including,
The patient is inconvenienced by bringing the magnet in close proximity to the implantable medical device;
when the magnetic sensor detects that the magnetic field intensity is larger than the trigger threshold, setting the first timing time and the second timing time through the timer, wherein the first timing time is smaller than the second timing time, and starting timing;
after the first timing time is over, the timer outputs a reset signal, the timing of the first timing time is restarted, and the reset signal is detected.
In a first specific embodiment, the method for triggering storage of an implantable medical device and a system as described above further includes, when the reset signal can be detected at least twice within the second timing time, storing, by the processor, a cardiac event within a time period corresponding to the trigger signal into the memory, the trigger signal including the reset signal.
In a second specific embodiment, the method for triggering and storing an implantable medical device and a system as described above further includes setting the third timing time when the reset signal can be detected at least twice within the second timing time, during the third timing time, the vibration sensor detects the vibration signal, the vibration signal is sent by the external device, and when the vibration signal includes the external excitation signal, the processor stores a cardiac event within a time period corresponding to the trigger signal into the memory, and the trigger signal includes the reset signal or the external excitation signal.
In a third specific embodiment, the method for triggering and storing an implantable medical device and a system as described above further includes that the magnetic sensor detects a magnetic field strength, the magnetic sensor outputs a level signal to the processor when the magnetic field strength is greater than the triggering threshold, the third timing time is set, the vibration sensor detects the vibration signal during the third timing time, the vibration signal is sent by the external device, and when the vibration signal includes the external excitation signal, the processor stores a cardiac event in a time period corresponding to the triggering signal into the memory, and the triggering signal includes the reset signal or the level signal or the external excitation signal.
The method for triggering and storing the implantable medical device and the implantable medical system further comprises the steps that the processor activates the communication module, and the cardiac event is sent to the external device through the communication module, or the cardiac event is stored in the memory first until the cardiac event is uploaded to the external device.
The corresponding time period is from 6 minutes before the trigger signal generation time to 1 minute after the trigger signal generation time.
The implanted medical device and the system have the beneficial effects that the implanted medical device is activated by using the external magnet to store cardiac events, no built-in coil is needed, the implanted medical device and the system have the advantages of small size, the magnet is convenient to carry, the structure is simple, and the external device can be realized by using a smart phone, a smart watch and the like. In addition, through setting up first timing time, second timing time, detecting magnetic field intensity, detecting vibration signal, can further get rid of the mistake trigger signal, prevent to record invalid electrocardiosignal, improve the reliability of monitoring.
In order to make the above features and advantages of the present invention more comprehensible, embodiments accompanied with figures are described in detail below.
Drawings
FIG. 1 is a schematic view of an implantable medical system according to the present invention.
Fig. 2 is a block diagram of a first embodiment of an implantable medical device of the present invention.
Fig. 3 is a schematic diagram of a storage structure of an implantable medical device according to the present invention.
Fig. 4 is a schematic diagram of the implantable medical system of the present invention communicating between a communication module and an external device.
Fig. 5 is a block diagram of a second embodiment of an implantable medical device of the present invention.
Fig. 6 is a flowchart of a first embodiment of a method of triggering storage by an implantable medical device and system of the present invention.
Fig. 7 is a flow chart of a second embodiment of a method of triggering storage by an implantable medical device and system of the present invention.
Fig. 8 is a flow chart of a third embodiment of a method of triggering storage of an implantable medical device and system of the present invention.
Fig. 9 is a flowchart of a fourth embodiment of a method of triggering storage by an implantable medical device and system of the present invention.
Fig. 10 is another embodiment of an implantable medical system according to the present invention.
In the drawings, like reference numerals refer to like elements.
Detailed Description
In order to make the purpose and technical solutions of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. It will be apparent that the described embodiments are some, but not all, embodiments of the invention. All other embodiments, which can be made by a person skilled in the art without creative efforts, based on the described embodiments of the present invention fall within the protection scope of the present invention.
Fig. 1 is a schematic diagram of an implantable medical device system of the present invention. As shown in fig. 1, 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 a surface of the implantable medical device head 120, the first electrode 130 is electrically connected to a feedthrough structure within the implantable medical device head 120, and the feedthrough structure is electrically connected to a first end of the housing 110. A second electrode 140 is positioned on a surface of the second end of the housing 110, the second electrode 140 being electrically connected to the housing 110. The implantable medical device head 120 may be made of a material having biocompatibility and wireless electromagnetic signal passing property, such as silica gel, through which electromagnetic signals pass, the surface of the housing 110 may be insulated, the surface of the housing 110 may be made non-conductive using a passivation process, and the first electrode 130 and the second electrode 140 may not be insulated.
The function of the magnet 300 is to generate a magnetic field when in proximity to the implantable medical device 100, and the external device 200 communicates with the implantable medical device 100 and receives cardiac events stored by the implantable medical device 100 by way of 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 comprises a handheld device such as a smart phone, a palm computer and the like, and also comprises special devices such as a household monitor, an ambulatory medical device, a program control instrument and the like. The cardiac event refers to an electrocardiosignal corresponding to an abnormal heart rate of a patient, such as an electrocardiosignal corresponding to atrial fibrillation, atrial flutter, asystole, bradycardia, tachycardia and slow syndromes, ventricular tachycardia, ventricular fibrillation, ventricular tachycardia and the like.
Fig. 2 shows a schematic structural diagram of a first specific embodiment of the internal circuit components of the implantable medical device 100. As shown in fig. 2, 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 electrocardiograph module 116, and a communication module 117.
The electrocardiograph module 116 is electrically connected to the first electrode 130 and the second electrode 140. The electrocardiograph module 116 includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module, where the analog-to-digital conversion module converts the analog signals output by the first electrode 130 and the second electrode 140 into digital signals, and outputs the signals to the processor 111 for processing after filtering by the filtering unit module and amplifying by the amplifying unit module.
The vibration sensor 115 is configured to detect a vibration signal emitted from the external device 200, where the vibration signal includes an external excitation signal. The magnetic sensor 114 is configured to detect a magnetic field strength B, when the patient holds the magnet 300 near the implantable medical device 100 and the detected magnetic field strength B is continuously greater than a set trigger threshold B S, optionally, the trigger threshold B S may be 13 oersted, the magnetic sensor 114 generates a continuous level signal and outputs the continuous level signal to the processor 111, the processor 111 wakes the timer 113 to start counting after receiving the level signal output by the magnetic sensor 114, the counted time is a first counted time T1, and the first counted time T1 is set by the processor 111, optionally, the first counted time T1 of the timer 113 may be set to 0.1-15 seconds. When the timer 113 finishes counting, the timer 113 generates a reset signal and outputs the reset signal to the processor 111, and the processor 111 performs subsequent operations. The timing of the timer 113 is set to ensure that the level signal output by the magnetic sensor 114 is actively triggered by the patient and not 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 fact that the magnetic sensor 114 is triggered by external environment with abnormal high frequency.
When the processor 111 does not receive the reset signal of the timer 113, the processor 111 stores the collected cardiac events in a cyclic recording manner, and the new cardiac event will cover the cardiac event of a certain historical time point, and when the processor 111 receives the trigger signal, the processor 111 stores the cardiac event in a time period t S corresponding to the trigger signal in the memory 112 in a permanent recording manner. Referring to fig. 3, fig. 3 is a schematic diagram of a storage structure of the implantable medical device 100, the corresponding time period t S is a time between a time t0 and a time t2, the time t0 is 6 minutes before the trigger signal generating time t1, and the time t2 is 1 minute after the trigger signal generating time t 1. Illustratively, the patient's heartbeat interval at the time of triggering is 240ms, the patient's heart rate is 250bpm, which is the ventricular rate, and the patient can experience significant physical discomfort, so 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 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 permanently recorded manner. The heart events are stored in a permanent record mode, so that a user or a doctor can conveniently check the heart events at any time later.
The memory 112 stores cardiac events and also stores computer programs for diagnosing cardiac events. The processor 111 invokes the computer program for diagnosing cardiac events, classifying cardiac events. Further, the processor 111 may transmit cardiac events stored in the memory 112 to the external device 200.
The processor 111 also invokes an anti-false trigger program. In a specific embodiment, the false triggering prevention procedure includes monitoring the number of occurrences of the reset signal during a second timing time T2, the second timing time T2 being set by the processor 111, and storing a cardiac event when the reset signal is detected at least twice during the second timing time T2. More specifically, the first reset signal occurs at time T S1, the second reset signal occurs at time T S2, and when T S2-tS1 is less than or equal to T2, the reset signal is considered to occur 2 times within the second timing time T2. In another embodiment, the false triggering prevention procedure includes monitoring a number of occurrences of the reset signal within a second timing time T2, the second timing time T2 being set by the processor 111, and storing a cardiac event when the reset signal is detected at least three times within the second timing time T2. More specifically, the first reset signal occurs at time T S1, the second reset signal occurs at time T S2, and the third reset signal occurs at time T S3, and when (T S3-tS2)+(tS2-tS1). Ltoreq.T2, the reset signal is considered to occur 3 times within the second timing time T2. Monitoring the number of times the reset signal is detected over time may reduce the likelihood of false triggers, and the patient may shake to activate storage by the magnet 300 in a position near the implantable medical device 100 during use.
The communication module 117 has a function of communicating with the external device 200, and may transmit the cardiac event stored in the memory 112 to the external device 200. Fig. 4 shows a schematic diagram of communication between the communication module 117 and the external device 200. When the timer 113 finishes counting, 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, where the first message M1 is used to display a prompt message on the external device 200 that the storage function of the implantable medical device 100 is activated, so that the user can conveniently understand the state of the implantable medical device 100. After the processor 111 completes the act of 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, where the second message M2 is used to display a prompt for the completion of storing on the external device 200. Optionally, the second message M2 further comprises a memory size of the cardiac event. The processor 111 also transmits a third message M3 to the external device 200 through the communication module 117, the third message M3 including the cardiac event, and the external device 200 receives and stores the third message M3. Meanwhile, the external device 200 may transmit the received first message M1, the second message M2, and the third message M3 to a cloud for further analysis. In a preferred embodiment, the communication module includes a bluetooth device, and the external device 200 is a smart phone.
Fig. 5 shows a block diagram of a second specific embodiment of the implantable medical device 100. As shown in fig. 5, 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 electrocardiograph module 116, and a communication module 117. The electrocardiograph module 116 is electrically connected to the first electrode 130 and the second electrode 140. The timer 113 is connected to the magnetic sensor 114, the vibration sensor 115, and the communication module 117, respectively.
The electrocardiograph module 116 is electrically connected to the first electrode 130 and the second electrode 140. The electrocardiograph module 116 includes a filtering unit module, an amplifying unit module, and an analog-to-digital conversion module, where the analog-to-digital conversion module converts the analog signals output by the first electrode 130 and the second electrode 140 into digital signals, and outputs the signals to the processor 111 for processing after filtering by the filtering unit module and amplifying by the amplifying unit module.
When the magnetic field intensity B detected by the magnetic sensor 114 is continuously greater than the set trigger threshold B S, the magnetic sensor 114 generates a continuous level signal and outputs the continuous level signal to the timer 113, and the timer 113 starts to count. When the timer 113 finishes counting, 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.
Alternatively, the timer 113 and the processor 111 may 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, and wakes up the timer 113 after receiving a signal, the timer 113 includes a signal output port, and outputs a reset signal to an input port of the execution unit.
Fig. 6 is a flowchart of a first embodiment of a method of triggering storage by an implantable medical device and system of the present invention. As shown in figure 6 of the drawings,
Step S100, when the patient feels uncomfortable, bringing the magnet 300 close to the implantable medical device 100.
In step S101, the magnetic sensor 114 detects the magnetic field strength B.
Step S102, judging whether the magnetic field intensity B is larger than the triggering threshold B S, when the magnetic field intensity B is not larger than the triggering threshold B S, regarding the magnetic field intensity B as an invalid signal, wherein the implantable medical device 100 does not respond to the invalid signal, and when the magnetic field intensity B is larger than the triggering threshold B S, performing step S103.
In step S103, the counted time of the timer 113 is set to be the first counted time T1, and the counting is started.
In step S104, after the timer 113 finishes counting, the timer 113 resets and outputs a reset signal, and at the same time, the magnetic sensor 114 detects the magnetic field strength B.
Step S105, determining 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, regarding the magnetic field strength B as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and 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 performing step S106.
In step S106, the processor 113 stores a triggering signal corresponding to a cardiac event in the time period T S in the memory 112, where the triggering signal includes a reset signal output by the timer 113 or a level signal output by the magnetic sensor 114.
In step S107, optionally, the processor 111 activates the communication module 117, and sends a cardiac event to the external device 200 through the communication module 117. Or cardiac events may be stored in the memory 112 until the cardiac events are uploaded to the external device 200.
In this embodiment, detecting the magnetic field strength B while the timer 113 is reset can exclude false triggering signals and prevent recording of ineffective cardiac events.
Fig. 7 is a flow chart of a second embodiment of a method of triggering storage by an implantable medical device and system of the present invention. As shown in figure 7 of the drawings,
Step S200, when the patient feels uncomfortable, bringing the magnet 300 close to the implantable medical device 100.
In step S201, the magnetic sensor 114 detects the magnetic field strength B.
Step S202, judging whether the magnetic field intensity B is larger than the triggering threshold B S, when the magnetic field intensity B is not larger than the triggering threshold B S, regarding the magnetic field intensity B as an invalid signal, wherein the implantable medical device 100 does not respond to the invalid signal, and when the magnetic field intensity B is larger than the triggering threshold B S, performing step S203.
In step S203, the counted time of the timer 113 is set to be the first counted time T1, and the counting is started.
In step S204, after the timer 113 finishes counting, the timer 113 resets and outputs a reset signal, and at the same time, the magnetic sensor 114 detects the magnetic field strength B.
In step S205, it is determined whether the magnetic field strength B is greater than the trigger threshold B S, and 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, the implantable medical device 100 does not respond to the invalid signal, and 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.
In step S206, a third timing time T3 is set, and in the third timing time T3, the vibration sensor 115 detects a vibration signal, and the vibration signal is sent out by the external device 200.
Step S207, judging whether the vibration signal contains an external excitation signal, when the vibration signal does not contain the external excitation signal, regarding the vibration signal as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and when the vibration signal contains the external excitation signal, performing step S208.
In step S208, the processor 113 stores a triggering signal corresponding to a cardiac event in the time period T S in the memory 112, where the triggering signal includes a reset signal output by the timer 113 or a level signal output by the magnetic sensor 114 or an external excitation signal sent by the external device 200.
In step S209, optionally, the processor 111 activates the communication module 117, and sends a cardiac event to the external device 200 through the communication module 117. Or cardiac events may be stored in the memory 112 until the cardiac events are uploaded to the external device 200.
In this embodiment, the step S204 may output a reset signal, and then the step S207 may be directly performed until the step S209 after the vibration sensor 115 in the step S206 detects a vibration signal. In the case that the timer 113 is reset and the magnetic field strength B is detected to be greater than the triggering threshold B S, by detecting whether the vibration signal includes an external triggering signal through the vibration sensor 115, the false triggering signal can be further eliminated, and the ineffective cardiac event can be prevented from being recorded.
Fig. 8 is a flow chart of a third embodiment of a method of triggering storage of an implantable medical device and system of the present invention. As shown in figure 8 of the drawings,
Step S300, when the patient feels uncomfortable, bringing the magnet 300 close to the implantable medical device 100.
In step S301, the magnetic sensor 114 detects the magnetic field strength B.
Step S302, judging whether the magnetic field intensity B is larger than the triggering threshold B S, when the magnetic field intensity B is not larger than the triggering threshold B S, regarding the magnetic field intensity B as an invalid signal, wherein the implantable medical device 100 does not respond to the invalid signal, and when the magnetic field intensity B is larger than the triggering threshold B S, performing step S303.
In step S303, the timer 113 sets a first timing time T1 and a second timing time T2, and the first timing time T1 is smaller than the second timing time T2, so as to start timing.
In step S304, after the first timing time T1 of the timer 113 is finished, the timer 113 outputs a reset signal, restarts the timing of the first timing time T1, and detects the reset signal.
Step S305, determining whether the reset signal can be detected at least twice within the second time period T2, when the reset signal cannot be detected at least twice within the second time period T2, regarding the reset signal as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and when the reset signal can be detected at least twice within the second time period T2, performing step S306.
In step S306, the processor 113 stores the cardiac event in the time period T S corresponding to the trigger signal in the memory 112, where the trigger signal includes the reset signal output by the timer 113.
In step S307, optionally, the processor 111 activates the communication module 117, and sends a cardiac event to the external device 200 through the communication module 117. Or cardiac events may be stored in the memory 112 until the cardiac events are uploaded to the external device 200.
In this embodiment, by detecting whether the reset signal of the timer 113 with the timing time T1 occurs twice or more in the second timing time T2, the false trigger signal can be further eliminated, and the recording of invalid electrocardiographic signals can be prevented.
Fig. 9 is a flowchart of a fourth embodiment of a method of triggering storage by an implantable medical device and system of the present invention. As shown in the figure 9 of the drawings,
Step S400, when the patient feels uncomfortable, bringing the magnet 300 close to the implantable medical device 100.
In step S401, the magnetic sensor 114 detects the magnetic field strength B.
Step S402, judging whether the magnetic field intensity B is larger than the triggering threshold B S, when the magnetic field intensity B is not larger than the triggering threshold B S, regarding the magnetic field intensity B as an invalid signal, wherein the implantable medical device 100 does not respond to the invalid signal, and when the magnetic field intensity B is larger than the triggering threshold B S, performing step S403.
In step S403, the timer 113 is used to design a first timing time T1 and a second timing time T2, and the first timing time T1 is smaller than the second timing time T2, so as to start timing.
In step S404, after the first timing time T1 of the timer 113 is finished, the timer 113 outputs a reset signal, restarts the timing of the first timing time T1, and detects the reset signal.
Step S405, determining whether the reset signal can be detected at least twice within the second time period T2, when the reset signal cannot be detected at least twice within the second time period T2, regarding the reset signal as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and when the reset signal can be detected at least twice within the second time period T2, performing step S406.
Step S406, the magnetic sensor 114 detects the magnetic field strength B;
Step S407, determining 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, regarding the magnetic field strength B as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and 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 performing step S408.
In step S408, a third timing time T3 is set, and in the third timing time T3, the vibration sensor 115 detects a vibration signal, and the vibration signal is sent out by the external device 200.
Step S409, judging whether the vibration signal contains an external excitation signal, when the vibration signal does not contain an external excitation signal, regarding the vibration signal as an invalid signal, the implantable medical device 100 does not respond to the invalid signal, and when the vibration signal contains an external excitation signal, performing step S410.
In step S410, the processor 113 stores a triggering signal corresponding to a cardiac event in the time period T S in the memory 112, where the triggering signal includes a reset signal output by the timer 113 or a level signal output by the magnetic sensor 114 or an external excitation signal sent by the external device 200.
In step S411, optionally, the processor 111 activates the communication module 117, and sends a cardiac event to the external device 200 through the communication module 117. Or cardiac events may be stored in the memory 112 until the cardiac events are uploaded to the external device 200.
In this embodiment, the step S405 may be directly performed after the step S408 detects the reset signal twice, and the step S409 may be further performed until the step S411. By detecting whether the reset signal of the timer 113 with the timing time T1 occurs at least twice 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 includes an external excitation signal, the false trigger signal can be further eliminated, and the invalid electrocardiograph signal can be prevented from being recorded.
In another specific embodiment of the implantable medical device system of the present invention, the external device and the magnet may be combined. As shown in fig. 10, 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 driving motor (not shown in the drawing), an eccentric wheel structure 211, a driving module 212 of the driving motor, and an encoder 213 connected to the driving module, the eccentric wheel structure 211 includes the magnet 214, when the eccentric wheel structure 211 rotates to a first position 215, the magnet 214 generates a magnetic field strength B greater than the triggering threshold B S, the encoder 213 controls the magnet 214 to stay in the first position 215 for greater than the first timing time T1, the encoder 213 controls the vibration module 210 to generate a vibration signal, the driving motor rotates according to a set vibration frequency or encodes according to a program of the encoder 213, the vibration signal includes a triggering signal, and when the implantable medical device 100 monitors the triggering signal, a cardiac event corresponding to the magnetic field strength B greater than the triggering threshold B S is stored for a time period S.
Although the present invention has been described with reference to the above embodiments, it should be understood that the invention is not limited thereto, but rather is capable of modification and variation without departing from the spirit and scope of the present invention.
Claims (17)
1. The implantable medical device is characterized by comprising a processor, a memory, a timer, a magnetic sensor, a vibration sensor, an electrocardio module and a communication module, wherein the processor is respectively connected with the memory, the timer, the magnetic sensor, the vibration sensor, the electrocardio module and the communication module, the electrocardio module is electrically connected with a first electrode and a second electrode, when the magnetic sensor detects that the magnetic field intensity is greater than a trigger threshold value, the timer is controlled to start timing, the timer outputs a reset signal to the processor after finishing timing, the processor is awakened to perform subsequent operation, a first timing time and a second timing time are designed through the timer, the timer outputs the reset signal after the first timing time is finished, the reset signal can be detected at least twice in the second timing time, a third timing time is set, and the vibration sensor detects the vibration signal in the third timing time.
2. The implantable medical device of claim 1, wherein the timer is coupled to the magnetic sensor, the shock sensor, and the communication module, respectively.
3. The implantable medical device of claim 1, wherein the electrocardiograph module comprises a filtering unit module, an amplifying unit module and an analog-to-digital conversion module, wherein the analog-to-digital conversion module converts analog signals output by the first electrode and the second electrode into digital signals, and the digital signals are filtered by the filtering unit module and amplified by the amplifying unit module and then output to the processor for processing.
4. An implantable medical device system comprising the implantable medical device of claim 1, further comprising an external device and a magnet, the magnet generating a magnetic field when in proximity to the implantable medical device, the external device in communication with the implantable medical device and a remote server, the external device generating a shock signal.
5. An implantable medical device system comprising the implantable medical device of claim 1, and further comprising an external device, wherein the magnet is located in a vibration module of the external device, the magnet is an eccentric magnet, the vibration module of the external device comprises a drive motor, an eccentric wheel structure, a drive module of the drive motor, and an encoder coupled to the drive module, the eccentric wheel structure comprises the magnet, and the magnet is driven by the drive motor.
6. The method for triggering storage of an implantable medical device and system as recited in claim 4, comprising,
The patient is inconvenienced by bringing the magnet in close proximity to the implantable medical device;
when the magnetic sensor detects that the magnetic field intensity is larger than a trigger threshold, setting the timing time of the timer to be first timing time, and starting timing;
And after the first timing time is over, the timer is reset, and a reset signal is output.
7. The method of triggering storage of an implantable medical device and system as recited in claim 6, further comprising,
The magnetic sensor detects magnetic field intensity, when the magnetic field intensity is larger than the trigger threshold value, the magnetic sensor outputs a level signal to the processor, the processor stores heart events in a time period corresponding to a trigger signal into the memory, and the trigger signal comprises the reset signal or the level signal.
8. The method of triggering storage of an implantable medical device and system as recited in claim 6, further comprising,
Setting a third timing time, in which the vibration sensor detects a vibration signal, the vibration signal is sent by the external device, and when the vibration signal contains an external excitation signal, the processor stores a cardiac event in a time period corresponding to a trigger signal into the memory, wherein the trigger signal comprises the reset signal or the external excitation signal.
9. The method of triggering storage of an implantable medical device and system as recited in claim 6, further comprising,
The magnetic sensor detects magnetic field intensity, when the magnetic field intensity is larger than the trigger threshold value, the magnetic sensor outputs a level signal to the processor, a third timing time is set, in the third timing time, the vibration sensor detects a vibration signal, the vibration signal is sent out by the external equipment, when the vibration signal contains an external excitation signal, the processor stores a cardiac event in a time period corresponding to the trigger signal into the memory, and the trigger signal comprises the reset signal or the level signal or the external excitation signal.
10. The method of triggering storage of an implantable medical device and system as recited in any one of claims 7-9, further comprising the processor activating the communication module to send the cardiac event to the external device via the communication module or the cardiac event is stored in the memory until the cardiac event is uploaded to the external device.
11. The method of implantable medical device and system trigger storage according to any one of claims 7-9, wherein the corresponding time period is 6 minutes before the trigger signal generation time to 1 minute after the trigger signal generation time.
12. The method for triggering storage of an implantable medical device and system as recited in claim 4, comprising,
The patient is inconvenienced by bringing the magnet in close proximity to the implantable medical device;
When the magnetic sensor detects that the magnetic field intensity is larger than the trigger threshold, a first timing time and a second timing time are set through the timer, wherein the first timing time is smaller than the second timing time, and timing is started;
after the first timing time is over, the timer outputs a reset signal, the timing of the first timing time is restarted, and the reset signal is detected.
13. The method of triggering storage of an implantable medical device and system as recited in claim 12, further comprising,
When the reset signal can be detected at least twice within the second timing time, the processor stores a cardiac event within a time period corresponding to a trigger signal into the memory, the trigger signal including the reset signal.
14. The method of triggering storage of an implantable medical device and system as recited in claim 12, further comprising,
Setting a third timing time when the reset signal can be detected at least twice within the second timing time, wherein the vibration sensor detects the vibration signal within the third timing time, the vibration signal is sent out by the external device, and when the vibration signal contains an external excitation signal, the processor stores a cardiac event within a time period corresponding to a trigger signal into the memory, and the trigger signal comprises the reset signal or the external excitation signal.
15. The method of triggering storage of an implantable medical device and system as recited in claim 12, further comprising,
The magnetic sensor detects magnetic field intensity, when the magnetic field intensity is larger than the trigger threshold value, the magnetic sensor outputs a level signal to the processor, a third timing time is set, in the third timing time, the vibration sensor detects the vibration signal, the vibration signal is sent out by the external equipment, when the vibration signal contains an external excitation signal, the processor stores a cardiac event in a time period corresponding to the trigger signal into the memory, and the trigger signal comprises the reset signal or the level signal or the external excitation signal.
16. The method of implantable medical device and system-triggered storage of any one of claims 13-15, further comprising the processor activating the communication module to send the cardiac event to the external device via the communication module, or the cardiac event is stored in the memory first until the cardiac event is uploaded to the external device.
17. The method of implantable medical device and system trigger storage according to any one of claims 13-15, wherein the corresponding time period is 6 minutes before the trigger signal generation time to 1 minute after the trigger signal generation time.
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| US8340776B2 (en) * | 2007-03-26 | 2012-12-25 | Cardiac Pacemakers, Inc. | Biased acoustic switch for implantable medical device |
| ES2593091T3 (en) * | 2007-12-12 | 2016-12-05 | Cardiac Pacemakers, Inc. | Implantable medical device with Hall sensor |
| JP2015506213A (en) * | 2012-01-10 | 2015-03-02 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | Capacitance sensor |
| US9288614B1 (en) * | 2015-03-03 | 2016-03-15 | Pacesetter, Inc. | Systems and methods for initiating a communication link between an implantable medical device and an external device |
| WO2018044408A1 (en) * | 2016-09-02 | 2018-03-08 | Medtronic, Inc. | Hall sensor circuit for magnetic field detection in implantable medical device |
| CN112022145A (en) * | 2020-09-30 | 2020-12-04 | 苏州无双医疗设备有限公司 | External defibrillation equipment and combined system thereof |
| CN112022146B (en) * | 2020-09-30 | 2022-06-17 | 苏州无双医疗设备有限公司 | Implantable cardiac pacemaker and wearable defibrillator combined system |
| CN114903432A (en) * | 2021-02-10 | 2022-08-16 | 海信视像科技股份有限公司 | display screen |
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| US6963779B1 (en) * | 2002-05-28 | 2005-11-08 | Pacesetter, Inc. | System for the selective activation of functions in an implantable device by a magnetic field |
| EP3695776A1 (en) * | 2019-02-13 | 2020-08-19 | Koninklijke Philips N.V. | A method and system for generating a respiration instability signal |
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