CN112022145A - External defibrillation equipment and combined system thereof - Google Patents

Abstract

The invention discloses an external defibrillation device and a combined system thereof, which comprises an implanted medical device and an external defibrillation device arranged outside a human body, wherein the implanted medical device calculates physiological parameters for diagnosing cardiac events according to sensed electrocardiosignals; the electrocardiosignals and/or the physiological parameters are transmitted in real time or periodically to an external defibrillation device; and the processor of the external defibrillation equipment takes the electrocardiosignal or the physiological parameter as a diagnosis basis and releases defibrillation electric shock when defibrillation treatment is needed.

Description

External defibrillation equipment and combined system thereof

Technical Field

The invention belongs to the field of medical equipment, and particularly relates to an improvement on a system for matching implantable medical equipment with other medical equipment.

Background

Cardiac pacemakers or monitors do not have defibrillation functionality. The cardiac pacemaker also fails anti-tachycardia pacing therapy ATP because anti-tachycardia pacing may cause more severe tachycardia, such as ventricular fibrillation, in which a timely defibrillation therapy is required to the heart to prevent Sudden Cardiac Death (SCD) from occurring, and the cardiac pacemaker does not have a function of defibrillation. For patients with implanted heart monitors (ICMs), implanted heart monitors have only the ability to monitor, analyze, and store cardiac electrical signals, and have no therapeutic capabilities. If a doctor suspects that the patient is at risk of sudden cardiac death, a wearable defibrillator (WCD) can be worn on the patient, but the WCD and the ICM do not establish communication at the moment, and the physiological information of the patient acquired by the WCD and the ICM working independently cannot be shared. And because the WCD detects the body surface electrocardiosignal, the electrocardiosignal is more easily interfered by external environment and the electromyographic signal compared with the implanted medical equipment.

Implantable cardiac defibrillators typically do not have an overly complex software system running on their internal processor for power consumption and body size requirements, such as training a cardiac event diagnostic neural network using physiological parameters, which limits the improvement of diagnostic algorithms using complex software. Meanwhile, the highest energy is lower than that of external defibrillation when the implantable cardiac defibrillator is used for defibrillation, and the implantable cardiac defibrillator can only perform repeated highest energy defibrillation under the condition that the implantable cardiac defibrillator can not be used for defibrillation after reaching the highest energy. Defibrillation therapy at higher energy levels can be provided if external defibrillation equipment can be utilized to defibrillate from outside the body, improving the success rate of defibrillation.

Disclosure of Invention

The invention aims to provide a combined system of an implantable medical device and an external defibrillation device and the external defibrillation device. In a combined system, the external defibrillation equipment utilizes the physiological parameters or heartbeat signals sent by the implanted medical equipment to diagnose. The external defibrillation device can perform higher-energy defibrillation in vitro when the highest-energy and highest-energy defibrillation of the implantable medical device fails, and provides more treatment means.

The implantable medical device and wearable defibrillation device combined system comprises an implantable medical device implanted in a human body and an external defibrillation device arranged outside the human body, wherein the implantable medical device comprises a sensing module, a processor and a communication module; the processor is configured to sense the cardiac electrical signal via the sensing module, the processor calculating a physiological parameter for diagnosing the cardiac event based on the sensed cardiac electrical signal; the electrocardiosignals and/or the physiological parameters are transmitted to external defibrillation equipment in real time or periodically;

the external defibrillation device comprises a processor, a communication module and a treatment module; the processor is configured to receive the electrocardiosignal and/or the physiological parameter sent by the implantable medical device through the communication module, and the processor of the external defibrillation device takes the electrocardiosignal or the physiological parameter as a diagnosis basis and releases defibrillation shock when defibrillation treatment is needed.

The implantable medical device collects electrocardiosignals and sends the electrocardiosignals or physiological parameters to the external defibrillation device, and the external defibrillation device can integrate a chip with higher computing power and a larger power supply device, so that the electrocardiosignals or the physiological parameters are sent to a more complex software algorithm for diagnosis, and the diagnosis accuracy is improved.

Meanwhile, the external defibrillation equipment can be matched with an implanted heart monitor (ICM) so that the ICM has the defibrillation capability, so that a patient does not need to implant a transvascular lead, and the lead complication and risk are reduced. And employing the transmitted signal of the implanted medical device as a basis for diagnostic analysis can reduce interference with other signals.

In a preferred embodiment, the processor of the implantable medical device is configured to transmit its own status information, including diagnostic information and therapy information, to the external defibrillation device.

In a preferred embodiment, the diagnostic information includes sinus rhythm, supraventricular tachycardia, ventricular tachycardia, tachyventricular tachycardia or ventricular fibrillation diagnosed from the physiological parameter or the cardiac signal.

In a preferred embodiment, the therapy information includes therapy to be or to be performed by the implantable medical device based on the diagnosis, the therapy including pacing, anti-tachycardia pacing, defibrillation or multi-level energy defibrillation.

In a preferred embodiment, the processor of the external defibrillation device is configured to determine whether to perform external defibrillation therapy based on the therapy status of the implantable medical device.

In a preferred embodiment, when the therapy state of the implantable medical device is that pacing, anti-tachycardia pacing, defibrillation or multi-level energy defibrillation is about to be performed, the external defibrillation device does not perform external defibrillation therapy.

In a preferred embodiment, the processor of the external defibrillation device is configured to perform external defibrillation by the external defibrillation device after the implantable medical device treatment state is that the highest energy defibrillation has been performed and sinus rhythm is not restored.

In this embodiment, the external defibrillation device performs external defibrillation when the implantable medical device fails to defibrillate, the external defibrillation device has a larger power supply and larger defibrillation energy, and the external defibrillation mode provides high possibility of restoring sinus rhythm.

In a preferred embodiment, the external defibrillation device comprises a sensing electrode, and the processor is configured to perform diagnosis according to the electrocardiosignals sensed by the sensing circuit and the sensing electrode; and comparing the diagnosis result with the result of diagnosis by using the electrocardiosignal or the physiological parameter sent by the implanted medical equipment; if the diagnosis results of the two are consistent, performing external defibrillation treatment; the implantable medical device and the external defibrillation device use different diagnostic algorithms.

The external defibrillation device comprises a processor, and a communication module, a treatment module and a sensing module which are connected with the processor; the processor is configured to transmit an implantable medical device interrogation message through the communication module; and setting a timeout period during which the external defibrillation device enters a therapy mode if the processor does not receive a response message from the implantable medical device; receiving a response message of the implantable medical device within the timeout period, wherein the response message is used as a diagnosis basis by the external defibrillation device, and a defibrillation electric shock is released when defibrillation treatment is needed; the response message comprises the electrocardiosignal and/or the physiological parameter which are sent by the implanted medical equipment in real time or periodically.

During the use process of the external defibrillation device, the defibrillation device can firstly enter an inquiry state to inquire whether the implantable cardiac defibrillator exists in the body of a patient or not, and receive parameters of the implantable cardiac defibrillator, so that the diagnosis and treatment history of the patient and the state of the patient are known, and the occurrence of wrong treatment is prevented. If the implantable cardiac defibrillation equipment is overtime, the implantable cardiac defibrillation equipment directly enters a treatment mode, and the extracorporeal equipment independently treats the patient.

In a preferred embodiment, the response message includes the cardiac signal and/or the physiological parameter or the status information of the response message.

In a preferred embodiment, in the treatment mode, the processor of the external defibrillation device is configured to sense a body surface signal through the sensing module, analyze the body surface electrocardiosignal and diagnose whether defibrillation treatment is needed according to the body surface electrocardiosignal.

In a preferred embodiment, the processor of the external defibrillation equipment compares the diagnosis result according to the body surface electrocardiosignal with the diagnosis result of the electrocardiosignal or the physiological parameter sent by the implanted medical equipment; if both diagnosis results are ventricular fibrillation, performing external defibrillation treatment; the implantable medical device and the external defibrillation device use different diagnostic algorithms.

In the real-time mode, the correctness of data diagnosis can be ensured by combining the in-vivo data diagnosis mode and the in-vitro diagnosis mode, and unnecessary wrong treatment is prevented.

Drawings

Fig. 1 is a schematic view of an implantable medical device implanted in a human body and a schematic view of an external defibrillation device worn on the human body.

Fig. 2 is a schematic diagram of an implantable medical device module.

Fig. 3 is a block diagram of an external defibrillation apparatus.

Fig. 4 is a flow chart of the operation of the implantable medical device and external defibrillation device combination system.

Fig. 5 is a schematic view of another implantable medical device in a body and external to the device.

Fig. 6 is a schematic diagram of another implantable medical device module.

Fig. 7 is a flow chart of another implantable medical device diagnostic treatment.

Fig. 8 is a flow chart of another implantable medical device and external defibrillation device combination system.

Detailed Description

The following describes the present invention in further detail with reference to the attached drawings to assist those skilled in the art to understand the technical solutions of the present invention.

Referring to fig. 1, an implantable medical device is shown implanted in a body P, including a pacemaker (see fig. 5) or a subcutaneously implanted heart monitor (ICM). The doctor can implant one of the two medical devices for the patient according to the condition of the patient. The implantable medical device can also be a transvenous Implantable Cardiac Defibrillator (ICD), a Subcutaneous Implantable Cardiac Defibrillator (SICD), a cardiac resynchronization therapy pacemaker with defibrillator function (CRTD), or a lead less pacemaker. An embodiment of a system combining a heart monitor (ICM) and anexternal defibrillation apparatus 100 is described by taking the ICM as an example.

The heart monitor (ICM) is implanted under the chest skin of a human body P through an operation, and the included angle of the heart monitor (ICM) and the vertical direction is approximately 45 degrees, and the heart monitor is used for collecting electrocardiosignals of the human body. The heart monitor (ICM) includes a housing including a body structure made of biocompatible materials including high polymer materials, glass, stainless steel, titanium alloys, etc., and a circuit assembly disposed inside the housing. Referring to fig. 1-2, ahead 202 is provided at the end of the body structure, thehead 202 including anantenna 214 for receiving the ICM for external communication, theantenna 214 for receiving or transmitting wireless communication signals for the ICM to communicate with external defibrillation equipment. The head of the ICM is also provided with afirst sensing electrode 218 for collecting electrocardiosignals, the other end of the head of the ICM opposite to the head is provided with asecond sensing electrode 230, and the first and second sensing electrodes form a loop for collecting the electrocardiosignals and transmitting the electrocardiosignals to the internal circuit component.

The heart monitor (ICM) circuit assembly includes a plurality of functional modules including a sensing module 204, aprocessor 210, acommunication module 212, and astorage module 216. The sensing module 204 is connected to electrodes (reference number 218\230) at two ends of the ICM, and the sensing module 204 is configured to sense an electrocardiographic signal and convert the electrocardiographic signal into a digital signal that can be processed by theprocessor 210.

The electrocardiosignal sensing module 204 comprises a signal input channel connected with theelectrode 218/230, the electrocardiosignal sensing module 204 further comprises an amplifying module for processing signals, a filtering module and an analog-to-digital conversion module ADC, the electrocardiosignals are finally converted into digital signals processed by theprocessor 210, and the digital electrocardiosignals are used as the basis for processing electrocardio data by theprocessor 210.

Thecommunication module 212 is connected to theprocessor 210, and theprocessor 210 transmits or receives data through thecommunication module 212. Thecommunication module 212 is connected to acommunication antenna 214 disposed in the head of the ICM, and thecommunication module 212 establishes a communication link with a programmer (not shown in the figure) by wireless communication, and the communication link is used for transmitting initialization parameters of the communication module during an implantation stage, or setting parameters during a patient follow-up visit, or communicating with a handheld device of the patient to give timely reminding or warning to the patient. This communication link is also used to deliver defibrillation signals to theexternal defibrillation device 100 when the ICM believes ventricular fibrillation occurs. The communication link is also used to transmit the cardiac electrical signals or physiological parameters detected by the ICM to the external defibrillation device via a wireless communication module. Thecommunication module 212 preferably establishes a communication link via wireless communication means such as WIFI, bluetooth, RF, ultrasonic, etc.

Theprocessor 210 may be a functional circuit, a logic circuit module, or a software module having data processing, controlling the implantable cardiac detector ICM. Theprocessor 210 is preferably an embedded processor (MCU) or an ASIC-specific application integrated circuit or FPGA circuit. Theprocessor 210 is connected to thecommunication module 212, the electrocardiosignal sensing module 204 and thestorage module 216, and is configured to control the modules to cooperatively work with each other to ensure normal functions of the implantable medical device. In a preferred embodiment, theprocessor 210 is connected to each functional module by a system bus.

In a preferred embodiment, thememory module 216 stores a control program for controlling the implantablemedical device 200. The control program comprises parameter data (such as patient information, sensing parameters, diagnosis parameters and treatment parameters) and a diagnosis and treatment logic module (refer to fig. 8) and a response protocol logic module, and the control program is pre-programmed in thestorage module 216.

With continued reference to the external defibrillator shown in fig. 1, the external defibrillator is a wearable external defibrillator 100(WCD) that may be an external defibrillation monitor, an automated external defibrillator, or a semi-automated external defibrillator, in addition to the wearable external defibrillator.

Theexternal defibrillation device 100 is connected to the patient in a wearable form. The wearable external defibrillator 100(WCD) comprisesshoulder straps 102 worn on the shoulders of a patient, aback strap 104 worn on the back of the patient (the WCD constituting a part behind the patient is shown by using a dotted line), and a connectingstructure 201 in the center of the back strap, wherein the connectingstructure 201 is used for connecting theback strap 104 close to the shoulders of the patient at the upper part and theback strap 104 close to the abdomen of the patient at the lower part, and the connecting structure is provided with a connectingelectrode 108 and anelectrode 110 on the surface contacting with the skin. The shoulder straps 102 extend rearwardly and are connected to aback strap 104, the bottom of which strap 104 is connected to a patient'swaist belt 106. Thewaistband 106 is used for fixing the wholewearable defibrillator 100 at the waist and abdomen position of a patient, thewaistband 106 can be of a detachable structure, and the connecting structure at the detachable position can be common means such as a button, a bayonet, a hook and a magic tape.

WCD100 is worn directly over the skin of the patient's upper body to ensure proper connection of the electrodes to the patient. Thewaistband 106 and theback band 104 of the WCD contain a plurality ofelectrodes 110 for sensing electrocardiosignals andelectrodes 108 for defibrillation, and the WCD can collect electrocardiosignals through thesensing electrodes 110 and perform defibrillation through thedefibrillation electrodes 108. Thesensing electrode 110 and the electrodes are used for collecting electrocardiosignals. Thedefibrillation electrode 108 is connected with acontroller 114 of the WCD through alead 118, thecontroller 114 is used for analyzing the electrocardiosignals sensed by theelectrode 110 and initiating defibrillation therapy through thedefibrillation electrode 108, and the processor can output defibrillation waves through different electrodes when defibrillation is performed and output defibrillation waveforms with different phases through the change of the output polarity of theelectrode 108. Thesensing electrode 110 can form a sensing electrode pair during sensing, and thedefibrillation electrode 118 and the sensing electrode can also form a sensing electrode pair therebetween.

In order to ensure the stability of the connection of theelectrode 108 or theelectrode 110 and prevent poor connection of the electrode, a conductive gel is coated at the connection position of theelectrode 108 or theelectrode 110 and the skin. The WCD can periodically detect the condition of connection of theelectrodes 108 or 110 and automatically apply the conductive gel if a poor connection is detected, and detect the condition of connection of theelectrodes 108 or 110 again after the application of the conductive gel is completed. TheWCD controller 114 is capable of recording the conduction detection record, and the silicone gel coating record, and updating the electrode connection status of the WCD, and feeding back the WCD electrode connection status to the implantablemedical device 200 when it interrogates the WCD status.

WCD controller 114 described with reference to fig. 3 includes apower supply 308, acommunication module 306, atherapy module 308, and aprocessor 302 module. Theprocessor 302 communicates 200 with the implantable medical device via acommunication module 306, wherein thecommunication module 306 preferably establishes a communication link via wireless communication such as WIFI, bluetooth, RF, ultrasound, etc., the communication link being configured to receive the cardiac electrical signals detected by the ICM and the cardiac related physiological parameters.

Thetherapy module 308 includes a high voltage circuit including a transformer and a high voltage capacitor. The transformer and the corresponding driving circuit are used for boosting the voltage of thepower supply 304 into defibrillation voltage, the voltage of the high-voltage capacitor after the voltage boosting of the transformer is 700-800v, and the energy of the high-voltage capacitor is 120J-360J.

Theprocessor 302 receives the cardiac electrical signal or the physiological parameter transmitted by the implantablemedical device 200 through thecommunication module 306. The high-voltage capacitor is charged and discharges to the human body for defibrillation, and the discharging process of the external defibrillation equipment comprises bidirectional or unidirectional discharging.

In a preferred embodiment, the external defibrillation further includes a sensing module 204 and astorage module 216, wherein the sensing module 204 is configured to convert the body surface cardiac electrical signal into a digital signal. Theexternal defibrillation apparatus 100 further includes asensing electrode 110 for sensing a body surface electrocardiosignal, and the sensing electrode is connected to the sensing module 204. The controller senses the electrocardiosignals through the sensing module 204 and analyzes the electrocardiosignals to diagnose the state of the patient.

Referring to fig. 4, a logic control flow diagram of a system combining the implantedmedical device 200 and theexternal defibrillation device 100 is shown. Both the implantablemedical device 200 and theexternal defibrillation device 100 are initialized insteps 402 and 412, including theexternal defibrillation device 100 detecting electrode continuity, setting initial operating parameters of the implantablemedical device 200, etc., and setting patient information.

Instep 404, the implantablemedical device 200 acquires an ecg signal, and in this process, the sensing module 204 senses the ecg signal via thesensing electrode 218 on the surface or thesensing electrode 218 and converts the ecg signal into a digital signal for processing by theprocessor 210.

Theprocessor 210 analyzes the cardiac electrical signals atstep 406 for diagnosing whether a malignant cardiac rhythm event has occurred or whether a malignant cardiac rhythm event is likely to occur. Theprocessor 210 judges whether the patient has the malignant heart rate events such as ventricular fibrillation, ventricular tachycardia and the like according to the methods such as paroxysmal, interphase degeneration, average heart rate and QRS waveform morphology of the heart rhythm of the patient, and distinguishes the malignant heart rate events such as ventricular fibrillation, ventricular tachycardia and the like from supraventricular tachycardia such as atrial fibrillation, atrial flutter, sinus rhythm and the like through the algorithms so as to prevent false shocks. Taking the judgment of ventricular fibrillation as an example, whether ventricular fibrillation occurs or not can be detected by setting an observation window, for example, 18/24 window threshold value is set as a judgment criterion for ventricular fibrillation. Of course, the judgment of whether ventricular fibrillation occurs can be combined with heart sound, blood pressure, blood flow and motion sensors to comprehensively judge whether ventricular fibrillation occurs, such as judging whether ventricular fibrillation occurs through blood flow, and judging the body posture of a patient through the motion sensors (such as judging whether the patient is syncope and evaluating the physiological activity level of the patient).

If it is determined instep 406 that a malignant cardiac rhythm event has not occurred, then the process continues back to step 404 to continue detecting cardiac electrical signals. If a malignant cardiac rhythm event is determined to occur or may occur,step 408 is performed to transmit information such as the cardiac electrical signal or the cardiac related physiological parameter to theexternal defibrillation apparatus 100 through the communication link provided by the communication module. The cardiac electrical signals or physiological parameters that are transmitted include historical data or real-time data. The electrocardiosignals comprise a body surface electrocardiogram similar to ICM detection or a ventricular electrocardiogram \ atrial electrocardiogram detected by an implantable cardiac pacemaker. The heart physiological parameters comprise paroxysmal, interphase degeneration, average heart rhythm heart sound, blood pressure, blood flow and motion sensors.

Instep 418, when theexternal defibrillation apparatus 200 does not receive the ecg signal or the cardiac physiological parameter transmitted by the implantablemedical device 100, it is in a low power consumption state, and theprocessor 302 is in a sleep state or the communication module is in a sleep state to save power consumption. Theprocessor 302 may set a wake-up interrupt to wake up by interrupt when thecommunication module 306 receives the communication module. After waking up, the communication module receives the electrocardiographic signal or the physiological parameter data sent by the implantable medical device instep 418.

Theprocessor 302 of theexternal defibrillation device 200 analyzes the cardiac electrical signal or the physiological parameter atstep 420. The analysis method in this step may include a conventional analysis method. Such as the ventricular fibrillation judging method described in the patent application No. CN201911296536.1, and the ventricular velocity judging method described in the patent application No. CN 201911295446.0. Also for example, the method of collecting other parameters of the heart using multiple sensors based on the description of the parameters of multiple sensors as described in patent application No. CN202010366336.5\ cn202010364410. x.

Identification of ventricular fibrillation may also be performed instep 420 using a complex neural network algorithm, such as that disclosed in volume 10, 40, 2016, volume 10, military medical college entitled "Multi-parameter fused BP neural network design for ventricular fibrillation rhythm identification" using a neural network algorithm to identify ventricular fibrillation. The volume of theexternal defibrillation device 200 is relatively unlimited and thus a higher performance processor may be integrated to support the neural network algorithm, while theexternal defibrillation device 100 may be provided with larger power supply components to support a higher power consumption high performance processor and may utilize a rechargeable design. Thus, theextracorporeal device 100 can compensate for the insufficient computing power of the implantable medical device and cannot support more complex rhythm algorithms such as neural networks which have better diagnostic effects.

The result of the analysis of the physiological parameters ofstep 420 is determined instep 422, and if defibrillation is required, defibrillation is performed instep 424. Theexternal defibrillation apparatus 100 is configured to charge a capacitor device inside theexternal defibrillation apparatus 306 under the control of theprocessor 302, and discharge the capacitor device to the human body through thedefibrillation electrode 118 after the charging is completed, where the discharge process includes a first phase discharge and a second phase discharge. The discharge slope is between 45% and 65% and the defibrillation energy is in the range of 120J to 360J. Depending on the defibrillation energy, the defibrillation energy level may be different depending on the analysis ofstep 420, for example, if the analysis ofstep 420 shows that the heart is experiencing ventricular tachycardia, then step 424 performs defibrillation at a lower energy level, and if it is detected that the heart is experiencing ventricular fibrillation instep 420, then step 424 directly performs defibrillation therapy at a higher energy level.

Preferably, a defibrillation counter is included instep 424 that records the number of consecutive treatments (e.g., 6) for the same ventricular fibrillation. If the number of defibrillating times of the defibrillation counter exceeds a set value, the external defibrillation device will stop defibrillating to prevent more unnecessary shock damage to the patient regardless of whether the patient is experiencing ventricular fibrillation.

Preferably, in thedefibrillation step 424, theexternal defibrillation apparatus 100 may transmit a defibrillation signal to the implantablemedical device 200, and the implantablemedical device 200 enters a protection state after receiving the defibrillation signal, in which the implantablemedical device 200 can continuously record the intracardiac electrocardiogram waveform and the cardiac depolarization signal when theexternal defibrillation apparatus 100 shocks, and meanwhile, the internal circuit devices are not damaged by the high voltage generated during the shock of theexternal defibrillation apparatus 100.

Preferably, theexternal defibrillation apparatus 100 periodically detects its own status and repairs possible problems therein, such as theexternal defibrillation apparatus 100 periodically detecting the electrode connection status and automatically applying a conductive gel when the electrode connection is poor.

After the defibrillation is completed, the control flow returns to step 418, the communication link continuously transmits the electrocardiographic signal or the cardiac physiological parameter from the implantable medical device to the external defibrillation device, and instep 420, the electrocardiographic signal or the cardiac physiological parameter after the defibrillation is analyzed. If the heart is still in the ventricular fibrillation state after defibrillation, defibrillation therapy is continued, and when the defibrillation counter is equal to the maximum continuous times in thestep 422, the therapy is stopped continuing, the control flow returns to thestep 410, the externaldefibrillation apparatus processor 302 sends a transmission termination message to the implanted medical apparatus through the communication link, and the implanted medical apparatus stops sending the electrocardiosignal and/or the physiological parameter information to the external defibrillation apparatus after receiving the transmission termination message.

If the patient is analyzed to have a sinus rhythm restored atstep 420, theprocessor 302 sends a termination message atstep 422, and the implantablemedical device 200 receives the termination message and control returns to step 404 where the implantable medical device continues to detect the cardiac signal. The control flow returns to step 410 to consider defibrillation therapy not needed if the analysis ofstep 420 is not consistent with the analysis of the implantable medical device ofstep 406.

It should be noted that the control flow of the implantablemedical device 200 and theexternal defibrillation device 100 is an asynchronous flow, the implantable medical device and the external defibrillation device communicate through thesteps 408 and 418, the sending and receiving process of the electrocardiograph signal may be continuous, and the processor notifies the sending of the electrocardiograph signal, the physiological parameter and other information after receiving the sending stop message sent in thestep 422 in thestep 410.

Preferably, theexternal defibrillation device 100 may confirm the cardiac status of the patient before theexternal defibrillation device 100 performs defibrillation. Theexternal defibrillation device 100 can sense the electrocardiosignals and analyze the electrocardiosignals to diagnose the state of the patient, and if the heart is also in a malignant rhythm state according to the electrocardiosignals, theexternal defibrillation device 100 can directly defibrillate the patient. If the analysis result of the external electrocardiographic signal is not consistent with the physiological parameter or the analysis result of the electrocardiographic signal sent by the implantablemedical device 200, defibrillation is not performed, and the externalmedical device 100 can wait for the implantablemedical device 200 to send the electrocardiographic signal and/or the physiological parameter information again through the communication link.

A patient interface is provided on thecontroller 114 of the external defibrillation device for alerting the patient or imparting certain defibrillation therapy control capabilities to the patient. The patient interface sends an alarm when defibrillation therapy is about to occur, and reminds the patient of the impending electric shock through sound, light, vibration and other modes. The patient interface is equipped withpatient operating components 116, such as buttons, touch screens, mice, keyboards, scroll wheels, etc., which the patient can operate to cancel an impending shock therapy when theexternal defibrillation apparatus 100 issues a shock alert. Thus, the patient can manually cancel the improper electric shock when the patient feels the physical normality, and the reasons for causing the improper electric shock comprise various reasons, such as signal interference, T wave passing perception, supraventricular tachycardia and the like.

Preferably, after the shock is completed instep 424, theexternal defibrillation apparatus 100 sends a shock complete feedback message to the implantablemedical device 200. After receiving the message that the electric shock of the implantablemedical device 200 is completed, theexternal defibrillation device 100 exits from the recording mode of the protection state, and meanwhile, the implantablemedical device 100 continues to analyze the cardiac signal and determine whether the patient recovers the sinus rhythm, and if the sinus rhythm is not recovered, the external defibrillation treatment continues. It is determined whether the number of shocks exceeds a threshold instep 422, which may be set, for example, to 6 times, and if the number of shocks exceeds the set threshold, treatment may not continue even if sinus rhythm is not restored to prevent further ineffective treatment from causing unnecessary damage to body tissue.

The above-described implantablemedical device 200 in combination with theexternal defibrillation device 100 can be combined with an implantablemedical device 200 that is not capable of defibrillation. The ICM100 is capable of collecting and analyzing cardiac electrical signals after implantation in a human body and sending cardiac electrical signals and/or physiological parameter messages to an external defibrillation device when a suspected heart rhythm is found. This combined system eliminates the risk of sudden cardiac death that may occur during ICM implantation.

With continued reference to fig. 5, a transvenous implantedpacemaker 500 is shown, thepacemaker 500 being implanted transvenously.

The illustrated transvenousimplantable pacemaker 500 includes apulse generator 502 disposed subcutaneously and a lead 504 coupled to thepulse generator 502. The veinimplantation type pacemaker 502 can be divided into a single cavity, a double cavity and a triple cavity according to the implantation position of thelead 504, and the number of the corresponding leads is also divided into 1 to 3. In fig. 5, a dual chamber pacemaker is shown, with leads entering the right ventricle V and right atrium a in a dual chamber configuration through the cephalic vein, the subclavian vein, and the superior vena cava S.

Thelead 504 is divided into a rightatrial lead 506 and aright ventricular lead 508, and the end of the rightatrial lead 506 is connected to the heart tissue o for sensing atrial signals. The right atriallead tip electrode 510 is capable of sensing electrical signals, i.e., P-waves, generated during atrial depolarization.

Theright ventricular lead 506 is divided into a proximal end connected to thepulse generator 502 and a distal end connected to the heart tissue o. The distal end of the lead includes ahelical electrode 512 that is connected to the cardiac tissue o, and the advancement of thehelical electrode 512 into the cardiac tissue o secures the leading end of the lead to the cardiac tissue. Near-field electrode 514 is disposed near the front end ofconductive wire 506, and near-field electrode 514 is used for sensing near-field electrocardiosignals reflecting depolarization and repolarization processes of local tissues of the heart.

Theproximal end 516 of the right ventricular lead is connected to aconnector 518 of thepulse generator 502. Aconnector 518 provides an electrical connection jack into which wires are inserted, theconnector 518 including a feedthrough assembly 604 (see fig. 6) therein, thefeedthrough assembly 604 connecting the wires to the circuitry of thepulse generator 502.Feedthrough assembly 604 is connected to sensing electrodes via wires, and sensing electrodes (eitherelectrode 512 orelectrode 514 or atrial electrodes) are connected tosensing module 602 withinpulse generator 502 viafeedthrough assembly 604. Thesensing module 602 is configured to sense the electrocardiographic signal, and further process the electrocardiographic signal to convert the electrocardiographic signal from an analog signal to a digital signal. Thefeedthrough assembly 604 connects the sensing electrodes on the leads to thesensing module 602.

Theconnector interior 518 also includes anantenna 606, and theantenna 606 is connected to the antenna within the pulse generator through thefeedthrough assembly 604. Theantenna 606 is used for thepulse generator 502 to establish a wireless connection communication connection with an external device. The external device D includes a program-controlled device D used by a hospital, a handheld device used by a patient such as a mobile phone, a patient assistant, and the wearable external defibrillation device described in the present application.

Reference is made to the schematic diagram of the hardware architecture withinpacemaker 502 shown in fig. 6. It includes asensing module 602 for sensing cardiac electrical signals, atherapy module 608 for providing therapy pulse signals, and acommunication module 610 for communicating with an external device defibrillation device. Amemory module 612 for storing patient data, parameters, and medical procedure code, thememory module 612 may include RAM, ROM, flash memory, and/or other memory circuitry. And thecontrol module 614 performs diagnosis and treatment procedures, processes and analyzes the electrocardiosignals sensed by thesensing module 602 according to the patient parameters and the diagnosis procedure setting, and judges whether electrical stimulation needs to be performed on the heart through thetreatment module 608 according to the diagnosis result.

Thesensing module 602 is connected to the electrode on theconducting wire 504, and thesensing module 602 includes an amplifier, a filter, a digital-to-analog conversion module, and the like. Thesensing module 602 can process the signals on theatrial lead 508 and theventricular lead 506 simultaneously and convert the sensed P-wave signal or R-wave signal into a digital signal, and thecontrol module 614 calculates PR intervals, AA intervals, RR intervals, and the AA intervals using the P-wave or R-wave signals to determine pacing time points.

Thecommunication module 610 is connected to theantenna 606, thecommunication module 610 is connected to the wearable external defibrillation device for communication, and the communication module is preferably a medical RF module. Those skilled in the art will appreciate that the communication module may also include WIFI, bluetooth, infrared, ultrasonic, etc. communication modules known to those skilled in the art.

Thetherapy module 608 includes a switch circuit, and when performing electrical stimulation, the control module controls the switch circuit therapy module to form an electrical stimulation loop, and the control module can control the therapy module to perform anti-tachycardia therapy.

When the implantablemedical device 100 is a defibrillator or a cardioverter defibrillator, the therapy module further includes a high-voltage capacitor and a high-voltage circuit for charging the high-voltage capacitor, the high-voltage circuit charges the high-voltage capacitor before defibrillation therapy, the high-voltage circuit is configured to charge the high-voltage capacitor with electric energy of different energies according to different therapy requirements, and the energy of the high-voltage capacitor is maintained within a range of 20J to 40J.

Referring to fig. 8, a schematic diagram of a system combining an implantablemedical device 100 and a wearable external defibrillation device is shown, the implantable medical device including a diagnostic therapy logic module 800, and a responseprotocol logic module 802, which are executed by a processor; the diagnostic therapy logic 800 controls the implantablemedical device 100 to diagnose and treat according to the workflow shown in fig. 7; thelogical response module 802 is configured to communicate with the external defibrillation apparatus and send physiological parameter information, electrocardiographic signals or diagnostic information, and therapy information to theexternal defibrillation apparatus 200.

The diagnosis and treatment module logic control flow chart described with reference to fig. 7. Instep 702, the system is initialized, which includes initializing the implantablemedical device 200 and theexternal defibrillation device 200, including detecting the conductivity of the electrodes, setting initial operating parameters, etc., and setting patient information. The initializing step further includes setting pacemaker parameters, such as respective pacemaker intervals AA interval, VA interval, PVBR interval, PVAR interval pacemaker thresholds, lowest or highest pacing rate, pacing mode (e.g., VVI, VAI, DDD or DDI, etc.). The parameters of thepacemaker 100 may be set by a programmer D instep 702, and a physician may set initialization parameters of the pacemaker by manipulating the programmer externally disposed to communicate with the pacemaker. Likewise, the physician communicates withpacemaker 500 via a programmer D disposed outside the body to set initialization parameters of the wearable external defibrillation device.

The pacemaker detects the cardiac electrical signal of the patient instep 704. The cardiac signals are conducted to thesensing module 602 throughsensing electrodes 512/514 on the atria and ventricles, and thesensing module 602 converts the signals into digital signals. Instep 706 the control module analyzes whether the current rhythm is sinus rhythm \ supraventricular tachycardia \ ventricular tachycardia \ rapid ventricular tachycardia or ventricular fibrillation.

Instep 706, the control module of the implantable medical device finds a malignant cardiac rhythm event such as ventricular tachycardia or ventricular fibrillation, and then performs treatment instep 708, wherein the treatment means instep 708 includes pacing \ anti-tachycardia pacing \ defibrillation \ multi-level energy defibrillation. In particular, the anti-tachycardia pacing comprises a brust and scan mode, and the multi-level energy defibrillation comprises different energy levels of 20-40J. Defibrillation therapy for ventricular fibrillation, either anti-tachycardia therapy or defibrillation therapy, is performed in the form of electrically stimulated myocardium.

Thecontrol module 614 of the implantablemedical device 200 records the detected cardiac signal and cardiac signal indicia, as well as the detection and treatment options in steps 702-708.

Theexternal defibrillation device 100 shown in fig. 8 may be a wearable external defibrillation device or a non-wearable external defibrillation device such as an AED, the external defibrillation device including aninitialization step 802, the wearable defibrillation device initialization process being similar to the initialization process ofstep 412 described previously. The initialization steps of the non-wearable external defibrillation equipment further comprise the processes of starting up, system self-checking and applying electrode plates of the AED to the skin surface of a syncope patient according to AED instructions by emergency personnel.

Atstep 804, after AED initialization is complete,processor 302 sends out an inquiry message viacommunication module 306 andprocessor 210 of the implantable medical device completes communication with the external defibrillation device by executing the control logic ofresponse protocol logic 822. It attempts to ask the patient whether or not to implant an implantable medical device. It should be noted that the implantablemedical device 200 and theexternal defibrillation device 100 should follow the same communication protocol to respond. The implantablemedical device 200 responds to inform the external defibrillation device of its own status, as well as the status of the patient, upon receipt of the interrogation message.

After receiving the inquiry message sent by theexternal defibrillation apparatus 100, the implantablemedical device 200 communicates with theexternal defibrillation apparatus 100 through the responseprotocol logic module 822, where the responseprotocol logic module 822 includes a communication protocol, and the communication protocol is used to send an electrocardiographic signal, a physiological parameter, or treatment information or patient status information to theexternal defibrillation apparatus 100 after responding to the inquiry and response. Theresponse logic module 822 also encrypts the transmitted information and decrypts the information at the external defibrillation device, and the correspondingresponse logic module 822 should contain the public key of the external defibrillation device for encryption and the private key for decryption. Theexternal defibrillation device 100 should include a private key for decryption and a public key for the implantable medical device for encryption.

While the AED is being interrogated sets a response timeout timer, the externaldefibrillation device processor 302 determines if the implantable medical device sent a response message within the time frame set by the timeout timer instep 806, and if receipt of the response message within the time frame indicates the presence of the implantablemedical device 200 in the patient, control passes directly to step 808. If the response message from the implantablemedical device 200 has not been received atstep 806 after the timeout period, the implantablemedical device 200 is considered to be absent from the patient and the process proceeds to step 810, where the sensing electrode is used to detect the patient ecg signal. To minimize the rescue time of the AED the response timeout time should be set short, e.g., between 100 milliseconds and 10 seconds.

The process of interrogation and response described above is important to a patient who has already implanted the implantablemedical device 200 in vivo. After the AED is started, the patient electrocardiosignals are sensed through theelectrodes 110 to judge and analyze whether the patient is experiencing malignant cardiac rhythm such as ventricular fibrillation, and if the patient is experiencing the malignant cardiac rhythm, the external defibrillation equipment considers that the patient has the risk of sudden cardiac death. If the implantablemedical device 200 is undergoing therapy preparation and is about to undergo therapy (e.g., discharging), theexternal defibrillation device 100 should wait for further cardiac electrical signal analysis after the therapy is completed. In this way, theexternal defibrillation apparatus 100 can make a comprehensive judgment on the subsequent diagnosis and treatment process to determine whether to perform defibrillation treatment in combination with the self-state and the patient state of the implantablemedical device 200 and the electrocardiographic signal sensed by the external defibrillation apparatus 10.

Instep 808, the implantablemedical device 200 transmits an electrocardiographic signal, a physiological parameter, or its own status information to theexternal defibrillation device 100, where the status information includes response messages such as diagnosis information and treatment information, and the messages are transmitted in real time or periodically. The response message may be sent by the implanted medical device actively, or after being interrogated by the external defibrillation device. The diagnosis information comprises sinus rhythm, supraventricular tachycardia, ventricular tachycardia, rapid ventricular tachycardia or ventricular fibrillation diagnosed according to the physiological parameters or the electrocardiosignals. The treatment information includes treatment means to be implemented or implemented by the implantablemedical device 200 according to the diagnosis result, and the treatment means includes pacing \ anti-tachycardia pacing \ defibrillation \ multi-level energy defibrillation.

The external defibrillation equipment takes the response message as a diagnosis basis and releases defibrillation electric shock when defibrillation treatment is needed. Specifically, instep 812, theprocessor 302 of theexternal defibrillation apparatus 100 is configured to perform diagnosis according to the cardiac electrical signal sensed by the sensing module 204 and thesensing electrode 110 instep 810; and compares the diagnostic result with the result of diagnosis using the electrocardiographic signal or physiological parameter transmitted by the implantablemedical device 200; if the diagnosis results of the two are consistent, performing external defibrillation treatment; the implantablemedical device 200 and theexternal defibrillation device 100 use different diagnostic algorithms to reduce the probability of a mis-therapy.

A typical approach is that theprocessor 302 of theexternal defibrillation device 100 is configured to decide whether to perform external defibrillation therapy based on the self-status of the implantablemedical device 200. For example, when the implantablemedical device 200 has diagnosed the patient's condition as ventricular fibrillation and is performing pre-defibrillation charging or defibrillation discharging or post-defibrillation diagnosis, theexternal defibrillation device 100 determines that such a condition requires waiting for a corresponding negative determination instep 814, and continues to detect the ecg signal throughstep 810.

For another example, instep 812, when the diagnosis result obtained by analyzing the electrocardiographic signal or the physiological parameter sent by the implantablemedical device 200 by theexternal defibrillation device 100 is inconsistent with the analysis result of sensing the electrocardiographic signal throughstep 810, it is determined that defibrillation is not required, if both the diagnosis results are ventricular fibrillation, external defibrillation is performed, the control flow returns to step 810, and instep 812, the diagnosis result of the implantablemedical device 200 is compared with the diagnosis result of the external defibrillation device in real time. It should be noted that theexternal defibrillation apparatus 100 and the implantable medical device may employ different diagnostic algorithms to reduce the misdiagnosis rate.

Theprocessor 302 of theexternal defibrillation apparatus 100 compares the diagnosis result according to the body surface electrocardiosignal with the diagnosis result of the electrocardiosignal or the physiological parameter sent by the implantedmedical apparatus 200; if both diagnosis results are ventricular fibrillation, performing external defibrillation treatment; the implantable medical device and the external defibrillation device use different diagnostic algorithms to ensure overall diagnostic accuracy reducing the rate of misdiagnosis.

For another example, if theprocessor 302 of the external defibrillation device is configured to continue to provide defibrillation at a higher external energy level after the implantable medical device therapy state is that the highest energy defibrillation has been performed and the sinus rhythm has not been restored and the external defibrillation device is capable of providing higher external higher energy level defibrillation therapy, as determined instep 812, then the external defibrillation device may continue to provide defibrillation at the higher energy level, and then a shock is delivered instep 816.

If theprocessor 302 does not receive a response message from the absence of the implantablemedical device 200 instep 806 and determines a timeout instep 807, then it will determine itself to treat the patient's condition by directly entering the treatment mode, which begins atstep 810. Theprocessor 302 of the external defibrillation apparatus instep 810 senses the body surface electrocardiosignals through the sensing module 204, analyzes the body surface electrocardiosignals, diagnoses whether defibrillation treatment is needed according to the body surface electrocardiosignals, further analyzes the sensing signals instep 812, and then enterssteps 814 and 816, or returns the control flow back to step 810 after the no branch ofstep 814.

Through the cooperation of the implanted cardiac pacemaker and the external defibrillator, the pacemaker not only can pace and also can perform anti-tachycardia pacing under the guarantee of the external defibrillator. Compared to the prior art, where pacemakers can be used to terminate ventricular tachycardia, anti-tachycardia pacing has the advantage that its low power consumption does not unduly reduce the battery life of the pacemaker.

Claims (12)

1. An external defibrillation equipment combination system comprises an implanted medical equipment implanted in a human body and an external defibrillation equipment arranged outside the human body, and is characterized in that the implanted medical equipment comprises a sensing module, a processor and a communication module; the processor is configured to sense the cardiac electrical signal via the sensing module, the processor calculating a physiological parameter for diagnosing the cardiac event based on the sensed cardiac electrical signal; the electrocardiosignals and/or the physiological parameters are transmitted in real time or periodically to an external defibrillation device;

the external defibrillation device comprises a processor, a communication module and a treatment module; the processor is configured to receive the electrocardiosignal and/or the physiological parameter sent by the implantable medical device through the communication module, and the processor of the external defibrillation device takes the electrocardiosignal or the physiological parameter as a diagnosis basis and releases the defibrillation shock when defibrillation treatment is needed according to the diagnosis result.

2. The external defibrillation device combination of claim 1, wherein the processor of the implantable medical device is configured to transmit its own status information to the external defibrillation device, the status information including diagnostic information and therapy information.

3. The external defibrillation device combination of claim 2, wherein the diagnostic information includes a sinus rhythm, supraventricular tachycardia, ventricular tachycardia, tachyventricular tachycardia, or ventricular fibrillation diagnosed by the processor of the implantable medical device based on the physiological parameter or the cardiac signal.

4. The external defibrillation device combination of claim 3, wherein the therapy information includes therapy to be or to be administered by the implantable medical device based on the self-diagnostic result, the therapy including pacing, anti-tachycardia pacing, defibrillation or multi-level energy defibrillation.

5. The external defibrillation device combination of claim 4, wherein the processor of the external defibrillation device is configured to decide whether to perform external defibrillation therapy based on the therapy status of the implantable medical device.

6. The external defibrillation device combination of claim 5, wherein the external defibrillation device is not configured to perform external defibrillation therapy when the therapy state of the implantable medical device is about to perform pacing, anti-tachycardia pacing, defibrillation, or multi-level energy defibrillation therapy.

7. The external defibrillation device combination of claim 5, wherein the processor of the external defibrillation device is configured to perform external defibrillation after the implantable medical device therapy state is that highest energy defibrillation has been performed and sinus rhythm has not been restored.

8. The external defibrillation device combination of claim 5, wherein the external defibrillation device comprises a sensing electrode, and the processor is configured to perform diagnosis based on the cardiac electrical signal sensed by the sensing circuit and the sensing electrode; and comparing the diagnosis result with the result of diagnosis by using the electrocardiosignal or the physiological parameter sent by the implanted medical equipment; if both diagnosis results are ventricular fibrillation, performing external defibrillation treatment; the implantable medical device and the external defibrillation device use different diagnostic algorithms.

9. An external defibrillation device is characterized by comprising a processor, and a communication module, a treatment module and a sensing module which are connected with the processor; the processor is configured to transmit an implantable medical device interrogation message through the communication module; and setting a timeout period during which the external defibrillation device enters a therapy mode if the processor does not receive a response message from the implantable medical device; receiving a response message of the implantable medical device within the timeout period, wherein the response message is used as a diagnosis basis by the external defibrillation device, and a defibrillation electric shock is released when defibrillation treatment is needed; the response message comprises the electrocardiosignal and/or the physiological parameter which are sent by the implanted medical equipment in real time or periodically.

10. The external defibrillation apparatus of claim 9, wherein the response message comprises an electrocardiographic signal and/or a physiological parameter or status information of the apparatus itself.

11. The external defibrillation apparatus of claim 10, wherein in the therapy mode, the processor of the external defibrillation apparatus is configured to sense a body surface signal through the sensing module, analyze the body surface cardiac signal, and diagnose whether defibrillation therapy is required according to the body surface cardiac signal.

12. The external defibrillation apparatus according to claim 11, wherein the processor of the external defibrillation apparatus compares the diagnosis result based on the body surface electrocardiosignal with the diagnosis result based on the electrocardiosignal or the physiological parameter transmitted by the implanted medical apparatus; if both diagnosis results are ventricular fibrillation, performing external defibrillation treatment; the implantable medical device and the external defibrillation device use different diagnostic algorithms.

Images