CN115721859A

CN115721859A - Defibrillation heart contractility regulating device and operation method thereof

Info

Publication number: CN115721859A
Application number: CN202211411729.9A
Authority: CN
Inventors: 陈越猛; 王志农
Original assignee: Shaoxing Mayo Heart Magnetism Medical Technology Co ltd
Current assignee: Shaoxing Mayo Heart Magnetism Medical Technology Co ltd
Priority date: 2022-11-11
Filing date: 2022-11-11
Publication date: 2023-03-03

Abstract

The invention provides a defibrillation heart contractility regulating device and an operation method thereof, wherein the regulating device comprises: the spiral electrode is implanted into the heart and used for monitoring ventricular electrocardiosignals and sending electrical stimulation pulse signals to the pulse heart; the MCU processor is in communication connection with the pulse spiral electrode and is used for generating a control signal; the pulse signal generator generates an electrical stimulation pulse signal according to a control signal of the pulse MCU processor and sends the electrical stimulation pulse signal to a pulse heart through a pulse spiral electrode; the power supply is used for supplying electric energy. According to the invention, the stimulating electrode is implanted into the right ventricular septum of the patient, when the spiral electrode detects ventricular fibrillation signals, the MCU processor controls the pulse signal generator to automatically output defibrillation electric signals to defibrillate the heart in time, so that the heart failure patient is prevented from being defibrillated in time and missing the optimal rescue time when serious complications such as ventricular fibrillation occur.

Description

Defibrillation heart contractility adjusting device and operation method thereof

Technical Field

The invention relates to the technical field of medical equipment, in particular to a defibrillation heart contractility regulating device and an operation method thereof.

Background

Chronic heart failure is a pathophysiological process with progressive cardiac deterioration, affects clinical syndromes of 2600 patients worldwide, is one of the most difficult diseases of the cardiovascular system, and usually cannot reverse disease progression through drug treatment.

At present, the total disease rate of heart failure in China is about 1.26 percent. The prognosis for patients with heart failure is often poor, with 65% of patients dying within 60 months. About 30% of patients with heart failure have wide QRS intervals and can usually improve cardiac function by Cardiac Resynchronization Therapy (CRT), but 70% of patients with narrow QRS intervals have no better instrumental treatment.

Of the deaths of patients with heart disease, about half belong to sudden death (i.e. sudden death). The most common cause of sudden death is severe ventricular arrhythmias such as ventricular fibrillation and ventricular tachycardia. These severe arrhythmias are usually not predictive and the drug does not completely prevent them from occurring. These arrhythmias must be terminated immediately upon occurrence, but even in hospitals, there are times when treatment is not available because when ventricular fibrillation occurs, the heart does not actually eject blood, and loss of consciousness occurs over 6 seconds of cerebral ischemia. If the heart stops shooting blood for more than 5 minutes, the chance of a successful rescue is less than 20%.

Clinically, these severe arrhythmias are terminated over time by implanted in vivo automatic defibrillators (ICDs), and numerous studies have shown that ICD implantation is much more effective than drug therapy. The ICD can detect and judge the type of serious ventricular arrhythmia of a patient at any time and give different treatments, thereby achieving the purposes of terminating arrhythmia and saving the life of the patient.

Because ventricular fibrillation is a serious complication of heart failure, part of patients with serious heart failure need to prevent ventricular fibrillation while regulating the heart contractility, and a heart contractility regulating device and an in-vivo automatic defibrillator (ICD) need to be implanted clinically, so that on one hand, the operation cost for implanting two devices is high, and on the other hand, the two devices are implanted subcutaneously, which also causes inconvenience to the daily activities of the patients.

The following problems exist in the use of existing cardiac contraction modifiers:

the clinically used heart contraction regulator does not have the defibrillation function, so that severe life-threatening complications such as ventricular fibrillation are relatively easy to occur to a heart failure patient, the ventricular fibrillation generally has no warning sign, the ventricular fibrillation must be stopped immediately when occurring, and the patient easily dies due to untimely defibrillation.

Clinically, the heart contractility regulator cannot be started at regular time, and the heart is overloaded by the continuous heart contractility regulation for a long time, so that other complications are generated.

Disclosure of Invention

The invention provides a defibrillation heart contractility regulating device and an operation method thereof, and aims to solve the technical problem of improving the performance of a heart contractility regulator.

The defibrillation cardiac contractility regulating device according to an embodiment of the present invention includes:

the spiral electrode is implanted into the heart and used for monitoring ventricular electrocardiosignals and sending electrical stimulation pulse signals to the heart;

the MCU processor is in communication connection with the spiral electrode and is used for generating a control signal based on the ventricular electrocardiosignal;

the pulse signal generator is in communication connection with the MCU processor and the spiral electrode, and is used for generating an electrical stimulation pulse signal according to a control signal of the MCU processor and sending the electrical stimulation pulse signal to the heart through the spiral electrode;

and the power supply is used for providing electric energy for the spiral electrode, the MCU processor and the pulse signal generator.

According to the defibrillation heart contractility regulating device provided by the embodiment of the invention, the stimulating electrode is implanted into the right ventricular septum of the patient, when the spiral electrode detects ventricular fibrillation signals, the MCU processor controls the pulse signal generator to automatically output defibrillation electric signals, so that the heart is defibrillated in time, and the problem that the defibrillation cannot be carried out in time and the optimal rescue time is missed when serious complications such as ventricular fibrillation occur to the heart failure patient is solved.

According to some embodiments of the invention, the helical electrode comprises: the first ventricular electrode and the second ventricular electrode are implanted in the right ventricular septum and are arranged at a preset distance, one of the first ventricular electrode and the second ventricular electrode is used for monitoring ventricular electrocardiosignals, and the other one of the first ventricular electrode and the second ventricular electrode is used for sending electrical stimulation pulse signals.

In some embodiments of the present invention, the first ventricular electrode and the second ventricular electrode are arranged at a predetermined distance interval in the up-down direction between the right ventricles, and the predetermined distance interval is not less than 2cm.

According to some embodiments of the invention the MCU processor has a timing device, the start and run times being controlled by a set time of the timing device.

In some embodiments of the present invention, the MCU processor is in communication connection with a remote configuration system through a data transmission configuration module, and the remote configuration system sets the timing device through the data transmission configuration module.

According to the cardiac contractility regulating method of the embodiment of the invention, the regulating method adopts the defibrillatable cardiac contractility regulating device to regulate the cardiac contractility.

According to some embodiments of the invention, the method of adjusting comprises:

when the first ventricular electrode monitors local electrical activity, the MCU processor controls the second ventricular electrode to send electrical stimulation to the heart after a preset time for starting QRS wave so as to adjust the heart contractility.

According to the defibrillation method provided by the embodiment of the invention, defibrillation is performed by adopting the defibrillation heart contractility regulating device.

According to some embodiments of the invention, the defibrillation method comprises:

when the first ventricular electrode monitors ventricular tachycardia, the MCU processor controls the pulse signal generator to output stimulation with the frequency greater than a preset value through the second ventricular electrode;

if ventricular tachycardia continues to occur or the first ventricular electrode monitors a ventricular fibrillation signal, the MCU processor controls the pulse signal generator to deliver current for defibrillation.

In some embodiments of the invention, the first ventricular electrode continuously monitors ventricular cardiac electrical signals in real time.

Drawings

FIG. 1 is a schematic diagram of a defibrillatable cardiac contractility adjustment apparatus according to an embodiment of the present invention;

FIG. 2 is a schematic view of a helical electrode implantation according to an embodiment of the present invention;

fig. 3 is a schematic diagram of the working principle of the spiral electrode according to the embodiment of the invention.

Reference numerals are as follows:

the adjustment device 100 is provided with a plurality of adjustment elements,

the spiral electrode 10, the first ventricular electrode 111, the second ventricular electrode 112,

MCU processor 20, pulse signal generator 30, power supply 40,

a data transmission configuration module 50, a remote configuration system 600.

Detailed Description

To further explain the technical means and effects of the present invention adopted to achieve the intended purpose, the present invention will be described in detail with reference to the accompanying drawings and preferred embodiments.

The description of the method flow in the present specification and the steps of the flow chart in the drawings of the present specification are not necessarily strictly performed by the step numbers, and the execution order of the method steps may be changed. Moreover, certain steps may be omitted, multiple steps combined into one step execution, and/or a step broken into multiple step executions.

As described in the background section, after heart failure occurs, arrhythmia, including ventricular fibrillation, is a kind of fatal malignant arrhythmia, which is manifested as disordered heart fibrillation, and cannot produce effective systole and diastole to ensure whole body blood supply, i.e. functional cardiac arrest, and if defibrillation cannot be performed in time, the patient will be endangered. Some existing heart contraction force regulators do not have a defibrillation function, when heart failure patients have serious complications such as ventricular fibrillation, the heart cannot be defibrillated in time, and the lives of the patients can be endangered.

Thus, the present invention provides a defibrillatable cardiac contractility modulation device 100, as shown in fig. 1, the modulation device 100 comprising: a helical electrode 10, an MCU processor 20, a pulse signal generator 30 and a power supply 40.

The spiral electrode 10 is implanted in the heart and used for sensing electrophysiological signals of the heart, monitoring ventricular electrocardiosignals and sending electrical stimulation pulse signals to the heart. The MCU processor 20 is connected to the spiral electrode 10 for generating a control signal based on the ventricular electrocardio signal. The pulse signal generator 30 is in communication connection with both the MCU processor 20 and the spiral electrode 10, and is configured to generate an electrical stimulation pulse signal according to a control signal of the MCU processor 20, and transmit the electrical stimulation pulse signal to the heart through the spiral electrode 10. The power supply 40 is used to supply power to the helical electrode 10, the MCU processor 20 and the pulse signal generator 30.

According to the defibrillation cardiac contractility regulating device 100 provided by the embodiment of the invention, the stimulation electrode is implanted into the right ventricular septum of the patient, when the spiral electrode 10 detects a ventricular fibrillation signal, the MCU processor 20 controls the pulse signal generator 30 to automatically output a defibrillation electric signal, so that the heart is defibrillated in time, and the heart failure patient is prevented from being defibrillated in time and missing optimal rescue time when serious complications such as ventricular fibrillation occur.

According to some embodiments of the invention, the helical electrode 10 comprises: a ventricular electrode and an atrial electrode, the ventricular electrode comprising: the first ventricular electrode 111 and the second ventricular electrode 112 are implanted in the right ventricular septum and are arranged at a preset distance, one of the first ventricular electrode 111 and the second ventricular electrode 112 is used for monitoring ventricular electrocardiosignals, and the other one is used for sending electrical stimulation pulse signals. Atrial electrodes are used to sense cardiac electrophysiological signals.

In some embodiments of the present invention, as shown in fig. 2, the first ventricular electrode 111 and the second ventricular electrode 112 are arranged at a preset distance interval at the right ventricular interval in the up-down direction, the preset distance being not less than 2cm.

According to some embodiments of the invention MCU processor 20 has a timing device, the start and run times being controlled by the set time of the timing device. That is, the MCU processor 20 is integrated with a timing device, which can freely set the interval time and start the adjustment of the cardiac contractility at regular time, for example, start the operation for one hour every three hours, so as to give a treatment interval to the patient, so that the heart can have a certain rest recovery period to prevent the occurrence of complications.

In some embodiments of the present invention, MCU processor 20 is communicatively coupled to remote configuration system 600 via data transmission configuration module 50, and remote configuration system 600 sets the timing device via data transmission configuration module 50.

According to the cardiac contractility regulating method of the embodiment of the invention, the regulating method adopts the defibrillatable cardiac contractility regulating device 100 to regulate the cardiac contractility.

when first ventricular electrode 111 monitors local electrical activity, MCU processor 20 controls second ventricular electrode 112 to send electrical stimulation to the heart after a preset time of onset of the QRS wave to modulate cardiac contractility. For example, after the first ventricular electrode 111 on the upper side of the right ventricle monitors the local electrical activity, 30 milliseconds after the start of the QRS wave, the second ventricular electrode 112 on the lower side of the right ventricle sends an electrical stimulation signal to adjust the force of heart contraction by electrical stimulation.

According to the defibrillation method of the embodiment of the invention, the defibrillation method adopts the defibrillation-able cardiac contractility regulating device 100 to perform defibrillation.

According to some embodiments of the invention, a method of defibrillation comprises:

when the first ventricular electrode 111 monitors ventricular tachycardia, the MCU processor 20 controls the pulse signal generator 30 to output a stimulus with a frequency greater than a preset value through the second ventricular electrode 112;

if ventricular tachycardia continues to occur or the first ventricular electrode 111 detects a ventricular fibrillation signal, the MCU processor 20 controls the pulse signal generator 30 to deliver current for defibrillation.

When the first ventricular electrode 111 detects a ventricular fibrillation signal, the ventricular fibrillation signal is fed back to the MCU processor 20, and the MCU processor 20 controls the pulse signal generator 30 to output a defibrillation signal from the second ventricular electrode 112, so as to start a defibrillation procedure.

In some embodiments of the present invention, the first ventricular electrode 111 continuously monitors ventricular cardiac electrical signals in real time. That is, the first ventricular electrode 111 continuously monitors, so that the second ventricular electrode 112 can accurately give pulse stimulation in the absolute refractory period of the cardiac muscle to increase the myocardial contractility, and because the stimulation to the cardiac muscle in the refractory period belongs to non-excitatory stimulation, the normal electrical signal conduction sequence of the heart cannot be interrupted, and ventricular arrhythmia cannot be triggered.

A defibrillatable cardiac contractility modulation device 100 and a method of operating the same according to the present invention are described in detail below in one embodiment with reference to the accompanying drawings. It is to be understood that the following description is exemplary only and should not be taken as limiting the invention in any way

As shown in fig. 1 and 2, the defibrillation heart contractility regulating device 100 of the present invention includes a contraction force regulator and a spiral electrode 10 implanted in the heart, the contraction force regulator includes a power source 40, an MCU processor 20 and a pulse signal generator 30, the spiral electrode 10 includes a right atrial electrode and two right ventricular electrodes, and the right atrial electrode is used for sensing electrophysiological signals of the heart.

As shown in FIG. 1, two right ventricular electrodes are implanted on the upper and lower sides of the right ventricular septum, respectively, at least 2cm apart. As shown in fig. 3, after the first ventricular electrode 111 monitors local electrical activity (30 ms after the start of QRS wave), the MCU processor 20 controls the pulse signal generator 30 to output an electrical stimulation signal from the second ventricular electrode 112 to electrically stimulate the heart within the absolute refractory period of the heart, where the electrical stimulation does not change the heart rate of the patient, and the electrical stimulation regulates the calcium influx and phosphorylation of the myocardial cells to up-regulate the expression of the proteins associated with calcium regulation, thereby changing the physiological status of the myocardium, enhancing the ability of heart contraction, and improving the cardiac function of the heart failure patient.

If ventricular tachycardia is monitored by the first ventricular electrode 111, the MCU processor 20 controls the pulse signal generator 30 to output faster frequency stimulation through the second ventricular electrode 112 to suppress the ventricular tachycardia, if the ventricular tachycardia continues to occur, the contraction regulator starts a defibrillation procedure, the MCU processor 20 controls the pulse signal generator 30 to emit larger current to defibrillate the heart and then recover to sinus rhythm, and if ventricular fibrillation is monitored by the first ventricular electrode 111, the MCU processor 20 also controls the pulse signal generator 30 to discharge to defibrillate the heart. When the heart failure patient has complications such as arrhythmia and even ventricular fibrillation, the cardiac failure patient can be defibrillated timely, death of the heart failure patient due to the complications such as ventricular fibrillation is avoided, and the survival rate of the heart failure patient is improved.

The detailed technical scheme is as follows:

the first ventricular electrode 111 continuously monitors the right ventricular cardiac signal without interruption and transmits the monitored electrical signal back to the pulse signal generator 30, the pulse signal generator 30 feeds back the received waveform to the MCU processor 20, and the MCU processor 20 determines whether to initiate contractile force modulation and when to initiate.

When five signals continuously measured by the first ventricular electrode 111 are all normal sinus activations and the QRS interval of the five normal sinus activations is greater than 60 milliseconds, the MCU processor 20 determines that the cardiac contractile force modulation can be started, and after 30 milliseconds from the start of the QRS wave of the sixth normal sinus activation, the MCU processor 20 controls the pulse signal generator 30 to send an electrical stimulation pulse signal to the second ventricular electrode 112 to increase the cardiac contractile force.

As shown in fig. 3, the pulse period of the pulse signal is 20 milliseconds, the amplitude is 8V, one electrical stimulation comprises two periods of the pulse signal, the two periods of the pulse signal are continuously released in the absolute refractory period of one normal sinus activation until the absolute refractory period of the next normal sinus activation, and the second ventricular electrode 112 releases the electrical stimulation pulse signal again, so that the heart contraction capacity is strengthened through circulation, and the heart function of the heart failure patient is improved.

If continuous sinus activation is interrupted, such as by monitoring an arrhythmia signal, an abnormal pacing activation signal, or a QRS wave interval of less than 60 milliseconds, the electrical stimulation pulse signal is immediately stopped and the adjustment of the contractility of the heart is stopped until the preconditions for initiating the adjustment of the contractility of the heart are re-met.

MCU processor 20 is integrated with a timing device that can be set at any time to start an interval, for example every three hours, an hour, or every four hours, so as to give the patient a treatment interval to allow the heart to adjust for a rest and recovery period.

As shown in fig. 1, the data transmission configuration module 50 is electrically connected to the MCU processor 20, the remote configuration system 600 sets the MCU processor 20 through the data transmission configuration module 50, for example, a timing device integrated with the MCU processor 20, the remote configuration system 600 can set the timing device through the data transmission configuration module 50, the operation time of the cardiac contractility regulating apparatus 100 can be periodically performed all day long, and high-amplitude non-excitatory biphasic electrical signals are provided for the myocardial refractory period in 7-12 hours, for example, the cardiac contractility regulating apparatus is operated for one hour every three hours or for one hour every four hours, and can be set according to the age and physical condition of the patient, so as to provide a treatment interval to the patient, and allow the cardiac regulation to have a certain rest and recovery period.

Remote configuration system 600 may set the defibrillation threshold of MCU processor 20 via data transmission configuration module 50, i.e., the minimum energy to convert ventricular velocity or ventricular fibrillation to sinus rhythm, obtain the defibrillation threshold via defibrillation threshold testing, and set according to the patient's condition. Patients are anesthetized with venous base before testing, and then are induced to have ventricular fibrillation, and currently, there are four methods for clinically inducing ventricular fibrillation:

1) T wave electric shock, 2) 50HZ direct current induction, 3) short-array rapid ventricular stimulation, and 4) programmed electrical stimulation. Defibrillation is carried out on the patient after ventricular fibrillation occurs, and a defibrillation threshold value is recorded. After the defibrillation threshold is obtained, the operator sets the defibrillation threshold for the MCU processor 20 through the remote configuration system 600, so as to prevent the defibrillation signal from being output too much during defibrillation and causing damage to the heart.

The power supply 40 adopts a rechargeable lithium battery to support wireless charging, a patient can perform wireless charging only by placing the charging chassis above the implantation position, can complete external charging only within 1-1.5 hours every week, does not need to go to a hospital to repeatedly replace the lithium battery, and supports lifelong use.

The housing of the contractile force modulation device 100 is made of titanium, and its connector is made of epoxy polymer resin, and the connector has 3-4 jacks respectively connected with the leads of the atrial electrode and the ventricular electrode, and the other ends of the atrial electrode and the ventricular electrode are respectively connected with the myocardial tissues of the right atrium and the right ventricle.

The operation procedure of the contraction force adjustment device 100 of the present invention is as follows:

s1, preparing related consumables before operation, including: tearing a sheath tube, a ventricular septal spiral electrode 10, a pacing system analyzer, a crocodile clip bridging line, sterile gauze, a sterile sleeve, a pacemaker surgical instrument and an external program control instrument.

S2, the spiral electrodes 10 are implanted into the vein paths by tearing the sheaths, the left vein path and the right vein path are selectable, the spiral electrodes comprise cephalic veins, subclavian veins, axillary veins and neck veins, are connected and implanted into the ventricular septum, and the distance between the spiral electrodes 10 on the two right ventricular septal veins is ensured to be more than 2 centimeters.

And S3, respectively testing the pacing threshold value (0.4-2V) and the pacing impedance (400-800 ohms) of the two ventricular electrodes 10 and recording to determine that the ventricular electrodes 10 are implanted well.

And S4, connecting the defibrillation contraction force regulator with the lead of the ventricular electrode 10 and implanting the defibrillation contraction force regulator below the clavicle.

And S5, setting various parameters of the defibrillation contraction regulator through the program controller.

And S6, the defibrillation contraction regulator starts to monitor the sinus rhythm, and after capturing the signal, sends a pulse electric signal in the absolute refractory period of the heart to enhance the contraction force of the heart.

In summary, in the present invention, two spiral electrodes 10 are respectively implanted at the upper and lower sides of the right ventricle, which are at least 2cm apart from each other, after the upper ventricular spiral electrode 10 monitors local electrical activity, and 30 ms after the start of a QRS wave, the spiral electrode 10 on the lower side of the right ventricle sends an electrical stimulation signal, the contractility of the heart is adjusted by electrical stimulation, if the upper spiral electrode 10 monitors ventricular fibrillation signals, the electrical stimulation signal is fed back to the MCU processor 20, and the MCU processor 20 controls the pulse signal generator 30 to output defibrillation signals from the lower spiral electrode 10, so as to start a defibrillation procedure.

MCU processor 20 is integrated with a timing device, which can freely set the interval time, and start the adjustment of the heart contractility at a fixed time, for example, start to operate for one hour every three hours, so as to give a treatment interval to the patient, so that the heart can have a certain rest recovery period, thereby preventing the generation of complications.

While the present invention has been described in connection with the preferred embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims

1. A defibrillatable cardiac contractility adjustment device, comprising:

2. The defibrillatable cardiac contractility force modulation device of claim 1, wherein the helical electrode comprises: the first ventricular electrode and the second ventricular electrode are implanted in the right ventricular septum and are arranged at a preset distance, one of the first ventricular electrode and the second ventricular electrode is used for monitoring ventricular electrocardiosignals, and the other one of the first ventricular electrode and the second ventricular electrode is used for sending electrical stimulation pulse signals.

3. The defibrillation cardiac contractility modulation device of claim 2, wherein the first ventricular electrode and the second ventricular electrode are arranged at a preset distance interval in the right ventricular interval in an up-down direction, the preset distance being not less than 2cm.

4. The defibrillatable cardiac contractility adjustment device according to claim 1, wherein the MCU processor has a timing device whose setup time controls the start and run times.

5. The defibrillatable cardiotonic apparatus of claim 4, wherein the MCU processor is communicatively coupled to a remote configuration system via a data transfer configuration module, and the remote configuration system sets the timing device via the data transfer configuration module.

6. A method of cardiac contractility modulation employing the defibrillatable cardiac contractility modulation device of any one of claims 1 to 5 for cardiac contractility modulation.

7. The cardiac contractility force modulation method according to claim 6, wherein the modulation method comprises:

when the first ventricular electrode monitors local electrical activity, after the QRS wave starts for a preset time, the MCU processor controls the second ventricular electrode to send electrical stimulation to the heart so as to adjust the heart contractility.

8. A method of defibrillation characterized in that the defibrillation method performs defibrillation using the defibrillatable cardiocontractility apparatus according to any one of claims 1 to 5.

9. The method of defibrillation of claim 8, wherein the defibrillation method comprises:

10. The method of defibrillation of claim 9, wherein the first ventricular electrode monitors ventricular cardiac electrical signals continuously in real time.