CN112089980A - Implantable medical device system - Google Patents
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
- A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
- A61N1/39622—Pacing therapy
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
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- A61N1/3981—High voltage charging circuitry
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Abstract
The invention belongs to the field of medical equipment, and relates to an implantable medical equipment system, which comprises: a first implantable medical device comprising a pulse generator, and a right ventricular lead and a right atrial lead coupled to the pulse generator; the pulse generator comprises a sensing module, a control module, a treatment module and a communication module; a plurality of second implantable medical devices implanted within the left ventricle, each second implantable medical device serving as a pacing site in a left ventricular multi-site pace; the second implantable medical device comprises a communication module, an energy receiving module, a pacing module and a treatment control module; the control module is configured to receive cardiac electrical cardiac signals via the sensing module and to determine whether to perform resynchronization pacing therapy based on the electrical cardiac signal analysis. Compared with the prior art, the invention can prolong the service life of the implanted medical equipment.
Description
Technical Field
The invention belongs to the field of implantable medical equipment, and particularly relates to improvement of a multi-equipment cooperation technology of implantable medical equipment.
Background
Heart failure, as the terminal stage of the clinical development of various organic heart diseases, is also one of the leading causes of death in patients with cardiovascular diseases. The cardiac resynchronization therapy adds left ventricular pacing on the basis of the traditional double-chamber pacing, recovers ventricular synchronous contraction, reduces mitral regurgitation, increases stroke output, improves ejection fraction, thereby relieving clinical symptoms and prolonging the life of patients. However, the traditional cardiac resynchronization therapy is affected by the problems of phrenic nerve stimulation, myocardial scar tissue influence, high incidence rate of left ventricular electrode dislocation and the like, so that postoperative patients have high complications and low response rate. To solve these problems, the appearance of multi-site pacing of the left ventricle has become a major breakthrough in the treatment of heart failure, which can capture a wider range of ventricular muscles, reduce complications and improve response rate.
The multi-point pacing needs a plurality of pacing points, the most practical multi-point pacing scheme at present is to implant a left ventricle lead in a left ventricle, a plurality of pacing electrodes are arranged on the left ventricle lead, and the pacing vector can be selected by equipment according to the situation. Such a left ventricular implant lead usually needs to be supported by a three-cavity implanted medical device, and the structure of the three-cavity second medical device is complicated and difficult to implant. In order to solve the problem, a medical device system which is matched with a second medical device without a lead and a SICD (subcutaneous defibrillator) is also provided in the industry, the second medical devices without the lead are respectively implanted in the left and the right heart cavities of the patient, and the second medical devices without the lead and the SICD cooperate to deal with different heart rhythm events of the patient. Defibrillation therapy is performed by the SICD, for example, by performing anti-tachycardia pacing and conventional pacing in the patient's heart with a leadless secondary medical device.
The above combination of solutions also presents the problem that 1, the leadless second medical device needs to be implanted inside the heart, because of its small volume, and therefore its built-in battery capacity is limited, and the leadless second medical device eventually fails to work because of the exhausted battery. 2. The implanted SICD is easily interfered by electromyographic signals under the skin of a human body, far-field signals of the heart sensed by subcutaneous leads are more easily interfered by other signals than near-field signals, and the sensed amplitude of the signals is low (generally 1mv or lower). 3. The inability to pace from the atrium without the atrial lead causes it to not pace from the atrium when the patient's AV conduction is abnormal, which is disadvantageous to the patient in that the pacing waveform for the leadless second medical device is wider relative to atrial pacing.
Disclosure of Invention
The present invention provides an implantable medical device system that addresses the above-mentioned problems. The medical device system uses a transvenous ICD and a leadless second implantable medical device whose pacing energy is derived by way of wireless charging. Thereby solving the problem of battery depletion of the leadless second implantable medical device.
The implantable medical device system, comprising: a first implantable medical device comprising a pulse generator, and a right ventricular lead and a right atrial lead connected to the pulse generator;
the pulse generator comprises a sensing module, a control module, a treatment module and a communication module;
a plurality of second implantable medical devices implanted within the left ventricle, each of the second implantable medical devices serving as a pacing site in left ventricular multi-site pacing;
the second implantable medical device comprises a communication module, an energy receiving module, a treatment module and a control module;
the control module of the first implantable medical device is configured to receive the cardiac electrical signal via the sensing module and to determine whether to perform resynchronization pacing therapy based on the cardiac electrical signal analysis; when pacing is needed, sending a pacing signal to the second implantable medical device through the communication module;
the control module of the second implantable medical device receives the pacing signal through the communication module and carries out synchronous pacing treatment, and the pacing energy of the second implantable medical device is obtained through the energy receiving module.
In a preferred embodiment, the first implantable medical device is used to charge a leadless second implantable medical device during a pacing interval.
In a preferred embodiment, the first implantable medical device is used to charge the leadless second implantable medical device during a ventricular or atrial refractory period of the atrial pacing or ventricular pacing.
In a preferred embodiment, the first implantable medical device is used to charge the leadless second implantable medical device during a blanking period of the atrial pacing or ventricular pacing.
In a preferred embodiment, the first implantable medical device includes an energy emitting module for providing pacing energy to the second implantable medical device.
The medical device also comprises a third medical device which comprises an energy emitting module and is arranged outside the human body, and the energy emitting module is used for providing pacing energy for the second implanted medical device.
In a preferred embodiment, the energy transmission module comprises a radio transmission coil and a transmission drive circuit, and the second implantable medical device comprises a radio reception coil.
In a preferred embodiment, the energy emitting module comprises an ultrasonic transduction module for converting electrical energy into ultrasonic waves; the second implantable medical device energy receiving module is an ultrasonic transduction module for converting ultrasonic waves into electric energy.
In a preferred embodiment, the control module is configured to analyze whether to deliver defibrillation therapy based on the cardiac electrical signal; determining defibrillation therapy the therapy module delivers a defibrillation shock through a right ventricular lead.
In a preferred embodiment, the control module is configured to analyze whether to perform an anti-tachycardia pacing therapy based on the cardiac electrical signal; the therapy module releases anti-tachycardia pacing via a right ventricular lead when anti-tachycardia pacing therapy is determined.
In a preferred embodiment, the second implantable medical device is an implantable leadless medical device, the second implantable medical device not including a battery assembly.
The pacing energy of the second implantable medical device is derived from externally generated energy, so that the second implantable medical device does not need to carry a battery, the second implantable medical device obtains the pacing energy from the first implantable medical device or the third medical device, and the second implantable medical device releases the pacing energy to pace the heart when receiving the pacing signal. By this approach the second implantable medical device lifetime is not affected by battery life.
Drawings
Fig. 1 is a schematic view of an implantable medical device implanted in a human body.
Fig. 2 is a schematic diagram of a hardware configuration of a first implantable medical device pulse generator.
Fig. 3 is a schematic diagram of a second implantable medical device hardware architecture.
Fig. 4 is an electrocardiogram sensed by the first implantable medical device in which atrial or ventricular pacing sites are identified.
Fig. 5 is a schematic control flow diagram illustrating a process of charging a second implantable medical device by a first implantable medical device during pacing.
Fig. 6 is a third medical device hardware architecture diagram.
Fig. 7 is a schematic flow diagram of a third medical device charging a second implantable medical device.
Detailed Description
Reference is made to the implantable medical device shown in fig. 1. Including a first implantable medical device 100 implanted subcutaneously in the chest and a second implantable medical device 300 implanted inside the left ventricle.
The first implantable medical device 100 includes a pulse generator 101 disposed subcutaneously and a lead 105 coupled to the pulse generator 101. The first implantable medical device 100 includes an implantable cardiac defibrillator, a cardiac pacemaker, and a cardiac pacemaker with defibrillation function. The first implantable medical device 100 can be divided into a single cavity, a double cavity and a triple cavity according to the implantation position of the lead 105, and the number of the corresponding leads is also divided into 1 to 3. Shown in fig. 1 is a single-lumen second implantable medical device 300, or ICD, having a dual-lumen configuration that can be accessed through the cephalic vein, the subclavian vein, and the superior vena cava S into the right ventricle V and right atrium a.
The lead 105 is divided into a right atrial lead 1051 and a right ventricular lead 1052, and the end of the right atrial lead 1051 is connected to the heart tissue o for sensing atrial signals. The right atrial lead 1051 distal electrode 117 is capable of sensing electrical signals, i.e., P-waves, generated during atrial depolarization.
The right ventricular lead 1052 is divided into a proximal end connected to the pulse generator 101 and a distal end connected to the cardiac tissue o. The distal end of the lead includes a helical electrode 124 connected to the cardiac tissue o, and the advancement of the helical electrode 124 into the cardiac tissue o secures the leading end of the lead to the cardiac tissue. The near-field electrode 126 is arranged near the front end of the lead, and the near-field electrode 126 is used for sensing near-field electrocardiosignals which reflect the o depolarization and repolarization processes of the local cardiac tissue.
The right ventricular lead 1052 includes a coil 122 for defibrillation. The defibrillation coil 122 is placed in the right ventricle, the defibrillation coil 122 is used for forming a treatment discharge circuit with the pulse generator 101, and the defibrillation coil 122 is located at a position capable of ensuring that a treatment vector formed by defibrillation current covers most myocardial tissues o.
The proximal end 120 of the right ventricular lead 1052 is connected to the connector 102 of the pulse generator 101. Connector 102 provides an electrical connection jack into which wires are inserted, and connector 102 includes a feedthrough assembly 202 (see fig. 2) within the interior thereof, feedthrough assembly 202 connecting the wires to circuitry within the pulse generator. The feed-through assembly 202 is connected with the sensing electrode through a lead, and the sensing electrode (electrode 124 or electrode 126 or electrode 117) is connected with the sensing circuit in the pulse generator through the feed-through assembly 202. The sensing circuit is used for sensing the electrocardiosignals and further processing the electrocardiosignals to convert the electrocardiosignals from analog signals into digital signals. The feedthrough assembly 202 connects the high-energy therapy coil 122 on a lead to the therapy circuitry within the pulse generator. The therapy circuit is used to deliver shock therapy when the heart experiences ventricular fibrillation or ventricular tachycardia.
The feedthrough assembly also includes an antenna 211, the antenna 211 being disposed within the head of the feedthrough assembly 202. The antenna is used for establishing wireless connection communication connection between the pulse generator 101 and external equipment. The external device D includes a program controller used in a hospital, a handheld device used by a patient such as a mobile phone, a patient assistant, and the like.
The second implantable medical device 300 is disposed within the left ventricle. The second implantable medical device 300 is small, implantable in the left ventricle of the human body by way of minimally invasive implantation, and is a leadless pacing device. Second implantable medical device 300 is secured to cardiac tissue o via a structural member (not shown) and second implantable medical device 300 is capable of receiving instructions from first implantable medical device 100 for pacing therapy to cardiac tissue o. To reduce the volume of second implantable medical device 300 and extend the life of second implantable medical device 300, second implantable medical device 300 does not have a battery configuration therein, and pacing energy from first implantable medical device 100 or third medical device 500.
Referring to fig. 2, a schematic diagram of the hardware architecture within the first implantable medical device pulse generator 101 is shown. It includes a sensing module 210 for sensing cardiac electrical signals, a therapy module 212 for providing therapy pulse signals, and a communication module 218 for communicating with an external device D or a second implantable medical device 300. A memory module 216 for storing patient data, parameters, and medical procedure code, the memory module 216 may include RAM, ROM, flash memory, and/or other memory circuitry. And the control module 214 performs diagnosis and treatment procedures, processes and analyzes the electrocardiosignals sensed by the sensing module according to the patient parameters and the diagnosis procedure setting, and judges whether electrical stimulation needs to be performed on the heart through the treatment module 212 according to the diagnosis result.
The sensing module 210 is connected to the electrode on the wire, and includes an amplifier, a filter, a digital-to-analog conversion module, and the like. The sensing module 210 can process the signals on the right atrial lead 1051 and the right ventricular lead 1052 simultaneously and the sensed P-wave or R-wave signals are converted to digital signals, which the control module 214 uses to calculate PR intervals, AA intervals, RR intervals, which are used to determine pacing time points.
The therapy module 212 includes a high voltage module and a capacitor. The high-voltage module is used for boosting low-voltage direct current (generally within 10 v) provided by the power supply 220 to 800v through the high-voltage module, and charging current into the capacitor through the charging circuit. The control module 214, upon determining that the heart requires electrical stimulation therapy, loops the heart tissue through the switching circuitry with the capacitance that discharges the heart for stimulation therapy.
The communication module 218 is coupled to the antenna 211, the communication module 218 communicates with the external device D or the second implantable medical device 300, and the communication module 218 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.
Optionally, the first implantable medical device 101 further comprises an energy emitting module for charging the second implantable medical device 300. The energy transmitting module 224 is configured to convert the electrical energy in the first implantable medical device 100 into ultrasound, a magnetic resonance field, a radio frequency signal, etc. and transmit the ultrasound, the magnetic resonance, the radio frequency signal, etc. to the second implantable medical device 300, the second implantable medical device 300 receives the energy and converts the energy into electrical energy, and the energy transmitting module may be a radio frequency coil, an antenna, or an ultrasound transducer.
In a preferred embodiment, the energy transmitting module 224 includes a radio transmitting coil and a transmitting driving circuit, and the control module 214 controls the transmitting driving circuit to transmit radio via a control signal. In some aspects the radio transmit coil is shared with an antenna of a communications module, the communications module 218 communicates using RF radio frequency signals, while the energy transmit module transmits energy using the coil, either time-multiplexed or carrier-modulated. To accommodate the first implantable medical device 100, the second implantable medical device 300 includes a radio receive coil.
In a preferred embodiment, the energy emitting module 224 includes an ultrasonic transducing module, which is used to convert the electric energy into ultrasonic waves; the ultrasonic energy conversion module is a piezoelectric module, and a high-frequency electric field is introduced through a driving circuit when ultrasonic energy is transmitted, and the high-frequency electric field causes the piezoelectric module to mechanically oscillate to generate ultrasonic waves. The energy receiving module of the second implantable medical device 300 is an ultrasonic transducer for converting ultrasonic waves into electric energy. The ultrasonic transducer is made of piezoelectric materials, receives ultrasonic oscillation and generates charges, and can be matched with circuits such as a filter rectifier and the like to form an output power supply.
Referring to fig. 3, a hardware architecture diagram of a second implantable medical device 300 is shown. It comprises an energy receiving module 333 for generating electrical energy, an energy storage module 334 for storing electrical energy, a communication module 311 for communicating with the first implantable medical device 100 or an external device, a therapy module 310 for releasing therapeutic stimulation.
The energy receiving module 333 is configured to convert the energy of the ultrasound waves, magnetic field resonance, radio frequency signals, etc. generated by the first implantable medical device 100 into electrical energy. The energy receiving module 333 is connected to an energy storage module 334, which is preferably a capacitor that stores energy required for one or more pacing stimuli. The capacitor stores less energy than the battery pack of the transmission, which can be depleted during one or more paces, but the capacitor is charged and discharged more often and has a longer life than the battery pack.
The communication module 316 is used to communicate D with the first implantable medical device 100 or an external device. First implantable medical device 100 delivers a pacing stimulation signal, or if necessary a charging control signal, to second implantable medical device 300 via a communication module. RF or inductive communication may alternatively be used, alternatively optical, acoustic or any other suitable medium.
The therapy control module 314 may be used to execute control instructions for the first implantable medical device 100. For example, the first implantable medical device 100 determines that the heart needs pacing after diagnosis, and sends a pacing instruction to the second implantable medical device 300 through the communication module 314, and the control module 314 executes the pacing instruction to control the therapy module to electrically stimulate the heart.
The therapy module 310 includes a switch circuit, the therapy module can be directly connected to the energy storage module 334, the therapy module 334 includes a switch circuit, and the control module controls the switch circuit to open when performing electrical stimulation, so that the heart and the energy storage module form a loop.
In fig. 1, the second implantable medical device 300 may comprise a plurality of implantable medical devices, and each implantable medical device 300 is configured to be implanted at a location that serves as a pacing point for a left ventricle. During ventricular synchronous therapy, the plurality of second implantable medical devices 300 may pace at different sites. Or the second implantable medical device 300 corresponding to the pacing point with the best pacing effect can be selected by programming.
Referring to fig. 4, which is an electrocardiogram detected by the sensing module, and an identified atrial or ventricular pacing site, the second implantable medical device 300 is shown in DDI mode (atrial-ventricular simultaneous pacing, atrial-ventricular simultaneous sensing, sensing of a signal followed by suppression of a pacing stimulus). Where signals C1, C2 represent control signals for first implantable medical device 100 to charge second implantable medical device 300, where a high level represents first implantable medical device 100 charging second implantable medical device 300 and a low level represents cessation of charging. The first implantable medical device 100 always charges the second implantable medical device 300 during the AV interval or VA interval, and in order to reduce the effect of the VA or AV interval charging signal on ventricular or atrial sensing, the energy transmitting module 224 and the receiving module 333 are preferably ultrasonic transmitting and receiving modules.
Referring to fig. 4, which is an electrocardiogram detected by the sensing module, and an identified atrial or ventricular pacing site, the second implantable medical device 300 is shown in DDI mode (atrial-ventricular simultaneous pacing, atrial-ventricular simultaneous sensing, sensing of a signal followed by inhibition of pacing stimulation), where t represents the time axis.
The upper time block of the electrical diagram in the center of fig. 4 represents the atrial refractory period 402 and the bottom time block represents the ventricular refractory period 404. The refractory period is the refractory period of first implantable medical device 100 during which first implantable medical device 100 does not process the sensed signal. The purpose of setting the refractory period is to prevent the pacing signals in the atria or ventricles from interfering with each other, while preventing the atria or ventricles from sensing oversensing due to the paced cardiac depolarization signal after pacing. While the refractory period of the first implantable medical device 100 also corresponds to the physiological refractory period of the cardiac tissue.
In fig. 4, the first implantable medical device 100 enters the atrial refractory period 408 and the post-atrial ventricular refractory period 412 after the right atrial lead 1051 initiates pacing stimulation 406. The atrial blanking period 410 is brief at the front of the atrial refractory period. During this blanking period 410, the right atrial lead 1051 does not sense any signals. The atrial blanking period 410 is followed by an atrial refractory period sensing period 408, in which the atrial lead 1051 is sensing but does not respond to any sensed signal, although it is sensing during this period 408. While the ventricular sense also enters the blanking period 412 after the atrial pacing stimulus 406, the right ventricular lead 1052 does not sense any signal during the ventricular sense blanking period 412 to prevent the electrical signal generated by the atrial pacing stimulus 406 from being sensed by the right ventricular lead 1052.
The ventricular refractory period PRP and the post-ventricular atrial refractory period ARP are entered after the delivery of the ventricular pacing stimulus 414 in fig. 4. The ventricular pacing stimulus 414 is a fused waveform of right ventricular stimulation and left ventricular stimulation that is delivered by the second implantable medical device 300 implanted in the left ventricle. The early ventricular refractory period following ventricular stimulation is ventricular blanking 416, where no signal is sensed at right 1052. Outside of the ventricular blanking period 416, the ventricles sense the signal but do not react to it. The simultaneous entry of the atria into a refractory period after ventricular pacing stimulus 414 is also known as post-ventricular atrial refractory period (PARP), the leading end of which is atrial blanking 418 during which no signal is sensed by right atrial lead 1051.
Signals C1, C2 represent control signals for the first implantable medical device 100 to charge the second implantable medical device 300. Wherein a high level of the control signal indicates that first implantable medical device 100 charges second implantable medical device 300, and a low level of the control signal indicates that first implantable medical device 100 stops charging second implantable medical device 300. The control module controls the first implantable medical device 100 to transmit energy to the first implantable medical device 100 through the energy conversion module 214 when the first implantable medical device 100 is in a refractory period. The second implantable medical device 300 receives the energy transmitted by the first implantable medical device 100 and converts it into electrical energy for storage in the energy storage device 334.
With continued reference to fig. 4, the first implantable medical device 100 elects to charge the second implantable medical device 300 during the blanking period. First implantable medical device 100 charges second implantable medical device 300 after the atrial pacing stimulus and for a period of time that is ventricular blanking 412 and atrial blanking 410, after which charging ceases. The first implantable medical device 100 charges the second implantable medical device 300 during the ventricular blanking period 416 and the post-ventricular atrial blanking period 416, as described above after the ventricular pacing stimulus 414. Charging during the blanking period can be less disruptive to the perception of first implantable medical device 100 than charging second implantable medical device 300 during the entire refractory period of second implantable medical device 300.
Referring to fig. 5, a schematic control flow diagram of first implantable medical device 100 charging second implantable medical device 300 during pacing is shown. Initialization of the device is included in flow 500, which includes setting basic parameters including sensing sensitivity, default pacing intervals, post-pacing refractory period length, etc. The first implantable medical device 100 may also automatically learn the patient's heart rate signal based on the patient's condition, gradually modifying various parameters.
In process 502 right atrial lead 1051 senses atrial signals and right ventricular lead 1052 senses ventricular electrical signals. The sensing circuit converts the sensed signal into a digital signal. The electrocardiosignals can be cached in the digital shift register so that the control module can carry out data analysis according to historical electrocardio data.
In flow 530 the control module 214 is configured to analyze whether to deliver defibrillation therapy based on the cardiac electrical signal; determining defibrillation therapy the therapy module 212 delivers a defibrillation shock through the coil 122 on the right ventricular lead 1052. Various parameters need to be calculated in the process 530 and a determination is made as to whether a malignant ventricular rhythm event has occurred based on the parameters. For example, the control module 214 may batch determine whether the heart is experiencing tachycardia or ventricular fibrillation based on the RR intervals, RR interval variability, heart rhythm paroxysmal, stability, and QRS waveform templates of the historical electrocardiographic data. When it is determined in the process 532 that tachycardia or ventricular fibrillation occurs, the first implantable medical device 100 first performs high-energy therapy on the heart with high-energy therapy as a first priority, the high-energy therapy is classified as anti-tachycardia therapy or defibrillation therapy, and the control module analyzes the cardiac electrical signal and determines to perform anti-tachycardia therapy or defibrillation therapy according to the occurrence condition of the heart. In flow 536, the high energy treatment includes charging a capacitor in the treatment circuit, discharging the heart when the charging voltage reaches a predetermined voltage, and controlling parameters such as the discharge slope phase. The control flow re-enters the pacing flow when the heart returns to normal, and also enters the pacing flow 506 when high energy therapy is not needed in flow 532.
In process 504, the control module calculates data, where the calculation includes that a plurality of cardiac parameters flow into the control module 214, and the heart rate may be calculated through the AA interval, and whether atrial pacing is needed or not is determined according to whether autonomous pacing occurs in the AA interval, and meanwhile, the control module 214 may also determine whether atrial flutter or atrial fibrillation occurs according to parameters such as waveform morphology and heart rate variability of atrial signals. If atrial autonomous pacing is not present during the AA interval.
If process 506 determines that atrial pacing is desired then first implantable medical device 100 releases the atrial pacing stimulus via atrial lead 1051 in process 508 and first implantable medical device 100 enters an atrial refractory period in process 510, which includes ventricular blanking period 412 with overlapping time ranges, atrial blanking period 410, refractory period 408, when the processor does not do any processing of the atrial electrical signal. In process 512, first implantable medical device 100 charges second implantable medical device 300, and first implantable medical device 100 may charge second implantable medical device 300 during the atrial refractory period (see control signal C1) or may charge second implantable medical device 300 during the atrial blanking period or post-atrial ventricular blanking period (see control signal C2).
Charging of second implantable medical device 300 by first implantable medical device 100 is performed all the time first implantable medical device 100 is in a refractory period, and interfering signals generated in right atrial lead 1051 and right ventricular lead 1052 when charging second implantable medical device 300 using RF or magnetic fields are shielded or ignored. During the atrial or ventricular blanking period, no signal is sensed by the atria or ventricles and the interfering signal is masked. And the control module does not process the sensed signal in a refractory period outside the blank period. Therefore, the influence of the charging energy field signal on the self-perception signal can be avoided when charging is carried out in the refractory period.
As shown in the right side electrocardiographic waveform of fig. 4, the first implantable medical device 100 in flow 512 or 520 may only pace the heart chambers in some cases. For example, in the event of atrial fibrillation, the second implantable medical device 300 automatically cancels the atrioventricular tracking function to switch the operating mode DDI to VDI, thereby reducing the ventricular impact of atrial fibrillation, atrial flutter, etc. I.e., the ventricular pacing is no longer synchronized with the atrial signal, is only performed during the ventricular refractory period or the atrial refractory period following ventricular pacing when the first implantable medical device 100 charges the second implantable medical device 300. In the charging control signal C1, the charging timing is preferably performed during either the atrial blanking period 420 or the ventricular blanking period 422.
Further, in the process 512 or 520, the charged amount of power may satisfy one pacing usage or multiple pacing usages, and is different according to the charging power and the charging time length for each second implantable medical device 300. First implantable medical device 100 may first communicate with second implantable medical device 300 by querying the power level of second implantable medical device 300 and then deciding whether to charge second implantable medical device 300. Not charging the second implantable medical device 300 if the charge of the second implantable medical device 300 reaches a set threshold.
Referring to fig. 6, a third medical device 602 is illustrated. Another charging scheme is shown in which the second implantable medical device 300 is charged by a dedicated third medical device 602. The third medical device is similar in functional structure to the first implantable medical device 100 and includes a control module 604 for controlling the logic functions of the third medical device, and a storage module 606 for storing control programs and patient and programming parameters. A communication module 608 for communicating with the first implantable medical device 100 or the second implantable medical device 300. A power module 610 for providing power, and an energy transmission module for charging the second implantable medical device 300. The third medical device 602 may be disposed outside the body and provide pacing energy for charging the second implantable medical device 300.
Referring to fig. 7, a schematic flow diagram of a third medical device charging a second implantable medical device 300 is shown. In the process 702, the first implantable medical device 100 detects an electrical cardiac signal, and determines whether atrial pacing is needed, the first implantable medical device 100 paces the right atrium via the right atrial lead 1051, then the first implantable medical device 100 sends a message 704 entering the atrial refractory period to the third device, where the message should include an atrial refractory period timestamp, the charging step 706 sends charging energy to the second implantable medical device 300 based on the timestamp, and the charging time is the timestamp plus the atrial refractory period interval or the atrial blanking period interval.
In a subsequent diagnostic process 708, the first implantable medical device 100 determines whether ventricular pacing is required, and similarly if the first implantable medical device 100 paces the ventricle, the first implantable medical device 100 sends a ventricular pacing message 712 to the second implantable medical device 300 and the third medical device, where the ventricular pacing message 712 includes a timestamp of the ventricular pacing. The second implantable medical device 300 receives the pacing message and then discharges pacing to the left ventricle, and the third medical device 500 subsequently charges the second implantable medical device 300 and expires after a ventricular refractory period or a ventricular blanking period.
It should be noted that the atrial or ventricular pacing message sent by the first implantable medical device 100 may alternatively be sent to the second implantable medical device 300 and forwarded by the second implantable medical device 300 to the third medical device 500 or forwarded by the third medical device 500 to the second implantable medical device 300. The pacing message may include a blanking period length, etc., in addition to the timestamp.
The charging pulse signal is synchronized with the atrial refractory period and the ventricular refractory period of the pacemaker when charged by the third medical device. The third medical equipment is outside the human body, can conveniently change the battery and the third medical equipment changes the maintenance and does not need any operation, consequently uses the external third medical equipment to provide the pacemaker energy and makes the life of pacemaker not receive battery life-span constraint.
Claims (11)
1. An implantable medical device system, comprising: a first implantable medical device comprising a pulse generator, and a right ventricular lead and a right atrial lead connected to the pulse generator;
the pulse generator comprises a sensing module, a control module, a treatment module and a communication module;
a plurality of second implantable medical devices implanted within the left ventricle, each of the second implantable medical devices serving as a pacing site in left ventricular multi-site pacing;
the second implantable medical device comprises a communication module, an energy receiving module, a treatment module and a control module;
the control module of the first implantable medical device is configured to receive the cardiac electrical signal via the sensing module and to determine whether to perform resynchronization pacing therapy based on the cardiac electrical signal analysis; when pacing is needed, sending a pacing signal to the second implantable medical device through the communication module;
the control module of the second implantable medical device receives the pacing signal through the communication module and carries out synchronous pacing treatment, and the pacing energy of the second implantable medical device is obtained through the energy receiving module.
2. The implantable medical device system of claim 1, wherein the first implantable medical device is used to charge a leadless second implantable medical device during a pacing interval.
3. The implantable medical system of claim 2, wherein the first implantable medical device is configured to charge the leadless second implantable medical device during a ventricular or atrial refractory period of the atrial pacing or ventricular pacing.
4. The implantable medical system of claim 3, wherein the first implantable medical device is configured to charge the leadless second implantable medical device during a blanking period of the atrial pacing or ventricular pacing.
5. The implantable medical device system of claim 1, wherein the first implantable medical device comprises an energy emitting module for providing pacing energy to the second implantable medical device.
6. The implantable medical device system of claim 1, further comprising a third medical device comprising an energy emitting module, the third medical device being disposed outside the body and providing pacing energy to the second implantable medical device via the energy emitting module.
7. The implantable medical device system of claim 5 or 6, wherein the energy transmitting module comprises a radio transmitting coil and a transmit driver circuit, and the second implantable medical device comprises a radio receiving coil.
8. The implantable medical device system of claim 5 or 6, wherein the energy emitting module comprises an ultrasound transducing module for converting electrical energy into ultrasound waves; the second implantable medical device energy receiving module is an ultrasonic transduction module for converting ultrasonic waves into electric energy.
9. The implantable medical device system of claim 1, wherein the control module is configured to analyze whether to perform defibrillation therapy based on the cardiac electrical signal; determining defibrillation therapy the therapy module delivers a defibrillation shock through a right ventricular lead.
10. The implantable medical device system of claim 9, wherein the control module is configured to analyze whether to perform anti-tachycardia pacing therapy based on the cardiac electrical signal; the therapy module releases anti-tachycardia pacing via a right ventricular lead when anti-tachycardia pacing therapy is determined.
11. The implantable medical device system of claim 1, wherein the second implantable medical device is an implantable leadless second implantable medical device that does not include a battery assembly.
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CN112754492A (en) * | 2021-01-14 | 2021-05-07 | 苏州无双医疗设备有限公司 | Implantable medical device and programmer for heart rhythm monitoring and anticoagulation |
CN115430042A (en) * | 2022-11-07 | 2022-12-06 | 苏州无双医疗设备有限公司 | Implanted lead |
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