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CN112089980B - Implantable medical equipment system - Google Patents

Implantable medical equipment system Download PDF

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Publication number
CN112089980B
CN112089980B CN202011065847.XA CN202011065847A CN112089980B CN 112089980 B CN112089980 B CN 112089980B CN 202011065847 A CN202011065847 A CN 202011065847A CN 112089980 B CN112089980 B CN 112089980B
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implantable medical
medical device
module
pacing
energy
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CN112089980A (en
Inventor
李娜
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Suzhou Wushuang Medical Equipment Co ltd
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Suzhou Wushuang Medical Equipment Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3956Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A61N1/39622Pacing therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3975Power supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3975Power supply
    • A61N1/3981High voltage charging circuitry

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  • Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Electrotherapy Devices (AREA)

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 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 second implantable medical device acting as a pacing site in a multi-site pacing of the left ventricle; 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 electrocardiosignals through the sensing module and to decide whether to perform resynchronization pacing therapy based on the electrocardiosignal analysis. Compared with the prior art, the invention can prolong the service life of the implantable medical equipment.

Description

Implantable medical equipment system
Technical Field
The invention belongs to the field of implantable medical equipment, and particularly relates to an improvement of multi-equipment cooperative technology of implantable medical equipment.
Background
Heart failure is also one of the leading causes of death in patients with cardiovascular disease as a terminal stage of the development of various organic heart diseases in clinic. The heart resynchronization therapy increases left ventricular pacing based on traditional dual-chamber pacing, restores ventricular synchronous contraction, reduces mitral regurgitation, increases stroke volume, and improves ejection fraction, thereby alleviating clinical symptoms and prolonging life of patients. However, the traditional heart resynchronization therapy is affected by problems such as phrenic nerve stimulation, myocardial scar tissue influence, high incidence of left ventricular electrode dislocation, etc., so that postoperative patients have high complications and low response rates. In order to solve the problems, the occurrence of left-room multi-site pacing becomes a major breakthrough in heart failure treatment, and the multi-site pacing can capture a wider range of ventricular muscles, reduce complications and improve response rate.
The multi-point pacing needs a plurality of pacing points, and the most practical multi-point pacing scheme at present is to implant a left chamber wire in a left chamber, and a plurality of pacing electrodes are arranged on the left chamber wire, so that the device can select a pacing vector according to conditions. Such left-handed implantable leads typically require three-lumen implantable medical device support, and three-lumen secondary medical devices are difficult to implant with complex structures. In order to solve the problem, a medical device system which is matched with a practical wireless second medical device and a SICD (subcutaneous defibrillator) is also proposed in the industry, wherein the wireless second medical device is respectively implanted into the left heart chamber and the right heart chamber of a patient, and different heart rhythm events of the patient are cooperatively dealt with through the SICD and the wireless second medical device. Anti-tachycardia pacing and conventional pacing are performed in the patient's heart, for example, by a leadless secondary medical device, and defibrillation therapy is performed by SICD.
The above solution combination also has problems, 1, the leadless second medical device needs to be implanted inside the heart, and because of its small volume, its built-in battery capacity is limited, and the leadless second medical device eventually cannot work because the battery is exhausted. 2. SICD implantation is prone to electromyographic signal interference under the skin of the human body, and subcutaneous lead-perceived far-field signals of the heart are more prone to other signal interference than near-field signals, with low signal perception amplitudes (typically 1mv or less). 3. The absence of an atrial lead failing to pace from the atrium, causing it to fail to pace from the atrium when the patient's AV conduction is abnormal, is disadvantageous to the patient in that the pacing waveform of the leadless second medical device is wider than for atrial pacing.
Disclosure of Invention
The present invention provides an implantable medical device system that solves the above-mentioned problems. The medical device system uses a transvenous ICD and a leadless second implantable medical device that has pacing energy derived from being obtained 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 acting as a pacing site in a multi-site pacing of the left ventricle;
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 an electrocardiosignal through the sensing module and decide whether to perform resynchronization pacing therapy according to the electrocardiosignal analysis; when pacing is needed, sending a pacing signal to the second implantable medical device through a communication module;
The control module of the second implantable medical device receives the pacing signal through the communication module and performs synchronous pacing therapy, 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 refractory period or an 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 comprises an energy emitting module for providing pacing energy to the second implantable medical device.
The device also comprises a third medical device, wherein the third medical device comprises an energy transmitting module, and the third medical device is arranged outside the human body and provides pacing energy for the second implantable medical device through the energy transmitting module.
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 electrical energy.
In a preferred embodiment, the control module is configured to analyze whether defibrillation therapy is being performed based on the electrocardiographic signals; determining defibrillation therapy the therapy module delivers a defibrillation shock via the right ventricular lead.
In a preferred embodiment, the control module is configured to analyze whether anti-tachycardia pacing therapy is being administered based on the electrocardiographic signals; the therapy module releases anti-tachycardia pacing via the right ventricular lead when determining anti-tachycardia pacing therapy.
In a preferred embodiment, the second implantable medical device is an implantable leadless medical device that does not include 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 inside, and the second implantable medical device obtains pacing energy from the first implantable medical device or the third medical device, releases the pacing energy when the second implantable medical device receives a pacing signal, and paces the heart. By this means the service life of the second implantable medical device is not affected by the battery life.
Drawings
Fig. 1 is a schematic illustration of the structure of an implanted medical device implanted in a human body.
Fig. 2 is a schematic hardware configuration of a pulse generator of the first implantable medical device.
Fig. 3 is a schematic diagram of a hardware architecture of a second implantable medical device.
Fig. 4 is an electrocardiogram perceived by the first implantable medical device, wherein atrial or ventricular pacing sites are identified.
The control flow diagram of the first implantable medical device charging the second implantable medical device during pacing is shown in fig. 5.
Fig. 6 is a schematic diagram of a third medical device hardware architecture.
Fig. 7 is a schematic flow chart of a third medical device charging a second implantable medical device.
Detailed Description
Referring 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 comprises a subcutaneously arranged pulse generator 101 and a lead 105 connected to the pulse generator 101. The first implantable medical device 100 includes an implantable cardiac defibrillator, a cardiac pacemaker with defibrillation capabilities. Wherein the first implantable medical device 100 is divided into a single lumen, a double lumen and a triple lumen according to the implantation site of the lead 105, and the number of corresponding leads is also divided into 1 to 3. Shown in fig. 1 is a single-lumen second implantable medical device 300 or ICD, which may be deployed through the cephalic vein, subclavian vein, superior vena cava S into right ventricle V and right atrium a in a dual-lumen configuration.
The leads 105 are divided into a right atrial lead 1051 and a right ventricular lead 1052, and the right atrial lead 1051 is connected at its distal end to cardiac tissue o for sensing atrial signals. The right atrial lead 1051 has a tip electrode 117 capable of sensing an electrical signal, i.e., a P-wave, 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 heart tissue o. The distal end of the lead includes a coiled electrode 124 that is attached to the heart tissue o, the coiled electrode 124 being advanced into the heart tissue o to secure the distal end of the lead to the heart tissue. Near the front end of the guided wire is disposed a near-field electrode 126, the near-field electrode 126 being configured to sense a near-field electrocardiographic signal reflecting the depolarization and repolarization process of the heart local tissue o.
The right ventricular lead 1052 includes a coil 122 for defibrillation. The defibrillation coil 122 is placed in the right ventricle and the defibrillation coil 122 is configured to form a therapeutic discharge circuit with the pulse generator 101. The defibrillation coil 122 is positioned to ensure that the therapeutic vector formed by the defibrillation current covers a substantial portion of the myocardial tissue o.
The proximal end 120 of the right ventricular lead 1052 is connected to the connector 102 of the pulse generator 101. The connector 102 provides an electrical connection receptacle into which a wire is inserted, and the connector 102 includes a feedthrough assembly 202 (see fig. 2) inside, the feedthrough assembly 202 connecting the wire with circuitry within the pulse generator. Feedthrough assembly 202 is connected to sense electrodes (electrode 124 or electrode 126 or electrode 117) by wires, and sense electrodes are connected to sense circuitry within the pulse generator by feedthrough assembly 202. The sensing circuit is used for sensing the electrocardiosignals and further processing the electrocardiosignals to enable the electrocardiosignals to be converted into digital signals from analog signals. The feedthrough assembly 202 connects the high energy therapeutic coil 122 on a lead with the therapeutic circuitry within the pulse generator. The therapy circuit is used to deliver shock therapy when ventricular fibrillation or ventricular tachycardia occurs in the heart.
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 a wireless connection communication connection between the pulse generator 101 and an external device. The external device D includes a program control instrument used in a hospital, a hand-held device used in a patient such as a mobile phone, a patient assistant, etc.
The second implantable medical device 300 is disposed within the left ventricle. The second implantable medical device 300 is small in size, implantable within the left ventricle of the human body by minimally invasive implantation, and is a leadless pacing device. The second implantable medical device 300 is secured to the cardiac tissue o by a structural member (not shown) and the second implantable medical device 300 is capable of receiving instructions from the first implantable medical device 100 to perform pacing therapy on the cardiac tissue o. To reduce the volume of the second implantable medical device 300 and extend the lifetime of the second implantable medical device 300, the second implantable medical device 300 does not have a battery structure inside, its pacing energy is from the first implantable medical device 100 or the 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 comprises a sensing module 210 for sensing an electrocardiographic signal, a therapy module 212 for providing a therapy pulse signal, a communication module 218 for communicating with an external device D or a second implantable medical device 300. The 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 parameters of the patient and the setting of the diagnosis procedure, and judges whether the heart needs to be electrically stimulated by the treatment module 212 according to the diagnosis result.
The sensing module 210 is connected to the upper electrode of the wire, and the sensing module includes an amplifier, a filter, a digital-to-analog conversion module, and the like. The sensing module 210 is capable of processing signals on the right atrial lead 1051 and the right ventricular lead 1052 simultaneously and converting the sensed P-wave or R-wave signals into digital signals, which are used by the control module 214 to calculate PR intervals, AA intervals, RR intervals, and the AA intervals for determining pacing time points.
The therapy module 212 includes a high voltage module and a capacitor. The high voltage module is used to boost the low voltage dc power (typically within 10 v) provided by the power supply 220 to 800v through the high voltage module and charge the capacitor with current through the charging circuit. The control module 214 loops the heart tissue with the capacitor through the switching circuit when it is determined that the heart requires electrical stimulation therapy, which discharges the heart for stimulation therapy.
The communication module 218 is connected 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. The communication module is known to those skilled in the art to further 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 conversion module 224 is configured to convert electrical energy in the first implantable medical device 100 into ultrasonic waves, magnetic resonance fields, radio frequency signals, etc. and send the ultrasonic waves, magnetic resonance fields, radio frequency signals, etc. to the second implantable medical device 300, where the second implantable medical device 300 receives the energy and converts it into electrical energy, and the energy transmission module may be a radio frequency coil, an antenna, or an ultrasonic 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 through a control signal. In some aspects the radio transmit coil is shared with the antenna of the communication module, the communication module 218 communicates using RF radio frequency signals, while the energy transmit module uses the coil to transmit energy, both of which may be time division multiplexed or carrier modulated. To accommodate the first implantable medical device 100, the second implantable medical device 300 includes a radio receiving coil.
In a preferred embodiment, the energy emitting module 224 includes an ultrasonic wave transduction module for converting electrical energy into ultrasonic waves; the ultrasonic transduction module is a piezoelectric module, and when ultrasonic energy is emitted, a high-frequency electric field is introduced through the driving circuit, 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 electrical energy. The ultrasonic transducer is made of piezoelectric material, receives ultrasonic oscillation and generates electric charge, and can be matched with circuits such as filtering rectification 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 treatment module 310 for releasing a therapeutic stimulus.
The energy receiving module 333 is configured to convert the energy of the ultrasonic wave, magnetic field resonance, radio frequency signal, etc. generated by the first implantable medical device 100 into electrical energy. The energy receiving module 333 is connected to an energy storage module, preferably a capacitor, which stores the energy required for one or more pacing stimuli 334. The capacitor stores less energy than a driven battery assembly, and the energy can be consumed in one or a plurality of pacing processes, but the repeated charge and discharge times and service life of the capacitor are far longer than those of the battery assembly.
The communication module 316 is configured to communicate D with the first implantable medical device 100 or an external device. The first implantable medical device 100 transmits pacing stimulus signals, or charge control signals if necessary, to the second implantable medical device 300 via the 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 configured to execute control instructions of the first implantable medical device 100. For example, the first implantable medical device 100 may determine that the heart requires pacing after diagnosis and may send pacing instructions to the second implantable medical device 300 via the communication module 314, with execution of the pacing instructions by the control module 314 controlling the therapy module to electrically stimulate the heart.
The treatment module 310 includes a switch circuit, and the treatment module may be directly connected to the energy storage module 334, where the treatment module 334 includes a switch circuit, and when the electrical stimulation is performed, the control module controls the switch circuit to be opened so that the heart and the energy storage module form a loop.
The second implantable medical device 300 in fig. 1 may include a plurality of implant locations, each of the second implantable medical devices 300 serving as a pacing site 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 site with the best pacing effect may be selected programmatically.
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, suppression of pacing stimulation after sensing a signal). Wherein 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 represents the first implantable medical device 100 to charge the second implantable medical device 300 and a low level represents to stop the charging. The first implantable medical device 100 always charges the second implantable medical device 300 during the AV interval or VA interval, and the energy transmitting module 224 and the receiving module 333 are preferably ultrasound transmitting and receiving modules in order to reduce the influence of VA or AV interval charging signals on the ventricular or atrial sense.
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, suppression of pacing stimulation after sensing a signal), where t represents a time axis.
The upper time block of the electrocardiogram in fig. 4 represents the atrial refractory period 402 and the bottom time block represents the ventricular refractory period 404. The refractory period is a refractory period of the first implantable medical device 100 during which the first implantable medical device 100 does not process the perceived signal. The purpose of the refractory period is to prevent the pacing signals in the atria or ventricles from interfering with each other, and to prevent the post-pacing atria or ventricles from sensing overdensing caused by post-pacing cardiac depolarization signals. While the refractory period of the first implantable medical device 100 also corresponds to the physiological refractory period of the heart tissue.
In fig. 4, first implantable medical device 100 enters atrial refractory period 408 and atrial postventricular refractory period 412 after right atrial lead 1051 initiates pacing stimulus 406. An atrial blanking period 410 is a short period of time before the atrial refractory period. During this blanking period 410, the right atrial lead 1051 does not sense any signal. The atrial blanking period 410 is followed by an atrial refractory period sensing period 408 in which the atrial lead 1051 senses but does not respond to the sensed signal. At the same time, the ventricular sense also enters blanking period 412 after atrial pacing stimulus 406, and right ventricular lead 1052 does not sense any signal during ventricular sense blanking period 412 to prevent the electrical signal generated by atrial pacing stimulus 406 from being sensed by right ventricular lead 1052.
Ventricular pacing stimulus 414 is delivered in fig. 4 followed by ventricular refractory period PRP and post-ventricular atrial refractory period ARP. The ventricular pacing stimulus 414 is a fused waveform of right ventricular stimulus and left ventricular stimulus that is emitted by the second implantable medical device 300 implanted in the left ventricle. The pre-ventricular refractory period following ventricular stimulation is ventricular blanking 416, and no signal is perceived at ventricular blanking right 1052. Outside of ventricular blanking 416, the ventricle perceives the signal but does not react to the signal. The atria enter a refractory period following ventricular pacing stimulus 414, also called post ventricular atrial refractory period (PARP), at the front of which is an atrial blanking period 418, during which time right atrial lead 1051 likewise does not sense a signal.
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 the first implantable medical device 100 is charging the second implantable medical device 300 and a low level indicates that the first implantable medical device 100 is not charging the 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 the refractory period. The second implantable medical device 300 receives the energy transmitted by the first implantable medical device 100 and converts it to electrical energy for storage in the energy storage device 334.
With continued reference to fig. 4, the first implantable medical device 100 selects to charge the second implantable medical device 300 during a blanking period. The first implantable medical device 100 charges the second implantable medical device 300 after the atrial pacing stimulus and during the ventricular blanking period 412 and the atrial blanking period 410, after which the charging is stopped. 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 after the ventricular pacing stimulus 414. Charging during a blanking period can provide less perceived interference with the first implantable medical device 100 than charging the second implantable medical device 300 during the entire refractory period of the second implantable medical device 300.
Referring to the control flow diagram of the first implantable medical device 100 charging the second implantable medical device 300 during pacing as shown in fig. 5. In flow 500, an initialization of the device is included, which includes setting basic parameters including perceived sensitivity, default pacing intervals, post-pacing refractory period length, and the like. The first implantable medical device 100 may also automatically learn the patient heart rate signal according to the patient's condition, gradually correcting various parameters.
In flow 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 a digital shift register for the control module to analyze data according to historical electrocardiosignal data.
At 530 the control module 214 is configured to analyze whether defibrillation therapy is to be performed based on the electrocardiographic signals; 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 flow 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 determine whether the heart is at tachycardia or ventricular fibrillation in batch based on RR intervals, RR interval variability of the historical electrocardiographic data, in combination with the arrhythmia, stability, and QRS waveform templates. When it is determined in the process 532 that tachycardia or ventricular fibrillation occurs, the first implantable medical device 100 performs high-energy treatment on the heart with the high-energy treatment as a first priority, where the high-energy treatment is classified as anti-tachycardia treatment or defibrillation treatment, and the control module analyzes the electrocardiograph signal and determines to perform anti-tachycardia treatment or defibrillation treatment according to the morbidity of the heart. In block 536, the high energy therapy includes charging a capacitor in the therapy circuit, discharging the heart when the charging voltage reaches a predetermined voltage, and controlling parameters such as a 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 the process 504, the control module calculates data, where the calculation includes that multiple cardiac parameters flow into the control module 214, and the heart rate can be calculated through the AA interval, and whether atrial pacing is needed is determined according to whether autonomous pacing occurs in the AA interval, and meanwhile, the control module 214 can also determine whether atrial flutter or atrial fibrillation occurs according to parameters such as waveform morphology and heart rate variability of atrial signals. Atrial autopacing does not occur during the AA interval.
If the flow 506 determines that atrial pacing is required, the first implantable medical device 100 releases atrial pacing stimulation via the atrial lead 1051 in flow 508 and the first implantable medical device 100 enters an atrial refractory period in flow 510, the atrial refractory period comprising a time-range overlapping ventricular blanking period 412, an atrial blanking period 410, and a refractory period 408, at which point the processor does not process any atrial electrical signals. The first implantable medical device 100 charges the second implantable medical device 300 in process 512, the first implantable medical device 100 may charge the second implantable medical device 300 during the atrial refractory period (see control signal C1) and may charge the second implantable medical device 300 during the atrial blanking period or the post-atrial ventricular blanking period (see control signal C2).
After determining whether atrial pacing is required, a similar control module 214 determines that ventricular pacing is required in flow 514, and after the end of pacing flow 516, the second implantable medical device is charged in flow 518 during a ventricular refractory period, and the second implantable medical device 300 is preferably charged in either a ventricular blanking period 418 or a post-ventricular atrial blanking period 416.
The first implantable medical device 100 charges the second implantable medical device 300 always while the first implantable medical device 100 is in a refractory period, and interference signals generated in the right atrial lead 1051 and the right ventricular lead 1052 when the second implantable medical device 300 is charged using RF or magnetic fields may be shielded or ignored. During the atrial or ventricular blanking period, the atrium or ventricle does not perceive any signal, and the interfering signal is masked. And the control module does not process the perceived signal in the refractory period outside the blank period. Therefore, the influence of the charging energy field signal on the self-sensing signal can be avoided when the charging is carried out in the refractory period.
As shown in the right side electrocardiographic waveform of fig. 4, in some cases the first implantable medical device 100 only paces the heart chamber in flow 512 or 520. For example, when atrial fibrillation occurs, the atrial beat frequency is too fast and the second implantable medical device 300 automatically cancels the atrioventricular tracking function to switch the operating mode DDI to VDI, thereby reducing the effects of atrial fibrillation\atrial flutter, etc. on the ventricles. I.e. the ventricular pacing is no longer synchronized with the atrial signal, only during the ventricular or atrial refractory period following ventricular pacing when the first implantable medical device 100 charges the second implantable medical device 300. In the charge control signal C1, the charging timing is preferably performed in the atrial blanking period 420 or the ventricular blanking period 422.
Further, in either of the flows 512 or 520, the amount of charge may be sufficient for one pacing use or multiple pacing uses, differing depending on the power and length of time that the second implantable medical device 300 is charged each time. The first implantable medical device 100 may communicate with the second implantable medical device 300 first, query the second implantable medical device 300 for power and then determine whether to charge the second implantable medical device 300. The second implantable medical device 300 is not charged if the power of the second implantable medical device 300 reaches a set threshold.
Referring to fig. 6, a third medical device 602 is illustrated. Another way of charging is shown in which the second implantable medical device 300 is charged by a dedicated third medical device 602. The third medical device functional structure is similar to the first implantable medical device 100 and includes a control module 604 for controlling the third medical device logic function, and a memory module 606 for storing control programs and patient parameters, 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 emitting module for charging the second implantable medical device 300. The third medical device 602 may be disposed outside the human body and provide pacing energy for charging the second implantable medical device 300.
Referring to fig. 7, a flow chart of a third medical device charging a second implantable medical device 300 is shown. Where the first implantable medical device 100 detects the cardiac signal in flow 702 and determines whether atrial pacing is required, the first implantable medical device 100 paces the right atrium via the right atrial lead 1051, and then the first implantable medical device 100 sends a third enter atrial refractory period message 704 that should include an atrial refractory period time stamp, based on which the third medical device sends charging energy to the second implantable medical device 300 at a time that is up to the time stamp plus the atrial refractory period or the atrial blanking period.
In a subsequent diagnostic procedure 708, the first implantable medical device 100 determines whether ventricular pacing is required, and likewise if the first implantable medical device 100 paces a 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, the ventricular pacing message 712 including a timestamp of ventricular pacing. The second implantable medical device 300 paces the left ventricular discharge after receiving a pacing message, and then the third medical device 500 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 first implantable medical device 100 may optionally send an atrial or ventricular pacing message to the second implantable medical device 300, which may be forwarded by the second implantable medical device 300 to the third medical device 500 or 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.
When the third medical device is charged, the charging pulse signal is synchronized with the atrial refractory period and the ventricular refractory period of the pacemaker. The third medical equipment is outside the human body, the battery can be conveniently replaced, and the third medical equipment is replaced and maintained without any operation, so that the external third medical equipment is used for providing pacemaker energy so that the service life of the pacemaker is not limited by the service life of the battery.

Claims (9)

1. An implantable medical device system, comprising: a first implantable medical device, and a plurality of second implantable medical devices, the first implantable medical device not being wired to the second implantable medical device;
The first implantable medical device includes a pulse generator, a first energy transmission module, 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 said second implantable medical devices implanted within the left ventricle, each of said second implantable medical devices acting as a pacing site in a 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 an electrocardiosignal through the sensing module and decide whether to perform resynchronization pacing therapy according to the electrocardiosignal analysis; when pacing is needed, transmitting pacing energy to an energy receiving module of the second implantable medical device through the first energy transmitting module, and transmitting a pacing signal to the second implantable medical device through a communication module;
the control module of the second implantable medical device receives the pacing signal via the communication module and performs synchronous pacing therapy.
2. An implantable medical system according to claim 1, wherein said first implantable medical device is used to charge said second implantable medical device during a ventricular refractory period or an atrial refractory period of said atrial pacing or ventricular pacing.
3. An implantable medical system according to claim 2, wherein said first implantable medical device is used to charge said second implantable medical device during a blanking period of said atrial pacing or ventricular pacing.
4. The implantable medical device system according to claim 1, further comprising a third medical device comprising a second energy emitting module, the third medical device being disposed outside the human body and providing pacing energy to the second implantable medical device via the second energy emitting module.
5. The implantable medical device system according to claim 4, wherein the second energy transmission module comprises a radio transmission coil and a transmission drive circuit, and wherein the second implantable medical device comprises a radio reception coil.
6. The implantable medical device system according to claim 4, wherein the second energy transmission 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 electrical energy.
7. The implantable medical device system of claim 1, wherein the control module is configured to analyze whether defibrillation therapy is being performed based on the electrocardiographic signals; determining defibrillation therapy the therapy module delivers a defibrillation shock via the right ventricular lead.
8. The implantable medical device system of claim 7, wherein the control module is configured to analyze whether to perform anti-tachycardia pacing therapy based on the electrocardiograph signals; the therapy module releases anti-tachycardia pacing via the right ventricular lead when determining anti-tachycardia pacing therapy.
9. The implantable medical device system according to claim 1, wherein the second implantable medical device is an implantable leadless pacing device that does not include a battery assembly.
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