CN118319468A - Catheter-mediated cardiovascular irreversible electroporation ablation system - Google Patents
Catheter-mediated cardiovascular irreversible electroporation ablation system Download PDFInfo
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Abstract
The embodiment of the invention discloses a catheter-mediated cardiovascular irreversible electroporation ablation system, which comprises a sampling assembly, a discharging assembly, a host fitting and an ablation host; the sampling assembly includes a sampling electrode; the discharge assembly comprises a discharge electrode and a discharge channel, and the discharge electrode is connected with the discharge channel; the host accessory comprises a host display device, a pedal device, a host input port, a host output port and a control panel; the ablation host is used for generating and adjusting electric energy, controlling an ablation signal, connecting the sampling electrode through the host input port, and connecting the discharge electrode through the discharge channel through the host output port. The invention can improve the operation accuracy and safety, increase the adaptability and is more reliable, flexible and effective in use.
Description
Technical Field
The invention relates to the technical field of electroporation ablation equipment, in particular to a cardiovascular irreversible electroporation ablation system for catheter intervention.
Background
Tumors are a common disease and frequently encountered disease, wherein malignant tumors are the most serious disease which endangers human health at present. Since the pathogenesis and etiology of malignant tumors is not fully understood, there is a lack of fundamental precautions. To date, humans have not been able to cure malignant tumors as much as other common frequently encountered diseases. Because of the intractability of malignant tumors, various nationalities have treated malignant tumors for centuries by combining surgery and radiotherapy and chemotherapy to obtain a longer survival period. But radiotherapy and chemotherapy have great influence on human immunity and seriously affect the quality of life.
Conventional methods of cardiovascular intervention typically use radiofrequency ablation or cryoablation techniques to treat cardiovascular diseases such as cardiac arrhythmias. Rf ablation techniques use high frequency current conducted through a conductive catheter to heart tissue, generating thermal energy to destroy abnormal tissue, however, rf ablation has a long operating time and a large exothermic range, which can easily lead to tissue cauterization, possibly causing complications such as thrombosis and esophageal pulsation. The cryoablation technique freezes heart tissue by cooling the catheter surface, thereby destroying abnormal tissue. However, cryoablation has a long freezing time, is complicated to operate, and is prone to excessive freezing and tissue structural damage.
Irreversible electroporation (IrreversibleElectroporation, IRE) is an emerging non-thermal ablation technique for treating tumors. The method uses microsecond-level high-voltage discharge pulse to form nanoscale pores on the cell membrane of the acted cell, so as to change the permeability of the cell membrane, destroy the internal balance of the cell and further cause apoptosis, and the process is called irreversible electroporation. A typical treatment for irreversible electroporation is a square wave pulse with a voltage of 1500v/cm and a pulse width of 50-100. Mu.s, the number of pulses being 70-100, which is unidirectionally transmitted between two electrode needles. The number of electrodes, the electrode spacing and the electrode exposure length can be adjusted according to the size and shape of the tumor during the treatment process. When IRE is used, most importantly, the electric field can damage cell membranes and simultaneously can not cause thermal effect, so that the tissue is damaged, and the IRE has wide application prospect in clinic, especially for lesions close to important blood vessels and nerves, minimally invasive ablation can be performed, and the safety of treatment is improved.
Irreversible electroporation is a precise technique, which requires stability and flexibility in operation, and affects the accuracy and effectiveness of treatment if the position and orientation of the device cannot be precisely controlled during operation.
Disclosure of Invention
Accordingly, it is an object of embodiments of the present invention to provide a catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system that can improve operational accuracy and safety, increase flexibility, and be more reliable, flexible, and efficient in use.
Embodiments of the present invention are implemented as follows:
A catheter-mediated, intra-cardiovascular irreversible electroporation ablation system includes a sampling assembly, a discharge assembly, a host fitting, and an ablation host.
The sampling assembly includes a sampling electrode.
The discharge assembly comprises a discharge electrode and a discharge channel, and the discharge electrode is connected with the discharge channel.
The host accessory comprises a host display device, a pedal device, a host input port, a host output port and a control panel.
The ablation host is used for generating and adjusting electric energy, controlling an ablation signal, connecting the sampling electrode through the host input port, and connecting the discharge electrode through the discharge channel through the host output port.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the ablation host comprises:
and the electric energy control module is used for generating and adjusting electric energy.
The main control module is used for receiving and processing the data and sending a signal for controlling ablation.
And the potential monitoring module is used for collecting and measuring potential parameters.
And the electrocardio control module is used for collecting and controlling electrocardiosignals.
The technical effects are as follows: the method can realize accurate control of the ablation process, intelligent data processing and control and real-time monitoring of physiological parameters of patients.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the power control module comprises:
and the direct-current high-voltage power supply is used for outputting electric energy.
And the energy storage element comprises at least one group of capacitor arrays and is used for receiving and storing the electric energy of the direct-current high-voltage power supply.
The switching element comprises at least one of a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a pulse bridge type generating circuit to control the charge and discharge of the energy storage element.
The channel selection switch element comprises at least one of a relay, a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a channel selection switch array to select and control connection or disconnection of a discharge channel.
And when the discharge is finished, the pulse bridge type generating circuit conducts the energy storage element and the energy consumption element, converts electric energy into heat energy and returns the electric potential to zero.
The technical effects are as follows: the direct-current high-voltage power supply can stably output electric energy, the energy storage element can receive and store the electric energy, high-efficiency energy storage and release can be realized, and stable and reliable energy supply required in the ablation process is ensured. The pulse bridge type generating circuit formed by the switching elements can accurately control the charging and discharging processes of the energy storage element, and the accurate adjustment and control of electric energy are realized. The channel selection switch array formed by the channel selection switch elements can select and control connection or disconnection of the discharge channels, so that flexible control of the discharge channels is realized. When the discharge is finished, the pulse bridge type generating circuit conducts the energy storage element and the energy consumption element to convert the electric energy into heat energy, so that the potential is zeroed, the residual electric energy after the discharge is effectively processed, and the safety and the stability of the system are ensured.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the main control module includes:
And the central control unit is used for controlling and scheduling the switching element and the channel selection switching element, setting and adjusting output pulse parameters and generating a pulse instruction.
The upper computer control unit receives the pulse instruction and the cardiovascular discharge feedback information, processes the pulse instruction and then issues the pulse instruction, processes the discharge feedback information and then transmits the processed discharge feedback information to the central control unit.
The technical effects are as follows: through the synergistic effect of the central control unit and the upper computer control unit, the technical effects of centralized control, data processing and transmission, intelligent treatment and the like of the catheter-mediated cardiovascular irreversible electroporation ablation system are realized, so that the accuracy, safety and effectiveness of treatment are improved.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the potential monitoring module comprises:
And the voltage sampling element is connected with the upper computer control unit and monitors the voltages of the energy storage element, the switching element and the channel selection switching element.
And the current sampling element is connected with the upper computer control unit and monitors the currents of the sampling electrode and the discharge electrode.
The technical effects are as follows: through the monitoring and feedback of the voltage sampling element and the current sampling element, the real-time monitoring and data processing of potential parameters in the cardiovascular irreversible electroporation ablation system of catheter intervention are realized, so that the accuracy, safety and effectiveness of treatment are improved.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the electrocardio control module comprises:
And the electrocardio feedback unit is connected with the sampling electrode and samples electrocardio stimulation signals.
And the electrocardio synchronization unit is connected with the electrocardio feedback unit, receives the electrocardio stimulation signals, recognizes R waves, judges the vulnerable period of the heart, and controls the discharge operation of the discharge electrode to be synchronous with the specific period of the heart by uploading the signals to the central control unit through the upper computer control unit.
The technical effects are as follows: through the cooperative work with the main control module, the electrocardio-synchronous unit sends corresponding signals to control the work of the discharge electrode according to the change of electrocardiosignals and the setting of discharge parameters. The discharge operation is ensured to be synchronous with the specific period of the heart, the damage risk to the heart is reduced, the safety and the effectiveness of the ablation treatment are improved, and the health of the heart of a patient is protected.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the pedal device is connected to the upper computer control unit, and is used for starting a discharge pulse sequence.
The technical effects are as follows: the device is connected to the upper computer control unit through the pedal device and used for starting a discharge pulse sequence, is convenient to operate, and can avoid hand interference and enhance safety.
In a preferred embodiment of the present invention, the catheter-mediated cardiovascular irreversible electroporation ablation system further comprises a catheter assembly for supporting the sampling assembly and the discharge assembly.
The catheter assembly comprises a middle fixed catheter, a supporting flexible branch and a movable catheter, wherein the fixed end of the supporting flexible branch is arranged on the middle fixed catheter, the movable end of the supporting flexible branch is connected with the movable catheter, and the supporting flexible branch is spiral.
The support flexible branches are distributed along the circumference of the middle fixed catheter.
Each supporting flexible branch is respectively connected with one sampling electrode or one discharging electrode.
The technical effects are as follows: the design of the support flexible branches can stably support the sampling electrode and the discharge electrode, and ensure the accurate positioning and stability of the electrode in the cardiovascular; the spiral design ensures that the cardiovascular structure has certain flexibility and adaptability and can be better adapted to cardiovascular structures with different forms; the sampling electrodes and the discharge electrodes are uniformly distributed along the circumference of the middle fixed catheter, so that the uniform coverage of the sampling electrodes and the discharge electrodes in the cardiac blood vessel can be ensured; each supporting flexible branch is respectively connected with one sampling electrode or one discharging electrode, so that the sampling electrodes or the discharging electrodes can be independently operated, and the flexibility and the controllability of treatment are improved.
In a preferred embodiment of the present invention, in the above-described catheter-mediated cardiovascular irreversible electroporation ablation system, the sampling electrode and the discharge electrode comprise biocompatible metals.
The biocompatible metal comprises at least one of titanium, palladium, silver, platinum, and a platinum alloy.
The technical effects are as follows: the sampling electrode and the discharge electrode are made of biocompatible metal, so that the biocompatibility and durability of the catheter-mediated cardiovascular irreversible electroporation ablation system are improved, and the stability of the system and the reliability of the treatment effect are ensured.
In a preferred embodiment of the present invention, in the catheter-mediated cardiovascular irreversible electroporation ablation system, the support flexible fingers comprise a flexible polymeric material, a rigid polymeric material, and a shape memory material.
The flexible polymer material comprises at least one of polytetrafluoroethylene, polyamide, nylon and polyether block amide.
The hard polymeric material comprises at least one of polyimide or PEEK.
The shape memory material comprises at least one of nickel-titanium alloy, polymer base material and liquid crystal elastomer.
The technical effects are as follows: the flexible support branches are made of flexible polymers, hard polymer materials and shape-recording materials, so that the adaptability, stability and safety of the catheter-mediated cardiovascular irreversible electroporation ablation system are improved, and meanwhile, the operability and durability are also improved.
The embodiment of the invention has the beneficial effects that:
According to the invention, through the electric energy control module and the main control module in the ablation host, the system can generate, regulate and send accurate electric energy and control signals, so that accurate control of an ablation process is realized. The main control module can receive, process and send data, and realize intelligent control and data processing of the ablation process, so that the intelligent degree and the treatment effect of the system are improved. The potential monitoring module and the electrocardio control module can monitor potential parameters and electrocardio signals of a patient in real time, and real-time monitoring and adjustment of a treatment process are realized through feedback information, so that the safety and the treatment effect of the patient are ensured. The direct-current high-voltage power supply and the energy storage element in the electric energy control module can stably store and release electric energy, and the pulse bridge type generating circuit and the channel selection switching element can realize efficient storage, release and control of the electric energy, so that stable and reliable energy supply required in the ablation process is ensured.
The invention ensures the safety and stability of the system and reduces the stimulation and damage to patients by the synergistic effect of each module and element in the cardiovascular irreversible electroporation ablation system which is inserted by the catheter and the electrode and support flexible branch which are made of biocompatible metal.
The supporting flexible branch in the catheter component adopts the combined design of the flexible polymer, the hard polymer material and the shape-recording material, so that the adaptability, the stability and the durability of the system are improved, and the effectiveness and the persistence of treatment are ensured.
The invention can place discharge electrodes on both sides of pulmonary vein crowns and hypertrophic cardiac muscles or renal artery positions through an intervention method, and can generate irreversible electroporation on both sides of cardiac myocytes, hypertrophic cardiac muscles or renal sympathetic nerves by releasing high-voltage high-frequency alternating asymmetric pulse waves, thereby being capable of treating atrial fibrillation, hypertrophic cardiomyopathy or intractable hypertension.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram of the structure of an intra-cardiovascular irreversible electroporation ablation system using catheter intervention in accordance with the present invention;
FIG. 2 is a schematic view of a catheter assembly of the cardiovascular irreversible electroporation ablation system of the present invention in a catheter intervention;
FIG. 3 is a schematic view showing the initial configuration of a catheter assembly of the cardiovascular irreversible electroporation ablation system according to the present invention;
FIG. 4 is a schematic illustration of the catheter assembly of the catheter-mediated, intra-cardiovascular irreversible electroporation ablation system of the present invention with the fingers deployed;
Fig. 5 is a schematic structural view of an embodiment of a catheter assembly of a catheter-mediated, intra-cardiovascular irreversible electroporation ablation system of the present invention.
In the figure: 1-an intermediate fixed catheter; 2-supporting a flexible shoot; 3-active catheter.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations.
Referring to fig. 1, an embodiment of the present invention provides a catheter-mediated cardiovascular irreversible electroporation ablation system, which includes a sampling assembly, a discharge assembly, a host fitting, and an ablation host; the sampling assembly includes a sampling electrode; the discharge assembly comprises a discharge electrode and a discharge channel, and the discharge electrode is connected with the discharge channel; the host accessory comprises a host display device, a pedal device, a host input port, a host output port and a control panel; the ablation host is used for generating and adjusting electric energy, controlling an ablation signal, connecting the sampling electrode through the host input port, and connecting the discharge electrode through the discharge channel through the host output port.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the ablation host comprises: the electric energy control module is used for generating and adjusting electric energy; the main control module is used for receiving and processing data and sending a signal for controlling ablation; the potential monitoring module is used for collecting and measuring potential parameters; and the electrocardio control module is used for collecting and controlling electrocardiosignals. The technical effects are as follows: the method can realize accurate control of the ablation process, intelligent data processing and control and real-time monitoring of physiological parameters of patients.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the power control module comprises: the direct-current high-voltage power supply is used for outputting electric energy; the energy storage element comprises at least one group of capacitor arrays and is used for receiving and storing the electric energy of the direct-current high-voltage power supply; the switching element comprises at least one of a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a pulse bridge type generating circuit to control the charge and discharge of the energy storage element; the channel selection switch element comprises at least one of a relay, a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a channel selection switch array to select and control connection or disconnection of a discharge channel; and when the discharge is finished, the pulse bridge type generating circuit conducts the energy storage element and the energy consumption element, converts electric energy into heat energy and returns the electric potential to zero.
Specifically, the transistor (IGBT) is a power switching element, which has high voltage and high current carrying capability, and can be rapidly switched between a switching state and a closing state, so as to control a charging and discharging process of the energy storage element; a power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) is a commonly used power switching element, has low resistance and quick response characteristics, and can realize efficient power control and quick charge and discharge; bipolar junction transistors, also known as bipolar transistors (BJTs), are a type of bipolar device that can be used for power amplification and switching control, and in electrical energy control modules for controlling the charging and discharging processes of energy storage elements; the bipolar field effect transistor (Bi-FET) combines the characteristics of a bipolar junction transistor and a field effect transistor, has the characteristics of high input impedance and low output impedance, and is suitable for high-speed switching and power control applications. The transistor, the power metal oxide semiconductor field effect transistor, the bipolar junction transistor and the bipolar field effect transistor are combined to form a pulse bridge type generating circuit, and the pulse bridge type generating circuit is chopped with direct current output by a capacitor to form asymmetric high-frequency alternating steep pulse with adjustable pulse width, adjustable duty ratio and adjustable positive and negative polarities. By means of different combinations of the switching elements, flexible electric energy control, such as control of pulse width, duty cycle and polarity, is achieved, and different requirements of an ablation host in an ablation process are met.
Relays are used to control and switch high current or high voltage signals in an electrical circuit by electromagnetically controlling the closing or opening of one or more switch contacts. By reasonably selecting and combining the channel selection switch elements, a selection switch array with 2 to 30 channels is constructed, so that the switch control of specific discharge channels and the discharge sequence of discharge electrodes are realized.
The dissipative element employs a resistive element to dissipate and zero the potential by converting electrical energy to thermal energy. It is ensured that the potential in the energy storage element is completely released, avoiding potential electrical energy residues or accumulations, thereby ensuring safety of the device and operation.
The technical effects are as follows: the direct-current high-voltage power supply can stably output electric energy, the energy storage element can receive and store the electric energy, high-efficiency energy storage and release can be realized, and stable and reliable energy supply required in the ablation process is ensured. The pulse bridge type generating circuit formed by the switching elements can accurately control the charging and discharging processes of the energy storage element, and the accurate adjustment and control of electric energy are realized. The channel selection switch array formed by the channel selection switch elements can select and control connection or disconnection of the discharge channels, so that flexible control of the discharge channels is realized. When the discharge is finished, the pulse bridge type generating circuit conducts the energy storage element and the energy consumption element to convert the electric energy into heat energy, so that the potential is zeroed, the residual electric energy after the discharge is effectively processed, and the safety and the stability of the system are ensured.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the main control module includes: the central control unit is used for controlling and scheduling the switching element and the channel selection switching element, setting and adjusting output pulse parameters and generating a pulse instruction; the upper computer control unit receives the pulse instruction and the cardiovascular discharge feedback information, processes the pulse instruction and then issues the pulse instruction, processes the discharge feedback information and then transmits the processed discharge feedback information to the central control unit.
Specifically, the central control unit may select CPLD, ARM or DSP; the upper computer control unit can select an industrial personal computer or a PC and is connected with the central control unit through serial communication, parallel communication or USB.
The technical effects are as follows: through the synergistic effect of the central control unit and the upper computer control unit, the technical effects of centralized control, data processing and transmission, intelligent treatment and the like of the catheter-mediated cardiovascular irreversible electroporation ablation system are realized, so that the accuracy, safety and effectiveness of treatment are improved.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the potential monitoring module comprises: the voltage sampling element is connected with the upper computer control unit and used for monitoring the voltages of the energy storage element, the switching element and the channel selection switching element; and the current sampling element is connected with the upper computer control unit and monitors the currents of the sampling electrode and the discharge electrode. The technical effects are as follows: through the monitoring and feedback of the voltage sampling element and the current sampling element, the real-time monitoring and data processing of potential parameters in the cardiovascular irreversible electroporation ablation system of catheter intervention are realized, so that the accuracy, safety and effectiveness of treatment are improved.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the electrocardio control module comprises: the electrocardio feedback unit is connected with the sampling electrode and samples electrocardio stimulation signals; and the electrocardio synchronization unit is connected with the electrocardio feedback unit, receives the electrocardio stimulation signals, recognizes R waves, judges the vulnerable period of the heart, and controls the discharge operation of the discharge electrode to be synchronous with the specific period of the heart by uploading the signals to the central control unit through the upper computer control unit.
Specifically, the electrocardio feedback unit is connected with the sampling electrode, acquires electrocardio stimulation signals of the heart of the patient in real time, and reflects the electric activity of the heart, including the excitation of a cardiac pacemaker and the contraction process of heart muscle. The electrocardio-synchronous unit processes and analyzes the electrocardio-stimulation signals to identify R waves in electrocardiosignals, wherein the R waves are characteristic waveforms in the electrocardiosignals and generally represent the beginning of heart contraction. By analyzing the time interval of R wave and the characteristics of electrocardiosignals, the vulnerable period of the heart is judged, wherein the vulnerable period is the period when the heart has higher sensitivity to electric stimulation in a specific period, and if discharge is carried out in the period, adverse reactions such as arrhythmia and the like can be caused. According to the judging result of the vulnerable period of the heart, the electrocardio-synchronous unit controls the discharging operation in the ablation host machine, ensures that the discharging operation is carried out in the refractory period of the heart, and avoids the vulnerable period.
The technical effects are as follows: through the cooperative work with the main control module, the electrocardio-synchronous unit sends corresponding signals to control the work of the discharge electrode according to the change of electrocardiosignals and the setting of discharge parameters. The discharge operation is ensured to be synchronous with the specific period of the heart, the damage risk to the heart is reduced, the safety and the effectiveness of the ablation treatment are improved, and the health of the heart of a patient is protected.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the pedal device is connected to the upper computer control unit, and is used for starting a discharge pulse sequence. The technical effects are as follows: the device is connected to the upper computer control unit through the pedal device and used for starting a discharge pulse sequence, is convenient to operate, and can avoid hand interference and enhance safety.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the apparatus further comprises a catheter assembly for supporting the sampling assembly and the discharge assembly; as shown in fig. 2, the catheter assembly comprises an intermediate fixed catheter 1, a supporting flexible branch 2 and a movable catheter 3, wherein the fixed end of the supporting flexible branch 2 is arranged on the intermediate fixed catheter 1, the movable end is connected with the movable catheter 3, and the supporting flexible branch 2 is in a spiral shape; the support flexible branches 2 are distributed along the circumference of the middle fixed catheter 1; each of the supporting flexible fingers 2 is connected to one of the sampling electrodes or the discharge electrodes, respectively.
Specifically, the arrangement of each spiral side branch of the supporting flexible branch 2 is defined by the number of side branches, and can be divided into a double-spiral, triple-spiral, four-spiral, five-spiral or six-spiral structure. The four-spiral structure can be set to have electrodes on four spiral side branches or two electrodes on opposite sides, and the other two spiral side branches are empty opposite to the electrodes for protecting the middle fixed catheter 1 after isolation and shrinkage. The double helix structure is shown in figure 5.
As shown in fig. 3, in the initial state, the movable catheter 3 is located at the lower end of the middle fixed catheter 1, and the supporting flexible branch 2 is attached to the fixed catheter at this time, so that the axial dimension is minimum, and the movable catheter 3 can move smoothly in the blood vessel; as shown in fig. 4, when moving to the upper end, the branches are spread, the axial distal end diameter reaches the maximum, so that the electrode is maximally circumferentially attached to the focal point, and the optimal ablation effect is realized.
The technical effects are as follows: the design of the support flexible branches can stably support the sampling electrode and the discharge electrode, and ensure the accurate positioning and stability of the electrode in the cardiovascular; the spiral design ensures that the cardiovascular structure has certain flexibility and adaptability and can be better adapted to cardiovascular structures with different forms; the sampling electrodes and the discharge electrodes are uniformly distributed along the circumference of the middle fixed catheter, so that the uniform coverage of the sampling electrodes and the discharge electrodes in the cardiac blood vessel can be ensured; each supporting flexible branch is respectively connected with one sampling electrode or one discharging electrode, so that the sampling electrodes or the discharging electrodes can be independently operated, and the flexibility and the controllability of treatment are improved.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the sampling electrode and the discharge electrode comprise biocompatible metals; the biocompatible metal comprises at least one of titanium, palladium, silver, platinum, and a platinum alloy.
In particular, the sampling electrode and the discharge electrode are constructed in the form of metal strips or rings, or in the form of flexible materials. The sampling electrode and the discharge electrode are in the form of a metal coil spring or spiral wrap around the fingers, wherein the flexibility of the fingers provides flexibility to the overall electrode. The electrodes are connected to insulated electrical leads leading to the proximal side of the catheter, wherein the insulator on each of the leads is capable of maintaining a potential difference of at least 700V across its thickness without dielectric breakdown.
The technical effects are as follows: the sampling electrode and the discharge electrode are made of biocompatible metal, so that the biocompatibility and durability of the catheter-mediated cardiovascular irreversible electroporation ablation system are improved, and the stability of the system and the reliability of the treatment effect are ensured.
In a preferred embodiment of the present invention, in the above-mentioned catheter-mediated cardiovascular irreversible electroporation ablation system, the support flexible fingers 2 comprise a flexible polymer material, a rigid polymer material and a shape-recording material; the flexible polymer material comprises at least one of polytetrafluoroethylene, polyamide, nylon and polyether block amide; the hard polymeric material comprises at least one of polyimide or PEEK; the shape memory material comprises at least one of nickel-titanium alloy, polymer base material and liquid crystal elastomer.
In particular, the support flexible fingers 2 are made of a relatively rigid material, so as to be expandable to a set of known reproducible shapes capable of maintaining a known spatial geometry in use, with the addition of assistance in combination with shape-memory materials or soft materials, to perform the function of supporting the flexible fingers 2.
The discharge pulse is an electrical energy discharge signal sent by the ablation host to the discharge assembly, having a set of pulse widths. The discharge pulse setting of the ablation host machine comprises the following three types:
the duration time comprises a group of pulse width, wherein the pulse width of the positive pulse is 0.5us-30us, the idle time is 0.1-30us, the negative pulse is 0.1-25us, and the idle time is 0.1-30us, and the negative pulse width is smaller than the positive pulse width or the positive pulse width is smaller than the negative pulse width. In each discharge cycle, the pulse energy is set to a pulse width ratio that is discharged in a lower cycle, and each cycle may contain a portion of the electrode path. After 90 to 200 discharge cycles are completed, the energy storage element is charged, and after the charging is completed, 90 to 200 discharge cycles are repeated until the discharging is completed between the two arranged discharge electrodes.
The duration time comprises a group of pulse width, the same interval between the positive pulse width and the negative pulse width is 0.5us-30us, and the idle time between the positive pulse and the negative pulse is 0.1-30 us. Each intra-group cycle is completed in one cardiac cycle. After completing 10 to 200 discharge cycles, the energy storage element is charged, and after completing the charging, 10 to 200 discharge cycles are repeated until the discharge is completed between the two discharge electrodes.
The duration comprises a set of pulse widths to synchronize the release of the pulse sequence over a cardiac cycle, the pulse width being 0.5us-150us, idle 0.1-30us, and the second pulse width being 0.5-150us, idle 0.1-30us. The discharge is cycled in 5 to 50 cardiac cycles until the discharge is completed between the two discharge electrodes provided.
The technical effects are as follows: the flexible support branches are made of flexible polymers, hard polymer materials and shape-recording materials, so that the adaptability, stability and safety of the catheter-mediated cardiovascular irreversible electroporation ablation system are improved, and meanwhile, the operability and durability are also improved.
In another embodiment of the present invention, the catheter assembly in the above-described catheter-mediated cardiovascular irreversible electroporation ablation system is umbrella-shaped, including a connection tip, a support membrane, a flexible branch, an inner support tube, a flexible branch traction tube, and a bundle tube. The support film is respectively connected with the connecting end and the flexible branch, the inner support tube is firmly connected with the connecting end, the flexible branch is connected with the flexible branch traction tube, the flexible branch is attached to the traction tube wall in an initial state and is bound in a groove of the bundle tube, when the traction tube moves upwards along the axial direction of the bundle tube, the flexible branch can scatter around due to self tension until the flexible branch reaches the maximum extension, and at the moment, the support film is opened to be umbrella-shaped and moves to the blood vessel wall to be tightly attached. The discharge electrode and the sampling electrode are sequentially arranged on the circumference of the hemispherical support film in a predetermined sequence, and perform regular discharge. After the discharge is finished, the flexible branch traction tube moves downwards, and the flexible branch is attached to the traction tube in a branch operation due to the rigid constraint of the bundle tube. The support film has enough flexibility, is easy to deform when the branches are stretched, can obviously increase the diameter before reaching tensile strength of thousands, and can reach stronger circumferential stress after keeping the compliance performance intact. The branches can be smoothly retracted when contracted, and have certain strength so as not to be scratched. Meanwhile, the adhesive property with the electrode is strong, and the electrode can not cause membrane damage when discharging. The flexible spline is of a relatively hard material so as to be expandable to a set of known reproducible shapes that can retain a known spatial geometry in use, which in some cases may be aided by the incorporation of a shape memory material or other hard polymeric material such as polyimide or PEEK into the flexible spline. The umbrella cover is a flexible plastic film, the surface of the film is provided with electrodes, each electrode can be addressed independently, the electrodes can be addressed along the direction of the umbrella stand, the discharge can be annular discharge, and the discharge can also be longitudinal discharge along the direction of the electrodes.
The invention can place discharge electrodes on both sides of pulmonary vein crowns and hypertrophic cardiac muscles or renal artery positions through an intervention method, and can generate irreversible electroporation on both sides of cardiac myocytes, hypertrophic cardiac muscles or renal sympathetic nerves by releasing high-voltage high-frequency alternating asymmetric pulse waves, thereby being capable of treating atrial fibrillation, hypertrophic cardiomyopathy or intractable hypertension.
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explanation of the principles of the present invention and are in no way limiting of the invention. Accordingly, any modification, equivalent replacement, improvement, etc. made without departing from the spirit and scope of the present invention should be included in the scope of the present invention. Furthermore, the appended claims are intended to cover all such changes and modifications that fall within the scope and boundary of the appended claims, or equivalents of such scope and boundary.
Claims (10)
1. A catheter-mediated cardiovascular irreversible electroporation ablation system, which is characterized by comprising a sampling assembly, a discharging assembly, a host fitting and an ablation host;
The sampling assembly includes a sampling electrode;
the discharge assembly comprises a discharge electrode and a discharge channel, and the discharge electrode is connected with the discharge channel;
The host accessory comprises a host display device, a pedal device, a host input port, a host output port and a control panel;
the ablation host is used for generating and adjusting electric energy, controlling an ablation signal, connecting the sampling electrode through the host input port, and connecting the discharge electrode through the discharge channel through the host output port.
2. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 1, wherein the ablation host comprises:
the electric energy control module is used for generating and adjusting electric energy;
the main control module is used for receiving and processing data and sending a signal for controlling ablation;
The potential monitoring module is used for collecting and measuring potential parameters;
And the electrocardio control module is used for collecting and controlling electrocardiosignals.
3. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 2, wherein the power control module comprises:
The direct-current high-voltage power supply is used for outputting electric energy;
the energy storage element comprises at least one group of capacitor arrays and is used for receiving and storing the electric energy of the direct-current high-voltage power supply;
The switching element comprises at least one of a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a pulse bridge type generating circuit to control the charge and discharge of the energy storage element;
the channel selection switch element comprises at least one of a relay, a transistor, a power metal oxide semiconductor field effect transistor, a bipolar junction transistor and a bipolar field effect transistor, and forms a channel selection switch array to select and control connection or disconnection of a discharge channel;
and when the discharge is finished, the pulse bridge type generating circuit conducts the energy storage element and the energy consumption element, converts electric energy into heat energy and returns the electric potential to zero.
4. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 3, wherein the master control module comprises:
the central control unit is used for controlling and scheduling the switching element and the channel selection switching element, setting and adjusting output pulse parameters and generating a pulse instruction;
the upper computer control unit receives the pulse instruction and the cardiovascular discharge feedback information, processes the pulse instruction and then issues the pulse instruction, processes the discharge feedback information and then transmits the processed discharge feedback information to the central control unit.
5. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 2, wherein the potential monitoring module comprises:
the voltage sampling element is connected with the upper computer control unit and used for monitoring the voltages of the energy storage element, the switching element and the channel selection switching element;
and the current sampling element is connected with the upper computer control unit and monitors the currents of the sampling electrode and the discharge electrode.
6. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 4, wherein the electrocardio control module comprises:
The electrocardio feedback unit is connected with the sampling electrode and samples electrocardio stimulation signals;
And the electrocardio synchronization unit is connected with the electrocardio feedback unit, receives the electrocardio stimulation signals, recognizes R waves, judges the vulnerable period of the heart, and controls the discharge operation of the discharge electrode to be synchronous with the specific period of the heart by uploading the signals to the central control unit through the upper computer control unit.
7. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 4,
The pedal device is connected with the upper computer control unit and is used for starting a discharge pulse sequence.
8. The catheter-mediated, intra-cardiovascular, irreversible electroporation ablation system of claim 1, further comprising a catheter assembly for supporting the sampling assembly and the discharge assembly;
The catheter assembly comprises a middle fixed catheter (1), a supporting flexible branch (2) and a movable catheter (3), wherein the fixed end of the supporting flexible branch (2) is arranged on the middle fixed catheter (1), the movable end is connected with the movable catheter (3), and the supporting flexible branch (2) is in a spiral shape;
The support flexible branches (2) are distributed along the circumference of the middle fixed conduit (1) respectively;
Each supporting flexible branch (2) is respectively connected with one sampling electrode or one discharging electrode.
9. The catheter-mediated, intra-cardiovascular irreversible electroporation ablation system of claim 8, wherein the sampling electrode and the discharge electrode comprise biocompatible metals;
The biocompatible metal comprises at least one of titanium, palladium, silver, platinum, and a platinum alloy.
10. Catheter-mediated, intra-cardiovascular irreversible electroporation ablation system according to claim 8, wherein said supporting flexible fingers (2) comprise a flexible polymeric material, a rigid polymeric material and a shape memory material;
the flexible polymer material comprises at least one of polytetrafluoroethylene, polyamide, nylon and polyether block amide;
the hard polymeric material comprises at least one of polyimide or PEEK;
The shape memory material comprises at least one of nickel-titanium alloy, polymer base material and liquid crystal elastomer.
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