CN112022331A - Irreversible electroporation ablation system - Google Patents
Irreversible electroporation ablation system Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/1206—Generators therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A—HUMAN NECESSITIES
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- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
- A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
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- A61B2018/00345—Vascular system
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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Abstract
The invention relates to an irreversible electroporation ablation system which comprises a host machine and an ablation device, wherein the host machine can generate high-voltage high-frequency alternating asymmetric pulses, the ablation device comprises at least one group of ablation electrodes and detection electrodes, the asymmetric pulses are applied to the ablation electrodes to enable the ablation electrodes to output electrical stimulation signals, idle time is set in the process that the asymmetric pulses are switched from positive pulses to negative pulses and from negative pulses to positive pulses, and the idle time is different. The electrode is pushed to target tissue through the catheter, and the electrode is unfolded to be in a shape fitting with the tissue or the vessel according to the structural characteristics of the electrode, so that ablation treatment is carried out on the tissue or the vessel. Through the specific high-voltage high-frequency alternating asymmetric pulse design, the ablation can form a uniform and effective ablation area under lower voltage, so that the ablation area of a patient is more uniform.
Description
Technical Field
The invention relates to the technical field of ablation control, in particular to an irreversible electroporation ablation system.
Background
The irreversible electroporation technology is characterized in that high-voltage ultrashort electric field pulses are applied between electrodes to act on phospholipid bilayer of cell membrane to generate nanometer-scale unrecoverable cavities, so that the balance in cells is destroyed, the cells are rapidly apoptotic, and the purpose of ablating cells with membrane structures is achieved.
The generation of irreversible electroporation requires that the ablation potential reaches a certain threshold value, and different membrane structure cell electroporation threshold values are different, so that the gradient characteristic can be utilized to realize specific ablation on the tissue with the membrane structure in an ablation region, the tissue which does not reach the ablation threshold value can be healed, and the tissue which reaches the threshold value generates irreversible electroporation, so that apoptosis necrosis is generated.
The existing pulse is mainly a symmetrical pulse, and animal experiments and cell experimental researches show that an ablation area formed by the symmetrical pulse under the same energy is smaller than an asymmetrical pulse, so that a brand-new pulse is provided, and flexible adjustment and application of characteristic pulses are realized on the circuit and structural design, which is a technical problem to be solved in the field.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides an irreversible electroporation ablation system, which is used for pushing an electrode to a target tissue through a catheter in the heart and the vessel, and treating the target tissue through a specific pulse; the electrode is unfolded to be in a shape which is matched with the tissue or the vessel according to the structural characteristics, and ablation treatment is carried out on the tissue or the vessel, such as treatment: atrial fibrillation, intractable hypertension, hypertrophic cardiomyopathy, and can effectively reduce the damage to the tissue of the treated part.
The invention is realized by the following technical scheme:
the invention provides an irreversible electroporation ablation system, which comprises a host machine and an ablation device, wherein the host machine can generate high-voltage high-frequency alternating asymmetric pulses; the asymmetrical pulse is applied to the ablation electrode to enable the ablation electrode to output an electric stimulation signal, the pulse width of a positive pulse of the asymmetrical pulse is different from that of a negative pulse, and idle time is set in the process of switching the positive pulse to the negative pulse and the process of switching the negative pulse to the positive pulse; the detection electrode detects the electric stimulation signal output by the ablation electrode and feeds back the electric stimulation signal to the host.
Further, the host comprises a host power supply, an asymmetric pulse discharge circuit, an upper computer and a lower computer;
the host power supply is used for providing direct current for the asymmetric pulse discharge circuit; the upper computer is used for receiving the working parameters of the asymmetric pulse and transmitting the working parameters to the lower computer;
and the lower computer generates a control signal according to the working parameters and transmits the control signal to the asymmetric pulse discharge circuit so as to control the asymmetric pulse discharge circuit to generate corresponding high-voltage high-frequency alternating asymmetric pulses according to the working parameters.
Further, the asymmetric pulse discharge circuit comprises a high-voltage power supply, a switch element group, an energy storage element, an isolation element group, a voltage monitoring element, a current monitoring element and a pulse output element;
the high voltage power supply generates a high voltage potential based on the direct current; the switch element group comprises a plurality of charging switch elements, discharging switch elements and output switch elements, the charging switch elements are used for controlling the energy storage elements to be charged, the energy storage elements are stopped to be charged after the output potential of the energy storage elements reaches a preset value, the discharging switch elements are used for controlling the energy storage elements to be discharged, and the output switch element group performs chopping and forward and reverse switching on the output of the energy storage elements according to the control signals to form asymmetric pulses; the energy storage element is a capacitor or a capacitor array consisting of a plurality of capacitors; the isolation element group isolates the lower computer from the asymmetric pulse discharge circuit; the voltage monitoring element comprises a charging voltage monitoring element and a discharging voltage monitoring element, the charging voltage monitoring element is used for monitoring the input potential of the energy storage element, and the discharging voltage monitoring element is used for monitoring the output potential of the energy storage element; the current monitoring element is used for monitoring the discharge current; the pulse output element includes a discharge electrode.
Furthermore, the discharge switch element is a bridge circuit composed of switch tubes, and 4 control drive units are used for controlling and respectively connected to one bridge arm; the lower computer generates a control signal, controls the conduction or cut-off of a bridge arm switching tube through the control driving unit after isolation, controls the conduction and cut-off time of the switching element, and performs chopping and output direction switching on direct current output by a capacitor in the energy storage element to form high-voltage high-frequency alternating asymmetric pulses with adjustable pulse width, adjustable duty ratio and adjustable positive and negative polarities.
Further, the discharge switch elements are a plurality of channel selection switch arrays composed of relays or switch tubes, the lower computer controls the on-off of each switch element in the switch arrays according to the discharge sequence, selects the discharge capacitor and selects the discharge electrode to output an electrical stimulation signal.
Further, the lower computer adjusts the output potential of the high-voltage power supply, compares the output potential with a set test voltage, and judges whether the discharge electrode is short-circuited or broken;
the lower computer controls to generate a test pulse, detects the discharge current, compares the discharge current with a set test current and judges whether the discharge current is normal or not;
if no short circuit or open circuit occurs and the discharge current is normal, the foot switch is allowed to be triggered to start generating the asymmetric pulse.
Furthermore, the upper computer comprises an input and output panel, the input and output panel comprises a detection electrode input port and a pulse energy output port, the detection electrode input port is connected with a detection electrode of the ablation device, and a plurality of channels of the detection electrode acquire electrical stimulation signals and feed back ablation effects and processes in real time; the pulse energy output port comprises a plurality of pulse energy output channels, and each ablation electrode at the tail end of the catheter of the ablation device is respectively and independently connected with one pulse energy output channel, or a plurality of ablation electrodes are connected with one pulse energy output channel.
Further, each capacitor of the energy storage element is discharged circularly under the set pulse width, after the set number of discharge cycles is completed, the energy storage element is charged, and after the charging is completed, the set number of discharge cycles is performed again; and repeatedly performing charging and discharging until discharging is completed.
Further, an electrocardio-stimulation signal is obtained through the detection electrode or the body surface monitor, R waves in the electrocardio-stimulation signal are identified, the heart vulnerable period is judged according to the R waves, effective electrocardio R waves are waited, and the energy storage element completes a group of circular discharge.
Further, the discharge pulse of the asymmetric pulse discharge circuit is set to: each discharge cycle comprises a group of pulses, wherein the pulse width of the positive pulse is set to be continuously adjustable from 0.5us to 150us, and the pulse width is continuously adjustable from 0.1 us to 30 us; the pulse width of the negative pulse is set to be 0.1-150us continuously adjustable, and the pulse width is idle for 0.1-30us continuously adjustable; and in the setting, the positive pulse width and the negative pulse width are required to be different, and if the positive pulse width and the negative pulse width are the same, a setting error is prompted.
Further, the ablation device comprises a fixed catheter, a movable catheter, a plurality of supporting flexible strips, ablation electrodes on the periphery and a detection electrode sequence close to the center; the movable catheter is arranged in the fixed catheter and can be driven to adjust the length extending out of the top end of the fixed catheter; one end of each supporting flexible strip is fixed to the fixed catheter, the other end of each supporting flexible strip is fixed to the movable catheter, an ablation electrode and a detection electrode are arranged on each supporting flexible strip, the detection electrodes can be switched to the ablation electrodes, and addressing can be achieved independently.
Further, the supporting flexible strips are arranged in a spiral mode, the spiral arrangement is arranged into a double-spiral, triple-spiral, four-spiral, five-spiral or six-spiral structure according to the number of the side branches of the spiral structure, and the ablation electrode and the detection electrode are arranged on the side branches.
Furthermore, when the movable catheter extends out of the fixed catheter for the longest length in the initial state, the supporting flexible strip is attached to the fixed catheter, so that the axial size of the supporting flexible strip is the smallest, and the movable catheter can move smoothly in a blood vessel; when the extending length of the movable catheter is reduced, the supporting flexible strip is unfolded, and when the extending length of the movable catheter is the minimum, the diameter of the axial far end of the supporting flexible strip (2300) is the maximum, so that the ablation electrode is circumferentially attached to the focus point to the maximum extent.
Furthermore, the ablation device comprises a connecting end head, a supporting membrane, a supporting flexible strip, an inner supporting tube, a supporting flexible strip traction tube, a bundle tube, an ablation electrode and a detection electrode; the support membrane is respectively connected with the connecting end and the upper end of the support flexible strip, the inner support tube fixes only the connecting end, the lower end of the support flexible strip is connected with the support flexible strip traction tube, and the support flexible strip traction tube is sleeved outside the inner support tube; the supporting flexible strip is in an initial state, attached to the wall of the supporting flexible strip traction tube and bound in the cutting groove of the bundle type tube, when the supporting flexible strip traction tube is driven to move upwards along the axis of the bundle type tube, the supporting flexible strip traction tube extends outwards gradually, and the supporting membrane is driven to be opened due to the fact that self tension can expand outwards until the supporting flexible strip traction tube reaches the maximum extension, at the moment, the supporting membrane is completely opened to be umbrella-shaped, and the supporting membrane moves to the vascular wall and is tightly attached to the vascular wall.
Further, the ablation electrode and the detection electrode are arranged on the circumferential surface of the support film, and the ablation electrode performs pulse cycle discharge; after discharging, the supporting flexible strip traction tube moves downwards along the shaft of the bundling tube under driving, and the supporting flexible strip is attached to and folded with the supporting flexible strip traction tube due to the rigid constraint of the bundling tube.
Further, the ablation electrode is a metal band, a metal ring or a flexible material, and the supporting flexible strip is made of a flexible polymer material; the support film is a flexible moldable film.
In summary, the present invention provides an irreversible electroporation ablation system, which is to push an electrode to a target tissue through a catheter, the electrode is deployed to a shape fitting to the tissue or vessel according to its structural characteristics, and perform ablation treatment on the tissue or vessel, such as treatment: atrial fibrillation, intractable hypertension, hypertrophic cardiomyopathy, and can effectively reduce the damage to the tissue of the treated part.
Compared with the prior art, the invention has the following advantages:
(1) the animal living body ablation experiment and the cell ablation experiment show that ablation can form a uniform and effective ablation area at lower voltage through a specific high-voltage high-frequency alternating asymmetric pulse design, so that the ablation area of a patient is more uniform; idle time is set in the process of switching the asymmetrical pulse positive pulse to the negative pulse and the process of switching the negative pulse to the positive pulse, the negative pulse of the high-frequency alternating pulse can effectively realize depolarization, convulsion caused in the discharging process is reduced or eliminated, and the positive asymmetrical pulse and the negative asymmetrical pulse can form a larger ablation area under the same pulse energy than the symmetrical pulse, so that ablation is more thorough and the isolation effect is good;
(2) the bipolar pulse parameters can be accurately set through the structural setting and parameter design of the asymmetric pulse discharge circuit;
(3) according to the invention, bipolar pulse discharge of a plurality of electrodes is adopted, and on the setting of a treatment area, high-voltage steep pulse forms a reticular discharge area in the tissue, so that an effective irreversible electric field covers the tissue to be treated as much as possible, ablation blind areas are reduced, and the effectiveness of a treatment plan is enhanced;
(4) according to the electrode, the electrode is unfolded into a shape which is attached to the tissue or the vessel according to the structural characteristics of the electrode, so that the tissue or the vessel is subjected to ablation treatment, and the damage to the tissue of a treatment part can be effectively reduced;
(5) the invention has good software and hardware protection mechanism and ensures the safety of the whole operation treatment.
(6) The electric field intensity required for ablation of different tissues is different, the specific electric field intensity for myocardial cell ablation is set, only the myocardial cells are ensured to be ablated, other tissues in the ablation area are not damaged, and important tissues in the ablation area can be effectively protected;
(7) the high-frequency alternating characteristic of the invention can reduce muscle twitch in the ablation process; the high-frequency alternation applies the characteristic that the tissue responds to depolarization, after the positive pulse stimulation, the tissue does not respond to twitch, and the negative pulse depolarizes, so that the tissue does not generate twitch response;
(8) the high-frequency alternating characteristic of the invention can eliminate the generation of ionized gas in the discharge process, and because of the alternating process, the positive pulse is ionized to generate gas, and the reverse pulse generates chemical combination reaction, the alternating process reduces or eliminates the generation of ionized gas in the discharge process;
(9) the switch control bridge circuit can effectively output the asymmetrical waveform with adjustable high-frequency alternating pulse width, thereby enhancing the treatment safety and effectiveness;
(10) the double-switch electrode selection circuit can safely select the output electrode, reduce the short-circuit risk of a discharge loop and realize safe discharge.
Drawings
Fig. 1 is a block diagram of the irreversible electroporation ablation system of the present invention;
FIG. 2(a) is an electrical schematic diagram of the host of the irreversible electroporation ablation system of the present invention; FIG. 2(b) is a schematic diagram of the electrode selection for the irreversible electroporation ablation system of the present invention;
FIG. 3(a) is a high voltage, high frequency alternating asymmetric pulse waveform diagram in one embodiment of the present invention; FIG. 3(b) is a high voltage high frequency alternating asymmetric pulse waveform diagram in yet another embodiment of the present invention; FIG. 3(c) is a schematic diagram of the discharge cycle of the high-voltage high-frequency alternating asymmetric pulse of the present invention; FIG. 3(d) is a waveform diagram of the electrical stimulation signal output by the present invention;
fig. 4(a) is a side view of an ablation device according to an embodiment of the invention; FIG. 4(b) is a schematic illustration of an ablation device deployment procedure according to an embodiment of the present invention; FIG. 4(b) is a schematic illustration of an ablation device deployment procedure according to an embodiment of the present invention; fig. 4(c) is a schematic view of an ablation device according to an embodiment of the invention in a deployed state;
FIG. 5(a) is a side view of an umbrella-shaped ablation device in accordance with one embodiment of the invention; fig. 5(a) is a top view of an umbrella-shaped ablation device in accordance with one embodiment of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings in conjunction with the following detailed description. It should be understood that the description is intended to be exemplary only, and is not intended to limit the scope of the present invention. Moreover, in the following description, descriptions of well-known structures and techniques are omitted so as to not unnecessarily obscure the concepts of the present invention.
The invention provides a system for irreversible electroporation ablation, which is used for irreversible electroporation ablation in heart and vessels, and as shown in figure 1, the system comprises a host 1000 and an ablation device 2000, wherein the host 1000 can generate high-voltage high-frequency alternating asymmetric pulses, and the ablation device 2000 comprises at least one group of electrodes, and the group of electrodes comprises a detection electrode and an ablation electrode which are connected to the host 1000 through ports.
The host 1000 includes a host power source 1100, a high voltage power source 1200, a switching element group 1300, an energy storage element 1400, an isolation element group 1500, a voltage monitoring element 1600, a current monitoring element 1700, a pulse output element 1800, an upper computer 1900, and a lower computer 1900' therein. The upper computer 1900 includes a console, a display device, a foot switch, an input/output panel, and a control unit.
The host power supply 1100 is a dc power supply for supplying power to the high voltage power supply 1200. As shown in fig. 2, the pulse output element 1800 includes a discharge electrode 1810, the high voltage power supply 1200 is a dc high voltage power supply, the output potential of the high voltage power supply 1200 can be adjusted to 5-3000V by controlling the high voltage power supply 1200 to adjust the output potential of the high voltage power supply 1200, when the output potential of the high voltage power supply 1200 is 5V, a test voltage is set, whether the discharge electrode 1810 has short circuit or disconnection is determined based on the test voltage, if the discharge electrode 1810 is in a normal state, the host computer operates according to the operating parameters input by the console of the host computer 1900, for example, the dc high voltage power supply 1200 outputs a potential of 400-.
The energy storage element 1400 is one or a group of capacitor arrays, the switch element group includes a charging switch element 1310, a discharging switch element 1320 and an output switch element, the dc high voltage power supply 1200 is connected to the charging switch element 1310, the charging switch element 1310 is connected to the energy storage element 1400, the dc high voltage power supply 1200 charges the energy storage element 1400 through the charging switch element 1310, when the output potential of the energy storage element 1400 reaches a preset value, the dc high voltage power supply 1200 stops charging the energy storage element 1400, and the energy storage element 1400 discharges through the discharging switch element 1320.
As shown in fig. 2(a), the discharge switching element 1320 may be a pulse bridge type generating circuit composed of a switching tube formed by a high power switching element (IGBT), and performs chopping with the direct current output by the capacitor in the energy storage element 1400 to form an asymmetric high frequency alternating steep pulse with adjustable pulse width, adjustable duty ratio, and adjustable positive and negative polarities. The high-power switch element can be one or more of a power Metal Oxide Semiconductor Field Effect Transistor (MOSFET), a bipolar junction transistor, a bipolar field effect transistor (Bi-FET) and an Insulated Gate Bipolar Transistor (IGBT).
Specifically, as shown in fig. 1 and 2, the lower computer 1900' generates a pulse control signal, and controls the on/off of the output switching element by controlling the driving unit after optical isolation. In one embodiment, as shown in fig. 2, the first output switch element K1 is turned on, the second output switch element K2 is turned off, the first output end 3 and the first input end 1 are in the same polarity, then the third output switch element K3 is turned off, the fourth output switch element K4 is turned on, the second output end 4 and the second input end 2 are in the same polarity, that is, K1 is turned on, K2 is turned off, K3 is turned off, and K4 is turned on, and then the driving unit is controlled to turn off all the output switch elements, return the pulse to zero, and generate a positive pulse at the output end; the control driving unit switches the conduction characteristic of the output switch element, the first output switch element K1 is switched off, the second output switch element K2 is switched on, the first output end 3 and the second input end 2 are in the same polarity, then the third output switch element K3 is switched on, the fourth output switch element K4 is switched off, the second output end 4 and the first input end 1 are in the same polarity, namely K1 is switched off, K2 is switched on, K3 is switched on, and K4 is switched off, then the control driving unit enables all the output switch elements to be switched off, the pulse returns to zero, the output end generates a reverse pulse, the control driving unit controls the conduction characteristic of the switch element to circularly switch the switch element, controls the switching time of the switch element to be switched on and switched off, and performs chopping on with direct current output by a capacitor in the energy storage element 1400 to form a high-voltage high-frequency asymmetric alternating pulse with adjustable pulse width, adjustable duty ratio and adjustable positive. Positive and negative pulses are formed by the bridge switching.
As shown in fig. 2(b), the discharge switch elements 1320 may be channel selection switch elements, and each of the switch elements in the switch array is respectively connected to a corresponding capacitor in the energy storage element 1400 and a corresponding discharge electrode 1810 in the pulse output element 1800, and is composed of relays or transistors (IGBTs), and the switching of each switch element in the switch array is controlled according to the discharge sequence of the discharge electrode. The transistor can be one or more of a power Metal Oxide Semiconductor Field Effect Transistor (MOSFET), a bipolar junction transistor or a bipolar field effect transistor (Bi-FET).
The isolation element group 1500 is isolated by an optical coupling method, and is used for performing photoelectric isolation on all input and output signals, so as to reduce noise interference of noise signals and improve the reliability of the system.
As shown in fig. 1, the voltage monitoring device 1600 includes a charging voltage monitoring device 1610 and a discharging voltage monitoring device 1620, where the charging voltage monitoring device 1610 is configured to monitor an input potential of the energy storage device 1400, and the discharging voltage monitoring device 1620 is configured to monitor an output potential of the energy storage device 1400, and feed back the output potential to a central control unit of the lower computer 1900' and then upload the output potential to the upper computer 1900; the current monitoring element 1700 is a discharge current monitoring element, which is a current transformer that samples a discharge current of the energy storage element 1400, and feeds back the current signal to the central control unit of the lower computer 1900' and then uploads the current signal to the upper computer 1900.
The lower computer 1900' includes a central control unit that can freely select the following core processors: the CPLD, the ARM and the DSP send out a pulse generation control instruction through the core processor to control the discharge switch element 1320 to be opened and closed, and generate a corresponding asymmetric high-frequency alternating steep pulse sequence according to pulse parameters set by the upper computer 1900, wherein the pulse parameters can be set through a central console of the upper computer 1900. The pulse parameters include: charging voltage, discharging pulse voltage, pulse width, number of group pulses and number of pulse groups.
The upper computer 1900 includes a console, a display device, a foot switch, an input/output panel, and a control unit. The foot switch is also replaced by a press switch, and when the work of the peripheral circuit is detected by the test pulse, the foot switch or the press switch is triggered to start the discharge pulse sequence. The control unit can be an industrial personal computer or a PC. The display device displays the interactive interface and the data processing result to enable data to be visualized.
The control unit of the upper computer 1900 is connected to the central control unit of the lower computer 1900' through serial communication, parallel communication, USB, and transmits a program execution instruction to receive the discharge operation state.
Working parameters are input through the central console of the upper computer, the upper computer 1900 transmits the working parameters to the central control unit of the lower computer 1900', the central control unit generates control signals according to the working parameters and transmits the control signals to the high-voltage high-frequency alternating asymmetric pulse discharge circuit so as to control the charge and discharge parameters of the high-voltage high-frequency alternating asymmetric pulse discharge circuit, and the high-voltage high-frequency alternating asymmetric pulse discharge circuit generates high-voltage high-frequency alternating asymmetric pulses; the high-voltage high-frequency alternating asymmetric pulse discharge circuit generates positive and negative bipolar high-voltage pulses, discharges the positive and negative bipolar high-voltage pulses through electrodes in the high-voltage high-frequency alternating asymmetric pulse discharge circuit, and transmits a feedback signal back to the upper computer 1900. High-voltage high-frequency alternating asymmetric pulses are applied to the ablation electrode to enable the ablation electrode to output an electrical stimulation signal, and the ablation potential exceeds a perforation threshold value. And selecting a discharge capacitor according to the perforation threshold value, and adjusting the amplitude of the high-voltage high-frequency alternating asymmetric pulse.
The input and output panel of the upper computer 1900 includes a detection electrode input port and a pulse energy output port. The input port of the detection electrode is connected with the detection electrode of the ablation device 2000, and the channels 2-10 of the detection electrode collect electrical stimulation signals to determine the ablation effect and progress in real time; the pulse energy output port comprises 2-30 pulse energy output channels, each of which can be freely switched, and each ablation electrode at the catheter end of the ablation device 2000 can be connected with one of the pulse energy output channels.
The host 1000 may further include a dissipative element, which is a resistive element, and when the discharge electrode 1810 finishes discharging, the switching element group 1300 turns on the energy storage element 1400 and the dissipative element, and the energy storage element 1400 returns to 0 by discharging through the dissipative element.
The main machine 1000 further comprises an electrocardio feedback unit, the electrocardio feedback unit can be a detection electrode at the tail end of a catheter of the ablation device, the detection electrode samples electrocardio stimulation signals, and the ablation effect is dynamically monitored and fed back in real time; the electrocardio feedback unit can also be a body surface monitor.
The host 1000 further comprises an electrocardiograph synchronization device, the electrocardiograph stimulation signals are obtained through the detection electrodes or the body surface monitor, R waves in the electrocardiograph stimulation signals are identified, the heart vulnerable period is judged according to the R waves, the discharge electrodes avoid the vulnerable period to discharge in the heart refractory period, after a group of pulse discharges are completed between the electrodes, the next effective electrocardiograph R wave is waited, the discharge electrodes 1810 avoid the vulnerable period again to discharge in the heart refractory period, and the discharges of all the electrode sequences are completed in a circulating mode.
In one embodiment of the invention, as shown in fig. 3(a), the discharge pulses are arranged to contain a set of pulses within each discharge cycle (for each discharge duration), with positive pulses having a pulse width of 0.5us-30us and idle pulses of 0.1-30 us; the pulse width of the negative pulse is 0.1-25us, and the idle time is 0.1-30 us. Wherein the pulse width of the positive pulse is different from that of the negative pulse. The pulse energy is discharged cyclically at the set pulse width. And after 90-200 discharge cycles are completed, the system charges the energy storage element, and after the charging is completed, the 90-200 discharge cycles are repeated until the discharging is completed.
In one embodiment of the present invention, as shown in fig. 3(b), the discharge pulse may be configured to include a set of pulses in each discharge cycle (each discharge duration), the positive pulse having the same pulse width as the negative pulse, the pulse width being 0.5us-30us, and the space between the positive and negative pulses being 0.1-30 us. The pulse energy is discharged cyclically at a set pulse width, each discharge cycle being completed within one cardiac cycle. And after 10-200 discharge cycles are completed, the system charges the energy storage element, and after the charging is completed, 10-200 discharge cycles are repeated until the discharging is completed.
As shown in fig. 3(c) (d), in one embodiment of the present invention, the discharge pulse is configured to contain a set of pulses in each discharge cycle (each discharge duration) synchronized to a cardiac cycle, with positive pulses having a pulse width of 0.5us-150us and idle 0.1-30 us; the pulse width of the negative pulse is 0.5-150us, and the idle time is 0.1-30 us. And discharging in 5-50 cardiac cycles in a circulating manner, charging the energy storage element by the system after 5-50 discharging cycles are completed, and repeating 5-50 discharging cycles until discharging is completed.
As shown in fig. 4, the ablation device 2000 comprises a fixed catheter 2100, a movable catheter 2200, a plurality of supporting flexible strips 2300, an ablation electrode 2400, a detection electrode 2500, the detection electrode and the ablation electrode are arranged in any way and can be independently addressed, the ablation electrode can also be connected together, but an electric lead 2600 needs to be addressed and insulated separately from the detection electrode, the insulated electric lead is arranged inside the flexible strips 2300, the electrode and the insulated electric lead are welded together, a pulse is output through a lead, and the top of the ablation electrode 2400 is in contact with the tissue. One end of the supporting flexible strip 2300 is fixed with the fixed conduit 2100, the other end of the supporting flexible strip 2300 is fixed with the movable conduit 2200, and the supporting flexible strip 2300 is arranged in a spiral manner. An ablation electrode 2400 and a detection electrode 2500 are arranged on each supporting flexible strip 2300 for ablation. In an initial state, the movable catheter 2200 is positioned at the lower end of the fixed catheter 2100, and the supporting flexible strip 2300 is attached to the fixed catheter 2100, so that the axial dimension is minimum, and the movable catheter can move smoothly in a blood vessel; when the movable catheter 2200 moves to the upper end of the fixed catheter 2100, the supporting flexible strip 2300 is unfolded, and the diameter of the axial distal end of the supporting flexible strip 2300 is maximized, so that the ablation electrode 2400 and the lesion point are circumferentially fitted to the maximum extent, and the optimal ablation effect is achieved.
The support flexible strip 2300 is of a relatively stiff material such that in use a certain geometry can be maintained and in some cases a polymeric material or other rigid polymeric material such as polyimide or PEEK may be incorporated into the support flexible strip 2300.
The ablation electrode 2400 may be a metal band or ring, or may be a flexible material. The ablation electrode 2400 may be in the form of a metal coil spring or a helically wound supporting flexible strip 2300. The ablation electrode 2400 may include a biocompatible metal such as titanium, palladium, silver, platinum, and/or a platinum alloy. The supporting flexible strip 2300 may be made of a flexible polymeric material, for example polytetrafluoroethylene, polyamide, such as nylon, or polyether block amide. The ablation electrode 2400 may be connected to insulated electrical leads 2600 leading to the proximal side of the fixed catheter 2100, where the insulation on each insulated electrical lead is capable of maintaining an electrical potential difference of at least 700V across its thickness without being dielectrically broken down.
The front section of the supporting flexible strip 2300 is of a spiral structure, the side branches of each spiral structure can be in various arrangement modes, the supporting flexible strip can be divided into a double-spiral structure, a triple-spiral structure, a quadruple-spiral structure, a quintupler structure and a hexa-spiral structure according to the number of the side branches, the four side branches can be designed to be provided with ablation electrodes 2400, the four side branches can also be designed to be provided with electrodes on two opposite side branches, and the electrodes on the other two opposite side branches are in no-load state and are used for protecting the middle sleeve after isolation and shrinkage.
As shown in fig. 5(a), (b), the ablation device 2000 may be an umbrella-shaped electroporation ablation device comprising an umbrella-shaped electroporation ablation electrode assembly, and the ablation device comprises a connection tip 2010, a support membrane 2020, a support flexible strip 2030, an inner support tube 2040, a support flexible strip traction tube 2050, a bundle tube 2060, an ablation electrode 2070 and a detection electrode 2080. The supporting membrane 2020 is connected with the connecting end 2010 and the supporting flexible strip 2030 respectively, the inner supporting tube 2040 is firmly connected with the connecting end 2010, the supporting flexible strip 2030 is connected with the supporting flexible strip traction tube 2050, the supporting flexible strip 2030 is attached to the wall of the supporting flexible strip traction tube 2050 in an initial state and bound in a cutting groove of the bundled tube 2060, when the supporting flexible strip traction tube 2050 moves in the axial direction of the bundled tube 2060, the supporting flexible strip traction tube 2050 can be scattered all around due to self tension until the supporting flexible strip traction tube 2050 reaches the maximum extension, and at the moment, the supporting membrane 2020 is opened to be umbrella-shaped and moves to the wall of the blood vessel and is tightly attached. The ablation electrode 2070 and the detection electrode 2080 are sequentially arranged on the circumferential surface of the hemispherical support film 2020 according to a predetermined sequence, and perform regular discharge. After the discharge is finished, the supporting flexible strip traction tube 2050 moves downwards, and the branches of the supporting flexible strip 2030 are attached to the supporting flexible strip traction tube 2050 due to the rigid constraint of the beam tube 2060.
The support film 2020 has sufficient flexibility, is a flexible and moldable film, is easily deformed when the branches supporting the flexible strips 2030 are stretched, and has a diameter that can be significantly increased before reaching a stretchable strength, and a compliance property that remains intact, and can achieve a strong circumferential stress. The fingers supporting the flexible strip 2030 are able to retract smoothly when contracted and have a certain strength to avoid scratching. Meanwhile, the electrode can be strongly adhered to the ablation electrode 2070 and the detection electrode 2080, and the membrane can not be damaged when the electrodes discharge.
The support flex 2030 is of a relatively stiff material so that a known spatial geometry can be maintained in use, and in some cases a polymeric material or other rigid polymeric material such as polyimide or PEEK may be incorporated into the support flex 2030.
Each electrode can be individually addressed, can also be the same addressing electrode along the umbrella stand direction, and the discharge can be annular discharge, also can be along electrode direction longitudinal discharge.
The ablation electrode of the ablation device is attached to the pulmonary vein crown in an intervention mode, and high-voltage high-frequency alternating asymmetric steep pulse waves are released to a focus through one or more groups of ablation electrodes to generate irreversible electroporation of cardiac muscle cells and treat atrial fibrillation.
The ablation electrodes of the ablation device are sent to two sides of the hypertrophic cardiomyopathy in an intervention mode, discharge is carried out through the ablation electrodes on two sides of one or more groups of hypertrophic cardiomyopathy, and high-voltage high-frequency alternating asymmetric steep pulse waves are released to focuses, so that irreversible electroporation is carried out on local myocardial cells, the hypertrophic cardiomyopathy is reduced, and the hypertrophic cardiomyopathy is treated.
The ablation electrodes of the ablation device are sent to renal artery in an intervention mode, and high-voltage high-frequency alternating asymmetric steep pulse waves are released to the focus through one or more groups of ablation electrodes to generate irreversible electroporation of renal sympathetic nerves and treat intractable hypertension.
In summary, the invention provides an irreversible electroporation ablation system, which comprises a host and an ablation device, wherein the host can generate high-voltage high-frequency alternating asymmetric pulses, the ablation device comprises at least one group of ablation electrodes and a detection electrode, the asymmetric pulses are applied to the ablation electrodes to enable the ablation electrodes to output electrical stimulation signals, idle time is set in the process of switching the asymmetric pulses from positive pulses to negative pulses and from negative pulses to positive pulses, and the idle time is different. The electrode is pushed to target tissue through the catheter, and the electrode is unfolded to be in a shape fitting with the tissue or the vessel according to the structural characteristics of the electrode, so that ablation treatment is carried out on the tissue or the vessel. Through the specific high-voltage high-frequency alternating asymmetric pulse design, the ablation can form a uniform and effective ablation area under lower voltage, so that the ablation area of a patient is more uniform.
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explaining the principles of the invention and are not to be construed as limiting the invention. Therefore, any modification, equivalent replacement, improvement and the like made without departing from the spirit and scope of the present invention should be included in the protection scope of the present invention. Further, it is intended that the appended claims cover all such variations and modifications as fall within the scope and boundaries of the appended claims or the equivalents of such scope and boundaries.
Claims (16)
1. An irreversible electroporation ablation system, characterized in that the system comprises a host machine (1000) and an ablation device (2000), the host machine (1000) can generate high-voltage high-frequency alternating asymmetric pulses, the ablation device (2000) comprises at least one ablation electrode and at least one detection electrode; the asymmetrical pulse is applied to the ablation electrode to enable the ablation electrode to output an electric stimulation signal, the pulse width of a positive pulse of the asymmetrical pulse is different from that of a negative pulse, and idle time is set in the process of switching the positive pulse to the negative pulse and the process of switching the negative pulse to the positive pulse; the detection electrode detects an electric stimulation signal output by the ablation electrode and feeds the electric stimulation signal back to the host (1000).
2. The irreversible electroporation ablation system of claim 1, wherein the host comprises a host power source (1100), an asymmetric pulse discharge circuit, an upper computer (1900), and a lower computer (1900');
the host power supply (1100) is used for providing direct current for the asymmetric pulse discharge circuit;
the upper computer (1900) is used for receiving working parameters of the asymmetric pulses and transmitting the working parameters to the lower computer (1900');
and the lower computer (1900') generates a control signal according to the working parameters and transmits the control signal to the asymmetric pulse discharge circuit so as to control the asymmetric pulse discharge circuit to generate corresponding high-voltage high-frequency alternating asymmetric pulses according to the working parameters.
3. The irreversible electroporation ablation system of claim 2, wherein the asymmetric pulse discharge circuit comprises a high voltage power supply (1200), a set of switching elements (1300), an energy storage element (1400), a set of isolation elements (1500), a voltage monitoring element (1600), a current monitoring element (1700), and a pulse output element (1800);
the high voltage power supply (1200) generates a high voltage potential based on the direct current; the switching element group (1300) comprises a plurality of charging switching elements (1310), discharging switching elements (1320) and output switching elements, wherein the charging switching elements (1310) are used for controlling the energy storage elements (1400) to be charged, the energy storage elements (1400) are stopped to be charged after the output potential of the energy storage elements (1400) reaches a preset value, the discharging switching elements (1320) are used for controlling the energy storage elements (1400) to be discharged, and the output switching element group (1300) performs chopping and forward and reverse switching on the output of the energy storage elements (1400) according to the control signals to form asymmetric pulses; the energy storage element (1400) is a capacitor or a capacitor array consisting of a plurality of capacitors; the isolation element group (1500) isolates the lower computer from the asymmetric pulse discharge circuit; the voltage monitoring element (1600) comprises a charging voltage monitoring element (1610) and a discharging voltage monitoring element (1620), wherein the charging voltage monitoring element (1610) is used for monitoring the input potential of the energy storage element (1400), and the discharging voltage monitoring element (1620) is used for monitoring the output potential of the energy storage element (1400); the current monitoring element (1700) is used for monitoring a discharge current; the pulse output element (1800) includes a discharge electrode (1810).
4. The irreversible electroporation ablation system of claim 3, wherein the discharge switching element (1320) is a bridge circuit composed of switching tubes, and 4 control driving units are respectively connected to one bridge arm; the lower computer (1900') generates a control signal, controls the conduction or cut-off of a bridge arm switching tube through the control driving unit after isolation, controls the conduction and cut-off time of a switching element, and performs chopping and output direction switching on direct current output by a capacitor in the energy storage element (1400) to form high-voltage high-frequency alternating asymmetric pulses with adjustable pulse width, duty ratio and positive and negative polarities.
5. The irreversible electroporation ablation system of claim 4, wherein the discharge switch element (1320) is a plurality of channel selection switch arrays composed of relays or switch tubes, the lower computer (1900') controls on/off of each switch element in the switch arrays according to a discharge sequence, selects a discharge capacitance and selects the discharge electrode (1810) to output an electrical stimulation signal.
6. The irreversible electroporation ablation system according to any one of claims 3 to 5, wherein the lower computer (1900') adjusts the output potential of the high voltage power supply (1200) to determine whether the discharge electrode (1810) is short-circuited or open-circuited, compared with a set test voltage;
the lower computer (1900') controls to generate a test pulse, detects the discharge current, compares the discharge current with a set test current and judges whether the discharge current is normal or not;
if no short circuit or open circuit occurs and the discharge current is normal, a foot switch (1930) is allowed to be triggered, initiating the generation of the asymmetric pulse.
7. The irreversible electroporation ablation system of any one of claims 3 to 5, wherein the host computer comprises an input and output panel (1940) which comprises a detection electrode input port and a pulse energy output port, the detection electrode input port is connected with a detection electrode of the ablation device (2000), and a plurality of channels of the detection electrode collect electrical stimulation signals and feed back ablation effect and progress in real time; the pulse energy output port comprises a plurality of pulse energy output channels, and each ablation electrode at the tail end of the catheter of the ablation device (2000) is connected with one pulse energy output channel independently or a plurality of ablation electrodes are connected with one pulse energy output channel together.
8. The irreversible electroporation ablation system of claim 7, wherein each capacitor of the energy storage element (1400) is cyclically discharged at a set pulse width, the energy storage element (1400) is charged after a set number of discharge cycles, and the set number of discharge cycles is performed again after the charging is completed; and repeatedly performing charging and discharging until discharging is completed.
9. The irreversible electroporation ablation system of claim 8, wherein the energy storage element (1400) completes a set of circular discharges by obtaining the ecg signals through the detection electrodes or the body surface monitor, identifying R-waves in the ecg signals, determining the vulnerable period of the heart according to the R-waves, and waiting for valid ecg R-waves.
10. The irreversible electroporation ablation system of any one of claims 1 to 3, wherein the discharge pulses of the asymmetric pulse discharge circuit are configured to: each discharge cycle comprises a group of pulses, wherein the pulse width of the positive pulse is set to be continuously adjustable from 0.5us to 150us, and the pulse width is continuously adjustable from 0.1 us to 30 us; the pulse width of the negative pulse is set to be 0.1-150us continuously adjustable, and the pulse width is idle for 0.1-30us continuously adjustable; and in the setting, the positive pulse width and the negative pulse width are required to be different, and if the positive pulse width and the negative pulse width are the same, a setting error is prompted.
11. The irreversible electroporation ablation system of any one of claims 1 to 3, wherein the ablation device (2000) comprises a fixed catheter (2100), a movable catheter (2200), a plurality of supporting flexible strips (2300), a peripheral ablation electrode (2400), and a near-center sensing electrode sequence (2500); the movable catheter (2200) is arranged inside the fixed catheter (2100) and can be driven to adjust the length extending out of the top end of the fixed catheter (2100); one end of the supporting flexible strips (2300) is fixed to the fixed catheter (2100), the other end of the supporting flexible strips is fixed to the movable catheter (2200), an ablation electrode (2400) and a detection electrode (2500) are arranged on each supporting flexible strip (2300), and the detection electrodes can be switched into ablation electrodes and can be independently addressed.
12. The irreversible electroporation ablation system of claim 11, wherein the supporting flexible strip (2300) adopts a helical arrangement, the helical arrangement being arranged in a double helix, a triple helix, a quadruple helix, a quintuplex helix or a hexa helix configuration depending on the number of lateral branches of the helical configuration on which the ablation electrode (2400) and the detection electrode (2500) are arranged.
13. The irreversible electroporation ablation system according to claim 11, wherein when the movable catheter (2200) is extended from the fixed catheter (2100) by the maximum length in an initial state, the supporting flexible strip (2300) is fitted to the fixed catheter (2100) so that the axial dimension of the supporting flexible strip (2300) is minimized and the movable catheter (2200) can move smoothly in a blood vessel; when the extending length of the movable catheter (2200) is reduced, the supporting flexible strip (2300) is unfolded, and when the extending length of the movable catheter (2200) is the minimum, the axial far-end diameter of the supporting flexible strip (2300) is the maximum, so that the ablation electrode (2400) is in maximum circumferential fit with the lesion site.
14. The irreversible electroporation ablation system of any one of claims 1 to 3, wherein the ablation device comprises a connection tip (2010), a support membrane (2020), a support flexible strip (2030), an inner support tube (2040), a support flexible strip pull tube (2050), a bundle tube (2060), an ablation electrode (2070), and a sensing electrode (2080); the supporting membrane (2020) is respectively connected with the connecting end head (2010) and the upper end of the supporting flexible strip (2030), the inner supporting tube (2040) is used for fixing the connecting end head (2010), the lower end of the supporting flexible strip (2030) is connected with the supporting flexible strip traction tube (2050), and the supporting flexible strip traction tube (2050) is sleeved outside the inner supporting tube (2040); the supporting flexible strip (2030) is attached to the wall of the supporting flexible strip traction tube (2050) in an initial state and is bound in the cutting groove of the bundle type tube (2060), when the supporting flexible strip traction tube (2050) is driven to move upwards along the axial direction of the bundle type tube (2060), the supporting flexible strip traction tube (2050) gradually extends outwards from the bundle type tube (2060), and the supporting membrane (2020) is driven to be opened due to the outward expansion of the supporting flexible strip traction tube (2050) until the supporting flexible strip traction tube (2050) reaches the maximum extension, at the moment, the supporting membrane (2020) is completely opened to form an umbrella shape, and the supporting membrane (2020) is moved to the wall of the blood vessel and is tightly attached to the wall of the blood vessel.
15. The irreversible electroporation ablation system of claim 14, wherein the ablation electrode (2070) and the detection electrode (2080) are disposed on a circumferential surface of the support membrane (2020), the ablation electrode (2070) performing pulsed cyclic discharge; after the discharge is finished, the supporting flexible strip traction tube (2050) moves downwards along the axial direction of the bundle type tube (2060) under the driving action, and the supporting flexible strip (2030) is attached to and folded with the supporting flexible strip traction tube (2050) due to the rigid constraint of the bundle type tube (2060).
16. The irreversible electroporation ablation system of claim 15, wherein the ablation electrode (2400) is a metal band, a metal ring or a flexible material, the supporting flexible strip (2300) is made of a flexible polymer material; the support film (2020) is a flexible moldable film.
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