A pulsed electric field ablation system and control method thereof

Abstract

The present application discloses a pulse electric field ablation system and a control method thereof, the ablation system comprising: a power module including two output terminals with opposite polarities; an ablation catheter including a plurality of electrode pairs; wherein each electrode pair comprises a pair of electrodes adjacent to each other and connected to the two output terminals of the power module respectively; two electrodes adjacent to each other and belonging to different electrode pairs are connected to the same output terminal of the power module. In the present application, the adjacent electrodes have opposite polarities only when they are in the same electrode pair, and there is no situation where the polarity of one electrode is opposite to that of the two adjacent electrodes. Therefore, the contact resistance of the adjacent electrodes will not reuse the voltage division, the voltage of the target resistance on the electrical path of the electrode pair is higher, and the electric field strength is more ideal.

Description

Technical Field

[0001] The present invention relates to the field of electronic devices, and in particular to a pulse electric field ablation system and a control method thereof. Background Art

[0002] Currently, for patients with arrhythmias that cannot be controlled by drugs, non-drug treatments such as catheter ablation and pacemaker implantation are usually used to control heart rate to improve symptoms. The ablation catheters used for catheter ablation are classified according to the number of electrodes into single-electrode catheters and multi-electrode catheters. Single-electrode catheters have low unit efficiency and take a long time to complete. Multi-electrode catheters have more contact points on electrodes, and the contact resistance of adjacent electrode contact points produces a voltage-dividing effect due to reuse, which leads to a decrease in the voltage of the target resistor on the electrical path of the catheter, weakening the effect of the electric field and failing to achieve the ideal electric field strength. The entire multi-electrode catheter has a poor effect.

[0003] Therefore, how to provide a solution to the above technical problems is a problem that those skilled in the art need to solve. Summary of the invention

[0004] In view of this, the purpose of the present invention is to provide a pulse electric field ablation system with an ideal electric field distribution. The specific scheme is as follows:

[0005] A pulsed electric field ablation system, comprising:

[0006] A power module including two output terminals with opposite polarities;

[0007] an ablation catheter including a plurality of electrode pairs;

[0008] Each of the electrode pairs includes a pair of electrodes that are adjacent to each other and are respectively connected to the two output terminals of the power module; and two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module.

[0009] Preferably, the ablation catheter further comprises one or more suspended electrodes, and the suspended electrodes are not connected to the two output ends of the power module.

[0010] Preferably, only two of the electrodes separated by the suspended electrode are connected to the same output terminal of the power module.

[0011] Preferably, the power module comprises:

[0012] A power supply circuit comprising a plurality of switching tubes;

[0013] A pulse controller controls the on and off of the switch tube according to a first preset frequency so that the power supply circuit outputs positive pulses and negative pulses respectively through the two output terminals.

[0014] Preferably, the pulsed electric field ablation system further comprises a switching array, and the plurality of electrodes are connected to the output end of the power module via switches of the switching array.

[0015] Preferably, the switching array controls the on and off of switches according to a second preset frequency to move the position of at least one of the electrode pairs.

[0016] Preferably, the ablation catheter specifically comprises:

[0017] A handle, a catheter, a plurality of electrodes located at the head end of the catheter, and a plurality of wires located inside the handle and the catheter, connected one by one with the plurality of electrodes, and receiving the pulse signal.

[0018] Preferably, the plurality of electrodes are distributed along the long axis direction of the catheter.

[0019] Preferably, in the working state, the spatial structure of the head end of the catheter is transformed into a ring shape, a spiral shape or a basket shape.

[0020] Correspondingly, the present application also discloses a control method for a pulsed electric field ablation system, which is applied to any of the pulsed electric field ablation systems described above, and the control method comprises:

[0021] determining a plurality of electrode pairs of the ablation catheter, wherein the electrode pairs include a pair of electrodes located adjacent to each other;

[0022] According to the electrode connection rule, a plurality of electrode pairs are connected to two output ends of the power module with opposite polarities, wherein the electrode connection rule is specifically as follows:

[0023] A pair of electrodes in each of the electrode pairs are respectively connected to the two output terminals of the power module;

[0024] Two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module.

[0025] The present application discloses a pulsed electric field ablation system, comprising: a power module including two output terminals with opposite polarities; an ablation catheter including a plurality of electrode pairs; wherein each electrode pair includes a pair of electrodes located adjacently and respectively connected to the two output terminals of the power module; two electrodes located adjacently and belonging to different electrode pairs are connected to the same output terminal of the power module. In the present application, the adjacent electrodes have opposite polarities only when they are in the same electrode pair, and there is no situation where the polarity of one electrode is opposite to that of the two adjacent electrodes. Therefore, the contact resistance of the adjacent electrodes will not reuse the voltage division, the voltage of the target resistance on the electrical path of the electrode pair is higher, and the electric field strength is more ideal. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0027] Figure 1 A schematic diagram of the structure of a pulsed electric field ablation system in an embodiment of the present invention;

[0028] Figure 2 An equivalent circuit diagram of an electrical path of multiple electrodes in the prior art;

[0029] Figure 3 is an equivalent circuit diagram of the electrical paths of multiple electrodes in an embodiment of the present invention;

[0030] Figure 4 It is a structural schematic diagram of a specific pulse electric field ablation system in an embodiment of the present invention;

[0031] Figure 5 This is a schematic structural diagram of an ablation catheter in an embodiment of the present invention;

[0032] Figure 6a and Figure 6b Schematic diagrams of effective ranges of pulsed electric field ablation systems with annular distribution of electrodes in this embodiment and the prior art respectively;

[0033] Figure 7a and Figure 7b Schematic diagrams of the effective range of the pulsed electric field ablation system with the long axis distribution of electrodes in this embodiment and the prior art respectively. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] In the prior art, since there are many contact points of electrodes in a multi-electrode catheter, the contact resistance of the contact points of adjacent electrodes produces a voltage-dividing effect due to reuse, resulting in a reduction in the voltage of the target resistance on the electrical path of the catheter, which weakens the effect of the electric field and fails to achieve the ideal electric field strength, resulting in a poor effect of the entire multi-electrode catheter. In the present application, the polarities of adjacent electrodes are opposite only when they are in the same electrode pair, and there is no situation where the polarity of one electrode is opposite to that of two adjacent electrodes. Therefore, the contact resistance of adjacent electrodes will not reuse the voltage-dividing effect, the voltage of the target resistance on the electrical path of the electrode pair is higher, and the electric field strength is more ideal.

[0036] The embodiment of the present invention discloses a pulse electric field ablation system, see Figure 1 As shown, including:

[0037] A power supply module 1 comprising two output terminals with opposite polarities;

[0038] an ablation catheter 2 comprising a plurality of electrode pairs;

[0039] Each electrode pair includes a pair of electrodes that are adjacent to each other and are respectively connected to two output terminals of the power module 1 ; two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module 1 .

[0040] It can be understood that the number of all electrode pairs and electrodes in the multiple electrode pairs in this embodiment can be configured according to demand, and can usually be set to 30 electrodes. In this embodiment, the two output terminals of the power module 1 with opposite polarities are respectively the output terminal of the positive pole and the output terminal of the negative pole. After these two output terminals are connected to any electrode, the polarity corresponding to the electrode is determined. According to the connection relationship between the electrodes and the output terminals in the electrode pairs in this embodiment: two electrodes adjacent to each other in an electrode pair are respectively connected to the two output terminals of the power module 1, and two electrodes adjacent to each other belonging to different electrode pairs are connected to the same output terminal of the power module 1. Taking ten electrodes as an example, the round brackets are one electrode pair, and the square brackets are the electrode polarities corresponding to the plurality of electrode pairs arranged in order of position. The polarity setting can have the following two schemes:

[0041] a.[(+,-),(-,+),(+,-),(-,+),(+,-)];

[0042] b.[(-,+),(+,-),(-,+),(+,-),(-,+)];

[0043] In general, the ablation catheter 2 should include at least one electrode pair; it can also switch between different schemes to adjust the position of the working electrode pair, such as switching between schemes a and b, so that when the ablation catheter 2 is not physically moved, the action area of ​​the electrical path is changed by moving the position of the working electrode pair. For the same ten electrodes, the polarity setting idea in the prior art is that the polarities of adjacent electrodes are opposite, that is:

[0044] [+, -, +, -, +, -, +, -, +, -];

[0045] At this time, there is no isolated electrode pair, and any electrode and its adjacent electrode become a working electrode pair.

[0046] It is understandable that two electrodes with the same polarity will not be conductive. At this time, the equivalent resistance between the contact resistance of the two electrodes and their contact points and the target resistance between the two contact resistances is extremely large, and it is generally considered difficult to conduct. Two electrodes with opposite polarities are more likely to conduct, and two adjacent electrodes with opposite polarities are more likely to establish an electrical path between the contact resistance of the two electrodes and their contact points and the target resistance between the two contact resistances.

[0047] According to the above description, the equivalent circuit diagram of the prior art can be obtained, such as Figure 2 As shown, Figure 2 The electrode pairs are not isolated. Each electrode has opposite polarity to the adjacent electrodes on the left and right and establishes an electrical path. The contact resistance R of the adjacent electrodes 接触 Multiplexing produces a voltage-dividing effect, resulting in a target resistance R 通路 The voltage is reduced, that is, the voltage applied to the patient impedance is lower; in the connection structure of the power module 1 and the ablation catheter 2 in this embodiment, only the two electrodes in the electrode pair can establish an electrical path. Even if there are adjacent electrodes facing the outside of the electrode, they will not establish a path with the electrodes in the electrode pair due to the same polarity. The equivalent circuit is as follows Figure 3 As shown, each electrode pair exists in isolation, and there is no contact resistance R of two electrical paths. 接触 In the case of , the equivalent contact impedance is lower, so the target resistance R 通路 The voltage is higher and the equivalent electric field strength is more ideal.

[0048] For further information, see Figure 1 and Figure 4 As shown, in terms of specific structure, the power module 1 includes:

[0049] A power supply circuit 11 including a plurality of switch tubes;

[0050] The pulse controller 12 controls the on and off of the switch tube according to the first preset frequency so that the power supply circuit 11 outputs positive pulses and negative pulses respectively through two output terminals.

[0051] It can be understood that the power supply circuit 11 mainly includes a power supply and a switch tube. When the switch tube is turned on, the power supply outputs a voltage to the output end, so that the electrodes are electrically connected.

[0052] Furthermore, from the perspective of safety and effect, the output of the power supply is usually direct current, so the power supply may include AC220V mains, an AC / DC conversion unit that converts AC220V to DC23V, a DC / DC conversion unit, and a voltage-stabilizing capacitor. Furthermore, considering the voltage output of different gears, two DC / DC conversion units may be set. These two DC / DC conversion units use two voltage regulation control logics to output two voltages HV1+ and HV2+ respectively, and correspond to two voltage-stabilizing capacitors C1 and C2, and add a single-pole double-throw voltage selection switch SPDT1 for selecting the voltage gear.

[0053] It can be understood that the power module 1 outputs positive voltage and negative voltage at the two output terminals at the same time, and uses the on-off control of the switch tube on the power supply circuit 11 to control the connection between the power supply and the electrode pair. Further, considering the flexible selection of the polarity of the two output terminals, the switch tubes Q1-Q4 are set to a fully controlled inverter structure, and the polarity of the two output terminals has two opposite situations: the switch tubes Q1 and Q4 are turned on, and the switch tubes Q2 and Q3 are turned on. Furthermore, the voltage output of the output terminal is expressed in the form of a pulse in the time domain, which is achieved by sending a pulse signal to the driving end of the switch tubes Q1-Q4 through the pulse controller 12, such as Figure 4 When Q1 and Q4 are turned on, they output positive pulse pulse+ and negative pulse pulse- respectively. The frequency corresponding to the pulse signal and the pulse voltage is the first preset frequency, which is set according to work requirements. The voltage measurement unit and the current measurement unit can also be set to monitor and protect the current and voltage of the pulse voltage.

[0054] Furthermore, the pulsed electric field ablation system in this embodiment also includes a switching array 3 , and a plurality of electrodes, namely electrode 1 -electrode n, and a back plate of the ablation catheter 2 are connected to the output end of the power module 1 via switches of the switching array 3 .

[0055] It can be understood that the switch array 3 is provided with a plurality of switches, and each electrode can be connected to the two output terminals of the power module 1 through a switch. Specifically, the switch here can be a single-pole double-throw switch in which the moving end is connected to the electrode and the two fixed ends are respectively connected to the two output terminals, or a switch pair, which includes two switches whose first ends are both connected to the switch and whose second ends are respectively connected to the two output terminals and which are not closed at the same time, such as Figure 4 shown.

[0056] It can be understood that the existence of these switches provides each electrode with the condition to be connected to any output terminal of the power module 1. According to work requirements, an array controller can be added to set the second preset frequency to control the on and off of the switch, thereby moving the position of at least one electrode pair to adjust the range of action of the ablation catheter 2.

[0057] Furthermore, in addition to multiple electrode pairs, the ablation catheter 2 may also include one or more suspended electrodes, and the suspended electrodes are not connected to the two output ends of the power module 1. The suspended electrodes and the electrodes in the electrode pairs are arranged on the ablation catheter 2 according to a certain rule. In addition to requiring that the positions of the two electrodes in a pair of electrode pairs must be adjacent, the positions between electrode pairs, between suspended electrodes, and between electrode pairs and suspended electrodes can be adjusted according to needs.

[0058] In order to further avoid the influence of multiplexing voltage division caused by the contact resistance between similar electrodes, only two electrodes separated by the suspended electrode are connected to the same output terminal of the power module 1 .

[0059] Still taking ten electrodes as an example, 0 represents a suspended electrode, and the position of the suspended electrode can be set between the electrode pairs, such as:

[0060] [(+, -), (0), (0), (-, +), (0), (+, -), (0)];

[0061] It is understandable that determining an electrode as a suspended electrode and other positive electrodes or negative electrodes can be determined according to the state of the switch corresponding to the electrode in the switching array 3. When the switch is not connected to both output ends of the power module 1, the electrode serves as a suspended electrode.

[0062] For further information, see Figure 5 As shown, the ablation catheter 2 specifically includes:

[0063] A handle 21, a catheter 22, a plurality of electrodes 23 located at the head end of the catheter 22, and a plurality of wires located inside the handle 21 and the catheter 22, connected one by one with the plurality of electrodes 23, and receiving pulse signals.

[0064] The plurality of electrodes 23 located at the head end of the catheter 22 are specifically a certain electrode in an electrode pair or a suspended electrode.

[0065] Furthermore, a plurality of electrodes 23 are distributed along the long axis direction of the catheter 22, and usually an ablation catheter 2 may include up to 30 electrodes. It is understandable that the head end of the catheter 22 is a flexible tube with a changeable shape, so in addition to the straight axis state, the spatial structure of the head end of the catheter 22 in the working state can be changed to a ring shape, a spiral shape or a basket shape, and the specific shape can be designed according to actual needs.

[0066] Furthermore, finite element simulation calculations are performed on the pulse electric field ablation system in this embodiment and the prior art, respectively. Figure 6a and Figure 6b are respectively the effective ranges of the pulse electric field ablation system with annular electrode distribution in this embodiment and the prior art. The maximum effective depth of this embodiment is increased by about 20%. Figure 7a and Figure 7b 4 and 4 are effective ranges of the pulse electric field ablation system with long axis distribution of electrodes in the present embodiment and the prior art, respectively. The maximum effective depth of the present embodiment is increased by about 30%, which shows that the present embodiment can generate an ideal and significant electric field strength.

[0067] The present application discloses a pulsed electric field ablation system, comprising: a power module including two output terminals with opposite polarities; an ablation catheter including a plurality of electrode pairs; wherein each electrode pair includes a pair of electrodes located adjacently and respectively connected to the two output terminals of the power module; two electrodes located adjacently and belonging to different electrode pairs are connected to the same output terminal of the power module. In the present application, the adjacent electrodes have opposite polarities only when they are in the same electrode pair, and there is no situation where the polarity of one electrode is opposite to that of the two adjacent electrodes. Therefore, the contact resistance of the adjacent electrodes will not reuse the voltage division, the voltage of the target resistance on the electrical path of the electrode pair is higher, and the electric field strength is more ideal.

[0068] Accordingly, the embodiment of the present application further discloses a control method of a pulsed electric field ablation system, which is applied to the pulsed electric field ablation system described in any of the above embodiments. The control method includes:

[0069] determining a plurality of electrode pairs of the ablation catheter, wherein the electrode pairs include a pair of electrodes located adjacent to each other;

[0070] According to the electrode connection rule, a plurality of electrode pairs are connected to two output ends of the power module with opposite polarities, wherein the electrode connection rule is specifically as follows:

[0071] A pair of electrodes in each of the electrode pairs are respectively connected to the two output terminals of the power module;

[0072] Two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module.

[0073] In the present application, adjacent electrodes have opposite polarities only when they are in the same electrode pair. There is no situation where the polarity of one electrode is opposite to that of two adjacent electrodes. Therefore, the contact resistance of adjacent electrodes will not reuse the voltage divider, the voltage of the target resistance on the electrical path of the electrode pair is higher, and the electric field strength is more ideal.

[0074] Finally, it should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the statement "comprise a ..." do not exclude the presence of other identical elements in the process, method, article or device including the elements.

[0075] The pulsed electric field ablation system and its control method provided by the present invention are introduced in detail above. Specific examples are used in this article to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea; at the same time, for general technical personnel in this field, according to the idea of ​​the present invention, there will be changes in the specific implementation method and application scope. In summary, the content of this specification should not be understood as a limitation on the present invention.

Claims

1. A pulsed electric field ablation system, characterized in that: include: A power module including two output terminals with opposite polarities; an ablation catheter including a plurality of electrode pairs; An array controller is included, which is used to control the switch to switch the electrode array on and off to change the position of the electrode pair; Each of the electrode pairs includes a pair of electrodes that are adjacent to each other and are respectively connected to the two output terminals of the power module; two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module; Among them, adjacent electrodes have opposite polarities when they are in the same electrode pair; The polarity states of each electrode include: positive polarity, negative polarity and floating; The position settings of the suspended electrodes include: between electrode pairs; The two electrodes separated only by the suspended electrode have the same polarity.

2. The pulsed electric field ablation system according to claim 1, characterized in that: The ablation catheter further includes one or more suspended electrodes, and the suspended electrodes are not connected to the two output ends of the power module.

3. The pulsed electric field ablation system according to claim 2, characterized in that: Only two of the electrodes separated by the suspended electrode are connected to the same output terminal of the power module.

4. The pulsed electric field ablation system according to claim 1, characterized in that: The power module comprises: A power supply circuit comprising a plurality of switching tubes; A pulse controller controls the on and off of the switch tube according to a first preset frequency so that the power supply circuit outputs positive pulses and negative pulses respectively through the two output terminals.

5. The pulsed electric field ablation system according to claim 4, characterized in that: It also includes a switching array, and the plurality of electrodes are connected to the output end of the power module through switches of the switching array.

6. The pulsed electric field ablation system according to claim 5, characterized in that: The switch array controls the on and off of switches according to a second preset frequency to move the position of at least one of the electrode pairs.

7. The pulsed electric field ablation system according to any one of claims 1 to 6, characterized in that: The ablation catheter specifically comprises: A handle, a catheter, a plurality of electrodes located at the head end of the catheter, and a plurality of wires located inside the handle and the catheter, connected one by one with the plurality of electrodes, and receiving pulse signals.

8. The pulsed electric field ablation system according to claim 7, characterized in that: The plurality of electrodes are distributed along the long axis direction of the catheter.

9. The pulsed electric field ablation system according to claim 8, characterized in that: In the working state, the spatial structure of the head end of the catheter is transformed into a ring shape, a spiral shape or a basket shape.

10. A control method for a pulsed electric field ablation system, characterized in that: Applied to the pulsed electric field ablation system according to any one of claims 1 to 9, the control method comprises: determining a plurality of electrode pairs of the ablation catheter, wherein the electrode pairs include a pair of electrodes located adjacent to each other; According to the electrode connection rule, a plurality of electrode pairs are connected to two output ends of the power module with opposite polarities, and the array controller is used to control the switch to switch the electrode array on and off to change the position of the electrode pairs; The electrode connection rule is specifically as follows: A pair of electrodes in each of the electrode pairs are respectively connected to the two output terminals of the power module; Two electrodes that are adjacent to each other and belong to different electrode pairs are connected to the same output terminal of the power module; Among them, adjacent electrodes have opposite polarities when they are in the same electrode pair; The polarity states of each electrode include: positive polarity, negative polarity and floating; The position settings of the suspended electrodes include: between electrode pairs; The two electrodes separated only by the suspended electrode have the same polarity; Includes an array controller for controlling the on and off of switches.

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