Pulse field ablation device

Abstract

The utility model discloses a pulsed field ablation device which comprises a sleeve, and an impedance detection electrode is arranged at the top end of the sleeve. The deformation supporting body can extend out of the interior of the cannula through deformation and then is unfolded, and a plurality of pulse field ablation electrodes are arranged on the deformation supporting body; the pulse field ablation power supply is used for supplying power to the pulse field ablation electrode; the impedance detection module is used for recording the impedance of the impedance detection electrode; and the switch control module is used for controlling the on-off state of the pulse field ablation power supply according to the magnitude of the impedance detection signal.

Description

Technical Field

[0001] The utility model relates to the technical field of pulse field ablation, in particular to a pulse field ablation device. Background Art

[0002] Pulsed Field Ablation technology generates unstable electric potential by applying high-voltage electric pulses to cell membranes in a short period of time, thereby causing irreversible penetrating damage and leading to cell death. After irreversible electroporation treatment, the treated area can be replaced by normal cells in a short period of time to restore its original function.

[0003] Impedance is used in radiofrequency ablation to indicate the degree of successful tissue ablation. In fact, impedance is used as an indicator to determine when to stop energy supply and end ablation during ablation surgery. Examples include Hologic's NoSure and Cardia's endometrial ablation devices. However, in pulsed field ablation, there is no such clear relationship, and no such indicator is currently used in ablation strategies. Usually, only one of the following energy control strategies is used: isopower or isothermal. In order to better control the energy supply endpoint of pulsed field ablation, a pulsed field ablation electrode device based on impedance control of the energy supply endpoint of pulsed field ablation is proposed. Utility Model Content

[0004] The utility model aims to provide an electrode pulse field ablation electrode device based on impedance-controlled energy supply endpoint of pulse field ablation. The above-mentioned purpose can be achieved through the implementation of the following technical solutions:

[0005] A pulsed field ablation device, comprising:

[0006] A sleeve, wherein an impedance detection electrode is provided on the top of the sleeve;

[0007] A deformable support body, which can be extended from the inside of the sleeve by deformation and then unfolded, and a plurality of pulsed field ablation electrodes are arranged on the deformable support body;

[0008] A pulsed field ablation power supply, used to supply power to the pulsed field ablation electrodes;

[0009] An impedance detection module, used for recording impedance data between each pulsed field ablation electrode and the impedance detection electrode and impedance data between each pulsed field ablation electrode;

[0010] The switch control module is used to control the switch state of the pulsed field ablation power supply according to the size of the impedance detection signal.

[0011] Optionally, the deformable support body includes a plurality of support parts, each support part is provided with two support rods, the surfaces of the support rods are insulated, and each support rod is provided with a pulsed field ablation electrode.

[0012] Optionally, each support rod is provided with at least two pulsed field ablation electrodes.

[0013] Optionally, the deformed support body is in a petal shape.

[0014] Optionally, the top ends of the two support rods in each support portion are connected to each other. By connecting the top ends to each other, the deformable support body can be kept in a relatively regular shape during the unfolding process of the deformable support body, and the spacing between the pulse field ablation electrodes can be maintained to ensure the accuracy of the impedance test process. It can also prevent the top end of the deformable support body from scratching the tissue.

[0015] Optionally, the top ends of the two support rods in each support portion are connected to each other via a connecting line.

[0016] Optionally, the support rod is made of a surface-insulated memory alloy.

[0017] Optionally, a guide wire is also provided inside the sleeve.

[0018] Optionally, the impedance detection electrode and the pulsed field ablation electrode are both connected to a pulsed field ablation power supply and an impedance detection module via a wire disposed inside the sleeve.

[0019] Optionally, an operating handle is provided at the bottom of the sleeve.

[0020] Optionally, the pulsed field ablation device also includes a sheath.

[0021] The technical solution of the utility model has the following advantages:

[0022] The utility model sets an impedance detection electrode on the sleeve of the pulse field ablation electrode, and the impedance detection electrode cooperates with the pulse field ablation electrode to fully reflect the impedance value of each part of the tissue undergoing pulse field ablation. During the pulse field ablation process, the impedance value of the ablated tissue will gradually decrease, and the level of impedance reduction after the ablation is completed will reach a statistically significant difference. Based on this difference, the switch control module can determine the end point of the ablation completion, so the utility model can effectively avoid side effects caused by excessive energy supply. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the utility model or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1It is a schematic diagram of the overall structure of the pulsed field ablation device;

[0025] Figure 2 is a schematic diagram of the contraction state of the deformed support body;

[0026] Figure 3 is a schematic diagram of the deformed support body in an open state;

[0027] Figure 4 It is a schematic diagram of the treatment of tissue by pulsed field ablation electrodes;

[0028] Figure 5 is the local impedance reduction value diagram in the test case; Figure 5 A is the average local impedance reduction value diagram, Figure 5 B is a graph showing the reduction in local impedance at different locations. DETAILED DESCRIPTION

[0029] Now, various exemplary embodiments of the present invention are described in detail. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics and embodiments of the present invention. It should be understood that the terms described in the present invention are only used to describe specific embodiments and are not used to limit the present invention.

[0030] In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the range are also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the range.

[0031] Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art in the field of the utility model. Although the utility model only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the utility model.

[0032] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0033] Example 1

[0034] like Figures 1 to 4 The pulsed field ablation device shown includes: a sleeve 2, an impedance detection electrode 5, a deformable support 3, a pulsed field ablation electrode 32, a pulsed field ablation power supply, an impedance detection module, and a switch control module.

[0035] The function of the sleeve 2 is to deliver the pulsed field ablation electrode to the location that needs to be treated, such as Figure 1 As shown, the device is also provided with a sheath tube 1 matched with the cannula 2. When in use, the sheath tube 1 and the guide wire are first used for positioning, and then the cannula 2 is inserted into the sheath tube 1 so that the top of the cannula 2 reaches the part to be treated. Figure 2 , 3 As shown, an impedance detection electrode 5 is provided on the top of the sleeve 2, and the deformable support body 3 is folded inside the sleeve 2. When in use, the deformable support body 3 is pushed out from the sleeve 2, and the deformable support body 3 can be extended from the inside of the sleeve by its own deformation and then unfolded.

[0036] like Figure 3 As shown, after the deformable support body is opened, a petal-shaped structure is formed, which includes a plurality of diamond-shaped support parts, each of which is provided with two support rods 31, and the support rods 31 are made of a surface-insulated memory alloy, and each support rod 31 is provided with two pulse field ablation electrodes 32. The top ends of the two support rods in each support part are connected to each other through a connecting line 33. By connecting the top ends to each other, the deformable support body can be maintained in a relatively regular shape during the unfolding process of the deformable support body, and the spacing between each pulse field ablation electrode can be maintained to ensure the accuracy of the impedance test process. It can also prevent the top end of the deformable support body from scratching the tissue.

[0037] like Figure 4 As shown, after the deformable support body 3 extends out from the inside of the sleeve 2 and is unfolded, each pulse field ablation electrode 32 can be in close contact with the tissue 7 at the site to be treated.

[0038] An operating handle 4 is provided at the bottom of the sleeve 2, and the operating handle 4 can control the position of the sleeve and the extension and retraction of the deformable support body 3. The impedance detection electrode 5 and each pulsed field ablation electrode are connected with a wire, which is arranged inside the sleeve 2 and passes through the bottom of the operating handle 4 to connect each electrode with an external device.

[0039] These external devices include:

[0040] The pulse field ablation power supply is used to supply power to the pulse field ablation electrodes; after the pulse field ablation electrodes are energized, high voltage electric pulses are generated to perform pulse field ablation treatment on the treated area.

[0041] An impedance detection module, used for recording impedance data between each pulsed field ablation electrode and the impedance detection electrode and impedance data between each pulsed field ablation electrode;

[0042] The switch control module is used to control the switch state of the pulse field ablation power supply according to the size of the impedance detection signal. During the pulse field ablation process, the impedance value of the ablated tissue will gradually decrease, and the level of impedance reduction after the ablation is completed will reach a statistically significant difference. Based on this difference, the switch control module can accurately determine the end point of the ablation. Therefore, the utility model can effectively avoid side effects caused by excessive energy supply.

[0043] The impedance detection module and the switch control module can be integrated on an intelligent device (such as a computer) to perform signal detection, recording, analysis and switch control.

[0044] Test example

[0045] This embodiment provides a pulsed field ablation control method, comprising the following steps:

[0046] Step 1) delivering the pulsed field ablation electrode device to the tissue location to be treated.

[0047] Step 2) The deformable support body can be extended from the inside of the sleeve by deformation and then unfolded, so that the pulsed field ablation electrode on the deformable support body is closely fitted to the tissue to be treated.

[0048] Step 3) Power is supplied to each impedance detection electrode to record the overall impedance and local impedance; the overall impedance is the impedance between all pulsed field ablation electrodes and the impedance detection electrodes; the local impedance includes the impedance between each pulsed field ablation electrode and the impedance detection electrode and the impedance between each pulsed field ablation electrode.

[0049] Step 4) The pulsed field ablation electrode is discharged, and the local impedance is recorded in real time during the discharge, and it is calculated whether the local impedance is statistically substantially different from the local impedance before the discharge.

[0050] Step 5) When the local impedance detected in real time shows a statistically substantial difference from the local impedance before discharge, the pulsed field ablation electrode stops discharging.

[0051] Alternatively, when there is a statistically substantial difference between the local impedance detected in real time and the local impedance before discharge, the pulsed field ablation electrode may stop discharging after the difference is maintained for a period of time (such as after a few more pulse beats).

[0052] The following is a specific example of the detection process:

[0053] Step 1) delivering the pulsed field ablation electrode device to the tissue location to be treated.

[0054] Step 2) The deformable support body can be extended from the inside of the sleeve by deformation and then unfolded, so that the pulsed field ablation electrode on the deformable support body is closely fitted to the tissue to be treated.

[0055] Step 3) Power on each impedance detection electrode and record the overall impedance and local impedance; the overall impedance is the impedance between all pulsed field ablation electrodes and the impedance detection electrode; the local impedance includes the impedance between each pulsed field ablation electrode and the impedance detection electrode and the impedance between each pulsed field ablation electrode. The impedance detection module detects that the average local impedance of each electrode in this embodiment is 124.3±5Ω.

[0056] Step 4) The pulsed field ablation electrode discharges, and the local impedance is recorded in real time during the discharge, and it is calculated whether the local impedance is statistically substantially different from the local impedance before the discharge. The local impedance value gradually decreases during the discharge process. Figure 4 As shown in the figure, after about 20 minutes of discharge treatment, the impedance detection module detected that the local impedance average value was reduced to 96.8±6Ω. According to statistical calculation, P<0.0001, reaching a significant difference. After calculation, the impedance of the front, lower, rear, and upper parts of the treatment position decreased by 28.0±5, 26.5±9, 26.8±3, and 28.8±10Ω, respectively.

[0057] Step 5) The switch control module controls the pulsed field ablation electrode to stop discharging.

[0058] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention of the utility model.

Claims

1. A pulsed field ablation device, characterized in that: include A sleeve, wherein an impedance detection electrode is provided on the top of the sleeve; A deformable support body, which can be extended from the inside of the sleeve by deformation and then unfolded, and a plurality of pulsed field ablation electrodes are arranged on the deformable support body; A pulsed field ablation power supply, used to supply power to the pulsed field ablation electrodes; An impedance detection module, used for recording impedance data between each pulsed field ablation electrode and the impedance detection electrode and impedance data between each pulsed field ablation electrode; The switch control module is used to control the switch state of the pulsed field ablation power supply according to the size of the impedance detection signal.

2. The pulsed field ablation device according to claim 1, characterized in that: The deformable support body comprises a plurality of support parts, each support part is provided with two support rods, the surface of the support rods is insulated, and each support rod is provided with a pulsed field ablation electrode.

3. The pulsed field ablation device according to claim 2, characterized in that: The top ends of the two support rods in each support portion are connected to each other.

4. The pulsed field ablation device according to claim 3, characterized in that: The top ends of the two support rods in each support portion are connected to each other through a connecting line.

5. The pulsed field ablation device according to claim 2, characterized in that: The support rod is made of a surface-insulated memory alloy.

6. The pulsed field ablation device according to claim 2, characterized in that: The support portion is a diamond-shaped support portion surrounded by two support rods.

7. The pulsed field ablation device according to claim 1, characterized in that: The impedance detection electrode and the pulsed field ablation electrode are both connected to the pulsed field ablation power supply and the impedance detection module through a wire arranged inside the sleeve.

8. The pulsed field ablation device according to claim 2, characterized in that: Each support rod is provided with at least two pulsed field ablation electrodes.

9. The pulsed field ablation device according to claim 1, characterized in that: An operating handle is provided at the bottom of the sleeve.

10. The pulsed field ablation device according to claim 1, characterized in that: The pulsed field ablation device also includes a sheath.

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