Pulse field ablation device and pulse field ablation control method

Abstract

The invention discloses a pulsed field ablation device and a pulsed field ablation control method. The pulsed field ablation device 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 present invention relates to the technical field of pulsed field ablation, and in particular to a pulsed field ablation device and a pulsed field ablation control method. Background Art

[0002] Pulsed Field Ablation (PFA) technology applies high-voltage electric pulses to cell membranes in a short period of time to generate unstable electric potential, 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, thereby restoring its original function.

[0003] In radiofrequency ablation, impedance is used to indicate the degree of successful tissue ablation. In fact, impedance is used as a metric to determine when to terminate energy delivery during ablation procedures. Examples include Hologic's Nosocomial and Cardia endometrial ablation devices. However, in pulsed field ablation, no such clear relationship exists, and such an indicator is not currently employed in ablation strategies. Typically, only one of the following energy control strategies is used: isopower or isothermal. To better control the energy delivery endpoint of pulsed field ablation, a pulsed field ablation electrode device and a pulsed field ablation control method are described. Summary of the Invention

[0004] The present invention aims to provide an electrode device and a pulsed field ablation control method for controlling the energy supply endpoint of pulsed field ablation based on impedance control. The above-mentioned object 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 expanded, and a plurality of pulsed field ablation electrodes are provided on the deformable support body;

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

[0009] An impedance detection module, configured to record impedance data between each pulsed field ablation electrode and the impedance detection electrode, as well as 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, the deformed support body is in a petal shape.

[0013] Optionally, the top ends of the two support rods in each support portion are interconnected. This interconnection maintains the deformable support body's relatively regular shape during deployment, maintains the spacing between the pulsed field ablation electrodes, and ensures accuracy during impedance testing. It also prevents the deformable support body's top end from scratching tissue.

[0014] Optionally, the top ends of the two support rods in each support portion are connected to each other via a connecting line.

[0015] Optionally, the support rod is made of surface-insulated memory alloy.

[0016] Optionally, a guide wire is further provided inside the sleeve.

[0017] Optionally, 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 via a wire disposed inside the cannula.

[0018] Optionally, an operating handle is provided at the bottom of the sleeve.

[0019] Optionally, the pulsed field ablation device further includes a sheath.

[0020] A pulsed field ablation control method comprises the following steps:

[0021] Step 1) delivering the pulsed field ablation electrode device to the tissue location to be treated;

[0022] Step 2) the deformable support body can be extended from the interior of the cannula by deformation and then expanded, so that the pulsed field ablation electrode on the deformable support body is closely fitted to the tissue to be treated;

[0023] Step 3) energizing each pulsed field ablation electrode and recording the local impedance of each pulsed field ablation 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;

[0024] Step 4) the pulsed field ablation electrode discharges, and the local impedance is recorded in real time during the discharge, and whether the local impedance is statistically substantially different from the local impedance before the discharge is calculated;

[0025] 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.

[0026] Optionally, the step 3) further includes recording the overall impedance: the overall impedance is the impedance between all the impedance detection electrodes and the pulsed field ablation electrodes.

[0027] Optionally, 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 stops discharging after the difference is maintained for a period of time.

[0028] The technical solution of the present invention has the following advantages:

[0029] The present invention incorporates an impedance detection electrode on the sleeve of the pulsed field ablation electrode. The impedance detection electrode and the pulsed field ablation electrode work together to comprehensively reflect the impedance values ​​at all locations in the tissue undergoing pulsed field ablation. During the pulsed field ablation process, the impedance value of the ablated tissue gradually decreases, and after ablation is complete, the impedance reduction level reaches a statistically significant level. Based on this difference, the switch control module can accurately determine the endpoint of ablation completion. Therefore, the present invention can effectively avoid side effects caused by excessive energy supply. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0031] Figure 1 This is a schematic diagram of the overall structure of the pulsed field ablation device;

[0032] Figure 2 Schematic diagram of the deformed support body in a contracted state;

[0033] Figure 3 Schematic diagram of the deformed support body in the expanded state;

[0034] Figure 4 It is a schematic diagram of the pulsed field ablation electrode treating tissue;

[0035] Figure 5 is a graph of the local impedance reduction value in Example 3; wherein 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

[0036] Various exemplary embodiments of the present invention are now 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, features, and embodiments of the present invention. It should be understood that the terms used in the present invention are only for describing specific embodiments and are not intended to limit the present invention.

[0037] In addition, for numerical ranges in the present invention, it is understood that each intervening value between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated value or stated range, and any other stated value or intervening value in the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention.

[0039] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0040] Example 1

[0041] like Figures 1 to 4 The pulsed field ablation device shown includes: a cannula 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.

[0042] The function of the cannula 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. The deformable support body 3 can be extended from the inside of the sleeve by its own deformation and then unfolded.

[0043] like Figure 3As shown, after the deformable support body is unfolded, it forms a petal-shaped structure, which includes multiple diamond-shaped support parts. Each support part is equipped with two support rods 31. The support rods 31 are made of a surface-insulated memory alloy. Each support rod 31 is equipped with two pulsed field ablation electrodes 32. The top ends of the two support rods in each support part are interconnected by a connecting wire 33. Connecting the top ends can maintain the deformable support body in a relatively regular shape during the expansion process of the deformable support body, maintain the spacing between the pulsed field ablation electrodes, and ensure the accuracy of the impedance testing process. It can also prevent the top of the deformable support body from scratching the tissue.

[0044] like Figure 4 As shown, after the deformable support body 3 extends from the inside of the sleeve 2 and is unfolded, each pulsed field ablation electrode 32 can be in close contact with the tissue 7 at the site to be treated.

[0045] An operating handle 4 is provided at the bottom of the cannula 2, which controls the cannula's position and the extension and retraction of the deformable support 3. The impedance detection electrode 5 and each pulsed field ablation electrode are connected to a wire that runs along the interior of the cannula 2 and exits from the bottom of the operating handle 4, connecting each electrode to an external device.

[0046] These external devices include:

[0047] The pulsed field ablation power supply is used to supply power to the pulsed field ablation electrodes; when the pulsed field ablation electrodes are energized, high-voltage electric pulses are generated to perform pulsed field ablation on the treated area.

[0048] An impedance detection module, configured to record impedance data between each pulsed field ablation electrode and the impedance detection electrode, as well as impedance data between each pulsed field ablation electrode;

[0049] The switch control module is used to control the on / off state of the pulsed field ablation power supply based on the magnitude of the impedance detection signal. During pulsed field ablation, the impedance of the ablated tissue gradually decreases, and the level of impedance reduction after ablation is complete reaches a statistically significant difference. Based on this difference, the switch control module can accurately determine the end point of ablation completion. Therefore, the present invention can effectively avoid side effects caused by excessive energy supply.

[0050] The impedance detection module and the switch control module can be integrated into an intelligent device (such as a computer) to perform signal detection, recording, analysis and switch control.

[0051] Example 2

[0052] This embodiment provides a pulsed field ablation control method, comprising the following steps:

[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 expanded, 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 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.

[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.

[0057] 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.

[0058] 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 (eg, after a few more pulse beats).

[0059] Example 3

[0060] This embodiment provides a specific process of performing pulsed field ablation using the pulsed field ablation control method in the above-mentioned embodiment 2.

[0061] Step 1) Delivering the pulsed field ablation electrode device to the tissue location to be treated.

[0062] Step 2) The deformable support body can be extended from the inside of the sleeve by deformation and then expanded, so that the pulsed field ablation electrode on the deformable support body is closely fitted to the tissue to be treated.

[0063] Step 3) Power was applied to each impedance detection electrode, and the overall impedance and local impedance were recorded. The overall impedance was the impedance between all pulsed field ablation electrodes and the impedance detection electrode. The local impedance included the impedance between each pulsed field ablation electrode and the impedance detection electrode, as well as the impedance between each pulsed field ablation electrode. The impedance detection module detected an average local impedance of 124.3 ± 5 Ω for each electrode in this embodiment.

[0064] Step 4) The pulsed field ablation electrode discharges, and the local impedance is recorded in real time during the discharge, and the local impedance is calculated to see whether it is statistically significantly different from the local impedance before the discharge. The local impedance value gradually decreases during the discharge process. Figure 4As shown, approximately 20 minutes after discharge treatment, the impedance detection module detected a decrease in the local average impedance to 96.8 ± 6 Ω. This difference reached a statistically significant level (P < 0.0001). The impedance at the anterior, inferior, posterior, and superior parts of the treated area decreased by 28.0 ± 5 Ω, 26.5 ± 9 Ω, 26.8 ± 3 Ω, and 28.8 ± 10 Ω, respectively.

[0065] Step 5) The switch control module controls the pulsed field ablation electrode to stop discharging.

[0066] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

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 expanded, and a plurality of pulsed field ablation electrodes are provided on the deformable support body; Pulsed field ablation power supply, used to power the pulsed field ablation electrodes; An impedance detection module, configured to record impedance data between each pulsed field ablation electrode and the impedance detection electrode, as well as 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 surfaces of the support rods are 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 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 via a wire arranged inside the sleeve.

8. A pulsed field ablation control method, characterized in that: The steps include: Step 1) delivering the pulsed field ablation electrode device to the tissue location to be treated; Step 2) the deformable support body can be extended from the interior of the cannula by deformation and then expanded, so that the pulsed field ablation electrode on the deformable support body is closely fitted to the tissue to be treated; Step 3) energizing each pulsed field ablation electrode and recording the local impedance of each pulsed field ablation 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; Step 4) the pulsed field ablation electrode discharges, and the local impedance is recorded in real time during the discharge, and whether the local impedance is statistically substantially different from the local impedance before the discharge is calculated; 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.

9. The method according to claim 8, characterized in that The step 3) further includes recording the overall impedance: the overall impedance is the impedance between all the impedance detection electrodes and the pulsed field ablation electrodes.

10. The method according to claim 8, characterized in that In step 5), 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 stops discharging after the difference is maintained for a period of time.

Images