An ablation system and method

Abstract

This invention provides an ablation system and method. The system includes: a radiofrequency ablation device and a catheter. The catheter includes a slender tube body and a distal treatment segment. The distal treatment segment is configured with multiple pairs of treatment electrodes, each pair of treatment electrodes being connected via an amplifier to acquire the potential difference between the individual treatment electrodes; or the distal treatment segment is configured with at least two treatment electrodes, each treatment electrode being connected via an amplifier to acquire the potential difference between the treatment electrodes; or the distal treatment segment is configured with at least one treatment electrode and one reference electrode, the treatment electrode and the reference electrode being connected via an amplifier to acquire the potential difference between the treatment electrode and the reference electrode. The radiofrequency ablation device determines whether the current treatment location is a densely nerve-rich area based on the amplitude of the potential difference, and outputs radiofrequency energy through the treatment electrode when the determination is yes. This scheme ensures that the treatment targets only densely nerve-rich areas and avoids insufficient treatment or excessive energy release.

Description

Technical Field

[0001] This invention relates to the field of ablation therapy technology, and more particularly to an ablation system and method. Background Technology

[0002] Renal sympathetic denervation (RDN) is a well-established interventional treatment for hypertension. This procedure uses radiofrequency / ultrasound heating to block the sympathetic nervous system surrounding the renal artery, reducing sympathetic nerve tone and thus achieving a long-term blood pressure-lowering effect. Its principle can be summarized in two aspects: first, by inhibiting the activity of sympathetic afferent nerve fibers, it can suppress the over-excitation of the sympathetic system throughout the body, thereby inhibiting abnormal vasoconstriction, suppressing abnormal increases in heart rate, and ultimately controlling blood pressure; second, by inhibiting the activity of renal sympathetic efferent nerves, it can suppress the excessive release of renin, thereby weakening the effect of the renin-angiotensin-aldosterone system on abnormally high systemic blood pressure.

[0003] However, current renal sympathectomy or RDN surgery results in insufficient blood pressure reduction or even an increase in blood pressure in some patients (approximately 20%). This is because only by blocking a certain proportion of the sympathetic nerves can a blood pressure-lowering effect be achieved. However, without any guidance during the procedure, it is difficult to ensure that the ablation targets areas with dense sympathetic nerve fibers, leading to many ablations occurring in non-nervous areas, thus affecting the final treatment outcome.

[0004] Therefore, there is a need for a method that can ensure ablation treatment targets only the densely nerve-rich areas and does not occur in non-densely nerve-rich areas. Summary of the Invention

[0005] The purpose of this invention is to provide an ablation system and method that can ensure that treatment is targeted only at areas with dense nerves, reducing unnecessary energy output and operation time; and can help determine whether the ablation treatment performed on the current location is sufficient to inhibit the nerve activity around it, avoiding situations where the treatment target is not adequately treated or where the treatment effect has been achieved but excessive ablation energy has been released.

[0006] The technical solution provided by this invention is as follows: In a first aspect, this application provides an ablation system, comprising: Radio frequency (RF) devices are used to output radio frequency energy. A catheter, connected to the radiofrequency device, the catheter comprising a slender tube body and a distal treatment segment; The distal treatment segment can be configured with multiple pairs of treatment electrodes, each pair of treatment electrodes being used to acquire the potential at a corresponding location, and each pair of treatment electrodes being connected via a differential amplifier to obtain the potential difference between each individual treatment electrode; or the distal treatment segment can be configured with at least two treatment electrodes, each treatment electrode being used to acquire the potential at a corresponding location, and each treatment electrode being connected via a differential amplifier to obtain the potential difference between each treatment electrode; or the distal treatment segment can be configured with at least one treatment electrode and one reference electrode, each treatment electrode and the reference electrode being used to acquire the potential at a corresponding location, and the treatment electrode and the reference electrode being connected via a differential amplifier to obtain the potential difference between the treatment electrode and the reference electrode. The radiofrequency device determines whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area based on the amplitude of the potential difference, and outputs radiofrequency energy through the treatment electrode when it determines that the current treatment location is a densely nerve-rich area.

[0007] In some implementations, when the temporal amplitude of the potential difference is less than a second threshold, the current treatment location is determined to be a non-nervous-dense region. When the time-domain amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, the current treatment location is determined to be a non-nervous dense region; if the difference is higher than the third threshold, the current treatment location is determined to be a nerve dense region.

[0008] In some embodiments, the radiofrequency device is also used to determine whether to stop the radiofrequency energy output based on the attenuation amplitude of the potential difference at the current treatment position after the radiofrequency energy is output through the treatment electrode. When the potential difference attenuation exceeds the first threshold, the radio frequency energy output is stopped. If the potential difference attenuation amplitude does not exceed the first threshold, radio frequency energy output continues until the potential difference attenuation amplitude exceeds the first threshold.

[0009] In some embodiments, the radio frequency instrument is electrically connected to the conduit via a conduit tail wire for potential difference acquisition and radio frequency energy transfer; The radio frequency device includes: The driver module is used to output radio frequency energy; The acquisition module is electrically connected to the differential amplifier and is used to acquire the potential difference in real time. An analog-to-digital converter is used to convert the potential difference into a digital neural signal; The processor is configured to analyze the digital neural signal, determine whether the current treatment location corresponding to the distal treatment segment is a densely neural region, and control the drive module to output radio frequency energy when the current treatment location is determined to be a densely neural region; the processor is also configured to control the drive module to stop outputting radio frequency energy when the potential difference attenuation amplitude at the current treatment location exceeds a first threshold.

[0010] In some embodiments, the processor is further configured to provide a reminder via a first reminder module when the current treatment location is determined to be a densely populated nerve area, and to provide a reminder via a second reminder module when the current treatment location is determined to be a non-densely populated nerve area.

[0011] In some embodiments, the differential amplifier is disposed at the distal treatment segment, or disposed in the elongated tube and close to the distal treatment segment.

[0012] In some embodiments, the elongated tube and the distal treatment section are hollow structures; the treatment electrode is disposed on the outer surface of the distal treatment section, or a portion of the electrode surface of the treatment electrode is exposed on the distal treatment section.

[0013] Secondly, this application provides an ablation method, comprising: By using at least two treatment electrodes disposed at the distal treatment segment of the catheter, the potential at the position corresponding to each of the treatment electrodes is obtained; The potential difference between the at least two treatment electrodes is obtained by a differential amplifier; The amplitude of the potential difference is used to determine whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area, and when the current treatment location is determined to be a densely nerve-rich area, radiofrequency energy is output through the treatment electrode.

[0014] In some embodiments, determining whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich region based on the amplitude of the potential difference includes: When the temporal amplitude of the potential difference is less than the second threshold, the current treatment location is determined to be a non-nervous dense region. When the time-domain amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, the current treatment location is determined to be a non-nervous dense region; if the difference is higher than the third threshold, the current treatment location is determined to be a nerve dense region.

[0015] In some embodiments, the ablation method provided in this application further includes: After radiofrequency energy is output through the treatment electrode, it is determined whether the radiofrequency energy output needs to be stopped based on the attenuation amplitude of the potential difference at the current treatment position. When the potential difference attenuation exceeds the first threshold, the radio frequency energy output is stopped. If the potential difference attenuation amplitude does not exceed the first threshold, radio frequency energy output continues until the potential difference attenuation amplitude exceeds the first threshold.

[0016] The ablation system and method provided by this invention have at least the following technical effects: 1) The digital samples generated by this application will be processed and analyzed to quantify the degree of neural density at the acquisition location, presenting the originally invisible neural structures to the surgeon in the form of data, ensuring that the treatment can target only the densely neural parts, reducing unnecessary energy output and operation time; 2) The acquisition and analysis of neural signals at a single location can be completed almost instantaneously, and since there is no energy output during the acquisition process, it will not cause any discomfort to the patient. 3) By comparing the characteristic changes of nerve signals at the same location before and after ablation treatment, this application can help determine whether the ablation treatment performed on the current location is sufficient to inhibit the surrounding nerve activity, and can avoid the situation where the treatment target is not adequately treated or the treatment effect has been achieved but excessive ablation energy has been released. 4) This application uses an amplifier placed near the electrodes to amplify the captured analog neural signals before transmitting them to the device. The amplified analog signals can avoid signal distortion caused by electromagnetic interference during long-distance transmission. Attached Figure Description

[0017] The preferred embodiments will now be described in a clear and easy-to-understand manner, with reference to the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages, and implementation methods of this solution.

[0018] Figure 1 This is a schematic diagram of the system structure according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the distal treatment segment of the catheter according to an embodiment of the present invention; Figure 3 This is a schematic diagram of two nerve signals collected at different locations during an animal experiment, according to an embodiment of the present invention. Figure 4 This is a schematic diagram of the neural dense region determination process according to an embodiment of the present invention; Figure 5 This is a time-domain image of neural signals collected at the same location and time before and after the ablation process in an animal experiment, according to an embodiment of the present invention. Figure 6 This is a schematic diagram comparing the time domain of nerve signals captured at the same location before and after the release of non-ablation electrical pulse energy and before and after the release of radiofrequency ablation energy in an animal experiment according to an embodiment of the present invention. Figure 7 This is a schematic diagram of the process for determining whether radio frequency energy output has stopped according to an embodiment of the present invention.

[0019] Numbering on the map: 1-Radio frequency transducer; 2-Driver module; 3-Acquisition module; 4-Analog-to-digital converter; 5-Processor; 6-Catheter tail wire; 7-Catheter; 8-Handle; 9-Slender tube body; 10-Distal treatment segment; 11-Differential amplifier; 12-Treatment electrode. Detailed Implementation

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0021] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0022] Renal sympathetic denervation (RDN) is a well-established interventional treatment for hypertension. This procedure uses radiofrequency / ultrasound heating to block the sympathetic nervous system surrounding the renal artery, reducing sympathetic nerve tone and thus achieving a long-term blood pressure-lowering effect. Its principle can be summarized in two aspects: first, by inhibiting the activity of sympathetic afferent nerve fibers, it can suppress the over-excitation of the sympathetic system throughout the body, thereby inhibiting abnormal vasoconstriction, suppressing abnormal increases in heart rate, and ultimately controlling blood pressure; second, by inhibiting the activity of renal sympathetic efferent nerves, it can suppress the excessive release of renin, thereby weakening the effect of the renin-angiotensin-aldosterone system on abnormally high systemic blood pressure.

[0023] Known RDN (renal renal resection) surgery involves using a catheter to reach both renal arteries via the femoral artery. The catheter is then used to control the release of radiofrequency, ultrasound, or microwave energy in selected areas, locally generating high temperatures in the renal artery intima to block the conduction function of some sympathetic nerve fibers in the renal artery wall. Currently, RDN surgery still faces a significant challenge. Although clinical results for second-generation RDN consistently show that the surgery can significantly reduce patients' blood pressure, in all clinical studies, without exception, a portion (approximately 20%) of patients in the surgical group experienced insufficient blood pressure reduction or even an increase in blood pressure. With the development of RDN surgery in recent years, basic research in the field has gradually revealed the reasons for this phenomenon: 1) Insufficient denervation of the sympathetic nervous system: Almost all studies have shown that only by blocking a certain proportion of the sympathetic nervous system can the effect of lowering blood pressure be achieved. However, without any guidance during the procedure, it is almost impossible to ensure that the ablation can target the denser parts of the sympathetic nerve fibers. This is because a large part of the ablation energy will be wasted in the parts with fewer or no sympathetic nerve fibers, while the ablation energy output to the dense sympathetic nerve parts may not be enough to block their activity.

[0024] 2) Intraoperative blocking of sympathetic inhibitory nerve fibers: In recent years, increasing basic research has identified evidence of the presence of sympathetic-inhibiting innervation around the renal artery using various methods. However, due to the balancing effect between these innervation and sympathetic nerves, blindly blocking sympathetic inhibitory nerves through ablation can actually exacerbate sympathetic activity, leading to worsening symptoms in hypertensive patients. Although methods using pulsed electrical stimulation to artificially activate nerves and observe blood pressure responses to determine the type of innervation in different locations exist, the stimulation itself not only increases surgical time but also increases the difficulty and risk of the procedure due to the intense pain caused during stimulation.

[0025] Therefore, a method is needed to ensure that ablation treatment targets only densely nerve-rich areas and avoids ablation in non-densely nerve-rich areas. This application acquires peripheral autonomic nerve signals coupled within the blood vessel lumen using treatment electrodes on the catheter portion of an interventional treatment system. The captured analog nerve signals are amplified by an amplifier placed near the electrodes before being transmitted to the device. The amplified analog signals avoid signal distortion caused by electromagnetic interference during long-distance transmission. An analog-to-digital converter then digitizes the analog signals to generate digital samples. The generated digital samples are processed and analyzed to quantify the degree of nerve density at the acquisition location, presenting previously invisible neural structures to the operator in data form. Using this method ensures that no densely nerve-rich areas are missed or undertreated during RDN surgery. Compared to existing methods that release stimulating pulse currents, the acquisition and analysis of nerve signals at a single location can be completed almost instantaneously, and since there is no energy output during the acquisition process, it does not cause any discomfort to the patient. The following is a detailed description of this method with reference to the accompanying drawings: In one embodiment, refer to the appendix to the specification. Figure 1 and attached Figure 2 This application provides an ablation system, including a radiofrequency ablation device 1 and a catheter 7. The radiofrequency ablation device 1 is used to output radiofrequency energy. The radiofrequency ablation device 1 is electrically connected to the catheter 7 via a catheter tail wire 6 for potential difference acquisition and radiofrequency energy transfer. The catheter 7 includes a handle 8, a slender tube body 9, and a distal treatment section 10. The slender tube body 9 is made of an elastic material and can be inserted into the lumen of a blood vessel. The handle 8 can be used by the physician to adjust the direction of movement and curvature of the slender tube body 9. The distal treatment section 10 is located at the distal end of the slender tube body 9 and can be close to the area to be treated.

[0026] The distal treatment segment 10 is equipped with a treatment electrode 12. The treatment electrode 12 can be used to collect nerve signals and transmit them to the radiofrequency device 1, and can also serve as a carrier for the radiofrequency energy output by the radiofrequency device 1. The slender tube body 9 and the distal treatment segment 10 are hollow structures; the treatment electrode 12 is disposed on the outer surface of the distal treatment segment 10, or part of the electrode surface of the treatment electrode 12 is exposed in the distal treatment segment 10.

[0027] The radiofrequency energy output from the radiofrequency device 1 is transmitted through the catheter tail wire 6, catheter handle 8, and slender tube body 9 to the treatment electrode 12 located at the distal end. During treatment, by placing the treatment electrode 12 against the inner wall of the lumen, the output radiofrequency energy can form a circuit through the treatment electrode 12 and the back electrode plate (not marked in the figure, usually placed on the back of the subject during the procedure), so that the radiofrequency energy acts on the tissue at the site where the treatment electrode 12 is attached to achieve the purpose of treatment.

[0028] This application does not limit the arrangement and number of treatment electrodes 12. For example, in one example, the distal treatment segment 10 may be configured with multiple pairs of treatment electrodes 12, each pair of treatment electrodes 12 being used to collect the potential at a corresponding location, and each pair of treatment electrodes 12 being connected through a differential amplifier 11 to obtain the potential difference between each individual treatment electrode 12. As another example, in one example, the distal treatment segment 10 may be configured with at least two treatment electrodes 12, each treatment electrode 12 being used to collect the potential at a corresponding location, and each treatment electrode 12 being connected through a differential amplifier 11 to obtain the potential difference between at least two treatment electrodes 12. As yet another example, the distal treatment segment 10 may be configured with at least one treatment electrode 12 and a reference electrode, the treatment electrode 12 and the reference electrode being used to collect the potential at a corresponding location, and the treatment electrode 12 and the reference electrode being connected through a differential amplifier 11 to obtain the potential difference between the treatment electrode 12 and the reference electrode. In specific implementation, the setting method and number of treatment electrodes 12 can be selected according to the usage scenario and requirements. In this embodiment, the example of configuring at least two treatment electrodes 12 in the distal treatment segment 10 is used for illustration.

[0029] The radiofrequency device 1 determines whether the current treatment location corresponding to the distal treatment segment 10 is a densely nerve-rich area based on the amplitude of the potential difference, and outputs radiofrequency energy through the treatment electrode 12 when it determines that the current treatment location is a densely nerve-rich area.

[0030] In at least two treatment electrodes 12, at least one serves as a signal electrode and at least one serves as a reference electrode. The potential difference (generally between 1 and 100 μV) generated by the nerve activity around the blood vessel is coupled to the treatment electrode attached to it through the blood vessel wall. The potentials of the "signal electrode" and the "reference electrode" are simultaneously acquired by the differential amplifier 11, amplifying only the potential difference between the two (i.e., the nerve signal) while suppressing the noise shared by both (such as 50 Hz mains interference, environmental electromagnetic noise, etc.).

[0031] The gain of differential amplifier 11 can be adjusted according to the actual scenario. For example, in one example, the gain of differential amplifier 11 is generally set to 10. 3 Up to 10 4 For signals with frequencies below 1 kHz, the common-mode rejection ratio (CMRR) is set to 80 to 100 dB.

[0032] Furthermore, due to the weakness of the original neural signal, long-distance (>100mm) transmission before the first-stage amplification is highly susceptible to environmental electromagnetic interference, introducing noise. Subsequent amplification will simultaneously affect both the signal itself and the noise introduced before amplification, resulting in signal distortion. Therefore, in this design, the differential amplifier 11 can be located in the distal treatment section 10, or within the slender tube 9 and close to the distal treatment section 10. (Appendix) Figure 2 The present invention illustrates a very simple form of differential amplifier. In other embodiments, a microcontroller that adjusts the amplifier gain through digital control can also be used as a preamplifier to ensure that only the signal is amplified and to minimize the introduction of noise. This application does not impose any limitations.

[0033] This scheme uses at least two treatment electrodes 12 to collect potentials at corresponding locations, and the at least two treatment electrodes 12 are connected by a differential amplifier 11 to obtain the potential difference between the at least two treatment electrodes 12. The radiofrequency device 1 can determine whether the current treatment location corresponding to the distal treatment segment 10 is a nerve-dense area based on the amplitude of the potential difference. When the current treatment location is determined to be a nerve-dense area, radiofrequency energy is output through the treatment electrodes 12, thereby ensuring that the treatment can target only the nerve-dense part, avoiding the waste of ablation energy in parts with few or no sympathetic nerve fibers, reducing unnecessary energy output and operation time.

[0034] In one embodiment, based on the foregoing embodiments, refer to the appendix to the specification. Figure 4 When the temporal amplitude of the potential difference is less than the second threshold, the current treatment location is determined to be a non-nervous dense region. When the temporal amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, the current treatment location is determined to be a non-nervous dense region. If the difference is higher than the third threshold, the current treatment location is determined to be a nerve-dense region.

[0035] After the radiofrequency device 1 acquires the potential difference between at least two treatment electrodes 12, the digitized neural signal sample obtained through analog-to-digital conversion is typically presented as the potential difference between the two electrodes 12 at a fixed frequency (>2kHz). The analysis methods for digitized neural signals are mainly divided into two types: one is time-related changes in potential difference, i.e., time-domain signal feature extraction; the other is frequency-related changes in potential difference, i.e., frequency-domain signal feature extraction.

[0036] When analyzing the time-domain characteristics of a signal, a sliding window approach is generally used. The window is set within a range of, for example, 10 to 30 seconds, continuously replacing old data with newly acquired data, ensuring that the analyzed data remains consistent within the duration of the window (see attached). Figure 3(As shown in the two images above). When analyzing the frequency domain characteristics of a signal, a Fast Fourier Transform (FFT) is required on the signal within the time domain window. A fixed frequency window is typically used, usually set within the range of 0 to 1000 Hz (as shown in the attached image). Figure 3 As shown in the two images below.

[0037] Appendix Figure 3 The images show two segments of neural signals collected at different locations during animal experiments using this invention (two images on the left and two on the right, each corresponding to a different location). During the experiment, the location information of the collection sites was recorded using a three-dimensional electrophysiological mapping system. Combined with the results of immediate anatomical section staining, it was determined that the left side was a densely nerve-rich area, while the right side was a sparsely nerve-rich area. Combining the time-domain and frequency-domain signal images from the two locations, we can find that: (i) In the time-domain image, the amplitude of the signal collected from the densely nerved area is significantly higher than that of the signal collected from the sparsely nerved area. After the same amplification gain, the amplitude range of the former can reach 0.5mV (-0.25 to 0.25mV), while that of the latter is only 0.2mV (-0.1 to 0.1mV); (ii) In the relationship between amplitude and frequency obtained by FFT, it can be confirmed that the frequency that causes the difference in time-domain amplitude mainly comes from the range of 10 to 500Hz (the evenly spaced, abnormally high-energy frequency bands in the figure are the interference of 50Hz mains power and its harmonics). The amplitude 13a of the signal in the densely nerved area is 3dB higher than the amplitude 13b of the higher frequency band (the frequency range of the group action points of the peripheral nerve trunk under normal circumstances is also in the range of 10 to 500Hz), while there is almost no difference between the two in the sparsely nerved area.

[0038] In summary, it can be determined that the intensity of the neural signals acquired using this invention is positively correlated with the density of neural distribution at the acquisition site. Therefore, the acquired signals can be analyzed using a two-step logic to determine whether there is abundant neural innervation at the current acquisition location. The first step determines whether the amplitude of the neural signal in the time domain reaches a second threshold (e.g., 0.5mV); the second step determines whether the amplitude within a preset frequency range (e.g., 10 to 500Hz) has stronger energy than other frequencies (e.g., the difference between the largest and smallest amplitudes is greater than 3dB). Using this method, treatment instructions can be provided during non-treatment periods of surgery by capturing neural signals at different locations during catheter movement in real time.

[0039] Preferably, the processor of the radiofrequency device 1 is also used to provide a reminder via a first reminder module when the current treatment location is determined to be a densely nerve-rich area, and to provide a reminder via a second reminder module when the current treatment location is determined to be a non-densely nerve-rich area.

[0040] For example, a green light indicates that the current site contains abundant nerve fibers, and the catheter should be moved and treatment should be initiated; a red light indicates that a suitable treatment site has not yet been found, and the catheter should be moved to explore more potential treatment sites.

[0041] In one embodiment, based on the foregoing embodiment, the radiofrequency device 1 is further configured to determine whether to stop the radiofrequency energy output based on the potential difference attenuation amplitude at the current treatment position after the radiofrequency energy output is performed through the treatment electrode 12; when the potential difference attenuation amplitude exceeds a first threshold, the radiofrequency energy output is stopped; when the potential difference attenuation amplitude does not exceed the first threshold, the radiofrequency energy output is continued until the potential difference attenuation amplitude exceeds the first threshold.

[0042] Another function of this protocol is that by comparing the characteristic changes in nerve signals at the same location before and after ablation treatment, it can help determine whether the ablation treatment performed on the current location is sufficient to inhibit surrounding neural activity. (Appendix) Figure 5 The images shown are time-domain images of neural signals acquired at the same location and time after the ablation process in animal experiments using this invention. The only difference is that the upper image shows the original neural signal, while the lower image shows the neural signal after a 500Hz low-pass filter (i.e., the signal within the neural activity frequency range). It can be observed that the amplitude of the neural signal with added low-pass filtering decreased significantly for a period of time after the ablation ended, indicating that the level of neural activity was suppressed after ablation.

[0043] Appendix Figure 6 The images show the time-domain representation of neural signals captured at the same location in animal experiments before and after the release of non-ablation electrical pulse energy (images 1 and 2 from top to bottom) and before and after the release of radiofrequency ablation energy (images 3 and 4 from top to bottom), after being low-pass filtered at 500Hz. It can be observed that: (i) the neural signals are almost unaffected before and after the release of non-ablation energy, indicating that the suppression of neural signals after ablation is not due to environmental interference; (ii) the neural signals are enhanced for a period after the release of radiofrequency ablation energy and then gradually weaken, with neural activity decreasing to a level lower than before ablation, indicating that the neural blockade caused by radiofrequency energy inhibits the intensity of neural signals. Therefore, by comparing the intensity of neural signals acquired before and after ablation, it can be determined whether the ablation treatment performed on the current location is sufficient to inhibit surrounding neural activity. (See attached image.) Figure 7As shown, this scheme starts the judgment of neural signal attenuation within the window and the radiofrequency energy output simultaneously. The intensity of neural signal attenuation during the ablation process is evaluated periodically (e.g., every 100ms / 1s / 5s) to determine whether to stop the output of radiofrequency energy. When the potential difference attenuation exceeds the first threshold (i.e., significant attenuation occurs), the output of radiofrequency energy is stopped; when the potential difference attenuation does not exceed the first threshold (i.e., no significant attenuation occurs), the output of radiofrequency energy continues until the potential difference attenuation exceeds the first threshold.

[0044] In one embodiment, based on the foregoing embodiments, refer to the appendix to the specification. Figure 1 The radio frequency instrument in this solution includes: a driver module 2, an acquisition module 3, an analog-to-digital converter 4, and a computing unit (processor) 5.

[0045] The driving module 2 is used to output radio frequency energy; the acquisition module 3 is electrically connected to the differential amplifier 11 and is used to acquire the potential difference in real time. The analog-to-digital converter 4 is used to convert the potential difference into a digital neural signal. In some embodiments, the analog-to-digital converter 4 can also be integrated with the pre-amplifier 11 in the distal treatment segment 10 of the catheter.

[0046] The processor 5 is used to analyze the digital neural signals, determine whether the current treatment position corresponding to the distal treatment segment 10 is a densely neural region, and control the drive module 2 to output radio frequency energy when the current treatment position is determined to be a densely neural region; the processor 5 is also used to control the drive module 2 to stop outputting radio frequency energy when the potential difference attenuation amplitude at the current treatment position exceeds a first threshold.

[0047] The ablation system provided by this invention has at least the following technical effects: 1) The digital samples generated by this application will be processed and analyzed to quantify the degree of neural density at the acquisition location, presenting the originally invisible neural structures to the surgeon in the form of data, ensuring that the treatment can target only the densely neural parts, reducing unnecessary energy output and operation time; 2) The acquisition and analysis of neural signals at a single location can be completed almost instantaneously, and since there is no energy output during the acquisition process, it will not cause any discomfort to the patient. 3) By comparing the characteristic changes of nerve signals at the same location before and after ablation treatment, this application can help determine whether the ablation treatment performed on the current location is sufficient to inhibit the surrounding nerve activity, and can avoid the situation where the treatment target is not adequately treated or the treatment effect has been achieved but excessive ablation energy has been released. 4) This application uses an amplifier placed near the electrodes to amplify the captured analog neural signals before transmitting them to the device. The amplified analog signals can avoid signal distortion caused by electromagnetic interference during long-distance transmission.

[0048] In one embodiment, this application provides an ablation method, comprising: S100. By using at least two treatment electrodes disposed at the distal treatment segment of the catheter, the potential corresponding to each treatment electrode position is obtained.

[0049] S200: Obtain the potential difference between at least two treatment electrodes through a differential amplifier.

[0050] S300: Determine whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area based on the amplitude of the potential difference, and output radiofrequency energy through the treatment electrode when the current treatment location is determined to be a densely nerve-rich area.

[0051] The technical concept of the ablation method in this embodiment is the same as that of the ablation system in the aforementioned embodiment, and will not be described again in this application. By measuring the amplitude of the potential difference between at least two treatment electrodes in the distal treatment segment, it is determined whether the current treatment location corresponding to the distal treatment segment 10 is a nerve-dense region. When it is determined that the current treatment location is a nerve-dense region, radiofrequency energy is output through the treatment electrode 12. This ensures that the treatment is targeted only at the nerve-dense part, avoiding the waste of ablation energy in parts with few or no sympathetic nerve fibers, thus reducing unnecessary energy output and operation time.

[0052] In one embodiment, based on the foregoing embodiments, determining whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich region based on the amplitude of the potential difference includes: When the temporal amplitude of the potential difference is less than the second threshold, the current treatment location is determined to be a non-nervous dense region. When the temporal amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, the current treatment location is determined to be a non-nervous dense region. If the difference is higher than the third threshold, the current treatment location is determined to be a nerve-dense region.

[0053] In one embodiment, based on the foregoing embodiments, the ablation method provided in this application further includes: After radiofrequency energy is output through the treatment electrode, it is determined whether to stop the radiofrequency energy output based on the potential difference attenuation amplitude at the current treatment position. If the potential difference attenuation amplitude exceeds the first threshold, the radiofrequency energy output is stopped. If the potential difference attenuation amplitude does not exceed the first threshold, the radiofrequency energy output continues until the potential difference attenuation amplitude exceeds the first threshold.

[0054] By comparing the characteristic changes in nerve signals at the same location before and after ablation treatment, it is possible to determine whether the ablation treatment performed on the current location is sufficient to inhibit the surrounding nerve activity. This can avoid situations where the treatment target is not adequately treated or where the treatment effect has been achieved but excessive ablation energy has been released.

[0055] It should be noted that the above embodiments can be freely combined as needed. The above description is only a preferred embodiment of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. An ablation system, characterized in that, include: Radio frequency (RF) devices are used to output radio frequency energy. A catheter, connected to the radiofrequency device, the catheter comprising a slender tube body and a distal treatment segment; The distal treatment segment can be configured with multiple pairs of treatment electrodes, each pair of treatment electrodes being used to acquire the potential at a corresponding location, and each pair of treatment electrodes being connected via a differential amplifier to obtain the potential difference between each individual treatment electrode; or the distal treatment segment can be configured with at least two treatment electrodes, each treatment electrode being used to acquire the potential at a corresponding location, and each treatment electrode being connected via a differential amplifier to obtain the potential difference between each treatment electrode; or the distal treatment segment can be configured with at least one treatment electrode and one reference electrode, each treatment electrode and the reference electrode being used to acquire the potential at a corresponding location, and the treatment electrode and the reference electrode being connected via a differential amplifier to obtain the potential difference between the treatment electrode and the reference electrode. The radiofrequency device determines whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area based on the amplitude of the potential difference, and outputs radiofrequency energy through the treatment electrode when it determines that the current treatment location is a densely nerve-rich area.

2. The ablation system according to claim 1, characterized in that, When the temporal amplitude of the potential difference is less than the second threshold, the current treatment location is determined to be a non-nervous dense region. When the time-domain amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, then the current treatment location is determined to be a non-nervous dense area; If the difference is higher than the third threshold, then the current treatment location is determined to be a densely nerve-rich area.

3. An ablation system according to claim 1 or 2, characterized in that, The radiofrequency device is also used to determine whether to stop the radiofrequency energy output based on the attenuation amplitude of the potential difference at the current treatment position after the radiofrequency energy is output through the treatment electrode. When the potential difference attenuation exceeds the first threshold, the radio frequency energy output is stopped. If the potential difference attenuation amplitude does not exceed the first threshold, radio frequency energy output continues until the potential difference attenuation amplitude exceeds the first threshold.

4. The ablation system according to claim 3, characterized in that, The radio frequency instrument is electrically connected to the conduit via the conduit tail wire and is used to collect the potential difference and transfer radio frequency energy. The radio frequency device includes: The driver module is used to output radio frequency energy; The acquisition module is electrically connected to the differential amplifier and is used to acquire the potential difference in real time. An analog-to-digital converter is used to convert the potential difference into a digital neural signal; The processor is configured to analyze the digital neural signal, determine whether the current treatment location corresponding to the distal treatment segment is a densely neural region, and control the drive module to output radio frequency energy when the current treatment location is determined to be a densely neural region; the processor is also configured to control the drive module to stop outputting radio frequency energy when the potential difference attenuation amplitude at the current treatment location exceeds a first threshold.

5. An ablation system according to claim 4, characterized in that, The processor is further configured to provide a reminder via a first reminder module when the current treatment location is determined to be a densely populated nerve area, and to provide a reminder via a second reminder module when the current treatment location is determined to be a non-densely populated nerve area.

6. The ablation system according to claim 1, characterized in that, The differential amplifier is located in the distal treatment section, or in the slender tube body and close to the distal treatment section.

7. The ablation system according to claim 1, characterized in that, The slender tube body and the distal treatment section are hollow structures; the treatment electrode is disposed on the outer surface of the distal treatment section, or a portion of the electrode surface of the treatment electrode is exposed on the distal treatment section.

8. An ablation method, characterized in that, include: By using at least two treatment electrodes disposed at the distal treatment segment of the catheter, the potential at the position corresponding to each of the treatment electrodes is obtained; The potential difference between the at least two treatment electrodes is obtained by a differential amplifier; The amplitude of the potential difference is used to determine whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area, and when the current treatment location is determined to be a densely nerve-rich area, radiofrequency energy is output through the treatment electrode.

9. The ablation method according to claim 8, characterized in that, The method of determining whether the current treatment location corresponding to the distal treatment segment is a densely nerve-rich area based on the amplitude of the potential difference includes: When the temporal amplitude of the potential difference is less than the second threshold, the current treatment location is determined to be a non-nervous dense region. When the time-domain amplitude of the potential difference is greater than the second threshold, it is further determined whether the difference between the maximum and minimum amplitudes of the potential difference in the preset frequency domain is higher than the third threshold. If the difference is lower than the third threshold, the current treatment location is determined to be a non-nervous dense region; if the difference is higher than the third threshold, the current treatment location is determined to be a nerve dense region.

10. An ablation method according to claim 8 or 9, characterized in that, Also includes: After radiofrequency energy is output through the treatment electrode, it is determined whether the radiofrequency energy output needs to be stopped based on the attenuation amplitude of the potential difference at the current treatment position. When the potential difference attenuation exceeds the first threshold, the radio frequency energy output is stopped. If the potential difference attenuation amplitude does not exceed the first threshold, radio frequency energy output continues until the potential difference attenuation amplitude exceeds the first threshold.

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