Pulsed electric field ablation device and system

Abstract

This invention discloses a pulsed electric field ablation device and system. The device includes a conduit, a support, an electrode array membrane comprising multiple electrode pairs, and a pulse generator. The pulse generator has a pulse signal output terminal coupled to the electrode pairs. The pulse generator is configured to output a sequence of pulse waves through the pulse signal output terminal to generate an ablation current on the electrode pairs. The sequence of pulse waves includes multiple biphasic pulse trains, each biphasic pulse train comprising multiple biphasic pulse pairs. Each biphasic pulse pair includes alternating positive and negative pulses, and the positive and negative pulses satisfy the following relationship: V p ·t p =V n ·t n And V p ≠V n , and t p ≠t n , where V p V is the peak voltage amplitude of the positive pulse. n t represents the peak voltage amplitude of the negative pulse. p t is the pulse width of a positive pulse. n This refers to the pulse width of a negative pulse. This invention enables highly selective tissue ablation of the duodenum.

Description

Technical Field

[0001] This invention relates to the field of pulse generation and medical device technology, and in particular to a pulsed electric field ablation device and system. Background Technology

[0002] In recent years, duodenal mucosal resurfacing (DMR) has been clinically proven to be significantly effective in improving glycemic control and metabolic indicators in patients with type 2 diabetes, and it also shows promising application prospects in the treatment of obesity. This technique physically reshapes the duodenal mucosal surface, thereby regulating intestinal hormone secretion and improving insulin sensitivity, providing a new approach to the treatment of metabolic diseases.

[0003] Currently, the ablation energy used in clinical DMR mainly relies on various thermal ablation techniques, such as radiofrequency ablation, cryoablation, and microwave ablation. However, when applied in the unique anatomical environment of the digestive tract, thermal ablation methods have inherent and insurmountable drawbacks. First, due to the non-selective nature of heat conduction, heat energy diffuses throughout the tissue and is difficult to confine strictly to the mucosal layer. This can easily cause irreversible thermal damage to deeper tissues of the digestive tract wall, including the smooth muscle layer, submucosa, and even the myenteric plexus. This significantly increases the risk of complications, including but not limited to duodenal stenosis, perforation, delayed ulcer healing, and gastrointestinal motility disorders, limiting the safety and widespread application of this technique. Second, the digestive tract wall itself is relatively thin, and different tissue layers have different tolerances to heat energy, making it difficult to precisely control the depth and range of energy penetration, resulting in a low margin for error and requiring a high level of operator experience.

[0004] To overcome the limitations of thermal ablation, pulsed field ablation (PFA) technology has begun to attract attention. PFA is based on the principle of irreversible electroporation (IRE). It applies high-intensity, ultrashort pulsed electric fields to create irreversible nanoscale pores in the cell membrane, leading to apoptosis. This process generates almost no Joule heating, thus belonging to non-thermal ablation. Theoretically, PFA has significant tissue selectivity; that is, by adjusting the electric field parameters, specific cell types can be selectively ablated with minimal damage to adjacent structures (such as blood vessels, nerves, and connective tissue matrix).

[0005] However, directly applying PFA technology to duodenal DMR also faces some challenges. Currently, commercially available PFA devices and their preset electric field parameters (such as field strength threshold, pulse waveform, pulse width, and frequency) are mainly designed for the ablation of cardiovascular diseases (such as atrial fibrillation ablation) or solid tumors. Their target sites and the cell biological characteristics (including cell membrane capacitance, conductivity, size, and arrangement) of cardiomyocytes or various tumor cells are fundamentally different from those of digestive tract tissue cells. In particular, the duodenal wall is composed of multiple layers of cells with vastly different functions and structures, and its mucosal epithelial cells and deep smooth muscle cells have completely different excitation thresholds, electroporation thresholds, and impedance characteristics under the influence of an electric field.

[0006] Simply applying existing PFA parameters for myocardium or tumors to ablate the duodenal mucosa will fail to achieve true and reliable "tissue-selective" ablation due to parameter mismatch. Inappropriate field strength may simultaneously reach or even exceed the irreversible electroporation threshold of smooth muscle cells, causing unexpected and irreversible electrical damage to deep muscle tissue while ablating the target mucosal layer. This can also lead to muscle scarring and contracture, ultimately resulting in serious complications such as duodenal stenosis or motility disorders, preventing the non-thermal advantages of PFA from translating into clinical safety advantages.

[0007] The disclosure of the above background technical content is only for the purpose of assisting in understanding the concept and technical solution of this application, and does not necessarily provide technical instruction. Summary of the Invention

[0008] The purpose of this invention is to provide a pulsed electric field ablation device and system. Based on the difference in sensitivity between duodenal mucosal cells and smooth muscle layer to specific high-frequency high-voltage electric pulses, by exploring better basic pulse parameters such as waveform, voltage, pulse width, and frequency for the duodenal ablation process, highly selective tissue ablation can be achieved.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A pulsed electric field ablation device, comprising: Slender tubes; A support body located at the distal end of the conduit, the support body having a contracted working state and an expanded working state; An electrode array film is arranged on the support body. When the support body is in an expanded working state, the electrode array film is opened on the support body. When the support body is in a contracted working state, the electrode array film is contracted on the support body. The electrode array film is provided with multiple pairs of electrodes, each consisting of a first electrode and an adjacent second electrode. A pulse generator has a pulse signal output terminal coupled to an electrode pair. The pulse generator is configured to output a sequence of pulse waves through the pulse signal output terminal to generate an ablation current on the electrode pair. The sequence of pulse waves includes multiple biphase pulse trains, each biphase pulse train including multiple biphase pulse pairs. Each biphase pulse pair includes alternating positive and negative pulses, the positive and negative pulses satisfying the following relationship: V p ·t p =V n ·t n And V p ≠V n , and t p ≠t n , where V p V represents the peak voltage amplitude of the positive pulse. n Let t be the peak voltage amplitude of the negative pulse. p Let t be the pulse width of the positive pulse. n The pulse width of the negative pulse is given.

[0010] Furthermore, following any one or a combination of the aforementioned technical solutions, the amplitude ratio of the positive pulse to the negative pulse is K. v K v =V p / V n The pulse width ratio of the positive pulse to the negative pulse is K. t K t =t p / t n K v ∈[1.5, 4.0], K t ∈[0.25, 0.67].

[0011] Furthermore, following any one or a combination of the aforementioned technical solutions, the amplitude ratio of the positive pulse to the negative pulse is K. v K v =V p / V n The pulse width ratio of the positive pulse to the negative pulse is K. t K t =t p / t n K v ∈[0.25, 0.67], K t ∈[1.5, 4.0].

[0012] Furthermore, following any one or a combination of the aforementioned technical solutions, in the biphase pulse pair, the time interval between adjacent positive and negative pulses is 0.1µs to 10µs.

[0013] Furthermore, based on any one or a combination of the aforementioned technical solutions, the electric field strength released by the biphase pulse pair on each electrode pair is 400V / cm to 1200V / cm.

[0014] Furthermore, based on any one or a combination of the aforementioned technical solutions, the multiple sets of biphase pulse trains include nanosecond biphase pulse trains and microsecond biphase pulse trains; The biphasic pulse pairs included in the nanosecond biphasic pulse train have a pulse width range of [100ns, 900ns] for the positive and negative pulses; The biphase pulse pairs included in the microsecond biphase pulse train have a pulse width range of [1µs, 10µs] for the positive and negative pulses.

[0015] Furthermore, following any one or a combination of the aforementioned technical solutions, the sequence pulse wave includes the first output microsecond biphase pulse train and the subsequent output nanosecond biphase pulse train; or, The sequence pulse wave includes alternating outputs of microsecond biphase pulse trains and nanosecond biphase pulse trains; or, The sequence of pulse waves includes the first output nanosecond biphase pulse train and the second output microsecond biphase pulse train.

[0016] Furthermore, following any one or a combination of the aforementioned technical solutions, the biphase pulse train consists of 10-100 biphase pulse pairs; and / or, The time interval between two adjacent biphase pulse trains is 100ms to 1000ms.

[0017] Furthermore, following any one or a combination of the aforementioned technical solutions, V p The range is [500V, 3000V]; V n The range is [500V, 3000V].

[0018] Furthermore, following any one or a combination of the aforementioned technical solutions, both the positive and negative pulses are square waves; and / or, The sequence pulse wave consists of 1-1000 sets of biphase pulse trains; and / or, The biphase pulse train consists of 10 to 100 biphase pulse pairs; and / or, The time interval between the two biphase pulse trains is 100ms-1000ms.

[0019] According to another aspect of the present invention, the present invention provides a digestive tract pulsed electric field ablation system, which includes the pulsed electric field ablation device as described in any one or a combination of the above technical solutions, and further includes: a gastroscopy device, the gastroscopy device including a gastroscopy body, the gastroscopy body being provided with a surgical instrument channel, and the support body and the electrode array membrane being disposed within the surgical instrument channel.

[0020] The beneficial effects of the technical solution provided by this invention are as follows: a. The pulse generator provided by the present invention is configured to generate a sequence of pulse waves with biphasic asymmetric waveforms. The biphasic pulses reduce the polarization effect and electrolytic bubbles on the electrode surface. The amplitude ratio and pulse width ratio of the positive pulse to the negative pulse in the asymmetric biphasic waveform are not 1. While maintaining the cell membrane depolarization effect, it can further reduce the probability of action potential triggering of muscle nerves, achieve highly selective tissue ablation, and further improve the accuracy, effectiveness and safety of ablation for the digestive tract, especially the duodenum. b. Based on the pulsed electric field ablation device provided by the present invention, the sequence of pulse waves generated by the pulse generator consists of multiple biphasic pulse trains, which are composed of multiple asymmetric biphasic pulses that satisfy zero net charge transport balance. Through specific nanosecond / microsecond-level high-frequency biphasic asymmetric pulse parameter combinations, the duodenal mucosa and submucosa are precisely located and ablated, avoiding damage to deep smooth muscle and vascular network, fundamentally eliminating the risk of digestive tract stenosis and perforation, and having higher tissue safety. c. This application significantly reduces muscle twitching by optimizing the combination of pulse width and frequency of positive and negative pulses in a biphasic pulse pair, which can reduce the dosage requirements of general anesthesia and muscle relaxants, and reduce systemic complications. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 A schematic diagram of a pulsed electric field ablation device provided as an exemplary embodiment of the present invention; Figure 2 A schematic diagram of the composition structure of a sequence pulse wave provided for an exemplary embodiment of the present invention; Figure 3 A schematic diagram of the composition structure of a biphase pulse train provided for an exemplary embodiment of the present invention; Figure 4A schematic diagram of the composition structure of a pulse generator provided as an exemplary embodiment of the present invention; Figure 5 A schematic diagram of the H-bridge topology of a pulse discharge module provided as an exemplary embodiment of the present invention.

[0023] Wherein: 1-conduit, 2-support, 3-electrode array membrane, 4-first electrode, 5-second electrode, 6-electrode pair, 71-first high-voltage switch, 72-second high-voltage switch, 73-third high-voltage switch, 74-fourth high-voltage switch, 75-pulse signal output terminal. Detailed Implementation

[0024] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0025] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, apparatus, product, or device that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or devices.

[0026] To improve the accuracy and success rate of ablation in the gallbladder, pancreas, liver, and digestive tract, Chinese patent CN119564320B proposes a method for determining ablation parameters in high-frequency pulsed electric field ablation. This method involves acquiring medical image data to determine a lesion box containing three-dimensional information about the lesion. Based on the potential information about the length, width, and depth of the lesion within the lesion box, the outline and depth of the lesion, as well as the electrode outline, are determined to determine the ablation parameters for each procedure. However, this method relies on complex AI model reasoning on preoperative or intraoperative medical images (such as CT scans). The development, training, calibration, and system integration of AI models are challenging, resulting in long clinical implementation cycles and high costs. Furthermore, within the duodenum, the organ is in a peristaltic state, and the endoscopic field of view and ablation location may change at any time. The outline and depth of the lesion (i.e., the mucosal area to be ablated), as well as the adhesion between the electrode and the tissue, are dynamically changing in real time, which also limits the ablation accuracy and dynamic adjustability of this approach.

[0027] To address the shortcomings of existing technologies, this invention aims to provide a pulsed electric field ablation device and system. Based on the difference in sensitivity between duodenal mucosal cells and smooth muscle layers to specific high-frequency high-voltage electric pulses, this invention explores optimal basic pulse parameters such as waveform, voltage, pulse width, and frequency for the duodenal ablation process to achieve highly selective tissue ablation, thereby making the treatment of metabolic diseases such as diabetes or obesity safer and more effective.

[0028] In one embodiment of the present invention, a pulsed electric field ablation device is provided, see [link to relevant documentation]. Figures 1 to 3 It includes: A slender catheter, at least a portion of which is capable of extending into the digestive tract; A support body located at the distal end of the catheter, that is, the end that can extend into the digestive tract, the support body having a contraction working state and an expansion working state; An electrode array film is arranged on the support body. When the support body is in an expanded working state, the electrode array film is opened on the support body. When the support body is in a contracted working state, the electrode array film is contracted on the support body. The electrode array film is provided with multiple pairs of electrodes, each consisting of a first electrode and an adjacent second electrode. A pulse generator has a pulse signal output terminal coupled to an electrode pair. The pulse generator is configured to output a sequence of pulse waves through the pulse signal output terminal to generate an ablation current on the electrode pair. The sequence of pulse waves includes multiple biphase pulse trains, each biphase pulse train including multiple biphase pulse pairs. Each biphase pulse pair includes alternating positive and negative pulses, the positive and negative pulses satisfying the following relationship: V p ·t p =V n·t n And V p ≠V n , and t p ≠t n , where V p The peak voltage amplitude (V) of the positive pulse p >0), V n The peak voltage amplitude (V) of the negative pulse n >0), t p The pulse width, i.e., the duration of the positive pulse, is t. n The pulse width of the negative pulse is the duration of the negative pulse.

[0029] To achieve highly selective tissue ablation and further improve the accuracy, effectiveness, and safety of ablation targeting the digestive tract, especially the duodenum, this application employs a biphasic asymmetric pulse waveform. This biphasic pulse reduces polarization effects and electrolytic bubbles on the electrode surface. Specifically, the amplitude ratio or pulse width ratio of the positive to negative pulses in the asymmetric biphasic waveform is not 1:1; for example, the voltage ratio is 2:1 and / or the pulse width ratio is 1:2. This approach maintains cell membrane depolarization while further reducing the probability of action potential triggering in muscle nerves.

[0030] This application sets V p ·t p =V n ·t n The zero net charge transport balance, the high voltage of the positive phase is responsible for breaking down the lipid bilayer of duodenal mucosal cells, while the subsequent low-pressure negative phase is insufficient to induce electroporation or action potential in smooth muscle cells, but it can just "pull back" the charge injected in the positive phase, eliminate electrode polarization, and thus achieve the dual requirements of tissue selectivity and safety.

[0031] In one embodiment of the present invention, the amplitude ratio of the positive pulse to the negative pulse is K. v K v =V p / V n The pulse width ratio of the positive pulse to the negative pulse is K. t K t =t p / t n Preferably, K v ∈[1.5, 4.0], correspondingly, K t ∈[0.25, 0.67]; or, the K v ∈[0.25, 0.67], correspondingly, K t ∈[1.5, 4.0]. Preferably, V p The range is [500V, 3000V]; Vn The range is [500V, 3000V].

[0032] In the biphasic pulse pair, the time interval between the positive pulse and the negative pulse is... Figure 2 and Figure 3 The phase interval shown is preferably 0.1µs to 10µs, and this phase interval is an adjustable parameter. Different cell types have different cell membrane capacitances and charging time constants. Gastrointestinal mucosal epithelial cells typically have larger membrane capacitances and longer charging time constants, while smooth muscle cells have relatively smaller membrane capacitances and charge faster. For mucosal epithelial cells, when a positive pulse is applied, the cell membrane begins to charge, and the transmembrane potential increases. If a negative pulse of opposite polarity is rapidly applied (after a microsecond delay) before the membrane potential has fully discharged, an electric field stress in opposite directions will be generated on the cell membrane. This rapid alternation of positive and negative electric field stress can generate mechanical fatigue and nanoscale perturbations on the phospholipid bilayer of the cell membrane, specifically targeting the large membrane capacitance structure of mucosal epithelial cells, efficiently inducing irreversible electroporation and leading to apoptosis. For smooth muscle cells, due to their small membrane capacitance and short charging time constant, their transmembrane potential rapidly reaches its peak during the positive pulse and may trigger a reversible electrical response. Therefore, this invention, through microsecond-level phase-to-phase intervals, ensures that the charge on the smooth muscle cell membrane has not yet had time to fully redistribute through ion channels or cause irreversible membrane structure damage. The subsequent negative pulse then "neutralizes" the previous electric field effect, preventing continuous unidirectional charge accumulation. This effectively denies the smooth muscle cells sufficient unidirectional electric field time to complete irreversible electroporation, thus preventing their transmembrane potential from exceeding the threshold of irreversible electroporation. Therefore, the microsecond-level phase-to-phase intervals of 0.1µs to 10µs set in this invention are used to specifically disrupt the cell membrane structure of digestive tract mucosal epithelial cells without giving smooth muscle cells sufficient time to accumulate charge. The pulse interval between biphasic pulse pairs is preferably an adjustable parameter within the range of 0.1µs to 5000ms. The voltage levels corresponding to both the phase-to-phase interval and the pulse interval are zero.

[0033] Pulse width determines whether the electric field energy primarily acts on the cell membrane or organelles. To improve the accuracy, effectiveness, and safety of ablation targeting the digestive tract, especially the duodenum, in one embodiment of the invention, the sequence pulse wave is constructed using biphasic pulses with mixed pulse widths ranging from nanoseconds to microseconds. Specifically, multiple sets of biphasic pulse trains include nanosecond biphasic pulse trains and microsecond biphasic pulse trains. The biphasic pulse pairs included in the nanosecond biphasic pulse train have a pulse width range of [100ns, 900ns] for the positive and negative pulses, primarily targeting intracellular organelles (such as mitochondria and endoplasmic reticulum), inducing target cell apoptosis, and reducing the inflammatory response in the digestive tract caused by acute necrosis. The biphasic pulse pairs included in the microsecond biphasic pulse train have a pulse width range of [1µs, 10µs] for the positive and negative pulses. More preferably, the single-phase pulse width is between 500ns and 5µs to maximize the difference in damage threshold between mucosal cells and smooth muscle cells.

[0034] In one specific embodiment of the present invention, the sequential pulse wave includes a microsecond biphasic pulse train output first and a nanosecond biphasic pulse train output subsequently. The microsecond biphasic pulse train first establishes an initial conduction channel, reducing overall impedance. The microsecond pulses open cell membrane channels, and the subsequent nanosecond pulses concentrate energy and act more effectively on the internal cell structures, thereby inducing apoptosis of target cells with lower voltage or fewer pulses, improving treatment efficiency and potentially reducing total energy input. This embodiment is more suitable for ablation targets with relatively well-defined lesions and clear boundaries.

[0035] In one specific embodiment of the present invention, the sequential pulse wave includes alternating outputs of microsecond biphasic pulse trains and nanosecond biphasic pulse trains. This alternating mode utilizes the microsecond pulse trains to continuously optimize cell membrane permeability, creating better conditions for the next round of nanosecond pulse trains; while the nanosecond pulse trains intermittently deliver "precise strikes" into the cell interior, jointly driving the cell towards death, resulting in clearer ablation boundaries and narrower transition zones. This method is generally more suitable for ablation targets that are large or irregular in size.

[0036] In one specific embodiment of the present invention, the sequential pulse wave includes the first output nanosecond biphasic pulse train and the second output microsecond biphasic pulse train. This mode is generally more suitable for patients with high requirements for postoperative inflammatory response control, or for situations where the mucosa is relatively fragile and it is desirable to preserve the submucosal matrix structure to the greatest extent.

[0037] Preferably, a high-frequency pulse burst mode is used to release energy to avoid heat accumulation and overcome the tetanic contraction of skeletal / smooth muscle, thus eliminating skeletal muscle twitching. Specifically, the intra-pulse frequency of the sequence pulse wave is set between 1 kHz and 2 MHz, and the high-frequency electric field can effectively penetrate the capacitance of mucosal cells, reducing neuromuscular stimulation. Both the positive and negative pulses are square waves.

[0038] Combination sequence architecture: The entire ablation cycle consists of multiple pulse trains. The sequence pulse wave comprises 1-1000 biphasic pulse trains, with a time interval of 0.1s-10s between two sequence pulse waves. Each biphasic pulse train includes 10 to 100 pairs of biphasic pulse trains. The time interval between two biphasic pulse trains is... Figure 3 The pulse train delay shown is preferably 100ms-1000ms to ensure that the heat in the ablation area can be carried away by the surrounding blood / body fluid in time, keeping the overall temperature rise below 5°C and ensuring an absolute non-thermal effect.

[0039] The irreversible electroporation threshold of duodenal mucosal epithelial cells is lower than that of the smooth muscle layer. Therefore, in one embodiment of the present invention, the system output voltage range is adjustable from 500V to 3000V. p The range is [500V, 3000V]; V n The range is [500V, 3000V]. The local electric field strength in the target area is controlled between 400V / cm and 1200V / cm, meaning the electric field strength released by the biphasic pulse pair on each electrode pair is between 400V / cm and 1200V / cm. This electric field strength range is sufficient to penetrate and kill target cells in the mucosa and submucosa, while remaining below the threshold for large-area irreversible electroporation of smooth muscle cells in the muscularis propria.

[0040] In one embodiment of the present invention, the pulsed electric field ablation device includes, in addition to the slender conduit, support, electrode array membrane, and pulse generator described in the above embodiments, a processor, controller, electrical isolation module, and display.

[0041] The controller is electrically connected to the processor via an electrical isolation module (such as optical coupling isolation, magnetic coupling isolation, or fiber optic isolation) to ensure safe isolation between the low-voltage and high-voltage sides and reliable signal transmission. By setting the electrical isolation module between the low-voltage control side and the high-voltage side, high voltage can be prevented from entering the low-voltage circuit, thereby protecting operators and patients from the risk of electric shock.

[0042] The controller is configured to run the main control program, coordinate and direct all other modules (processor, high-voltage power supply, etc.) to work together. The controller is configured to input control parameters for the pulse generator. The processor is configured to receive control commands from the controller and convert these commands into precise, high-speed timing control signals to generate precise pulse trigger signals (PWM signals) and transmit them to the pulse generator. The processor controls the start time, width, interval, and number of sequential pulse waves generated by the pulse discharge module as described in the above embodiments.

[0043] See Figure 4 The pulse generator includes a high-voltage power supply, a pulse discharge module, and an electrode selection module. The high-voltage power supply is electrically connected to the processor and is configured to provide high voltage to the subsequent pulse discharge module. The pulse discharge module is the core power component that generates the actual high-voltage pulse, and it receives precise timing signals sent by the processor.

[0044] See Figure 5 The pulse discharge module adopts an H-bridge topology with high-frequency switching and overcurrent protection capabilities. A bridge circuit consisting of a first high-voltage switch 71, a second high-voltage switch 72, a third high-voltage switch 73, and a fourth high-voltage switch 74 outputs the sequenced pulse wave at both ends of the pulse signal output terminal 75. The pulse generator also includes a current sensor for sensing the current flowing between the electrode pairs 6. The current sensor shown is located at... Figure 4 The detection module shown uses a current sensor to acquire the impedance and phase angle changes of the duodenal wall in real time. Based on the water content of the mucosa and the impedance drop characteristics after cell rupture, the device automatically switches waveforms, adjusts pulse widths, or cuts off voltage output within the above parameter range, thereby controlling the ablation depth in a closed loop and physically blocking energy penetration into the muscle layer.

[0045] The electrode selection module is electrically connected to the pulse discharge module and the electrode array membrane, respectively. According to the settings and control of the controller, the electrode selection module, in response to the control signal output by the processor, flexibly distributes the high-voltage pulses generated by the pulse discharge module to one or more designated first and / or second electrodes to achieve different ablation modes.

[0046] Based on the pulsed electric field ablation device provided by the present invention, the sequence of pulse waves generated by the pulse generator consists of multiple biphasic pulse trains, which are composed of multiple asymmetric biphasic pulses that satisfy zero net charge transport balance. Through specific nanosecond / microsecond-level high-frequency biphasic asymmetric pulse parameter combinations, the device can accurately locate and ablate the duodenal mucosa and submucosa, avoiding damage to deep smooth muscle and vascular network, fundamentally eliminating the risk of digestive tract stenosis and perforation, and having higher tissue safety.

[0047] This application significantly reduces muscle twitching by optimizing the combination of pulse width and frequency of positive and negative pulses in a biphasic pulse pair, thereby reducing the need for general anesthesia and muscle relaxants and reducing systemic complications.

[0048] Furthermore, this application combines dynamic detection feedback with high-frequency switching of high-voltage pulse sequences, making the targeted remodeling process for treating diabetes and obesity more standardized and controllable, improving surgical consistency and precise energy control.

[0049] In one embodiment of the present invention, a pulsed electric field ablation system is provided, which includes a pulsed electric field ablation device as described in any of the above embodiments, and further includes: a gastroscopy device, the gastroscopy device including a gastroscopy body, the gastroscopy body being provided with a surgical instrument channel, and the support body and the electrode array membrane being disposed within the surgical instrument channel.

[0050] It should be noted that the above-described pulsed electric field ablation system embodiments and pulsed electric field ablation device embodiments share the same inventive concept. All contents of the pulsed electric field ablation device embodiments are incorporated into the pulsed electric field ablation system embodiments by reference.

[0051] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0052] The above description is only a specific embodiment of this application. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A pulsed electric field ablation device, characterized in that, It includes: Slender tubes; A support body located at the distal end of the conduit, the support body having a contracted working state and an expanded working state; An electrode array film is arranged on the support body. When the support body is in an expanded working state, the electrode array film is opened on the support body. When the support body is in a contracted working state, the electrode array film is contracted on the support body. The electrode array film is provided with multiple pairs of electrodes, each consisting of a first electrode and an adjacent second electrode. A pulse generator has a pulse signal output terminal coupled to an electrode pair. The pulse generator is configured to output a sequence of pulse waves through the pulse signal output terminal to generate an ablation current on the electrode pair. The sequence of pulse waves includes multiple biphase pulse trains, each biphase pulse train including multiple biphase pulse pairs. Each biphase pulse pair includes alternating positive and negative pulses, the positive and negative pulses satisfying the following relationship: V p ∙t p =V n ∙t n And V p ≠V n , and t p ≠t n , where V p V represents the peak voltage amplitude of the positive pulse. n Let t be the peak voltage amplitude of the negative pulse. p Let t be the pulse width of the positive pulse. n The pulse width of the negative pulse is K; the amplitude ratio of the positive pulse to the negative pulse is K. v K v =V p / V n The pulse width ratio of the positive pulse to the negative pulse is K. t K t =t p / t n K v ∈[1.5, 4.0], K t ∈[0.25, 0.67], or K v ∈[0.25, 0.67], K t ∈[1.5, 4.0]; V p The range is [500V, 3000V]; V n The range is [500V, 3000V], the time interval between two adjacent biphase pulse trains is 100ms to 1000ms, and the electric field strength released by the biphase pulse pair on each electrode pair is 400V / cm to 1200V / cm; multiple sets of biphase pulse trains include nanosecond biphase pulse trains and microsecond biphase pulse trains; the pulse width range of the positive and negative pulses of the biphase pulse pairs included in the nanosecond biphase pulse train is [100ns, 900ns]; the pulse width range of the positive and negative pulses of the biphase pulse pairs included in the microsecond biphase pulse train is [1µs, 10µs]; the sequence pulse wave includes one of the following: the microsecond biphase pulse train output first and the nanosecond biphase pulse train output later; the microsecond biphase pulse train and the nanosecond biphase pulse train output alternately; the nanosecond biphase pulse train output first and the microsecond biphase pulse train output later.

2. The pulsed electric field ablation device according to claim 1, characterized in that, In the biphase pulse pair, the time interval between adjacent positive and negative pulses is 0.1µs to 10µs.

3. The pulsed electric field ablation device according to claim 1, characterized in that, The biphase pulse train consists of 10-100 biphase pulse pairs.

4. The pulsed electric field ablation device according to claim 1, characterized in that, Both the positive and negative pulses are square waves; and / or, The sequence pulse wave consists of 1-1000 sets of biphase pulse trains; and / or, The time interval between the two biphase pulse trains is 100ms-1000ms.

5. A digestive tract pulsed electric field ablation system, characterized in that, It includes the pulsed electric field ablation device as described in any one of claims 1 to 4, and further includes: a gastroscopy device, the gastroscopy device including a gastroscopy body, the gastroscopy body being provided with a surgical instrument channel, the support and the electrode array membrane being disposed within the surgical instrument channel.

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