Device and system for performing electric field treatment on digestive tract

Abstract

The invention discloses a device and system for conducting electric field treatment on the digestive tract, the device for conducting electric field treatment on the digestive tract comprises a slender catheter, a supporting body located at the far end of the catheter, an electrode array film and a pulse generator, the electrode array film and the pulse generator are arranged on the supporting body, and the output end of the pulse generator is coupled with an electrode pair on the electrode array film. A sequence pulse wave output by the pulse generator comprises a plurality of groups of nanosecond pulse strings, and the time interval between the adjacent nanosecond pulse strings is 1us-10000 us; the nanosecond pulse string is composed of a plurality of nanosecond pulse pairs, and the time interval between every two adjacent nanosecond pulse pairs ranges from 50 ns to 10000 ns; the nanosecond pulse pair comprises positive pulses and negative pulses which appear alternately, the pulse width of the positive pulses and the pulse width of the negative pulses are 10-1000 ns, and the time interval is 10-1000 ns. The cell membrane permeability and the cell death efficiency can be remarkably improved, and the limitation of the traditional IRE technology is broken through.

Description

Technical Field

[0001] The present invention relates to the technical field of pulse generation and medical equipment, and in particular to a device and system for performing electric field treatment on the digestive tract. Background Art

[0002] In recent years, with the deepening of research on the bioeffects of pulsed electric fields, more and more technologies and devices based on the principles of electric pulse bioeffects have entered clinical application. Electric field therapy devices based on cell ablation are minimally invasive treatment devices that use electrodes to deliver pulsed electric fields under image guidance to destroy cellular activity in target tissues.

[0003] Research in the field of cell electroablation has shown that single nanosecond or microsecond pulses, such as those disclosed in Chinese patent applications with publication numbers CN117159123A and CN221654541U, have poor ablation effects on tumor cells. Specifically, while traditional microsecond pulses can produce sufficiently large cell membrane pores, their pore efficiency is highly sensitive to cell size. When the difference in the radii of the cells to be perforated exceeds 1.55 times, large cells are prone to death due to excessive perforation, while small cells are prone to insufficient perforation, resulting in a significant decrease in the overall fusion rate.

[0004] Nanosecond pulses are insensitive to cell size and are virtually unaffected by cell size, enabling the induction of nanoscale pores in membranes. However, due to their extremely small size and rapid membrane elastic recovery, these pores typically close completely within microseconds, unable to sustain the sustained pore opening time (on the order of milliseconds) required for cell fusion, thus limiting fusion success rates.

[0005] To address the technical problem of poor tumor cell ablation effect of a single pulse, Chinese patent application publication number CN113824431A proposes a collaborative pulse generating circuit, generating device, and generating method thereof. By stimulating microsecond pulses and nanosecond pulses in different time periods, and then combining the microsecond pulses with the nanosecond pulses, the ablation effect of tumor cells is enhanced.

[0006] The disclosure of the above background technology content is only used to assist in understanding the inventive concept and technical solution of the present invention. It does not necessarily belong to the prior art of the present application, nor does it necessarily provide technical guidance. In the absence of clear evidence that the above content has been disclosed before the filing date of the present application, the above background technology should not be used to evaluate the novelty and creativity of the present application. Summary of the Invention

[0007] The purpose of the present invention is to provide a device and system for electric field therapy of the digestive tract, which can significantly improve the permeability of cell membranes and cell death efficiency, breaking through the limitations of traditional IRE technology.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is as follows: A device for performing electric field treatment on the digestive tract, comprising: a long, thin catheter; A support body located at the distal end of the catheter, wherein the support body has a contracted working state and an expanded working state; an electrode array membrane, the electrode array membrane being arranged on the support body and being stretched on the support body when the support body is in an expanded working state, and being contracted on the support body when the support body is in a contracted working state, wherein the electrode array membrane is provided with a plurality of electrode pairs consisting of a first electrode and an adjacent second electrode; A pulse generator having a pulse signal output end, which is coupled to the electrode pair and is used to generate an ablation current on the electrode pair when the pulse generator outputs a sequence pulse wave; the sequence pulse wave includes multiple groups of nanosecond pulse trains, and the time interval between two adjacent groups of nanosecond pulse trains is 1us-10000us; the nanosecond pulse train is composed of multiple nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 50ns-10000ns; the nanosecond pulse pair is composed of alternating positive pulses and negative pulses, and the pulse width of each positive pulse or negative pulse is 10ns-1000ns, and the time interval between the positive pulse and the negative pulse is 10ns-1000ns.

[0009] Furthermore, according to any one of the aforementioned technical solutions or a combination of multiple technical solutions, the electric field energy released by the nanosecond pulse pair on each electrode pair is 10-100 kV / cm.

[0010] Furthermore, according to any one of the technical solutions or a combination of multiple technical solutions described above, each group of nanosecond pulse trains consists of multiple nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns.

[0011] Furthermore, based on any one of the technical solutions or a combination of multiple technical solutions described above, each nanosecond pulse pair is composed of alternating positive pulses and negative pulses, the pulse width of each positive pulse or negative pulse is 50ns-500ns, and the time interval between the positive pulse and the negative pulse is 50ns-500ns.

[0012] Furthermore, based on any one of the above technical solutions or a combination of multiple technical solutions, the time period during which the pulse generator outputs the sequence of pulse waves includes a first time period to an Nth time period, where N is a positive integer not less than 2. Determine the iThe time interval between two adjacent nanosecond pulse trains in the pulse sequence within the time period is T i ,but T i < T i+1 , i Take an integer from 1 to N-1.

[0013] Furthermore, based on any one of the above technical solutions or a combination of multiple technical solutions, the time period during which the pulse generator outputs the sequence of pulse waves includes, from earliest to latest, a first time period, a second time period, and a third time period; T 1 The value range is 1us-2000us, T 2 The value range is 10us-5000us, T 3 The value range is 50us-10000us, T j Indicates the j The time interval between two adjacent nanosecond pulse trains in a pulse sequence within a time period. j 1 or 2 or 3.

[0014] Furthermore, according to any one of the above technical solutions or a combination of multiple technical solutions, the positive pulse and the negative pulse are both square waves; and / or, The absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the positive pulse.

[0015] Furthermore, based on any one of the technical solutions or a combination of multiple technical solutions described above, the time interval between the two adjacent groups of nanosecond pulse trains is 10us-1000us.

[0016] Furthermore, according to any one of the technical solutions or a combination of multiple technical solutions described above, each group of nanosecond pulse trains consists of 1-1000 nanosecond pulse pairs.

[0017] Furthermore, based on any one of the technical solutions or a combination of multiple technical solutions described above, the sequence pulse wave consists of 1-1000 groups of nanosecond pulse trains, and the time interval between two of the sequence pulse waves is 0.1s-10s.

[0018] Furthermore, based on any one of the above technical solutions or a combination of multiple technical solutions, it also includes an operating handle, which is located at the proximal end of the catheter and is used to manipulate the support body to switch between the contracted working state and the expanded working state; and / or, The pulse generator includes a pulse discharge module, the number of the pulse discharge module is one, and the pulse discharge module is configured to output the sequence of pulse waves; and / or, The pulse generator includes an electrode selection module configured to control a portion or all of the electrodes on the electrode array membrane to generate the ablation current.

[0019] According to another aspect of the present invention, the present invention provides a system for performing ablation treatment on the digestive tract, which includes a device for performing electric field treatment on the digestive tract as described in any technical solution or a combination of multiple technical solutions, and it also includes: a gastroscopic device, the gastroscopic device includes a gastroscopic body, a surgical instrument channel is provided on the gastroscopic body, and the support body and the electrode array membrane are arranged in the surgical instrument channel.

[0020] The beneficial effects brought about by the technical solution provided by the present invention are as follows: a. The device provided herein for electric field therapy of the digestive tract uses a pulse generator to generate a millisecond-scale pulse train. This pulse train comprises a microsecond-scale nanosecond pulse train formed by a composite nesting of multiple nanosecond pulses. The multiple nanosecond pulse pairs within the nanosecond pulse train can cause extensive but shallow electroporation of target cells. The dense nanosecond pulses within the nanosecond pulse train ensure that the local electric field intensity meets the required standards, and the time interval between trains allows for dynamic recovery of tissue conductivity. This ensures continuous electric field action on cells of various sizes while also adjusting the uniformity of the electric field distribution, ultimately forming a more continuous, transmural ablation zone. This significantly improves cell membrane permeability and cell death efficiency, overcoming the limitations of traditional IRE technology and demonstrating significant value in terms of improved efficacy, optimized safety, and expanded indications. b. The pulse generator provided by the present invention only requires one pulse discharge module to generate a sequence of nanosecond, microsecond, and millisecond composite nested pulses, which can lower the electric field strength threshold for irreversible electroporation in tissues. A lower total energy input can form effective ablation damage in the target tissue, reduce ineffective energy consumption, improve ablation efficiency, and have low cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in this application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0022] Figure 1 A schematic diagram of a device for performing electric field therapy on the digestive tract in a human body provided by an exemplary embodiment of the present invention; Figure 2 A schematic structural diagram of a gastroscope body provided with an electrode array membrane provided in accordance with an exemplary embodiment of the present invention; Figure 3 A schematic structural diagram of a support body and an electrode array membrane provided by an exemplary embodiment of the present invention; Figure 4 A block diagram of a device for performing electric field therapy on the digestive tract according to an exemplary embodiment of the present invention; Figure 5 A schematic structural diagram of a device for performing electric field therapy on the digestive tract provided by an exemplary embodiment of the present invention; Figure 6 A schematic diagram of the circuit principle of a device for performing electric field therapy on the digestive tract provided by an exemplary embodiment of the present invention; Figure 7 A schematic diagram of the working process of a device for performing electric field therapy on the digestive tract provided by an exemplary embodiment of the present invention; Figure 8 A schematic diagram of the structure of a pulse train provided by an exemplary embodiment of the present invention; Figure 9 A schematic diagram of the composition structure of a pulse sequence wave provided for an exemplary embodiment of the present invention.

[0023] Among them: 1. Catheter; 2. Support body; 3. Electrode array membrane; 4. First electrode; 5. Second electrode; 6. Electrode pair; 7. Pulse generator; 10. Gastroscope display screen; 11. Operating handle; 12. Stomach; 13. Duodenum; 14. Gastroscope body; 15. Surgical instrument channel; 16. Light source; 17. Knob. DETAILED DESCRIPTION

[0024] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts should fall within the scope of protection of the present invention.

[0025] It should be noted that the terms "first", "second", etc. in the description and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way can be interchanged where appropriate, so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, apparatus, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0026] The technical solution proposed in the Chinese patent application with publication number CN113824431A can improve the ablation effect of tumor cells to a certain extent by combining microsecond pulses and nanosecond pulses. However, the essence of this technical solution is still the time-sharing multiplexing of microsecond pulses and nanosecond pulses, and it cannot achieve the advantages of microsecond pulses and nanosecond pulses on cell ablation at the same time and avoid the disadvantages of both on cell ablation. Specifically, with respect to the technical solution provided by this patent application, during the period of using microsecond pulses for cell ablation, there is still the problem of insufficient overall fusion rate due to the death of large cells due to excessive perforation and insufficient perforation of small cells; during the period of using nanosecond pulses for cell ablation, there is still the technical problem of limited fusion success rate due to the rapid recovery of nanoscale micropores.

[0027] To address the deficiencies of the prior art, this application proposes a device for performing electric field therapy on the digestive tract. Figures 1 to 3 and Figure 5 The device for performing electric field therapy on the digestive tract includes a slender catheter 1, a support body 2, an operating handle 11, an electrode array membrane 3 and a pulse generator 7.

[0028] The support body 2 is located at the distal end of the catheter 1 and has a contracted operating state and an expanded operating state. Before the distal end of the catheter 1 reaches the target location, the support body 2 is configured to be in the contracted operating state to facilitate movement of the catheter 1 and support body 2 and minimize damage to the human body. When the distal end of the catheter 1 reaches the target location, the support body 2 is configured to be in the expanded operating state to control the device to release a pulsed electric field at the target location.

[0029] The operating handle 11 is located at the proximal end of the catheter 1 and is used to manipulate the support body 2 to switch between the contraction working state and the expansion working state. Figure 5As shown, the operating handle 11 is provided with a knob 17, and the support body 2 is manipulated to switch between the contraction working state and the expansion working state by rotating the knob 17.

[0030] The electrode array membrane 3 is arranged on the support body 2, and when the support body 2 is in an expanded working state, the electrode array membrane 3 is spread out on the support body 2; when the support body 2 is in a contracted working state, the electrode array membrane 3 is contracted on the support body 2. The electrode array membrane 3 is provided with a plurality of electrode pairs 6 consisting of a first electrode 4 and an adjacent second electrode 5.

[0031] The pulse generator 7 has a pulse signal output terminal, which is coupled to the electrode pair 6 and is used to generate an ablation current on the electrode pair 6 when the pulse generator 7 outputs a sequence of pulse waves. Figure 8 and Figure 9 As shown, the pulse sequence wave includes multiple groups of nanosecond pulse trains, and the time interval between two adjacent groups of nanosecond pulse trains is 1 us-10000 us. More preferably, the time interval between two adjacent groups of nanosecond pulse trains is 10 us-1000 us.

[0032] The nanosecond pulse train is composed of a plurality of nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 50ns-10000ns. More preferably, the time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns; and each group of nanosecond pulse trains is composed of 1-1000 nanosecond pulse pairs.

[0033] The nanosecond pulse pairs are composed of alternating positive and negative pulses, each of which has a pulse width of 10-1000 ns and a time interval of 10-1000 ns. More preferably, each of which has a pulse width of 50-500 ns and a time interval of 50-500 ns. Preferably, both the positive and negative pulses are square waves, and the absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the positive pulse.

[0034] The present invention uses nanosecond pulses with a pulse width of 10-1000ns and a time interval of 10-1000ns between positive and negative pulses to cause extensive but shallow electroporation in target cells. A nanosecond pulse train consisting of multiple nanosecond pulse pairs forms a nanosecond pulse train with a duration of microseconds, and the time interval between nanosecond pulse trains is in the microsecond range (optionally 1us-10000us, preferably 10us-1000us). The nanosecond pulse train applies a continuous electric field in the microsecond range, expanding the initial micropores formed by the nanosecond pulse pairs into irreversible transmembrane channels, ultimately leading to osmotic imbalance and apoptosis of the cells. In this way, this technical solution combines the advantages of nanosecond pulses being insensitive to cell size with the ability to address the technical problem of rapid closure of nanoscale micropores.

[0035] It's important to note that the core function of pulse intervals is to provide a time window for biological systems (from microscopic ions to macroscopic tissues) to respond and recover between two high-voltage shocks. This response and recovery process differs significantly between microsecond and nanosecond timescales. Microsecond pulses (typically with a pulse width >1μs) primarily target the cell membrane, disrupting the lipid bilayer of the cell membrane through irreversible electroporation (IRE), leading to cell death. As discussed in the background art, using these microsecond pulses for cell ablation suffers from size sensitivity. The time interval between microsecond pulses serves to dissipate heat and prevent thermal damage, as well as stabilize the cell membrane and electric field distribution. Nanosecond pulses (typically with a pulse width <1000ns) have extremely short pulse widths and extremely high voltages. Their core effect is to create nanoscale pores in the cell membrane while also directly affecting intracellular organelles (such as mitochondria and the nuclear membrane), leading to cell death through, for example, induction of apoptotic signaling. As discussed in the background art, using a single nanosecond pulse has the drawback of preventing the pores from healing in a timely manner, thus compromising ablation effectiveness. The core function of the time interval between nanosecond pulses is to maintain the long-lived permeability of the cell membrane, ensuring that the pores in the membrane do not close immediately and avoiding thermal and electrolytic effects. This application combines the unique biological effects of nanosecond pulses (the nanosecond pulses in a nanosecond pulse train are insensitive to cell size) with the physical regulatory effects of microsecond intervals (short intervals may cause bubbles or electrolysis products generated by the previous pulse to change local conductivity, affecting the electric field distribution of the next pulse, while microsecond intervals between pulse trains favor the electric field distribution of the next pulse train). This enables more efficient, safer, and more controllable cell ablation. Without the microsecond intervals between nanosecond pulse trains provided by this application, nanosecond pulses are simply energy superposition, repeatedly cycling through the "perforation-perforation healing-perforation" process. With this microsecond interval, the time intervals between pulse trains create "biological synergy," achieving a 1+1>2 effect, thereby achieving more effective therapeutic goals with lower total energy.

[0036] In the present embodiment, the electric field energy released by the nanosecond pulse pair on each electrode pair is preferably 10-100kV / cm. More preferably, the electric field energy released by the nanosecond pulse pair on each electrode pair is preferably 10-50kV / cm. In the prior art, a single nanosecond pulse is used for cell ablation, and the electric field energy released on each electrode pair is generally 1-10kV / cm; a single microsecond pulse is used for cell ablation, and the electric field energy released on each electrode pair is generally 10-30kV / cm. The present application uses nanosecond pulses with extremely high electric field strength to instantly induce the production of high-density nanopores in the cell membrane, while penetrating the cell membrane to directly act on organelles such as the nuclear membrane and mitochondria, triggering an intracellular electroporation effect.

[0037] like Figure 9 As shown, the pulse train consists of 1-1000 nanosecond pulse trains, with the interval between two pulse trains ranging from 0.1s to 10s. The pulse train interval and pulse train interval proposed in this application can partially close cell membrane pores before subsequent pulse shock, exacerbating ion imbalance and causing irreversible membrane damage, further increasing the apoptosis rate of cancer cells.

[0038] In one embodiment of the present invention, unlike the above embodiment in which the time interval between two adjacent groups of nanosecond pulse trains is an equal time interval of microseconds, in this embodiment, the time period for the pulse generator to output the sequence of pulse waves includes a first time period to an Nth time period from the first to the last, where N is a positive integer not less than 2, and the Nth time period is determined. i The time interval between two adjacent nanosecond pulse trains in the pulse sequence within the time period is T i ,but T i < T i+1 , i Take an integer from 1 to N.

[0039] For example, the time period during which the pulse generator outputs the sequence of pulse waves includes, from earliest to latest, the first time period, the second time period and the third time period. Preferably, T 1 The value range is 1us-2000us, T 2 The value range is 10us-5000us, T 3 The value range is 50us-10000us, T j Indicates the j The time interval between two adjacent nanosecond pulse trains in a pulse sequence within a time period. j 1 or 2 or 3.

[0040] This embodiment divides the entire treatment time into multiple time periods from early to late, and sets the time interval between two adjacent groups of nanosecond pulse trains in the late time period to be larger than that in the early time period. This can further reduce the healing probability of the nanopores, better meet the requirements of dynamic recovery of tissue conductivity, and improve local temperature rise, thereby better protecting adjacent blood vessels, bile ducts and nerve tissues.

[0041] Preferably, the time interval between two pulse sequences in different treatment phases is also adaptively adjusted to achieve better treatment effects. For example, the time period during which the pulse generator outputs the pulse sequence (i.e., the entire time period of electric field therapy) is divided into a first time period (front), a second time period (middle), and a third time period (back). t j Indicates the j The time interval between two adjacent pulse waves in a pulse sequence within a time period. j It is 1 or 2 or 3, preferably, t2>t1 and t2>t3, optionally, t1=t3 or t1≠t3.

[0042] In one embodiment of the present invention, Figure 4 As shown, the pulse generator 7 includes a display, a main controller, an electrical isolation module, a microprocessor, a high-voltage power supply, a pulse discharge module, and an electrode selection module. The display is electrically connected to the main controller and configured to display the operating status of the pulse generator. The main controller is electrically connected to the microprocessor via the electrical isolation module and is configured to run the main control program and coordinate and direct the coordinated operation of all other modules (microprocessor, high-voltage power supply, etc.). The display and / or the main controller are configured to input control parameters for the pulse generator.

[0043] The microprocessor is configured to receive control instructions from the main controller and convert them into precise, high-speed timing control signals, generating precise pulse trigger signals (PWM signals). The microprocessor controls the start time, width, interval, and number of pulses generated by the pulse discharge module.

[0044] The main controller and microprocessor are electrically isolated via the electrical isolation module (e.g., optical coupling, magnetic coupling, or fiber optic isolation), ensuring safe isolation between the low-voltage and high-voltage sides and ensuring good signal transmission. This electrical isolation module establishes a high-insulation barrier between the low-voltage control side (main controller, display) and the high-voltage side (microprocessor, pulse discharge, electrode selection, and high-voltage power supply control terminal), preventing high voltage from entering the low-voltage circuit, thereby protecting operators and patients from the risk of electric shock.

[0045] The high-voltage power supply is electrically connected to the microprocessor and is configured to provide high voltage to a subsequent pulse discharge module.

[0046] The pulse discharge module is the core power component that generates the actual high voltage pulse, which receives the precise timing signal sent by the microprocessor. The pulse discharge module can be a magnetic compression resonant circuit (such as a power switch (such as IGBT, MOSFET, SiC or a dedicated high voltage solid state switch)) composed of a power switch (such as IGBT, MOSFET, SiC or a dedicated high voltage solid state switch). Figure 6 shown) or Marx Bank circuit, etc.

[0047] The electrode selection module is configured to be electrically connected to the pulse discharge module and the electrode array membrane. The electrode selection module is configured to flexibly distribute the high-voltage pulses generated by the pulse discharge module to one or more designated first electrodes and / or second electrodes according to the settings and control of the main controller to achieve different ablation modes. The electrode selection module is typically composed of a series of high-voltage relays or a solid-state switch array.

[0048] Its workflow is as follows Figure 7 As shown, the catheter is controlled to the target location and the ablation operation begins. Under the control of the main controller and the microprocessor, the pulse generator outputs nanosecond pulses with a preset pulse width and a preset time interval. When the number of nanosecond pulses reaches a preset first threshold, the output of a set of nanosecond pulse trains is completed, and the output of nanosecond pulses is paused. When the pause duration reaches a preset pulse train interval (i.e., the time interval between two adjacent nanosecond pulse trains), the output of the next set of nanosecond pulse trains is started. When the number of output nanosecond pulse trains reaches a preset second threshold, the output of nanosecond pulses is paused. When the pause duration reaches a preset sequence pulse wave interval (i.e., the time interval between two adjacent sequence pulse waves), the output of the next sequence pulse wave is started. The above steps are repeated to output multiple sequence pulse waves until the pulse wave output stops, and the ablation is completed.

[0049] The device for ablation treatment of the digestive tract is based on the above-mentioned method to output nanosecond, microsecond, and millisecond composite nested pulses, which can reduce the electric field strength threshold for irreversible electroporation of tissues, form effective ablation damage in the target tissue at a lower total energy input, reduce ineffective energy consumption, and improve ablation efficiency. The pulses in the nanosecond train penetrate the cell membrane to form extensive but shallow electroporation, increase membrane permeability, and reduce impedance. The microsecond pulse train acts on the enlarged pores and penetrates deep into the cells, inducing a stronger electrolytic effect and ion imbalance, leading to irreversible membrane damage. At the same time, it can avoid the local temperature increase (>42°C) that may be caused by microsecond pulses in traditional IRE, thereby protecting adjacent blood vessels, bile ducts, and nerve tissues. By ablating the corresponding digestive tract tissues, it is possible to treat some digestive tract diseases, such as Figure 1 As shown, the device for performing electric field treatment on the digestive tract proposed by the present invention is used to extend the distal end of the catheter through the stomach 12 into the duodenum 13 and output the sequence of pulse waves, which can perform more efficient cell ablation on the villi tissue of the duodenum, reshape the surface of the duodenum, and treat diabetes.

[0050] Furthermore, in the device for ablation therapy of the digestive tract proposed by the present invention, the pulse generator only needs to use a single pulse discharge module to output the aforementioned nanosecond, microsecond, and millisecond composite nested pulses, eliminating the need for at least two sets of pulse discharge modules, as required by Chinese patent application publication number CN113824431A, one for generating nanosecond pulses and the other for generating microsecond pulses. Therefore, this technical solution not only achieves better cell ablation effects than existing technologies, but is also low-cost and easy to implement.

[0051] In one embodiment of the present invention, a system for performing ablation treatment on the digestive tract is provided, which includes a gastroscopic device and a device for performing electric field treatment on the digestive tract as described in any one of the above embodiments or a combination of multiple embodiments. The gastroscopic device includes a gastroscopic display screen 10, a gastroscopic catheter, and a gastroscopic body 14. The gastroscopic body 14 is arranged at the distal end of the gastroscopic catheter. The gastroscopic body 14 is provided with a surgical instrument channel 15 and a light-emitting body 16, and the light-emitting body 16 is used to provide lighting. The support body 2 and the electrode array membrane 3 in the device for performing electric field treatment on the digestive tract are arranged in the surgical instrument channel 15. A channel is provided inside the gastroscopic catheter, and the channel is used to accommodate the catheter 1 in the device for performing electric field treatment on the digestive tract. The gastroscopic display screen 10 is arranged at the proximal end of the gastroscopic catheter and is electrically connected to the gastroscopic body 14 for displaying information such as the shooting image and / or working status of the gastroscopic body 14.

[0052] It should be noted that the system for ablation treatment of the digestive tract provided by the present invention has the same inventive concept as the above-mentioned device embodiment for ablation treatment of the digestive tract. The entire content of the device embodiment for ablation treatment of the digestive tract is incorporated into the system embodiment for ablation treatment of the digestive tract by introduction.

[0053] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0054] The above is only a specific implementation method of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. A device for electric field treatment of the digestive tract, characterized in that: It includes: a long, thin catheter; A support body located at the distal end of the catheter, wherein the support body has a contracted working state and an expanded working state; an electrode array membrane, the electrode array membrane being arranged on the support body and being stretched on the support body when the support body is in an expanded working state, and being contracted on the support body when the support body is in a contracted working state, wherein the electrode array membrane is provided with a plurality of electrode pairs consisting of a first electrode and an adjacent second electrode; A pulse generator having a pulse signal output end, which is coupled to the electrode pair and is used to generate an ablation current on the electrode pair when the pulse generator outputs a sequence pulse wave; the sequence pulse wave includes multiple groups of nanosecond pulse trains, and the time interval between two adjacent groups of nanosecond pulse trains is 1us-10000us; the nanosecond pulse train is composed of multiple nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 50ns-10000ns; the nanosecond pulse pair is composed of alternating positive pulses and negative pulses, and the pulse width of each positive pulse or negative pulse is 10ns-1000ns, and the time interval between the positive pulse and the negative pulse is 10ns-1000ns.

2. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The electric field energy released by the nanosecond pulse pair on each electrode pair is 10-100 kV / cm.

3. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: Each group of nanosecond pulse trains is composed of a plurality of nanosecond pulse pairs, and the time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns.

4. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: Each nanosecond pulse pair is composed of alternating positive pulses and negative pulses. The pulse width of each positive pulse or negative pulse is 50ns-500ns, and the time interval between the positive pulse and the negative pulse is 50ns-500ns.

5. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The time period during which the pulse generator outputs the sequence of pulse waves includes a first time period to an Nth time period, where N is a positive integer not less than 2; Determine the i The time interval between two adjacent nanosecond pulse trains in the pulse sequence within the time period is T i ,but T i < T i+1 , i Take an integer from 1 to N-1.

6. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The time period during which the pulse generator outputs the sequence of pulse waves includes, from earliest to latest, a first time period, a second time period and a third time period; T 1 The value range is 1us-2000us, T 2 The value range is 10us-5000us, T 3 The value range is 50us-10000us, T j Indicates the j The time interval between two adjacent nanosecond pulse trains in a pulse sequence within a time period. j 1 or 2 or 3.

7. The device for electric field therapy of the digestive tract according to claim 4, characterized in that: The positive pulse and negative pulse are both square waves; and / or, The absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the positive pulse.

8. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The time interval between two adjacent groups of nanosecond pulse trains is 10 us-1000 us.

9. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: Each group of nanosecond pulse trains consists of 1-1000 nanosecond pulse pairs.

10. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The sequence pulse wave is composed of 1-1000 groups of nanosecond pulse trains, and the time interval between two of the sequence pulse waves is 0.1s-10s.

11. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: It also includes an operating handle, which is located at the proximal end of the catheter and is used to manipulate the support body to switch between a contracted working state and an expanded working state; and / or, The pulse generator includes a pulse discharge module, the number of the pulse discharge module is one, and the pulse discharge module is configured to output the sequence of pulse waves; and / or, The pulse generator includes an electrode selection module configured to control a portion or all of the electrodes on the electrode array membrane to generate the ablation current.

12. A system for ablation treatment of the digestive tract, characterized in that: It includes a device for performing electric field treatment on the digestive tract as described in any one of claims 1-11, and it also includes: a gastroscopic device, the gastroscopic device includes a gastroscopic body, a surgical instrument channel is provided on the gastroscopic body, and the support body and the electrode array membrane are arranged in the surgical instrument channel.

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