A device and system for applying electric field therapy to the digestive tract.

Abstract

This invention discloses a device and system for electric field therapy of the digestive tract. The device includes a slender catheter, a support at the distal end of the catheter, an electrode array membrane disposed on the support, and a pulse generator. The output end of the pulse generator is coupled to the electrode pairs on the electrode array membrane. The sequential pulse wave output by the pulse generator includes multiple nanosecond pulse trains, with a time interval of 1µs-10000µs between adjacent nanosecond pulse trains. Each nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 50ns-10000ns between two adjacent nanosecond pulse pairs. Each nanosecond pulse pair includes alternating positive and negative pulses, with pulse widths of 10-1000ns and time intervals of 10-1000ns. This invention can significantly improve cell membrane permeability and cell death efficiency, overcoming the limitations of traditional IRE technology.

Description

Technical Field

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

[0002] In recent years, with the deepening research on the biological effects of pulsed electric fields, more and more technologies and devices based on the principles of electropulse biological effects have entered clinical applications. Cell ablation-based electric field therapy devices are minimally invasive treatment devices that use electrodes to provide pulsed electric fields under image guidance to destroy the cellular activity of target tissues.

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

[0004] Nanosecond-level pulses are not sensitive to cell size and are almost unaffected by cell size, allowing them to induce nanoscale micropores on membranes. However, due to their extremely small size and rapid membrane elastic recovery, these micropores typically close completely within microseconds, which cannot support the sustained open-pore time (milliseconds) required for cell fusion, thus limiting the fusion success rate.

[0005] To address the technical problem of poor ablation effect of single pulses on tumor cells, Chinese patent application CN113824431A proposes a synergistic pulse generation circuit, generation device and generation method, which excites microsecond pulses and nanosecond pulses at different time periods, and then combines the microsecond pulses and nanosecond pulses to improve the ablation effect on tumor cells.

[0006] The above background information is provided only to assist in understanding the inventive concept and technical solution of this invention. It does not necessarily belong to the prior art of this application, nor does it necessarily provide technical teaching. In the absence of clear evidence that the above information was disclosed before the filing date of this application, the above background information should not be used to evaluate the novelty and inventiveness of this application. Summary of the Invention

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

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] A device for applying an electric field to the digestive tract, comprising:

[0010] Slender tubes;

[0011] A support body located at the distal end of the conduit, the support body having a contracted working state and an expanded working state;

[0012] 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.

[0013] A pulse generator has a pulse signal output terminal coupled to the electrode pair, used to generate an ablation current on the electrode pair when the pulse generator outputs a sequence of pulse waves; the sequence of pulse waves includes multiple sets of nanosecond pulse trains, with a time interval of 1μs-10000μs between adjacent sets of nanosecond pulse trains; each nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 50ns-10000ns between adjacent nanosecond pulse pairs; each nanosecond pulse pair consists of alternating positive and negative pulses, with a pulse width of 10ns-1000ns for each positive or negative pulse, and a time interval of 10ns-1000ns between the positive and negative pulses.

[0014] Furthermore, based on any one or a combination of the aforementioned technical solutions, the electric field energy released by the nanosecond pulse pair on each electrode pair is 10-100 kV / cm.

[0015] Furthermore, following any one or a combination of the aforementioned technical solutions, each nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 100ns-1000ns between two adjacent nanosecond pulse pairs.

[0016] Furthermore, following any one or a combination of the aforementioned technical solutions, each nanosecond pulse pair consists of alternating positive and negative pulses, with each positive or negative pulse having a pulse width of 50ns-500ns and a time interval of 50ns-500ns between the positive and negative pulses.

[0017] Furthermore, following any one or a combination of the aforementioned technical solutions, the time period for which the pulse generator outputs the sequence pulse wave includes the first time period from the beginning to the Nth time period, where N is a positive integer not less than 2.

[0018] Determine the first i The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a time period is T i ,but T i < T i+1 , i Take an integer from 1 to N-1.

[0019] Furthermore, based on any one or a combination of the aforementioned technical solutions, the time period for the pulse generator to output the sequence pulse wave includes a first time period, a second time period, and a third time period, arranged from beginning to end.

[0020] T 1 The value range is 1μs-2000μs. T 2 The value range is 10μs-5000μs. T 3 The value range is 50μs-10000μs. T j Indicates the first j The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a time period. j It can be 1, 2, or 3.

[0021] Furthermore, following any one or a combination of the aforementioned technical solutions, the positive pulse and negative pulse are both square waves; and / or,

[0022] 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.

[0023] Furthermore, based on any one or a combination of the aforementioned technical solutions, the time interval between two adjacent nanosecond pulse trains is 10μs-1000μs.

[0024] Furthermore, following any one or a combination of the aforementioned technical solutions, each nanosecond pulse train consists of 1-1000 nanosecond pulse pairs.

[0025] Furthermore, following any one or a combination of the aforementioned technical solutions, the sequence pulse wave is composed of 1-1000 nanosecond pulse trains, and the time interval between two of the aforementioned sequence pulse waves is 0.1s-10s.

[0026] Furthermore, following any one or a combination of the foregoing technical solutions, it further includes an operating handle located at the proximal end of the conduit, used to manipulate the support body to switch between a contraction working state and an expansion working state; and / or,

[0027] The pulse generator includes a pulse discharge module, and the number of pulse discharge modules is one. The pulse discharge module is configured to output the sequence of pulse waves; and / or,

[0028] The pulse generator includes an electrode selection module configured to control some or all of the electrodes on the electrode array film to generate the ablation current.

[0029] According to another aspect of the present invention, the present invention provides a system for ablation therapy of the digestive tract, comprising an apparatus for electric field therapy of the digestive tract as described in any one or a combination of technical solutions, further comprising: a gastroscopy device, the gastroscopy device comprising a gastroscope body, the gastroscope body having a surgical instrument channel, the support body and the electrode array membrane being disposed within the surgical instrument channel.

[0030] The beneficial effects of the technical solution provided by this invention are as follows:

[0031] a. The device for electric field therapy of the digestive tract provided by the present invention generates millisecond-level sequential pulse waves through a pulse generator. The sequential pulse waves include microsecond-level nanosecond pulse trains formed by multiple nanosecond pulses nested together. Multiple nanosecond pulses in the nanosecond pulse train can form extensive but shallow electroporation on the target cells. The dense nanosecond pulses in the nanosecond pulse train ensure that the local electric field intensity reaches the target, and the time interval between trains allows the tissue conductivity to recover dynamically. In this way, the electric field can be continuously applied to cells of various sizes, while also adjusting the uniformity of the electric field distribution, ultimately forming a more continuous, transmural ablation area. This can significantly improve cell membrane permeability and cell death efficiency, breaking through the limitations of traditional IRE technology and showing significant value in terms of improved efficacy, optimized safety, and expanded indications.

[0032] b. The pulse generator provided by this invention only requires a pulse discharge module to generate a sequence of nanosecond, microsecond, and millisecond composite nested pulses, which can reduce the electric field strength threshold for irreversible electroporation of tissues. The lower total energy input can form effective ablation damage in the target tissue, reduce ineffective energy consumption, improve ablation efficiency, and has low cost. Attached Figure Description

[0033] 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.

[0034] Figure 1 A schematic diagram of an apparatus for applying an electric field to the digestive tract in the human body, provided as an exemplary embodiment of the present invention;

[0035] Figure 2 A schematic diagram of the structure of a gastroscope body equipped with an electrode array membrane, provided as an exemplary embodiment of the present invention;

[0036] Figure 3 A schematic diagram of the structure of the support and electrode array film provided in an exemplary embodiment of the present invention;

[0037] Figure 4 A block diagram of an apparatus for applying an electric field to the digestive tract, provided as an exemplary embodiment of the present invention;

[0038] Figure 5 A schematic diagram of a device for applying an electric field to the digestive tract, provided as an exemplary embodiment of the present invention;

[0039] Figure 6 A schematic diagram of the circuit principle of an apparatus for electric field therapy of the digestive tract provided as an exemplary embodiment of the present invention;

[0040] Figure 7 A schematic diagram of the working process of an apparatus for electric field therapy of the digestive tract provided as an exemplary embodiment of the present invention;

[0041] Figure 8 A schematic diagram of the composition structure of a pulse train provided for an exemplary embodiment of the present invention;

[0042] Figure 9 A schematic diagram of the composition structure of a sequence pulse wave provided for an exemplary embodiment of the present invention.

[0043] The components include: 1. Catheter; 2. Support body; 3. Electrode array membrane; 4. First electrode; 5. Second electrode; 6. Electrode pair; 7. Pulse generator; 10. Endoscope display screen; 11. Operating handle; 12. Stomach; 13. Duodenum; 14. Endoscope body; 15. Surgical instrument channel; 16. Light-emitting element; 17. Knob. Detailed Implementation

[0044] 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.

[0045] 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.

[0046] The Chinese patent application CN113824431A proposes a technical solution that combines microsecond and nanosecond pulses, which can improve the ablation effect on tumor cells to some extent. However, this technical solution is essentially still a time-division multiplexing of microsecond and nanosecond pulses, and cannot simultaneously achieve the advantages of both microsecond and nanosecond pulses in cell ablation while avoiding their disadvantages. Specifically, regarding the technical solution provided in this patent application, during the period of cell ablation using microsecond pulses, there are still problems such as large cells being prone to death due to excessive perforation and small cells having insufficient perforation leading to insufficient overall fusion rate; during the period of cell ablation using nanosecond pulses, there is still the technical problem of limited fusion success rate due to the rapid recovery of nanoscale micropores.

[0047] To address the shortcomings of existing technologies, this application proposes a device for applying electric field therapy to the digestive tract, see [link to relevant documentation]. Figures 1 to 3 and Figure 5 The device for electric field therapy of the digestive tract includes a slender catheter 1, a support 2, an operating handle 11, an electrode array membrane 3, and a pulse generator 7.

[0048] The support 2 is located at the distal end of the conduit 1, and has a contracted working state and an expanded working state. Before the distal end of the conduit 1 reaches the target position, the support 2 is configured in the contracted working state to facilitate the movement of the conduit 1 and the support 2 and reduce injury to the human body. When the distal end of the conduit 1 reaches the target position, the support 2 is configured in the expanded working state to control the device to release a pulsed electric field at the target position.

[0049] The operating handle 11 is located at the proximal end of the conduit 1, and the operating handle 11 is used to manipulate the support 2 to switch between a contraction working state and an expansion working state. Specifically, as shown... Figure 5 As shown, the operating handle 11 is provided with a knob 17, which is rotated to switch the support body 2 between the contraction working state and the expansion working state.

[0050] The electrode array film 3 is arranged on the support body 2. When the support body 2 is in an expanded working state, the electrode array film 3 is open on the support body 2. When the support body 2 is in a contracted working state, the electrode array film 3 is contracted on the support body 2. The electrode array film 3 is provided with multiple pairs of electrode pairs 6, each consisting of a first electrode 4 and an adjacent second electrode 5.

[0051] The pulse generator 7 has a pulse signal output terminal, which is coupled to the electrode pair 6. When the pulse generator 7 outputs a sequence of pulse waves, an ablation current is generated on the electrode pair 6. Figure 8 and Figure 9 As shown, the sequence pulse wave includes multiple nanosecond pulse trains, with a time interval of 1 μs to 10,000 μs between adjacent nanosecond pulse trains. More preferably, the time interval between adjacent nanosecond pulse trains is 10 μs to 1,000 μs.

[0052] The nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 50ns-10000ns between two adjacent nanosecond pulse pairs. More preferably, the time interval between two adjacent nanosecond pulse pairs is 100ns-1000ns; each nanosecond pulse train consists of 1-1000 nanosecond pulse pairs.

[0053] The nanosecond pulse pair consists of alternating positive and negative pulses, each with a pulse width of 10-1000 ns and a time interval of 10-1000 ns between them. More preferably, each positive or negative pulse has a pulse width of 50-500 ns and a time interval of 50-500 ns between them. Preferably, both the positive and negative pulses are square waves; 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.

[0054] This invention utilizes nanosecond pulses with a pulse width of 10-1000 ns and a time interval of 10-1000 ns between positive and negative pulses to create extensive but shallow electroporation in target cells. Multiple nanosecond pulse pairs form a nanosecond pulse train with a duration reaching the microsecond level, and the time interval between nanosecond pulse trains is in the microsecond range (selectively 1 μs-10000 μs, preferably 10 μs-1000 μs). Through the continuous electric field applied by the nanosecond pulse train, the initial micropores formed by the nanosecond pulse pairs are expanded into irreversible transmembrane channels, ultimately leading to osmotic imbalance and apoptosis in the cells. Thus, this technical solution possesses the advantage of nanosecond pulses being insensitive to cell size while also solving the technical problem of rapid closure of nanoscale micropores.

[0055] It is important to note that the core function of the pulse interval is to provide a time window for response and recovery in biological systems (from microscopic ions to macroscopic tissues) between two high-voltage electrical shocks. This response and recovery differ significantly at the microsecond and nanosecond scales. Microsecond pulses (typically with a pulse width > 1 μs) primarily target the cell membrane, disrupting the lipid bilayer through irreversible electroporation (IRE), leading to cell death. As described in the background section, using microsecond pulses for cell ablation suffers from excessive sensitivity to size. The time interval between microsecond pulses serves to dissipate heat and prevent thermal damage, as well as stabilize the cell membrane state and electric field distribution. Nanosecond pulses (typically with a pulse width < 1000 ns) have extremely short pulse widths and extremely high voltages. Their core effect is to create nanoscale pores in the cell membrane while directly acting on intracellular organs (such as mitochondria and nuclear membranes), leading to cell death through the induction of apoptosis signals. As described in the background section, using a single nanosecond pulse results in the inability to heal perforations promptly, thus affecting the ablation effect. 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 on the membrane do not close immediately and avoiding thermal and electrolytic effects. This application combines the unique biological effects of nanosecond pulses (nanosecond pulses in a nanosecond pulse train are insensitive to cell size) with the physical modulating effect of microsecond intervals (short intervals may cause bubbles or electrolytic products generated by the previous pulse to change the local conductivity, affecting the electric field distribution of the next pulse, while microsecond-level pulse train time intervals are beneficial to the electric field distribution of the next pulse train), enabling more efficient, safer, and more controllable cell ablation. Without the microsecond-level time interval between nanosecond pulse trains provided in this application, nanosecond pulses are simply energy superpositions, repeatedly cycling through the process of "perforation-perforation healing-perforation". With this microsecond-level interval, a "biological synergy" is created between the time intervals of pulse trains, achieving a 1+1>2 effect, thereby achieving a more effective therapeutic goal with lower total energy.

[0056] In this embodiment, the electric field energy released by the nanosecond pulse pair on each electrode pair is preferably 10-100 kV / cm. More preferably, the electric field energy released by the nanosecond pulse pair on each electrode pair is preferably 10-50 kV / cm. In the prior art, when using a single nanosecond pulse for cell ablation, the electric field energy released on each electrode pair is typically 1-10 kV / cm; when using a single microsecond pulse for cell ablation, the electric field energy released on each electrode pair is typically 10-30 kV / cm. This application uses nanosecond pulses with extremely high electric field strength to instantaneously induce high-density nanopores in the cell membrane, while simultaneously penetrating the cell membrane to directly act on organelles such as the nuclear membrane and mitochondria, triggering an intracellular electroporation effect.

[0057] like Figure 9As shown, the sequence pulse wave consists of 1-1000 nanosecond pulse trains, and the time interval between two sequence pulse waves is 0.1s-10s. Based on the pulse train interval and sequence pulse wave interval proposed in this application, the cell membrane pores can be partially closed before being impacted by subsequent pulses, exacerbating ion imbalance, achieving irreversible membrane damage, and further increasing the apoptosis rate of cancer cells.

[0058] In one embodiment of the present invention, unlike the above embodiment where the time interval between two adjacent nanosecond pulse trains is a microsecond-level equal time interval, in this embodiment, the time period for the pulse generator to output the sequence pulse wave includes a first time period from beginning to end to the Nth time period, where N is a positive integer not less than 2, to determine the Nth time period. i The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a time period is T i ,but T i < T i+1 , i Take an integer from 1 to N.

[0059] For example, the time intervals during which the pulse generator outputs the sequential pulse wave include a first time interval, a second time interval, and a third time interval, from beginning to end. Preferably, T 1 The value range is 1μs-2000μs. T 2 The value range is 10μs-5000μs. T 3 The value range is 50μs-10000μs. T j Indicates the first j The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a time period. j It can be 1, 2, or 3.

[0060] This embodiment divides the entire treatment time into multiple time periods from beginning to end, and sets the time interval between two adjacent nanosecond pulse trains to be larger in the later time period than in the earlier time period. This can further reduce the healing probability of nanopores, better meet the requirements of dynamic recovery of tissue conductivity, and improve the local temperature rise, thus better protecting adjacent blood vessels, bile ducts, and nerve tissues.

[0061] Preferably, the time interval between the two sequential pulse waves in different treatment stages is also adaptively adjusted to achieve better therapeutic effects. For example, the time period during which the pulse generator outputs the sequential pulse waves (i.e., the entire time period of electric field therapy) is divided into a first time period (before), a second time period (middle), and a third time period (after), from beginning to end. t j Indicates the first j The time interval between two adjacent pulse waves in a pulse wave sequence within a time period. j The t2 value is 1, 2, or 3. Preferably, t2 > t1 and t2 > t3. Alternatively, t1 = t3 or t1 ≠ t3.

[0062] In one embodiment of the present invention, such as 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 is 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 a main control program, coordinate and direct the collaborative work 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.

[0063] The microprocessor is configured to receive control commands from the main controller and convert the received control commands into precise, high-speed timing control signals to generate precise pulse trigger signals (PWM signals). The microprocessor controls the start time, width, interval, and number of pulses generated by the pulse discharge module.

[0064] The main controller and the microprocessor are electrically isolated through the 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 good signal transmission. The electrical isolation module establishes a high-insulation-strength barrier between the low-voltage control side (main controller, display) and the high-voltage side (microprocessor, pulse discharge, electrode selection, high-voltage power supply control terminal), preventing high voltage from entering the low-voltage circuit and thus protecting operators and patients from the risk of electric shock.

[0065] The high-voltage power supply is electrically connected to the microprocessor and is configured to provide high voltage to the subsequent pulse discharge module.

[0066] 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 microprocessor. The pulse discharge module can employ a magnetic compression resonant circuit composed of power switches (such as IGBTs, MOSFETs, SiC, or dedicated high-voltage solid-state switches) (e.g.,...). Figure 6 (as shown) or Marx Bank circuits, etc.

[0067] The electrode selection module is configured to be electrically connected to both 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 and / or second electrodes, according to the settings and control of the main controller, to achieve different ablation modes. The electrode selection module typically consists of a series of high-voltage relays or solid-state switch arrays.

[0068] Its workflow is as follows Figure 7 As shown, the catheter is controlled to the target position to begin the ablation operation. Under the control of the main controller and the microprocessor, the pulse generator outputs nanosecond pulses with preset pulse widths and preset time intervals. When the number of nanosecond pulses reaches a preset first threshold, 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 next set of nanosecond pulse trains is output. 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 next sequence pulse wave is output. The above steps are repeated to output multiple sequence pulse waves until the pulse wave output stops, at which point the ablation ends.

[0069] The aforementioned device for ablation therapy of the digestive tract achieves output of nanosecond, microsecond, and millisecond composite nested pulses based on the above-described method. This reduces the electric field strength threshold for irreversible electroporation in tissues, resulting in effective ablation damage in the target tissue with lower total energy input, reducing ineffective energy consumption and improving ablation efficiency. Within the nanosecond pulse train, pulses penetrate the cell membrane, forming extensive but shallow electroporation, increasing membrane permeability and reducing impedance. The microsecond pulse train acts on the enlarged pores, penetrating deeper into the cell, inducing stronger electrolytic effects and ion imbalances, leading to irreversible membrane damage. Simultaneously, it avoids the local temperature rise (>42℃) that may be caused by microsecond pulses in traditional IREs, thus protecting adjacent blood vessels, bile ducts, and nerve tissue. By ablating corresponding digestive tract tissues, it is possible to treat some digestive tract diseases, such as… Figure 1As shown, the device for electric field therapy of the digestive tract proposed in this invention extends the distal end of the catheter through the stomach 12 into the duodenum 13 and outputs the sequence of pulse waves, which can more efficiently ablate the villi tissue of the duodenum, reconstruct the surface of the duodenum, and treat diabetes.

[0070] Furthermore, the device for ablation therapy of the digestive tract proposed in this invention requires only one pulse discharge module to output the aforementioned nested nanosecond, microsecond, and millisecond pulses. Unlike Chinese patent application CN113824431A, which uses at least two sets of pulse discharge modules—one for generating nanosecond pulses and the other for generating microsecond pulses—this invention offers a significantly improved cell ablation effect compared to existing technologies. It is also cost-effective and easy to implement.

[0071] In one embodiment of the present invention, a system for ablation therapy of the digestive tract is provided, comprising an endoscope and an apparatus for electric field therapy of the digestive tract as described in any of the preceding embodiments or combinations thereof. The endoscope includes an endoscope display screen 10, an endoscope catheter, and an endoscope body 14. The endoscope body 14 is disposed at the distal end of the endoscope catheter, and has a surgical instrument channel 15 and a light-emitting element 16 for providing illumination. The support 2 and the electrode array membrane 3 of the apparatus for electric field therapy of the digestive tract are disposed within the surgical instrument channel 15. The endoscope catheter has an internal channel for accommodating the catheter 1 of the apparatus for electric field therapy of the digestive tract. The endoscope display screen 10 is disposed at the proximal end of the endoscope catheter and electrically connected to the endoscope body 14, for displaying images captured by the endoscope body 14 and / or information such as its operating status.

[0072] 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-described device embodiment for ablation treatment of the digestive tract. The entire contents of the device embodiment for ablation treatment of the digestive tract are incorporated into the system embodiment for ablation treatment of the digestive tract by means of introduction.

[0073] 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.

[0074] 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 device for applying an electric field to the digestive tract, 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 the electrode pair, used to generate an ablation current on the electrode pair when the pulse generator outputs a sequence of pulse waves; the sequence of pulse waves includes multiple sets of nanosecond pulse trains, with a time interval of 1μs-10000μs between adjacent sets of nanosecond pulse trains; each nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 50ns-10000ns between adjacent nanosecond pulse pairs; each nanosecond pulse pair consists of alternating positive and negative pulses, with a pulse width of 10ns-1000ns for each positive or negative pulse, and a time interval of 10ns-1000ns between the positive and negative pulses.

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 nanosecond pulse train consists of multiple nanosecond pulse pairs, with a time interval of 100ns-1000ns between two adjacent nanosecond pulse pairs.

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

5. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The pulse generator outputs the sequence of pulse waves over a period of time, from the first time period to the Nth time period, where N is a positive integer not less than 2. Determine the first i The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a 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 pulse generator outputs the sequence of pulse waves over time periods including a first time period, a second time period, and a third time period, from beginning to end. T 1 The value range is 1μs-2000μs. T 2 The value range is 10μs-5000μs. T 3 The value range is 50μs-10000μs. T j Indicates the first j The time interval between two adjacent nanosecond pulse trains in a sequence of pulse waves within a time period. j It can be 1, 2, or 3.

7. The device for electric field therapy of the digestive tract according to claim 4, characterized in that: Both the positive and negative pulses mentioned are 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 nanosecond pulse trains is 10μs-1000μs.

9. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: Each nanosecond pulse train 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 consists of 1-1000 nanosecond pulse trains, and the time interval between two 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 located at the proximal end of the conduit for manipulating the support body to switch between a contraction working state and an expansion working state; And / or, The pulse generator includes a pulse discharge module, and the number of the pulse discharge module is one. 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 some or all of the electrodes on the electrode array film to generate the ablation current.

12. A system for ablation therapy of the digestive tract, characterized in that, It includes an apparatus for applying electric field therapy to the digestive tract as described in any one of claims 1-11, and further includes: a gastroscopy device, the gastroscopy device including a gastroscope body, the gastroscope body having a surgical instrument channel, and the support and the electrode array membrane disposed within the surgical instrument channel.

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