Devices and systems for applying electric fields to the digestive tract

Abstract

This invention relates to a device for electric field therapy of the digestive tract, comprising a catheter, a support, an electrode array membrane, and a pulse generator; the pulse generator includes a current sensor for sensing the current flowing through the electrode pairs; during an initial time period, in a first sequence of pulse waves, the voltage amplitude of subsequent pulses is greater than the voltage amplitude of preceding pulses, and the current sensor senses a current equal to or exceeding a lower limit value I of a set range. S(MIN) At that time, in the next time period, the absolute value U of the voltage amplitude of each pulse of the second sequence pulse wave S Equal. This invention controls the output voltage amplitude of the pulse generator through feedback from a current sensor, making treatment safer for the human body.

Description

Technical Field

[0001] This invention relates to a medical device, particularly a device for applying energy to the digestive tract to ablate its tissues. Background Technology

[0002] In existing technologies, the use of electric field ablation to treat the villi or mucosa of the duodenal wall to treat diabetes has gained widespread consensus in the medical community. Chinese Patent Application No. 202310866398.6 discloses an electric pulse transmitter and a balloon electrode electric pulse ablation system: "Each energy level selection switch is connected in series with a discharge capacitor. A resistor connected in parallel with the switch is used to prevent false triggering of the MOSFET. A capacitor connected in parallel with the capacitor is used to release residual energy across the capacitor terminals, ensuring safety. A current detection point is provided between the energy level selection switch and the discharge capacitor to detect the current path when the energy level selection switch is on. Specifically, VS1-6 is connected to the MOSFET driver to detect the charging current value of each capacitor. The current detection terminal is equipped with an ASC712 Hall current sensor. The current sensor converts the current signal into a voltage signal in an isolated mode before transmitting it." This system only detects the current signal to prevent overcurrent. Chinese Patent Application No. 202180029712.4 discloses a system and method for delivering targeted therapy: "Comprising: at least one characterization sensor for providing data to detect identified target cells within tissue in a body cavity wall, wherein the body cavity wall comprises a cell layer; an elongated device including a proximal portion, a distal portion, and at least one ablation element coupled to the distal portion, the at least one ablation element being configured to ablate the identified target cells within the tissue; and a labeling system configured to label the tissue in the body cavity wall, wherein the tissue includes the ablated target cells. The characterization sensor includes an efficacy sensor that provides data to determine the effectiveness of the ablation. The efficacy sensor includes at least one selected from the group consisting of an imaging sensor, a temperature sensor, a current sensor, an impedance sensor, a pH sensor, or a peptide sensor." Therefore, existing gastrointestinal pulsed ablation techniques only detect current during energy output, making it impossible to predict the ablation effect. Meanwhile, due to differences in human gastrointestinal tissues and the varying degrees of contact between ablation elements, the ablation current may be too large or too small. If the ablation current is too small, it will affect the treatment effect; if the ablation current is too large, the excessive output energy may cause arcing, sparking, or other issues, leading to risks such as tissue carbonization and gastrointestinal perforation. Summary of the Invention

[0003] The purpose of this invention is to provide a device for electric field therapy of the digestive tract, wherein the amplitude of the output pulse voltage of the pulse generator is controlled according to the current value detected by the current sensor.

[0004] The technical solution of the present invention is: a device for applying electric field therapy to the digestive tract, comprising:

[0005] Slender tubes;

[0006] A support body located at the distal end of the conduit, the support body having a contracted working state and an expanded working state;

[0007] 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 open 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, including a first electrode and a second electrode.

[0008] A pulse generator has a pulse signal output terminal coupled to the electrode pair for generating an ablation current on the electrode pair when the pulse generator outputs a sequence of pulse waves. The pulse generator includes a current sensor for sensing the current flowing through the electrode pair. During an initial time period, the absolute value of the voltage amplitude of subsequent pulses in the first sequence of pulse waves is greater than the absolute value of the voltage amplitude of preceding pulses, and the current sensor senses a current equal to or exceeding a lower limit value I of a set range. S(MIN) At that time, in the next time period, the absolute value U of the voltage amplitude of each pulse of the second sequence pulse wave S equal.

[0009] Optionally, the set range may also have an upper limit value I. S(MAX) When the current sensor detects a current greater than or equal to the upper limit value I of the set range. S(MAX) Then, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the sequence pulse wave. S ', forming a third sequence of pulse waves, the adjusted U S Satisfy the following formula: U S '=(U S / I L -R0)*I S(MIN)

[0010] Among them, I L R0 is the sensed current value, and R0 is the resistance value of the circuit through which the current passes, which is a constant.

[0011] Optionally, the sequence of pulse waves includes alternating positive and negative pulses.

[0012] Optionally, in the first sequence of pulse waves, the absolute value of the voltage amplitude of the subsequent positive pulse is greater than the absolute value of the voltage amplitude of the preceding positive pulse, and the absolute value of the voltage amplitude of the subsequent negative pulse is greater than the absolute value of the voltage amplitude of the preceding negative pulse.

[0013] Optionally, the absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the preceding positive pulse.

[0014] Optionally, the absolute value of the voltage amplitude of the negative pulse is greater than the absolute value of the voltage amplitude of the preceding positive pulse, and the absolute value of the voltage amplitude of the positive pulse is also greater than the absolute value of the voltage amplitude of the preceding negative pulse.

[0015] A system for ablation therapy of the digestive tract, the device for electric field therapy of the digestive tract, further includes: an operating handle located at the proximal end of a catheter for manipulating the support body to switch between a contraction working state and an expansion working state.

[0016] Compared with the prior art, the present invention has the following advantages:

[0017] Discharge is achieved by progressively increasing pulse voltage amplitude, meaning that in the first sequence of pulse waves, the absolute value of the voltage amplitude of subsequent pulses is greater than the absolute value of the voltage amplitude of preceding pulses. The ablation current is monitored in real time, and the discharge occurs when the current sensor detects a current equal to or exceeding the lower limit value I of the set range. S(MIN) When the ablation current reaches the preset range, the ablation parameters are maintained, which can stably perform electric field ablation on the target tissue, making the ablation procedure safer. Attached Figure Description

[0018] Appendix Figure 1 This is a schematic diagram of the system structure of the device of the present invention when it is located in the surgical instrument channel of the endoscope and is inserted into the duodenum through the endoscope, before the expandable component extends out of the endoscope;

[0019] Appendix Figure 2 For the appendix Figure 1 The enlarged detailed structural diagram at point F shows that the support structure is a support frame and is in a retracted working state.

[0020] Appendix Figure 3 A front view of the structure of the support and the electrode array membrane arranged on the support when the balloon is selected as the support and is in the expansion working state;

[0021] Appendix Figure 4 Here is a circuit block diagram of a pulse generator;

[0022] Appendix Figure 5 The system structure diagram of the present invention is shown when a support frame is selected for the support body and the body is in a retracted working state.

[0023] Appendix Figure 6 This is the circuit diagram of a pulse generator;

[0024] Appendix Figure 7 This is a flowchart of the pulse discharge process of the pulse generator during the ablation treatment of the duodenum and other parts of the digestive tract using this device;

[0025] Appendix Figure 8 This is a waveform diagram of the first embodiment of the first sequence of pulse waves;

[0026] Appendix Figure 9 The waveform diagram is for the second embodiment of the first sequence of pulse waves;

[0027] Appendix Figure 10 The waveform diagram is for the third embodiment of the first sequence of pulse waves;

[0028] Appendix Figure 11 This is a waveform diagram of the fourth embodiment of the first sequence of pulse waves;

[0029] 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; 15. Surgical instrument channel of the endoscope; 16. Light-emitting element of the endoscope; 17. Knob; 18. Posterior guide cap; 19. Anterior guide cap;

[0030] I S(MIN) Set the lower limit of the range; U S The voltage amplitude of each pulse in the second sequence of pulse waves; I S(MAX) The upper limit of the set range; the absolute value U of the pulse voltage amplitude of the third sequence pulse wave. S '; I L The sensed current value; R0, the resistance value of the circuit; Detailed Implementation

[0031] In this invention, the digestive tract refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, and anus. The upper digestive tract refers to the areas that a gastroscopy can penetrate, including the esophagus, stomach, and duodenum. This invention is particularly applicable to the upper digestive tract. "Front" in this invention refers to the direction in which the device advances into the digestive tract, and "rear" refers to the direction of retraction, for example, as shown in the attached image. Figure 5 In this context, the left-facing direction is considered the front, and the right-facing direction is considered the rear. The terms "front" and "rear" in this article are defined in the same direction. The front end also refers to the end furthest from the operator (doctor), and is also known in the industry as the distal end; the rear end refers to the end closest to the operator, and is also known in the industry as the proximal end.

[0032] See appendix Figure 1Appendix Figure 2 Appendix Figure 3 Appendix Figure 5 A device for applying an electric field to the digestive tract, comprising:

[0033] The elongated catheter 1, in one alternative embodiment, is a support 2 selected as shown in the attached figure. Figure 2 Or attached Figure 5 The supporting frame shown includes an outer catheter 1 and an inner catheter located within the lumen of the outer catheter, both of which can slide or rotate in the front-to-back direction to control the supporting frame in a contracted or expanded working state; alternative embodiments may include a support 2 selected as shown in the attached figure. Figure 3 The balloon shown has a conduit 1 containing a tube for infusing media such as saline into the balloon;

[0034] The support 2 located at the distal end of the catheter has a contracted working state and an expanded working state; the support 2 may be equipped with an attachment Figure 3 The balloon shown expands to its dilation state by injecting saline solution into the tubing within catheter 1, or forms the support frame in this embodiment as described in Chinese Patent Application No. 202420286431.8, with numerous embodiments of the support frame. The support frame described in this specification includes, but is not limited to, the structures described above. The support body 2 switches between the contraction and dilation states by sliding or rotating the outer and inner catheters in the anterior-posterior direction. The support frame or balloon as the support body 2 can be existing technology, and will not be described in detail in this embodiment.

[0035] Electrode array film 3, wherein the electrode array film 3 is arranged on the support 2, and the support 2 is in an expanded working state (as shown in the attached figure). Figure 3 As shown in the attached diagram, the electrode array film 3 is spread out on the support 2; when the support 2 is in the contracted working state, the electrode array film 3 is contracted onto the support 2 (as shown in the attached diagram). Figure 5 As shown in the figure, the electrode array membrane 3 is divided into multiple regional modules, and during treatment, only some modules can be selected for discharge. Each regional module is provided with multiple electrode pairs 6, including a first electrode 4 and a second electrode 5. Each electrode pair 6 is connected in parallel across the pulse signal output terminals (as shown in the attached figure). Figure 6 As shown), after applying a pulse wave to the selected area module, multiple pairs of electrodes 6 discharge simultaneously, that is, after the first electrode 4 and the second electrode 5 discharge, an ablation current is formed to ablate the villi or mucosa of the digestive tract wall.

[0036] Pulse generator 7, see appendix Figure 4 and attached Figure 6It has a pulse signal output terminal, which is coupled to the plurality of electrode pairs 6, and is used to generate an ablation current between the plurality of electrode pairs 6 when the pulse generator 7 outputs a sequence of pulse waves; a bridge circuit composed of a first high-voltage switch, a second high-voltage switch, a third high-voltage switch, and a fourth high-voltage switch can output pulse waves at both ends of the pulse signal output terminal; the pulse generator 7 also includes a current sensor for sensing the current flowing between the electrode pairs 6, see Appendix Figure 4 The current sensor is located in the discharge current detection module.

[0037] See appendix Figure 7 The flowchart illustrates the process. Before surgery, an ablation current threshold is preset for the output current of pulse generator 7. Initially, a first sequence of pulse waves is applied to electrode pair 6. As time progresses, the amplitude of subsequent pulse voltages continuously increases, and multiple electrode pairs 6 discharge. The total current value of tissue ablation caused by the discharge of multiple electrode pairs 6 is detected and obtained in real time by a current sensor. When the ablation current enters the preset range, i.e., greater than or equal to I... S(MIN)， The ablation parameters are maintained, meaning the voltage amplitude of subsequent pulses remains constant. In some embodiments, the current threshold can be any range from 10A to 100A, and different ranges are set depending on the ablation location, the patient's condition, the doctor's experience, or the treatment plan. During a period of time at the start of the ablation procedure, if the absolute value of the voltage amplitude of subsequent pulses in the first sequence of pulses is greater than the absolute value of the voltage amplitude of preceding pulses, and the current sensor detects a current equal to or exceeding the lower limit value I of the set range... S(MIN) At that time, in the next time period, the absolute value U of the voltage amplitude of each pulse of the second sequence pulse wave S Equal to maintain the second sequence of pulse waves for safe ablation treatment.

[0038] For examples of the first sequence of pulse waves with progressively increasing ablation pulse voltage, please refer to the appendix. Figure 8 To be continued Figure 11 The aforementioned sequence of pulse waves includes alternating positive and negative pulses, which can reduce muscle stimulation during ablation surgery.

[0039] See appendix Figure 8 Appendix Figure 11The first sequence of pulse waves, in which the absolute values ​​of the voltage amplitude (i.e., voltage peak value) of each group of positive and negative square waves (or sine waves) are the same, can significantly reduce muscle stimulation. Specifically, in the first sequence of pulse waves, the absolute value of the voltage amplitude of the subsequent positive pulse (second voltage) is greater than the absolute value of the voltage amplitude of the preceding positive pulse (first voltage), the absolute value of the voltage amplitude of the subsequent negative pulse (second voltage) is greater than the absolute value of the voltage amplitude of the preceding negative pulse (first voltage), and the absolute value of the voltage amplitude of the negative pulses in the same group (first voltage) is equal to the absolute value of the voltage amplitude of the adjacent preceding positive pulse (first voltage). (See attached...) Figure 8 Appendix Figure 11 As shown, the third voltage amplitude is greater than the second voltage amplitude, and the fourth voltage amplitude is greater than the third voltage amplitude. (The appendix...) Figure 8 The pulse wave is a square wave, with... Figure 11 The pulse wave is a sine wave.

[0040] See appendix Figure 10 The first sequence of pulse waves, whether positive or negative, consists of a series of pulses where the absolute value of the voltage amplitude of each subsequent pulse increases relative to the absolute value of the voltage amplitude of the preceding pulse. In the diagram, the second voltage amplitude is greater than the first, the third is greater than the second, the fourth is greater than the third, the fifth is greater than the fourth, the sixth is greater than the fifth, the seventh is greater than the sixth, and the eighth is greater than the seventh. That is, the absolute value of the negative pulse's voltage amplitude is greater than the absolute value of the voltage amplitude of the preceding positive pulse, and the absolute value of the positive pulse's voltage amplitude is also greater than the absolute value of the voltage amplitude of the preceding negative pulse. This pulse wave can quickly reach the lower limit value I of a set range. S(MIN) .

[0041] See appendix Figure 9 The first sequence of pulse waves generates several (e.g., 2 to 4) positive and negative pulse waves with the same voltage amplitude (absolute value). The absolute value of the voltage amplitude of subsequent positive and negative pulses increases, meaning the pulse waves intermittently increase. This first sequence of pulse waves can be slowly increased to a predetermined lower limit value I, depending on the treatment needs. S(MIN) .

[0042] See appendix Figure 4 Appendix Figure 6 and attached Figure 7 The pulse generator 7 is controlled by a microprocessor, and the ablation current setting range also has an upper limit value I. S(MAX) Exceeding this upper limit is unsafe for the human body; after the pulse generator 7 continuously outputs the second sequence of pulse waves, if the current sensor senses that the total ablation current is greater than or equal to the upper limit value I of the set range, S(MAX)Then, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the sequence pulse wave. S ', forming a third sequence of pulse waves, the adjusted U S Satisfy the following formula: U S '=(U S / I L -R0)*I S(MIN)

[0043] Among them, I L R0 is the total current value sensed by the multiple discharging electrode pairs 6, and R0 is the resistance value of the entire circuit of the pulse generator 7 through which the current passes when the electrode pairs 6 discharge (excluding the resistance of the digestive tract wall as a load). This is a constant after the circuit of the pulse generator 7 is determined. The third sequence of pulse waves keeps the current generated by the pulse within the set safe treatment range.

[0044] See appendix Figure 5 A system for ablation therapy of the digestive tract, further comprising: an operating handle 11 located at the proximal end of a catheter 1 for manipulating the support body to switch between a contraction and expansion state via a knob 17.

[0045] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

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 open 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, including a first electrode and a second electrode. A pulse generator has a pulse signal output terminal coupled to the electrode pair for generating an ablation current on the electrode pair when the pulse generator outputs a sequence of pulse waves; the pulse generator includes a current sensor for sensing the current flowing through the electrode pair. During an initial time period, in the first sequence of pulse waves, the absolute value of the voltage amplitude of subsequent pulses is greater than the absolute value of the voltage amplitude of preceding pulses, and the current sensor detects a current equal to or exceeding the lower limit value I of the set range. S(MIN) At that time, in the next time period, the absolute value U of the voltage amplitude of each pulse of the second sequence pulse wave S equal; The set range also has an upper limit value I. S(MAX) When the current sensor detects a current greater than or equal to the upper limit value I of the set range. S(MAX) Then, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the sequence pulse wave. S ', forming a third sequence of pulse waves, the adjusted U S Satisfy the following formula: U S '=(U S / I L -R0)*I S(MIN) ; Among them, I L R0 is the sensed current value, and R0 is the resistance value of the circuit through which the current passes, which is a constant.

2. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The sequence of pulse waves includes alternating positive and negative pulses.

3. The device for electric field therapy of the digestive tract according to claim 2, characterized in that: In the first sequence of pulse waves, the absolute value of the voltage amplitude of the subsequent positive pulse is greater than the absolute value of the voltage amplitude of the preceding positive pulse, and the absolute value of the voltage amplitude of the subsequent negative pulse is greater than the absolute value of the voltage amplitude of the preceding negative pulse.

4. The device for electric field therapy of the digestive tract according to claim 3, characterized in that: The absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the preceding positive pulse.

5. The device for electric field therapy of the digestive tract according to claim 3, characterized in that: The absolute value of the voltage amplitude of the negative pulse is greater than the absolute value of the voltage amplitude of the preceding positive pulse, and the absolute value of the voltage amplitude of the positive pulse is also greater than the absolute value of the voltage amplitude of the preceding negative pulse.

6. A system for ablation therapy of the digestive tract, characterized in that, It includes a device for applying an electric field to the digestive tract as described in any one of claims 1-5, and further includes: an operating handle located at the proximal end of the catheter for manipulating the support body to switch between a contraction working state and a dilation working state.

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