Device and system for performing electric field treatment on digestive tract

Abstract

The invention relates to a device for performing electric field treatment on a digestive tract. The device comprises a catheter, a support body, an electrode array film and a pulse generator, the pulse generator comprises a current sensor for sensing current flowing through the electrode pair; in the initial time period, the voltage amplitude of the back pulse in the first sequence of pulse waves is larger than the voltage amplitude of the front pulse, and when the current sensor senses that the current is equal to or exceeds the lower limit value IS (MIN) of the set range, the absolute value US of the voltage amplitude of each pulse in the second sequence of pulse waves is equal in the next time period. The amplitude of the output voltage of the pulse generator is controlled through feedback of the current sensor, and the therapeutic instrument is safer for a human body during treatment.

Description

Technical Field

[0001] The present invention relates to a medical device, in particular to a device that applies energy to the digestive tract to ablate tissues thereof. Background Art

[0002] In the prior art, it has been widely agreed in the medical community that diabetes can be treated by performing electric field ablation on the villi or mucosa of the inner wall of the duodenum. Chinese Patent Application No. 202310866398.6 discloses an electric pulse transmitter and balloon electrode electric pulse ablation system: "Each energy level selection switch is connected in series with a discharge capacitor. The resistor in parallel with the switch is used to prevent the MOS tube from being falsely triggered and turned on. The capacitor in parallel with the capacitor is used to release the residual electric energy at both ends of the capacitor to ensure safety. A current detection point is provided between the energy level selection switch and the discharge capacitor to detect the path current when the energy level selection switch is turned on. Specifically, VS1-6 is connected to the MOS tube driver to detect the charging current value of each capacitor. The current detection end is provided with an ASC712 type Hall current sensor, which converts the current signal into a voltage signal through an isolated mode and transmits it out." The system only performs current signal detection 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 target cells identified in tissue in a body cavity wall, wherein the body cavity wall includes a cell layer; an elongated device comprising 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 in the tissue; and a marking system configured to mark the tissue in the body cavity wall, wherein the tissue includes 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, the existing gastrointestinal pulse ablation only detects current during energy output and cannot predict the ablation effect. At the same time, due to the differences in the gastrointestinal tissues of the human body and the differences in the degree of contact of the ablation elements, the ablation current may be too large or too small. If the ablation current is too small, the treatment effect will be affected; if the ablation current is too large, due to the excessive output energy, arcing and sparking may occur, leading to risks such as tissue carbonization and gastrointestinal perforation. Summary of the Invention

[0003] The object of the present invention is to provide a device for performing electric field therapy on the digestive tract, which controls the output pulse voltage amplitude of the pulse generator according to the current value detected by the current sensor.

[0004] The technical solution of the present invention is: a device for performing electric field treatment on the digestive tract, which comprises: 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 including a first electrode and a second electrode; A pulse generator having 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; within a time period at the beginning, the absolute value of the voltage amplitude of the pulse following the first sequence of pulse waves in time is greater than the absolute value of the voltage amplitude of the preceding pulse, and when the current sensor senses that the current is equal to or exceeds the lower limit value I of the set range, the ablation current is generated. S(MIN) When, in the next time period, the absolute value of the voltage amplitude of each pulse of the second series pulse wave is U S equal.

[0005] Optionally, the setting range also has an upper limit value I S(MAX) , when the current sensor senses that the current is greater than or equal to the upper limit value of the set range I S(MAX) After that, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the pulse wave sequence S ', forming the third sequence pulse wave, the adjusted U S 'Satisfy the following formula: U S '=(U S / I L -R0)*I S(MIN) Among them, I L is the sensed current value, and R0 is the resistance value of the circuit through which the current passes, which is a constant.

[0006] Optionally, the sequence of pulse waves includes alternating positive pulses and negative pulses.

[0007] 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 previous 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 previous negative pulse.

[0008] Optionally, the absolute value of the voltage amplitude of the negative pulse is equal to the absolute value of the voltage amplitude of the adjacent previous positive pulse.

[0009] Optionally, the absolute value of the voltage amplitude of the negative pulse is greater than the absolute value of the voltage amplitude of the adjacent previous 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 adjacent previous negative pulse.

[0010] A system for ablation treatment of the digestive tract, the device for electric field treatment of the digestive tract also includes: an operating handle, the operating handle is located at the proximal end of the catheter and is used to manipulate the support body to switch between a contraction working state and an expansion working state.

[0011] Compared with the prior art, the present invention has the following advantages: The ablation current is detected in real time by increasing the pulse voltage amplitude. When the current sensor senses that the current is equal to or exceeds the lower limit value I of the set range, the ablation current is detected in real time. S(MIN) When the ablation current reaches the preset range, the ablation parameters are maintained, and the target tissue can be stably ablated by electric field, making the ablation operation safer. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Attachment Figure 1 This is a schematic diagram of the system structure when the device of the present invention is located in the surgical instrument channel of a gastroscope and is extended into the duodenum through the gastroscope, before the expandable component is extended out of the gastroscope; Attachment Figure 2 For attachment Figure 1 The detailed structural diagram at F is enlarged, wherein the support body is selected to support the skeleton and is in a retracted working state; Attachment Figure 3 A front view of the structure of the support body and the electrode array membrane arranged on the support body when a balloon is selected for the support body and the support body is in an expanded working state; Attachment Figure 4 This is the circuit block diagram of the pulse generator; Attachment Figure 5 The system structure diagram of the present invention when a support frame is selected for the support body and is in a retracted working state; Attachment Figure 6 This is the circuit schematic diagram of the pulse generator; Attachment Figure 7 This is a flow chart of the pulse discharge of the pulse generator during the ablation treatment of the digestive tract such as the duodenum by this device; Attachment Figure 8 A waveform diagram of a first embodiment of a first sequence of pulse waves; Attachment Figure 9A waveform diagram of a second embodiment of the first sequence of pulse waves; Attachment Figure 10 is a waveform diagram of a third embodiment of the first sequence of pulse waves; Attachment Figure 11 This is a waveform diagram of the fourth embodiment of the first sequence of pulse waves; Components include: 1. Catheter; 2. Support; 3. Electrode array membrane; 4. First electrode; 5. Second electrode; 6. Electrode pair; 7. Pulse generator; 10. Gastroscope display; 11. Operating handle; 12. Stomach; 13. Duodenum; 14. Gastroscope; 15. Surgical instrument channel for the gastroscope; 16. Light source for the gastroscope; 17. Knob; 18. Rear guide cap; 19. Front guide cap. I S(MIN) , set the lower limit of the range; U S , the voltage amplitude of each pulse of the second sequence pulse wave; I S(MAX) , the upper limit of the setting range; the absolute value of the pulse voltage amplitude of the third sequence pulse wave U S '; I L , sensed current value; R0, circuit resistance value; DETAILED DESCRIPTION

[0013] The digestive tract of the present invention refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, anus, etc. The upper digestive tract refers to the part where the gastroscope can be inserted, including the esophagus, stomach, and duodenum. The present invention is particularly suitable for the upper digestive tract. The front of the present invention refers to the direction in which the device moves forward into the digestive tract, and the rear refers to the direction in which it moves backward, for example, Figure 5 In the text, the left side is the front, and the right side is the rear. The terms "front" and "rear" are also defined in this way in this article. The front end refers to the end away from the operator (doctor), also known as the distal end in the industry. The rear end refers to the end closer to the operator, also known as the proximal end in the industry.

[0014] See attached Figure 1 , Attachment Figure 2 , Attachment Figure 3 , Attachment Figure 5 , a device for performing electric field treatment on the digestive tract, comprising: An optional embodiment of the elongated catheter 1 is that the support 2 is selected as shown in the attached Figure 2 or attached Figure 5 The support frame shown in the figure, the catheter 1 includes an outer catheter and an inner catheter located in the inner cavity of the outer catheter, both of which can slide or rotate in the front and back directions to control the support frame to be in a contracted working state or an expanded working state; other optional embodiments are that the support body 2 is selected as shown in the attached Figure 3 In the balloon shown, a tube is provided in the catheter 1 for inputting a medium such as physiological saline into the balloon; The support body 2 is located at the distal end of the catheter, and the support body 2 has a contraction working state and an expansion working state; the support body 2 can be attached Figure 3 The balloon shown is expanded by injecting physiological saline into the water pipe in the catheter 1 and enters the expanded working state, or the support frame 13 in the Chinese patent application No. 202420286431.8 forms the support frame in this embodiment. There are many embodiments of the support frame, and the support frame described in this specification includes but is not limited to the above-mentioned structure; the support body 2 is switched between the contracted working state and the expanded working state by sliding or rotating the outer catheter and the inner catheter in the front-to-back direction. The support frame or balloon as the support body 2 can be existing technology and is not described in detail in this embodiment; The electrode array membrane 3 is arranged on the support body 2 and is in an expanded working state (such as the attached Figure 3 As shown in FIG), the electrode array membrane 3 is spread out on the support 2; when the support 2 is in a contracted working state, the electrode array membrane 3 is contracted on the support 2 (as shown in FIG). Figure 5 As shown in FIG. 3 , the electrode array membrane 3 is divided into a plurality of regional modules, and some modules can be selected for discharge during treatment. Each regional module is provided with a plurality of electrode pairs 6 including a first electrode 4 and a second electrode 5, and each electrode pair 6 is connected in parallel to the two ends of the pulse signal output (as shown in FIG. Figure 6 As shown), after applying a pulse wave to the selected area module, multiple pairs of electrodes 6 discharge simultaneously, that is, discharge between the first electrode 4 and the second electrode 5 forms an ablation current to ablate the villi or mucosa on the inner wall of the digestive tract; Pulse generator 7, see attached Figure 4 and attached Figure 6 , which has a pulse signal output terminal, the pulse signal output terminal is coupled to the multiple electrode pairs 6, and is used to generate ablation current between the multiple electrode pairs 6 when the pulse generator 7 outputs a sequence pulse wave; the bridge circuit composed of the first high-voltage switch, the second high-voltage switch, the third high-voltage switch, and the 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 the attached Figure 4 , the current sensor is set in the discharge current detection module.

[0015] See attached Figure 7Flowchart, before the operation, the output current of the pulse generator 7 is preset to an ablation current threshold. At the beginning, the first sequence of pulse waves is applied to the electrode pairs 6. As time goes by, the amplitude of the subsequent pulse voltages increases continuously and multiple electrode pairs 6 discharge. The total current value of the discharge of multiple electrode pairs 6 and the ablation of tissue is detected and obtained in real time by the current sensor. When the ablation current enters the preset range, that is, greater than or equal to I S(MIN)， Then the ablation parameter is maintained, that is, the voltage amplitude of the subsequent pulse is maintained unchanged. In some embodiments, the current threshold can be any interval value within the range of 10A-100A. The current threshold is set to different interval values ​​according to different ablation locations, different conditions, doctor's experience or different plans. Within a period of time when the ablation procedure begins, the absolute value of the voltage amplitude of the pulse after the first sequence of pulse waves is greater than the absolute value of the voltage amplitude of the previous pulse, and when the current sensor senses that the current is equal to or exceeds the lower limit value I of the set range, the ablation parameter is maintained, that is, the voltage amplitude of the subsequent pulse is maintained unchanged. In some embodiments, the current threshold can be any interval value within the range of 10A-100A. The current threshold is set to different interval values ​​according to different ablation locations, different conditions, doctor's experience or different plans. S(MIN) When, in the next time period, the absolute value of the voltage amplitude of each pulse of the second series pulse wave is U S Equal, maintain the second sequence of pulse waves for safe ablation treatment.

[0016] For various embodiments of the first sequence of pulse waves with gradually increasing ablation pulse voltage, see the attached Figure 8 To the attached Figure 11 The pulse waves of each sequence include alternating positive pulses and negative pulses, which can reduce the stimulation to the muscles during ablation surgery.

[0017] See attached Figure 8 , Attachment Figure 11 The first sequence of pulse waves, in which the absolute values ​​of the voltage amplitudes (i.e., voltage peaks) of each group of positive and negative pulse square waves (or sine waves) are the same, can significantly reduce muscle stimulation. That is, in the first sequence of pulse waves, the absolute value of the voltage amplitude of the following positive pulse (the second voltage) is greater than the absolute value of the voltage amplitude of the preceding positive pulse (the first voltage), the absolute value of the voltage amplitude of the following negative pulse (the second voltage) is greater than the absolute value of the voltage amplitude of the preceding negative pulse (the first voltage), and the absolute value of the voltage amplitude of the negative pulse in the same group (the first voltage) is equal to the absolute value of the voltage amplitude of the adjacent preceding positive pulse (the first voltage). As shown in the attached figure, Figure 8 , Attachment 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. Figure 8 The pulse wave is a square wave, Figure 11 The pulse wave is a sine wave.

[0018] See attached Figure 10The first sequence of pulse waves, whether positive or negative, is such that the absolute value of the voltage amplitude of the subsequent pulse increases relative to the absolute value of the voltage amplitude of the previous pulse. In the figure, the second voltage amplitude is greater than the first voltage amplitude, the third voltage amplitude is greater than the second voltage amplitude, the fourth voltage amplitude is greater than the third voltage amplitude, the fifth voltage amplitude is greater than the fourth voltage amplitude, the sixth voltage amplitude is greater than the fifth voltage amplitude, the seventh voltage amplitude is greater than the sixth voltage amplitude, and the eighth voltage amplitude is greater than the seventh voltage amplitude. That is, the absolute value of the voltage amplitude of the negative pulse is greater than the absolute value of the voltage amplitude of the adjacent previous 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 adjacent previous negative pulse. This pulse wave can quickly reach the lower limit value I of the set range. S(MIN) .

[0019] See attached Figure 9 The first sequence of pulse waves, after generating several (for example, 2 to 4) positive and negative pulse waves of the same voltage amplitude (absolute value), the voltage amplitude absolute values ​​of the subsequent several positive and negative pulses increase, that is, the pulse wave increases intermittently. This first sequence of pulse waves can slowly reach the lower limit value I of the set range according to the needs of treatment. S(MIN) .

[0020] See attached Figure 4 , Attachment Figure 6 and attached Figure 7 The pulse generator 7 is controlled by a microprocessor, and the setting range of the ablation current 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) After that, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the pulse wave sequence S ', forming the third sequence pulse wave, 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 total current sensed by the multiple discharges of the electrode pairs 6. R0 is the resistance of the entire pulse generator 7 circuit (excluding the resistance of the digestive tract wall as a load) through which the current passes during discharge of the electrode pairs 6. This value is a constant once the circuit of the pulse generator 7 is established. The third pulse wave sequence maintains the generated current within the set safe therapeutic range.

[0021] See attached Figure 5, a system for ablation treatment of the digestive tract, which also includes: an operating handle 11, the operating handle 11 is located at the proximal end of the catheter 1, and is used to manipulate the support body to switch between a contraction working state and an expansion working state through a knob 17.

[0022] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

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 including a first electrode and a second electrode; A pulse generator having 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; In the initial period, the absolute value of the voltage amplitude of the subsequent pulses in the first pulse wave is greater than the absolute value of the voltage amplitude of the preceding pulse, and the current sensor senses that the current is equal to or exceeds the lower limit value I of the set range. S(MIN) When, in the next time period, the absolute value of the voltage amplitude of each pulse of the second series pulse wave is U S equal.

2. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The setting range also has an upper limit value I S(MAX) , when the current sensor senses that the current is greater than or equal to the upper limit value of the set range I S(MAX) After that, in the next time period, adjust the absolute value U of the pulse voltage amplitude of the pulse wave sequence S ', forming the third sequence pulse wave, the adjusted U S 'Satisfy the following formula: U S '=(U S / I L -R0)*I S(MIN) Among them, I L is the sensed current value, and R0 is the resistance value of the circuit through which the current passes, which is a constant.

3. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The sequence pulse wave includes positive pulses and negative pulses that appear alternately.

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

5. The device for electric field therapy of the digestive tract according to claim 4, 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 adjacent previous positive pulse.

6. The device for electric field therapy of the digestive tract according to claim 4, 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 adjacent previous 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 adjacent previous negative pulse.

7. 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 1-6, and 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 contraction working state and an expansion working state.

Images