Device and electrode array membrane for electric field therapy of digestive tract

Abstract

The present invention relates to a device for performing electric field therapy on the digestive tract. The device comprises a support, an electrode array membrane, and a pulse generator. The electrodes are coupled to the pulse generator via electrode leads embedded in the membrane body. A heating wire is also embedded in the membrane body and coupled to the pulse signal output terminal of the pulse generator via heating wire leads embedded in the membrane body. On the electrode array membrane, there is at least one electrical connection point between the heating wire and the electrodes, and the voltage signal between the heating wire lead and the electrode lead serves as a temperature sensing signal. The present invention combines a temperature sensing circuit with an electric heating circuit, resulting in a simple circuit and a reduced number of leads on the electrode array membrane.

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, CN114786605A discloses a device for duodenal pulsed electric field therapy. This device uses an expandable member wrapped around a second elongated body to adapt to the shape of the inner wall of the duodenum. The expandable member is typically made of a flexible polymeric membrane with electrodes mounted on it. After expansion, the membrane's inherent rigidity adheres to the inner wall of the digestive tract, thereby ablating the inner wall of the duodenum. Figure 51A of the specification depicts a circuit diagram for measuring temperature by disposing temperature sensing traces within the electrode membrane. This figure requires two leads for inputting current, acquiring the sensed current at corresponding points along the sensing traces, and then extracting the sensed signal via two additional signal leads for signal processing, requiring at least four leads. Figure 52B shows a heating wire 5220 disposed within the electrode membrane to heat and mark the tissue. The heating wire also requires heating wire leads and is electrically connected to a pulse generator. Furthermore, each electrode is arranged with positive and negative polarity alternating between them and also requires an electrode lead for electrical connection to the pulse generator. This requires numerous leads to be routed across the electrode membrane, where the leads are typically not located. Consequently, the large number of leads reduces the electrode arrangement area within the membrane, forcing the membrane to be larger. However, larger membranes are difficult to navigate within the tortuous digestive tract. Furthermore, the large number of leads and circuitry increases the difficulty and cost of manufacturing the membrane. 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 has the functions of sensing temperature and ablation marks, and the arrangement of the leads and other circuits is simple.

[0004] The technical solution of the present invention is:

[0005] A device for performing electric field treatment on the digestive tract, comprising:

[0006] A support body, wherein the support body has a contracted working state and an expanded working state;

[0007] An electrode array membrane, wherein the electrode array membrane is arranged on the support body and is stretched on the support body when the support body is in an expanded working state, and is contracted on the support body when the support body is in a contracted working state, and the electrode array membrane comprises a membrane body and a plurality of electrodes located on the membrane body;

[0008] A pulse generator having a pulse signal output terminal, wherein the electrode is coupled to the pulse signal output terminal of the pulse generator via an electrode lead embedded in the membrane body, and the electrode is used to receive a first sequence of pulse waves output by the pulse generator;

[0009] A heating wire is also embedded in the membrane body. The heating wire is coiled and forms a heating area on the electrode array membrane. The heating wire is coupled to the pulse signal output end of the pulse generator through a heating wire lead embedded in the membrane body. The heating wire is used to receive the second sequence of pulse waves output by the pulse generator. On the electrode array membrane, there is at least one electrical connection point between the heating wire and the electrode. The voltage signal between the heating wire lead and the electrode lead is used as a temperature sensing signal, and the temperature sensing signal is coupled to the input end of the processor.

[0010] An electrode array membrane comprises: a membrane body, and a plurality of electrodes located on the membrane body; a heating wire is also embedded in the membrane body, the heating wire is coiled and forms a heating area on the electrode array membrane, and the heating wire has a heating wire lead embedded in the membrane body; on the electrode array membrane, there is at least one electrical connection point between the heating wire and the electrode, and the voltage signal between the heating wire lead and the electrode lead serves as the output temperature sensing signal.

[0011] Preferably, on the electrode array membrane within the heating area, there is at least one electrical connection point between the heating wire and the electrode.

[0012] Preferably, the electrical connection point is a blind hole, the inner wall of the blind hole has a conductive layer, the conductive layer electrically connects the electrode and the heating wire, and the opening of the blind hole is located on the electrode.

[0013] Preferably, the conductive layer is made of the same metal material as the electrode.

[0014] Preferably, the pulse generator selectively outputs the first sequence of pulse waves or the second sequence of pulse waves to the electrode or the heating wire.

[0015] Preferably, the multiple electrode leads are coupled to the pulse signal output end through a first switch, and the heating wire lead is coupled to the pulse signal output end through a second switch. During the time period when the pulse signal output end outputs the pulse signal, only one of the first switch and the second switch is in a closed state.

[0016] Preferably, the heating wire is made of a copper-nickel alloy material, and the electrode is made of copper material.

[0017] Preferably, on the electrode array membrane, in addition to the electrical connection points, an insulating layer is provided between the heating wire and the electrodes.

[0018] Compared with the prior art, the present invention has the following advantages:

[0019] Through at least one electrical connection point between the heating wire and the electrode, the voltage signal sensed between the heating wire lead and the electrode lead is used as a temperature sensing signal, thereby integrating the temperature sensing circuit and the electric heating circuit into one. The circuit is simple, and there is no need to set a separate temperature sensing circuit on the electrode membrane, and the number of leads on the electrode array membrane is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Attachment Figure 1 This is a front view of the system when the present invention is placed in a gastroscope before ablation treatment of the digestive tract, with its support body in a contracted working state;

[0021] Attachment Figure 2 For attachment Figure 1 Enlarged cross-sectional view at point F;

[0022] Attachment Figure 3 This is a front view of the structure of the support body and the electrode array membrane when the support body is in an expanded working state;

[0023] Attachment Figure 4 For attachment Figure 3 A front view of the electrode array membrane in an unfolded state;

[0024] Attachment Figure 5 For attachment Figure 4 A magnified view of point A;

[0025] Attachment Figure 6 For attachment Figure 4 DD direction enlarged cross-sectional view;

[0026] Attachment Figure 7 For attachment Figure 6 Enlarged view of point B;

[0027] Attachment Figure 8 For attachment Figure 4 EE direction enlarged cross-sectional view;

[0028] Attachment Figure 9 For attachment Figure 8 Enlarged view of point C;

[0029] Attachment Figure 10 A circuit block diagram of the present invention;

[0030] Attachment Figure 11 is the program flow chart of the processor;

[0031] Among them: 1. Support body; 2. Electrode array membrane; 3. Base layer; 4. Electrode; 5. Pulse generator; 6. Heating wire; 7. Processor; 8. Blind hole; 9. Conductive layer; 10. First switch; 10', Fourth switch; 11. Second switch; 12. Insulating layer; 13. Stomach; 14. Duodenum; 15. Operating handle; 16. Gastroscope; 17. Surgical instrument channel; 18. Illuminating device; 19. Surface layer; 20. Electrode lead; 21. Third switch; 22. Heating wire lead; 23. Amplifier; 24. Analog-to-digital converter; 25. Display; 26. Signal isolator. DETAILED DESCRIPTION

[0032] The digestive tract of the present invention refers to the mouth, 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.

[0033] See attached Figure 1 , Attachment Figure 2 and attached Figure 3 , a device for performing electric field treatment on the digestive tract, comprising:

[0034] Support 1, the support 1 has an attached Figure 2 The shrinkage working state and attachment Figure 3 In the expanded working state, the support body 1 can be attached Figure 2 The bracket shown can also be attached Figure 3 The balloon shown;

[0035] Electrode array membrane 2, as attached Figure 2 and attached Figure 3 As shown, the electrode array membrane 2 is wound in a spring-like manner and arranged on the support body 1. The outer end of the electrode array membrane 2 is a free end, and the inner end is fixed to the support body 1. Figure 3 As shown, the support body 1 is in an expanded working state, and the electrode array membrane 2 is stretched and opened on the support body 1. Figure 2 As shown, when the support body 1 is in a contracted working state, the electrode array membrane 2 is contracted onto the support body 1. The electrode array membrane 2 comprises a membrane body composed of a base layer 3, an insulating layer 12, and a surface layer 19. The membrane body is made of a flexible polymeric insulating film, such as polyamide or PET. Multiple exposed electrodes 4 are provided on the surface of the membrane body, including positive and negative electrodes arranged at intervals.

[0036] The pulse generator 5 has a pulse signal output end. The electrode 4 is coupled to the pulse signal output end of the pulse generator 5 via an electrode lead 20 embedded in the membrane body. The electrode 4 is used to receive a first sequence of pulse waves output by the pulse generator 5. The first sequence of pulse waves is a group of pulse signals used to apply an electric field to the inner wall of the digestive tract to achieve the purpose of ablating the villi on the inner wall of the digestive tract, especially the duodenum.

[0037] The membrane body is also embedded with a heating wire 6, see the attached Figure 4 , Attachment Figure 5 and attached Figure 10 The heating wire 6 is coiled and forms a heating area on the electrode array membrane 2. The heating wire 6 is coupled to the pulse signal output end of the pulse generator 5 through the heating wire lead 22 embedded in the membrane body. The heating wire 6 is used to receive the second sequence of pulse waves output by the pulse generator 5. The second sequence of pulse waves is different from the first sequence of pulse waves. The second sequence of pulse waves uses the resistance of the heating wire 6 to generate heat, so that after the heating wire 6 in the heating area receives the second sequence of pulse waves, the heating area is heated, forming a white mark on the inner wall of the digestive tract. Through the visual device, the doctor can see the mark point and confirm the location of the ablation operation. See Appendix Figure 5 -Attached Figure 7 On the electrode array membrane 2, there is at least one electrical connection point between the heating wire 6 and the electrode 4. The heating wire 6 is made of a copper-nickel alloy, wherein copper accounts for 55%. The electrode 4 is made of pure copper, and the surface of the electrode 4 can be plated with gold or silver. The voltage signal value between the heating wire lead 22 and the electrode 4 lead can correspond to the temperature signal of the temperature sensor. The temperature sensor signal is detected by the attached Figure 10 The third switch 21, amplifier 23, analog-to-digital converter 24, and signal isolator 26 shown are then coupled to the input end of the processor 7, and the corresponding temperature can then be displayed on the display.

[0038] See attached Figure 4 -Attached Figure 9 , an electrode array membrane, which includes: a membrane body, a plurality of electrodes 4 located on the membrane body, a heating wire 6 buried in the membrane body, the heating wire 6 is coiled and forms a heating area on the electrode array membrane 2, the heating wire 6 has a heating wire lead 22 buried in the membrane body; on the electrode array membrane 2, there is at least one electrical connection point between the heating wire 6 and the electrode 4, and the voltage signal between the heating wire lead 22 and the electrode lead 20 is used as the output temperature sensing signal.

[0039] See attached Figure 5 , Attachment Figure 6 and attached Figure 7On the electrode array membrane 2 within the heating area, there is at least one electrical connection point between the heating wire 6 and the electrode 4. This electrical connection point is a blind hole 8. The inner wall of the blind hole 8 has a conductive layer 9 that electrically connects the electrode 4 and the heating wire 6. The opening of the blind hole 8 is located on the electrode 4. The conductive layer 9 is made of the same copper metal material as the electrode 4. The heating wire 6 is made of a copper-nickel alloy with a copper content of 55%. The electrode 4 is made of pure copper, and the surface of the electrode 4 can be gold- or silver-plated. In addition to the electrical connection point, an insulating layer 12 is provided between the heating wire 6 and the electrode 4 on the electrode array membrane 2.

[0040] See attached Figure 10 and attached Figure 11 The pulse generator 5 selectively outputs the first sequence of pulse waves to the electrode 4, or the pulse generator 5 selectively outputs the second sequence of pulse waves to the heating wire 6, so that the electrode 4 or the heating wire 6 will not work simultaneously within a set time period, that is, the electrode 4 and the heating wire 6 will not receive the first sequence of pulse waves or the second sequence of pulse waves at the same time.

[0041] See attached Figure 10 , a portion of the plurality of electrode leads 20 is coupled to the pulse signal output terminal through the fourth switch 10 ', another portion of the plurality of electrode leads 20 is coupled to the pulse signal output terminal through the first switch 10, and the heating wire lead 22 is coupled to the pulse signal output terminal through the second switch 11. See the attached Figure 11 During the period when the pulse signal output terminal outputs the pulse signal, only one of the first switch 10 and the second switch 11 is in the closed state, and the opening and closing of each switch is controlled by the processor. The control program of the processor is shown in the attached Figure 11 Program flow chart.

Claims

1. A device for performing electric field therapy on the digestive tract, comprising: A support body, wherein the support body has a contracted working state and an expanded working state; An electrode array membrane, wherein the electrode array membrane is arranged on the support body and is stretched on the support body when the support body is in an expanded working state, and is contracted on the support body when the support body is in a contracted working state, and the electrode array membrane comprises a membrane body and a plurality of electrodes located on the membrane body; A pulse generator having a pulse signal output terminal, wherein the electrode is coupled to the pulse signal output terminal of the pulse generator via an electrode lead embedded in the membrane body, and the electrode is used to receive a first sequence of pulse waves output by the pulse generator; It is characterized in that a heating wire is further buried in the membrane body, the heating wire is coiled and forms a heating area on the electrode array membrane, the heating wire is coupled to the pulse signal output end of the pulse generator through a heating wire lead buried in the membrane body, and the heating wire is used to receive the second sequence of pulse waves output by the pulse generator; on the electrode array membrane, there is at least one electrical connection point between the heating wire and the electrode, and the voltage signal between the heating wire lead and the electrode lead is used as a temperature sensing signal, and the temperature sensing signal is coupled to the input end of the processor; The pulse generator selectively outputs the first sequence of pulse waves or the second sequence of pulse waves to the electrode or the heating wire; The multiple electrode leads are coupled to the pulse signal output end through a first switch, and the heating wire lead is coupled to the pulse signal output end through a second switch. During the time period when the pulse signal output end outputs a pulse signal, only one of the first switch and the second switch is in a closed state.

2. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: On the electrode array film within the heating area, there is at least one electrical connection point between the heating wire and the electrode.

3. The device for electric field therapy of the digestive tract according to claim 2, characterized in that: The electrical connection point is a blind hole, the inner wall of the blind hole has a conductive layer, the conductive layer is electrically connected to the electrode and the heating wire, and the opening of the blind hole is located on the electrode.

4. The device for electric field therapy of the digestive tract according to claim 3, characterized in that: The conductive layer is made of the same metal material as the electrode.

5. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: The heating wire is made of copper-nickel alloy material, and the electrode is made of copper material.

6. The device for electric field therapy of the digestive tract according to claim 1, characterized in that: On the electrode array film, in addition to the electrical connection points, an insulating layer is provided between the heating wires and the electrodes.

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