Electrode array film for device for electric field treatment of digestive tract

Abstract

The application relates to an electrode array film for a device for electric field treatment of the digestive tract, which comprises a film body, a plurality of electrodes on the film body, an electric heating wire embedded in the film body, the electric heating wire being coiled and forming a heating area on the electrode array film, the electric heating wire having an electric heating wire lead embedded in the film body, at least one electric connection point between the electric heating wire and the electrodes on the electrode array film, and a voltage signal between the electric heating wire lead and an electrode lead as an output temperature sensing signal. The temperature sensing circuit and the electric heating circuit are combined, the circuit is simple, and the leads on the electrode array film are reduced.

Description

[0001] This invention is a divisional application of Chinese Patent Application No. 202511006106.7, filed on July 22, 2025, entitled "Device and Electrode Array Membrane for Electric Field Therapy of the Digestive Tract". Technical Field

[0002] This invention relates to a medical device, particularly a device for applying energy to the digestive tract to ablate its tissues. Background Technology

[0003] In the prior art, CN114786605A discloses a device for duodenal pulsed electric field therapy. This device adapts to the shape of the duodenal wall using an expandable member wound around a second elongated body. This expandable member is generally made of a flexible polymer membrane with electrodes disposed on it. The membrane, after expansion, rigidly adheres to the inner wall of the digestive tract, thereby ablating the duodenal wall. Figure 51A in the specification describes a circuit diagram for measuring temperature by arranging temperature sensing traces within the electrode membrane. This figure requires two leads for input current, and sensing current is acquired at corresponding points on the sensing traces. The sensed signals are then extracted 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 alternating positive and negative poles and also needs to be electrically connected to the pulse generator via electrode leads. Thus, numerous leads need to be arranged on the electrode membrane, and the electrode membrane generally does not have electrodes at the locations of the leads. Therefore, the large number of leads reduces the electrode arrangement area of ​​the electrode membrane, necessitating an increase in the size of the electrode membrane. However, larger electrode membranes are difficult to pass through the winding digestive tract. In addition, the large number of leads and circuit arrangements also increase the processing difficulty and cost of the electrode membrane. Summary of the Invention

[0004] The purpose of this invention is to provide a device for electric field therapy of the digestive tract, which has the functions of sensing temperature and ablation marking, and its wiring and other circuit arrangements are simple.

[0005] The technical solution of this invention is:

[0006] A device for applying an electric field to the digestive tract, comprising:

[0007] The support body has a contracted working state and an expanded working state;

[0008] An electrode array membrane is arranged on a support body. When the support body is in an expanded working state, the electrode array membrane is open on the support body. When the support body is in a contracted working state, the electrode array membrane is contracted on the support body. The electrode array membrane includes a membrane body and multiple electrodes located on the membrane body.

[0009] A pulse generator has a pulse signal output terminal. The electrode is coupled to the pulse signal output terminal of the pulse generator through an electrode lead embedded in the membrane body. The electrode is used to receive the first sequence of pulse waves output by the pulse generator.

[0010] The membrane body also contains an embedded heating wire, which is coiled and forms a heating area on the electrode array membrane. The heating wire is coupled to the pulse signal output terminal of the pulse generator through heating wire leads 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 serves as a temperature sensing signal, which is coupled to the input terminal of the processor.

[0011] An electrode array membrane includes: 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, the heating wire has 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 electrode, and the voltage signal between the heating wire leads and the electrode leads serves as an output temperature sensing signal.

[0012] Preferably, on the electrode array film within the heating region, there is at least one electrical connection point between the heating wire and the electrode.

[0013] Preferably, 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.

[0014] Preferably, the conductive layer is made of the same metallic material as the electrode.

[0015] 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.

[0016] Preferably, the multiple electrode leads are coupled to the pulse signal output terminal via a first switch, and the heating wire leads are coupled to the pulse signal output terminal via a second switch. During the time period when the pulse signal output terminal outputs a pulse signal, only one of the first and second switches is in a closed state.

[0017] Preferably, the heating wire is made of copper-nickel alloy, and the electrode is made of copper.

[0018] Preferably, an insulating layer is provided between the heating wire and the electrode on the electrode array film, in addition to the electrical connection point.

[0019] Compared with the prior art, the present invention has the following advantages:

[0020] By using 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 the temperature sensing signal, thus integrating the temperature sensing circuit and the electric heating circuit into one. The circuit is simple and does not require a separate temperature sensing circuit on the electrode film, reducing the number of leads on the electrode array film. Attached Figure Description

[0021] Appendix Figure 1 This is a front view of the system before ablation treatment of the digestive tract when the present invention is placed inside a gastroscope, with its support body in a contracted working state.

[0022] Appendix Figure 2 For the appendix Figure 1 Enlarged sectional view at point F;

[0023] Appendix Figure 3 This is a front view of the support and electrode array film structure when the support is in the expanded working state.

[0024] Appendix Figure 4 For the appendix Figure 3 A front view of the electrode array film in its unfolded state;

[0025] Appendix Figure 5 For the appendix Figure 4 Enlarged view of point A;

[0026] Appendix Figure 6 For the appendix Figure 4 Enlarged sectional view in the DD direction;

[0027] Appendix Figure 7 For the appendix Figure 6 Enlarged view of point B;

[0028] Appendix Figure 8 For the appendix Figure 4 Enlarged sectional view in the EE direction;

[0029] Appendix Figure 9 For the appendix Figure 8 Enlarged view of point C;

[0030] Appendix Figure 10 This is a circuit block diagram of the present invention;

[0031] Appendix Figure 11 This is the program flowchart for the processor;

[0032] The components are as follows: 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. Endoscope; 17. Surgical instrument channel; 18. Lighting 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 Implementation

[0033] The digestive tract of this invention refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, anus, etc. The upper digestive tract refers to the parts that a gastroscopy can penetrate, including the esophagus, stomach, and duodenum. This invention is particularly applicable to the upper digestive tract.

[0034] See appendix Figure 1 Appendix Figure 2 and appendix Figure 3 A device for applying an electric field to the digestive tract, comprising:

[0035] Support 1, said support 1 has an attached Figure 2 The contraction working state and attachment Figure 3 In its expanded working state, support 1 can be an attachment. Figure 2 The bracket shown can also be an attachment. Figure 3 The shown spherical capsule;

[0036] Electrode array film 2, as shown in the attached image Figure 2 and attached Figure 3 As shown, the electrode array film 2 is wound in a spring-like shape and arranged on the support 1. The outer end of the electrode array film 2 is a free end, and the inner end is fixed to the support 1. (See attached diagram.) Figure 3 As shown, the support 1 is in an expanded working state, and the electrode array film 2 is stretched and opened on the support 1, as shown in the attached figure. Figure 2As shown, when the support 1 is in a contracted working state, the electrode array membrane 2 contracts onto the support 1. The electrode array membrane 2 includes 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 polymer insulating film, such as polyamide or PET material. Multiple exposed electrodes 4 are present on the surface of the membrane body, including positive and negative electrodes arranged at intervals.

[0037] The pulse generator 5 has a pulse signal output terminal. The electrode 4 is coupled to the pulse signal output terminal of the pulse generator 5 through the electrode lead 20 embedded in the membrane body. The electrode 4 is used to receive the first sequence of pulse waves output by the pulse generator 5. The first sequence of pulse waves is a set of pulse signals used to apply an electric field to the inner wall of the digestive tract in order to ablate the villi of the digestive tract, especially the inner wall of the duodenum.

[0038] The membrane body also contains an electric heating wire 6, see attached document. Figure 4 Appendix 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 terminal of the pulse generator 5 via heating wire leads 22 embedded in the membrane body. The heating wire 6 receives a second sequence of pulse waves output by the pulse generator 5. This second sequence of pulse waves differs from the first sequence of pulse waves. The second sequence of pulse waves utilizes the resistance of the heating wire 6 to generate heat, causing the heating area of ​​the heating wire 6 to heat up upon receiving the second sequence of pulse waves, forming a white mark on the inner wall of the digestive tract. This mark can be seen by the doctor through a visual device, confirming the location of the ablation procedure. (See appendix) Figure 5 -Appendix Figure 7 On the electrode array film 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 copper-nickel alloy, with copper accounting for 55% of the material. The electrode 4 is made of pure copper, and its surface can be plated with gold or silver. The voltage signal value between the heating wire lead 22 and the electrode lead 4 can correspond to the temperature signal of a temperature sensor. This temperature sensing signal is further processed by... Figure 10 The third switch 21, amplifier 23, analog-to-digital converter 24, and signal isolator 26 shown are coupled to the input terminal of processor 7, and the corresponding temperature can be displayed on the screen.

[0039] See appendix Figure 4 -Appendix Figure 9An electrode array membrane 2 includes: a membrane body, multiple electrodes 4 located on the membrane body, and a heating wire 6 embedded 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 embedded 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 electrodes 4. The voltage signal between the heating wire lead 22 and the electrode lead 20 serves as the output temperature sensing signal.

[0040] See appendix Figure 5 Appendix Figure 6 and attached Figure 7 On the electrode array film 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 which has a conductive layer 9. This conductive layer 9 electrically connects the electrode 4 and the heating wire 6, and 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 copper comprising 55% of its composition. The electrode 4 is made of pure copper, and its surface can be plated with gold or silver. 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 film 2.

[0041] See appendix 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.

[0042] See appendix Figure 10 A portion of the multiple electrode leads 20 are coupled to the pulse signal output terminal via a fourth switch 10', another portion of the multiple electrode leads 20 are coupled to the pulse signal output terminal via a first switch 10, and the heating wire lead 22 is coupled to the pulse signal output terminal via a second switch 11. See Appendix. Figure 11 During the time period when the pulse signal is output at the pulse signal output terminal, 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 processor's control program is shown in the appendix. Figure 11 The program flowchart.

Claims

1. An electrode array membrane for a device for applying an electric field to the digestive tract, comprising: The membrane body and multiple electrodes located on the membrane body are characterized in that 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 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.

2. The electrode array membrane for 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 electrode array membrane for 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, and the inner wall of the blind hole has a conductive layer that electrically connects the electrode and the heating wire. The opening of the blind hole is located on the electrode.

4. The electrode array membrane for 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 metallic material as the electrodes.

5. The electrode array membrane for 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, and the electrode is made of copper.

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

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