Electropulsers and balloon electrode electropulse ablation systems

Abstract

The application discloses an electric pulse transmitter and a balloon electrode electric pulse ablation system, and relates to the technical field of medical treatment, in particular to an electric pulse transmitter and a balloon electrode electric pulse ablation system. The balloon electrode comprises an outer sheath, a push tube and a balloon which are sequentially connected inside the sheath, and a plurality of electrode connecting lines are uniformly distributed on the outer surface of the balloon. The tail end of each electrode connecting line is threaded into a threading pipe arranged in the center of the balloon. The head end of each electrode connecting line is provided with an electrode sheet. A plurality of electrode sheets are arranged on the same circumference of the outer surface of the balloon. The electrode connecting line of the application is led out from the head end of the balloon. The head end of each electrode connecting line is provided with an electrode sheet. The electrode connecting line and the electrode sheet are attached to the outer surface of the balloon, so that the positive and negative electrode connecting lines are prevented from being gathered together to cause short circuit. The electrode sheets are uniformly and fully arranged on the outer surface of the balloon. According to the size of the ablation pipeline, the balloon can be shrunk and expanded, so that the pipeline inner surface can be fully attached, and the best ablation effect can be achieved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a balloon electrode and an electropulse ablation system. Background Technology

[0002] Diabetes is a common disease among middle-aged and elderly people, and it is showing a trend of affecting younger people. Currently, there is no cure. The best treatment for diabetes remains insulin injection, although proper insulin administration can effectively control blood sugar. However, like all treatments, insulin has side effects, such as hypoglycemia, subcutaneous fat atrophy or hyperplasia, rapid weight gain, and increased risk of tumors. Research shows that signals from the small intestine (especially the duodenum) are key regulators of metabolic function, including blood sugar management. When signals in the duodenum become abnormal, the body lacks the ability to properly regulate blood sugar, leading to persistently high blood sugar levels in patients with type VI diabetes.

[0003] Endoscopic thermal ablation of the duodenal mucosa using a heated balloon (70°C) works by thermally damaging the duodenal mucosa. The surrounding temperature decreases with increasing conduction distance, minimizing damage to surrounding tissues. Furthermore, the technology, which allows for fixed energy levels and the synergistic effect of bipolar catheters, controls the depth of energy delivery to 500-1000 μm, further reducing the risk of complications related to mucosal damage (such as postoperative bleeding, perforation, and stenosis). Ultimately, the thermal damage to the duodenal mucosa allows for self-repair and remodeling, enabling the body to regulate glucose metabolism.

[0004] Most existing balloon ablation electrodes have electrode connection lines that extend from the tail end of the balloon and converge at the head end. There is no separation between the positive and negative electrode lines, and the electrodes are connected in the middle part of the electrode connection lines, which may cause a short circuit at the convergence point. Summary of the Invention

[0005] To address the above technical problems, this invention provides a balloon electrode and an electro-pulse ablation system to achieve thermal damage treatment of the duodenal intestinal wall mucosa.

[0006] The present invention adopts the following technical solution:

[0007] An electrical pulse transmitter includes an AC / DC module, a DC / DC module, an energy level selection module, a control unit, and a discharge switch module.

[0008] The control unit is used to control the voltage output value, discharge energy level, and the start and end of the discharge; the AC / DC module is used to convert the mains frequency AC power into low voltage DC power.

[0009] The output terminal of the AC / DC module is connected to the input terminal of the DC / DC module to convert the input low-voltage DC power into high-voltage DC power.

[0010] The energy level selection module connects the output of the DC / DC module to the input of the energy level selection module. By connecting several energy level selection switches in series with several different capacitors, different capacitors can output different voltage values, thus forming the discharge energy level selection.

[0011] The discharge switch module and the output terminal of the energy level selection module are connected to a discharge switch.

[0012] Preferably, the energy level selection module controls the switching of the switching transistor composed of a Zener diode and an NMOS transistor through a control unit to control the on / off state of the circuit.

[0013] Preferably, the energy level selection module includes an energy level selection circuit, which includes an input terminal, an energy level selection terminal, a discharge switch control terminal, and a current detection terminal. The energy level selection terminal includes a plurality of energy level selection switches, and the discharge switch control terminal is provided with a discharge switch.

[0014] Preferably, each energy level selection switch is connected in series with a discharge capacitor.

[0015] Preferably, a current detection point is provided between the energy level selection switch and the discharge capacitor to detect the current in the path when the energy level selection switch is turned on.

[0016] Preferably, the current detection terminal is equipped with an ASC712 Hall current sensor.

[0017] An electro-pulse ablation system includes any of the above-described electro-pulse transmitters, and also includes a balloon electrode, with the output terminal of a discharge switch connected to the balloon electrode.

[0018] Preferably, the device includes an outer sheath and a push tube and a balloon connected in sequence inside the sheath. Several electrode connecting lines are radially and evenly distributed on the outer surface of the balloon. The tail ends of the electrode connecting lines pass through a threading tube arranged in the center of the balloon. Each electrode connecting line has an electrode plate at its head end, and several electrode plates are located on the same circumference on the outer surface of the balloon.

[0019] Preferably, the conduit has two chambers, through which the positive electrode connecting wire and the negative electrode connecting wire are respectively threaded.

[0020] Preferably, the threading tube is connected to and communicates with the push tube head.

[0021] Preferably, the balloon has a head end sheath at the front end and is fixedly connected to the push tube at the rear end, with the head end sheath covering the outside of the threading tube.

[0022] Preferably, the conduit has several outlet holes circumferentially located near its head end, and the outlet holes are through which the electrode connecting wires pass.

[0023] Compared with the prior art, the present invention has the following advantages:

[0024] 1. The electrode connecting wires of the present invention are led out from the head end of the balloon. Each electrode connecting wire is provided with an electrode plate at the head end. The electrode connecting wires and electrode plates are attached to the outer surface of the balloon to prevent the positive and negative electrode connecting wires from converging in one place and causing a short circuit. The electrode plates are evenly distributed around the circumference of the balloon. According to the size of the ablation channel, the electrode plates fully adhere to the inner surface of the channel as the balloon expands and contracts, so as to achieve the best ablation effect.

[0025] 2. The conduit of the present invention has a dual-cavity structure, through which positive and negative electrode connecting wires are passed respectively, which facilitates the electrode connecting wires to pass through the top of the balloon and perform cross wiring of positive and negative electrodes on the outer surface of the balloon.

[0026] 3. The pulse ablation energy of the electropulse ablation system of the present invention can be adjusted by an energy level selection switch, and multiple pairs of positive and negative electrodes can be controlled individually, resulting in precise ablation range. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of the balloon electrode of the present invention.

[0028] Figure 2 This is a structural diagram of the electropulse ablation system of the present invention.

[0029] Figure 3 This is a side sectional view of the present invention.

[0030] Figure 4 This is a schematic diagram of the electrode distribution of the balloon electrode of the present invention.

[0031] Figure 5 This is a circuit diagram of the balloon electrode electropulse ablation system of the present invention.

[0032] Figure 6 This is a circuit diagram of the energy level selection module of the present invention.

[0033] In the figure, there are: sheath 1, push tube 2, balloon 3, head end sheath 4, electrode plate 5, electrode connecting wire 6, conduit 7, control unit 10, AC / DC module 20, DC / DC module 30, energy level selection module 40, input terminal 401, energy level selection terminal 402, discharge switch control terminal 403, current detection terminal 404, and discharge switch module 50. Detailed Implementation

[0034] To facilitate understanding of the technical solution of the present invention, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments.

[0035] like Figure 1-4 As shown, the present invention discloses a balloon electrode, including an outer sheath 1 and a push tube 2 and a balloon 3 connected in sequence inside the sheath. A plurality of electrode connecting lines 6 are radially and uniformly distributed on the outer surface of the balloon 3. The tail ends of the electrode connecting lines pass through a threading tube 7 arranged in the center of the balloon 3. Each electrode connecting line has an electrode plate 5 at its head end. The plurality of electrode plates are located on the same circumference on the outer surface of the balloon.

[0036] The electrode connecting wires of this invention extend from the head end of the balloon. Each electrode connecting wire has an electrode plate at its head end. Both the electrode connecting wires and the electrode plates are attached to the outer surface of the balloon to prevent the positive and negative electrode connecting wires from converging in one place and causing a short circuit. The electrode plates are evenly distributed around the circumference of the balloon and, depending on the size of the ablation channel, fully adhere to the inner surface of the channel as the balloon expands and contracts, achieving the best ablation effect.

[0037] The conduit 7 has two chambers, through which the positive electrode connection wire and the negative electrode connection wire are respectively threaded.

[0038] The threading tube 7 is connected to the push tube head and they are mutually conductive.

[0039] The balloon 3 has a head end sheath 4 at the front end and is fixedly connected to the push tube 2 at the rear end. The head end sheath is sleeved outside the threading tube.

[0040] The conduit has several outlet holes circumferentially located near its head end, and the outlet holes are through which the electrode connecting wires pass.

[0041] like Figure 5 As shown, the present invention also discloses an electro-pulse ablation system, including the aforementioned balloon electrode and an electro-pulse transmitter. The electro-pulse transmitter includes a control unit 10 for controlling the voltage output value, discharge energy level, and the start and end of the discharge; an AC / DC module 20 for converting power frequency AC to low-voltage DC; a DC / DC module 30 for converting low-voltage DC to high-voltage DC; and an energy level selection module 40 for controlling the discharge energy level. The output terminal of the AC / DC module 20 is connected to the input terminal of the DC / DC module 30, and the output terminal of the DC / DC module 30 is connected to the input terminal of the energy level selection module 40. The output terminal of the energy level selection module is connected to a discharge switch 8 and the balloon electrode controlled by the discharge switch.

[0042] like Figure 6As shown, the energy level selection module 40 includes an energy level selection circuit, which includes an input terminal 401, an energy level selection terminal 402, a discharge switch control terminal 403, and a current detection terminal 404. The energy level selection terminal 402 includes several energy level selection switches Q2, Q3, Q4, Q5, and Q6. In the figure, C10-C14 are the corresponding energy levels, which can be selected as needed. The discharge switch control terminal 403 is equipped with a discharge switch Q7.

[0043] The energy level selection module controls the switching of the switching transistor composed of a Zener diode and an NMOS transistor through the control unit to control the on / off state of the circuit; specifically, the energy level selection switches Q2, Q3, Q4, Q5 and Q6 and the discharge switch Q are switching transistors composed of a Zener diode and an NMOS transistor to control the on / off state of the circuit.

[0044] The energy level selection switches Q2, Q3, Q4, Q5 and Q6 are all connected in series with voltage sensors.

[0045] Each energy level selection switch is connected in series with a discharge capacitor. A resistor connected in parallel with the switch prevents the MOSFET from being falsely triggered, and a capacitor connected in parallel with the capacitor releases residual energy across its terminals, ensuring safety. A current detection point is provided between the energy level selection switch and the discharge capacitor to detect the current flowing through the switch when it is turned on. Specifically, VS1-6 is connected to the MOSFET driver to detect the charging current value of each capacitor.

[0046] The current detection terminal is equipped with an ASC712 Hall effect current sensor. The current sensor converts the current signal into a voltage signal in an isolated mode before transmitting it. It connects to the balloon via port 7.

[0047] It should be noted that the electrical pulse transmitter of the present invention also includes a human-machine interaction module, which can replace the control unit via a PC to control the voltage applied to the operation control circuit, select the output energy level, and control the discharge switching.

[0048] The pulse ablation energy of the electropulse ablation system of this invention can be adjusted by an energy level selection switch, and multiple pairs of positive and negative electrodes can be controlled individually, resulting in precise ablation range.

[0049] In use, this invention first uses an endoscopic ultrasound channel or directly inserts the sheath from the patient's esophagus into the duodenum. Then, the balloon is pushed out of the sheath, inflated, and the pressure of the balloon on the intestinal wall is monitored to ensure that the electrode pads on the balloon are fully in contact with the intestinal wall. Pulsed electric field therapy is then applied, the balloon is contracted, the electrodes are moved to the next treatment segment, and the treatment is repeated until the entire duodenum segment is treated. Finally, the balloon is retrieved into the sheath and removed from the body.

[0050] The above are merely preferred embodiments of the present invention. The scope of protection of the present invention shall be determined by the scope defined in the claims. Any improvements and modifications made by those skilled in the art without departing from the spirit and scope of the present invention shall also be considered as within the scope of protection of the present invention.

Claims

1. An electrical pulse transmitter, characterized in that, The electrical pulse transmitter includes an AC / DC module, a DC / DC module, an energy level selection module, a control unit, and a discharge switch module. Control unit (10) is used to control the voltage output value, discharge energy level and the start and end of discharge; AC / DC module (20) is used to convert the power frequency AC power into low voltage DC power; DC / DC module (30), the output terminal of AC / DC module (20) is connected to the input terminal of DC / DC module (30) to convert the input low-voltage DC power into high-voltage DC power; The output terminal of the energy level selection module (40) is connected to the input terminal of the DC / DC module (30). Several different capacitors are connected in series through several energy level selection switches, so that different capacitors output different voltage values, forming a discharge energy level selection. The discharge switch module (50) is connected to the output terminal of the energy level selection module; The energy level selection module (40) includes an energy level selection circuit, which includes an input terminal (401), an energy level selection terminal (402), a discharge switch control terminal (403), and a current detection terminal. The energy level selection terminal (402) includes a plurality of energy level selection switches, and the discharge switch control terminal (403) is provided with a discharge switch. Each of the energy level selection switches is connected in series with a discharge capacitor, and 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. The current detection terminal is equipped with an ACS712 Hall current sensor.

2. The electrical pulse transmitter according to claim 1, characterized in that, The energy level selection module controls the switching of the switching transistor, which is composed of a Zener diode and an NMOS transistor, through a control unit to control the on / off state of the circuit.

3. An electro-pulse ablation system, characterized in that, The device includes the electrical pulse transmitter as described in claims 1-2, and also includes a balloon electrode, with the output of the discharge switch (8) connected to the balloon electrode via a current sensor.

4. The electro-pulse ablation system according to claim 3, characterized in that, It includes an outer sheath (1) and a push tube (2) and a balloon (3) connected in sequence inside the sheath. Several electrode connecting lines (6) are radially and evenly distributed on the outer surface of the balloon (3). The tail end of the electrode connecting line passes around and enters the thread tube (7) arranged in the center of the balloon (3). Each electrode connecting line has an electrode plate (5) at its head end. Several electrode plates are located on the same circumference on the outer surface of the balloon.

5. The electro-pulse ablation system according to claim 4, characterized in that, The conduit (7) has two chambers, through which the positive electrode connecting wire and the negative electrode connecting wire are respectively threaded.

6. The electro-pulse ablation system according to claim 4, characterized in that, The threading tube (7) is connected to the push tube head and they are interconnected.

7. The electro-pulse ablation system according to claim 4, characterized in that, The balloon (3) has a head end sheath (4) at the front end and is fixedly connected to the push tube (2) at the rear end. The head end sheath is sleeved outside the threading tube.

8. The electro-pulse ablation system according to claim 4, characterized in that, The conduit has several outlet holes circumferentially located near its head end, and the outlet holes are through which the electrode connecting wires pass.

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