Flexible bipolar radiofrequency ablation catheter with perfusion function

Abstract

The utility model provides a flexible bipolar radiofrequency ablation catheter with a perfusion function, the flexible bipolar radiofrequency ablation catheter is communicated with a perfusion device, a perfusion medium is stored in the perfusion device, the flexible bipolar radiofrequency ablation catheter comprises a needle head, the needle head is provided with a liquid inlet pipeline and a liquid outlet hole, and the liquid inlet pipeline and the liquid outlet hole are communicated with each other; a liquid return part is arranged between the flexible pipeline and the liquid inlet pipeline, and the liquid return part is provided with a liquid return pipeline and a liquid return hole communicated with the liquid return pipeline; the insulating ring is arranged between the liquid outlet hole and the liquid return hole; the filling device is communicated with the liquid inlet pipeline, and when the filling device works, the filling medium flows out of the needle head through the liquid inlet pipeline and the liquid outlet hole and enters the liquid return pipeline through the liquid return hole, so that the needle head and the liquid return pipeline are short-circuited. The flexible bipolar radiofrequency ablation catheter does not need to attach a negative plate during surgery, current does not pass through the body of a patient, the flexible bipolar radiofrequency ablation catheter is provided with the positive electrode and the negative electrode, the distance between the positive electrode and the negative electrode is short, impedance is small, and energy output is stable.

Description

Technical Field

[0001] The embodiments of the present application relate to the technical field of medical devices, and in particular to a flexible bipolar radiofrequency ablation catheter with an irrigation function. Background Art

[0002] The incidence of malignant tumors is increasing year by year, posing an increasing threat to human health. Traditional treatment methods such as surgery, radiotherapy, chemotherapy and other technologies are becoming more and more mature, but they will inevitably cause varying degrees of damage to the normal functions of the body, and the success rate of treatment still needs to be improved. With the development of science and technology, especially the advancement of medical imaging technologies such as magnetic resonance imaging and ultrasound imaging, minimally invasive surgeries such as cryotherapy and heating ablation therapy for tumors have made great progress and are becoming more and more popular. Radiofrequency ablation is currently the most mature and widely used ablation treatment method in clinical practice. Its principle is to apply a high-frequency alternating electric field between the positive and negative electrodes of the probe, forcing the charged particles in the tissue to move in the direction of the alternating electric field, causing frictional heat generation, and then causing cell thermal damage.

[0003] Most of the radiofrequency ablation probes on the market are percutaneous puncture probes, which are used to reach the tumor site through percutaneous puncture during surgery for radiofrequency ablation treatment. According to the electrode form, they are divided into monopolar, bipolar and multipolar (claw-shaped) probes. For tumors in some special locations, such as those near natural cavities such as the respiratory tract, esophagus, and urethra, it is difficult for the ablation catheter to enter the tumor through percutaneous puncture without causing trauma to the tissue in the cavity. Once the wall of the above cavity is pierced, the result is often fatal. The development of flexible radiofrequency ablation catheters that can smoothly reach the target tumor through natural cavities and implement radiofrequency treatment will significantly reduce tissue trauma and improve surgical efficiency, which is of great significance in the treatment of cavity tumors. At present, the related development work of flexible radiofrequency ablation catheters is generally a monopolar needle structure, which enters the human body through an endoscope to reach the tumor site, and the needle tip is close to the tumor tissue and cooperates with the negative electrode to perform radiofrequency ablation treatment. The safety accidents caused by improper use of the negative electrode sheet deserve attention. During surgery, the electric current flows through the patient's whole body. When the negative electrode sheet is not tightly attached to the patient, falls off, or is pasted in an incorrect position, it will cause burns to the patient's skin. Generally, the negative electrode sheet is pasted at least 15 cm away from the surgical site. The positive and negative electrodes of the traditional monopolar needle are far apart, so the impedance becomes larger, and the current becomes smaller, and the power is also smaller, which affects the ablation quality, prolongs the operation time, and increases the difficulty of the operation.

[0004] Therefore, it is necessary to study a flexible bipolar radiofrequency ablation catheter that can reach the tumor location through the instrument channel of the endoscope. The bipolar structure does not require the negative electrode plate to be pasted when used. Physiological saline is used as the working medium to enable the positive and negative electrodes to conduct and stimulate bipolar energy to ablate the tissue, thereby reducing the harm to the patient caused by the negative electrode plate during surgery. Utility Model Content

[0005] In view of the above problems, the present application provides a flexible bipolar radiofrequency ablation catheter to overcome the above problems or at least partially solve the above problems.

[0006] An embodiment of the present application provides a flexible bipolar radiofrequency ablation catheter, which is connected to an irrigation device, in which an irrigation medium is stored. The flexible bipolar radiofrequency ablation catheter comprises: a needle, which is provided with a liquid inlet pipeline and a liquid outlet hole that are interconnected; a flexible pipeline, in which a liquid return portion is provided between the flexible pipeline and the liquid inlet pipeline, and the liquid return portion is provided with a liquid return pipeline and a liquid return hole connected to the liquid return pipeline; an insulating ring is provided between the liquid outlet hole and the liquid return hole; the irrigation device is connected to the liquid inlet pipeline, and when the irrigation device is working, the irrigation medium flows out of the needle via the liquid inlet pipeline and the liquid outlet hole, and enters the liquid return pipeline via the liquid return hole to short-circuit the needle and the liquid return pipeline.

[0007] Optionally, the flexible bipolar radiofrequency ablation catheter is also electrically connected to an energy output device, wherein the energy output device is electrically connected to the needle and the liquid return pipeline respectively. When the energy output device is working, the energy output device outputs energy to the needle and the liquid return pipeline, so that the needle is short-circuited with the liquid return pipeline through the perfusion medium.

[0008] Optionally, the flexible bipolar radiofrequency ablation catheter further includes an insulating tube, which is arranged between the liquid inlet pipeline and the liquid return pipeline.

[0009] Optionally, the flexible bipolar radiofrequency ablation catheter further comprises: a first tube body connected to the needle and connected to the liquid inlet pipeline; a second tube body connected to the liquid return pipeline; and a gap between the liquid return hole and the distal end of the flexible pipeline.

[0010] Optionally, the insulating tube covers at least a portion of the first tube body from the outer periphery of the first tube body, and the liquid return portion is arranged on the outer periphery of the insulating tube.

[0011] Optionally, the distal end of the needle is connected to a first electrode wire, and the second electrode wire is connected to the inner wall of the liquid return pipeline, and the first electrode wire and the second electrode wire are electrically connected to the energy output device respectively.

[0012] Optionally, the flexible bipolar radiofrequency ablation catheter is further provided with: a radiofrequency circuit, and the energy output device is electrically connected to the needle and the liquid return part respectively via the radiofrequency circuit.

[0013] Optionally, the perfusion device is provided with a first starting mechanism, and the energy output device is provided with a second starting mechanism, and the first starting mechanism is associated with the second starting mechanism, so that when one of the first starting mechanism and the second starting mechanism is started, the other is also started simultaneously.

[0014] Optionally, the exposed area of ​​the needle is smaller than the exposed area of ​​the liquid return portion.

[0015] Optionally, the proximal end of the radio frequency circuit and the energy output device are respectively provided with quick-connect connectors, and at least one of the quick-connect connectors is provided with an identification resistor for identifying whether the two quick-connect connectors are inserted into place. If not, the energy output device issues an alarm prompt.

[0016] It can be seen from the above technical solutions that the flexible bipolar radiofrequency ablation catheter of the embodiment of the present application does not need to be attached with a negative electrode sheet during surgery, the current does not pass through the patient's body, it has its own positive and negative electrodes and the positive and negative electrodes are close to each other, the impedance is small, the energy output during ablation is high and stable, the thermal damage to the ablated tissue is small in a saline environment, and the patient recovers quickly after surgery. The exposed area of ​​the negative electrode is larger than the exposed area of ​​the positive electrode, and the bipolar energy excitation is faster.

[0017] The positive and negative electrodes output energy at the same time, which increases the ablation area, improves surgical efficiency, and shortens the operation time. In addition, ablation in a saline environment causes less thermal damage to the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0019] Figure 1 It is an overall schematic diagram of an embodiment of a flexible bipolar radiofrequency ablation catheter of the present application;

[0020] Figure 2 is a cross-sectional view of a distal end portion of an embodiment of a flexible bipolar radiofrequency ablation catheter of the present application;

[0021] Figure 3 and Figure 4 They are respectively a stereoscopic view and a cross-sectional view of an embodiment of a needle of a flexible bipolar radiofrequency ablation catheter of the present application;

[0022] Figure 5 and Figure 6 They are respectively a stereoscopic view and a cross-sectional view of another embodiment of a needle of a flexible bipolar radiofrequency ablation catheter of the present application.

[0023] Component number

[0024] 1: needle; 2-5: liquid outlet; 6: insulating ring; 7: liquid return part; 8: insulating tube; 14: second electrode wire; 10: flexible pipeline; 12, 18: first tube body; 13: handle; 15: base; 16, 21: first electrode wire; 17: radio frequency circuit; 19: quick connector; 20: Luer connector; 22: conversion head; 30: liquid inlet pipeline; 31: second tube body; 32: liquid return pipeline; 33: liquid return hole; 34: main body. DETAILED DESCRIPTION

[0025] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the embodiments of the present application should fall within the scope of protection of the embodiments of the present application.

[0026] The “distal end” mentioned above refers to the end of the radiofrequency ablation catheter away from the operator during the surgical operation; the “proximal end” mentioned above refers to the end of the radiofrequency ablation catheter close to the operator during the surgical operation.

[0027] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0028] See also Figures 1 to 6 In a specific implementation of the present application, a flexible bipolar radiofrequency ablation catheter is provided, which includes: a needle 1, the needle 1 is provided with a liquid inlet pipeline 30 and a liquid outlet hole 2-5, and the liquid inlet pipeline 30 and the liquid outlet hole 2-5 are connected to each other; a flexible pipeline 10, a liquid return portion 7 is provided between the flexible pipeline 10 and the liquid inlet pipeline 30, and the liquid return portion 7 is provided with a liquid return pipeline 32 and a liquid return hole 33 connected to the liquid return pipeline 32; an insulating ring 6, the insulating ring 6 is provided between the liquid outlet hole 2-5 and the liquid return hole 33; a perfusion device (not shown in the figure), the perfusion device is connected to the liquid inlet pipeline 30, and a perfusion medium is stored in the perfusion device. When the perfusion device is working, the perfusion medium flows out of the needle 1 through the liquid inlet pipeline 30 and the liquid outlet hole 2-5, and enters the liquid return pipeline 32 through the liquid return hole 33 to short-circuit the needle and the liquid return pipeline 32.

[0029] The energy output device (not shown in the figure) is also electrically connected to the flexible bipolar radiofrequency ablation catheter, wherein the energy output device is electrically connected to the needle and the liquid return line 32 respectively. When the energy output device is working, the energy output device outputs energy to the needle and the liquid return line 32, so that the needle is short-circuited with the liquid return line 32 through the perfusion medium. The perfusion device can be a perfusion pump.

[0030] In one embodiment, the perfusion medium output by the perfusion device can enter the first tube body 12, 18 through the Luer connector 20, and then enter the liquid inlet pipeline 30 of the needle 1 through the first tube body 12, 18 (the first tube body 12, 18 is connected to the liquid inlet pipeline 30).

[0031] In one embodiment, the flexible bipolar radiofrequency ablation catheter further includes an insulating tube 8 , which is disposed between the liquid inlet pipeline 30 and the liquid return pipeline 32 .

[0032] In one embodiment, the flexible bipolar radiofrequency ablation catheter further comprises: a first tube body, which is connected to the needle 1 and communicated with the liquid inlet pipeline 30; a second tube body 31, which communicated with the liquid return pipeline 32, and the liquid return portion 7 may be provided with an annular body 34, and a liquid return hole 33 is provided on the body 34, and there is a gap between the liquid return hole 33 and the distal end of the flexible pipeline.

[0033] In one embodiment, the insulating tube 8 covers at least a portion of the first tube body from the outer periphery of the first tube body, and the liquid return portion 7 is disposed on the outer periphery of the insulating tube 8 .

[0034] In one embodiment, the distal end of the needle 1 is connected to the first electrode wires 16 and 21, the second electrode wire 14 is connected to the inner wall of the liquid return pipeline 32, and the first electrode wires 16 and 21 and the second electrode wire 14 are electrically connected to the energy output device respectively.

[0035] In one embodiment, the proximal end of the flexible tube 10 covers at least a portion of the liquid return portion 7 from the outer periphery of the liquid return portion 7 .

[0036] The flexible bipolar radiofrequency ablation catheter is also provided with a radiofrequency circuit 17, through which the energy output device is electrically connected to the needle 1 and the liquid return portion, respectively, to transfer the radiofrequency energy output by the energy output device to the positive and negative electrodes of the needle. The radiofrequency circuit 17 can be a double-core wire, one of which is connected to the liquid return portion and the other is connected to the base 15 inside the handle, and then connected to the needle 1 via the base 15. The radiofrequency ablation catheter is also provided with a conversion head 22, which is used as a conversion structure between the flexible pipeline 10 and the handle 13.

[0037] In one embodiment, the perfusion device is provided with a first starting mechanism, and the energy output device is provided with a second starting mechanism, and the first starting mechanism is associated with the second starting mechanism so that when one of the first starting mechanism and the second starting mechanism is started, the other is also started simultaneously.

[0038] In one embodiment, the exposed area of ​​the needle 1 is smaller than the exposed area of ​​the liquid return portion 7. For example, the exposed area ratio of the needle 1 (positive electrode) to the liquid return portion 7 (negative electrode) can be 1:3 or other ratios. The larger the exposed area of ​​the negative electrode, the faster the bipolar energy is excited and the faster the ablation efficiency is.

[0039] In one embodiment, the proximal end of the RF circuit 17 and the energy output device are respectively provided with quick connectors 19, and at least one of the quick connectors 19 is provided with an identification resistor for identifying whether the two quick connectors 19 are inserted into place. If not, the energy output device issues an alarm.

[0040] The liquid return portion 7 can be a metal ring. In this application, the needle 1 is used as the positive electrode and the metal ring is used as the negative electrode. When energy is introduced into the needle 1, the metal ring also has energy through the conduction of the saline solution. Therefore, the positive electrode and the negative electrode are in a conductive state at this time. Both the positive electrode and the negative electrode can excite energy. During the operation, both the positive electrode and the negative electrode can be placed close to the tumor tissue, thereby increasing the ablation area, improving the surgical efficiency, and shortening the operation time. At the same time, compared with the ablation catheter that directly performs ablation without saline solution, the ablation catheter of this application causes less thermal damage to the tissue, and the patient recovers faster after the operation.

[0041] like Figure 3-4 As shown, the needle 1 can be a circular structure, which will not cause scratches, punctures, or other damage to the inner wall of the channel when entering the endoscope instrument channel, and two pairs of upper and lower liquid outlet holes 2-5 are provided inside the needle 1. The number of liquid outlet holes is not limited, and can also be 1 pair, 3 pairs, or more.

[0042] like Figure 5-6 As shown, the needle 1 may also be a sharp structure, in which case the needle 1 may be used to puncture tissue for treatment.

[0043] When the radio frequency energy is excited, the perfusion pump is started synchronously to perfuse the liquid inlet pipeline 30 with saline to the liquid outlet holes 2-5 of the needle 1, so that the needle 1 and the metal ring form a local short circuit, stimulate the positive and negative bipolar radio frequency energy, and perform surgical treatment on the tumor tissue. The insulating tube 8 can be made of polymer material, and the needle 1 can be made of metal. The insulating tube 8 and the needle 1 can be connected, fixed and sealed by structural processes such as external threads, convex strips or adhesive bonding (for example, after making external threads and convex strips on the metal needle 1, it is assembled with the insulating tube 8. When the insulating tube 8 is assembled, the inner diameter is squeezed and slightly deformed by the external threads and convex strips of the needle 1, which can achieve fixation and sealing).

[0044] The insulating tube 8 is mainly used for axial insulation between the needle 1 and the metal ring, and provides an insulating layer for the excitation of the bipolar. The material of the insulating tube 8 can be a polymer material tube such as a polyamide hose and a PTFE tube. The insulating ring 6 is arranged between the needle 1 and the metal ring, and is radially insulated between the needle 1 and the metal ring, and provides an insulating section for the excitation of the bipolar. The material of the insulating ring 6 can be a non-conductive and high-temperature resistant material such as nylon and ceramic. The metal ring is the negative pole in the bipolar, and the electrode wires 9 and 14 are connected to it, assembled between the insulating ring 6 and the flexible tube, and connected and fixed with the flexible tube by a laser welding process, and close to the tumor tissue during surgery to excite the bipolar and perform radiofrequency ablation treatment. The flexible pipeline 10 is connected and fixed with the metal ring and assembled into the handle 13, and is connected and fixed with the external thread at the front end of the handle 13. The surface is smooth and insulated, and can smoothly enter the endoscope instrument channel without jamming. The tube body can bend synchronously with the bending of the endoscope head end, and the flexible tube material can be PTFE, Nylon, PEBAX and other polymer materials. The handle 13 has an ergonomic design and is comfortable and convenient to hold. The handle 13 can be used to adjust the entry and exit of the ablation catheter immediately according to surgical needs.

[0045] The radio frequency circuit 17 transmits the radio frequency energy output by the energy output device (such as the host) to the needle 1. The quick connector 19 can be a standard male and female connector, which can be quickly connected and unplugged from the host. An identification resistor is installed inside the quick connector 19. When the quick connector 19 is inserted into the corresponding connector of the host, the host can recognize that it has been inserted in place. When it is not inserted or not inserted in place, an alarm prompt will be issued.

[0046] The proximal ends of the first tubes 12 and 18 can be connected to an infusion pump to provide an internal channel for infusing saline into the needle 1. When the radio frequency energy is output, the infusion pump will also be started synchronously to continuously provide infusion liquid to the liquid inlet pipeline 30. The Luer connector 20 can be a standard Luer female connector, which is connected to the Luer male connector on the infusion pump during preoperative preparation to form a pipeline passage to provide a medium for bipolar excitation.

[0047] During the operation, the Luer connector 20 at the rear end of the ablation catheter is first connected to the Luer connector 20 on the perfusion pump, and the quick-connect connector 19 is connected to the corresponding interface of the host. The pipeline is vented through the perfusion pump so that the perfusion liquid fills the entire needle inlet pipeline 30. Then, the ablation catheter is inserted into the instrument channel of the endoscope and enters the human body to reach the tumor position. Finally, the needle 1 and the metal ring are pressed against the tumor tissue and the foot switch connected to the host is stepped on to output energy. The synchronous perfusion pump starts continuous perfusion. At this time, the perfusion liquid acts as a medium to form a local short circuit between the needle 1 and the metal ring, and bipolar radio frequency energy is stimulated to perform surgical treatment on the tumor tissue. The host energy output and the perfusion pump start perfusion are linked mechanisms (stepping on the foot switch connected to the host, the switch is turned on and the energy is output at the same time, and the perfusion pump also starts to perfuse physiological saline at the same time). The ablation catheter has its own positive and negative poles, and there is no need to attach a negative pole sheet during the operation. It is safer that the current does not pass through the human body, and the closer the distance between the positive and negative poles, the smaller the impedance, the more stable the energy output, and the rapid and effective excitation of bipolar energy for radio frequency treatment of tumor tissue.

[0048] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A flexible bipolar radiofrequency ablation catheter with an irrigation function, the flexible bipolar radiofrequency ablation catheter is connected to an irrigation device, and the irrigation medium is stored in the irrigation device, characterized in that: The flexible bipolar radiofrequency ablation catheter comprises: A needle, the needle being provided with a liquid inlet pipeline and a liquid outlet hole which are interconnected; A flexible pipeline, wherein a liquid return portion is provided between the flexible pipeline and the liquid inlet pipeline, and the liquid return portion is provided with a liquid return pipeline and a liquid return hole communicated with the liquid return pipeline; An insulating ring, disposed between the liquid outlet and the liquid return hole; The perfusion device is connected with the liquid inlet pipeline. When the perfusion device is working, the perfusion medium flows out of the needle through the liquid inlet pipeline and the liquid outlet hole, and enters the liquid return pipeline through the liquid return hole to short-circuit the needle and the liquid return pipeline.

2. The flexible bipolar radiofrequency ablation catheter according to claim 1, characterized in that: The flexible bipolar radiofrequency ablation catheter is also electrically connected to an energy output device, wherein the energy output device is electrically connected to the needle and the liquid return pipeline respectively. When the energy output device is working, the energy output device outputs energy to the needle and the liquid return pipeline, so that the needle is short-circuited with the liquid return pipeline through the perfusion medium.

3. The flexible bipolar radiofrequency ablation catheter according to claim 2, characterized in that: The flexible bipolar radiofrequency ablation catheter also includes an insulating tube, which is arranged between the liquid inlet pipeline and the liquid return pipeline.

4. The flexible bipolar radiofrequency ablation catheter according to claim 3, characterized in that: The flexible bipolar radiofrequency ablation catheter also has: A first tube body connected to the needle and communicated with the liquid inlet pipeline; A second pipe body, which is connected to the liquid return pipeline; A gap is provided between the liquid return hole and the distal end of the flexible pipe.

5. The flexible bipolar radiofrequency ablation catheter according to claim 4, characterized in that: The insulating tube covers at least a portion of the first tube body from the outer periphery of the first tube body, and the liquid return portion is arranged on the outer periphery of the insulating tube.

6. The flexible bipolar radiofrequency ablation catheter according to claim 4, characterized in that: The distal end of the needle is connected to a first electrode wire, and a second electrode wire is connected to an inner wall of the liquid return pipeline. The first electrode wire and the second electrode wire are electrically connected to the energy output device respectively.

7. The flexible bipolar radiofrequency ablation catheter according to claim 6, characterized in that: The flexible bipolar radiofrequency ablation catheter also has: A radio frequency circuit, wherein the energy output device is electrically connected to the needle and the liquid return portion respectively via the radio frequency circuit.

8. The flexible bipolar radiofrequency ablation catheter according to claim 6, characterized in that: The infusion device is provided with a first starting mechanism, and the energy output device is provided with a second starting mechanism. The first starting mechanism is associated with the second starting mechanism, so that when one of the first starting mechanism and the second starting mechanism is started, the other is also started simultaneously.

9. The flexible bipolar radiofrequency ablation catheter according to claim 1, characterized in that: The exposed area of ​​the needle is smaller than the exposed area of ​​the liquid return portion.

10. The flexible bipolar radiofrequency ablation catheter according to claim 7, characterized in that: The proximal end of the radio frequency circuit and the energy output device are respectively provided with quick-connect connectors, and at least one of the quick-connect connectors is provided with an identification resistor for identifying whether the two quick-connect connectors are inserted in place. If not, the energy output device will issue an alarm prompt.

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