Ablation catheter and ablation system

Abstract

The invention relates to an ablation catheter and an ablation system. The ablation catheter comprises a catheter body, a balloon and a plurality of electrodes. The sacculus comprises a sacculus body and a plurality of protrusions arranged on the surface of the sacculus body, the sacculus body is connected to the first end of the tube body, and the sacculus body and the protrusions extend in the axial direction of the tube body; the plurality of electrodes are respectively arranged on the plurality of protrusions, and the electrodes are at least arranged on the surfaces of the sides, away from the balloon body, of the protrusions. According to the ablation catheter, based on the balloon with the protrusions, the electrodes are arranged on the protrusions, so that the electrodes can enter focus tissue with complex structures such as intestinal wrinkles along with the protrusions, the attaching effect of the electrodes and the focus tissue is improved, and then the ablation effect on the focus tissue is improved; and the balloon body and the bulge extend in the axial direction of the tube body, so that a larger contact area can be formed between the whole balloon and the corresponding electrode and the focus tissue, and the fitting effect between the balloon and the focus tissue can be further improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an ablation catheter and ablation system. Background Technology

[0002] Ablation technology is a minimally invasive treatment method that precisely and controllably destroys specific lesion tissue through physical or chemical means while maximizing the protection of surrounding normal tissue. Ablation technology can be divided into several types according to different principles and modes of action, such as thermal ablation, cold ablation, and pulsed electric field ablation. Taking pulsed electric field ablation as an example, its principle is to apply a non-thermal, high-voltage pulsed electric field to the target tissue, creating permanent electroporation in the cell membrane, leading to cell death, thereby achieving ablation treatment of the target tissue.

[0003] When the aforementioned ablation techniques are applied to the intestines, the complex mucosal structure inside the intestines (such as the duodenum) can sometimes lead to poor ablation results. For example, taking the aforementioned pulsed electric field ablation as an example, the complex mucosal structure inside the intestines can result in poor adhesion between the ablation electrodes of existing ablation catheters and the intestinal tissue, thus affecting the ablation effect. Summary of the Invention

[0004] Therefore, it is necessary to provide an ablation catheter and ablation system to solve the problem that existing ablation catheters have poor tissue adhesion when applied to complex tissue structures such as the intestine, which affects the ablation effect.

[0005] An ablation catheter includes a tube body, a balloon, and electrodes. The tube body has opposing first and second ends; the balloon includes a balloon body and a plurality of protrusions disposed on the surface of the balloon body, the balloon body being connected to the first end of the tube body, the balloon body being configured as a cylindrical structure extending axially along the tube body, and the protrusions extending axially along the surface of the balloon body; the number of electrodes is plurality of, the plurality of electrodes being disposed on the plurality of protrusions, and the electrodes being disposed at least on the surface of the protrusions away from the balloon body.

[0006] The aforementioned ablation catheter, based on a balloon with protrusions, allows electrodes to be positioned on these protrusions, enabling them to penetrate into lesions with complex structures such as intestinal folds. This improves the adhesion between the electrodes and the lesions, thereby enhancing the ablation effect of the pulsed electric field generated by the electrodes. Furthermore, since both the balloon body and the protrusions extend axially along the catheter body, the protrusions and the electrodes positioned on them have a sufficiently large area. This allows for a larger contact area between the balloon and the corresponding electrodes and the lesions during actual use, further improving the adhesion between the balloon and the lesions.

[0007] In some embodiments, the protrusion has a first end and a second end opposite to each other in the tube body axial direction, and the end faces of the first end and / or the second end of the protrusion are configured as inclined surfaces; wherein the inclination direction of the inclined surfaces is such that the distance between the end faces of the first end and the second end of the protrusion near the side edge of the balloon body is greater than the distance between the end faces of the first end and the second end of the protrusion away from the side edge of the balloon body.

[0008] In some embodiments, the balloon body includes a first body portion, a second body portion, and a third body portion connected in sequence, with one end of the first body portion and / or the third body portion away from the second body portion connected to the tube body; wherein the second body portion is configured as a cylindrical structure extending axially along the tube body, and a protrusion is provided at least on the surface of the second body portion.

[0009] In some embodiments, the third body portion is closer to the second end of the tube than the first body portion, and a portion of the electrode is disposed on the surface of the third body portion.

[0010] In some embodiments, the length of the second body portion in the axial direction of the tube is greater than or equal to the sum of the lengths of the first body portion and the third body portion in the axial direction of the tube.

[0011] In some embodiments, the protrusion extends along the axial direction of the tube body in a straight or tortuous path.

[0012] In some embodiments, multiple protrusions are spaced apart circumferentially on the tube body.

[0013] In some embodiments, a lasso assembly is also included, which includes a lasso and a pull rod. The lasso is inserted into the tube, and a first end of the lasso is provided with an annular lasso portion. The second end of the lasso is connected to the pull rod. The first end of the tube penetrates the balloon body and is exposed outside the balloon body, and the lasso portion is exposed outside the first end of the tube body.

[0014] In some embodiments, the sheath assembly further includes a sheath tube, which is inserted into the tube body, and a sheath is inserted into the sheath tube. The first end of the sheath tube is exposed at the first end of the tube body, and the sheath portion is exposed at the first end of the sheath tube.

[0015] In some embodiments, the first end of the lasso is exposed outside the first end of the lasso tube, and the end face of the first end of the lasso is fixed to the end face of the first end of the lasso tube to form an annular lasso portion at the first end of the lasso.

[0016] In some embodiments, the tube body includes a first tube and a second tube sleeved outside the first tube, with the first end of the first tube exposed outside the first end of the second tube; wherein, the first end of the second tube penetrates and is fixedly connected to one end of the balloon body, the first end of the first tube penetrates and is fixedly connected to the other end of the balloon body, and there is a medium channel between the first tube and the second tube communicating with the interior of the balloon body.

[0017] In some embodiments, the first end of the second tube has a medium channel that connects to the inside of the balloon body.

[0018] In some embodiments, a handle is also included, the handle including a handle body and a Luer interface disposed on the handle body, a medium cavity disposed within the handle body, and the medium cavity communicating with the Luer interface; wherein, the handle body is connected to the second end of the tube, and the medium cavity is communicating with the medium channel.

[0019] In some embodiments, the handle further includes a push button disposed on the handle body, the handle body is provided with a slide rail, and the push button is partially disposed in the slide rail; wherein, the first tube and the second tube are axially movable, the second end of the first tube is exposed above the second end of the second tube, the second end of the second tube is fixedly connected to the handle body, and the second end of the first tube is fixedly connected to the push button.

[0020] In some embodiments, the handle also includes an elastic element, one end of which is fixed to the handle body and the other end of which is fixed to the push button.

[0021] In some embodiments, the tube body further includes a third tube, which is sleeved outside the second tube and is fixedly connected to the second tube; wherein, there is a wiring channel between the second tube and the third tube, and a wire is provided in the wiring channel, and the wire is connected to the electrode.

[0022] An ablation system includes an endoscope and the aforementioned ablation catheter, wherein a sheath assembly of the ablation catheter is used for connection to the endoscope. This ablation system possesses all the technical effects of the aforementioned ablation catheter. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the ablation catheter in some embodiments of this application.

[0024] Figure 2 This is an exploded view of the ablation catheter structure in some embodiments of this application.

[0025] Figure 3 for Figure 1 A magnified view of a portion of the central balloon.

[0026] Figure 4 for Figure 3 The front view of the structure shown.

[0027] Figure 5 for Figure 3 A cross-sectional view of the structure shown.

[0028] Figure 6 for Figure 5 A magnified view of a portion of the structure shown.

[0029] Figure 7 for Figure 1 A sectional view of the middle handle section.

[0030] Figure 8 for Figure 2 A magnified view of the cable sleeve section of the middle cable sleeve assembly.

[0031] Figure label:

[0032] 10-Pipe body, 101-Media channel, 102-Wiring channel, 11-First pipe, 12-Second pipe, 121-Media hole, 13-Third pipe;

[0033] 20-Balloon, 21-Balloon body, 211-First body part, 212-Second body part, 213-Third body part, 22-Protrusion, 221-Sloping surface, 23-Connecting part;

[0034] 30-electrode;

[0035] 40-Sling assembly, 41-Sling, 411-Sling part, 42-Tie rod, 43-Sling tube, 431-Assembly slot;

[0036] 50-Handle, 51-Handle body, 511-Media chamber, 512-Slide rail, 52-Luer interface, 53-Push button, 54-Elastic element, 55-Cable connector. Detailed Implementation

[0037] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0038] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0039] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0040] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0041] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0042] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0043] In some embodiments, please refer to Figure 1 and Figure 2 This application provides an ablation catheter, which includes a tube body 10, a balloon 20, and an electrode 30. The tube body 10 and the balloon 20 together constitute the main structure of the ablation catheter, and the electrode 30 is disposed on the balloon 20 to generate a pulsed electric field.

[0044] For details, please refer to further information. Figure 3 and Figure 4 The tube body 10 has a first end and a second end, respectively. The first end (distal end) of the tube body 10 is used to connect to the balloon 20, and the second end (proximal end) of the tube body 10 is used to connect to the control components (e.g., the handle 50). The balloon 20 includes a balloon body 21, which is connected to the first end of the tube body 10. The balloon body 21 can be made of an elastic material such as rubber so that it can expand or contract elastically. Electrodes 30 are disposed on the balloon body 21. Depending on the configuration requirements, the electrodes 30 can be flexible electrodes.

[0045] Based on this, in some examples, the electrode 30 can be directly disposed on the surface of the balloon body 21. After the balloon 20 reaches the lesion with the ablation catheter, the balloon body 21 can be inflated and come into contact with the lesion tissue, thereby allowing the electrode 30 disposed on the surface of the balloon body 21 to come into contact with the lesion tissue, so that the pulsed electric field generated by the electrode 30 can act on the lesion tissue to achieve ablation treatment.

[0046] However, since lesions may exist in different organs of the body, ablation catheters may be used to ablate lesions in different organs. Therefore, in some organs, due to the characteristics of the organ's structure, the tissue structure of the lesions is relatively complex. For example, in the intestine, the lining tissue usually has complex folds, especially in the duodenum. In this case, for the ablation catheter, the balloon body 21 of the balloon 20 does not adhere well to the intestinal wall after inflation; specifically, the surface of the balloon body 21 cannot contact the internal area of ​​the folds, thus preventing the electrode 30 from penetrating deep into the folds. Consequently, the pulsed electric field generated by the electrode 30 cannot effectively ablate the interior of the folds, limiting the ablation effect.

[0047] In other examples, the balloon body 21 also includes a plurality of protrusions 22 disposed on the surface of the balloon body 21. For example, the plurality of protrusions 22 may be distributed at intervals on the surface of the balloon body 21. A plurality of electrodes 30 are disposed on the plurality of protrusions 22. For example, the electrodes 30 may be disposed at least on the surface of the protrusions 22 away from the balloon body 21.

[0048] Taking the duodenum as an example, after reaching the lesion area, the balloon body 21 expands and contacts the folds of the intestinal wall. The protrusion 22 can extend into the interior of the folds, so that the electrode 30 on the protrusion 22 can penetrate into the interior of the folds and adhere to the tissue surface inside the folds, thereby enhancing the ablation effect of the pulsed electric field generated by the electrode 30 on the interior of the folds.

[0049] In this way, the above-mentioned ablation catheter, based on the balloon 20 with the protrusion 22, allows the electrode 30 to be placed on the protrusion 22, so that the electrode 30 can enter the interior of lesion tissue with a relatively complex structure such as intestinal folds along with the protrusion 22, thereby improving the adhesion between the electrode 30 and the lesion tissue, and thus enhancing the ablation effect of the pulsed electric field generated by the electrode 30 on the lesion tissue.

[0050] Furthermore, both the balloon body 21 and the protrusion 22 are configured to extend along the axial direction of the tube 10, wherein the balloon body 21 is configured as a cylindrical structure extending along the axial direction of the tube 10.

[0051] In this way, the cylindrical structure of the balloon body 21 makes the balloon 20 relatively flat overall. Thus, the protrusion 22 can be set as a strip structure extending along the axial direction of the tube 10 on the surface of the balloon body 21. This allows the protrusion 22 and the electrode 30 set on the protrusion 22 to have a sufficiently large area, so that in actual use, the balloon 20 as a whole and the corresponding electrode 30 can have a larger contact area with the lesion tissue, which can further improve the fit between the balloon 20 as a whole and the electrode 30 and the lesion tissue.

[0052] In addition, the electrode 30 can also be disposed on the side of the protrusion 22, or it can also be disposed on the surface of the balloon body 21 located in the area between the two protrusions 22.

[0053] It should be noted that the protrusion 22 of the balloon 20 can be integrally formed with the balloon body 21. For example, the protrusion 22 can be injection molded with the balloon body 21 using materials such as rubber (including single injection molding or double injection molding), wherein the injection molding thickness of the protrusion 22 needs to be greater than that of the balloon body 21. Alternatively, the protrusion 22 can also be assembled with the balloon body 21. For example, a separately prepared protrusion 22 can be assembled with the balloon body 21 by means of bonding or other methods.

[0054] In some examples, the protrusion heights of the multiple protrusions 22 relative to the balloon body 21 can be set to be different. In this case, based on the structure of the multiple protrusions 22 being distributed at intervals on the surface of the balloon 20, two adjacent protrusions 22 with higher protrusion heights can be adjacent to each other (i.e., there are no protrusions 22 with lower protrusion heights between them), or they can have one or more protrusions 22 with lower protrusion heights between them. Similarly, two adjacent protrusions 22 with lower protrusion heights can be adjacent to each other (i.e., there are no protrusions 22 with higher protrusion heights between them), or they can have one or more protrusions 22 with higher protrusion heights between them.

[0055] In this way, based on the protrusions 22 with different protrusion heights, there is a height difference between the surface of the balloon body 21 and the protrusion 22 with the lower protrusion height, another height difference between the protrusion 22 with the lower protrusion height and the protrusion 22 with the higher protrusion height, and yet another height difference between the surface of the balloon body 21 and the protrusion 22 with the higher protrusion height. This results in a multi-layered, undulating structure on the overall outer surface of the balloon 20, which can further adapt to some more complex tissues, such as the multi-layered folds on the intestinal wall.

[0056] In other examples, based on the above-mentioned configuration of the protrusion 22 extending axially along the tube body 10, that is, the two ends of the protrusion 22 being opposite each other along the axial direction of the tube body 10, the protrusion 22 can be configured as a straight structure extending strictly along the axial direction of the tube body 10 (e.g.) as needed. Figure 3 and Figure 4 As shown in the figure, the extension path of the protrusion 22 is a straight path parallel to the axis of the tube body 10; the protrusion 22 can also be set as a tortuous structure with the main direction along the axis of the tube body 10, that is, the extension path of the protrusion 22 is a tortuous path. The specific shape of the tortuous structure can be S-shaped (i.e., wave-shaped), W-shaped (i.e., zigzag-shaped), Y-shaped, etc.

[0057] In some other examples, the aforementioned protrusions 22 can be spaced apart in the circumferential direction of the tube body 10. For example, the distance between two adjacent protrusions 22 in the circumferential direction of the tube body 10 can be fixed, that is, the multiple protrusions 22 are evenly spaced apart in the circumferential direction of the tube body 10.

[0058] In some embodiments, please continue reading Figure 3 and Figure 4 The balloon body 21 includes a first body part 211, a second body part 212 and a third body part 213 connected in sequence, wherein the second body part 212 is the main body part of the balloon body 21, and the first body part 211 and the third body part 213 are the two ends of the balloon body 21.

[0059] In the connection structure between the balloon body 21 and the tube body 10, the first body part 211 can be connected to the tube body 10, the third body part 213 can be connected to the tube body 10, or the first body part 211 and the third body part 213 can be connected to the tube body 10 respectively. Taking the first body part 211 and the third body part 213 being connected to the tube body 10 respectively as an example, the specific connection relationship can be:

[0060] The tube 10 penetrates the balloon body 21 along opposite directions at both ends. A portion of the tube 10 penetrates the end of the first body portion 211 away from the second body portion 212, and a portion penetrates the end of the third body portion 213 away from the second body portion 212. At this point, the ends of the first body portion 211 and the third body portion 213 away from the second body portion 212 are essentially fitted onto the tube 10, allowing the first body portion 211 and the third body portion 213 to be fixedly connected to the outer wall of the tube 10 (e.g., by adhesive bonding).

[0061] Furthermore, in this embodiment, since the aforementioned balloon body 21 is configured as a cylindrical structure extending axially along the tube 10, the second body portion 212, which is the main body of the balloon body 21, is also configured as a cylindrical structure extending axially along the tube 10, for example, it can be a cylindrical structure. It is understood that the cylindrical structure here refers to the shape exhibited by the second body portion 212 when the balloon body 21 is inflated. The shapes of the first body portion 211 and the third body portion 213 in the inflated state of the balloon body 21 are constricted cones or approximately cones, such as cones or approximately cones. Based on this, the protrusion 22 is at least provided on the second body portion 212, and consequently, the electrode 30 is at least provided on the second body portion 212.

[0062] Based on the above, the protrusion 22 is at least provided on the second body part 212. If necessary, the protrusion 22 can also be further provided on the first body part 211 and / or the third body part 213. In this case, the length of the protrusion 22 extending along the axial direction of the tube 10 is longer, and the surface area of ​​the protrusion 22 is larger, which can meet the need to further increase the area of ​​the electrode 30, that is, meet the need to increase the coverage range of the pulse electric field.

[0063] Of the first body portion 211, the second body portion 212, and the third body portion 213 described above, the second body portion 212 has the longest length along the axial direction of the tube body 10. For example, the length can be 28-50 mm, such as 28 mm, 29 mm, 30 mm...38 mm, 39 mm, 40 mm...48 mm, 49 mm, 50 mm, etc. In this embodiment, it can specifically be 40 mm. In order to avoid redundancy, the specifications within the above-mentioned 28-50 mm range are not listed one by one. In general, any natural number of length specifications within the 28-50 mm range can be used; or it can be based on the aforementioned range, with a further increase or decrease of 0.5 mm on the basis of natural number length specifications.

[0064] Furthermore, the length of the second body portion 212 along the axial direction of the tube body 10 is greater than or equal to the sum of the lengths of the first body portion 211 and the third body portion 213 along the axial direction of the tube body 10. This arrangement is intended to ensure that the second body portion 212 of the balloon body 21 is the primary area of ​​contact with the lesion tissue during actual application. Therefore, based on the overall structure of the balloon body 21, setting the axial length of the second body portion 212 to be as large as possible—that is, greater than or equal to the sum of the lengths of the first body portion 211 and the third body portion 213 along the axial direction of the tube body 10—guarantees a larger contact area with the lesion tissue, thereby allowing the ablation catheter to have a larger single ablation range.

[0065] In some examples, based on the first body portion 211, the second body portion 212 and the third body portion 213 described above, when the balloon body 21 is connected to the tube body 10, the third body portion 213 is closer to the second end of the tube body 10 than the first body portion 211. In this case, the first body portion 211 is the distal end of the balloon body 21 and the third body portion 213 is the proximal end of the balloon body 21.

[0066] Based on this, a portion of the electrode 30 disposed on the protrusion 22 of the second body portion 212 can be located on the surface of the third body portion 213. That is, the electrode 30 can be disposed simultaneously on both the main body portion (i.e., the second body portion 212) and the proximal portion (i.e., the third body portion 213) of the balloon body 21. In this way, since a portion of the electrode 30 is disposed on the proximal portion (i.e., the third body portion 213) of the balloon body 21, the wire connected to the electrode 30 can directly extend from the second end of the tube 10 to the proximal portion of the balloon body 21 and connect to the electrode 30, thereby simplifying the wiring and electrical connection structure of the electrode 30. Furthermore, based on the simplification of the wiring and electrical connection structure, the collapse size of the balloon body 21 can be reduced (this effect is also reflected in the fact that this application eliminates the electrode support in related technologies, and directly places the electrode 30 on the surface of the balloon body 21, thus reducing the collapse size of the balloon body 21).

[0067] In some embodiments, please continue reading Figure 3 and Figure 4 The protrusion 22 also has a first end and a second end that are axially opposite to each other in the tube body 10. The end face of the first end or the second end of the protrusion 22 is set as a chamfer 221, or both the end faces of the first end and the second end of the protrusion 22 are set as chamfers 221.

[0068] The inclined direction of the slope 221 is such that the distance between the end faces of the first and second ends of the protrusion 22 near the edge of the balloon body 21 is greater than the distance between the end faces of the first and second ends of the protrusion 22 away from the edge of the balloon body 21. This distance refers to the distance along the axial direction of the tube body 10. That is, the inclined direction of the slope 221 is such that the length of the root of the protrusion 22 (the part connected to the balloon body 21) is greater than the length of the tip of the protrusion 22 (the part away from the balloon body 21). This length also refers to the length along the axial direction of the tube body 10.

[0069] Based on the aforementioned design of the inclined surface 221, the end face of the protrusion 22 can smoothly transition to the surface of the balloon body 21. This reduces the bending angle of the electrode 30 as it transitions from the surface of the protrusion 22 to the surface of the balloon body 21, preventing excessive bending stress and improving the reliability of the electrode 30. Furthermore, even if the electrode 30 is only disposed on the surface of the protrusion 22 without transitioning to the surface of the balloon body 21, it still requires electrical connection structures (such as wires) for power supply. The inclined surface 221 of the protrusion 22 facilitates the arrangement of these electrical connection structures on the balloon body 21, for example, by reducing the bending angle of the electrical connection structures and preventing excessive bending angles from affecting the reliability of conductivity.

[0070] In some examples, the aforementioned inclined surface 221 may be provided only on one end face of the protrusion 22, specifically, the end face of the protrusion 22 closest to the second end of the tube body 10 (i.e., the proximal end of the tube body 10) may be provided as inclined surface 221. For example, the second end of the protrusion 22 may be closer to the second end of the tube body 10 than the first end of the protrusion 22, i.e., the first end of the protrusion 22 is its distal end and the second end of the protrusion 22 is its proximal end. In this case, only the end face of the second end of the protrusion 22 may be provided as inclined surface 221.

[0071] Specifically, the second end of the protrusion 22 is closer to the second end of the tube body 10, and the electrical connection structure of the electrode 30 needs to be laid from the protrusion 22 where the electrode 30 is located to the second end of the tube body 10 to connect the corresponding power supply components. At this time, the second end of the protrusion 22 is the area that the electrical connection structure must pass through. Therefore, setting the second end of the protrusion 22 as a slope 221 will help in the layout of the electrical connection structure.

[0072] In other examples, where the second end of the protrusion 22 is closer to the second end of the tube body 10 than the first end of the protrusion 22, the end face of the second end of the protrusion 22 is set as a slope 221. The second end of the protrusion 22 can be located on the second body portion 212 of the aforementioned balloon body 21, in which case the slope 221 of the second end of the protrusion 22 smoothly transitions with the surface of the second body portion 212. The second end of the protrusion 22 can also be located at the connection between the second body portion 212 and one of the first body portion 211 or the third body portion 213, which is closer to the second end of the tube body 10. Taking the third body portion 213 as an example, which is closer to the second end of the tube body 10, the second end of the protrusion 22 can be located at the connection between the second body portion 212 and the third body portion 213, or the second end of the protrusion 22 can be further located on the third body portion 213, in which case the slope 221 smoothly transitions with the surface of the third body portion 213.

[0073] Furthermore, taking the second end of the third body portion 213 closer to the tube body 10 as an example, if the second end of the protrusion 22 is located at the connection between the second body portion 212 and the third body portion 213, since the third body portion 213 is actually a conical or approximately conical structure, that is, the surface of the third body portion 213 is also an inclined surface, the inclined surface 221 of the second end of the protrusion 22 and the surface of the third body portion 213 can be parallel to each other, that is, the two surfaces are coplanar. At this time, the electrode 30 or the electrical connection component of the electrode 30 can transition from the end face of the second end of the protrusion 22 to the surface of the third body portion 213 without bending, thereby reducing the number of bends required for the electrode 30 or the electrical connection component of the electrode 30.

[0074] In some embodiments, please refer to Figure 2 The ablation catheter also includes a sheath assembly 40, which is used to connect the ablation catheter with other instruments used in conjunction to form a whole. When entering and exiting the lesion tissue, the ablation catheter and other instruments used in conjunction can enter and exit synchronously, improving the convenience of operation.

[0075] Specifically, the lasso assembly 40 includes a lasso 41 and a pull rod 42. The lasso 41 passes through the tube body 10, and the pull rod 42 is located outside the tube body 10 and at the second end of the tube body 10. The second end of the lasso 41 is exposed at the second end of the tube body 10 and connected to the pull rod 42. The first end of the lasso 41 is located at the first end of the tube body 10, and the first end of the lasso 41 forms an annular lasso portion 411. For example, the first end of the lasso 41 can be partially bent or coiled to form an annular structure, which serves as the lasso portion 411. Since the first end of the tube body 10 penetrates the balloon body 21, for example, through the first body portion 211 of the balloon body 21, the lasso portion 411 is exposed at both the balloon body 21 and the first end of the tube body 10.

[0076] When using an ablation catheter, taking an endoscope as an example, the ablation catheter itself may not have a power structure (such as a guidewire traction structure) to drive it into and out of the lesion tissue or even the human body. Therefore, the ablation catheter itself needs to be used with the aid of other instruments such as an endoscope to enter and exit the lesion tissue or even the human body. Based on this, in the preparation stage, the ablation catheter can be connected to the endoscope through the lasso 41 of the lasso assembly 40. Specifically, the lasso part 411 of the lasso 41 is placed on the structure at the distal end of the endoscope, and the lasso part 411 is tightened by the pull rod 42 to ensure the reliability of the connection. This allows the ablation catheter and the endoscope to be connected as a whole, and can enter and exit organs such as the duodenum or lesion tissue or even the human body together with the endoscope.

[0077] In some examples, the aforementioned lasso assembly 40 further includes a lasso tube 43, which passes through the tube body 10, and a lasso 41 passes through the lasso tube 43. The first end of the lasso tube 43 is located at the first end of the tube body 10, and the first end of the lasso tube 43 is exposed outside the first end of the tube body 10. The first end of the lasso 41 is located at the first end of the lasso tube 43, and the first end of the lasso 41 is exposed outside the first end of the lasso tube 43; that is, the lasso portion 411 of the first end of the lasso 41 is exposed outside the first end of the lasso tube 43.

[0078] Further, please refer to Figure 8 Based on the aforementioned cable sleeve 43, a lasso 41 is inserted inside the cable sleeve 43. An assembly groove 431 is provided on the end face of the first end of the cable sleeve 43. After the first end of the lasso 41 is partially bent to form a ring structure, the end of the first end of the lasso 41 is fixed within the assembly groove 431, thereby forming a ring-shaped cable sleeve portion 411. The fixing method can be, for example, by filling the assembly groove 431 with an adhesive medium, and after the adhesive medium cures, the end of the first end of the lasso 41 is fixedly connected to the assembly groove 431; other fixing methods can also be used.

[0079] Based on this, since the end of the first end of the lasso 41 is fixed to the end face of the first end of the lasso tube 43, the size of the annular lasso part 411 can be changed by pushing the first end of the lasso 41 inward or pulling it outward by the aforementioned pull rod 42, that is, the tightening and loosening of the lasso part 411 can be achieved.

[0080] In some embodiments, please refer to Figure 2 and Figure 5 The ablation catheter body 10 includes a first tube 11 and a second tube 12. The second tube 12 is coaxially sleeved outside the first tube 11, that is, the first tube 11 passes through the second tube 12. The first tube 11 and the second tube 12 have a first end and a second end, that is, corresponding to the first end and the second end of the tube body 10, and the first end of the first tube 11 is exposed at the first end of the second tube 12.

[0081] Furthermore, based on the connection method between the tube body 10 and the balloon body 21, the tube body 10 can penetrate through the balloon body 21. Based on the aforementioned first tube 11 and second tube 12, the second tube 12 only penetrates one end of the balloon body 21, specifically the end of the balloon body 21 near the second end of the tube body 10, i.e., the proximal end of the balloon body 21, for example, the aforementioned third body portion 213; the first tube 11 extends from the second tube 12 into the interior of the balloon body 21 and further penetrates the other end of the balloon body 21, specifically the end of the balloon body 21 away from the second end of the tube body 10, i.e., the distal end of the balloon body 21, for example, the aforementioned first body portion 211.

[0082] At this point, the first end of the second tube 12 penetrates the proximal end of the balloon body 21, and the proximal end of the balloon body 21 is essentially fitted over the first end of the second tube 12, with the proximal end of the balloon body 21 fixedly connected to and sealed with the first end of the second tube 12. Similarly, the first end of the first tube 11 penetrates the distal end of the balloon body 21, and the distal end of the balloon body 21 is essentially fitted over the first end of the first tube 11, with the distal end of the balloon body 21 fixedly connected to and sealed with the first end of the first tube 11.

[0083] Based on this, please refer to Figure 6 A medium channel 101 is provided between the first tube 11 and the second tube 12. For example, the medium channel 101 can be formed by an annular space gap between the first tube 11 and the second tube 12. The medium channel 101 (specifically, the first end of the medium channel 101) is connected to the internal space of the balloon body 21. At this time, liquid or gas medium can be introduced into or extracted from the balloon body 21 through the second end of the medium channel 101 to control the expansion and contraction (or collapse) of the balloon 20.

[0084] It should be noted that, in order to improve the reliability of the fixed connection and sealing between the balloon body 21 and the first tube 11 and the second tube 12, connecting portions 23 extending a certain length along the axial direction of the tube body 10 can be provided at the proximal and distal ends of the balloon body 21. The connecting portions 23 are tubular structures, sleeved and fixed (for example, by adhesive bonding) to the first ends of the first tube 11 and the second tube 12. The connecting portions 23 can increase the contact area with the first tube 11 and the second tube 12, thereby improving the reliability of the fixed connection and sealing.

[0085] In addition, for the above-mentioned cable assembly 40, the cable tube 43 can be inserted into the first tube 11, and the cable tube 43 can be fixedly connected to the first tube 11.

[0086] In some examples, the first end of the second tube 12 is located inside the balloon body 21, and a medium hole 121 is provided on the end tube 10 of the first end of the second tube 12. The medium hole 121 is radially connected to the interior of the balloon body 21 of the medium channel 101. In this case, the medium hole 121 allows the medium to flow between the medium channel 101 and the interior of the balloon body 21.

[0087] Furthermore, the aforementioned medium holes 121 can be configured as multiple, for example, multiple medium holes 121 can be distributed circumferentially along the second tube 12, or multiple medium holes 121 can also be distributed axially along the second tube 12, or multiple medium holes 121 can be distributed circumferentially and axially along the second tube 12 at the same time.

[0088] In other examples, the tube body 10 also includes a third tube 13 sleeved outside the second tube 12, that is, the first tube 11, the second tube 12, and the third tube 13 are coaxially sleeved sequentially from the inside to the outside. The third tube 13 is fixedly connected to the second tube 12 (either directly or indirectly). A direct connection may be achieved by partially bonding or welding the third tube 13 to the second tube 12, while an indirect connection may involve simultaneously connecting the third tube 13 to another component of the ablation catheter (e.g., a handle 50) along with the second tube 12.

[0089] A wiring channel 102 is provided between the third tube 13 and the second tube 12. The wiring channel 102 can be formed by an annular gap between the third tube 13 and the second tube 12. The wiring channel 102 is used for the arrangement of electrical connection components connected to the electrode 30. For example, a wire can be placed in the wiring channel 102, with one end of the wire connected to the electrode 30 provided on the balloon 20 and the other end connected to the power supply component.

[0090] It should be noted that the fixed connection method between the first tube 11 and the cable sleeve 43 can refer to the fixed connection method between the third tube 13 and the second tube 12.

[0091] In some embodiments, please refer to Figure 2 and Figure 7 The ablation catheter also includes a handle 50 as a control component. The handle 50 includes a handle body 51 connected to the second end of the tube body 10. The second ends of the first tube 11, the second tube 12, and the third tube 13 in the tube body 10 can be connected to the handle body 51 as needed. A medium cavity 511 is provided inside the handle body 51. The medium cavity 511 communicates with the Luer interface 52 provided on the handle body 51, and the medium cavity 511 also communicates with the medium channel 101 between the first tube 11 and the second tube 12.

[0092] Based on this, the Luer interface 52 can be connected to an external media delivery component, so that the media can be input into or extracted from the media channel 101 through the media cavity 511, that is, the balloon body 21 can be input into or extracted, so as to control the inflation and deflation of the balloon body 21.

[0093] In some examples, the handle 50 also includes a cable connector 55 disposed on the handle body 51, which is connected to the electrode 30 via the aforementioned electrical connection components (e.g., wires). The cable connector 55 is used to connect to an external power supply component, such as a power supply component in an ablation device, to supply power to the electrode 30.

[0094] In some embodiments, the first tube 11 and the second tube 12 are configured to be relatively movable, specifically, the first tube 11 and the second tube 12 can be relatively movable in the axial direction. For example, the length of the first end of the first tube 11 exposed above the first end of the second tube 12 can be changed by the relative movement. Since the first ends of the first tube 11 and the second tube 12 are respectively connected to the proximal and distal ends of the balloon body 21, the relative movement of the first tube 11 and the second tube 12 in the axial direction can actually change the distance between the proximal and distal ends of the balloon body 21, thereby further adjusting and controlling the state and shape of the balloon body 21.

[0095] Based on this, please refer to Figure 7 The aforementioned handle 50 also includes a push button 53 disposed on the handle body 51. The handle body 51 is provided with a slide rail 512 extending axially along the tube 10. A portion of the push button 53 is fitted into the slide rail 512, thereby allowing the push button 53 to slide axially along the tube 10 within the slide rail 512. Simultaneously, the second end of the first tube 11 is exposed to the second end of the second tube 12. The push button 53 is fixedly connected to the second end of the first tube 11, and the second end of the second tube 12 is fixedly connected to the handle body 51.

[0096] In this way, by operating the push button 53 to slide along the axis of the tube 10 in the slide 512, the first tube 11 can be moved axially relative to the second tube 12, thereby changing the distance between the proximal and distal ends of the balloon body 21, and realizing further adjustment and control of the state and shape of the balloon body 21.

[0097] It should be noted that, since the second end of the second tube 12 needs to be fixedly connected to the handle body 51, based on the aforementioned third tube 13 sleeved outside the second tube 12, the second end of the second tube 12 needs to be exposed beyond the second end of the third tube 13 so that the second end of the second tube 12 can be fixedly connected to the handle body 51. At this time, the second end of the third tube 13 is also fixedly connected to the handle body 51.

[0098] In some examples, the handle 50 also includes an elastic element 54, which may specifically be a spring, bellows, or other structure. One end of the elastic element 54 is fixed to the handle body 51, and the other end is fixed to the push button 53. When the push button 53 moves, it causes the elastic element 54 to deform, and the elastic force generated by this deformation can reset the push button 53.

[0099] In some embodiments, this application provides an ablation system including an endoscope (not shown in the accompanying drawings) and the ablation catheter described in the above embodiments. The ablation catheter can be connected to the endoscope via its sheath assembly 40 to form a single unit for entry and exit into the lesion tissue or even the human body. Furthermore, this ablation system also possesses all the technical effects of the ablation catheter described in the above embodiments.

[0100] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0101] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An ablation catheter, characterized in that, include: A tube having a first end and a second end; A balloon includes a balloon body and a plurality of protrusions disposed on the surface of the balloon body. The balloon body is connected to a first end of a tube. The balloon body is configured as a cylindrical structure extending axially along the tube. The protrusions extend axially along the tube on the surface of the balloon body. The electrodes are multiple in number, and the multiple electrodes are respectively disposed on the multiple protrusions, with at least one electrode disposed on the surface of the protrusion away from the balloon body.

2. The ablation catheter according to claim 1, characterized in that, The protrusion has a first end and a second end that are axially opposite each other in the tube body, and the end faces of the first end and / or the second end of the protrusion are set as inclined surfaces; The inclined direction of the slope is such that the distance between the end faces of the first and second ends of the protrusion near the edge of the balloon body is greater than the distance between the end faces of the first and second ends of the protrusion away from the edge of the balloon body.

3. The ablation catheter according to claim 1, characterized in that, The balloon body includes a first body part, a second body part and a third body part connected in sequence, and the end of the first body part and / or the third body part away from the second body part is connected to the tube body. The second body portion is configured as a cylindrical structure extending axially along the tube body, and the protrusion is provided at least on the surface of the second body portion.

4. The ablation catheter according to claim 3, characterized in that, The third body portion is closer to the second end of the tube than the first body portion, and a portion of the electrode is disposed on the surface of the third body portion.

5. The ablation catheter according to claim 3, characterized in that, The length of the second body portion in the axial direction of the tube is greater than or equal to the sum of the lengths of the first body portion and the third body portion in the axial direction of the tube.

6. The ablation catheter according to any one of claims 1 to 5, characterized in that, The protrusion extends along the axial direction of the tube body in a straight line or a tortuous path.

7. The ablation catheter according to any one of claims 1 to 5, characterized in that, The plurality of protrusions are spaced apart in the circumferential direction of the tube body.

8. The ablation catheter according to any one of claims 1 to 5, characterized in that, Also includes: A lasso assembly includes a lasso and a pull rod. The lasso is inserted into the tube. The first end of the lasso is provided with an annular lasso portion, and the second end of the lasso is connected to the pull rod. The first end of the tube penetrates the balloon body and is exposed outside the balloon body, while the sheath portion is exposed outside the first end of the tube.

9. The ablation catheter according to claim 8, characterized in that, The sheath assembly further includes a sheath tube, which is inserted into the tube body, and the sheath is inserted into the sheath tube. The first end of the sheath tube is exposed at the first end of the tube body, and the sheath portion is exposed at the first end of the sheath tube.

10. The ablation catheter according to claim 9, characterized in that, The first end of the lasso is exposed at the first end of the lasso tube, and the end of the first end of the lasso is fixed to the end face of the first end of the lasso tube to form an annular lasso portion at the first end of the lasso.

11. The ablation catheter according to any one of claims 1 to 5, characterized in that, The tube body includes a first tube and a second tube sleeved outside the first tube, with the first end of the first tube exposed outside the first end of the second tube; The first end of the second tube passes through and is fixedly connected to one end of the balloon body, and the first end of the first tube passes through and is fixedly connected to the other end of the balloon body. There is a medium channel between the first tube and the second tube that communicates with the interior of the balloon body.

12. The ablation catheter according to claim 11, characterized in that, The first end of the second tube has a medium hole that connects the medium channel with the inside of the balloon body.

13. The ablation catheter according to claim 11, characterized in that, Also includes: A handle, comprising a handle body and a Luer interface disposed on the handle body, wherein a medium cavity is disposed within the handle body and the medium cavity is connected to the Luer interface; The handle body is connected to the second end of the tube, and the medium cavity is connected to the medium channel.

14. The ablation catheter according to claim 13, characterized in that, The handle also includes a push button disposed on the handle body, and the handle body is provided with a slide rail, the push button being partially disposed within the slide rail; The first tube and the second tube are axially movable, the second end of the first tube is exposed above the second end of the second tube, the second end of the second tube is fixedly connected to the handle body, and the second end of the first tube is fixedly connected to the push button.

15. The ablation catheter according to claim 14, characterized in that, The handle also includes an elastic element, one end of which is fixed to the handle body and the other end of which is fixed to the push button.

16. The ablation catheter according to claim 11, characterized in that, The tube body also includes a third tube, which is sleeved outside the second tube and is fixedly connected to the second tube; The second tube and the third tube are connected by a wiring channel, and a wire is provided in the wiring channel and the wire is connected to the electrode.

17. An ablation system, characterized in that, Includes an endoscope and an ablation catheter as described in any one of claims 1 to 16, wherein the sheath assembly of the ablation catheter is used for connection to the endoscope.

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