A catheter

By designing a catheter system suitable for mapping and ablation, the complexity of circumferential pulmonary vein and pulmonary vein ablation surgery was solved, achieving efficient and safe ablation operations and improving the success rate of the surgery.

CN224331020UActive Publication Date: 2026-06-09艾科脉医疗器械(绍兴)有限公司

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
艾科脉医疗器械(绍兴)有限公司
Filing Date
2025-04-18
Publication Date
2026-06-09

AI Technical Summary

Technical Problem

In existing technologies, pulmonary vein ablation surgery requires repeated manipulation of multiple catheters, resulting in a complex surgical procedure, a long learning curve, and numerous trial-and-error attempts, which affects surgical safety and efficiency.

Method used

A catheter system comprising a first catheter and a second catheter was designed. The first catheter is used for mapping, and the second catheter is used for ablation. The two are slidably connected. The radial dimension of the tip of the first catheter is smaller than that of the second catheter to accommodate different pulmonary vein sizes, forming a conical structure for easy entry and positioning. It is combined with a magnetic sensor for precise guidance.

Benefits of technology

This method enables one-step ablation of the pulmonary veins and surrounding pulmonary veins, improving surgical efficiency, reducing operational steps, lowering surgical risks, and increasing surgical success rate and safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application relates to the technical field of medical devices, in particular to a catheter. The catheter comprises a first catheter and a second catheter, the first catheter can be used for mapping an electrical signal of a tissue, and the second catheter can be used for ablation of the tissue; the extension direction of the first catheter is the same as that of the second catheter; the first catheter can also release the electrical signal to ablate the tissue. The large and small loop structures can be quickly positioned, have high adaptability, effectively reduce the operation of a surgeon, and improve the operation efficiency.
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Description

Technical Field

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

[0002] Electrophysiological ablation aimed at isolating abnormal electrical signals in the pulmonary veins is a common treatment for atrial fibrillation. This typically involves first marking abnormal signal points and reentry areas using a mapping catheter, followed by ablation using an ablation catheter to target these marked points or areas. However, ablation of the pulmonary region and pulmonary veins usually employs a point-to-point approach, requiring the operator to repeatedly manipulate multiple catheters for mapping and ablation during the procedure. This process is complex, has a long learning curve, involves numerous trials and errors, and negatively impacts overall surgical safety and efficiency. Utility Model Content

[0003] In order to solve the problems existing in the prior art, this application provides a conduit.

[0004] The specific technical solution of this application is as follows:

[0005] A catheter includes a first catheter and a second catheter, the first catheter and the second catheter having the same extension direction, and the first catheter and the second catheter being capable of mapping and / or ablation, respectively.

[0006] The first catheter has a first tip at its distal end, and the second catheter has a second tip at its distal end, with the first tip located at the distal end of the second tip.

[0007] The radial dimension of the first head end is smaller than the radial dimension of the second head end.

[0008] In one specific embodiment, the first catheter can be used to map tissue electrical signals, and the second catheter can be used to ablate tissue.

[0009] In one specific embodiment, the first catheter can also release an electrical signal to ablate the tissue.

[0010] In one specific embodiment, the first head end is annular, the second head end is annular, and the diameter of the first head end is smaller than the diameter of the second head end.

[0011] In one specific embodiment, the plane containing the first tip is perpendicular to the extension direction of the first catheter, the plane containing the second tip is perpendicular to the extension direction of the second catheter, and the first tip and the second tip are arranged parallel to each other.

[0012] In one specific embodiment, the first catheter and the second catheter are slidably connected, the first catheter is disposed in the annular structure of the second end, and the first catheter is slidable relative to the second catheter along the axial direction.

[0013] In one specific embodiment, the diameter of the first head end is 7–22 mm.

[0014] In one specific embodiment, the diameter of the first head end is 12-17 mm.

[0015] In one specific embodiment, a pull wire is connected to the first end, which is capable of adjusting the diameter of the first end.

[0016] In one specific embodiment, the distal end of the pull wire is disposed inside the first head end, the proximal end of the pull wire is disposed inside the first conduit, and a control component capable of pulling the pull wire is disposed on the proximal end of the first conduit.

[0017] In one specific embodiment, the diameter of the second head end is variable.

[0018] In one specific embodiment, the diameter of the second head end ranges from 10 to 50 mm.

[0019] In one specific embodiment, the diameter of the second head end ranges from 15 to 30 mm.

[0020] In one specific embodiment, the diameter of the second head end is a fixed diameter.

[0021] In one specific embodiment, the diameter of the second head end is any value between 10 and 50 mm.

[0022] In one specific embodiment, the diameter of the second head end is any value between 15 and 30 mm.

[0023] In one specific embodiment, the diameter of the second head end is any integer value between 15 and 30 mm.

[0024] In one specific embodiment, a first electrode is provided on the first head end.

[0025] In one specific embodiment, the first electrode includes an ablation electrode.

[0026] In one specific embodiment, the first electrode includes a calibration electrode.

[0027] In one specific embodiment, the first electrode is a combined electrode with mapping and ablation functions.

[0028] In one specific embodiment, a plurality of uniformly arranged second electrodes are provided on the second head end.

[0029] In one specific embodiment, the second electrode includes a calibration electrode.

[0030] In one specific embodiment, the second electrode includes an ablation electrode.

[0031] In one specific embodiment, the second electrode is a combined electrode with mapping and ablation functions.

[0032] In one specific embodiment, a first transition portion for connection is provided between the first conduit and the first tip, and a second transition portion for connection is provided between the second conduit and the second tip.

[0033] In one specific embodiment, the distance between the first tip and the second tip along the extension direction of the first or second catheter is 2 to 15 mm.

[0034] In one specific embodiment, the distance between the first tip and the second tip along the extension direction of the first or second catheter is 5 to 10 mm.

[0035] In one specific embodiment, the conduit further includes a tube body through which both the first and second conduits pass, and a magnetic sensor is disposed at the distal end of the tube body.

[0036] In one specific embodiment, both the first conduit and the second conduit are slidably connected to the tube body.

[0037] Beneficial effects

[0038] The catheter of this application allows for initial mapping of the circumpulmonary region and pulmonary veins using the first tip, followed by direct ablation using electrodes on both the first and second tips. The first tip is variable in diameter, ranging from 12 to 17 mm, to accommodate different pulmonary vein sizes under varying physiological and anatomical structures. This allows for mapping of pulmonary veins of a wider range of sizes.

[0039] The boundary line connecting the first and second cephalic ends forms a cone shape, which makes it easier for the first cephalic end to enter the circumferential pulmonary vein, and the second cephalic end can simultaneously abut against the circumferential pulmonary vein orifice.

[0040] Furthermore, in this application, the catheter can directly perform ablation operations on the pulmonary veins and the area around the pulmonary vein openings, achieving isolation in one step.

[0041] The catheter in this application can perform both mapping and ablation functions. The first and second tips form large and small ring structures, which can quickly locate the target, are highly adaptable, effectively reduce the surgeon's workload, and improve surgical efficiency. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of the structure of the catheter in this application;

[0043] Figure 2 This is a diagram of the structure of the catheter used in this application for tissue ablation;

[0044] Figure 3 This is a cross-sectional view of the tissue ablation performed by the catheter in this application;

[0045] Figure 4 This is a schematic diagram of the movement position of the catheter in this application.

[0046] In the figure, 1 is the first catheter; 11 is the first tip; 2 is the second catheter; 22 is the second tip; 3 is the tube body; 4 is the magnetic sensor; 5 is the tissue; and 6 is the ring electrode. Detailed Implementation

[0047] The present application will now be described in detail. While specific embodiments of the present application are shown, it should be understood that the present application can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0048] It should be noted that certain terms are used in the specification and claims to refer to specific components. Those skilled in the art will understand that different terms may be used to refer to the same component. This specification and claims do not distinguish components based on differences in terminology, but rather on differences in function. The terms "comprising" or "including" used throughout the specification and claims are open-ended and should be interpreted as "comprising but not limited to." The following descriptions in the specification are preferred embodiments for carrying out this application; however, these descriptions are for the purpose of understanding the general principles of the specification and are not intended to limit the scope of this application. The scope of protection of this application shall be determined by the appended claims.

[0049] refer to Figure 1 This application provides a catheter. It includes a first catheter 1 and a second catheter 2, which have the same extension direction. The first catheter 1 and the second catheter 2 are respectively capable of mapping and / or ablation.

[0050] In the field of interventional medicine, the end closer to the operator is defined as the "proximal end," and the end farther from the operator is defined as the "distal end." For elongated objects, the direction parallel to their length is defined as the "axial direction," and the direction perpendicular to their length is defined as the "radial direction." For objects with a circular cross-section, the direction surrounding their axis is defined as the "circumferential direction."

[0051] refer to Figure 1 and Figure 2 The first catheter 1 and the second catheter 2 are arranged side by side, both extending distally. A ring electrode 6 is provided on both the first catheter 1 and the second catheter 2. The ring electrode 6 can be used for mapping and / or ablation.

[0052] After the first catheter 1 and the second catheter 2 are inserted into the human body, the first catheter 1 and the second catheter 2 can respectively map or ablate the human tissue 5. The combined action of the first catheter 1 and the second catheter 2 greatly improves the work efficiency compared to using a conventional single catheter.

[0053] refer to Figure 2 and Figure 3 When using the first catheter 1 and the second catheter 2, appropriate structural dimensions are selected based on the actual situation to enable the first catheter 1 and the second catheter 2 to perform mapping and / or ablation functions as expected. For example, when mapping and ablation are performed at the pulmonary vein orifice, the diameter of the vein orifice is relatively large, while the internal diameter of the vein is relatively small. Therefore, the catheter with the larger radial dimension is used for mapping, while the one with the smaller radial dimension enters the vein for ablation. Similarly, depending on the situation, the first catheter 1 and the second catheter 2 can be used separately for mapping or ablation to achieve precise treatment of human tissue 5; at the same time, the simultaneous use of the first catheter 1 and the second catheter 2 greatly improves work efficiency. Furthermore, it can effectively reduce the surgeon's workload, reduce the possibility of surgical errors, and improve the safety and success rate of the surgery.

[0054] The first catheter 1 has a first tip 11 at its distal end, and the second catheter 2 has a second tip 22 at its distal end, with the first tip 11 located at the distal end of the second tip 22.

[0055] refer to Figure 1 The radial dimension of the first end 11 is smaller than the radial dimension of the second end 22.

[0056] The first end 11 with a smaller radial dimension is located at the distal end of the second end 22, thus forming a tapered shape between the first end 11 and the second end 22 with a radial dimension that gradually decreases from the proximal end to the distal end.

[0057] refer to Figure 1 and Figure 3It is worth mentioning that the cone-shaped structure formed between the first head end 11 and the second head end 22 is similar to the pulmonary vein orifice structure of human tissue 5. For example Figure 3 In the process, the first end 11 and the second end 22 are respectively attached to the tissues on the inner and outer sides of the pulmonary vein opening; therefore, when the first end 11 and the second end 22 penetrate into the human pulmonary vein opening, the smaller first end 11 can easily enter the pulmonary vein from the larger pulmonary vein opening, and then the first end 11 can also guide the second end 22 so that the second end 22 can accurately locate the position of the pulmonary vein opening.

[0058] refer to Figure 3 Furthermore, once the second tip 22, guided by the first tip 11, reaches the pulmonary vein opening, it comes into contact with the surrounding human tissue 5, achieving abutment. Specifically, the distal end of the second tip 22 abuts against the human tissue. At this point, the human tissue 5 provides support for the second tip 22, making it easier for the surgeon to control both the first tip 11 and the second tip 22. Moreover, after the second tip 22 is abutted against the human tissue 5, the surgeon can more easily control the first tip 11 to reach the target position by relying on the support of the second tip 22 and the human tissue 5. This greatly improves the control precision of the first tip 11 and also increases its ease of control.

[0059] refer to Figure 1 The first catheter 1 can be used to map the electrical signals of tissue 5, and the second catheter 2 can be used to ablate tissue 5.

[0060] In routine use, when ablating tissue 5, the tissue 5 is mapped based on its electrophysiological characteristics to locate the lesion. The mapping catheter is then replaced with an ablation catheter to perform ablation treatment on the lesion. This process of mapping, catheter replacement, and subsequent ablation, compared to the method in this application where both the first catheter 1 and the second catheter 2 are inserted into the body, saves significant surgical time and reduces the steps of catheter insertion and removal, further minimizing the possibility of complications and improving the success rate of the procedure.

[0061] refer to Figure 3 On the other hand, since the internal size of the pulmonary vein is small, in order to accurately locate the lesion, it is necessary to perform electrophysiological mapping on the part of the pulmonary vein near the heart. However, the larger second end 22 is difficult to enter the pulmonary vein. Therefore, this application uses the smaller radial size of the first end 11 for mapping, thereby enabling more comprehensive electrophysiological mapping of the human heart and pulmonary veins to find the precise location of the lesion.

[0062] The first catheter 1 can also release ablation energy to ablate tissue 5.

[0063] Furthermore, in certain specific cases, the lesion is located inside the pulmonary vein, and the second catheter 2, with its larger radial dimensions, is difficult to access into the pulmonary vein. Therefore, in this application, the first catheter 1 is configured to perform ablation, thereby enabling the tissue 5 located inside the pulmonary vein to be ablated.

[0064] refer to Figure 1 The first end 11 is annular, the second end 22 is annular, and the diameter of the first end 11 is smaller than the diameter of the second end 22.

[0065] Both the first end 11 and the second end 22 are configured as a ring structure, which hides the ends of the first end 11 and the second end 22 in the ring structure, thereby reducing the sharpness between the first end 11 and the second end 22, and thus reducing the possibility of the first end 11 and the second end 22 causing puncture wounds to the tissue 5.

[0066] The annular diameter of the first end 11 is smaller than the diameter of the second end 22. Therefore, when the first catheter 1 and the second catheter 2 penetrate deep into the human body, the first end 11 can penetrate into the smaller diameter human tissue 5. The second end 22, due to its larger radial dimension, abuts against the outer side of the smaller diameter human tissue 5 structure.

[0067] refer to Figure 2 The annular structure of the first tip 11 and the second tip 22 serves two purposes. First, it conceals the sharp ends, reducing the sharpness of the first catheter 1 and the second catheter 2 at their distal positions, and decreasing the possibility of the first tip 11 and the second tip 22 causing puncture wounds to the human tissue 5. Second, the small size of the first tip 11, located distal to the second tip 22, allows the first tip 11 to enter the smaller human tissue 5. The first tip 11 can guide the second tip 22, and once inside the human tissue 5, the second tip 22, when in contact with the tissue 5, can provide support for the first tip 11, improving its positioning accuracy.

[0068] refer to Figure 3 The plane of the first end 11 is perpendicular to the extension direction of the first conduit 1, and the plane of the second end 22 is perpendicular to the extension direction of the second conduit 2. The first end 11 and the second end 22 are arranged parallel to each other.

[0069] The plane containing the annular structure of the first end 11 and the second end 22 is perpendicular to the position of the catheter, that is, the first end 11 and the second end 22 are on the radial plane surrounding the first catheter 1 and the second catheter 2.

[0070] refer to Figure 3Thus, when the first end 11 enters the human pulmonary vein, the outer peripheral surface of the first end 11 contacts the inner wall of the pulmonary vein, and the distal end face of the second end 22 adheres to the circumferential direction of the pulmonary vein opening.

[0071] The first tip 11 and the second tip 22, positioned perpendicular to the first catheter 1 and the second catheter 2, form a frustum-shaped three-dimensional structure at the distal ends of the first catheter 1 and the second catheter 2. This makes the first tip 11 and the second tip 22 similar in shape to the pulmonary vein opening of the heart, facilitating better contact between them. This reduces the likelihood of ablation failure due to misalignment during the ablation of human tissue 5, thus minimizing the risk of complications.

[0072] On the other hand, after the radially arranged first tip 11 enters the pulmonary vein, the first tip 11 can make complete contact with the circumference of the inner wall of the pulmonary vein, which greatly increases the contact area between the first tip 11 and the pulmonary vein. Furthermore, when mapping or ablating human tissue, increasing the contact area can bring higher efficiency, effectively reduce operation time, reduce the complexity of the operation, improve the convenience of the operation, and thus achieve the goal of improving the success rate of the operation.

[0073] refer to Figure 4 The first conduit 1 and the second conduit 2 are slidably connected. The first conduit 1 is disposed in the annular structure of the second end 22, and the first conduit 1 can slide relative to the second conduit 2 along the axial direction.

[0074] Guided by the first catheter 1, the second catheter 2 comes into contact with the human tissue 5 and becomes fixedly attached to it. While the second catheter 2 provides support for the first catheter 1, the fixed structure of the human tissue 5 also makes it difficult for the second catheter 2 to move further. If the tissue 5 to be ablated or mapped by the first catheter 1 is located deeper, it will be difficult to reach the target position due to the limitation imposed by the second catheter 2. Therefore, in this application, the first catheter 1 is designed to slide relative to the second catheter 2. When the second catheter 2 is attached to the human tissue 5, the first catheter 1 can still penetrate or retract, thus enabling the first catheter 1 to accurately reach the target position with the support of the second catheter 2. This improves the ablation accuracy of the surgery, thereby reducing the possibility of postoperative complications and increasing the success rate of the surgery.

[0075] The diameter of the first end 11 is 7–22 mm; preferably 12–17 mm.

[0076] Specifically, the diameter of the first end 11 is: 7mm, 7.5mm, 8mm, 8.5mm, 9mm, 9.5mm, 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm, 22mm.

[0077] More specifically, in one embodiment, the diameter of the first head end varies within the range of: 7–17 mm, 8–18 mm, 9–19 mm, 10–20 mm, 11–21 mm, and 12–22 mm.

[0078] In another specific embodiment, the diameter of the first end varies in the following ranges: 7–12 mm, 8–13 mm, 9–14 mm, 10–15 mm, 11–16 mm, 12–17 mm, 13–18 mm, 14–19 mm, 15–20 mm, 16–21 mm, and 17–22 mm.

[0079] refer to Figure 1 A pull wire (not shown in the figure) is connected to the first end 11, which can adjust the diameter of the first end 11.

[0080] The far end of the pull wire is fixedly connected to the end of the first end 11, and the pull wire is slidably connected inside the first end 11.

[0081] When the end of the first end 11 is pulled toward the proximal end by the pull line, the pull line inside the first end 11 becomes shorter, which in turn causes the first end 11 to contract inward, making the first end 11 into a ring with a smaller diameter.

[0082] The diameter of the annular first end 11 can be controlled by pulling a string. During use, after the first end 11 enters the pulmonary vein, its diameter gradually decreases as it penetrates deeper. Therefore, when the first end 11 needs to enter the deep part of the pulmonary vein, its radial diameter needs to be reduced to a size smaller than the depth of the pulmonary vein. Conversely, when the first end 11 is located superficially within the pulmonary vein near the heart, and if it needs to adhere to the pulmonary vein, its diameter needs to be increased.

[0083] refer to Figure 1The radial dimensions of the first end 11 are controlled by a drawstring, allowing it to fit both superficially and deeply into smaller areas of the pulmonary vein or other tissues 5. This improves the adaptability of the first end 11 and enables it to handle a wider range of applications.

[0084] The distal end of the pull wire is located inside the first head end 11, and the proximal end of the pull wire is located inside the first conduit 1. A control component capable of pulling the pull wire is provided on the proximal end of the first conduit 1.

[0085] refer to Figure 1 A handle (not shown in the figure) is located at the proximal end of the catheter, which the surgeon holds to manipulate the catheter. Control components are located on the handle, at its distal end, for easy access by the surgeon.

[0086] refer to Figure 1 The surgeon can control the diameter of the first end 11 through the control components, so that the first end 11 can be operated on at the appropriate size during the operation.

[0087] The diameter of the second end 22 is variable.

[0088] The control assembly includes a first control unit capable of controlling the first head end and a second control unit capable of controlling the second head end.

[0089] The first control unit can control the diameter change of the first end by pulling a wire.

[0090] Similarly, in one specific embodiment, when the second end has a variable diameter, a second pull wire is also connected to the second end, and the second control unit can control the second pull wire to change the diameter of the second end.

[0091] The first control unit can pull the cable towards either the distal or proximal end. When the first control unit pulls the cable towards the proximal end, the first end contracts inward, thus reducing its diameter. Conversely, when the first control unit moves the cable towards the distal end, the first end expands outward, increasing its diameter. Similarly, the second end expands or contracts under the action of the second control unit.

[0092] In one specific embodiment, the diameter of the second head end 22 is in the range of 10 to 50 mm; more preferably, the diameter of the second head end 22 is in the range of 15 to 30 mm.

[0093] Specifically, the diameter of the second head end can be controlled to be: 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm, 22mm, 22.5mm, 23mm, 23.5mm, 24mm, 24.5mm, 25mm, 25.5mm, 26mm, 26.5mm, 27mm, 27.5mm, 28mm, 28.5mm, 29mm , 29.5mm, 30mm, 30.5mm, 31mm, 31.5mm, 32mm, 32.5mm, 33mm, 33.5mm, 34mm, 34.5mm, 35mm, 35.5mm, 36mm, 36.5mm, 37mm, 37.5mm, 38mm, 38.5mm, 39mm, 39.5m m, 40mm, 40.5mm, 41mm, 41.5mm, 42mm, 42.5mm, 43mm, 43.5mm, 44mm, 44.5mm, 45mm, 45.5mm, 46mm, 46.5mm, 47mm, 47.5mm, 48mm, 48.5mm, 49mm, 49.5mm, 50mm.

[0094] More specifically, in one embodiment, the diameter of the second head end can be varied within the range of: 10-20mm, 15-25mm, 20-30mm, 25-35mm, 30-40mm, 35-45mm, and 40-50mm.

[0095] In another specific embodiment, the diameter of the second head end can be varied in the following ranges: 10-25mm, 15-30mm, 20-35mm, 25-40mm, 30-45mm, and 35-50mm.

[0096] The diameter of the second end 22 is a fixed diameter.

[0097] Preferably, the diameter of the second head end 22 is any value between 10 and 50 mm; more preferably, the diameter of the second head end 22 is any value between 15 and 30 mm; even more preferably, the diameter of the second head end 22 is any integer value between 15 and 30 mm.

[0098] Specifically, the diameter range of the second head end is: 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm, 22mm, 22.5mm, 23mm, 23.5mm, 24mm, 24.5mm, 25mm, 25.5mm, 26mm, 26.5mm, 27mm, 27.5mm, 28mm, 28.5mm, 29mm, 2... 9.5mm, 30mm, 30.5mm, 31mm, 31.5mm, 32mm, 32.5mm, 33mm, 33.5mm, 34mm, 34.5mm, 35mm, 35.5mm, 36mm, 36.5mm, 37mm, 37.5mm, 38mm, 38.5mm, 39mm, 39.5mm , 40mm, 40.5mm, 41mm, 41.5mm, 42mm, 42.5mm, 43mm, 43.5mm, 44mm, 44.5mm, 45mm, 45.5mm, 46mm, 46.5mm, 47mm, 47.5mm, 48mm, 48.5mm, 49mm, 49.5mm, 50mm.

[0099] refer to Figure 1 A first electrode is provided on the first end 11. A plurality of second electrodes are provided on the second end 22, which are evenly arranged.

[0100] That is, the ring electrode 6 includes a first electrode disposed on the first end 11 and a second electrode disposed on the second end 22.

[0101] In this field, the purpose of the first electrode and the second electrode is determined by the implementation dimensions. When the dimensions of the first electrode or the second electrode meet the measurement accuracy, measurement can be performed. When the dimensions of the first electrode or the second electrode meet the ablation dimensions, ablation can be performed. At the same time, if both the measurement and ablation dimensions can be met in the process, the measurement and ablation functions of the first electrode and the second electrode can be met simultaneously.

[0102] The first tip 11 uses a first electrode to map and / or ablate tissue 5. Multiple first electrodes are provided on the first tip 11, and the multiple first electrodes are arranged with different intervals or densities according to different applications.

[0103] refer to Figure 1In one specific embodiment, the first electrode is an ablation electrode. At this time, the first tip 11 is used to ablate the tissue 5. After the human tissue 5 is mapped, the lesion point is diagnosed according to the electrophysiological three-dimensional model, and then the first electrode on the first tip 11 is used to ablate the tissue 5, thereby completing the ablation surgery.

[0104] When using the first tip 11 for ablation, the first tip 11 can be controlled to have a smaller diameter to facilitate penetration into the human tissue 5. Then, the diameter of the first tip 11 can be increased to fit into the interior of the tissue 5, thereby achieving ablation of the deep parts of the human tissue 5.

[0105] refer to Figure 1 In one specific embodiment, the first electrode is a calibration electrode;

[0106] In this embodiment, a first electrode on the first tip 11 is used to map human tissue 5. Once the first tip 11 penetrates into human tissue 5, such as pulmonary veins, its diameter can be expanded to allow for close contact with the human tissue 5, enabling mapping and obtaining an electrophysiological three-dimensional model of the human tissue 5. Because the size of the first tip 11 can be changed according to usage, it allows for deep mapping of human tissue 5, such as pulmonary veins. Simultaneously, the first tip 11 can also map smaller human tissues 5.

[0107] refer to Figure 1 In one specific embodiment, the first electrode is a combined electrode with mapping and ablation functions.

[0108] When the first electrode can simultaneously perform mapping and ablation, the first tip 11 can penetrate deep into the pulmonary vein or other tissues 5 to map the human tissue 5. This yields a precise three-dimensional electrophysiological model of the human tissue 5, allowing for the diagnosis of lesions. The first electrode on the first tip 11 is then used to ablate the lesions, thus achieving ablation treatment for the patient.

[0109] Using the first tip 11 to perform mapping and ablation simultaneously greatly reduces the mapping and ablation time of human tissue 5, further reducing the number of surgical steps and achieving the goal of reducing surgical risks.

[0110] refer to Figure 1 In one specific embodiment, the second electrode is an ablation electrode;

[0111] In this embodiment, the second tip 22 is used to ablate the tissue 5. Because the second tip 22 is relatively large, it is difficult to fully observe and control it when it is in contact with the tissue 5. Therefore, the first tip 11 is used to first enter the interior of structures such as pulmonary veins. Guided by the first tip 11, the second tip 22 is then positioned to contact the tissue 5. The second tip 22 is a large-diameter ring shape, allowing it to contact and ablate larger ring-shaped tissues 5, effectively increasing the area of ​​tissue 5 that can be ablated and improving the ablation efficiency.

[0112] refer to Figure 1 In one specific embodiment, preferably, the second electrode is a calibration electrode;

[0113] When using the second end 22 for calibration, the second electrode can calibrate a larger range due to the larger diameter of the second end 22. Therefore, the second end 22 can be used for rapid calibration when the accuracy requirements are low.

[0114] refer to Figure 1 In one specific embodiment, it is further preferred that the second electrode is a combined electrode with mapping and ablation functions.

[0115] In this embodiment, when the second end 22 can be used for both mapping and ablation, the first end 11 is usually used in conjunction with it for mapping. The second end 22 performs large-scale coarse mapping, and then the first end 11 is used for precise mapping to obtain a precise three-dimensional model of human tissue 5 for diagnosing lesions.

[0116] Then, the large-sized second end 22 is used to perform large-area ablation on the lesion.

[0117] A first transition portion for connection is provided between the first conduit 1 and the first tip 11, and a second transition portion for connection is provided between the second conduit 2 and the second tip 22.

[0118] Since the first catheter 1 extends distally along its central axis, and the plane containing the annular first tip 11 is perpendicular to the central axis of the first catheter 1, the first transition portion is curved, extending from the distal end of the first catheter 1 in a direction away from the central axis of the first catheter 1, and connecting with the first tip 11. The first transition portion is used to connect the first tip 11 to the first catheter 1. This allows the first tip 11 to form a structure perpendicular to the axis of the first catheter 1 inside the human body for mapping and / or ablation.

[0119] Similarly, the second transition portion is used to connect the second catheter 2 and the second tip 22. Furthermore, the second transition portion also provides support for the second tip 22, allowing it to abut against the human tissue 5.

[0120] The distance between the first end 11 and the second end 22 along the extension direction of the first conduit 1 or the second conduit 2 is 2 to 15 mm; preferably 5 to 10 mm.

[0121] Specifically, the distance between the first end 11 and the second end 22 is: 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm.

[0122] refer to Figure 1 The conduit also includes a tube body 3, through which both the first conduit 1 and the second conduit 2 pass. A magnetic sensor 4 is provided at the distal end of the tube body 3.

[0123] refer to Figure 4 The tube body 3 is used to connect and enclose the first catheter 1 and the second catheter 2, both of which are located inside the tube body 3. This reduces the possibility of changes in the distance between the first tip 11 and the second tip 22 when the first catheter 1 and the second catheter 2 are used for mapping or ablation inside the human body. In addition, the connection between the first catheter 1 and the second catheter 2 via the tube body 3 allows the first tip 11 to guide the second tip 22 more smoothly, while the second tip 22 can also support the first tip 11.

[0124] refer to Figure 4 In another specific embodiment, the tube body 3 can also replace the sheath to house the first end 11 and the second end 22. That is, when delivering the first end 11 and the second end 22 into the human body, both the first end 11 and the second end 22 need to be housed inside the tube body 3, so that the annular structure of the first end 11 and the second end 22 elastically deforms into a straight line under the constraint of the tube body 3, and then is delivered to the target location inside the human body via a vein.

[0125] refer to Figure 4 The magnetic sensor is used for positioning. The surgeon can detect the magnetic sensor, thereby determining the specific position of the distal end of the tube body 3. The distal end of the tube body 3 is close to the first end 11 and the second end 22. Therefore, by positioning the tube body 3 using the magnetic sensor, the surgeon can know the precise position of the first end 11 and the second end 22, and thus accurately deliver the first end 11 and the second end 22 to the target position.

[0126] refer to Figure 4The tube body 3 is connected to the first conduit 1 and the second conduit 2 at a position near the distal end;

[0127] In one embodiment, both the first conduit 1 and the second conduit 2 are slidably connected to the tube body 3, and both the first conduit 1 and the second conduit 2 can slide back and forth inside the tube body 3, thereby realizing the control of the position between the first end 11 and the second end 22.

[0128] refer to Figure 4 In one specific embodiment, both the first catheter 1 and the second catheter 2 are fixedly connected to the tube body 3, and the position between the first tip 11 and the second tip 22 is fixed. This significantly reduces the possibility of displacement between the first tip 11 and the second tip 22 once the catheter is inserted into the body. This approach is suitable when the fixed dimensions of the first tip 11 and the second tip 22 are similar to the dimensions of the patient's tissue 5.

[0129] refer to Figure 4 In one specific embodiment, the first catheter 1 is fixedly connected to the tube body 3, and the second catheter 2 is slidably connected to the tube body 3. After the first tip 11 enters the tissue 5, it can control the second catheter 2 to move toward the distal end, thereby reducing the distance between the first tip 11 and the second tip 22, so that the first tip 11 can immediately abut against the position of the pulmonary vein opening after the first tip 11 enters the position of the pulmonary vein opening or similar tissue 5.

[0130] refer to Figure 4 Preferably, in one specific embodiment, the first conduit 1 is slidably connected to the tube body 3, and the second conduit 2 is fixedly connected to the tube body 3.

[0131] The first tip 11 can reciprocate along the tube body 3, greatly increasing its flexibility. This allows the first tip 11 to be more easily aligned with locations such as the pulmonary vein opening. Furthermore, during the insertion into the pulmonary vein, the reciprocating movement of the first tip 11 can be controlled to adjust the positions of the first tip 11 and the second tip 22, improving the positioning accuracy of the first tip 11 and the second tip 22. This, in turn, improves the accuracy and efficiency of mapping or ablation during ablation procedures, increasing the success rate of the surgery.

[0132] refer to Figure 4 In a further preferred embodiment, both the first conduit 1 and the second conduit 2 are slidably connected to the tube body 3.

[0133] After the first catheter 1 and the second catheter 2 are inserted into the human body through the tube body 3, the distance between the first tip 11 and the second tip 22 can be changed by sliding between the first catheter 1 and the second catheter 2 and the tube body 3. Furthermore, since both the first catheter 1 and the second catheter 2 can move within the tube body 3, the distance between the first tip 11 and the second tip 22 and the tube body 3 can also be controlled. Therefore, during use, the first tip 11 and the second tip 22 can be moved within the tube body 3 until they are in a suitable position before tissue ablation. This gives the first tip 11 and the second tip 22 greater flexibility, allowing them to better cope with and adapt to different environmental conditions during tissue ablation.

[0134] In summary, this application provides a catheter that is delivered into the human body via a sheath. Inside the body, a first tip 11 and a second tip 22 are first extended from the sheath, forming a ring shape within the body. The first tip 11 and the second tip 22 are simultaneously delivered to the target location in the human tissue 5. First, the first tip 11 is delivered into a small tissue such as the pulmonary vein. Then, guided by the first tip 11, the second tip 22 is delivered forward until it adheres to the tissue 5. Because the shapes of the first tip 11 and the second tip 22 are similar to those of the pulmonary vein opening, they can achieve perfect adhesion to the tissue 5. Supported by the force between the second tip 22 and the tissue 5, the surgeon can control the first tip 11, precisely positioning it to the target location for mapping or to the lesion for ablation, thereby completing the mapping and ablation surgery for the patient. Simultaneously, the second end 22 can also make contact with a large area of ​​tissue 5, enabling simultaneous ablation of a large area of ​​tissue 5 and improving ablation efficiency. This reduces surgical time and steps, lowers the possibility of surgical complications, and increases the success rate of the procedure.

[0135] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A catheter, characterized in that, It includes a first catheter and a second catheter, which have the same extension direction, and the first catheter and the second catheter are respectively capable of mapping and / or ablation; The first catheter has a first tip at its distal end, and the second catheter has a second tip at its distal end, with the first tip located at the distal end of the second tip. The radial dimension of the first head end is smaller than the radial dimension of the second head end.

2. The catheter according to claim 1, characterized in that, The first catheter can be used to map tissue electrical signals, and the second catheter can be used to ablate tissue.

3. The catheter according to claim 1, characterized in that, The first catheter can also release electrical signals to ablate tissue.

4. The catheter according to claim 3, characterized in that, The first head end is annular, the second head end is annular, and the diameter of the first head end is smaller than the diameter of the second head end.

5. The catheter according to claim 3, characterized in that, The plane containing the first tip is perpendicular to the extension direction of the first catheter, and the plane containing the second tip is perpendicular to the extension direction of the second catheter. The first tip and the second tip are arranged parallel to each other.

6. The catheter according to claim 3, characterized in that, The diameter of the first head end is 7–22 mm.

7. The catheter according to claim 6, characterized in that, The diameter of the first head end is 12-17 mm.

8. The catheter according to claim 3, characterized in that, The first end is connected to a pull wire that allows adjustment of the diameter of the first end.

9. The catheter according to claim 8, characterized in that, The distal end of the pull wire is located inside the first head end, and the proximal end of the pull wire is located inside the first conduit. A control component capable of pulling the pull wire is provided on the proximal end of the first conduit.

10. The catheter according to claim 3, characterized in that, The diameter of the second head end is variable.