Medical balloon and ablation catheter

Abstract

The invention provides a medical balloon and an ablation catheter, a plurality of electrode assemblies are arranged, the plurality of electrode assemblies are distributed on the surface of a balloon main body along the longitude direction of the balloon main body, each electrode assembly comprises a substrate, a first electrode and a second electrode, and the first electrode and the second electrode are both connected with the substrate; the width of at least one of the first electrode and the second electrode is reduced along with increasing of the latitude of the balloon body, the first electrode and the second electrode are arranged on the base plate in a staggered mode in the longitude direction, and a spacer area is arranged between the far end of the base plate and the far end of the balloon body. The width of the balloon main body is reduced along with the increase of latitude, so that the actual attaching area of the balloon main body and a target tissue is changed along with the different attaching positions of the balloon main body and the target tissue in the latitude direction, and the area of the attached first electrode or second electrode is also changed along with the change of the actual attaching area, thereby providing equal-proportion discharge areas in different states. And under the condition that other discharge conditions are not changed, the consistency of the ablation effect is ensured.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to medical balloons and ablation catheters. Background Art

[0002] Atrial fibrillation is a common arrhythmia with symptoms of irregular heart beats. Patients with atrial fibrillation have a very high risk of stroke, which is an important cause of death. Strokes caused by atrial fibrillation usually have more severe clinical manifestations, higher mortality rates, and are more likely to recur. Therefore, the treatment of atrial fibrillation cannot be delayed.

[0003] At present, the most widely used treatment is to ablate the pulmonary veins by applying energy through an interventional catheter, thereby isolating the pulmonary vein potential and achieving the therapeutic effect. Common treatment methods include radiofrequency ablation catheters, cryoablation catheters, etc. Many ablation catheters are designed to better fit the pulmonary vein orifices and make the ablation energy more directly and effectively applied.

[0004] Most existing catheters with balloons are cryoablation catheters, which use liquid nitrogen or other means to release cryoenergy to the target tissue to cause necrosis, thereby achieving the treatment of atrial fibrillation. The technical means of pulsed electric field ablation can be more effective and the damage to tissues can be controlled. How to combine the flexible electrode sheet of pulsed ablation with the balloon to form an effective contact with the target tissue and achieve biphasic bipolar pulse ablation is a technical problem that needs to be solved in this field. Summary of the invention

[0005] Based on this, it is necessary to provide a medical balloon and an ablation catheter to address the above-mentioned technical problems.

[0006] The present application provides a medical balloon, comprising:

[0007] A balloon body, wherein the balloon body has longitude and latitude, and the two ends of the balloon body in the latitude direction are respectively a distal end and a proximal end, the distal end of the balloon body is provided with a distal through hole, and the proximal end of the balloon body is provided with a proximal through hole, and the distal through hole and the proximal through hole of the balloon body are both connected to the balloon inner cavity of the balloon body;

[0008] An electrode assembly, wherein the number of the electrode assemblies is configured to be several, and the several electrode assemblies are distributed on the surface of the balloon body along the longitudinal direction of the balloon body, wherein the electrode assembly includes a substrate, a first electrode and a second electrode, the first electrode and the second electrode are both connected to the substrate, and the width of at least one of the first electrode and the second electrode decreases with the increase of the latitude of the balloon body, the first electrode and the second electrode are staggered on the substrate along the longitudinal direction, and there is a spacing area between the distal end of the substrate and the distal end of the balloon body.

[0009] In one embodiment, a distal tube portion is provided at the distal end of the balloon body, the distal tube portion is located in the balloon lumen of the balloon body, and the distal end of the distal tube portion is connected to the distal through hole of the balloon body; and / or,

[0010] A proximal tube body portion is disposed at the proximal end of the balloon body, the proximal tube body portion is located outside the balloon inner cavity of the balloon body, and the distal end of the proximal tube body portion is connected to the proximal through hole of the balloon body; and / or,

[0011] The first electrode and the second electrode of the electrode assembly are located at different latitudes of the balloon body; and / or,

[0012] The polarities of the first electrode and the second electrode of the electrode assembly are the same or different; and / or,

[0013] The substrate is arranged on the surface of the balloon body along the latitudinal direction of the balloon body, and a chamfered structure is arranged on at least a portion of the edge of the substrate; and / or,

[0014] The substrate is a flexible substrate; and / or,

[0015] A first electrical trace and a second electrical trace are provided on the substrate, the first electrical trace is connected to the first electrode, the second electrical trace is connected to the second electrode, and at least one of the first electrical trace and the second electrical trace is connected to the proximal end of the balloon body; and / or,

[0016] At least one of the first electrode and the second electrode is a ring structure with a hollow inner circle; wherein the maximum width of the first electrode gradually increases from the distal end to the proximal end; the maximum width of the second electrode first gradually increases and then gradually decreases from the distal end to the proximal end; and / or,

[0017] The latitude of the first electrode in the balloon body is higher than the latitude of the second electrode in the balloon body, the area occupied by the first electrode on the surface of the balloon body is smaller than the area occupied by the second electrode on the surface of the balloon body, and the coating area of ​​the first electrode is smaller than the coating area of ​​the second electrode; and / or,

[0018] The number of the electrode assemblies is configured to be 6 to 24; and / or,

[0019] The electrode assemblies are evenly spaced along the longitudinal direction of the balloon body.

[0020] In one embodiment, the balloon body, the distal tube portion and the proximal tube portion are configured as an integrally formed structure; and / or,

[0021] The distal tube body is sleeved with a distal fixing tube, and the distal fixing tube includes a distal fixing section and a proximal fixing section connected along the axial direction, the distal fixing section is sleeved inside the distal tube body, the diameter of the distal fixing section is smaller than the diameter of the proximal fixing section, and the connecting position of the distal fixing section and the proximal fixing section forms a step structure; and / or,

[0022] The first electrode and the second electrode of the electrode assembly are disposed on opposite sides of the substrate along the longitudinal direction; and / or,

[0023] The polarities of the first electrode and the second electrode of the electrode assembly are the same, and the polarities of the electrode assemblies adjacent to each other in the longitudinal direction are different.

[0024] The present application provides an ablation catheter, the ablation catheter comprising:

[0025] A catheter assembly, the catheter assembly comprising a first tube body, a second tube body and a third tube body, the interior of the first tube body being configured to form a guidewire cavity, the second tube body being sleeved on the outside of the first tube body, a first inter-tube layer channel being formed between an outer tube wall of the first tube body and an inner tube wall of the second tube body, the second tube body being provided with a discharge hole connected to the first inter-tube layer channel, the second tube body being passed through the balloon inner cavity of the balloon body, the discharge hole being located in the balloon inner cavity of the balloon body, the third tube body being sleeved on the outside of the second tube body, a second inter-tube layer channel being formed between an outer tube wall of the second tube body and an inner tube wall of the third tube body;

[0026] The medical balloon is connected to the catheter assembly.

[0027] In one embodiment, a guidewire introduction tube is provided at the distal end of the first tube body, the inner cavity of the guidewire introduction tube is connected to the guidewire cavity formed inside the first tube body, and the diameter of the guidewire introduction tube gradually increases from the proximal end to the distal end; and / or,

[0028] The second tube body includes a distal tube segment, an intermediate tube segment and a proximal tube segment, the distal tube segment is connected to the distal end of the balloon body, the distal end of the intermediate tube segment is connected to the proximal end of the distal tube segment, the distal end of the proximal tube segment is connected to the proximal end of the intermediate tube segment, the intermediate tube segment is located in the balloon inner cavity of the balloon body, the intermediate tube segment has deformation ability, and the distal tube segment can at least move axially relative to the proximal tube segment based on the deformation ability of the intermediate tube segment.

[0029] In one embodiment, the distal end of the medical balloon does not exceed the distal end of the guidewire introduction tube in the axial direction of the catheter assembly and in the distal direction; and / or,

[0030] The middle tube section is a spring tube; and / or,

[0031] The first tube body is connected to the distal end section of the second tube body.

[0032] In one embodiment, the distal end of the third tube body is configured to be connected to a proximal tube body portion disposed at the proximal end of the balloon body, wherein a gap exists between the proximal tube body portion of the balloon body and the third tube body, and a proximal transition tube is disposed at the proximal end of the balloon body, wherein the proximal transition tube is located between the proximal tube body portion of the balloon body and the third tube body, and wherein the proximal transition tube is configured to shield the gap between the balloon body and the third tube body.

[0033] In one embodiment, the proximal transition tube includes a distal transition section and a proximal transition section connected in the axial direction, the distal transition section is sleeved on the distal tube body portion, the diameter of the distal transition section is larger than the diameter of the proximal transition section, the connecting position of the distal transition section and the proximal transition section forms a step structure, the distal transition section is sleeved on the outside of the proximal tube body portion of the balloon body, and the proximal transition section is penetrated into the interior of the third tube body, thereby being configured to shield the gap between the balloon body and the third tube body;

[0034] Wherein, the distal transition section is provided with a wire through hole.

[0035] In one embodiment, the first tube body comprises at least two unit tube segments, and a plurality of the unit tube segments are sequentially connected along the axial direction of the first tube body to form the first tube body, wherein at least two of the unit tube segments have different hardnesses; and / or,

[0036] The number of the discharge holes is configured to be multiple, and the multiple discharge holes are distributed in a spiral form along the circumference and axial direction of the second tube body; and / or,

[0037] The second tube body is provided with an injection hole connected to the first tube layer inter-channel, and the injection hole is located outside the balloon inner cavity of the balloon body; and / or,

[0038] At least a portion of the third tube body has a bending function; and / or,

[0039] A braided layer is arranged outside the third tube body.

[0040] In one embodiment, the hardness of the plurality of unit tube segments gradually increases from the distal end to the proximal end of the first tube body.

[0041] In the above-mentioned medical balloon and ablation catheter, since the balloon body is roughly spherical in structure when in the expanded state, when the balloon body is in contact with the target tissue (especially the pulmonary vein orifice) in the expanded state, the actual contact shape between the balloon body and the target tissue is annular. Ideally, the actual contact shape is a circular ring in the longitude direction. In this state, the width of the first electrode or the second electrode is limited to decrease with increasing latitude, which can ensure that the actual contact area between the balloon body and the target tissue changes with the different positions of contact with the target tissue in the latitude direction, and the area of ​​the contacted first electrode or the second electrode also changes accordingly, thereby providing proportional discharge areas in different states, and ensuring the consistency of the ablation effect when other discharge conditions remain unchanged. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 A three-dimensional schematic diagram of an ablation catheter provided in accordance with an embodiment of the present application.

[0043] Figure 2 For Figure 1 An exploded view of the ablation catheter is shown.

[0044] Figure 3 For Figure 2 A partially enlarged schematic diagram of the ablation catheter is shown.

[0045] Figure 4 For Figure 3 An exploded view of the local ablation catheter is shown.

[0046] Figure 5 A partial plan view of an ablation catheter provided in one embodiment of the present application.

[0047] Figure 6 For Figure 5 A partially enlarged schematic diagram of the ablation catheter is shown.

[0048] Figure 7 A three-dimensional perspective schematic diagram of a medical balloon provided in accordance with an embodiment of the present application.

[0049] Figure 8 A three-dimensional perspective schematic diagram of a balloon body provided for one embodiment of the present application.

[0050] Fig. 9 A three-dimensional schematic diagram of several electrode assemblies provided according to an embodiment of the present application.

[0051] Fig.10 A three-dimensional schematic diagram of a distal fixing tube provided in accordance with an embodiment of the present application.

[0052] Fig.11 A schematic plan view of an electrode assembly provided in accordance with an embodiment of the present application.

[0053] Fig.12 A three-dimensional schematic diagram of a proximal transition tube provided in accordance with an embodiment of the present application.

[0054] Fig.13 For Fig.12 A schematic plan view of the proximal transition tube is shown.

[0055] Fig.14 A schematic diagram of the internal structure of a control handle provided in one embodiment of the present application.

[0056] Figure Number:

[0057] 1000, medical balloon; 2000, catheter assembly; 3000, control handle;

[0058] 1100, balloon body; 1200, electrode assembly;

[0059] 1110, distal tube body; 1120, proximal tube body; 1130, distal fixing tube; 1140, proximal transition tube;

[0060] 1131, distal fixed segment; 1132, proximal fixed segment;

[0061] 1141, distal transition section; 1142, proximal transition section; 1143, wire penetration;

[0062] 1210, substrate; 1220, first electrode; 1230, second electrode; 1240, first electrical trace; 1250, second electrical trace;

[0063] 2100, the first tube body; 2200, the second tube body; 2300, the third tube body;

[0064] 2110, guide wire introduction tube;

[0065] 2210, distal pipe section; 2220, middle pipe section; 2230, proximal pipe section;

[0066] 3100. Sliding button; 3200. Sliding element; 3300. Telescopic tube. DETAILED DESCRIPTION

[0067] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0068] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0069] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0070] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0071] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0072] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, 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 implementation method.

[0073] See also Figures 1 to 14 As shown, the present application provides an ablation system, which includes an outer sheath and an ablation catheter, wherein the ablation catheter can be movably arranged in the inner cavity of the outer sheath. The outer sheath is a tube body with an inner cavity and two ends connected. Figures 1 to 5 As shown, the ablation catheter may include at least a catheter assembly 2000 and a medical balloon 1000, wherein the medical balloon 1000 is connected to the catheter assembly 2000. In addition, in one embodiment, the ablation catheter may further include a control handle 3000, wherein the control handle 3000 is used to be connected to the catheter assembly 2000 for control.

[0074] See also Figures 6 to 9 As shown, regarding the medical balloon 1000 mentioned above, in one embodiment, the medical balloon 1000 may include a balloon body 1100 and an electrode assembly 1200. The balloon body 1100 has a balloon lumen inside, and the balloon body 1100 is made of a deformable material, so that when the balloon lumen of the balloon body 1100 is filled with a filling material, the balloon body 1100 can be expanded, otherwise the balloon body 1100 shrinks, and the balloon body 1100 can be called an expanded state when it is expanded, and the balloon body 1100 can be called a contracted state when it is contracted.

[0075] When the balloon body 1100 is in an expanded state, it may be in the form of a sphere, a rugby ball, or the like, which is not limited here. Therefore, in order to facilitate the introduction of the distribution of the electrode assembly 1200 on the balloon body 1100, the balloon body 1100 may be limited to have longitude and latitude, and the balloon body 1100 may have several longitudes in the longitude direction, and the balloon body 1100 may have several latitudes in the latitude direction, which may refer to the longitude and latitude of the earth. The two ends of the balloon body 1100 in the latitude direction are the distal end of the balloon body 1100 and the proximal end of the balloon body 1100.

[0076] For example, the two ends of the balloon body 1100 in the latitudinal direction are the distal end and the proximal end, respectively, the distal end of the balloon body 1100 is provided with a distal through hole, the proximal end of the balloon body 1100 is provided with a proximal through hole, and the distal through hole and the proximal through hole of the balloon body 1100 are both connected to the balloon lumen of the balloon body 1100. The balloon body 1100, the distal tube portion 1110, and the proximal tube portion 1120 are configured as an integrally formed structure.

[0077] The electrode assembly 1200 is configured as a flexible electrode assembly 1200, see Figure 6 and Figure 7 As shown, the number of electrode assemblies 1200 is configured as a plurality, for example, the number of electrode assemblies 1200 is configured as 6 to 24. Based on the above definition of longitude and latitude, it can be defined that a plurality of electrode assemblies 1200 are distributed on the surface of the balloon body 1100 along the longitude direction of the balloon body 1100, that is, a plurality of electrode assemblies 1200 are distributed along the longitude direction of the balloon body 1100. Figure 6 The electrode assemblies 1200 are distributed on the surface of the balloon body 1100 in the transverse direction around the balloon body 1100. For example, the electrode assemblies 1200 are evenly spaced along the longitudinal direction of the balloon body 1100. Each electrode assembly 1200 extends in the latitudinal direction of the balloon body 1100, that is, each electrode assembly 1200 extends along the longitudinal direction of the balloon body 1100. Figure 6 The vertical direction shown extends.

[0078] At least a portion of the plate edge of the substrate 1210 may be chamfered, thereby forming a chamfered structure at at least a portion of the plate edge of the substrate 1210. In one embodiment, all plate edges of the substrate 1210 may be chamfered, thereby forming a chamfered structure at all plate edges of the substrate 1210. The plate edge of the substrate 1210 is chamfered to form a chamfered structure, which can make the ablation catheter smoother when returning to the sheath, and the substrate 1210 is not easy to warp.

[0079] When the balloon body 1100 is in an expanded state, it presents a spherical structure, and the electrode assembly 1200 is distributed along the longitude of the balloon body 1100. At this time, the electrode assembly 1200 can be used to emit pulse energy to ablate the target tissue. In one embodiment, the electrode assembly 1200 may include a substrate 1210, a first electrode 1220, and a second electrode 1230. The first electrode 1220 and the second electrode 1230 are both connected to the substrate 1210. Figure 6 As shown, based on the above definition of longitude and latitude, it can be defined that the width of at least one of the first electrode 1220 and the second electrode 1230 decreases as the latitude of the balloon body 1100 increases. Figure 6 The width in the lateral direction shown decreases as the latitude of the balloon body 1100 increases. Figure 6 The width in the lateral direction shown decreases as the latitude of the balloon body 1100 increases.

[0080] Since the balloon body 1100 is in a generally spherical structure when in an expanded state, when the balloon body 1100 is in contact with the target tissue (especially the pulmonary vein orifice) in the expanded state, the actual contact shape between the balloon body 1100 and the target tissue is annular. Ideally, the actual contact shape is a circular ring in the longitude direction. In this state, the width of the first electrode 1220 or the second electrode 1230 is limited to decrease with increasing latitude, which can ensure that the actual contact area between the balloon body 1100 and the target tissue changes with the different positions of contact with the target tissue in the latitude direction, and the area of ​​the contacted first electrode 1220 or the second electrode 1230 also changes, thereby providing equal-proportional discharge areas in different states, and ensuring the consistency of the ablation effect when other discharge conditions remain unchanged.

[0081] The polarity of the first electrode 1220 and the second electrode 1230 of the electrode assembly 1200 is the same, and the polarity of the electrode assemblies 1200 adjacent in the longitudinal direction is different. That is, the polarity of the first electrode 1220 and the second electrode 1230 contained in each electrode assembly 1200 is the same, but in the radial direction, the polarity of the first electrode 1220 and the second electrode 1230 contained in each electrode assembly 1200 is different from the polarity of the first electrode 1220 and the second electrode 1230 contained in other adjacent electrode assemblies 1200, thereby making the polarity of several electrode assemblies 1200 alternately distributed in the longitudinal direction. Therefore, the above-mentioned medical balloon 1000 can not only release single-phase pulse energy for ablation by a single or a single electrode at the same time, but also can release bipolar biphasic pulse electric field for ablation.

[0082] When performing bipolar biphasic pulse electric field ablation, the first electrode 1220 and the second electrode 1230 are prone to arc generation due to the problem of excessive voltage and small spacing. In order to reduce the generation of arc, in one embodiment, continue to refer to Figure 6 and Figure 7 As shown, the first electrode 1220 and the second electrode 1230 of each electrode assembly 1200 can be limited to be arranged on opposite sides of its substrate 1210 along the longitude direction, and the first electrode 1220 and the second electrode 1230 of each electrode assembly 1200 can also be located at different latitudes of the balloon body 1100. For example, the first electrode 1220 is located within the latitude range of 40° to 75° of the balloon body 1100, and the second electrode 1230 is located within the latitude range of 0° to 30° of the balloon body 1100.

[0083] In one embodiment, if Figure 6As shown, the first electrode 1220 and the second electrode 1230 are not only located on both sides of the substrate 1210, but also in an asymmetric position (staggered position) on the left and right sides of the substrate 1210, forming a staggered arrangement in both longitude and latitude directions, thereby maximizing the spacing between the first electrode 1220 and the second electrode 1230 in each electrode assembly 1200. For example, the latitude of the first electrode 1220 in the balloon body 1100 is higher than the latitude of the second electrode 1230 in the balloon body 1100, and the area occupied by the first electrode 1220 on the surface of the balloon body 1100 is smaller than the area occupied by the second electrode 1230 on the surface of the balloon body 1100, thereby making the glue coating area of ​​the first electrode 1220 smaller than the glue coating area of ​​the second electrode 1230.

[0084] Furthermore, in one of the embodiments, when entering the pulmonary vein orifice for ablation, since the operator cannot ensure that the balloon body 1100 and the pulmonary vein orifice are always level, there is often an angle between the two. Therefore, in order to ensure adhesion, a plurality of first electrodes 1220 that are continuous in longitude and located on different electrode assemblies 1200, and a plurality of second electrodes 1230 that are continuous in longitude and located on different electrode assemblies 1200 can work together. From a spatial point of view, two fan-shaped ablation areas with different radii are formed. However, under the condition of sufficient voltage, the edges of the two fan-shaped areas can be merged to form a continuous ablation area, thereby achieving pulse ablation isolation of the pulmonary vein orifice and ensuring the ablation effect.

[0085] The distal end of the balloon body 1100 is provided with a distal tube portion 1110. Figure 8 As shown, the distal tube part 1110 is located in the balloon lumen of the balloon body 1100, and the distal end of the distal tube part 1110 is connected to the distal through hole of the balloon body 1100, so that the distal tube part 1110 can be entirely located in the balloon lumen of the balloon body 1100. The proximal end of the balloon body 1100 is provided with a proximal tube part 1120, which is located outside the balloon lumen of the balloon body 1100, and the distal end of the proximal tube part 1120 is connected to the proximal through hole of the balloon body 1100, so that the entire proximal tube part 1120 is located outside the balloon lumen of the balloon body 1100.

[0086] From the above, it can be seen that since the distal tube body portion 1110 is located in the balloon inner cavity of the balloon body 1100, and the distal end of the distal tube body portion 1110 is connected to the distal through hole of the balloon body 1100, the distal tube body portion 1110 of the balloon body 1100 is not connected to the distal end of the balloon body 1100 and continues to extend to the distal end of the balloon body 1100, but is connected to the distal end of the balloon body 1100 and continues to extend to the proximal end of the balloon body 1100, that is, an inwardly concave structure is presented at the distal end of the balloon body 1100.

[0087] Since the distal tube portion 1110 of the balloon body 1100 extends proximally rather than distally, the distal end of the balloon body 1100 will no longer be provided with auxiliary structures such as a head cap, thereby reducing the distal length of the entire ablation catheter. When it is necessary to implement bending control on the entire ablation catheter, the ablation catheter can have a relatively smaller turning radius, which is convenient for operation and has a wider range of applications. For example, it can be used for circumferential lung and posterior wall ablation.

[0088] Continue reading Figure 7 and Fig.10 As shown, the distal tube body 1110 is sleeved with a distal fixing tube 1130, and the distal fixing tube 1130 includes a distal fixing segment 1131 and a proximal fixing segment 1132 connected along the axial direction, the diameter of the distal fixing segment 1131 is smaller than the diameter of the proximal fixing segment 1132, and the connecting position of the distal fixing segment 1131 and the proximal fixing segment 1132 forms a step structure.

[0089] The distal fixing section 1131 is sleeved inside the distal tube body 1110, so the entire distal fixing tube 1130 is also located in the balloon lumen of the balloon body 1100. The distal fixing tube 1130 is located in the balloon lumen of the balloon body 1100, and the guidewire introduction tube 2110 is located outside the distal end of the balloon body 1100, so that the distal fixing tube 1130 and the guidewire introduction tube 2110 are mutually avoided to avoid mutual interference, thereby increasing the reliability between the balloon body 1100 and the guidewire introduction tube 2110.

[0090] Continue reading Fig.11 As shown, the substrate 1210 may have a first electrical trace 1240 and a second electrical trace 1250. The substrate 1210 is connected to the first electrode 1220 via the first electrical trace 1240, and the substrate 1210 is connected to the second electrode 1230 via the second electrical trace 1250. In this case, the first electrical trace 1240 and the second electrical trace 1250 may also be distributed separately to reduce the insulation requirements of the substrate 1210 and reduce the cost. The two ends of the balloon body 1100 in the latitudinal direction are the distal end and the proximal end, respectively. At least one of the first electrical trace 1240 and the second electrical trace 1250 is connected to the proximal end of the balloon body 1100, and the proximal position of the balloon body 1100 may be connected to the electrical conductor at this location.

[0091] The substrate 1210 is a linear structure, so that the substrate 1210 can be arranged on the surface of the balloon body 1100 along the latitudinal direction of the balloon body 1100 based on the linear structure. The substrate 1210 is a flexible substrate 1210, and at least one of the first electrode 1220 and the second electrode 1230 is a flexible electrode sheet, so that the substrate 1210, the first electrode 1220 and the second electrode 1230 are directly attached to the surface of the balloon body 1100, and the structure is simpler. The substrate 1210 can adopt a single-layer plate structure instead of a conventional double-layer plate structure. The thickness of the substrate 1210 is reduced by the structural design of the single-layer plate, and it is more flexible and conformable.

[0092] The two ends of the balloon body 1100 in the latitudinal direction are the distal end and the proximal end, respectively. There is a spacing area between the distal end of the substrate 1210 and the distal end of the balloon body 1100, that is, when the electrode assembly 1200 (substrate 1210) is extended from the proximal end of the balloon body 1100 toward the distal end along the latitudinal direction, the electrode assembly 1200 (substrate 1210) will not extend to the distal end of the balloon body 1100, so that Figure 6 and Figure 7 As shown, an unconnected spacing region is formed between the distal end of the electrode assembly 1200 (substrate 1210 ) and the distal end of the balloon body 1100 , so that the electrode assembly 1200 does not completely cover the balloon body 1100 along the longitude.

[0093] The above-mentioned design structure can make the distal end of the electrode assembly 1200 not connected to the distal end of the balloon body 1100, so that the substrate 1210 of the electrode assembly 1200 does not affect the size of the distal end of the balloon body 1100 (does not increase the size of the distal end), and also does not affect the flexibility of the balloon body 1100. Therefore, it can be ensured that the size and hardness of the distal end of the balloon body 1100 are determined by the balloon body 1100 (or the balloon body 1100 and other matching structures together), and are kept at a small size level and high flexibility, avoiding the substrate 1210 of the electrode assembly 1200 from affecting its size level and flexibility.

[0094] At least one of the first electrode 1220 and the second electrode 1230 is a ring structure with a hollow inner ring, for example Figure 6As shown, the first electrode 1220 or the second electrode 1230 can be designed as a ring electrode, and the shape of the ring can be designed according to actual needs, so that the first electrode 1220 or the second electrode 1230 has an inner ring inside, which is used to form the hollow inner ring mentioned above. Among them, the maximum width of the first electrode 1220 gradually increases from the distal end to the proximal end, for example, the first electrode 1220 can be roughly triangular. The maximum width of the second electrode 1230 first gradually increases and then gradually decreases from the distal end to the proximal end, for example, the second electrode 1230 can be roughly rugby-shaped. The surface area of ​​the first electrode 1220 is smaller than that of the second electrode 1230, so as to increase the glue coating area of ​​the second electrode 1230 and improve the adhesion of the second electrode 1230 to the surface of the balloon body 1100.

[0095] Since a hollow inner ring is provided in the middle of the first electrode 1220 or the second electrode 1230, when the first electrode 1220 or the second electrode 1230 is fixed to the balloon body 1100 by means of glue, the glue can be applied to the outer periphery of the first electrode 1220 or the second electrode 1230, and the glue can also be applied to the inner periphery of the hollow inner ring of the first electrode 1220 or the second electrode 1230, and a portion of glue overflow is formed. This glue fixing method of applying glue to both the inner and outer peripheries can improve the firmness of the first electrode 1220 or the second electrode 1230 on the balloon body 1100. At the same time, the annular structure of the first electrode 1220 or the second electrode 1230 can reduce the surface area of ​​the electrode. Under the same voltage, reducing the surface area of ​​the electrode increases the current density and the electric field strength, which can improve the treatment effect.

[0096] See also Figure 3 , Figure 4 As shown, in one embodiment, the catheter assembly 2000 includes a first tube body 2100, a second tube body 2200 and a third tube body 2300. The first tube body 2100, the second tube body 2200 and the third tube body 2300 are all hollow tube bodies, and the inner diameters of the first tube body 2100, the second tube body 2200 and the third tube body 2300 increase sequentially.

[0097] The interior of the first tube body 2100 is configured to form a guidewire cavity. A guidewire introduction tube 2110 is disposed at the distal end of the first tube body 2100. The inner cavity of the guidewire introduction tube 2110 is connected to the guidewire cavity formed inside the first tube body 2100, and the diameter of the guidewire introduction tube 2110 gradually increases from the proximal end to the distal end, for example, as shown in FIG. Figure 3The trumpet-shaped guidewire introduction tube 2110 is convenient for the insertion of the guidewire, so that the guidewire can quickly and smoothly enter the guidewire cavity inside the first tube body 2100. Moreover, the farthest end of the medical balloon 1000 does not exceed the farthest end of the guidewire introduction tube 2110 in the axial direction of the catheter assembly 2000 and in the direction toward the far end, that is, the medical balloon 1000 does not exceed the farthest end of the guidewire introduction tube 2110 whether it is filled or not filled.

[0098] The material of the first tube body 2100 can be polyimide material, and the inner diameter of the first tube body 2100 can be set between 0.8 mm and 1.4 mm. The material of the second tube body 2200 can be nylon or pebax polymer (block polyetheramide resin, pebax is the trade name determined by the French ATOFINA company for its block polyetheramide resin product), and the inner diameter of the second tube body 2200 can be set between 1.2 mm and 2.4 mm. The material of the third tube body 2300 can be Pebax polymer or Pebax metal braided tube material, and the inner diameter of the third tube body 2300 can be set between 2.6 mm and 4.5 mm.

[0099] In one embodiment, the distal fixing tube 1130 can be sleeved on the first tube 2100, the distal tube portion 1110 of the balloon main body 1100 is sleeved on the distal fixing segment 1131 of the distal fixing tube 1130, and the distal end of the distal tube portion 1110 can be axially limited based on the guide wire introduction tube 2110, and the proximal end of the distal tube portion 1110 can be axially limited based on the step structure formed between the distal fixing segment 1131 and the proximal fixing segment 1132 on the distal fixing tube 1130. Preferably, the distal fixing segment 1131 of the distal fixing tube 1130 can be sleeved inside the distal tube portion 1110, and the proximal fixing segment 1132 of the distal fixing tube 1130 can be sleeved outside the distal end of the second tube 2200. The balloon body 1100 can be fixed to the distal fixing section 1131 of the distal fixing tube 1130 by gluing or other means. The distal end of the balloon body 1100, the first tube body 2100, and the distal fixing tube 1130 are relatively fixed. The axial movement of the first tube body 2100 can drive the balloon body 1100 to change its structural state.

[0100] The second tube body 2200 is sleeved on the outside of the first tube body 2100, and a first inter-tube channel is formed between the outer tube wall of the first tube body 2100 and the inner tube wall of the second tube body 2200. The first inter-tube channel is an annular gap channel formed between the outer tube wall of the first tube body 2100 and the inner tube wall of the second tube body 2200 based on the sleeve relationship, which is used to inject liquid into the balloon lumen of the balloon body 1100 to fill it. The second tube body 2200 is provided with a discharge hole connected to the first inter-tube channel. The second tube body 2200 is penetrated in the balloon lumen of the balloon body 1100, and the discharge hole is located in the balloon lumen of the balloon body 1100, which can be used to inject liquid into the balloon lumen of the balloon body 1100. The distal ends of the first tube body 2100 and the second tube body 2200 extend from the distal tube body portion 1110 of the balloon body 1100.

[0101] For example, the number of discharge holes is configured to be several, and the several discharge holes are distributed in a spiral form along the circumference and axial direction of the second tube body 2200. The spiral distribution can improve the efficiency of filling and draining the balloon body 1100, and shorten the operation waiting time. At the same time, the second tube body 2200 is also provided with an injection hole connected to the first tube layer channel, and the injection hole is located outside the balloon lumen of the balloon body 1100. At this time, liquid can be injected into the first tube layer channel through the injection hole, so as to inject liquid into the balloon lumen of the balloon body 1100 from the discharge hole.

[0102] The third tube body 2300 is sleeved on the outside of the second tube body 2200, and the third tube body 2300 is used to provide support. A second inter-tube layer channel is formed between the outer tube wall of the second tube body 2200 and the inner tube wall of the third tube body 2300. The second inter-tube layer channel is an annular gap channel formed between the outer tube wall of the second tube body 2200 and the inner tube wall of the third tube body 2300 based on the sleeve relationship, and is used to pass the electrical wire connected to the electrode assembly 1200. The inner cavity of the first tube body 2100 is configured as a guide wire channel, which is used to pass the guide wire to guide the pulse balloon ablation catheter into the target tissue.

[0103] In one embodiment, the second tube body 2200 includes a distal tube segment 2210, an intermediate tube segment 2220, and a proximal tube segment 2230. The distal end of the intermediate tube segment 2220 is connected to the proximal end of the distal tube segment 2210, and the distal end of the proximal tube segment 2230 is connected to the proximal end of the intermediate tube segment 2220. The intermediate tube segment 2220 has a deformable ability, and the distal tube segment 2210 can at least move axially relative to the proximal tube segment 2230 based on the deformable ability of the intermediate tube segment 2220. The distal tube segment 2210 and the proximal tube segment 2230 are made of the same material, and the two ends of the intermediate tube segment 2220 can be connected to the ends of the distal tube segment 2210 and the proximal tube segment 2230 respectively by welding, gluing, etc. For example, the distal tube segment 2210 and the proximal tube segment 2230 can be divided from the same tube body, and then the intermediate tube segment 2220 is connected between the two divided tube segments. At this time, the balloon body 1100 can be fixed to the second tube body 2200 by welding, gluing, etc., so that the distal end of the balloon body 1100 can be connected to the distal end of the distal tube segment 2210, and the proximal end of the balloon body 1100 can be connected to the proximal tube segment 2230, thereby wrapping the middle tube segment 2220 in the balloon inner cavity of the balloon body 1100.

[0104] In one embodiment, the middle tube section 2220 is a spring tube, which has elasticity, and can make the distal tube section 2210 move axially relative to the proximal tube section 2230 based on the elasticity of the spring tube. When the ablation catheter is used, it is necessary to retract or extend the outer sheath used in conjunction, and rotate the ablation catheter. The elasticity of the spring tube can be set according to the use requirements. Based on the elasticity of the spring tube, the balloon body 1100 can be more tightly contracted and more smoothly retreated into the outer sheath during the process of retracting and extending the outer sheath. Moreover, a gap can also be formed when the spring tube is axially extended and retracted, thereby playing the function of filling the discharge hole and ensuring the circulation of the liquid.

[0105] The first tube body 2100 is connected to the distal tube segment 2210 of the second tube body 2200. Therefore, the ablation catheter in the contained state (the medical balloon 1000 is in an unfilled contracted state) is introduced through the proximal end of the matching outer sheath tube. After being led out from the distal end of the outer sheath tube, the first tube body 2100 can be controlled to move in the proximal direction, thereby driving the distal tube segment 2210 of the second tube body 2200 to stretch from the distal end to the proximal end. At this time, the middle tube segment 2220 is compressed, so that the distal tube segment 2210 moves axially relative to the proximal tube segment 2230, thereby changing the state of the balloon body 1100. At the same time, liquid can be injected into the balloon inner cavity of the balloon body 1100 through the first tube interlayer channel, so that the balloon body 1100 is in an expanded state after being filled, and the expanded balloon body 1100 is close to the target tissue for pulse ablation. It should be noted that if the second tube body 2200 does not include the distal tube segment 2210, the middle tube segment 2220 and the proximal tube segment 2230, liquid can be injected into the balloon inner cavity of the balloon body 1100 only through the first tube layer interlayer channel, so that the balloon body 1100 is in an expanded state after being filled.

[0106] After pulse ablation is completed, liquid is extracted through the first tube interlayer channel, and the balloon body 1100 is no longer filled. At this time, the first tube body 2100 is released, eliminating the force on the middle tube section 2220, so that the middle tube section 2220 is no longer compressed by force, and the compressed state is restored to a free state. Under the elastic force of this recovery process, the previously changed balloon body 1100 will be axially stretched again and restored to a longer balloon shape. At this time, the electrode assembly 1200 will also be straightened as the shape of the balloon body 1100 changes. When being received in the outer sheath tube, several electrode assemblies 1200 will not be staggered to increase the outer diameter of the balloon body 1100, and will not hinder the reception into the outer sheath tube, making it convenient to receive.

[0107] The control handle 3000 is used to control and connect with the catheter assembly 2000. For example, the control handle 3000 can be used to at least control the relative movement between the first tube body 2100 and the second tube body 2200 of the catheter assembly 2000. The control handle 3000 can adopt a variety of mechanical drive forms, such as gear drive, motor drive, screw drive and other suitable drive modes.

[0108] In one embodiment, the control handle 3000 may include a handle base, a sliding button 3100, a sliding element 3200, and a telescopic tube 3300 disposed on the handle base. Fig.14As shown, the sliding button 3100 is connected to the sliding element 3200, and the sliding element 3200 can be a block structure. The sliding button 3100 can drive the handle base of the sliding element 3200 to slide along the axial direction of the handle base, for example, by a slide groove or a slide rail set on the handle base. The telescopic tube body 3300 is retractable, for example, a foldable water pipe can be used. The telescopic tube body 3300 can be connected to the sliding element 3200, so that when the sliding button 3100 drives the sliding element 3200 to change its position, the stability of the connection with the first tube layer channel is ensured to ensure that there is no water leakage.

[0109] The distal end of the third tube 2300 is configured to be connected to the proximal tube portion 1120 provided at the proximal end of the balloon body 1100, wherein there is a gap between the proximal tube portion 1120 of the balloon body 1100 and the third tube 2300, and the proximal end of the balloon body 1100 is provided with a proximal tube portion 1120 of the balloon body 1100. Fig.12 and Fig.13 The proximal transition tube 1140 shown is disposed between the proximal tube body portion 1120 of the balloon body 1100 and the third tube body 2300 , and is configured to shield the gap between the balloon body 1100 and the third tube body 2300 .

[0110] The gap between the balloon body 1100 and the third tube body 2300 mentioned above is used to electrically connect the electrode assembly 1200 of the balloon body 1100 to the control handle 3000 and the external ablation instrument through the second tube layer channel between the second tube body 2200 and the third tube body 2300. At this time, the proximal transition tube 1140 can be used to shield the gap between the balloon body 1100 and the third tube body 2300, mainly used to increase the connection strength between the balloon body 1100, the electrical wire and the third tube body 2300, and at the same time play a role in aesthetics and protection of electrical connection.

[0111] In the gap shielded by the proximal transition tube 1140, the positive and negative conductors of the electrical conductors can be arranged in layers, that is, all positive conductors are connected to the same layer, and all negative conductors are connected to another layer, and the two layers are separated by an insulating material to increase the insulating gap. In this embodiment, the substrate 1210 and the first and second electrical traces 1240 and 1250 thereon do not extend into the third tube body 2300.

[0112] In one embodiment, the proximal transition tube 1140 includes a distal transition section 1141 and a proximal transition section 1142 connected along the axial direction, the distal transition section 1141 is sleeved on the distal tube body portion 1110, the diameter of the distal transition section 1141 is larger than the diameter of the proximal transition section 1142, and the connected position of the distal transition section 1141 and the proximal transition section 1142 forms a step structure, the distal transition section 1141 is sleeved on the outside of the proximal tube body portion 1120 of the balloon body 1100, and the proximal transition section 1142 is penetrated into the interior of the third tube body 2300, thereby being configured to shield the gap between the balloon body 1100 and the third tube body 2300.

[0113] At this time, a flexible electrode assembly 1200 can also pass through between the distal transition section 1141 of the proximal transition tube 1140 and the proximal tube body portion 1120 of the balloon body 1100, and a wire through-hole 1143 is provided in the distal transition section 1141. The wire through-hole 1143 can be used to allow the flexible electrode assembly 1200 to pass through between the distal transition section 1141 of the proximal transition tube 1140 and the proximal tube body portion 1120 of the balloon body 1100 and penetrate into the second inter-tube layer channel between the second tube body 2200 and the third tube body 2300 through the wire through-hole 1143.

[0114] In addition, the substrate 1210 and the first electrical trace 1240 and the second electrical trace 1250 thereon can also be extended into the third tube 2300 and all the way to the control handle 3000, and then welded with the enameled wire to avoid welding at the proximal end of the balloon body 1100, reduce the process difficulty, and facilitate wiring. Those skilled in the art can set a suitable design scheme according to actual needs, which is not limited here.

[0115] In one embodiment, the first tube body 2100 includes at least two unit tube segments, and several unit tube segments are sequentially connected along the axial direction of the first tube body 2100 to form the first tube body 2100, wherein at least two unit tube segments have different hardnesses, for example, at least two unit tube segments can be made of tubes with different hardnesses. In one embodiment, the hardness of several unit tube segments can gradually increase from the distal end to the proximal end of the first tube body 2100, so as to provide a certain degree of bending through the unit tube segment at the distal end, ensure the hardness of the unit tube segment at the proximal end, and provide good controllability and torsion transmission. At least a part of the tube segment of the third tube body 2300 has a bending function. A braided layer is arranged on the outside of the third tube body 2300 to improve the hardness of the third tube body 2300 and improve the torsion transmission of the third tube body 2300.

[0116] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described 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.

[0117] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A medical balloon, characterized in that: The medical balloon comprises: A balloon body, wherein the balloon body has longitude and latitude, and the two ends of the balloon body in the latitude direction are respectively a distal end and a proximal end, the distal end of the balloon body is provided with a distal through hole, and the proximal end of the balloon body is provided with a proximal through hole, and the distal through hole and the proximal through hole of the balloon body are both connected to the balloon inner cavity of the balloon body; An electrode assembly, wherein the number of the electrode assemblies is configured to be several, and the several electrode assemblies are distributed on the surface of the balloon body along the longitudinal direction of the balloon body, wherein the electrode assembly includes a substrate, a first electrode and a second electrode, the first electrode and the second electrode are both connected to the substrate, and the width of at least one of the first electrode and the second electrode decreases with the increase of the latitude of the balloon body, the first electrode and the second electrode are staggered on the substrate along the longitudinal direction, and there is a spacing area between the distal end of the substrate and the distal end of the balloon body.

2. The medical balloon according to claim 1, characterized in that: A distal tube body portion is provided at the distal end of the balloon body, the distal tube body portion is located in the balloon inner cavity of the balloon body, and the distal end of the distal tube body portion is connected to the distal through hole of the balloon body; and / or, A proximal tube body portion is disposed at the proximal end of the balloon body, the proximal tube body portion is located outside the balloon inner cavity of the balloon body, and the distal end of the proximal tube body portion is connected to the proximal through hole of the balloon body; and / or, The first electrode and the second electrode of the electrode assembly are located at different latitudes of the balloon body; and / or, The polarities of the first electrode and the second electrode of the electrode assembly are the same or different; and / or, The substrate is arranged on the surface of the balloon body along the latitudinal direction of the balloon body, and a chamfer structure is arranged on at least a portion of the plate edge of the substrate; and / or, The substrate is a flexible substrate; and / or, A first electrical trace and a second electrical trace are disposed on the substrate, the first electrical trace is connected to the first electrode, the second electrical trace is connected to the second electrode, and at least one of the first electrical trace and the second electrical trace is connected to the proximal end of the balloon body; and / or, At least one of the first electrode and the second electrode is a ring structure with a hollow inner circle; wherein the maximum width of the first electrode gradually increases from the distal end to the proximal end; the maximum width of the second electrode first gradually increases and then gradually decreases from the distal end to the proximal end; and / or, The latitude of the first electrode in the balloon body is higher than the latitude of the second electrode in the balloon body, the area occupied by the first electrode on the surface of the balloon body is smaller than the area occupied by the second electrode on the surface of the balloon body, and the coating area of ​​the first electrode is smaller than the coating area of ​​the second electrode; and / or, The number of the electrode assemblies is configured to be 6 to 24; and / or, The electrode assemblies are evenly spaced along the longitudinal direction of the balloon body.

3. The medical balloon according to claim 2, characterized in that: The balloon body, the distal tube portion and the proximal tube portion are configured as an integrally formed structure; and / or, The distal tube body is sleeved with a distal fixing tube, and the distal fixing tube includes a distal fixing section and a proximal fixing section connected along the axial direction, the distal fixing section is sleeved inside the distal tube body, the diameter of the distal fixing section is smaller than the diameter of the proximal fixing section, and the connecting position of the distal fixing section and the proximal fixing section forms a step structure; and / or, The first electrode and the second electrode of the electrode assembly are disposed on opposite sides of the substrate along the longitudinal direction; and / or, The polarities of the first electrode and the second electrode of the electrode assembly are the same, and the polarities of the electrode assemblies adjacent to each other in the longitudinal direction are different.

4. An ablation catheter, characterized in that: The ablation catheter comprises: A catheter assembly, the catheter assembly comprising a first tube body, a second tube body and a third tube body, the interior of the first tube body being configured to form a guidewire cavity, the second tube body being sleeved on the outside of the first tube body, a first inter-tube layer channel being formed between an outer tube wall of the first tube body and an inner tube wall of the second tube body, the second tube body being provided with a discharge hole connected to the first inter-tube layer channel, the second tube body being passed through the balloon inner cavity of the balloon body, the discharge hole being located in the balloon inner cavity of the balloon body, the third tube body being sleeved on the outside of the second tube body, a second inter-tube layer channel being formed between an outer tube wall of the second tube body and an inner tube wall of the third tube body; The medical balloon according to any one of claims 1-3, wherein the medical balloon is connected to the catheter assembly.

5. The ablation catheter according to claim 4, characterized in that: A guidewire introduction tube is provided at the distal end of the first tube body, the inner cavity of the guidewire introduction tube is connected to the guidewire cavity formed inside the first tube body, and the diameter of the guidewire introduction tube gradually increases from the proximal end to the distal end; and / or, The second tube body includes a distal tube segment, an intermediate tube segment and a proximal tube segment, the distal tube segment is connected to the distal end of the balloon body, the distal end of the intermediate tube segment is connected to the proximal end of the distal tube segment, the distal end of the proximal tube segment is connected to the proximal end of the intermediate tube segment, the intermediate tube segment is located in the balloon inner cavity of the balloon body, the intermediate tube segment has deformation ability, and the distal tube segment can at least move axially relative to the proximal tube segment based on the deformation ability of the intermediate tube segment.

6. The ablation catheter according to claim 5, characterized in that: The most distal end of the medical balloon does not exceed the most distal end of the guidewire introduction tube in the axial direction of the catheter assembly and in the distal direction; and / or, The intermediate tube section is a spring tube; and / or, The first tube body is connected to the distal end section of the second tube body.

7. The ablation catheter according to claim 4, characterized in that: The distal end of the third tube body is configured to be connected to a proximal tube body portion arranged at the proximal end of the balloon body, wherein there is a gap between the proximal tube body portion of the balloon body and the third tube body, and a proximal transition tube is arranged at the proximal end of the balloon body, and the proximal transition tube is arranged between the proximal tube body portion of the balloon body and the third tube body, and the proximal transition tube is configured to shield the gap between the balloon body and the third tube body.

8. The ablation catheter according to claim 7, characterized in that: The proximal transition tube includes a distal transition section and a proximal transition section connected along the axial direction, the distal transition section is sleeved on the distal tube body portion, the diameter of the distal transition section is larger than the diameter of the proximal transition section, the connecting position of the distal transition section and the proximal transition section forms a step structure, the distal transition section is sleeved on the outside of the proximal tube body portion of the balloon body, and the proximal transition section is penetrated into the interior of the third tube body, thereby being configured to shield the gap between the balloon body and the third tube body; Wherein, the distal transition section is provided with a wire through-hole.

9. The ablation catheter according to claim 4, characterized in that: The first tube body comprises at least two unit tube segments, and a plurality of the unit tube segments are sequentially connected along the axial direction of the first tube body to form the first tube body, wherein at least two of the unit tube segments have different hardnesses; and / or, The number of the discharge holes is configured to be multiple, and the multiple discharge holes are distributed in a spiral form along the circumference and axial direction of the second tube body; and / or, The second tube body is provided with an injection hole connected to the first tube layer inter-channel, and the injection hole is located outside the balloon inner cavity of the balloon body; and / or, At least a portion of the third tube body has a bending function; and / or, A braided layer is arranged outside the third tube body.

10. The ablation catheter according to claim 9, characterized in that: The hardness of the plurality of unit tube segments gradually increases from the distal end to the proximal end of the first tube body.

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