Medical balloon and ablation catheter

Abstract

The invention provides a medical balloon and an ablation catheter, and relates to the technical field of medical instruments.A balloon body has longitude and latitude, the number of electrode assemblies is multiple, the electrode assemblies are distributed on the surface of the balloon body in the longitude direction of the balloon body, each electrode assembly comprises a base plate, a first electrode and a second electrode, and the first electrode and the second electrode are arranged on the base plate. 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 the increase of the latitude of the balloon main body, and a spacing area is arranged between the far end of the substrate and the far end of the balloon main 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, the balloon body having a longitude and a latitude;

[0008] An electrode assembly, wherein the number of the electrode assemblies is configured as a plurality of electrode assemblies, and the plurality of 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 as the latitude of the balloon body increases, the two ends of the balloon body in the latitudinal direction are respectively a distal end and a proximal end, 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, the first electrode and the second electrode of the electrode assembly are staggered on the substrate along the longitudinal direction; and / or,

[0010] The first electrode and the second electrode of the electrode assembly are located at different latitudes of the balloon body; and / or,

[0011] The polarities of the first electrode and the second electrode of the electrode assembly are the same or different; and / or,

[0012] The substrate is a linear structure, and the substrate is arranged on the surface of the balloon body along the latitudinal direction of the balloon body; and / or,

[0013] The substrate is a flexible substrate; and / or,

[0014] The substrate has a first electrical trace and a second electrical trace, the substrate is connected to the first electrode via the first electrical trace, the substrate is connected to the second electrode via the second electrical trace, 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,

[0015] At least one of the first electrode and the second electrode is a ring structure having a hollow inner circle; and / or,

[0016] The latitude of the first electrode in the balloon body is higher than the latitude of the second electrode in the balloon body, and 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 / or,

[0017] The number of the electrode assemblies is configured to be 6 to 24; and / or,

[0018] The electrode assemblies are evenly spaced along the longitudinal direction of the balloon body.

[0019] In one embodiment, 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,

[0020] 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.

[0021] The present application provides an ablation catheter, the ablation catheter comprising:

[0022] 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;

[0023] The medical balloon is connected to the catheter assembly.

[0024] In one embodiment, the second tube comprises:

[0025] A distal tube segment, the distal tube segment being connected to the distal end of the balloon body;

[0026] an intermediate pipe section, wherein the distal end of the intermediate pipe section is connected to the proximal end of the distal pipe section;

[0027] A proximal tube segment, wherein the distal end of the proximal tube segment is connected to the proximal end of the middle tube segment;

[0028] The middle tube segment is located in the balloon inner cavity of the balloon body, and the middle tube segment has deformation capability. The distal tube segment can at least axially move relative to the proximal tube segment based on the deformation capability of the middle tube segment.

[0029] In one embodiment, the intermediate tube section is a spring tube; and / or,

[0030] The first tube body is connected to the distal end section of the second tube body; and / or,

[0031] A distal filling tube is arranged at the distal end of the balloon body, a proximal filling tube is arranged at the proximal end of the balloon body, the distal tube section is connected to the distal filling tube, the proximal tube section is connected to the proximal filling tube, and the proximal filling tube is used to fill the distal channel opening of the second tube interlayer channel; and / or,

[0032] A distal cap is disposed at the distal end of the first tube body and the distal end of the second tube body, and the distal cap is used for sealing and connecting the distal ends of the first tube body and the second tube body.

[0033] In one embodiment, there is a gap between the balloon body and the third tube body, and a transition tube is provided at the proximal end of the balloon body. The transition tube is located between the proximal end of the balloon body and the third tube body, and the transition tube is configured to shield the gap between the balloon body and the third tube body.

[0034] 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,

[0035] 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,

[0036] 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,

[0037] At least a portion of the third tube body has a bending function; and / or,

[0038] A braided layer is arranged outside the third tube body.

[0039] 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.

[0040] In one embodiment, the ablation catheter comprises:

[0041] A control handle, the control handle comprising a handle base and a sliding button, a limiting tooth, a sliding element, a sliding groove and a telescopic tube body arranged on the handle base; the sliding element is slidably assembled in the sliding groove; the sliding button and the sliding element are elastically connected to limit the elastic limiting engagement between the sliding button and the limiting tooth; the telescopic tube body is connected to the sliding element, wherein the sliding element is connected to one of the first tube body and the second tube body of the catheter assembly, and is used to control the relative movement between the first tube body and the second tube body.

[0042] 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

[0043] Figure 1 A three-dimensional schematic diagram of an ablation catheter provided in accordance with an embodiment of the present application.

[0044] Figure 2 For Figure 1 An exploded view of the ablation catheter is shown.

[0045] Figure 3 For Figure 2 A partially enlarged schematic diagram of the ablation catheter is shown.

[0046] Figure 4 For Figure 1 A partially enlarged schematic diagram of the ablation catheter is shown.

[0047] Figure 5 For Figure 4 An axial cross-sectional view of an ablation catheter is shown.

[0048] Figure 6 A schematic diagram of the structure of an electrode assembly provided in one embodiment of the present application.

[0049] Figure 7 A schematic diagram of the first state connection between the balloon body and the electrode assembly provided in one embodiment of the present application.

[0050] Figure 8 For Figure 7 An axial cross-sectional view of an ablation catheter is shown.

[0051] Fig. 9 A schematic diagram of the second state connection of the balloon body and the electrode assembly provided in one embodiment of the present application.

[0052] Figure Number:

[0053] 1000, medical balloon; 2000, catheter assembly; 3000, control handle;

[0054] 1100, balloon body; 1200, electrode assembly;

[0055] 1210, substrate; 1220, first electrode; 1230, second electrode; 1240, first electrical trace; 1250, second electrical trace;

[0056] 2100, first tube body; 2200, second tube body; 2300, third tube body; 2400, distal filling tube; 2500, proximal filling tube; 2600, transition tube; 2700, distal cap;

[0057] 2210, distal pipe section; 2220, middle pipe section; 2230, proximal pipe section;

[0058] 3100, sliding button; 3200, limiting tooth; 3300, sliding element; 3400, sliding groove; 3500, telescopic tube body. DETAILED DESCRIPTION

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] In order to more clearly describe the medical balloon and the ablation catheter, the term "distal end" is defined here to mean the end away from the operator during the surgical operation, and the term "proximal end" is defined here to mean the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by technicians in the technical field of this application. The terms used in this application in the specification are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0066] The present application provides an ablation system, which includes an outer sheath tube and an ablation catheter. The ablation catheter can be movably arranged in the inner cavity of the outer sheath tube. The outer sheath tube 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.

[0067] See also Figures 6 to 9As shown, the present application provides a medical balloon 1000, which includes 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.

[0068] When the balloon body 1100 is in an expanded state, it presents a spherical structure. Therefore, in order to conveniently introduce the distribution of the electrode assembly 1200 on the balloon body 1100, the balloon body 1100 can be defined as having longitude and latitude. The balloon body 1100 can have several longitudes in the longitude direction, and the balloon body 1100 can have several latitudes in the latitude direction, which can 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.

[0069] The electrode assembly 1200 is configured as a flexible electrode assembly 1200, see Figure 6 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.

[0070] 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 6The 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] In one embodiment, if Figure 6 As 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.

[0075] Meanwhile, 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, thereby reducing the insulation requirements of the substrate 1210 and reducing 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 end of the balloon body 1100 may be connected to the electrical conductor at this location.

[0076] 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.

[0077] 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.

[0078] 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 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.

[0079] 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.

[0080] 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 described above, the first electrode 1220 or the second electrode 1230 can be designed as an annular electrode, and the annular shape 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. Since the hollow inner ring is set 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 in which glue is applied to both the inner periphery and the outer periphery 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, the surface area of ​​the electrode is reduced, the current density is increased, the electric field strength is increased, and the treatment effect can be improved.

[0081] See also Figure 2 , Figure 3 as well as Figure 8 and Fig. 9 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 in sequence. 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 0.8mm and 1.4mm. 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 1.2mm and 2.4mm. 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.

[0082] The second tube body 2200 is sleeved on the outside of the first tube body 2100, and a first inter-tube layer 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 layer 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, and is used to inject liquid into the inner cavity of the balloon 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 layer channel, and the second tube body 2200 is penetrated in the inner cavity of the balloon of the balloon body 1100. The discharge hole is located in the inner cavity of the balloon of the balloon body 1100, and can be used to inject liquid into the inner cavity of the balloon of the balloon body 1100.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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 methods. In one embodiment, the control handle 3000 may include a handle base and a sliding button 3100, a limit tooth 3200, a sliding element 3300, a sliding groove 3400 and a telescopic tube 3500 disposed on the handle base. See FIG. Figure 5As shown, the sliding button 3100 and the sliding element 3300 can be connected by a spring, the sliding element 3300 can be a block structure, the sliding groove 3400 can be a linear groove, the sliding button 3100 can drive the sliding element 3300 to slide in the sliding groove 3400, and at the same time, the sliding button 3100 and the limiting tooth 3200 can be limited by the elastic force of the spring. When the sliding button 3100 is pressed, the sliding element 3300 can be driven to slide, and after the sliding button 3100 is released, the sliding button 3100 can be limited and fixed by the limiting tooth 3200 under the elastic force of the spring. The telescopic tube body 3500 is retractable, for example, a foldable water pipe can be used, and the telescopic tube body 3500 can be connected to the sliding element 3300, so that when the sliding button 3100 drives the sliding element 3300 to change position, the stability of the connection with the first tube layer channel is ensured to ensure watertightness.

[0090] The distal end of the balloon body 1100 is provided with a distal filling tube 2400 by bonding, forging, etc., and the proximal end of the balloon body 1100 is provided with a proximal filling tube 2500 by bonding, forging, etc., the distal tube section 2210 is connected to the distal filling tube 2400, and the proximal tube section 2230 is connected to the proximal filling tube 2500, and the proximal filling tube 2500 is used to fill the distal channel opening of the second tube interlayer channel. Since the filled balloon body 1100 has expansion stress, there is a risk of falling off when the balloon body 1100 is fixed only by a single adhesive, so the setting of the distal filling tube 2400 and the proximal filling tube 2500 can increase the fixation reliability. Moreover, the gap (diameter) between the second tube body 2200 and the third tube body 2300 is relatively large, and the thickness of the balloon body 1100 is not enough to fill the gap between the second tube body 2200 and the third tube body 2300. Therefore, a distal filling tube 2400 and a proximal filling tube 2500 are provided, and both ends of the balloon body 1100 can be bonded and fixed to the distal filling tube 2400 and the proximal filling tube 2500 to increase the thickness.

[0091] A transition tube 2600 is disposed at the proximal end of the balloon body 1100, wherein the transition tube 2600 is located between the proximal end of the balloon body 1100 and the third tube body 2300, and Fig. 9As shown, there is still a gap, which 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 transition tube 2600 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. Among them, at the gap shielded by the transition tube 2600, the positive and negative wires of the electrical wires can be arranged in layers, that is, all positive wires are connected to the same layer, all negative wires are connected to another layer, and the two layers are separated by an insulating material, which increases 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.

[0092] 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.

[0093] The distal end of the balloon body 1100 has a distal port, the proximal end of the balloon body 1100 has a proximal port, the first tube body 2100 and the second tube body 2200 are inserted into the balloon lumen of the balloon body 1100, and the distal ends of the first tube body 2100 and the second tube body 2200 extend from the distal port of the balloon body 1100, and the distal ends of the first tube body 2100 and the second tube body 2200 are provided with a distal cap 2700, and the distal cap 2700 is used to seal and connect the distal ends of the first tube body 2100 and the second tube body 2200. The surface of the distal cap 2700 is smooth, and when the ablation catheter is extended into the target tissue, the smooth surface can avoid damaging other tissues. The proximal end of the inner surface of the distal cap 2700 may be provided with micro-teeth. During the installation process, the micro-teeth can maintain coaxiality with the balloon body 1100 and the catheter assembly 2000. The micro-teeth can also increase the glue capacity space to ensure that the distal cap 2700 can be more firmly and reliably bonded to the distal ends of the first tube body 2100 and the second tube body 2200.

[0094] 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.

[0095] 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.

[0096] 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, the balloon body having a longitude and a latitude; An electrode assembly, wherein the number of the electrode assemblies is configured as a plurality of electrode assemblies, and the plurality of 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 as the latitude of the balloon body increases, the two ends of the balloon body in the latitudinal direction are respectively a distal end and a proximal end, 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: The first electrode and the second electrode of the electrode assembly are staggered on the substrate along the longitudinal direction; 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 a linear structure, and the substrate is arranged on the surface of the balloon body along the latitudinal direction of the balloon body; and / or, The substrate is a flexible substrate; and / or, The substrate has a first electrical trace and a second electrical trace, the substrate is connected to the first electrode through the first electrical trace, the substrate is connected to the second electrode through the second electrical trace, 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; 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, and 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 / 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 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: The second tube body comprises: A distal tube segment, the distal tube segment being connected to the distal end of the balloon body; an intermediate pipe section, wherein the distal end of the intermediate pipe section is connected to the proximal end of the distal pipe section; A proximal tube segment, wherein the distal end of the proximal tube segment is connected to the proximal end of the middle tube segment; The middle tube segment is located in the balloon inner cavity of the balloon body, and the middle tube segment has deformation capability. The distal tube segment can at least axially move relative to the proximal tube segment based on the deformation capability of the middle tube segment.

6. The ablation catheter according to claim 5, characterized in that: The middle tube section is a spring tube; and / or, The first tube body is connected to the distal end section of the second tube body; and / or, A distal filling tube is arranged at the distal end of the balloon body, and a proximal filling tube is arranged at the proximal end of the balloon body. The distal tube section is connected to the distal filling tube, and the proximal tube section is connected to the proximal filling tube. The proximal filling tube is used to fill the distal channel opening of the second tube interlayer channel. and / or, A distal cap is disposed at the distal end of the first tube body and the distal end of the second tube body, and the distal cap is used for sealing and connecting the distal ends of the first tube body and the second tube body.

7. The ablation catheter according to claim 4, characterized in that: There is a gap between the balloon body and the third tube body. A transition tube is arranged at the proximal end of the balloon body. The transition tube is located between the proximal end of the balloon body and the third tube body. The transition tube is configured to shield the gap between the balloon body and the third tube body.

8. 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.

9. The ablation catheter according to claim 8, 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.

10. The ablation catheter according to claim 3, characterized in that: The ablation catheter comprises: A control handle, the control handle comprising a handle base and a sliding button, a limiting tooth, a sliding element, a sliding groove and a telescopic tube body arranged on the handle base; the sliding element is slidably assembled in the sliding groove; the sliding button and the sliding element are elastically connected to limit the elastic limiting engagement between the sliding button and the limiting tooth; the telescopic tube body is connected to the sliding element, wherein the sliding element is connected to one of the first tube body and the second tube body of the catheter assembly, and is used to control the relative movement between the first tube body and the second tube body.

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