Balloon catheter

Abstract

The present invention relates to the field of electrophysiology catheters, and in particular relates to a balloon catheter. The balloon catheter comprises: an operation handle; a balloon electrode assembly, which comprises a balloon body and an electrode arranged on the surface of the balloon body; and an insertion tube, which is connected between the operation handle and the balloon electrode assembly and comprises an outer tube and an inner tube, the inner tube running through the outer tube, wherein the outer tube comprises a bending segment located on the distal end side, and the inner tube comprises a bending adaptation segment located on the distal end side, the bending adaptation segment being located within the bending segment; the bending adaptation segment is made of a rigid material and has a bendable structure that forms slots in the tube wall of the bending adaptation segment; and the inner tube further comprises a flexible sealing tube, which is located on the radial outer side of the bending adaptation segment and is used to prevent fluid in the inner tube from leaking from the slots. The present invention mainly solves the technical problem of inner tubes of balloon catheters being prone to collapsing and deforming in tortuous vascular pathways and thus failing to maintain the lumen shape.

Description

balloon catheter Technical Field

[0001] This invention relates to the field of electrophysiological catheters, and more specifically to a balloon-type catheter. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, and its incidence gradually increases with age. Currently, catheter ablation has become an important treatment for AF. Pulsed electric field ablation is a novel tissue ablation technique based on physical energy factors that has emerged in recent years. It mainly utilizes the principle of irreversible electroporation, applying a high-voltage pulsed electric field to cells to cause irreversible perforation of the cell membrane, leading to gradual cell necrosis and ultimately achieving tissue ablation.

[0003] Pulsed electric field ablation can be achieved using a balloon-type catheter. A balloon-type catheter generally includes an operating handle, an insertion tube, and a balloon electrode assembly. The insertion tube is connected to the distal end of the operating handle; the balloon electrode assembly is connected to the distal end of the insertion tube. The balloon electrode assembly includes a balloon body and a flexible circuit board. The balloon body is inflatable and deflateable, providing support and positioning for the flexible circuit board. The flexible circuit board is attached to the balloon body and has electrode pads on it, which are used to generate a pulsed electric field.

[0004] In some related technologies, the insertion cannula of a balloon catheter may include an outer tube and an inner tube. The outer tube comprises a support segment, a bending segment, and a balloon body connecting tube, connected sequentially from proximal to distal. The support segment can withstand push-pull forces and torque to facilitate the delivery of the insertion cannula; the bending segment can be bent to adjust the posture of the balloon electrode assembly; and the balloon body connecting tube connects to the balloon body and serves as a transition. The inner tube passes through the lumen of the outer tube and can move axially within the lumen of the outer tube, providing support and adjustment for the balloon electrode assembly. In some cases, the inner tube can form a fluid channel, allowing fluid to enter and exit the balloon to achieve balloon inflation and deflation. To accommodate the bending requirements of the bending segment, the inner tube can be made of polymer materials to achieve a certain degree of flexibility. However, for tortuous vascular pathways, the inner tube may collapse and deform under torsion or thrust, causing the inner lumen shape to be compromised, resulting in ineffective force transmission or impaired fluid flow. Summary of the Invention

[0005] The present invention mainly solves the technical problem that the inner tube of a balloon catheter is prone to shrinkage and deformation in tortuous vascular paths, and cannot maintain the shape of the inner lumen.

[0006] In one embodiment, a balloon-type catheter is provided.

[0007] Balloon catheters, including:

[0008] Operating handle;

[0009] A balloon electrode assembly, the balloon electrode assembly comprising a balloon body and electrodes disposed on the surface of the balloon body;

[0010] And an insertion tube connected between the operating handle and the balloon electrode assembly; the insertion tube includes an outer tube and an inner tube, the inner tube passing through the outer tube;

[0011] The outer tube includes a bending section located on the distal side, and the inner tube includes a bending adapter section located on the distal side, the bending adapter section being located within the bending section.

[0012] The bending adapter section is made of a rigid material and has a bendable structure, which forms a gap in the tube wall of the bending adapter section; the inner tube also includes a flexible sealing tube, which is located radially outside the bending adapter section and is used to prevent fluid in the inner tube from leaking out from the gap.

[0013] In one embodiment, the flexible structure includes multiple wires arranged side by side, which are spirally coiled to form a tubular structure.

[0014] In one embodiment, the wire is a stainless steel wire, a nickel-titanium alloy wire, or a precious metal wire.

[0015] In one embodiment, the flexible structure is a hygroscopic tube structure or a snake bone structure.

[0016] In one embodiment, the hyaluronic acid tube structure includes a first groove and a second groove respectively disposed on opposite sides of the tube wall of the bending adapter section, the depth of the first groove and the second groove being less than the radius of the bending adapter section, and the first groove and the second groove being offset along the axial direction of the bending adapter section.

[0017] In one embodiment, the rigid material is a metallic material.

[0018] In one embodiment, the flexible sealing tube is a polymer material tube.

[0019] In one embodiment, the inner tube includes a proximal support section connected to the proximal end of the bending adapter section, the proximal support section being a metal tube.

[0020] In one embodiment, the connection between the proximal support section and the bending adapter section is wrapped by the flexible sealing tube.

[0021] In one embodiment, the balloon electrode assembly includes a balloon body that is inflatable and deflate, a distal end of the balloon body having a distal connector, the distal end of the inner tube being fixed to the distal connector, and at least a portion of the bending adapter segment being located within the balloon body.

[0022] The beneficial effects of this invention are:

[0023] According to the balloon-type catheter of the present invention, the inner tube of the insertion tube includes a bending adapter section that at least partially corresponds to the bending section of the outer tube. The bending adapter section is made of a rigid material and has a bendable structure. It can not only achieve its own bending by relying on the bendable structure to adapt to the bending operation of the bending section in the outer tube, but also has high structural strength due to the use of a rigid material. This helps to prevent the bending adapter section from collapsing and deforming when the bending section bends, and can more stably maintain the shape of the inner cavity, which helps to ensure the effective transmission of force and / or smooth flow of fluid. At the same time, the inner tube also includes a flexible sealing tube, which is located radially outside the bending adapter section. The flexible sealing tube is used to prevent the fluid in the inner tube from leaking from the gap, which can ensure the sealing of the inner cavity of the inner tube and meet the corresponding working requirements. Attached Figure Description

[0024] Figure 1 is a schematic diagram of an embodiment of the balloon-type catheter of the present invention;

[0025] Figure 2 is a top view of Figure 1;

[0026] Figure 3 is a schematic diagram of the internal structure of Figure 2;

[0027] Figure 4 is a three-dimensional view of the balloon electrode assembly in Figure 1;

[0028] Figure 5 is a schematic diagram of the flow channel inside the balloon catheter;

[0029] Figure 6 is a three-dimensional view of the sealing seat in Figure 5;

[0030] Figure 7 is a schematic diagram of the inner tube structure in one embodiment of the balloon catheter;

[0031] Figure 8 is a magnified view of part A in Figure 7;

[0032] Figure 9 is a schematic diagram of the inner tube structure in another embodiment of the balloon catheter;

[0033] Figure 10 is a magnified view of part B in Figure 9;

[0034] Figure 11 is a schematic diagram of the liquid flow path in one embodiment of a balloon catheter.

[0035] List of feature names corresponding to the labels in the figure:

[0036] 100. Operating handle; 110. Handle housing; 121. Bending knob; 122. Adjustment push knob;

[0037] 130. Sealing seat; 131. First channel; 1311. Expanded diameter section; 132. Second channel; 133. Drainage port; 134. Check valve; 135. Sealing sleeve; 136. Sealing cap; 137. Infusion port;

[0038] 200. Insert tube;

[0039] 210. Outer pipe; 211. Support pipe section; 212. Bending section; 213. Bladder connecting pipe section;

[0040] 220. Inner tube; 221. Bending adapter section; 222. Flexible sealing tube; 223. First groove; 224. Second groove; 225. Proximal support section; 226. Distal connection section;

[0041] 230. Magnetic positioning sensor;

[0042] 300, balloon electrode assembly; 310, balloon body; 320, flexible circuit board; 321, electrode; 330, distal connector; 331, connecting hole; 332, axial through hole. Detailed Implementation

[0043] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0044] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0045] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0046] For balloon catheters with an insertable tube consisting of an outer and inner tube, some related technologies use polymer materials for the inner tube to achieve a certain degree of flexibility, allowing it to navigate through tortuous vascular pathways. However, the inner tube may collapse and deform under torsion or thrust, causing it to lose its luminal shape and resulting in ineffective force transmission or impaired fluid flow. In an embodiment of the present invention, the inner tube 220 includes a bending adapter section 221 disposed within the bending section 212 of the outer tube 210. The bending adapter section 221 is made of a rigid material to meet strength requirements. The bending of the bending adapter section 221 is achieved by a bendable structure that can form a gap on the tube wall of the bending adapter section 221. This allows for both the fulfillment of force transmission requirements with high structural strength and the fulfillment of bending requirements with a bendable structure. In addition, the inner tube 220 also includes a flexible sealing tube 222 located radially outside the bending adapter section 221. The flexible sealing tube 222 can prevent fluid in the inner tube 220 from leaking from the gap, thus taking into account the strength, bending and fluid flow channel functions of the inner tube 220 as a whole.

[0047] Examples of balloon-type catheters in this invention:

[0048] Please refer to Figure 1. In one embodiment, the balloon catheter includes an operating handle 100, an insertion tube 200, and a balloon electrode assembly 300, which are connected sequentially from the proximal end to the distal end of the balloon catheter.

[0049] The operating handle 100 allows the operator to grip and perform corresponding operations. Its specific operating functions can be designed as needed, such as controlling the bending of the balloon catheter and controlling the inflation and deflation of the balloon 310. In one embodiment, the operating handle 100 may include a handle housing 110, a bending knob 121, an adjustment push button 122, and a sealing seat 130. A pull rope extends from the bending section 212 on the distal side of the insertion tube 200. The bending knob 121 can tighten and loosen the pull rope to achieve bending of the bending section 212. The adjustment push button 122 can drive the inner tube 220 of the insertion tube 200 to move in the proximal-distal direction, thereby adjusting the inflation shape of the balloon 310. The sealing seat 130 allows the inner tube 220 to pass through in a sealed manner and forms a corresponding fluid channel. The specific structure will be further described below.

[0050] The insertion tube 200 is connected to the distal end of the operating handle 100, enabling movement of the balloon electrode assembly 300 and providing a substrate for the corresponding circuits, liquid circuits, and / or gas circuits, allowing these circuits, liquid circuits, and / or gas circuits to connect to the balloon electrode assembly 300 via the operating handle 100. The insertion tube 200 includes the aforementioned outer tube 210 and inner tube 220. The inner tube 220 passes through the outer tube 210, with its distal end able to enter the balloon body 310 and its proximal end able to connect to the operating handle 100 and communicate with a corresponding fluid connector, enabling fluid injection.

[0051] Those skilled in the art should understand that the terms "proximal" and "distal" used in this document are conventional medical terms. For the instrument to be operated, the proximal end is the end closer to the operator, and the distal end is the end farther from the operator. The distal end is usually the end that first enters the patient's body. The proximal and distal ends can be referred to in the diagram for their orientation. Correspondingly, the proximal-distal direction refers to the distribution direction of the proximal and distal ends of the corresponding components, while the circumferential direction refers to the direction in which the corresponding components revolve around the axis corresponding to the proximal-distal direction.

[0052] The specific structure of the balloon catheter will be described in detail below.

[0053] The balloon electrode assembly 300 includes a balloon body 310 and an electrode 321. The balloon body 310 is inflatable and deflateable, and the electrode 321 is disposed on the balloon body 310, enabling it to contact the target tissue, such as the myocardium causing atrial fibrillation, when the balloon body 310 is inflated, thereby achieving electrical energy conduction. Those skilled in the art will understand that, in some specific embodiments, the balloon body 310 of the balloon electrode assembly 300 can be made of polymeric materials such as nylon (PA), block polyetheramide (PEBAX), polyethylene terephthalate (PET), and polyurethane (PU), and is flexible, capable of being inflated by filling with liquid or gas and deflate when the liquid or gas is expelled; when the balloon body 310 is inflated, it can generate tension and form a corresponding shape, such as spherical, ellipsoidal, or other desired shape; when the balloon body 310 deflates, the balloon electrode assembly 300 transforms into a cylindrical structure, facilitating entry and exit from the sheath.

[0054] The flexible circuit board 320 includes an insulating substrate and electrodes 321. The electrodes 321 can be formed from electrode sheets located on the flexible circuit board 320. The insulating substrate is attached to the capsule 310, and the electrode sheets 321 are fixed to the insulating substrate. The number of flexible circuit boards 320 can be set as needed. For example, the capsule 310 in Figure 1 has six flexible circuit boards 320, each of which is strip-shaped, forming a circuit strip. The flexible circuit boards 320 are distributed circumferentially along the capsule 310. The flexible circuit boards 320 can be fixed by methods such as bonding or hot pressing, and can deform with the deformation of the capsule 310 to present the desired shape for contact with the target tissue. When the capsule 310 reaches its full state, it has a large outer surface area, which allows it to support a large area of ​​electrodes 321.

[0055] The proximal end of the balloon electrode assembly 300 is fixedly connected to the outer tube 210, and the distal end is fixedly connected to the inner tube 220.

[0056] In one embodiment, referring to FIG2, the outer tube 210 may include a support tube segment 211, a bending section 212, and a bladder connecting tube segment 213 connected sequentially from the proximal end to the distal end. Referring to FIG4, the proximal end of the bladder 310 can form a nested structure with the distal end of the outer tube 210 to achieve fixation and seal, while allowing the inner cavity of the outer tube 210 to communicate with the inner cavity of the bladder 310. Those skilled in the art will understand that a magnetic positioning sensor 230 can be provided at the distal end of the outer tube 210, and the magnetic positioning sensor 230 can be arranged side-by-side with the inner tube 220.

[0057] Those skilled in the art will understand that the inner tube 220 can move along the insertion tube 200 to adjust the position of the distal end of the balloon 310. For example, pushing the inner tube 220 distally increases the axial (i.e., proximal-distal) dimension of the balloon 310, while moving the inner tube 220 proximally decreases the axial dimension of the balloon 310. A distal connector 330 can be provided at the distal end of the balloon electrode assembly 300, and the inner tube 220 can be connected to the distal connector 330. In addition, a communication hole 331 can be provided on the distal connector 330, forming an opening on the outer peripheral surface of the distal connector 330. The lumen of the inner tube 220 communicates with the communication hole 331, thereby allowing the injection of a corresponding liquid or gas into the balloon 310 through the inner tube 220 and the communication hole 331, achieving balloon inflation. Meanwhile, a flow channel can be formed between the inner tube 220 and the outer tube 210, which is connected to the proximal end of the capsule 310, thereby allowing the corresponding liquid or gas to be discharged from the capsule 310.

[0058] In some embodiments, the inner tube 220 and the outer tube 210 are nested, and the proximal ends of both can be connected to the sealing seat 130. Referring to Figures 5 and 6, the sealing seat 130 has a first channel 131 and a second channel 132. The proximal end of the outer tube 210 is connected to the sealing seat 130 and communicates with the first channel 131; the second channel 132 extends from the outer periphery of the first channel 131 and communicates with the first channel 131. By providing the first channel 131, it can cooperate with the outer tube 210 to form a passage for fluid exchange with the inner cavity of the capsule 310, and the second channel 132 allows fluid in the capsule 310 to be discharged. Those skilled in the art should understand that the fluid mentioned above in this invention can be a gas or a liquid.

[0059] Please refer to Figures 5 and 6. The sealing seat 130 can be a tubular structure. The connection method between the proximal end of the outer tube 210 and the sealing seat 130 is not limited. For example, the proximal end of the outer tube 210 can be fixed to one end of the sealing seat 130 by insertion, welding, bonding, or other connection methods, so that the outer tube 210 and the first channel 131 are in communication. Those skilled in the art will understand that in some embodiments, the proximal end of the outer tube 210 can be inserted into the first channel 131 to achieve the connection between the outer tube 210 and the sealing seat 130, and to make the outer tube 210 and the first channel 131 in communication.

[0060] In addition, those skilled in the art should know that a suitable angle between the second channel 132 and the first channel 131 facilitates the flow of fluid from the first channel 131 into the second channel 132. For example, the angle between the second channel 132 and the first channel 131 can be 30°, 45°, 60° or other acute angles, so that the angle between the fluid flow direction in the second channel 132 and the fluid flow direction in the first channel 131 is acute, so that the fluid in the first channel 131 enters the second channel 132 when it flows through the connection between the first channel 131 and the second channel 132, and is then discharged from the second channel 132.

[0061] The inner tube 220 passes through the first channel 131 and the outer tube 210, forming a first flow channel between the inner tube 220 and the inner wall of the first channel 131 and the inner wall of the outer tube 210. This first flow channel communicates with the inner cavity of the capsule 310. Those skilled in the art will understand that the outer diameter of the inner tube 220 should be smaller than the inner diameters of the first channel 131 and the outer tube 210. The lumen of the inner tube 220 forms a second flow channel. The inner tube 220 has a distal end for communicating with the inner cavity of the capsule 310 and a proximal end extending from the first channel 131. A sealing structure is provided between the inner tube 220 and the first channel 131. The connection point between the second channel 132 and the first channel 131 is closer to the distal end of the sealing seat 130 than the sealing structure.

[0062] Those skilled in the art will understand that the second flow channel and the first flow channel can be combined to form an inflation and deflation path, which helps to expel air from the inner cavity of the balloon 310. The proximal end of the inner tube 220 can be connected to an infusion port 137. In use, the infusion port 137 can be connected to an injection device such as a syringe. The second flow channel formed by the inner tube 220 can be used to inject fluid into the inner cavity of the balloon 310 to inflate the balloon. As fluid is injected into the inner cavity of the balloon 310, the gas in the balloon cavity is compressed and can be discharged from the balloon cavity along the first flow channel. The gas entering the first flow channel is blocked by the sealing structure and is finally discharged along the second channel 132.

[0063] To prevent the backflow of gas or liquid discharged from the second channel 132, and to prevent fluid outside the second channel 132 from being injected back into the first flow channel along the second channel 132, in one embodiment, the second channel 132 is connected to a drain port 133, which is equipped with a one-way valve 134. The one-way valve 134 is used to allow fluid to flow unidirectionally from the first flow channel to the second channel 132. It should be noted that the opening pressure of the one-way valve 134 can be determined according to the required filling degree of the bladder 310. For example, the opening pressure can be set to 10 kPa, 12 kPa, 15 kPa, 20 kPa, or other one-way valves 134 with an opening pressure not less than 10 kPa. Of course, in other embodiments, a one-way valve 134 with an opening pressure less than 10 kPa can also be selected as needed.

[0064] The arrangement and type of the aforementioned one-way valve 134 are not limited, and existing structures in related technologies can be used, which will not be further described here. In addition, it should be noted that in some other embodiments, the drain port 133 can be omitted, and the one-way valve 134 can be provided in the second channel 132.

[0065] When using a balloon catheter, the inner tube 220 needs to be able to bend together with the bending section 212 of the outer tube 210 to pass through a tortuous vascular path. Therefore, the inner tube 220 includes a bending adapter section 221 located on the distal side, which is located within the bending section 212. In another embodiment, when using the balloon catheter, the inner tube 220 can be axially movable through the first channel 131. The operator can push, pull, and twist the inner tube 220 to deform and rotate the balloon body 310.

[0066] In one embodiment, referring to Figure 5, the sealing structure includes a sealing sleeve 135 disposed between the cavity wall of the first channel 131 and the outer wall of the inner tube 220. The proximal end of the first channel 131 has an enlarged diameter section 1311. Those skilled in the art should understand that the enlarged diameter section 1311 can refer to a segment of the first channel 131 with a diameter larger than that of an adjacent portion of the first channel 131. The end of the enlarged diameter section 1311 opposite to the insertion tube 200 has an installation port. The sealing sleeve 135 is disposed in the enlarged diameter section 1311. The filling and venting assembly also includes a sealing cap 136 connected to the installation port. The sealing cap 136 abuts against the sealing sleeve 135 axially. The sealing cap 136 has a through hole through which the inner tube 220 passes. The sealing cap 136 and the enlarged diameter section 1311 cooperate to form a sealing cavity for inserting the sealing sleeve 135, thereby limiting the position of the sealing sleeve 135. The connection method between the sealing cap 136 and the sealing seat 130 is not limited. For example, they can be connected and fixed by threaded connection, bonding, ultrasonic welding, etc. For example, referring to Figure 2, the sealing cap 136 and the sealing seat 130 are threadedly connected at one end with an enlarged diameter section 1311 to facilitate the installation of the sealing sleeve 135. In some other embodiments, the sealing structure can also be replaced with other forms that can seal the radial gap between the inner tube 220 and the first channel 131. For example, if the inner tube 220 does not need to move relative to the outer tube 210, the sealing structure can also be a colloid filled in the radial gap between the inner tube 220 and the first channel 131, which fixes the inner tube 220 in the first channel 131.

[0067] It should be noted that the fluid distribution formed by the sealing seat 130 between the proximal end of the inner tube 220 and the proximal end of the outer tube 210 is only one example. In some other embodiments, fluid can be injected into or discharged from the balloon 310 simply through the annular gap between the inner tube 220 and the outer tube 210. Furthermore, in some other embodiments, when using the sealing seat 130 shown in the figure, which has a first channel 131 and a second channel 132, fluid can be injected into or discharged from the balloon 310 simply through the second channel 132. An axial through-hole 332 can be provided on the distal connector 330 (see Figure 11). The distal end of the inner tube 220 communicates with the axial through-hole 332, allowing liquid to be injected through the inner tube 220 and discharged from the distal end of the distal connector 330, thus providing a flushing and cooling effect on the target tissue. Moreover, those skilled in the art will understand that a guidewire can also be inserted into the inner tube 220 at this time, guiding the movement of the balloon-type catheter.

[0068] To prevent the inner tube 220 from collapsing and deforming when the balloon catheter travels through tortuous vascular pathways, the bending adapter section 221 is made of a rigid material and has a flexible structure. This flexible structure creates a gap in the wall of the bending adapter section 221. The inner tube 220 also includes a flexible sealing tube 222, located radially outside the bending adapter section 221. The flexible sealing tube 222 prevents fluid leakage from the inner tube 220 through the gap. The rigid material of the bending adapter section 221 provides higher structural strength, facilitating the transmission of torque and / or axial force and ensuring the dimensions of the inner lumen. The flexible structure meets the bending requirements of the bending adapter section 221, while the flexible sealing tube 222 ensures the sealing of the inner tube 220. This prevents the flexible material inner tube 220 from collapsing and deforming under bending or stress, thus avoiding the problem of losing its lumen shape.

[0069] In some embodiments, the rigid material used to form the bending adapter segment 221 can be a metallic material, which can achieve better structural strength. Of course, in some other embodiments, the rigid material used to form the bending adapter segment 221 can also be other materials, such as rigid plastics made of polyethylene, polyetheretherketone, or polycarbonate.

[0070] In one embodiment, the flexible structure is a thallium tube structure or a snake bone structure. Those skilled in the art will understand that the specific structure of the thallium tube structure or snake bone structure can refer to existing structures in related technologies, which can realize the bending of the catheter or sheath, for example, it can be used for the bending section of the catheter or sheath.

[0071] In one specific embodiment of the sodium hypochlorite tube structure, referring to Figures 7 and 8, the sodium hypochlorite tube structure may include a first groove 223 and a second groove 224 respectively disposed on opposite sides of the tube wall of the bending adapter section 221. The depth of the first groove 223 and the second groove 224 is less than the radius of the bending adapter section 221, and the first groove 223 and the second groove 224 are offset along the axial direction of the bending adapter section 221. In some other embodiments, the first groove 223 and the second groove 224 may also be arranged aligned.

[0072] For the snake-bone structure, the flexible structure can be a hinged structure set between two adjacent snake-bone unit segments. Such a hinged structure can refer to existing structures in related technologies, and will not be elaborated here.

[0073] In one embodiment, referring to Figures 9 and 10, the flexible structure may include multiple wires arranged side-by-side, spirally wound to form a tubular structure, resembling a multi-threaded helix. The wires may be stainless steel, nickel-titanium alloy, or precious metal wires. The number of strands can be set as needed, for example, 3 to 18 strands, i.e., 3 to 18 wires arranged side-by-side. Multiple wires arranged side-by-side have higher mechanical properties than a single wire, which is beneficial for more complete transmission of torque from the proximal end to the distal end, and also facilitates stable rotation in narrow, tortuous blood vessels.

[0074] The grooves in the hyaluronic acid tube structure, the gaps between unit sections in the serpentine structure, and the gaps between multiple parallel wires can create gaps in the wall of the bending adapter section 221, preventing it from forming a sealed space for fluid transport. Therefore, in embodiments of the present invention, a flexible sealing tube 222 is provided on the radially outer side of the bending adapter section 221 to prevent fluid leakage from the inner tube 220 through the gaps. In some embodiments, the flexible sealing tube 222 can be a polymer material tube, such as PI (Polyimide). The forming method of the flexible sealing tube 222 on the bending adapter section 221 is not limited; for example, it can be fitted onto the bendable structure and sealed by heat shrinking, elastic shrinking, or bonding, or it can be directly attached to the bendable structure to form a tubular structure by coating or dip coating.

[0075] For the portion of the inner tube 220 located near the proximal end of the bending adapter section 221, in some embodiments, where significant bending deformation is not required, the inner tube 220 includes a proximal support section 225 connected to the proximal end of the bending adapter section 221. The proximal support section 225 is a metal tube, which improves the force transmission performance of the inner tube 220. The proximal support section 225 and the bending adapter section 221 can be connected by welding, bonding, or other methods.

[0076] In some embodiments, the inner tube 220 may further include a distal connecting section 226 connected to the distal end of the bending adapter section 221. The distal connecting section 226 is a cylindrical section, which facilitates the connection between the inner tube 220 and the distal connecting seat 330. The distal connecting section 226 itself does not have a bendable structure, but its length can be controlled to meet the overall bending requirements of the distal end of the inner tube 220. In some embodiments, at least one of the proximal support section 225, the distal connecting section 226, and the connection portion of the bending adapter section 221 can be wrapped by a flexible sealing tube 222, which helps to better ensure the sealing performance of the flexible sealing tube 222.

[0077] Furthermore, in some embodiments, at least a portion of the bending adapter segment 221 may be located within the balloon body 310, thereby making the balloon body 310 portion of the balloon catheter easier to bend.

[0078] By setting the bending adapter section 221 in the embodiment of the present invention on the inner tube 220, the rigid material, the bendable structure and the flexible sealing tube 222 can cooperate with each other to meet the functions of force transmission, bending and fluid passage of the bending adapter section 221. It is not easy to cause collapse deformation, which helps to maintain the shape of the inner cavity. It is also easy for the balloon 310 to be filled and contracted relatively quickly and easily, and it is also easy to ensure the stable and reliable operation of the balloon catheter.

[0079] It should be noted that the capsule-type 310 catheter in this invention can be an ablation catheter used to perform ablation operations, or a mapping catheter used to perform electrophysiological mapping.

[0080] The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims

1. A balloon-type catheter, characterized in that, include: Operating handle; A balloon electrode assembly, the balloon electrode assembly comprising a balloon body and electrodes disposed on the surface of the balloon body; And an insertion tube connected between the operating handle and the balloon electrode assembly; the insertion tube includes an outer tube and an inner tube, the inner tube passing through the outer tube; The outer tube includes a bending section located on the distal side, and the inner tube includes a bending adapter section located on the distal side, the bending adapter section being located within the bending section. The bending adapter section is made of a rigid material and has a bendable structure, which forms a gap in the tube wall of the bending adapter section; the inner tube also includes a flexible sealing tube, which is located radially outside the bending adapter section and is used to prevent fluid in the inner tube from leaking out from the gap.

2. The balloon catheter as described in claim 1, characterized in that, The flexible structure comprises multiple wires arranged side by side, which are spirally coiled to form a tubular structure.

3. The balloon catheter as described in claim 2, characterized in that, The wire is made of stainless steel, nickel-titanium alloy, or precious metal.

4. The balloon catheter as described in claim 1, characterized in that, The flexible structure is a wave tube structure or a snake bone structure.

5. The balloon catheter as described in claim 4, characterized in that, The hyaluronic acid tube structure includes a first groove and a second groove respectively disposed on opposite sides of the tube wall of the bending adapter section. The depth of the first groove and the second groove is less than the radius of the bending adapter section, and the first groove and the second groove are offset along the axial direction of the bending adapter section.

6. The balloon catheter as described in any one of claims 1 to 5, characterized in that, The hard material is a metallic material.

7. The balloon catheter as described in any one of claims 1 to 5, characterized in that, The flexible sealing tube is made of polymer material.

8. The balloon catheter as described in any one of claims 1 to 5, characterized in that, The inner tube includes a proximal support section, which is connected to the proximal end of the bending adapter section, and the proximal support section is a metal tube.

9. The balloon catheter as described in claim 8, characterized in that, The connection between the proximal support section and the bending adapter section is wrapped by the flexible sealing tube.

10. The balloon catheter as described in any one of claims 1 to 5, characterized in that, The balloon electrode assembly includes a balloon body that is inflatable and deflateable. A distal connector is provided at the distal end of the balloon body. The distal end of the inner tube is fixed to the distal connector. At least a portion of the curved adapter segment is located within the balloon body.

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