Balloon catheter and insertion tube structure of balloon catheter

Abstract

The present invention relates to the field of balloon catheters, and particularly relates to a balloon catheter and an insertion tube structure of a balloon catheter. Said insertion tube structure comprises: a tube body, the tube wall of the tube body enclosing a hollow tube cavity; an insulating tube, the insulating tube being provided in the hollow tube cavity, the tube cavity of the insulating tube forming a first channel, a second channel being formed between the tube wall of the insulating tube and the inner wall of the tube body, and the first channel and the second channel being isolated from each other; a wire, the wire being provided in the insulating tube, the wire comprising a conductive wire core and an insulating layer that covers the conductive wire core, and the space between the distal end of the first channel and the wire being sealed; and a seal seat, the seal seat plugging the proximal end of the hollow tube cavity, the seal seat being provided with a fluid communication opening and a wire lead-out opening, the fluid communication opening being used for communicating the second channel with the outside of the seal seat, the wire lead-out opening being sealingly connected to the insulating tube, and the wire lead-out opening being used for leading out the wire. The present invention mainly solves the technical problem of limited cross-sectional areas of pressure cavities of balloon catheters.

Description

Balloon catheter and its insertion cannula structure Technical Field

[0001] This invention relates to the field of balloon catheters, and more specifically to a balloon catheter and its insertion tube structure. Background Technology

[0002] Pulsed electric field ablation catheters come in various shapes and sizes, such as linear catheters, basket-shaped catheters, petal-shaped catheters, and balloon catheters. Pulsed electric field ablation catheters typically reach the target tissue through a sheath passage of 8-13 Fr (Fr is a unit used in the field of catheter-related medical devices to describe diameter; 3 Fr = 1 mm, 8-13 Fr is 2.67-4.33 mm). This imposes considerable limitations on the internal structure and functionality of the pulsed electric field ablation catheter.

[0003] The electrodes of a pulsed electric field ablation catheter are connected to wires, which typically pass through the insertion tube and are eventually led out through a connector on the operating handle. The basic principle of pulsed electric field ablation technology is to induce cell necrosis or apoptosis through electric field energy. This electric field energy usually reaches hundreds or even thousands of volts. The corresponding wires in the pulsed electric field ablation catheter carry high-voltage pulses during operation, which poses a challenge to the insulation of the various components within the catheter. To meet the insulation requirements of the wires, an insulating layer is often placed outside the conductive core of the wire as basic insulation, and additional insulating layers may be required for reinforcement.

[0004] However, balloon catheters typically include a pressure chamber for the filling fluid (air or liquid). By controlling the pressure changes of this fluid, the balloon is inflated and deflated, resulting in corresponding morphological changes. Adding an insulation layer occupies space within the insertion tube, limiting the cross-sectional area of ​​the pressure chamber. According to fluid mechanics equations, given a constant flow rate, the time required for balloon deflation and inflation depends primarily on the cross-sectional area of ​​the pressure chamber and the applied pressure. Currently, balloon catheters face technical bottlenecks in applying pulsed electric field technology: more efficient ablation requires more electrodes, which necessitates more insulation, but also results in a smaller pressure chamber cross-sectional area. A smaller pressure chamber requires greater pressure and longer inflation time, leading to a poorer user experience. Summary of the Invention

[0005] This invention primarily addresses the technical problem of limited cross-sectional area of ​​the pressure chamber in balloon catheters.

[0006] In one aspect, an insertion tube structure for a balloon catheter is provided in one embodiment.

[0007] The insertion cannula structure of a balloon catheter includes:

[0008] The tube body, the tube wall of which forms a hollow cavity;

[0009] An insulating tube is disposed within the hollow tube cavity, the tube cavity forming a first channel, and a second channel forming between the tube wall and the inner wall of the tube body, the first channel and the second channel being isolated from each other;

[0010] A conductor, wherein the conductor is disposed within the insulating tube, the conductor comprising a conductive core and an insulating layer wrapped around the conductive core, and the distal end of the first channel is sealed to the conductor;

[0011] The sealing seat is provided with a fluid communication port and a wire outlet. The fluid communication port is used to connect the second channel to the outside of the sealing seat. The wire outlet is sealed to the insulating tube and is used for the lead-out of the wire.

[0012] In one embodiment, the insulating tube is a tube of equal diameter; or, the insulating tube is a heat-shrinkable tube, and the wire is wrapped in the heat-shrinkable insulating tube.

[0013] In one embodiment, the number of insulating tubes is greater than or equal to 2, at least one of the insulating tubes is a tube of equal diameter, and / or at least one of the insulating tubes is a heat shrink tubing.

[0014] In one embodiment, the sealing seat has a fluid cavity, the fluid communication port is connected to the fluid cavity, the proximal end of the tube body is connected to the fluid cavity, and the hollow tube cavity is connected to the fluid cavity.

[0015] In one embodiment, the tube body includes a bending section located at the distal end, and a pull rope cavity is provided on the tube wall of the tube body; the insertion tube structure further includes a pull rope tube and a pulling rope for adjusting the bending section, the pull rope tube is inserted into the pull rope cavity, and the pulling rope is inserted into the pull rope tube;

[0016] The pull rope tube passes through the sealing seat, and the inner cavity of the pull rope tube is isolated from the fluid cavity; or, the proximal end of the pull rope tube is sealed to the fluid cavity, the pull rope passes through the fluid cavity, the sealing seat is provided with a pull rope through hole for the pull rope to be led out, the pull rope passes through the pull rope through hole, and a dynamic sealing structure is provided between the pull rope through hole and the pull rope.

[0017] In one embodiment, the sealing seat includes a seat body and a cover, the cover being fixed to the distal end of the seat body, and the fluid cavity being enclosed by the seat body and the cover.

[0018] In one embodiment, the sealing seat is provided with a insertion hole, and the proximal end of the tube body is inserted into the insertion hole to form a seal with the sealing seat.

[0019] In one embodiment, a central rod is further included, which is disposed within the hollow tube cavity, with the distal end of the central rod extending out of the tube body and the proximal end of the central rod passing through the sealing seat and sealing with the sealing seat.

[0020] In one embodiment, the system further includes an inner liner tube located inside the distal end of the hollow cavity. The inner liner tube is sleeved on the outside of the central rod, which is movable in the inner liner tube along the proximal-distal direction. An insulating tube passes through the space between the inner liner tube and the cavity wall of the hollow cavity. A sealing material is provided between the cavity wall of the hollow cavity and the outer peripheral surface of the inner liner tube, and a seal is formed between the outer peripheral surface of the insulating tube and the sealing material.

[0021] Secondly, one embodiment provides a balloon catheter.

[0022] Balloon catheters, including:

[0023] Operating handle;

[0024] A balloon electrode assembly, the balloon electrode assembly comprising a balloon body and electrodes disposed on the surface of the balloon body;

[0025] And an insertion tube connected between the operating handle and the balloon electrode assembly, the insertion tube having an insertion tube structure as described in any of the above, and the sealing seat being disposed on the operating handle.

[0026] The beneficial effects of this invention are:

[0027] According to the insertion tube structure in the embodiments of the present invention, the tube wall of the tube body forms a hollow cavity, and an insulating tube is provided inside the hollow cavity. The wire can be placed in the first channel formed by the insulating tube, and the second channel formed between the insulating tube and the cavity wall of the hollow cavity can form a pressure cavity for the filling fluid to pass through, thereby achieving a larger pressure cavity cross-sectional area. At the same time, by sealing the distal end of the first channel with the wire and providing a sealing seat, the filling fluid and the wire can be isolated. Furthermore, the fluid communication port and the wire outlet on the sealing seat can meet the injection requirements of external filling fluid and the wire exit requirements. Overall, better insulation effect and a larger pressure cavity cross-sectional area can be achieved, creating conditions for improving product reliability and operational efficiency. Attached Figure Description

[0028] Figure 1 is a schematic diagram of an embodiment of the balloon catheter in this invention;

[0029] Figure 2 is an enlarged view of the balloon assembly in Figure 1;

[0030] Figure 3 is an enlarged view of the operating handle in Figure 1;

[0031] Figure 4 is a cross-sectional view of AA in Figure 1;

[0032] Figure 5 is a sectional view of BB in Figure 1;

[0033] Figure 6 is a schematic diagram of the internal structure at point C in Figure 1;

[0034] Figure 7 is a partial enlarged view of the sealing seat in Figure 6;

[0035] Figure 8 is a schematic diagram of the internal structure of the part corresponding to point C in Figure 1 in another embodiment of the balloon catheter;

[0036] Figure 9 is a partial enlarged view of the sealing seat in Figure 8;

[0037] Figure 10 is a schematic diagram of an embodiment of the balloon catheter in this invention;

[0038] Figure 11 is a cross-sectional view of the part corresponding to point B in Figure 1 in another embodiment of the balloon catheter of the present invention.

[0039] List of feature names corresponding to the labels in the figure:

[0040] 100. Operating handle; 110. Connector; 120. Filler connector; 130. Center rod connector;

[0041] 200. Insertion tube; 201. Tube body; 2011. Hollow cavity; 2012. Pull rope cavity;

[0042] 210. Insulating tube; 211. First channel;

[0043] 220. Second Channel;

[0044] 230. Conductor; 231. Conductive core; 232. Insulation layer;

[0045] 240. Sealing seat; 241. Seat body; 242. Cover; 243. Fluid cavity; 244. Elastic sealing sleeve; 245. Gland; 246. Fluid communication port;

[0046] 250. Pull rope;

[0047] 260. Pull rope tube;

[0048] 270. Center rod;

[0049] 280. Inner lining tube;

[0050] 290. Filling tube;

[0051] 300. Balloon assembly; 310. Balloon body; 320. Flexible circuit board; 330. Electrode sheet. Detailed Implementation

[0052] 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.

[0053] 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.

[0054] 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).

[0055] Pulsed electric field ablation has begun to be applied in the electrophysiology industry. However, the shapes of ablation catheters are mostly linear, basket-shaped, and petal-shaped. Among them, linear catheters have lower ablation efficiency, while basket-shaped and petal-shaped catheters, due to the limitation of electrode area, often require multiple shape changes and posture adjustments at the same location. This introduces uncertainty and makes it difficult to control the accuracy of the ablation target. Furthermore, the electrodes of basket-shaped and petal-shaped catheters are generally placed on a flexible framework. During contact with human tissue, their shape is often difficult to maintain as expected, which can easily lead to electrode short circuits, electric arcs, and make it difficult to achieve effective ablation, potentially causing other complications. Balloon catheters, on the other hand, place the electrodes on a compliant balloon. This allows for better contact with the ablation site and facilitates effective control of electrode position, reducing the risk of electric arcs in the body. At the same time, the combination of the balloon and flexible electrodes allows for the development of unique electrode shapes and arrangements to achieve highly efficient ablation.

[0056] Balloon catheters inflate and deflate during operation. To achieve this inflation and deflation of the balloon assembly, a separate fluid injection tube is required to form a pressure chamber. This fluid injection tube occupies a portion of the space within the insertion tube. This is especially true when there are many electrodes on the balloon assembly or when the connecting wires require thicker insulation. The space within the tube becomes even more limited, making it difficult to install a fluid injection tube with a large radial dimension. Furthermore, the fluid injection tube often requires a certain wall thickness to withstand pressure, making it difficult to form a pressure chamber with a large cross-sectional area. This results in a longer inflation and deflation time for the balloon, higher inflation pressure, and greater effort required from the operator.

[0057] In the embodiments of the present invention, the balloon catheter insertion tube structure does not have a separate pressure chamber. Instead, the pressure chamber is formed directly by the tube wall. Functional channels, such as wire channels, can be set inside the pressure chamber. This helps to ensure that the pressure chamber has a large cross-sectional area to the maximum extent, thereby shortening the balloon inflation and deflation time and using less force for inflation operation, which helps to improve product performance and enhance user experience.

[0058] Examples of balloon catheters in this invention:

[0059] Please refer to Figure 1. In one embodiment, the balloon catheter includes an operating handle 100, an insertion tube 200, and a balloon assembly 300, which are connected sequentially from the proximal end to the distal end of the balloon catheter.

[0060] 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 of the axis around the corresponding component that is parallel to the proximal-distal direction.

[0061] The operating handle 100 can be gripped by the operator to perform corresponding operations. Its specific operating functions can be designed as needed, such as adjusting the bend of the balloon catheter and controlling the inflation and contraction of the balloon 310.

[0062] The insertion tube 200 is connected to the distal end of the operating handle 100, enabling movement of the balloon assembly 300 and providing a substrate for the corresponding circuits, fluid lines, and / or gas lines, allowing these circuits, fluid lines, and / or gas lines to connect to the balloon assembly 300 via the operating handle 100. In some embodiments, referring to Figures 4 and 5, the insertion tube 200 may include a tube body 201, the walls of which form a hollow cavity 2011. The tube body 201 may include a support section and a bending section arranged sequentially from the proximal end to the distal end. The support section enables force transmission, and the bending section enables bending and straightening of the distal end of the insertion tube 200, allowing the balloon assembly 300 to conform to the target tissue in a suitable posture. Those skilled in the art should know that the specific structure of the bending section can refer to existing structures in related technologies, such as using various forms of snake bones, relying on the hinge structure of adjacent snake bones to generate bending, and the bending power can be a pull rope 250 set on the side wall of the bending section, with the distal end of the pull rope 250 fixed to the farthest snake bone. The pull rope 250 can be made of steel wire rope, and a pull rope 250 drive mechanism can be set inside the housing of the operating handle 100. By tightening the steel wire rope on the corresponding side of the bending section through the pull rope 250 drive mechanism, the bending section can bend towards the side where the steel wire rope is tightened.

[0063] Referring to Figure 2, the balloon assembly 300 may include a balloon body 310 and electrode pads 330. The balloon body 310 is inflatable and deflate. The electrode pads 330 are disposed on the surface of the balloon body 310 and can inflate and deflate with the balloon body 310. When inflated, they can contact the target tissue, such as the myocardium causing atrial fibrillation, thereby enabling the transfer of electrical energy and forming electrodes for ablation or mapping. In some embodiments, a proximal connecting tube may be provided at the proximal end of the balloon body 310. The balloon assembly 300 can be connected to the distal end of the insertion tube 200 through the proximal connecting tube. The connection method is not limited, for example, by bonding or thermal fusion. In some other embodiments, the balloon body 310 may also be directly connected to the distal end of the insertion tube 200, that is, the proximal connecting tube may be part of the insertion tube 200.

[0064] Furthermore, those skilled in the art should know that the balloon assembly 300 of the present invention can be made of polymer materials such as nylon (PA), block polyetheramide (PEBAX), polyethylene terephthalate (PET), and polyurethane (PU), and is flexible, capable of being filled with liquid or gas, and contracting when the liquid or gas is discharged; when the balloon 310 is filled, it can generate tension and form a corresponding shape, such as spherical, ellipsoidal, or other desired shape; when the balloon 310 contracts, the balloon assembly 300 transforms into a cylindrical structure, facilitating entry and exit of the sheath.

[0065] In some embodiments, the electrode pads 330 may be located on the flexible circuit board 320. The flexible circuit board 320 includes an insulating substrate and electrode pads 330. The insulating substrate is attached to the capsule 310, and the electrode pads 330 are fixed to the insulating substrate. The number of flexible circuit boards 320 can be set as needed. Each flexible circuit board 320 may be strip-shaped, forming a circuit strip. Each flexible circuit board 320 is distributed circumferentially along the capsule 310, and the electrode pads 330 on each flexible circuit board 320 form a group. Referring to Figure 2, in some embodiments, two electrode pads 330 may be provided on one flexible circuit board 320, and both electrode pads 330 are located on the distal side of the capsule 310. Of course, the number and placement of the electrode pads 330 can be set as needed and are not limited to the structure shown in the figures.

[0066] The flexible circuit board 320 can be fixed to the capsule 310 by means 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 electrodes of a large area. Those skilled in the art will understand that the insulating substrate can be made of common materials in the field of flexible circuit boards 320, such as PI or PET; as an example, the electrode sheet 330 can be made of copper, silver, etc., and can be plated, such as with a gold plating layer. Of course, plating is not a necessary structure.

[0067] In some cases, the balloon catheter may further include a central rod 270, which passes through the insertion tube 200 and enters the balloon body 310. The distal end of the balloon assembly 300 is fixedly connected to the central rod 270, and the central rod 270 is used to move along the insertion tube 200 to adjust the position of the distal end of the balloon body 310. For example, pushing the central rod 270 distally can increase the axial (i.e., proximal-distal) dimension of the balloon body 310, while moving the central rod 270 proximally can decrease the axial dimension of the balloon body 310. Those skilled in the art will understand that in some embodiments, the central rod 270 may be a solid rod or a hollow rod. When a hollow rod is used, fluid can also be delivered through the central rod 270, or the hollow rod can pass through the distal end of the balloon body 310, thereby allowing the central rod 270 to serve as a guidewire channel, enabling the balloon assembly 300 and the insertion tube 200 to be fitted onto the guidewire and move along the guidewire under its guidance. At this time, a center rod connector 130 connected to the center rod 270 can be provided on the operating handle 100 (due to the perspective, the center rod connector 130 and the connector 110 are coincident in position in the figure; in reality, the center rod connector 130 and the connector 110 are led out from the operating handle 100 respectively) to realize fluid delivery or form a guide wire channel. In addition, in some other embodiments, the center rod 270 is not a necessary structure and can be omitted, relying solely on filling or discharging fluid to change the shape of the capsule 310.

[0068] It should be noted that the balloon catheter in the embodiments of the present invention can be an ablation catheter used to ablate the target tissue, for example, it can be used for pulsed electric field ablation; in addition, in some other embodiments, the balloon catheter in the embodiments of the present invention can be a mapping catheter used to collect electrophysiological signals of the target tissue.

[0069] To achieve ablation or mapping, different electrode pads 330 need to be connected to circuits of corresponding polarities via wires 230. In addition, the balloon assembly 300 may also need to be equipped with functional modules such as position sensors, imaging modules, and ultrasound modules. These functional modules also need to be connected via wires 230. These wires 230 often need to be led out from the insertion tube 200 to the operating handle 100, and then connected to external devices, such as ablation hosts or mapping hosts, via the operating handle 100.

[0070] It should be noted that the connection method between the wire 230 and the electrode sheet 330 or the corresponding functional module is not limited. For example, corresponding traces can be laid on the flexible circuit board 320, and each electrode sheet 330 is connected to the corresponding trace. The traces can be led to the connection part near the end of the flexible circuit board 320. The connection part can be provided with pads connected to the traces, and the wire 230 can be soldered on the pads. The traces can be formed using the molding method commonly used in the field of flexible circuit boards 320, such as by etching. As another example, the side of the electrode sheet 330 near the capsule 310 can be provided with a pad, and the wire 230 can be soldered on the pad. After passing through the capsule 310, the wire 230 enters the insertion tube 200 through the inside of the capsule 310, and then leads to the operating handle 100, and then connects to the ablation host or the mapping host through the connector 110 on the operating handle 100.

[0071] However, the wire 230 connected to the electrode needs to have good insulation performance. If it relies solely on the insulation layer 232 wrapped around the conductive core 231 of the conventional wire 230, there is a certain probability of insulation failure. When a conductive medium is used as the filling fluid, the filling fluid may become charged, resulting in dangerous energy appearing on the outer surface of the ablation catheter or at the filling connector 120 on the operating handle 100 leading to the pressure chamber. Therefore, an additional insulation structure needs to be added to the outside of the wire 230. Those skilled in the art will understand that this will lead to space constraints within the tube body 201, making it difficult to guarantee the cross-section of the pressure chamber. In addition, if there are a large number of wires 230, it will further complicate the guarantee of the cross-section of the pressure chamber.

[0072] To address the aforementioned issues, the balloon catheter insertion tube 200 of this invention employs a novel insertion tube structure.

[0073] In some embodiments, referring to Figures 6 and 7, the insertion tube structure includes an insulating tube 210, a wire 230, and a sealing seat 240. The insulating tube 210 is disposed within the hollow cavity 2011, forming a first channel 211. A second channel 220 is formed between the wall of the insulating tube 210 and the inner wall of the tube body 201. The first channel 211 and the second channel 220 are isolated from each other by the wall of the insulating tube 210. The material of the insulating tube 210 can be selected according to performance requirements, such as, but not limited to, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene copolymer), PI (polyimide), etc. The wire 230 is disposed within the insulating tube 210, which provides a second layer of sealing protection for the wire 230.

[0074] The number of insulating tubes 210 can be set according to the number of wires 230 and protection requirements. For example, in Figures 4 and 5, the number of insulating tubes 210 is three, and the radial dimensions of any two insulating tubes can be the same or different. In some embodiments, at least one insulating tube 210 contains two or more wires 230. Compared to adding an additional insulation layer 232 to each wire 230 with an insulation layer 232, this application is more advantageous in reducing the space occupied by the additional insulation, thereby creating conditions for achieving a larger pressure chamber cross-sectional area to improve the efficiency of balloon inflation and contraction, while also reducing the probability of dangerous situations caused by the failure of the insulation layer 232 of the wires 230. Of course, an insulation layer can also be added to only one of the wires 230. Since the tube body serving as a separate medium channel is omitted, it is still advantageous to increase the cross-sectional area of ​​the pressure chamber.

[0075] In some embodiments, the insulating tube 210 can be a tube of equal diameter, that is, a tube with a substantially uniform cross-sectional shape throughout the axial direction. For example, an extruded tube can be used, and the tube shape can be circular, elliptical, polygonal, etc.; or, the insulating tube 210 can be a heat-shrinkable tube, which can wrap the wires 230 around the heat-shrinkable insulating tube 210, thereby bringing them closer together and integrating them into a bundle, resulting in a more compact structure and further reducing the space occupied by the insulating tubes 210 and the wires 230. Those skilled in the art will understand that when the number of insulating tubes 210 is greater than or equal to 2, at least one insulating tube 210 can be a tube of equal diameter, and / or at least one insulating tube 210 can be a heat-shrinkable tube. In addition, the size of each insulating tube 210 is not limited and can be set as needed.

[0076] A sealing seat 240 seals the proximal end of the hollow tube cavity 2011. The sealing seat 240 has a fluid communication port 246 and a wire outlet. The fluid communication port 246 connects the second channel 220 to the outside of the sealing seat 240, allowing filling fluid to enter and exit the second channel 220. The wire outlet can be a channel (not shown in the figure) provided on the sealing seat 240, connecting the fluid cavity to the outside of the sealing seat 240. The wire outlet is connected to the insulating tube 210, allowing the wire 230 to be led out. The wire outlet and the insulating tube 210 are sealed, isolating the cavity of the insulating tube 210 from the second channel 220. In one specific embodiment, the fluid communication port 246 can be connected to a filling tube 290, which extends out of the operating handle 100 and connects to a filling connector 120. In addition, the insulating tube 210 can be inserted, sleeved, or butted at the outlet and sealed with the sealing seat 240 in any way, such as by bonding, interference fit, or heat fusion.

[0077] In some embodiments, the sealing seat 240 may include a seat body 241 and a cover 242, with the cover 242 fixed to the distal end of the seat body 241. The seat body 241 and the cover 242 form a fluid cavity 243. Providing the seat body 241 and the cover 242 facilitates the manufacture of the sealing seat 240 and its assembly with other components in the insertion tube 200. The fixing method between the seat body 241 and the cover 242 is not limited, and may include bonding, welding, etc.

[0078] The proximal end of the tube body 201 is connected to the fluid cavity 243. In one specific embodiment, the sealing seat 240 is provided with an insertion hole, and the proximal end of the tube body 201 is inserted into the insertion hole, forming a seal between the tube wall of the tube body 201 and the sealing seat 240. The seal between the tube body 201 and the sealing seat 240 can be achieved by bonding, or by other methods, such as welding, interference fit, sealing ring, etc. Alternatively, the proximal end of the tube body 201 can also be connected and sealed to the sealing seat 240 in the form of end-to-end contact or sleeve connection. The hollow tube cavity 2011 communicates with the fluid cavity 243, and the fluid communication port 246 communicates with the fluid cavity 243, ultimately enabling the second channel 220 inside the tube body 201 to communicate with the outside of the sealing seat 240, facilitating the injection of filling fluid.

[0079] In addition to enabling the second channel 220 to connect with the outside, the sealing seat 240 can also enable the wire 230 to connect with the outside, as well as the pull rope 250 to be led out.

[0080] For the conductor 230, the proximal end of the insulating tube 210 can pass through the fluid cavity 243 and then exit through the cavity wall of the fluid cavity 243, forming a sealed fit with the cavity wall of the fluid cavity 243, for example, by bonding. When the fluid cavity 243 is not provided, the conductor 230 can also directly pass through the through hole provided on the sealing seat 240. In this case, since the first channel 211 and the second channel 220 formed by the cavity of the insulating tube 210 are isolated from each other by the tube wall of the insulating tube 210, a sealing structure is not required between the conductor 230 and the sealing seat 240.

[0081] In some other embodiments, the fluid cavity 243 may be omitted from the sealing seat 240, so that the tube body 201 is sealed to the sealing seat 240, the insulating tube 210 is connected to the sealing seat 240, the wire 230 is led out from the outlet, and the fluid communication port 246 on the sealing seat 240 can be directly connected to the second channel 220 to form a fluid channel.

[0082] Referring to Figures 4 and 5, for the pull rope 250, in some embodiments, a pull rope cavity 2012 may be provided on the wall of the tube body 201, extending to the proximal end of the tube body 201. The insertion tube structure also includes a pull rope tube 260 and a pull rope 250 for adjusting the bending section. The pull rope tube 260 is inserted into the pull rope cavity 2012, and the pull rope 250 is inserted into the pull rope tube 260. The material of the pull rope tube 260 can be selected as needed, such as PTFE, FEP, etc. Of course, those skilled in the art will understand that, in order to prevent the filling fluid from entering the pull rope tube 260, a sealing structure can be provided between the distal end of the pull rope tube 260 and the pull rope 250, for example, using sealant.

[0083] Referring to Figures 6 and 7, in some embodiments, the pull cord 260 can pass through the sealing seat 240, and the inner cavity of the pull cord 260 is isolated from the fluid cavity 243. Alternatively, referring to Figures 8 and 9, the proximal end of the pull cord 260 can be sealed to the fluid cavity 243, and the pull cord 250 passes through the fluid cavity 243. The sealing seat 240 is provided with a pull cord through hole for the pull cord 250 to be led out, and the pull cord 250 passes through the pull cord through hole. A dynamic sealing structure is provided between the pull cord through hole and the pull cord 250. The aforementioned dynamic sealing structure may include an elastic sealing sleeve 244 and a gland 245. The elastic sealing sleeve 244 and the gland 245 are provided with through holes. The pull rope 250 passes through the through holes on the elastic sealing sleeve 244 and the gland 245. The gland 245 presses the elastic sealing sleeve 244 tightly into the countersunk hole on the sealing seat 240, which can cause the elastic sealing sleeve 244 to undergo compression deformation, so that the inner wall of the through hole of the elastic sealing sleeve 244 is in close contact with the pull rope 250. Even if the pull rope 250 moves along the through hole, the sealing performance can still be achieved, and leakage of the filling fluid can be avoided.

[0084] In some other embodiments, referring to FIG11, the drawstring cavity 2012 may be omitted on the portion of the tube body 201 located near the bending section. Additionally, the number of insulating tubes 210 may be two. Each insulating tube 210 may contain two or more conductors 230 with insulating layers 232.

[0085] For a balloon catheter including a central rod 270, the central rod 270 is disposed within the hollow lumen 2011, with its distal end extending out of the tube body 201, forming a guidewire outlet at the distal end of the balloon body 310. The proximal end of the central rod 270 passes through and seals against the sealing seat 240, thus preventing leakage of filling fluid from the central rod 270 and meeting the usage requirements of the central rod 270. For the central rod 270, which needs to move along its axis relative to the tube body 201, a dynamic sealing structure can also be provided between the central rod 270 and the sealing seat 240. The dynamic sealing structure can use the same sealing principle as the dynamic sealing structure between the pull rope 250 and the sealing seat 240.

[0086] In addition, it should be noted that, apart from the rope cavity 2012 for threading the traction rope 250, the tube body 201 can have one, two, or more cavity channels extending along the axis. That is, the tube body 201 can be a single-cavity tube, a two-cavity tube, or a multi-cavity tube.

[0087] Of course, the distal end of the cavity of the insulating tube 210 is sealed with the conductor 230. For example, sealant (such as polyurethane) can be injected into the distal end of the cavity of the insulating tube 210 to prevent the filling fluid from contacting the conductor 230 from the distal end of the insulating tube 210.

[0088] In some embodiments, for the distal end of the insertion tube 200, the insertion tube structure further includes an inner liner tube 280, which is located inside the distal end of the hollow cavity 2011. The inner liner tube 280 is sleeved on the outside of the central rod 270, and the insulating tube 210 passes through the space between the inner liner tube 280 and the cavity wall of the hollow cavity 2011. A sealing material, such as sealant, is provided between the cavity wall of the hollow cavity 2011 and the outer peripheral surface of the inner liner tube 280. The sealant cures to form the aforementioned sealing material. A seal is formed between the outer peripheral surface of the insulating tube 210 and the sealant, and a seal can also be formed between the distal end of the cavity of the insulating tube 210 and the wire 230 through the sealant. The inner liner tube 280 facilitates the sealing operation between the distal end of the cavity of the insulating tube 210 and the lead wire 230, preventing the center rod 270 from contacting the sealant and becoming immobile, and ensuring that the center rod 270 can move along the proximal-distal direction to control the shape of the balloon electrode assembly; in addition, the inner liner tube 280 also facilitates the positioning of the distal ends of the insulating tube 210 and the lead wire.

[0089] According to the balloon catheter of the present invention, referring to FIG10, the second channel 220 formed between the insulating tube 210 and the tube body 201 forms a medium channel for injecting filling medium into the balloon body 310. It is not necessary to set up a separate tube body as a medium channel. In use, the filling medium can be directly delivered to the balloon body 310 through the second channel 220, which is conducive to achieving a larger pressure chamber cross-sectional area. The insulating tube 210 can also isolate the wire 230 from the pressure chamber at the same time, improve the insulation performance of the wire 230, which is conducive to improving the inflation and contraction efficiency of the balloon catheter, reducing the operating force, and improving the insulation reliability.

[0090] An embodiment of the insertion tube structure of the balloon catheter in this invention:

[0091] In some embodiments, the insertion tube structure of the balloon catheter may include a tube body 201, an insulating tube 210, a wire 230, and a sealing seat 240. The structure and assembly relationship of the corresponding components may be the same as the structure in any of the above embodiments of the balloon catheter, and will not be described again here.

[0092] 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. The insertion tube structure of a balloon catheter, characterized in that, include: The tube body, the tube wall of which forms a hollow cavity; An insulating tube is disposed within the hollow tube cavity, the tube cavity forming a first channel, and a second channel forming between the tube wall and the inner wall of the tube body, the first channel and the second channel being isolated from each other; A conductor, wherein the conductor is disposed within the insulating tube, the conductor comprising a conductive core and an insulating layer wrapped around the conductive core, and the distal end of the first channel is sealed to the conductor; The sealing seat is provided with a fluid communication port and a wire outlet. The fluid communication port is used to connect the second channel to the outside of the sealing seat. The wire outlet is sealed to the insulating tube and is used for the lead-out of the wire.

2. The insertion tube structure as described in claim 1, characterized in that, The insulating tube is a tube of equal diameter; or, the insulating tube is a heat-shrinkable tube, and the wire is wrapped in the heat-shrinkable insulating tube.

3. The insertion tube structure as described in claim 2, characterized in that, The number of insulating tubes is greater than or equal to 2, at least one of the insulating tubes is a tube of equal diameter, and / or at least one of the insulating tubes is a heat shrink tubing.

4. The insertion tube structure as described in claim 1, 2, or 3, characterized in that, The sealing seat has a fluid cavity, the fluid communication port is connected to the fluid cavity, the proximal end of the tube body is connected to the fluid cavity, and the hollow tube cavity is connected to the fluid cavity.

5. The insertion tube structure as described in claim 4, characterized in that, The tube body includes a bending section located at the distal end, and a pull rope cavity is provided on the tube wall of the tube body; the insertion tube structure also includes a pull rope tube and a pulling rope for adjusting the bending section, the pull rope tube is inserted into the pull rope cavity, and the pulling rope is inserted into the pull rope tube; The pull rope tube passes through the sealing seat, and the inner cavity of the pull rope tube is isolated from the fluid cavity; or, the proximal end of the pull rope tube is sealed to the fluid cavity, the pull rope passes through the fluid cavity, the sealing seat is provided with a pull rope through hole for the pull rope to be led out, the pull rope passes through the pull rope through hole, and a dynamic sealing structure is provided between the pull rope through hole and the pull rope.

6. The insertion tube structure as described in claim 4, characterized in that, The sealing seat includes a seat body and a cover body, the cover body being fixed to the distal end of the seat body, and the fluid cavity being enclosed by the seat body and the cover body.

7. The insertion tube structure as described in claim 1, 2, or 3, characterized in that, The sealing seat is provided with a insertion hole, and the proximal end of the tube body is inserted into the insertion hole to form a seal with the sealing seat.

8. The insertion tube structure as described in claim 1, 2, or 3, characterized in that, It also includes a central rod disposed within the hollow tube cavity, with the distal end of the central rod extending out of the tube body and the proximal end of the central rod passing through the sealing seat and sealing with the sealing seat.

9. The insertion tube structure as described in claim 1, 2, or 3, characterized in that, It also includes an inner liner tube located inside the distal end of the hollow tube cavity. The inner liner tube is sleeved on the outside of the central rod, which can move in the inner liner tube along the proximal-distal direction. An insulating tube passes through the space between the inner liner tube and the wall of the hollow tube cavity. A sealing material is provided between the wall of the hollow tube cavity and the outer peripheral surface of the inner liner tube, and a seal is formed between the outer peripheral surface of the insulating tube and the sealing material.

10. A balloon 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 having an insertion tube structure as described in any one of claims 1 to 9, the sealing seat being disposed on the operating handle.

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