Balloon catheters and balloon electrode assemblies of balloon catheters

Abstract

This utility model relates to the field of electrophysiological catheters, specifically to a balloon catheter and a balloon electrode assembly for the balloon catheter. The balloon electrode assembly for the balloon catheter includes: a balloon body, electrode pads, the balloon body being inflatable and deflated, the electrode pads being disposed on the surface of the balloon body, and the electrode pads being used to contact target tissue; a cavity is provided at the distal end of the balloon electrode assembly, the cavity having a cavity opening facing the distal end of the balloon electrode assembly; and at least one functional component, at least a portion of which is located within the cavity. This utility model mainly solves the technical problem of the difficulty in setting functional components on the balloon electrode assembly of the balloon catheter.

Description

Technical Field

[0001] This utility model relates to the field of electrophysiological catheters, specifically to a balloon catheter and a balloon electrode assembly for the balloon catheter. Background Technology

[0002] Atrial fibrillation is the most common arrhythmia in clinical practice, and it can be treated with pulsed electric field ablation. Pulsed electric field ablation is a novel tissue ablation method 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, thereby causing the cells to gradually die and ultimately achieving the purpose of tissue ablation.

[0003] Pulsed electric field ablation can be achieved using a balloon catheter. A balloon catheter typically 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, and 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 that can be used to generate a pulsed electric field.

[0004] When using an ablation catheter, a sheath is first used to create a catheter channel in the body for the ablation catheter to pass through. The industry generally recommends an inner diameter of 12Fr-13Fr (Fr is a unit used to describe diameter in the field of catheter medical devices, 3Fr = 1mm). Therefore, the outer diameter of the ablation catheter is generally less than 4mm, or even less than 3mm. For balloon catheters, the diameter when the balloon is in a contracted state is greatly limited, and it is not easy to set additional functional components on the balloon electrode assembly. Utility Model Content

[0005] This invention mainly solves the technical problem that it is difficult to set functional components on the balloon electrode assembly of a balloon catheter.

[0006] In one aspect, one embodiment provides a balloon electrode assembly for a balloon catheter.

[0007] The balloon electrode assembly of the balloon catheter includes:

[0008] The balloon electrode assembly includes a capsule and an electrode pad. The capsule is inflatable and deflateable, and the electrode pad is disposed on the surface of the capsule and is used to contact the target tissue. The distal end of the balloon electrode assembly has a cavity with a cavity opening facing the distal end of the balloon electrode assembly.

[0009] And at least one functional component, at least a portion of which is located within the cavity.

[0010] In one embodiment, the balloon electrode assembly includes a distal connector connected to the distal end of the balloon body and arranged coaxially with the balloon body. The distal end of the balloon body has a concave structure, and the concave structure and the distal connector together form the cavity.

[0011] In one embodiment, the functional component is fixedly connected to the remote connector.

[0012] In one embodiment, the functional component is retracted into the cavity.

[0013] In one embodiment, the distal end of the bladder has a cylindrical portion, the cylindrical portion being configured to fold back toward the proximal end of the bladder, and the concave structure is formed by the cylindrical portion.

[0014] In one embodiment, the distal connector has an embedded portion that is embedded within the cylindrical portion.

[0015] In one embodiment, the functional components include at least one of a pressure sensor, a ranging module, a visual imaging module, or an ultrasound module; the pressure sensor is used to detect the contact force between the balloon electrode assembly and the target tissue, the ranging module is used to detect the distance between the balloon and the target tissue, the visual imaging module is used to image the surrounding environment at the distal end of the balloon electrode assembly, and the ultrasound module is used to perform ultrasound detection on the target tissue.

[0016] In one embodiment, the opening of the cavity has a rounded corner structure.

[0017] Secondly, one implementation provides a balloon catheter.

[0018] Balloon catheters, including:

[0019] Operating handle;

[0020] An insertion tube is connected to the distal end of the operating handle;

[0021] And the balloon electrode assembly described in any of the preceding claims, wherein the balloon electrode assembly is connected to the distal end of the insertion tube.

[0022] In one embodiment, the device further includes a central rod that passes through the insertion tube and enters the balloon body. The portion of the balloon electrode assembly with the cavity is fixedly connected to the central rod, which is used to move along the insertion tube to adjust the position of the distal end of the balloon body.

[0023] The beneficial effects of this utility model are:

[0024] According to the balloon electrode assembly in this embodiment of the present invention, the balloon electrode assembly has a cavity at its distal end, and the cavity has a cavity opening facing the distal end of the balloon electrode assembly. At least a portion of the functional components can be disposed in the cavity. Compared with additionally disposing of functional components in the balloon electrode assembly, this is beneficial to reduce the radial space occupied by the balloon electrode assembly, thereby enabling the arrangement of corresponding functional components with limited outer diameter of the balloon electrode assembly, and helping the balloon electrode assembly to achieve richer functions. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of one embodiment of the balloon catheter in this utility model;

[0026] Figure 2 yes Figure 1 A three-dimensional view of the distal portion of the balloon catheter;

[0027] Figure 3 yes Figure 2 Orthographic view;

[0028] Figure 4 yes Figure 3 A sectional view, the section passing through the line connecting the proximal and distal ends of the balloon catheter and the axis of the central rod;

[0029] Figure 5 This is a perspective view of another embodiment of the balloon catheter.

[0030] List of feature names corresponding to the labels in the figure:

[0031] 100. Operating handle;

[0032] 200. Insert tube;

[0033] 300. Balloon electrode assembly; 310. Balloon body; 311. Cylindrical section;

[0034] 320. Electrode plates;

[0035] 330. Cavity; 331. Cavity opening; 332. Rounded corner structure;

[0036] 340. Remote connector; 341. Collar;

[0037] 350. Functional components;

[0038] 400, center rod. Detailed Implementation

[0039] 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.

[0040] 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.

[0041] 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).

[0042] In an embodiment of this utility model, a cavity 330 is provided at the distal end of the balloon electrode assembly 300, and at least one functional component 350 is disposed in the cavity 330. In this way, the functional component 350 can form at least partially overlapping projections with other components located at the line connecting the proximal and distal ends of the balloon electrode assembly 300 on a projection plane perpendicular to the line connecting the proximal and distal ends of the balloon electrode assembly 300. This helps to reduce the occupancy of the radial space of the balloon electrode assembly 300 and helps to meet the setting requirements of the functional component 350 under the condition of limited radial dimensions.

[0043] An embodiment of the balloon catheter in this utility model:

[0044] 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.

[0045] The operating handle 100 allows the operator to grip and perform corresponding operations; its specific functions can be designed according to needs. 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. For example... Figure 2 The balloon electrode assembly 300 includes a balloon body 310 ( Figure 2 The capsule 310 (displayed in a transparent state) and electrode pads 320 are present. The capsule 310 can be inflated and deflated. The electrode pads 320 are disposed on the surface of the capsule 310 and can follow the capsule 310 inflating and deflated. When inflated, they can come into contact with the target tissue, such as the myocardium that causes atrial fibrillation, thereby realizing the conduction of electrical energy.

[0046] 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, 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 surround the axis corresponding to the proximal-distal direction.

[0047] Furthermore, those skilled in the art should understand that the balloon electrode assembly 300 of this invention can have a balloon body 310 made of polymer materials such as nylon, PEBAX, PET, and polyurethane, and is flexible, capable of being filled with liquid or gas and contracting when the liquid or gas is expelled. When inflated, the balloon body 310 generates tension, forming a corresponding shape, such as spherical, ellipsoidal, or other desired shapes. When contracted, the balloon electrode assembly 300 transforms into a cylindrical structure, facilitating entry and exit from the sheath. The electrode sheet 320 can be located on a flexible circuit board, which is attached to the outer surface of the balloon body 310. The number of flexible circuit boards can be set as needed; for example, the balloon body 310 in the figure has six flexible circuit boards, each distributed circumferentially around the balloon body 310. The flexible circuit boards can be fixed by methods such as bonding or hot pressing, and can deform with the deformation of the balloon body 310, presenting the desired shape to contact the target tissue. When inflated, the balloon body 310 has a large outer surface area, allowing it to support electrodes with a larger area.

[0048] In some cases, the balloon catheter may further include a central rod 400, which passes through the insertion tube 200 and enters the balloon body 310. The distal end of the balloon electrode assembly 300 is fixedly connected to the central rod 400, and the central rod 400 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 400 distally can increase the axial (i.e., proximal-distal) dimension of the balloon body 310, while moving the central rod 400 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 400 may be a solid rod or a hollow rod; when a hollow rod is used, fluid can still be delivered through the central rod 400. Furthermore, in some other embodiments, the central rod 400 is not a necessary structure and may be omitted, with the shape of the balloon body 310 changed solely by inflating or deflated fluid.

[0049] The specific structures of the aforementioned operating handle 100, insertion tube 200, electrode plate 320, center rod 400, and other components can be referred to existing structures in related technologies. Considering that they are not directly related to the innovative content of this application and the technical problem to be solved, they will not be described in detail here.

[0050] It should be noted that the balloon catheter in the embodiments of this utility model 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 this utility model can be a mapping catheter used to collect electrophysiological signals of the target tissue.

[0051] When the balloon catheter is in operation, those skilled in the art will understand that, in order to facilitate the operation of the balloon catheter or achieve better results, the operator may have some additional needs. For example, there may be a need for pressure detection to detect the contact force between the balloon electrode assembly 300 and the target tissue; there may also be a need for distance measurement, such as detecting the distance between the balloon body 310 and the target tissue; there may also be a need for imaging to image the surrounding environment at the distal end of the balloon electrode assembly 300; and there may also be a need for ultrasound detection to perform ultrasound detection on the target tissue.

[0052] However, to achieve the aforementioned functions, the balloon electrode assembly 300 needs to be equipped with corresponding functional components. The balloon catheter needs to enter and exit the sheath to reach the target tissue within the body. To reduce trauma and discomfort, the diameter of the sheath is limited; therefore, the radial dimension of the balloon catheter is also restricted, especially in the balloon electrode assembly 300 area. Due to the numerous components, complex structure, and poor shape stability, the radial dimension of the balloon electrode assembly 300 requires particular attention. Incorporating these functional components can easily lead to an increase in the radial dimension of the balloon electrode assembly 300.

[0053] In some embodiments of this utility model, please refer to Figures 2 to 4 The distal end of the balloon electrode assembly 300 is provided with a cavity 330, which has a cavity opening 331 facing the distal end of the balloon electrode assembly 300. At least a portion of at least one functional component 350 is located within the cavity 330. In this way, the functional component 350 can utilize the space formed by the cavity 330 without occupying additional radial space, thus allowing it to be conveniently mounted on the balloon electrode assembly 300 and facilitating the balloon electrode assembly 300 to perform its corresponding functions.

[0054] In some embodiments, the functional component 350 includes at least one of a pressure sensor, a ranging module, a visual imaging module, or an ultrasound module; the pressure sensor is used to detect the contact force between the balloon electrode assembly 300 and the target tissue, the ranging module is used to detect the distance between the balloon body 310 and the target tissue, the visual imaging module is used to image the surrounding environment at the distal end of the balloon electrode assembly 300, and the ultrasound module is used to perform ultrasound detection on the target tissue. The cavity 330 at the distal end of the balloon electrode assembly 300 may contain only one, two, three, or more of the aforementioned functional components 350, and may also contain other functional components 350 besides those described above to achieve more functions. The shape of the functional component 350 is not limited, for example, it may be as follows: Figure 2 The cylindrical shape shown, or as Figure 5 The prism shape shown.

[0055] It should be noted that the specific structure of the aforementioned functional component 350 can be referenced from existing structures in related technologies.

[0056] For example, the pressure sensor described above can be a sensor represented by Johnson & Johnson's Smarttouch, which uses spring deformation to provide feedback on the pressure magnitude. Other types of pressure sensors are also possible, such as photosensitive pressure sensors that use optical interferometry to provide pressure feedback. Those skilled in the art will understand that a contact-type pressure sensor generally includes two parts capable of relative displacement (which can be caused by minute deformation). When installing the pressure sensor, the fixed part can be fixed to a mounting base, such as the center rod 400, while the movable part can form an integral component with the bladder 310, displaying the direction and magnitude of the force regardless of the direction of the force applied to the bladder 310. Of course, the pressure sensor can also detect pressure in other ways, such as detecting the pressure inside the bladder 310. Since the pressure inside the bladder 310 corresponds to the contact pressure between the bladder 310 and the target tissue, it can reflect the magnitude of the contact pressure.

[0057] For example, the aforementioned visual imaging module can employ a camera module capable of real-time imaging to observe the adhesion between the balloon electrode assembly 300 and the target tissue. It can also monitor bubble formation during the ablation process, facilitating feedback control of the output high-voltage pulse signal and timely control of the amount of bubbles generated. When the data obtained from the electrochemical impedance parameters exceeds the safety threshold, i.e., when excessive bubble precipitation occurs, the output of the high-voltage pulse signal can be stopped promptly to ensure patient safety.

[0058] For example, in the aforementioned ranging module, the ranging sensor can send a signal from the tip of the balloon catheter, record the time elapsed from sending the signal to receiving it back, measure the distance from the tip of the balloon catheter to the surface of the target tissue, and display the result in real time through a display device connected to the balloon catheter. This is beneficial for obtaining information on the ablation adhesion and ensuring operational safety.

[0059] The specific structural form of the cavity 330 in the balloon electrode assembly 300 is not limited. In one embodiment, the balloon electrode assembly 300 includes a distal connector 340, which is connected to the distal end of the balloon body 310 and arranged coaxially with the balloon body 310. The distal end of the balloon body 310 has a concave structure, which, together with the distal connector 340, forms the cavity 330. In some other embodiments, the cavity 330 may also be disposed on the distal connector 340.

[0060] The distal connector 340 facilitates the closure of the distal end of the capsule 310 and also facilitates the connection of structures such as the central rod 400. However, those skilled in the art will understand that in some other embodiments, the distal connector 340 may be omitted, in which case the distal end of the capsule 310 itself can be a closed structure.

[0061] To form a concave structure at the distal end of the capsule 310, in one embodiment, the distal end of the capsule 310 has a cylindrical portion 311, which is folded back towards the proximal end of the capsule 310, and the concave structure is formed by the cylindrical portion 311. It should be noted that the aforementioned "folding back" is not intended to limit the cylindrical portion 311 to being manufactured only in a folded manner; for example, the cylindrical portion 311 can also be directly molded into the aforementioned folded shape using a mold. In some other embodiments, the distal connector 340 may have an embedded portion that is inserted into the cylindrical portion 311, thereby facilitating the fixed connection and sealing of the cylindrical portion 311 and the distal connector 340. Please refer to... Figure 4 A collar 341 can also be provided outside the cylindrical part 311 of the capsule 310. The collar 341 holds the cylindrical part 311 tightly on the distal connecting seat 340, which improves the fixation reliability. The collar 341 can be a developing ring, which can realize the developing function at the same time.

[0062] Please refer to Figure 4In some embodiments, the rim of the cavity opening 331 can be a rounded corner structure 332, which helps to avoid the bladder 310 from obstructing the functional component 350, and also helps to avoid stress concentration at the distal end of the bladder 310, and also helps to control the shape of the bladder 310 after it is filled.

[0063] The method of fixing the functional component 350 within the cavity 330 is not limited. For example, the functional component can be fixedly connected to the distal connector 340, or to the sidewall of the concave structure on the capsule 310, or simultaneously to both the capsule 310 and the distal connector 340. The fixing structure of the functional component 350 can be selected as needed, such as by adhesive bonding, fastener connection, or threaded connection. In some specific embodiments, the functional component 350 can be recessed into the cavity 330, which avoids forming a protruding structure at the distal end of the balloon electrode assembly 300, making the distal end of the balloon electrode assembly 300 a smooth shape, which facilitates the balloon electrode assembly 300 to fit against the target tissue in a more flexible posture. Of course, in some other embodiments, a portion of the functional component 350 can also protrude from the cavity opening 331 of the cavity 330.

[0064] During manufacturing, the corresponding functional component 350 can transmit signals to the outside via wired or wireless means. When using wired means, the connecting wire can be led to the operating handle 100 through the insertion tube 200.

[0065] When the balloon catheter is in operation, the functional component 350 in the cavity 330 at the distal end of the balloon electrode assembly 300 performs its corresponding function, realizing the detection of the external environment, the stress state of the balloon body 310, or the target tissue, thereby enabling the balloon catheter to have more functions. At the same time, the functional component 350 can achieve a small radial space occupation, which is convenient for installation on the balloon electrode assembly 300.

[0066] An embodiment of the balloon electrode assembly of the balloon catheter in this utility model:

[0067] The balloon electrode assembly structure of the balloon catheter is the same as that of the balloon electrode assembly 300 in any embodiment of the balloon catheter described above, and will not be described again here.

[0068] The above-described specific examples are for illustrative purposes only and are not intended to limit the scope of this invention. Those skilled in the art to which this invention pertains can make various simple deductions, modifications, or substitutions based on the concept of this invention.

Claims

1. A balloon electrode assembly for a balloon catheter, characterized by, include: The capsule and the electrode pads are provided. The capsule is inflatable and contractible, and the electrode pads are disposed on the surface of the capsule and are used to contact the target tissue. The distal end of the balloon electrode assembly is provided with a cavity, the cavity having a cavity opening facing the distal end of the balloon electrode assembly; And at least one functional component, at least a portion of which is located within the cavity.

2. The balloon electrode assembly of claim 1, wherein, The balloon electrode assembly includes a distal connector, which is connected to the distal end of the balloon body and arranged coaxially with the balloon body. The distal end of the balloon body has a concave structure, which together with the distal connector forms the cavity.

3. The balloon electrode assembly of claim 2, wherein, The functional component is fixedly connected to the remote connector.

4. The balloon electrode assembly of claim 2 or 3, wherein, The functional component retracts into the cavity.

5. The balloon electrode assembly of claim 2 or 3, wherein, The distal end of the bladder has a cylindrical portion, which is arranged in a shape that folds back toward the proximal end of the bladder, and the concave structure is formed by the cylindrical portion.

6. The balloon electrode assembly of claim 5, wherein, The remote connector has an embedded portion that is embedded within the cylindrical portion.

7. The balloon electrode assembly of any one of claims 1 to 3, wherein, The functional components include at least one of a pressure sensor, a ranging module, a visual imaging module, or an ultrasound module; the pressure sensor is used to detect the contact force between the balloon electrode assembly and the target tissue, the ranging module is used to detect the distance between the balloon and the target tissue, the visual imaging module is used to image the surrounding environment at the distal end of the balloon electrode assembly, and the ultrasound module is used to perform ultrasound detection on the target tissue.

8. The balloon electrode assembly of any one of claims 1 to 3, wherein, The opening of the cavity has a rounded corner structure.

9. A balloon catheter characterized by, include: Operating handle; An insertion tube is connected to the distal end of the operating handle; And the balloon electrode assembly according to any one of claims 1 to 8, the balloon electrode assembly being connected to the distal end of the insertion tube.

10. The balloon catheter of claim 9, wherein, It also includes a central rod that passes through the insertion tube and enters the sac. The portion of the balloon electrode assembly with the cavity is fixedly connected to the central rod. The central rod is used to move along the insertion tube to adjust the position of the distal end of the sac.

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