Balloon ablation catheter with adjustable electrode

Abstract

The utility model provides a balloon ablation catheter with an adjustable electrode. The balloon ablation catheter comprises a balloon catheter body, a sliding electrode set, an electrode channel and an electrode pushing assembly. The balloon catheter is arranged in the center of the balloon ablation catheter, and the balloon can be filled at the far end; the sliding electrode sets correspond to the electrode channels and the electrode pushing assemblies one to one, the sliding electrode sets are arranged at the top ends of the electrode pushing assemblies and at least comprise one sliding electrode, and the sliding electrode sets, the electrode pushing assemblies and the electrode channels are distributed around the balloon catheter. The electrode pushing assembly is arranged in the electrode channel, and each or each group of sliding electrodes are sequentially pushed through the electrode pushing assembly, so that the sliding electrodes slide towards the far end along the electrode channel, and continuously extend in the tangential direction of the contact point with the balloon after touching the filled balloon. The ablation electric field can better adapt to anatomical structures of different pulmonary vein openings, and therefore more comprehensive and safer atrial fibrillation ablation is achieved.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a balloon ablation catheter with adjustable electrodes. Background Technology

[0002] Atrial fibrillation (AF) is a common cardiac arrhythmia associated with an increased risk of stroke, heart failure, and death. Currently, catheter ablation is considered an effective treatment for AF and for maintaining sinus rhythm. Traditional thermal ablation techniques, such as radiofrequency ablation and cryoablation, carry some unavoidable risks and complications. These complications include pulmonary vein stenosis, stroke, phrenic nerve palsy, and atrioesophageal fistula, the latter having a mortality rate as high as 50%.

[0003] As a newly emerging atrial fibrillation ablation technology in recent years, pulsed field ablation (PFA) has the characteristics of non-thermal ablation, good tissue specificity, high efficiency and speed, which greatly reduces the incidence of the above-mentioned complications.

[0004] However, existing pulse ablation catheters still have certain drawbacks: the size, direction, and shape of the pulmonary vein openings can vary greatly among different patients, and existing pulse ablation catheters still cannot achieve perfect contact. There are cases where some electrodes do not contact the myocardium and are directly exposed to the blood. When the electrodes discharge, air bubbles are likely to appear in the blood. In addition, the high-voltage pulse electric field has a certain risk of arc discharge. Therefore, it is very important to solve the problem of contact between the ablation catheter and the pulmonary vein opening.

[0005] Abbott's Volt ablation catheter and Cardiac Navigation's PFBasket ablation catheter employ a basket design to address apposition issues, improving apposition compared to previous generations. However, the compliance of the flexible circuitry remains limited, and because the basket's cross-section is always a regular circle, its effectiveness is limited for irregularly shaped pulmonary vein openings. Furthermore, these catheters are relatively bulky and cannot perform electrophysiological mapping or 3D anatomical modeling functions, requiring additional mapping catheters. Therefore, there is currently a lack of ablation catheters that offer reliable apposition, flexible operation, and comprehensive functionality. Utility Model Content

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing an electrode-adjustable balloon ablation catheter that allows the ablation electric field to better adapt to the different anatomical structures of pulmonary vein openings, thereby achieving more comprehensive and safer atrial fibrillation ablation.

[0007] To achieve the above objectives, this utility model provides an adjustable balloon ablation catheter comprising: a balloon catheter, a sliding electrode assembly, an electrode channel, and an electrode pushing assembly; the balloon catheter is disposed at the center of the balloon ablation catheter, and the balloon can be inflated distally; the sliding electrode assembly corresponds one-to-one with the electrode channel and the electrode pushing assembly, and at least two sets are provided; the sliding electrode assembly is disposed at the top of the electrode pushing assembly and includes at least one sliding electrode; the sliding electrode assembly, the electrode pushing assembly, and the electrode channel are distributed around the balloon catheter, and the electrode pushing assembly is disposed within the electrode channel; each or each set of sliding electrodes is pushed sequentially by the electrode pushing assembly, causing it to slide distally along the electrode channel, and after contacting the inflated balloon, it continues to extend along the tangential direction of the contact point with the balloon.

[0008] The balloon catheter also includes a hollow cavity for placing guidewires and mapping catheters. The balloon ablation catheter includes at least four sets of sliding electrodes. The sliding electrode sets, electrode delivery device, and electrode channels are evenly distributed around the balloon catheter.

[0009] Preferably, a step is provided 5-30 mm from the proximal end of the balloon, which thickens the main body of the balloon catheter, and the electrode channel is arranged in the thickened part of the main body of the balloon catheter.

[0010] Furthermore, the balloon ablation catheter also includes an outer cannula, which has a central channel and an electrode channel inside. The electrode channels are distributed around the central channel and can be connected to the central channel or be independent channels. The balloon catheter is placed inside the central channel. Thanks to the design of the outer cannula, the distance between the distal end of the outer cannula and the distal end of the balloon catheter can be controlled during use, thereby adjusting the position and tangential direction of the contact point between the electrode pushing component and the inflating balloon.

[0011] Furthermore, the balloon catheter is equipped with electrode tracks to provide more precise guidance for the sliding electrode assembly. The electrode tracks are long, thin filaments or strips, corresponding one-to-one with the sliding electrode assembly, electrode delivery component, and electrode channel. The electrode tracks are placed within the electrode channel, with their distal ends connected to the balloon catheter and their proximal ends connected to the handle of the balloon catheter. The electrode delivery component can be a hollow delivery tube; this hollow design allows the electrode delivery component to be fitted onto the electrode tracks, making the delivery direction more controllable. After the sliding electrode assembly is delivered into position, the farthest electrode of the sliding electrode assembly is used, and an electrical signal is configured to alternate the positive and negative poles of adjacent electrodes.

[0012] The significance of this invention also lies in providing an adjustable balloon ablation catheter. By independently adjusting the position of each or each group of electrodes, the ablation electric field can better adapt to the different anatomical structures of pulmonary vein openings, thereby achieving more comprehensive and safer atrial fibrillation ablation.

[0013] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0014] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0015] Figure 1 This is a schematic diagram of the structure of one embodiment of the present utility model;

[0016] Figure 2 This is a schematic diagram of one embodiment of the balloon catheter, push rod, and outer cannula.

[0017] Figure 3 These are schematic diagrams showing different shapes of balloon catheters;

[0018] Figure 4 These are schematic diagrams illustrating different implementations of the outer sleeve;

[0019] Figure 5 This is a schematic diagram of the balloon ablation catheter before and after balloon inflation;

[0020] Figure 6 This is a schematic diagram showing the connection of the balloon ablation catheter electrode track via springs;

[0021] Figure 7 This is a schematic diagram of pulmonary vein isolation achieved using a balloon ablation catheter;

[0022] Figure 8 This is a schematic diagram of pulmonary vein isolation achieved using a balloon ablation catheter. Detailed Implementation

[0023] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0024] Please refer to Figure 1 , Figure 1 This is a schematic diagram of one embodiment of the present invention. It includes a balloon catheter 1, a sliding electrode assembly 2, an electrode channel 3, and an electrode delivery component 4. The balloon 11 is positioned at the distal end of the balloon catheter 1. After inflation, it can abut against the opening of the pulmonary vein, or slightly open the opening of the pulmonary vein to make its shape more regular. This ensures that the balloon ablation catheter is properly positioned against the opening of the pulmonary vein while preventing the electrodes of the sliding electrode assembly 2 from entering the pulmonary vein and stimulating the phrenic nerve during ablation.

[0025] In some embodiments, the balloon catheter 1 can be as follows: Figure 1 As shown in the two examples above, a step is provided 5-30 mm proximal to the balloon 11, which thickens the main body of the balloon catheter 1. The thickened part can be like... Figure 1 The example above shows that only in the middle and proximal part is the electrode pushing component 4 exposed for direct manual pushing; it can also be as follows: Figure 1 As shown in the middle example, the thickened portion connects to the handle, and the position of the distal sliding electrode assembly 2 is adjusted by the push slider 13 on the handle, which corresponds one-to-one with the electrode push assembly 4. In the above embodiment, the electrode channel 3 is arranged in the thickened portion of the balloon catheter body. In other embodiments, the balloon ablation catheter may also have an outer sheath 5 outside the balloon catheter 1, see reference. Figure 1 The following is an example.

[0026] The sliding electrode group 2 corresponds one-to-one with the electrode channel 3 and the electrode pushing component 4, and at least two groups are provided. The electrode channel 3 is preferably distributed around the axis of the balloon catheter 1. Figure 1 The illustrated embodiment includes eight sliding electrode groups 2, eight electrode channels 3, and eight electrode pushing components 4; wherein the sliding electrode groups 2 are disposed at the distal end of the electrode pushing components 4, and each sliding electrode group 2 includes at least one sliding electrode 20. Figure 1 In the illustrated embodiment, the sliding electrode assembly 2 is provided with 3 sliding electrodes 20, meaning the entire balloon ablation catheter includes a total of 24 sliding electrodes 20. During use, the electric field of each sliding electrode can be selectively switched on or adjusted, making the position of the ablation electrode, the ablation electric field, and the ablation area more selective. After the balloon 11 blocks the pulmonary vein opening, each sliding electrode assembly 2 is pushed sequentially by the electrode pushing component 4, sliding it distally along the electrode channel 3. After contacting the inflated balloon 11, it continues to extend along the tangential direction of the contact point with the balloon until it reaches the myocardium surrounding the pulmonary vein opening.

[0027] Further, refer to Figure 2 , Figure 2This is a schematic diagram of one embodiment of the balloon catheter, push rod, and outer cannula. The balloon catheter 1 has a hollow cavity 12 inside, which can be used to place a guidewire, or to place a mapping catheter before the balloon 11 is inflated to perform operations such as mapping and modeling of the heart; in addition, the balloon catheter 1 and / or balloon 11 can also be provided with contrast material to facilitate the operator to confirm the position of the balloon and whether the pulmonary vein opening is blocked.

[0028] Figure 3 These are schematic diagrams of different shapes of balloon catheters. Figure 3 The balloon 11 can be in a special shape such as olive, gourd, or pear, as shown, to better block the pulmonary vein opening, and the larger tangential slope of the proximal end of the balloon 11 avoids interference with the sliding electrode assembly 2 during operation. Figure 7 and Figure 8 The contact point of the myocardium 02 is too far from the opening of the pulmonary vein 01.

[0029] Figure 2 and Figure 3 A main implementation of the electrode pushing assembly 4 is introduced, namely the pushing rod 4a, which has good support and pushing properties. The sliding electrode 20 is preferably directly fixed to the top of the pushing rod 4a by means of pressing, bonding, welding or other methods. In order to make the pushing rod more smoothly adhere to the edge of the balloon 11 and push it in the tangential direction, the 5-30mm part of the pushing rod 4a can be pre-bent to 135-175°. When in use, the pre-bent part is expanded outward in the radial direction of the balloon conduit into a "trumpet" shape.

[0030] Figure 4 This is a schematic diagram of different implementations of the outer sheath. In embodiments with an outer sheath 5, the electrode channel 3 is arranged inside the outer sheath 5, surrounding a central channel 51. The balloon catheter 1 is placed inside the central channel 51, allowing the position and tangential direction of the contact point between the electrode pushing component 4 and the inflated balloon 11 to be adjusted by changing the distance between the distal end of the outer sheath 5 and the distal end of the balloon catheter 1, thereby controlling the position of the sliding electrode 20 in contact with the myocardium. In such embodiments, the electrode pushing component 4 can be directly pinched or pressed by hand for pushing, or it can be adjusted by the pushing slider 13. Furthermore, the central channel 51 can be as follows: Figure 4 The first and second examples show that they are independent of electrode channel 3, and can also be like... Figure 4 The third example shows a connection to electrode channel 3, thereby reducing the overall volume of the balloon ablation catheter.

[0031] In the above embodiments, the sliding electrode assembly 2 can also be used for mapping and spatial modeling. In this case, the balloon catheter 1 can be left unextended from the outer tube 5 or even completely withdrawn. Similarly, since the outer tube 5 provides the central channel 51, the balloon catheter 1 can be directly replaced with the mapping catheter during operation. After the mapping is completed, the balloon catheter 1 can be replaced with the sliding electrode assembly 2 to perform ablation.

[0032] To make the electric field distribution more controllable and uniform, in a preferred embodiment of this invention, the electrode channel 3 and the electrode pushing assembly 4 inside it are uniformly distributed circumferentially along the balloon catheter 1; furthermore, to reduce or avoid the electrode pushing assembly 4 twisting within the electrode channel 3, causing adjacent sliding electrode groups to be too close or too far apart, the electrode pushing assembly 4 and the electrode channel 3 can be as follows: Figure 5 The second and third examples and Figure 2 The shapes shown are designed as ellipses, semicircles, or other non-axisymmetric forms.

[0033] Figure 5 This is a schematic diagram of the balloon ablation catheter before and after balloon inflation. Balloon 11 is... Figure 5 The shape shown is spherical. (Reference) Figure 5 The distal end of the electrode track 14 is connected to the distal end of the balloon catheter 1 by means of bonding, welding, knotting, etc., and the proximal end is connected to the handle of the balloon catheter 1. The push tube 4b is sleeved on the electrode track 14 and slides along the path of the electrode track 14 during push. Figure 5 The first example is a schematic diagram of the distal and proximal ends of the catheter when the balloon is not inflated. The electrode track 14 hangs naturally around the balloon 11, and the push tube 4b is housed within the electrode channel 3 of the outer tube 5, with a relatively long portion of its tail protruding from the outer tube for easy subsequent push; when the balloon 11 is inflated... Figure 6 In the latter example, after inflation, the electrode track 14 deforms and adheres tightly to the balloon 11. Next, the push tube 4b is held and pushed further until resistance is felt, causing the sliding electrode assembly 2 at the tip of the push tube 4b to... Figure 8 The image shows the position where the myocardium 02, which is positioned just around the opening of the pulmonary vein 01, contacts the balloon 11.

[0034] Figure 6 This is a schematic diagram showing the connection of the balloon ablation catheter electrode track via springs. Figure 6 In this design, the electrode track 14 can be a highly elastic material, such as an elastic rope made of nylon or spandex, or a composite wire made of polymer materials braided or cored with metal wire. Furthermore, to better ensure the tension and stability of the electrode track 14 and prevent the push tube 4b from failing to conform to the shape of the electrode track 14 or from displacing or deflecting during the pushing process, the electrode track 14 can be made of a material with a high Young's modulus, such as metal wire, and has a tail end such as... Figure 6 The balloon catheter 1 is connected to the proximal end of the balloon via a lightweight spring 15 or an elastic cord of similar principle. The elongation or compression of the elastic material at the tail end is used to adapt to the changes in the electrode track 14 before and after the balloon 11 is inflated.

[0035] Next, combine Figure 5 , Figure 6 and Figure 8Another embodiment of this utility model is introduced, namely, the case where the electrode pushing component 4 is a pushing tube 4b. In these embodiments, the balloon catheter 1 is provided with a thin filament or strip electrode track 14, and the number and assembly of the electrode track 14 correspond one-to-one with the sliding electrode group 2, the electrode pushing component 4, and the electrode channel 3.

[0036] It is worth noting that, Figure 4 and Figure 2 The shape of the electrode channel 3 and the electrode pushing component 4 shown. Figure 3 The balloon shape shown is designed with a hollow cavity 12 and is applicable to any embodiment of this utility model.

[0037] Figure 7 This is a schematic diagram of pulmonary vein isolation achieved by a balloon ablation catheter. The balloon 11 is positioned at the distal end of the balloon catheter 1. After inflation, it can abut against the pulmonary vein opening 01, or slightly open the pulmonary vein opening 01 to make its shape more regular. While achieving the abutment of the balloon ablation catheter against the pulmonary vein opening 01, it avoids the electrodes of the sliding electrode group 2 from entering the pulmonary vein and stimulating the phrenic nerve during the ablation process.

[0038] Figure 8 This is a schematic diagram of pulmonary vein isolation achieved using a balloon ablation catheter. Figure 8 The sliding electrode assembly 2 at the tip of the push tube 4b shown is positioned at the point where the myocardium 02 around the opening of the pulmonary vein 01 contacts the balloon 11.

[0039] Although embodiments of this utility model have been disclosed above, they are not limited to the applications listed in the specification and embodiments. It can be applied to various fields suitable for this utility model. Other modifications can be readily implemented by those skilled in the art. Therefore, without departing from the general concept defined by the claims and their equivalents, this utility model is not limited to the specific details and examples shown and described herein.

Claims

1. The characteristic of the electrode-adjustable balloon ablation catheter is that... include: The balloon catheter, sliding electrode assembly, electrode channel, and electrode delivery component; the balloon catheter is positioned at the center of the balloon ablation catheter, and the balloon can be inflated distally. The sliding electrode group corresponds one-to-one with the electrode channel and the electrode pushing component, and at least two groups are provided. The sliding electrode group is configured at the top of the electrode pushing component and includes at least one sliding electrode. The sliding electrode group, the electrode pushing component and the electrode channel are distributed around the balloon catheter, and the electrode pushing component is configured in the electrode channel. Each or each group of sliding electrodes is pushed sequentially by the electrode pushing component, so that it slides along the electrode channel to the distal end. After touching the inflated balloon, it continues to extend along the tangential direction of the contact point with the balloon.

2. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The balloon catheter also includes a hollow cavity, which can be used to place guidewires and mapping catheters.

3. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The balloon ablation catheter includes at least four sets of sliding electrodes.

4. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The sliding electrode assembly, electrode pushing device, and electrode channel are evenly distributed around the balloon catheter.

5. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The balloon has a step 5-30 mm from the proximal end, which thickens the main body of the balloon catheter, and the electrode channel is arranged in the thickened part of the main body of the balloon catheter.

6. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The balloon ablation catheter also includes an outer cannula, which has a central channel and an electrode channel inside. The electrode channels are distributed around the central channel and can be connected to the central channel or be independent channels. The balloon catheter is placed inside the central channel. In use, the distance between the distal end of the outer cannula and the distal end of the balloon catheter can be controlled to adjust the position and tangential direction of the contact point between the electrode pushing component and the inflated balloon.

7. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The balloon catheter is also equipped with an electrode track to provide more precise guidance for the sliding electrode assembly; the electrode track is a thin filament or strip, corresponding one-to-one with the sliding electrode assembly, electrode pushing component, and electrode channel; the electrode track is placed inside the electrode channel, with its distal end connected to the balloon catheter and its proximal end connected to the handle of the balloon catheter.

8. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... The electrode pushing component can be a hollow pushing tube. The hollow design of the pushing tube allows the electrode pushing component to be fitted onto the electrode track, making the pushing direction more controllable.

9. The adjustable-electrode balloon ablation catheter as described in claim 1, characterized in that... After the sliding electrode group is pushed into place, the farthest electrode of the sliding electrode group is used, and an electrical signal is configured to make the adjacent electrodes alternate between positive and negative poles.

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