A deployable structure for providing electrodes on the surface of an endoscope-guided laser ablation catheter used for ablation and electrophysiological mapping.

Abstract

An ablation balloon catheter includes an outer catheter shaft and an inflatable balloon whose first end is connected to the outer catheter shaft. The catheter includes a movable nose tip to which the second end of the inflatable balloon is connected. The catheter has a first electrode basket having a plurality of first splines, whose first end is connected to the outer catheter shaft and whose second end is connected to the nose tip. A second electrode basket is also provided, which has a plurality of second splines, whose first end is connected to the outer catheter shaft and whose second end is connected to the nose tip. The second electrode basket is positioned above the first electrode basket, and the plurality of first splines are rotationally offset from the plurality of second splines. One or more first splines support one or more electrodes, and one or more second splines support one or more electrodes. The catheter has an actuator that moves the nose tip axially to facilitate the transition of the first and second electrode baskets to a folded state when the balloon deflates. The multiple first splines and multiple second splines are configured to expand radially when the inflatable balloon is inflated, with the multiple first splines interposing between the multiple second splines.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority based on U.S. Provisional Patent Application No. 63 / 504,465, filed on May 26, 2023, and the entire content of the application is incorporated herein by reference as if it were fully and explicitly set forth herein in its entirety.

[0002] The present disclosure relates to ablation of atrial fibrillation, particularly ablation of atrial fibrillation using an apparatus including a deployable structure for providing electrodes on the surface of an endoscopic - guided laser ablation catheter used for ablation and electrophysiological mapping.

Background Art

[0003] Balloon catheters configured to perform ablation of atrial fibrillation are well - known and are described in US9421066B2 by Melsky et al. and US9033961B2 by Melsky et al., the entire contents of these patents being hereby expressly incorporated by reference. In the aforementioned patents, atrial fibrillation is treated by forming non - electrically - conductive lesions (ablation lesions) in atrial tissue such that a circumferential lesion (ablation lesion) ring is formed in the region of the left atrium where the pulmonary veins connect to the atrium using an energy source. Such circumferential lesions (ablation lesions) prevent electrical signals generated from the veins from being transmitted to the atrium and vice versa. By blocking the transmission of such electrical signals, in most cases, the sinus rhythm of the left atrium, which was previously fibrillating, can be restored.

[0004] Typically, atrial fibrillation ablation involves inserting an ablation catheter into the left atrium, forming a circumferential lesion (ablation lesion) around the pulmonary veins, and then confirming that the circumferential lesion (ablation lesion) is properly formed to substantially block electrical signals. This confirmation process generally consists of removing the ablation catheter, inserting a catheter with multiple electrodes that can be positioned distal to the pulmonary veins beyond the circumferential lesion (ablation lesion), and then monitoring the electrocardiogram emanating from the pulmonary veins using these electrodes. When the veins are electrically isolated from the atria, they become silent, and only distant-field electrical activity is observed within them. Accidental spikes may occur within the veins, but they do not conduct to other parts of the atrium. By pacing the atria with a catheter whose electrodes are positioned in the coronary sinuses, it can be confirmed that only distant-field activity and random spikes are observed within the veins.

[0005] While the aforementioned devices described by Melsky et al. in US9421066B2 and US9033961B2 are effective ablation devices, like many other ablation devices, they lack a means to quickly and easily confirm electrical isolation after venous ablation is complete. It is highly desirable to be able to ablate a vein and then confirm that the desired electrical isolation of the vein has been achieved by ablation without subsequently changing the catheter. Therefore, one object of the present invention is to provide an ablation device that provides endoscopic-guided laser ablation and a means to confirm that electrical isolation of the pulmonary veins has been achieved, thereby enabling such confirmation without removing or changing the catheter. Catheter exchange, if not performed correctly, carries the risk of introducing air into the left atrium. If air enters the left atrium, it can reach the capillary beds of the brain, heart, or other organs, obstructing blood flow there and potentially damaging these organs. For this reason, catheter exchange is always performed slowly and carefully to minimize the risk of air entry. However, slow and careful catheter exchange increases the completion time of the ablation procedure. Reducing the number of catheter changes during a procedure is desirable, as prolonged procedures not only pose other risks to the patient but also increase the cost of the procedure.

[0006] Adding electrodes to the ablation catheter described by Melsky et al. in US9421066B2 and US9033961B2 not only confirms that electrical isolation of the vein has been achieved, but also enables the supply of ablation energy that requires an electrical conduction pathway from the energy source to the ablation area. The supplied ablation energy may be radiofrequency energy, electroperforation energy (also called pulsed-field ablation energy), or other energy such as laser or microwave. The ability to supply these other types of ablation energy may be desirable if certain energies are more advantageous than others from an anatomical perspective. For example, laser energy is desirable because it forms a lesion (ablated lesion) that penetrates the entire thickness of the atrium, thus ensuring that the electrical isolation by the lesion (ablated lesion) formed by the laser energy is reliable and durable. However, in situations where the esophagus is in contact with the left atrium in the area requiring ablation, the use of electroporation energy in this specific area may be desirable. This is because the electroporation energy is suggested to create lesions (ablated lesions) differently in cardiac and esophageal tissue, potentially allowing for safe ablation of cardiac tissue adjacent to the esophagus by electroporation without the need to closely monitor the esophageal temperature or stop ablation if the esophageal temperature rises too high. [Overview of the Initiative]

[0007] In summary, one object of the present disclosure is to provide a means for rapidly and easily confirming the electrical isolation of pulmonary veins isolated by endoscopic laser ablation using an apparatus similar to that described by Melsky et al. in US9421066B2 and US9033961B2. A further object of the present invention is to provide such a means without requiring catheter replacement. Yet another object of the present invention is to provide a means for confirming isolation while simultaneously supplying other forms of ablation energy that can be supplied via an electrode in contact with or adjacent to the tissue. Yet another object of the present invention is to provide an isolation confirmation or ablation electrode that can be endoscopically visualized using an endoscopic apparatus already described by Melsky et al. in US9421066B2 and US9033961B2.

[0008] In one exemplary embodiment, the ablation balloon catheter is External catheter shaft, An inflatable balloon, the first end of which is connected to the outer catheter shaft, The second end of the inflatable balloon is connected to a translatable nose tip, A first electrode basket having multiple first splines, with its first end connected to the outer catheter shaft and its second end connected to the nose tip, A second electrode basket having a plurality of second splines, the first end of which is connected to the outer catheter shaft and the second end of which is connected to the nose tip, wherein the second electrode basket is positioned on the first electrode basket, the plurality of first splines are rotationally offset from the plurality of second splines, one or more of the first splines support one or more electrodes, and one or more of the second splines support one or more electrodes, The system includes an actuator that moves the nose tip in the axial direction to facilitate the transition of the first electrode basket and the second electrode basket to a folded state when the balloon is deflated, The plurality of first splines and the plurality of second splines are configured to expand radially when the inflatable balloon is inflated, with the plurality of first splines being interposed between the plurality of second splines. [Brief explanation of the drawing]

[0009] [Figure 1] One exemplary apparatus of this disclosure shows the deployed state on the surface of an inflated balloon of an exemplary balloon catheter. [Figure 2] Figure 1 shows the retracted state of the device, ready to be advanced over the deflated balloon of the balloon catheter. [Figure 3] Figure 1 shows the device in the state where it has been advanced over the inflated balloon of the balloon catheter, and in the state where it has been partially deployed by the inflation of the balloon. [Figure 4] This shows a basket attached to a PFA catheter. [Figure 5] This shows an electrode catheter used in conjunction with a balloon catheter. [Figure 6] Figure 5 shows a dual transseptal / second catheter device in which the electrode catheter is positioned above the balloon catheter. [Figure 7] An embodiment of a retractable tine electrode array is shown. [Figure 8A] Figure 8A shows one of the various states of a retractable tine electrode array. [Figure 8B] Figure 8B shows one of the various states of a retractable tine electrode array. [Figure 8C] Figure 8C shows one of the various states of a retractable tine electrode array. [Figure 9] This shows a balloon catheter equipped with a PFA braided wire mesh electrode array. [Figure 10] This shows a balloon equipped with an implantable electrode array. [Figure 11]A balloon catheter having micropores and an internal electrode array is shown. [Figure 12] A balloon catheter having micropores and an internal electrode array is shown. [Figure 13] Another balloon catheter having micropores and an internal electrode array is shown. [Figure 14] FIG. 9 is a block diagram showing exemplary components of an endoscopic guide cardiac ablation system according to the present invention. [Figure 15A] FIG. 15A is a perspective view of a translatable tip balloon catheter according to one embodiment, showing its folded state. [Figure 15B] FIG. 15B is a perspective view of the translatable tip balloon catheter of FIG. 15A in an expanded state. [Figure 16A] FIG. 16A is a perspective view of a handle suitable for use with the translatable tip balloon catheter of FIG. 15A, showing its deployed state. [Figure 16B] FIG. 16B is a perspective view of the handle of FIG. 16A in a retracted state.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 shows an example of an exemplary balloon catheter as described in US9421066B2 and US9033961B2 by Melsky et al., which are hereby incorporated by reference in their entirety.

[0011] <Exemplary Ablation System> FIG. 14 is an exemplary schematic block diagram showing an ablation / endoscopic system 10 according to the present invention, generally designated by the reference numeral 10. The ablation system 10 preferably includes a therapeutic ablation device as described herein, preferably including an endoscope and an ablation device as described hereinafter.

[0012] The ablator system 10 preferably further includes a aiming light source 20 and an illumination light source 24. The processor 12 is designed to receive input data and output data from the connected devices, namely the display 14 and the controller 16, and process the data into visual information.

[0013] As can also be understood from the following description, the endoscope is preferably provided in the ablation device 100 and has a function of capturing and recording both live images and still images. The illumination light is used to provide surgical illumination to the treatment site. This illumination light is light in a frequency band that allows the user to identify various tissues present at the surgical site. The aiming light source 20 is used to visualize the position where the ablation device 100 supplies energy to the tissue. It is assumed that the aiming light is light with a wavelength that can be recorded by the imaging device and is visible on the display 14.

[0014] The processor 12 can be designed to be able to process not only live visual data but also data from the controller and display of the ablation device. The processor 12 is configured to execute a series of software modules and / or hardware modules that are configured to interpret, process, and record the visual information received from the treatment site. The processor 12 can further be configured to process and provide illustrative graphic overlays and composite or hybrid visual data to the display device.

[0015] As shown in Figure 14, the system 10 further includes a controller 16, an energy source 18, a targeting light source 20, and a user interface 22. The controller 16 is preferably configured to control the output of the energy source 18, as well as the illumination light source 24 and excitation light source 25 of the energy transmitter, and is also configured to determine the distance and movement of the energy transmitter to the tissue of the ablation treatment site (as will be further described below). As will also be understood from the following description, the endoscope is preferably supported by the ablation device and takes images that can be processed by the processor 12 to determine whether sufficient ablation energy has been delivered to a specific area of ​​the treatment site. The data acquired from the endoscope includes real-time video or still images of the treatment site as seen from the ablation device. As described herein, these images / videos may be stored in memory for later use.

[0016] The targeting light source 20 is used to visualize the location of the treatment site from which the ablation device will deliver energy to the target tissue. Preferably, the targeting light source 20 emits light in the visible region of the electromagnetic spectrum. Once the user has confirmed the appropriate ablation path, the controller 16 can transfer radiant energy from the ablation device to the target tissue site via the energy source 18 to perform ablation by the lesion (ablation lesion). It should be noted that, as used herein, the term “radiant energy” is intended to include energy sources that do not primarily rely on heat transfer by conduction or convection. Such sources include, but are not limited to, acoustic sources, laser energy sources, electroporation energy sources, electromagnetic radiation sources, and more specifically, microwave sources, X-ray sources, gamma-ray sources, ultrasonic sources, and synchrotron radiation sources. Additionally, as used herein, the term “light” is intended to include electromagnetic radiation such as visible light, infrared radiation, and ultraviolet radiation.

[0017] The illumination light source 24 is a light source used to provide appropriate illumination to the treatment site. This illumination is configured so that the surgeon can easily identify natural biological colors and shades.

[0018] The controller 16 provides the user with the ability to control the functions of the targeting light source 20, the user input device, and the ablation equipment. The controller 16 functions as the primary control interface of the ablation system. The user can turn both the targeting light and the illumination light on and off via the controller 16. Furthermore, the controller 16 also has the ability to change the intensity of the illumination light and the targeting light. The ability to switch the user interface or display device is also envisioned. In addition, the controller 16 provides access to the ablation equipment, including control of discharge intensity, duration and location of ablation energy discharge. The controller 16 may also provide the ability to safely shut down the system if a clear transmission path between the radiant energy source and the target tissue is lost during energy supply (see, for example, U.S. Patent Application No. 12 / 896,010, jointly owned and filed 1 October 2010, which is incorporated herein by reference in its entirety).

[0019] The controller 16 may be an independent microprocessor-based control interface hardware, or it may be part of a module that operates via a processor-based computer system configured to accept and control inputs from various physical devices.

[0020] <Ablation energy due to pulsed electric field> While the field of pulsed electric field technology in tissue therapy continues to evolve, it is generally known that applying a short-duration high DC voltage to tissue generates a locally strong electric field, typically several hundred volts per centimeter, which destroys the cell membrane by forming pores. Although the precise mechanism of this electrically induced pore formation or electroperforation is still being studied, it is thought that applying a strong electric field for a relatively short time causes instability in the lipid bilayer of the cell membrane, resulting in the distribution of localized gaps or pores in the cell membrane. This electroperforation becomes irreversible when the electric field applied to the membrane exceeds a threshold, and the pores remain open instead of closing, allowing biomaterials to be exchanged across the membrane and causing necrosis and / or apoptosis (cell death). Subsequently, the surrounding tissue may heal spontaneously.

[0021] Generally, a system for supplying a pulsed waveform to tissue, as described herein, includes a signal generator configured to generate a pulsed waveform and an ablation device connected to the signal generator and configured to receive the pulsed waveform. In some embodiments, the ablation device is configured to generate an electric field strength of about 200 V / cm to about 1500 V / cm. Thus, a tissue ablation system described herein may include a signal generator and an ablation device having one or more electrodes and expandable / inflatable members (e.g., balloons) to selectively and rapidly apply a DC voltage to drive electroporation.

[0022] In some embodiments, the voltage pulse waveforms disclosed herein may be hierarchical and have a nested structure.

[0023] The irreversible electroporation systems described herein may include a signal generator and a processor configured to supply energy to a target region by applying one or more voltage pulse waveforms to a set of electrodes. To supply the pulse waveforms generated by the signal generator, one or more electrodes of the ablation apparatus may, in at least one embodiment, have insulated electrical leads configured to maintain a voltage potential of at least about 2500 V without causing dielectric breakdown of the corresponding insulator. In some embodiments, at least some electrodes are individually addressable so that each electrode can be controlled (e.g., supplied with energy) independently of any other electrodes of the apparatus.

[0024] As shown in Figure 14, the system may include a signal generator 29 configured to generate pulse waveforms for irreversible electroperforation of tissue, such as pulmonary veins. For example, the signal generator 29 may be a voltage pulse waveform generator and configured to supply pulse waveforms to any of the ablation apparatus (ablation equipment) described herein. The processor 12 may use data received from memory to determine the parameters of the pulse waveform generated by the signal generator 29, some of which parameters, such as voltage, may be input by the user. The memory may further store instructions, such as pulse waveforms, for the signal generator 29 to execute modules, processes, and / or functions related to the system. For example, the memory may be configured to store pulse waveforms for pulse waveform generation.

[0025] Some embodiments relate to pulsed high-voltage waveforms combined with a sequenced delivery method for supplying energy to tissue via a set of electrodes. The signal generator and processor may be configured to apply pulsed voltage waveforms to a selection of electrodes or a subset of electrodes of the ablation apparatus.

[0026] In some applications, the pulse voltage waveform may take the form of a sequence of double pulses, where each pulse is related to pulse width or duration. The pulse width / duration may be approximately 0.5 microseconds, approximately 1 microsecond, approximately 5 microseconds, approximately 10 microseconds, approximately 25 microseconds, approximately 50 microseconds, approximately 100 microseconds, approximately 125 microseconds, approximately 140 microseconds, approximately 150 microseconds, etc. (including all values ​​and subranges between these). The pulse waveform may also be defined by a set of single-phase pulses where all pulses have the same polarity (e.g., all are positive when measured from a zero reference line). In some embodiments, for example in irreversible electroporation applications, the height or voltage amplitude of each pulse may be in the range of approximately 400 volts, approximately 1,000 volts, approximately 5,000 volts, approximately 10,000 volts, approximately 15,000 volts (e.g., in some applications, a maximum amplitude of 2,500 volts is used) (including all values ​​and subranges between these). Pulses are separated from adjacent pulses by a time interval (also called the first time interval). For example, to form irreversible electroporation, the first time interval may be about 1 microsecond, about 50 microseconds, about 100 microseconds, about 200 microseconds, about 500 microseconds, about 800 microseconds, or about 1 millisecond (including all values ​​and subranges in between). Note that values ​​outside the above ranges may exist for other applications, so the values ​​mentioned above are merely illustrative and do not limit the scope of the present invention.

[0027] <Example of an ablation catheter> As shown in Figures 1 to 3, one exemplary ablation device typically involves a flexible, elongated structure 1, which is slidably positioned on the elongated shaft 2 of a balloon ablation catheter. The elongated structure 1 may also be considered a sleeve that is longitudinally displaceable on the balloon catheter. While the term “elongated structure” is used herein, it should be understood that the term “sleeve” may also be used interchangeably. As described herein, the elongated structure 1 may move along the balloon catheter to cover different regions of the balloon catheter. As described herein, the elongated structure 1 is configured to follow the movement of the balloon ablation catheter, particularly the expansion and contraction of the balloon when the elongated structure covers the balloon at least partially.

[0028] The elongated structure 1 generally has several distinct parts, including a proximal and distal portion. The proximal portion of the elongated structure 1 includes a first tubular portion 3, as shown in Figure 1. This proximal region is positioned 2 cm to 4 cm behind the distal end, but this is merely an illustrative value and does not limit the scope of the invention. The first tubular portion 3 is configured such that the shaft 2 of the balloon ablation catheter passes through its lumen. In other words, the first tubular portion 3 completely surrounds the catheter shaft 2 in at least one region of the first tubular portion 3.

[0029] The first tubular portion 3 may be formed from a flexible material.

[0030] The distal portion of the elongated structure 1 is multi-branched into two or more, preferably six or more, branch sections 4, and these branch sections 4 are also flexible. Each branch section 4 has one or more electrodes 5 on its outward-facing surface. Each electrode 5 is connected to an insulated conductor embedded in the body of the elongated flexible structure 1, but these conductors and the like are not shown in Figure 1. For example, the structure 1 may be overmolded over the conductors. As shown, when multiple electrodes 5 are used in each branch section 4, these electrodes 5 are arranged at longitudinal intervals along each branch section 4. It should also be noted that the electrodes 5 may all be of the same type or of different types. In other words, the electrodes 5 may be of different sizes and / or shapes. The arrangement of the electrodes 5 may be asymmetrical in that the electrodes 5 may be concentrated in one or more regions of the branch section 4. For example, the electrodes 5 may be located more centrally or distally along the branch section 4, rather than proximal.

[0031] Thus, the branching sections 4 may be arranged at intervals from one another in the circumferential direction and may unfold circumferentially around the balloon. Furthermore, the branching sections 4 may be designed in an asymmetrical shape, in that the angular displacements between the branching sections 4 may not be symmetrical, but rather asymmetrical. In other words, one half of the elongated structure 1 may have branching sections 4 of a certain type, while the other half may have different angular displacements. In other words, one half of the structure 1 may have more branching sections 4 than the other half. For example, one half in the first circumferential direction may have a first number of electrodes, and the other half in the second circumferential direction may have a second number of electrodes different from the first number.

[0032] As shown in the figure, each branch 4 has a first end (proximal end) and a second end (distal end) opposite it. The first end of the branch 4 is attached to the first tubular portion 3, and in one embodiment, the branch 4 is formed integrally with the first tubular portion 3.

[0033] Multiple flexible branches 4 merge again at their second ends to form a second tubular structure 6 at the distal end of the elongated structure 1. The second tubular structure 6 slidably surrounds the distal tip 7 of the balloon ablation catheter (both axially and rotationally).

[0034] Generally, the multi-branch section (branch section 4) forms an expandable cage-like structure that surrounds the inflated balloon 8 circumferentially when the elongated structure 1 is positioned over at least a portion of the balloon. The proximal portion of the elongated structure 1 may maintain a tubular shape proximal to the posterior multi-branch section (branch section 4), or alternatively, the proximal portion of the elongated structure 1 may consist only of a circumferential portion of the tube as shown in 9, which is more flexible and has a smaller volume than when the whole is tubular. The shaft 2 may be visible through the portions of the elongated structure 1.

[0035] It should be noted that this device is preferably formed as a single elongated structure 1 in which the tubular portions 3 and 6 and the branching portion 4 located between them are formed as a single integrated part (e.g., a molded part).

[0036] Figure 2 shows the movement of the elongated structure 1 on a balloon catheter. More specifically, the first tubular section 3 and the branch section 4 are shown in a relaxed state. This represents the normal, stationary state of the elongated structure 1. This state clearly demonstrates how such a structure can be manufactured by forming a series of longitudinal slits 10 in a roughly thin, flat material formed into a tubular shape. In other words, the branch section 4 is formed by incorporating longitudinal slits into the structure 1 and defining one branch between two adjacent slits. Suitable thin, flat materials include polyimide films commonly used in the manufacture of flexible printed circuit boards or flexible circuits. Of course, it should be noted that other materials can be used as well.

[0037] Figures 1 and 2 both illustrate how this device achieves the objective of providing a means to enable pulmonary vein isolation using an endoscope-guided balloon catheter, and additionally, a means to confirm electrical isolation of the vein without catheter replacement as in the prior art. As will be described in more detail below, the inner surface of the tubular structure may include markers on the inner surface that are visible with an endoscope to indicate the position of the electrodes.

[0038] Therefore, there are two distinct operational stages. The first stage is the ablation stage in which the elongated structure 1 is not used. In this ablation stage, as shown in Figure 2, the elongated structure 1 is located proximal to the balloon of the balloon catheter and is folded to closely surround the shaft 2 of the balloon catheter. In this stage and state, the entire elongated structure 1 is displaced from the balloon of the balloon catheter and is located proximal to the balloon. Therefore, the distal second tubular shaft portion 6 is located proximal to the balloon.

[0039] In this state (first stage), the elongated structure 1 allows the balloon of the ablation catheter to be inflated and placed in the pulmonary vein without being obstructed by the elongated structure 1. The vein may be visualized endoscopically by the ablation catheter, and laser energy may be supplied to the vein regardless of the present invention. In other words, as in the applicant's previous ablation catheter designs, the energy from the movable energy emitter 60 (Figure 2) located in the balloon passes through the balloon and reaches the target site without being obstructed by the elongated structure 1, because the elongated structure 1 is positioned at a distance from and not in contact with the inflated operating area of ​​the balloon.

[0040] This situation would not occur if the electrode (e.g., electrode 5) were placed directly on the surface of the balloon, because such an electrode would block both the laser energy and endoscopic visualization in the portion of the balloon where the electrode is located.

[0041] Once the venous ablation (first stage) is complete, the balloon of the ablation catheter is deflated, but the elongated structure 1 of the ablation catheter remains in position relative to the vein. With the ablation catheter structure immobile relative to the ablated vein, the elongated structure 1 is advanced distally over the deflated balloon. Subsequently, the balloon is reinflated, and this reinflation expands the branch (multi-branch) 4 of the elongated structure 1, pressing at least some of the electrodes 5 into contact with the lumen of the vein. These electrodes 5 can now be used to confirm electrical isolation by connecting a conductor, which is connected to the electrodes 5 and extends proximal along the proximal portion of the elongated structure 1 that extends outside the patient's body, to a known device capable of amplifying and displaying the electrical activity emitted from the tissue in contact with the electrodes 5.

[0042] Furthermore, it should be noted that when electrode 5 is in contact with pulmonary venous tissue (or other target tissue), ablation energy such as radiofrequency energy, electroporation energy, or microwave energy can be supplied by connecting such an energy source to the wire attached to the electrode. It should also be noted that the electrode position is visible by an endoscope 50 (Figure 2) located within the balloon of the ablation catheter. This visibility is achieved by manufacturing the multi-furcation 4 from a transparent material or by marking the inner surface of the multi-furcation directly adjacent to the electrode position. Endoscopic visualization of the electrode position allows for a visual assessment of the contact state between the electrode and tissue. For example, a particular electrode may be in firm contact with venous tissue throughout the entire cardiac cycle. Alternatively, electrode 5 may be in contact with tissue for part of the cardiac cycle and in the rest of the cardiac cycle in contact with blood rather than tissue, or it may not be in contact with tissue at all during the cardiac cycle. Such a visual assessment of the contact state between tissue and electrode is not available with any currently known device. Such an assessment is useful in interpreting the electrocardiogram measured by the electrode. Furthermore, when electrodes are used to apply radiofrequency ablation energy, electroporation ablation energy, or microwave ablation energy, such visual information regarding the degree of tissue contact can be used to determine which of multiple electrodes is suitable for supplying ablation energy based on the degree of tissue contact shown by each electrode. Endoscopic images can also be used, if necessary, to guide changes in the position of the balloon within the vein to more accurately assess the electrical activity within the vein, or to improve the contact between the electrode and venous tissue for electrode contact that enables ablation by application of radiofrequency energy or electroporation energy.

[0043] <Sliding motion of the elongated structure 1> As described herein, the elongated structure 1 is configured to move longitudinally along the balloon catheter, as shown in Figures 1 to 3. It can also rotate relative to the balloon. The elongated structure 1 may be moved manually by grasping one end of the elongated structure 1 (e.g., the first tubular portion 3) and moving the entire structure 1 longitudinally distally or proximal. Alternatively, to move the elongated structure 1 proximal, the first tubular portion 3 may be grasped and pulled proximal. Preferably, the first tubular portion 3 extends proximal to a position outside the body where it can be directly grasped by the user. To assist the user in moving the structure 1, the structure 1 may have a grasping portion at its most proximal end, such as a ring-shaped portion that extends from the proximal end of the first tubular portion 3. Alternatively, one or more regions of the first tubular portion 3 may be provided with a surface texture or the like.

[0044] As the elongated structure 1 is retracted and moves proximal, it may enter the lumen formed in the catheter structure, or the lumen in a guide sheath or deflectable sheath commonly used in atrial ablation procedures. The balloon catheter and the tubular structure pass through these lumens. That is, the tubular structure may be slid into the catheter shaft or into the guide sheath or deflectable sheath, and this retraction folds the elongated structure 1 and withdraws it from the relevant portion around the balloon. Retraction of the structure 1 into the lumen of the catheter shaft folds the branch into a compact state. Note that when the tubular structure is retracted into the guide sheath or deflectable sheath, the multi-branch of the tubular structure is supported by the inner surface of such sheath, suppressing outward expansion or deflection, and inward deflection is also suppressed by the shaft of the balloon catheter. In this state, the tubular structure can be more easily repositioned relative to the balloon catheter because its expansion or contraction is limited. In the case of a device where the ablation energy used is supplied only through electrodes, it is not necessary to retract the elongated structure to a position completely proximal to the balloon. In other words, the elongated structure 1 is movable between several positions, one of which is a position where at least some of the electrodes cover at least partially the balloon.

[0045] <Controllable electrodes> The overall ablation system described herein, including the elongated structure 1 and the ablation balloon catheter, can communicate with various machines configured to send and receive content, data, and instructions that, when executed, operate various connected components / mechanisms over a network. The content and data may include, in non-limiting examples, information in various forms such as text, audio, images, and video, and may include embedded information such as links to other resources on the network, metadata, and / or machine-executable instructions. Each computing device may be in a conventional configuration, and a server that provides various content and services to other devices such as mobile computing devices is described, but one or more server computing devices may include the same machine as understood by those skilled in the art, or in large-scale implementations they may be distributed across multiple machines. In the relevant parts, each computer server has one or more processors, computer-readable memory that stores code configured to cause the processors to perform at least one function, and a communication port for connecting to a network. The code may include one or more programs, libraries, functions, or routines, and for the purposes of this specification, may be described with respect to multiple modules stored in a representative code / instruction storage, these modules performing different parts of the process described herein. As described herein, each robotic device (tool) includes a controller (processor) and therefore comprises one form of the computing device described above.

[0046] Furthermore, computer programs such as image processing software or measurement software (also commonly referred to herein as computer-controlled logic or computer-readable program code) may be stored in main memory and / or secondary memory and executed by one or more processors (such as controllers), causing one or more processors to perform the functions of the present invention as described herein. In this document, the terms “memory,” “machine-readable medium,” “computer program medium,” and “computer-usable medium” are used generally to refer to media such as random access memory (RAM), read-only memory (ROM), removable storage units (such as magnetic disks, optical disks, flash memory devices), and hard disks. In the case of mobile computing devices (e.g., tablets), it should be understood that computer programs such as image processing software may take the form of applications that run on the mobile computing device.

[0047] The system may include a graphical user interface (GUI) which may be provided to enable remote control of the system. As is well known, a GUI is a system of interactive visual elements for computer software. A GUI displays objects that convey information and represent activities that a user can perform. When a user interacts with an object, its color, size, or visibility changes. GUI objects include icons, cursors, and buttons. These graphic elements may be enhanced by sound or visual effects such as transparency and drop shadows.

[0048] A graphical user interface typically includes a display, such as a touchscreen display, that can register user input, and once input is registered, it is processed by the main controller (main processor).

[0049] In one exemplary embodiment, a main controller may be used to control the operation of electrode 5. In other words, the main controller may be used to operate (activate) the selected electrode 5 at a specific time. Ablation energy is supplied to the activated electrode 5, and no ablation energy is supplied to the non-activated electrode 5. As described, since electrode 5 is wired to an electrical connector that is itself connected to a terminal (console) or the like (e.g., a socket or its plug), power may be supplied to electrode 5.

[0050] Depending on certain parameters such as the position of the balloon catheter in the body, a specific electrode 5 may be activated and turned on, while a specific electrode 5 may be turned off and deactivated. For example, when the balloon catheter and the tubular structure contact a specific tissue and the contact with the tissue is visualized by an endoscope inside the balloon, the user may want to supply ablation energy only to the electrode 5 in contact with the tissue, so based on guidance by the endoscope or the like, the surgeon can strategically select the branch 4 and electrode 5 to be activated.

[0051] The master controller may communicate with a display that can display images and data.

[0052] The branch 4 and electrode 5 to be activated (energized) may be selected using a touch screen or the like. For example, a graphic image of the elongated structure 1, more specifically, a graphic image of the branch 4 and electrode 5 may be displayed to the surgeon, and the surgeon may select the branch 4 / electrode 5 to be activated. When using a touch screen, the surgeon only needs to highlight and select the branch 4 / electrode 5 to be activated with a finger. It should also be noted that it is possible to use AI-based software to determine which electrode is in contact with the tissue and recommend to the user the electrode to be activated based on that determination.

[0053] <PFA Catheter Mounted Basket> Figure 4 shows a balloon catheter 100 including a main catheter shaft 110 having a distal end. Note that the balloon catheter 100 typically includes two or more shafts, often including an inner catheter shaft and an outer catheter shaft, but may also include multiple concentric tubular structures. An inflatable balloon 120 is included, and the inflatable balloon 120 is connected to the main catheter shaft 110 such that its distal end is close to the distal end of the main catheter shaft 110 and its proximal end is spaced away from the distal end of the main catheter shaft 110. In this way, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0054] Figure 4 shows the inner shaft 115 along with the endoscope 125. The endoscope 125 extends along the outside of the inner shaft 115 and is typically positioned at one end of the balloon, facing forward toward the other end of the balloon, thus being a forward-viewing type.

[0055] The inflatable balloon 120 is preferably a compliant balloon.

[0056] The inflatable balloon 120 also includes an endoscope 125 located within the compliant balloon. This endoscope allows the catheter operator to visualize the surface of the balloon, enabling them to direct laser energy to the portion of the balloon surface that comes into contact with the atrial tissue to be treated with laser energy. Such systems are described by Melsky et al. (U.S. Patent No. 9,421,066 ('066 patent)) and Melsky et al. (U.S. Patent No. 9,033,961 ('961 patent)), the entirety of which these patents are incorporated by reference. The endoscope 125 is located proximal to the point where energy is supplied to the tissue, allowing the user to observe the energy supply and the resulting tissue lesion (ablation lesion). The endoscope 125 may be one of the endoscopes described herein, or one of the documents incorporated by reference herein.

[0057] Figure 4 shows an energy emitter 127, but it should be noted that in embodiments where the electrode array is intended to remain in a position surrounding the inflatable balloon 120, the energy emitter 127 can be omitted or, if present, is never used. The energy emitter 127 may be used if the electrode array can be displaced from the balloon.

[0058] The endoscope 125 is forward-facing and positioned adjacent to one of the catheter shafts, such as a central tube typically formed of a transparent polymer material. As used herein, the term “forward-facing” refers to the endoscope’s field of view distal to the catheter body. Similarly, the term “lateral” refers to the endoscope’s field of view radially outward from the side of the catheter body.

[0059] The endoscope 125 may be a fiber optic endoscope that is inserted through the lumen of the catheter and positioned within the proximal region of the inflatable balloon 120.

[0060] In another embodiment, the ablation catheter 100 includes a first imaging device and a second imaging device for directly visualizing the treatment area, the first imaging device being fixed to the catheter body. The first and second imaging devices may be in the form of a first imaging chip endoscope and a second imaging chip endoscope. Details of the first and second imaging chip endoscopes are described in U.S. Patent Application No. 17 / 524,472, which is expressly incorporated herein by reference in its entirety.

[0061] The balloon catheter 100 includes an expandable basket 130, which surrounds an inflatable balloon 120 and is configured to expand when the inflatable balloon 120 is inflated, and similarly to contract when the inflatable balloon 120 is deflated and reduced. The expandable basket 130 includes a first collar (first ring) 132 at its first (proximal) end and a second collar (second ring) 134 at its second (distal) end. The first collar 132 and the second collar 134 are annular and may have a continuous ring shape. The two collars 132 and 134 may be of different sizes, and in the illustrated embodiment, the first collar 132 is larger than the second collar 134. The two collars 132 and 134 are sized to fixate the expandable basket 130 to the main catheter shaft 110 (or one or more other catheter shafts) such that the inflatable balloon 120 is positioned between the two collars 132 and 134. Therefore, preferably, the first collar 132 is located proximal to the inflatable balloon 120, and the second collar 134 is located distal to the inflatable balloon 120.

[0062] The expandable basket 130 includes a plurality of splines 140, one end of which is attached to a first collar 132 and the other end to a second collar 134. The plurality of splines 140 unfold longitudinally along the length of the inflatable balloon 120. The plurality of splines 140 are offset from each other circumferentially so that spaces are formed between adjacent splines 140. The splines 140 are configured to expand or contract under the action of the underlying inflatable balloon 120. Specifically, when the inflatable balloon 120 expands during inflation, the splines 140 expand outward, and conversely, when the inflatable balloon 120 contracts during deflation, the splines 140 contract inward. In this way, the shape of the splines 140 matches the shape of the inflatable balloon 120.

[0063] Each spline 140 holds one or more electrodes 150. For example, each spline 140 may include multiple electrodes 150, which may be described as an electrode array. In the illustrated embodiment, three electrodes 150 are arranged along the length of the spline 140. The electrodes 150 are spaced longitudinally (in series) along the spline. Thus, the electrodes 150 are spaced apart from each other by a predetermined set distance. The position of the spline 140 along the spline 140 is selected so that the electrodes 150 are centered relative to the inflatable balloon 120, as the electrodes 150 are displaced relative to the target tissue to be ablated using PFA technology, as described herein, when the inflatable balloon 120 is inflated.

[0064] The electrodes 150 that define the electrodes may be different even if they are of the same type. For example, the shape and size of the electrodes 150 may be the same as shown in the figure. The material of the expandable basket 130 is non-elastic in that the splines do not stretch elastically in the longitudinal direction, but can be expanded or contracted together with the inflatable balloon 120 of the lower layer. Therefore, even when the expandable basket 130 moves between the expanded and retracted positions, the longitudinal spacing between the electrodes 150 does not change. Rather, the important thing is that the spacing is a fixed distance, and this information is used during the visualization and ablation process to form a desired lesion (ablation lesion), as described herein.

[0065] In comparison with the embodiments shown in Figures 1 to 3, Figure 4 shows a product in which the expandable basket 130 is fixed in at least one embodiment.

[0066] In yet another aspect of this disclosure, the system may include electrode markers indicating the position of the electrode 150 along the spline. Specifically, the electrode 150 is located on the outer surface of the spline 140, and since the spline is typically formed of an opaque material, the electrode 150 is not visible in the live endoscopic image. Since the spline 140 is typically formed of an opaque material, the electrode 150 is not visible because the endoscope 125 only sees the inner surface of the spline 140. Markers may be provided along the inner surface of the spline 140 to determine the position of the electrode 150 during visualization (i.e., use of the endoscope 125). Each marker is positioned on the inner surface of the spline 140 so as to face the position of the electrode 150 in order to indicate the position of the electrode 150. The markers may be in the form of visual marks formed along the inner surface of the spline 140, since they are visually identifiable in the live endoscopic image. For example, the visual marks may be in the form of numbers and / or text marks. Furthermore, the visual marks are selected so as to distinguish one electrode from another. For example, each spline may be numbered, such as spline 1, and each electrode 150 may be labeled with a letter such as A, B, C. Therefore, in the illustrated embodiment, the most distal electrode of spline 1 can be identified by marker 1A, the intermediate electrode by marker 1B, and the most proximal electrode by marker 1C. Similarly, for the adjacent spline 2, the markers may be 2A, 2B, and 2C. Note that there are many ways to visually distinguish electrodes on one spline from electrodes on another.

[0067] For example, one spline 140 may be distinguished from another spline 140 by color. For instance, the letters A, B, C, or the numbers 1, 2, 3 may be assigned a different color to one spline and a different color to another. Symbols may also be used as markers.

[0068] Please note that not all electrodes 150 are visible in the live endoscopic image. This is because not all electrodes are in the desired contact state with the target tissue. Therefore, it is important to understand which electrodes are visible in the live endoscopic image and which can be activated by contact with the tissue.

[0069] The movement of the expandable basket 130 and the inflatable balloon 120 may vary depending on the embodiment. For example, in one embodiment, the expandable basket 130 and the inflatable balloon 120 may move together, while in another embodiment, the basket 130 may move independently of the balloon 120. For example, the basket 130 may be fixed in the rotational direction, but may move axially (vertically), or in another embodiment, it may be fixed.

[0070] The movement of the expandable basket 130 relative to the catheter body and inflatable balloon 120 may be either an automated process using an electronic control device or a manual process operated by the user. These controls enable desired movement in the rotational and / or longitudinal directions.

[0071] Regarding energy supply and electrode selection, in one embodiment, energy is supplied to two or more electrodes 150 arranged along the same spline 140. In this embodiment, the distance between electrodes 150 on one spline 140 is fixed and does not change with basket expansion. This allows for selection of the PFA dosage because the distance between the activated electrodes 150 is known. In another embodiment, energy is supplied between two electrodes 150 that are not arranged along the same spline 140 but along adjacent splines 140. In this case, the distance between the splines 140 changes depending on the degree of basket expansion. For example, the greater the degree of basket expansion, the greater the distance between the splines 140, and therefore the greater the distance between the electrodes 150. When the electrode spacing is fixed, the predictability of the dosage is increased.

[0072] The PFA dosage is selected based on the visualization information and the position and spacing of the electrodes that are activated to induce the formation of lesions (absorbed lesions). The correct (optimal) dosage is one that effectively isolates the tissue without adversely affecting its quality.

[0073] In tissue ablation, instead of activating all electrodes 150, only specific selected electrodes 150 are activated. Only the electrodes 150 in direct contact with the tissue are activated to supply energy and form a tissue lesion (ablated lesion).

[0074] Depending on the visualization information, it may be necessary to move the basket 130 axially and / or rotationally to perform ablation. For example, if the electrode spacing is too wide, it may be necessary to supply energy to form the first lesion (ablated lesion), then move the basket relative to the balloon (axially and / or rotationally) to change the electrode position, and then supply energy to form a second lesion (ablated lesion) that combines with the first lesion (ablated lesion) to form a complete lesion (ablated lesion). Alternatively, the circumferential electrode spacing may be estimated from the endoscopic image, and the PFA dosage may be adjusted to compensate for different electrode spacings.

[0075] The shape and size of the formed lesion (ablated lesion) vary depending on which electrode is activated and its position. For example, activating two electrodes 150 positioned along the same spline 140 results in a lesion (ablated lesion) that extends more vertically, while activating two electrodes 150 positioned along adjacent splines results in a lesion (ablated lesion) that extends more circumferentially.

[0076] <Double transseptal / secondary catheter> Figures 5 and 6 show a balloon catheter 200 similar to balloon catheter 100, except that it does not include the expandable basket 130. Therefore, the reference numerals used in Figure 4 are also used in Figures 5 and 6 for parts common to both embodiments. Since inflatable balloons are typically transparent, Figure 6 shows a transparent balloon configuration.

[0077] The balloon catheter 200 typically includes two or more shafts, often including a main catheter shaft 110 which includes an inner catheter shaft and an outer catheter shaft, but may also include multiple concentric tubular structures as shown. It includes an inflatable compliant balloon 120 which is connected to the main catheter shaft 110 such that its distal end is close to the distal end of the main catheter shaft 110 and its proximal end is spaced away from the distal end of the main catheter shaft 110. In this way, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0078] In this embodiment, there is a second catheter, namely an electrode catheter 210, used in conjunction with the balloon catheter 200. The electrode catheter 210 is an elongated structure having an open distal end and comprising a proximal region 220 and a distal electrode region 230. The proximal region 220 may include an elongated, arch-shaped body that is not perfectly circumferential. Conversely, the distal electrode region 230 is a perfectly circumferential structure. The distal electrode region 230 includes a proximal collar 232 at its proximal end and a distal collar 234 at its distal end. Between the two collars 232, 234, the body of the distal electrode region 230 includes a plurality of longitudinal slits 240 arranged circumferentially around the body at intervals. These slits 240 define a plurality of longitudinal splines 245. The slits 240 do not extend into the regions of the two collars 232, 234. Similar to spline 140, spline 245 holds one or more, preferably multiple, electrodes (e.g., electrode 150) arranged along the outer surface (outer surface) of spline 245. As in the previous embodiment, each spline 245 may hold multiple electrodes, for example, three or more electrodes, arranged in series along the longitudinal direction of spline 245 and spaced apart from one another.

[0079] The distal electrode region 230 is a tubular structure having open ends, as both ends are open, and is configured to receive a retracted (collapsed) stationary balloon catheter as described herein.

[0080] Similar to the previous embodiment, the spline 245 does not stretch because it is not elastic, but it can expand in response to the expansion of the inflatable balloon 120. Therefore, the distance between electrodes along the same spline 245 does not change whether the spline 245 is expanding or contracting. However, similar to the previous embodiment, the distance between two electrodes on two different splines 245 changes depending on the degree of expansion.

[0081] The balloon catheter is inserted into the hollow interior (internal lumen) of the electrode catheter 210 and passes through it, so that the splines 245 surround the inflatable balloon 120. When the balloon inflates, the splines 245 expand radially outward and separate from each other.

[0082] As in other embodiments, the spline 245 may be folded by retracting the spline 245 into the main (outer) catheter shaft.

[0083] In this embodiment as well, visualization can be used to determine which electrodes are in contact with the tissue, and visualization can also guide the user when adjusting the balloon catheter and / or electrode catheter to form a complete and continuous lesion (ablation lesion).

[0084] <Retractable Tine electrode array> Figures 7 and 8A-C show a balloon catheter 300 similar to balloon catheter 100, except that it does not include the expandable basket 130. Therefore, the reference numerals used in Figure 4 are also used in Figures 7 and 8A-C for parts common to both embodiments.

[0085] The balloon catheter 300 typically includes two or more shafts, often including a main catheter shaft 110 which includes an inner catheter shaft and an outer catheter shaft, but may also include multiple concentric tubular structures as shown. It includes an inflatable balloon 120 which is connected to the main catheter shaft 110 and / or an additional shaft such that its distal end is close to the distal end of the main catheter shaft 110 and its proximal end is spaced away from the distal end of the main catheter shaft 110. In this way, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0086] The balloon catheter 300 further includes a retractable electrode sheath 310 configured to be retracted into the main catheter shaft 110 or another shaft of the catheter. Thus, as described herein, the retractable electrode sheath 310 is designed to move longitudinally along the main catheter shaft 110, and more specifically, the retractable electrode sheath 310 can move within the main catheter shaft 110 to move between a fully retracted position and a fully deployed position. In the fully retracted position, at least a considerable length of the retractable electrode sheath 310 is housed within the main catheter shaft 110, and in the fully deployed position, a considerable length of the retractable electrode sheath 310 is positioned outside the main catheter shaft 110 and surrounds the inflatable balloon 120 as described herein. As illustrated, in the fully deployed position, the tine 320 may be deployed over at least 75% of the length of the balloon 120 and over 90% or more of the length of the balloon 120. In another embodiment, the tine 320 extends over at least 50% of the length of the balloon 120 (for example, at least to the widest part of the inflated balloon 120).

[0087] The retractable electrode sheath 310 includes a proximal collar 312, which may be a continuous cylindrical structure, and a plurality of expandable tines 320, the proximal ends of which are integrated with the proximal collar 312. Each tine 320 is a cantilever structure in that its distal end is a free end and is not attached to any other structure. The tines 320 are spaced apart and, when in the fully deployed position, unfold circumferentially around the balloon 120.

[0088] As with other embodiments, the tine 320 is non-elastic and does not stretch in any way. However, the tine 320 can expand outward (radially) as the inflatable balloon 120 inflates, and similarly, the tine 320 can contract as the inflatable balloon 120 deflates. Thus, the tine 320 can fit onto the compliant balloon 120.

[0089] To retract and completely fold the tine 320, the retractable electrode sheath 310 is pulled back proximal to the main catheter shaft 110. Once the retractable electrode sheath 310 is inside the main catheter shaft 110, the presence of the surrounding main catheter shaft 110 applies an inward force to the tine 320, causing it to fold and move within the main catheter shaft 110, retracting it away from the balloon 120.

[0090] As shown in the figure, each tine 320 includes one or more electrodes 150, preferably multiple electrodes 150, spaced apart along the tine 320. The electrodes 150 are arranged in series along the length of the tine 320. The electrodes 150 along the tine 320 may be of the same type (e.g., the same shape and size), and in another embodiment, different types of electrodes may be used.

[0091] As in other embodiments, visualization (e.g., endoscopy) may be used to determine which electrode 150 is in contact with the tissue, and the selected electrode may be activated to form a lesion (ablation lesion). The user interface can identify the electrode 150 in contact with the tissue and supply power to it. As previously mentioned, the operating software may be programmed to calculate an appropriate dose based on the distance between the activated electrodes 150 and to supply the required energy to the electrodes 150.

[0092] As with all embodiments, it is desirable to activate only the electrodes necessary to form the lesion (absorbed lesion) (part).

[0093] Figure 8A shows the inflatable balloon 120 in a deflated state, with the tine 320 fully retracted and positioned almost inside the main catheter shaft 110 (for example, only the tip of the tine 320 protruding outside the main catheter shaft 110).

[0094] Figure 8B shows the inflatable balloon 120 still in a deflated state, but with the tines 320 deployed. As described, the degree to which the tines 320 cover the balloon 120 can vary.

[0095] Figure 8C shows the balloon 120 inflated, and the tine 320 that is deployed by this inflation expanding. In this figure, the tine 320 is shown to be deployed over approximately 50% of the length of the balloon 120, but this is merely an illustrative form and should be understood to mean that it may be deployed along the length of the balloon.

[0096] Therefore, in the embodiments shown in Figures 7 and 8A-C, the system consists of semi-rigid retractable tines 320, each having one or more electrodes 150 along its outer surface, which are housed within the catheter (main catheter shaft 110) and deployed by sliding a retractable electrode sheath 310 distally using a controller (manual or electric) before inflating the balloon 120. When the balloon 120 is inflated, the electrodes 150 are pressed against the inner surface of the blood vessel, achieving tissue contact. As in other embodiments, in this embodiment, tissue contact and electrode spacing can be directly and visually confirmed by an endoscope inside the balloon 120. Once tissue contact and the desired electrode spacing are confirmed, energy is applied to the desired (selected) electrode 150 to form a lesion (ablation lesion). In this embodiment, only four deployable tines 320 may be incorporated, but more tines 320 are likely to provide the user with an optimal number of electrodes 150 and electrode spacing for effective treatment.

[0097] In this embodiment, similar to other embodiments, by providing markers along the inner surface of the tine 320, the position of the electrode 150 along the tine 320 can be identified by visualization. Thereby, the user can determine which electrode 150 is in contact with the tissue and instruct the energy supply module to supply energy to the selected electrode 150. Further, in one embodiment, the system may include image recognition software that analyzes the live image feed from the endoscope and identifies the existing electrode markers. For example, if markers such as A1 and A2 are present, the image recognition module identifies these electrodes and provides the option for the user to confirm whether to activate the electrodes corresponding to markers A1 and A2 to supply energy to the user.

[0098] This image recognition function may be implemented in any other embodiment described herein where electrode markers are present and may provide an electrode activation plan recommended to the user.

[0099] <Balloon with PFA Braided Wire Mesh Electrode Array> FIG. 9 shows a balloon catheter 400 similar to other balloon catheters described herein. Therefore, the reference numbers used in FIG. 4 are also used in FIG. 9 for parts common to the two embodiments.

[0100] The balloon catheter 400 typically includes two or more shafts and often includes a main catheter shaft 110 that includes an inner catheter shaft and an outer catheter shaft, but may include a plurality of concentric tubular structures. An inflatable balloon 120 is included, and the inflatable balloon 120 is connected to the main catheter shaft 110 such that the distal end is close to the distal end of the main catheter shaft 110 and the proximal end is spaced from the distal end of the main catheter shaft 110. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0101] The balloon catheter 400 includes a wire braid 410 positioned on an inflatable balloon 120 and configured to expand radially as the inflatable balloon 120 inflates. The wire braid 410 may include a mesh-like wire braid as shown. This wire mesh is used as a support structure for an electrode array formed by electrodes 150 and may be made of an insulating material. The electrodes 150 are positioned along the outer surface of the wire braid 410, and the coverage of the electrodes 150 may be uniform or non-uniform. In embodiments where the coverage is non-uniform, the electrodes 150 may be concentrated in one or more regions of the wire braid 410. For example, the electrodes 150 may be mainly located in the central region of the wire braid 410 where contact with tissue is more likely to occur.

[0102] Furthermore, the spacing between electrodes may be the same throughout the entire electrode array, or it may vary in one or more regions of the wire braid 410. For example, the spacing may be narrower in the central region of the wire braid 410.

[0103] Similar to other embodiments, the electrode 150 is connected to an energy source using conventional electrical wiring or wires (conductive paths) associated with and / or incorporated into the wire braid.

[0104] Alternatively, the wire braid 410 (support structure) itself may function as an electrode array, and the electrode array may be defined by incorporating an insulating coating into conductive (metallic) braided wires, stripping the coating at locations where energy supply is required, and forming individual electrodes in the areas where the coating has been removed. The wire braid 410 is operably connected to an energy source, and current (energy) is supplied throughout the wire braid 410 so that the areas where the insulating coating has been removed define the electrodes that constitute the electrode array.

[0105] The wire mesh braid may be formed from independent, separate insulated wires, thereby defining individual paths where electrodes reside. By defining individual electrode paths, individual regions can be activated without activating other areas of the wire mesh braid, thus enabling the activation of only the electrode or electrode region in contact with the tissue.

[0106] As shown in the figure, the wire braid 410 may extend beyond the inflatable balloon 120, with one end extending proximally to the inflatable balloon 120 and the other end extending distally to the inflatable balloon 120.

[0107] As in other embodiments, this embodiment uses an endoscope inside the balloon 120 to confirm electrode displacement and contact with tissue. The number of electrodes 150 in the array may vary depending on the number of braided wires to achieve the most clinically effective energy delivery, and the user can select or deselect the number of electrodes to customize the treatment area.

[0108] <Balloon equipped with an implanted electrode array> Figure 10 shows a balloon catheter 500, similar to other embodiments, which includes a main catheter shaft 110 and an inflatable balloon 510 connected to and deploying along the main catheter shaft 110. The inflatable balloon 510 has its distal end connected to the distal end of the main catheter shaft 110 and its proximal end connected to the main catheter shaft 110 at a position spaced apart from the distal end of the main catheter shaft 110.

[0109] The inflatable balloon 510 is a compliant balloon with an integrated electrode 150. The balloon 510 itself includes the electrode 150 and flexible wire wiring 151 embedded in the balloon material.

[0110] In this embodiment, the electrodes 150 may be positioned inside the balloon 510 and integrated with it as part of the balloon 510 molding process. The electrodes 150 are spaced apart throughout the balloon 510 in a desired pattern. For example, the electrodes 150 are arranged circumferentially around the balloon 510. Alternatively, instead of being positioned and attached to the balloon material during the manufacturing process, the electrodes 150 may be attached to the balloon 510 after the manufacturing process. In particular, the electrodes 150 may be attached to the outer surface of the balloon 510 so that the wiring 151 is also attached to the outer surface of the balloon 510. Various conventional techniques, such as adhesives and binders, may be used to attach these elements to the outside of the balloon 510.

[0111] The electrodes 150 are formed such that the outer surface of each electrode 150 is exposed along the surface of the balloon 510 in order to be displaced to contact the tissue. Each flexible wire 151 is formed in a zigzag pattern, such a pattern is to allow the flexible wire 151 to move with the compliant balloon during inflation / deflation and displacement to the tissue. In other words, this zigzag pattern conforms to the flexible wire 151 during the expansion and contraction of the balloon, suppressing damage to the wire. Each flexible wire 151 is operably connected to an energy source and can supply energy to the selected electrode 150.

[0112] As in other embodiments, in this embodiment, an endoscope is used inside the balloon 510 to check the displacement of the electrodes and their contact with the tissue. After determining which electrodes 150 are in contact with the tissue, the user may select and activate those electrodes.

[0113] Furthermore, as in other embodiments, by providing electrode markers visible to the endoscope from inside the balloon 510, the user or image recognition software can determine which electrodes are clearly visible within the endoscope's field of view. Based on this information, energy is supplied to the selected electrode 150 to form a lesion (absorbent lesion). The user interface may be configured to allow the user to easily select the electrode to which energy is supplied by providing the user with a touchscreen with an electrode map and / or having image recognition software that automatically populates the screen with a recommended electrode activation map showing electrodes that are visible within the endoscope's field of view and in contact with tissue.

[0114] <Balloon equipped with micropores and internal electrode array> Figures 11 and 12 show a balloon catheter 600 including a main catheter shaft 110 and an inflatable compliant balloon 610 connected to and deployed along the main catheter shaft 110. An outer catheter body or sleeve 115 is also present, and as described, the catheter 600 may include other shafts such as an outer catheter shaft and an inner catheter shaft. The inflatable balloon 610 has its distal end connected to the distal end of the main catheter shaft 110 and its proximal end connected to the main catheter shaft 110 at a position spaced apart from the distal end of the main catheter shaft 110.

[0115] As in other embodiments, the endoscope may be located inside the balloon 610 and connected to the main catheter shaft 110. The endoscope is forward-looking and allows for visualization of the transparent balloon 610 and its contact with the surrounding tissue.

[0116] According to this embodiment, at least a portion of the balloon 610 has micropores 611 formed therein. Preferably, the micropores 611 are formed in one or more regions of the balloon 610 where energy is supplied to the tissue. In the illustrated embodiment, the balloon 610 has micropores 611 in the central region, but not in the proximal and distal ends, because this central region is the one that comes into contact with the tissue during use.

[0117] For simplification, the micropores 611 in Figure 12 are shown as larger in dimensions than those in Figure 11, but it should be understood that the micropores in Figures 11 and 12 may be the same size and number. However, Figure 12 shows that the micropores 611 can be formed in different sizes and even different shapes.

[0118] The micropores 611 may have a uniform structure (i.e., the same size and shape), or there may be two or more types of micropores 611. The micropores 611 may be formed in a uniform pattern as shown, or in a non-uniform pattern. For example, as shown, the micropores 611 may be formed in a grid pattern that unfolds to surround the entire balloon 610 in the circumferential direction.

[0119] The balloon catheter 600 also includes an electrode carrier 620 positioned within the balloon, which in at least one embodiment can move within the balloon 610 (i.e., can move rotationally and / or longitudinally within the balloon 610). The electrode carrier 620 includes one or more electrodes 622 housed within a housing (hood) 624. In the illustrated embodiment, there is a pair of electrodes 622 within the housing 624 (however, a single electrode can also be used within the hood as the hood rotates inside the porous balloon). The housing 624 serves to contain and direct the energy of the electrodes 622. The electrodes 622 are positioned close to the balloon itself, and the housing itself is positioned in direct contact with the inner surface of the balloon. The hood 624 can optimize the rate of ablation energy delivered to the tissue, but the hood 624 is optional and not always necessary.

[0120] Therefore, the electrode array 622 is housed within a housing 624, which also serves to enclose a conductive liquid medium, such as saline (e.g., isotonic or hypertonic saline), that can directly deliver energy into the tissue through the micropores 611. In other words, the conductive liquid medium can be supplied to the housing 624 using one or more conduits 626 that open into the interior of the housing 624. When the electrodes 622 are activated, energy is generated from the electrodes (e.g., between the electrodes), and since the electrodes 622 are immersed in the conductive liquid medium, this energy serves to heat the conductive liquid medium. Due to the presence of the micropores 611, the heated conductive liquid medium penetrates into the tissue through the micropores 611, and in combination with the conduction of energy from the electrodes 622 through the balloon material, the target lesion (absorbent lesion) is formed. In particular, the lesion (absorbent lesion) portion is formed. To form a complete lesion (absorbent lesion), the electrode carrier 620 may be rotated and / or moved along the inner surface of the balloon. The electrode carrier 620 is held in contact with the inner surface of the balloon 610 by a secondary balloon that can be mechanically adjusted by the user or by the user to adjust the electrode contact pressure by inflating or deflating it.

[0121] The combination of the electrode array and the conductive liquid medium defines the conductive pathway used to form the lesion (cautery lesion) portion. Note that the inflation medium for controlling the inflation or deflation of balloon 610 may be the same as or different from the conductive liquid medium supplied inside housing 624.

[0122] In yet another embodiment, the balloon 610 does not contain micropores 611 and is instead formed of a conductive balloon material (e.g., a balloon material doped with carbon nanotubes). In this alternative embodiment, the housing (hood) may also be omitted or retained. Thus, a non-conductive fluid may be used inside the balloon. The electrode array (or single electrode) is still positioned inside the balloon 610 and is movable within the balloon, as it can rotate freely and / or move longitudinally. In this way, the energy supplied to the electrode array is transferred to a local region of the conductive balloon adjacent to the electrode array to form a lesion (ablation lesion). In other words, the electrode array faces a local region of the balloon, and the energy supplied to the electrode array is conducted to this local region of the balloon to form a lesion (ablation lesion).

[0123] Referring here to Figure 13, in yet another embodiment, a porous balloon catheter 700 is shown. The porous balloon catheter 700 is similar to the balloon catheter 600, and similar elements are numbered the same way. For this reason, the balloon contains micropores 611. Instead of an electrode carrier 620, the balloon catheter 700 includes an elongated structure 710, which is similar to elongated structure 1 in Figure 1, but with some notable differences, such as the fact that the elongated structure 710 is located inside the balloon rather than outside the balloon as in Figure 1. The elongated structure 710 includes a first tubular portion 712 and a second tubular portion 714 surrounding the catheter shaft. The elongated structure 710 is multi-branched into two or more, preferably six or more, branch portions 720, each branch portion 720 containing one or more electrodes 715 on its outward-facing surface. The elongated structure 710 may be manufactured from an elastic material that is pre-formed into a shape that allows it to expand as the balloon inflates and maintain contact with the inner surface of the balloon. When the liquid is removed from the balloon under vacuum and the balloon is deflated, the elongated structure 710 folds due to the balloon. In other words, when the balloon inflates, the elongated structure is configured to expand automatically and naturally, and similarly, it shrinks with the contraction of the balloon. This occurs naturally due to the shape memory properties of the elongated structure 710. Thus, the electrode 715 on the outer surface of the elongated structure 710 comes into contact with the inner surface of the porous balloon. As in other embodiments, the balloon contains a conductive fluid passing through the micropores. Therefore, energy from the electrode 715 is conducted through the balloon itself, and / or the conductive fluid within the balloon passes through the micropores to reach the target structure.

[0124] It should be noted that in all embodiments, the electrodes are connected to an energy source controllable by conventional technology, such as electrical leads, wires, or conductive paths. The energy source may be controlled using a conventional control device, such as a master controller, which may be part of a console that allows the user to input and control and select different operating parameters, such as administration information (administered power (watts)).

[0125] These embodiments incorporating electrode arrays are particularly suitable for supplying electroporation ablation energy (PFA).

[0126] Additional details relating to specific embodiments of this disclosure are as follows:

[0127] This device modifies tissue to achieve desired results, with the aim of changing its conduction properties and other characteristics.

[0128] This is an external sheath that is placed on top of an existing catheter system.

[0129] It consists of three distinct parts: a rigid positioning collar at the distal end, a balloon-expandable portion made of a softer, more flexible material (or an alternative configuration) located near the main balloon, and an overcoat on the catheter body that extends near the proximal end.

[0130] The electrodes may be positioned on a rigid collar to measure distal electrical activity, or applied to an energy supply.

[0131] Electrodes are primarily placed in balloon-inflatable sections in various configurations (different parts) to supply energy to alter the properties of the target tissue.

[0132] The main body's overcoat incorporates conductors for distal measurement and energy supply, which are terminated near the control unit for the rotation of other energy sources.

[0133] The electrodes on the color may have various configurations and may include two, four, or six square electrodes arranged at equal intervals around the measurement area on the color.

[0134] The electrodes in the balloon-expandable region are intended for primary energy delivery (treatment) by this device. The most likely embodiment is a configuration of 16 electrodes spaced equally apart proximal to the primary treatment region, such configuration allows the electrode array to be deployed distally toward the treatment region by slightly deflating the balloon, although it does not need to be in an arc similar in position to where the primary energy is delivered or intended to be delivered. This region is configured with the specified inflation pressure for "PFA" treatment, with electrodes spaced equally apart and separated so that they can be accessed individually or in different groups.

[0135] The catheter overcoat is equipped with conductive means for all sensing electrodes and energy supply electrodes (some or all serving a dual purpose) so as not to interfere with the bending or rotation of the main catheter, or at least minimally. This may be a helical path that can use various helical pitches.

[0136] The balloon-expandable portion of this device may be a complete sheath made of a highly elastic material with electrodes on its surface, or a portion of the device may be removed to form a more rigid structure, allowing the electrodes to be positioned in a desired area by displacement of the structure.

[0137] <Parallel-transfer type tip balloon catheter (Figures 15A and 15B)> Referring now to Figures 15A and 15B, these figures illustrate the parallel-transfer tip balloon catheter 800. Figure 15A shows the catheter 800 in a folded state for delivery to a target site, and Figure 15B shows the catheter 800 in an expanded state for use. The catheter 800 includes an elongated outer catheter (shaft) 810 having a distal end 812 and a proximal end 814 opposite to it (Figure 16A). The outer catheter 810 is an elongated hollow structure. The catheter 800 also includes a handle 820 for the user to grasp (Figure 16A). The handle 820 is connected to the proximal end 814 of the outer catheter 810. More details about the handle 820 will be discussed later.

[0138] The handle 820 may take various forms, such as being composed of two parts attached to each other to define the hollow interior that houses the working part of the parallel-moving tip balloon catheter 800.

[0139] The catheter 800 also includes an inflatable balloon 830 connected to the distal end 812 of the outer catheter 810. The outer catheter 810 may terminate proximal to the balloon 830 or may partially extend into the balloon 830, but the outer catheter 810 does not extend all the way to the distal end of the catheter 800.

[0140] Balloon 830 includes a compliant balloon. Note that catheter 800 and balloon 830 have conventional inflation and deflation structures, such as an inflation and / or deflation lumen through which an inflation medium flows to inflate the balloon. As is well known, the inflation medium may be circulated using a pump or the like.

[0141] The catheter 800 is configured to supply PFA energy using an expandable electrode basket structure surrounding the balloon 830 and an actuator or translation mechanism that expands and folds the electrode basket structure into a flatter state. More specifically, this translation mechanism may include an elongated structure such as a tube or solid rod 850, with a first (proximal) end connected to a handle and a second (distal) end connected to a flexible nose tip 860 (Figure 16B). Thus, although element 850 is described as a tube, it should be noted that it does not necessarily have to be a tubular structure and may be solid.

[0142] In one embodiment, tube 850 includes a nitinol tube.

[0143] The nose tip 860 defines the distal end of the catheter 800. The nose tip 860 is not directly attached to the outer catheter 810, but is instead axially movable relative to the outer catheter 810, thereby enabling axial translation of the catheter 800. Thus, the tube 850 passes through the inside of the balloon 830, with its distal end fixedly attached to the nose tip 860. As a result, when the tube 850 is driven forward, the nose tip 860 is driven forward, and conversely, when the tube 850 is driven backward, the nose tip 860 is driven backward toward the handle.

[0144] According to one embodiment, the expandable electrode basket is formed by a first electrode basket 870 and a second electrode basket 880, which will be described in more detail below. The first electrode basket 870 and the second electrode basket 880 are connected to both the distal end 812 and the nose tip 860 of the outer catheter 810, respectively. As shown in the figure, the first electrode basket 870 and the second electrode basket 880 are arranged in layers, with the first electrode basket 870 being considered the inner basket and the second electrode basket 880 being considered the outer basket.

[0145] The first electrode basket 870 includes a distal end portion which may be in the form of a solid cylindrical portion and a proximal end portion which may similarly be in the form of a solid cylindrical portion. Similarly, the second electrode basket 880 also includes a distal end portion which may be in the form of a solid cylindrical portion and a proximal end portion which may similarly be in the form of a solid cylindrical portion. The distal end portion of the first electrode basket 870 may be connected to and surround the nose tip 860, and the distal end portion of the second electrode basket 880 (e.g., collar) may surround (or overlap) the distal end portion of the first electrode basket 870, as it is positioned directly above the distal end portion of the first electrode basket 870 (e.g., collar). Similarly, the proximal end portion of the second electrode basket 880 (e.g., collar) may surround (or overlap) the proximal end portion of the first electrode basket 870, as it is positioned above the proximal end portion of the first electrode basket 870 (e.g., collar). In other words, the first electrode basket may be a slitted tubular structure with solid ends, and the second electrode basket may be a slitted tubular structure with solid ends. These two tubular structures are superimposed such that the slitted tubular structure of the second electrode basket is positioned directly above the slitted tubular structure of the first electrode basket, and the slits are offset from each other in the circumferential direction.

[0146] Each of the first electrode basket 870 and the second electrode basket 880 holds one or more electrodes. As shown in the figures, the first electrode basket 870 and the second electrode basket 880 are splined structures in that the first electrode basket 870 has a plurality of longitudinal slits defined by a plurality of first splines 875 that unfold circumferentially around the first electrode basket 870. The second electrode basket 880 includes a plurality of longitudinal slits defined by a plurality of second splines 885 that unfold circumferentially around the second electrode basket 880. As described herein, the positions of the first splines 875 and the second splines 885 are deliberately selected by the orientation of the first electrode basket 870 and the second electrode basket 880 so that when the balloon 830 expands and the first splines 875 and the second splines 885 move into an expanded state (Figure 15B), the first splines 875 and the second splines 885 are interposed to each other without overlapping. In other words, each second spline 885 is located between two adjacent first splines 875, and vice versa. This configuration allows for complete coverage of the entire perimeter of the balloon 830.

[0147] In one embodiment, the first electrode basket 870 and the second electrode basket 880 are each configured to have six splines, and as a result, the first electrode basket 870 and the second electrode basket 880 are superimposed and offset from each other to form a total of 12 splines. Therefore, the first electrode basket 870 and the second electrode basket 880 may have the same or very similar structure, such that one is superimposed on the other and rotated so that the respective splines are rotationally offset. Since each spline may hold one or more electrodes, when the balloon is inflated and the splines 875, 885 are in an expanded state, the 12 splines are spaced apart circumferentially along the outside of the balloon, expanding the electrode coverage area for contact with tissue. If only one electrode basket (one sheath or collar) is used, if enough longitudinal slits are provided to form 12 splines, the width of each spline is insufficient to hold the desired ablation electrode (e.g., a PFA electrode). This configuration of two overlapping electrode baskets with rotational offset overcomes this drawback and allows for 12 splines wide enough to hold one or more electrodes of the desired size suitable for PFA.

[0148] In the initial folded state, the first spline 875 is covered at least substantially by the second electrode basket 880, and in this initial folded state, the first electrode basket 870 is covered, so only the second electrode basket 880 is substantially visible.

[0149] In one embodiment, each spline 875, 885 holds one or more electrodes 890 (electrodes 890 are omitted in Figure 15A for ease of explanation). In the illustrated embodiment, each spline 875, 885 includes four electrodes 890 arranged in series (longitudinally) spaced apart along the spline. In one embodiment, each electrode 890 may be controlled individually, while in another embodiment, all electrodes 890 on a single spline 875, 885 may be controlled together. As is well known, a controller is used to control the supply of ablation energy (e.g., PFA) to the electrodes 890, and in some embodiments, visualization may be used to detect which spline electrodes 890 are in contact with the target tissue. In one embodiment, instead of supplying energy to all electrodes 890, energy may be supplied to selected spline electrodes 890 (e.g., the electrodes 890 in contact with the target tissue).

[0150] The first electrode basket 870 and the second electrode basket 880 are not as flexible as the balloon 830. In one embodiment, the first electrode basket 870 and the second electrode basket 880 are made of polyimide.

[0151] The electrodes 890 are fixed to the spline by conventional techniques such as adhesive bonding. Each electrode 890 may be connected to an energy source by electrical wiring, as is well known. For example, the electrical wiring may be copper wiring, and the electrodes 890 may be gold-plated electrodes.

[0152] Referring here to Figures 15A to 16B, the handle 820 has a through-opening 821, within which the actuator 822 is movably positioned and housed. For example, the actuator 822 may be in the form of a slider that can be accessed and operated from both opposing sides of the handle 820. Since the front end of the actuator 822 is fixedly connected to the tube 850, when the actuator 822 moves axially, the tube 850 also moves axially (there is no relative movement between them) because they are fixed to each other. Therefore, when the actuator 822 moves forward, the tube 850 also moves forward, and this movement is converted into forward movement of the nose tip 860. Since the balloon 830, the first electrode basket 870 and the second electrode basket 880 are fixedly attached to the nose tip 860, all of these structures move forward. This forward movement causes the balloon 830, the first electrode basket 870 and the second electrode basket 880 to flatten (stretch) toward the position shown in Figure 15A. Conversely, when actuator 822 moves backward, tube 850 also moves backward, and this movement is converted into backward movement of nose tip 860. Since balloon 830, first electrode basket 870, and second electrode basket 880 are fixedly attached to nose tip 860, all of these structures move backward. This backward movement causes balloon 830, first electrode basket 870, and second electrode basket 880 to expand (move radially outward) toward the position shown in Figure 15B.

[0153] As balloon 830 inflates, splines 875 and 885 expand to the shape of the balloon, and nose tip 860 is pulled proximally.

[0154] For further details regarding actuator 822, please refer to U.S. Patent No. 11,389,236, which is incorporated herein by reference in its entirety.

[0155] In yet another embodiment, the handle 820 includes a biasing mechanism that acts on the tube 850. Specifically, this biasing mechanism may be in the form of a spring 890 housed inside the handle and applying a biasing force to the rear end of the actuator 822. The spring 890 may be a coil spring. One end of the spring 890 abuts against a fixed surface of the handle, and the other end abuts against the rear of the actuator 822. The illustrated spring 890 is designed to assist some of these movements. To deliver the catheter 800 to the target site, the catheter 800 may be delivered through a delivery sheath (not shown). As it passes through the sheath, the distal nose tip 860 is pushed proximal by the frictional force during insertion into the sheath. Some force is required to resist this movement, and the spring 890 provides that force. After entering the patient's body and reaching its designated position, the physician inflates the balloon 830.

[0156] In one embodiment of this design, the spring 890 is designed such that the expansion of the balloon 830 exceeds the force of the spring 890, pulling the distal nose tip 860 backward and expanding the splines 875, 885 to the shape of the balloon 830. In another embodiment, some removable locking mechanism is provided so that the spring 890 is not pressed against the Nitinol tube 850 or is pressed against it. This is simplified here by a removable block 900 located proximal to the spring 890.

[0157] Figure 16A shows the handle and actuator 822 in the deployed state, and Figure 16B is a perspective view of the handle of Figure 16A in the retracted state. When the balloon 830 is deflated and the first electrode basket 870 and the second electrode basket 880 are in the flattened state shown in Figure 15A, the actuator 822 is in the position shown in Figure 16A, and conversely, when the balloon 830 is in the inflated state shown in Figure 15B, the actuator 822 is in the position shown in Figure 16B. Therefore, as the balloon 830 deflates, at some point the spring force of the spring 890 exceeds the force applied by the balloon 830, and the actuator 822 is driven to the deployed position shown in Figure 16A, which is the resting position of the catheter when the balloon 830 is deflated and the first electrode basket 870 and the second electrode basket 880 are in the flattened state shown in Figure 15A.

[0158] Furthermore, it should be noted that in another embodiment, the catheter 800 includes only a single electrode basket, i.e., a first electrode basket 870 having a plurality of first splines 875. Therefore, the second electrode basket 880 is omitted. In one embodiment, the plurality of first splines 875 includes six or more splines spaced apart in the circumferential direction. Thus, the single-basket embodiment appears as shown in Figure 15A, in that there is one electrode basket connected to the outer catheter 810 and nose tip 860, as described herein. In Figure 15A, the outermost second electrode basket 880 is shown, but in the single-basket design, the second electrode basket in Figure 15A may be called the first electrode basket because it represents the only electrode basket and there is only one.

[0159] The single catheter basket design functions exactly the same as the two-basket design in that, when the user operates actuator 822 to move the nitinol tube 850 axially, which moves the nose tip 860 axially, and as a result the balloon 830 inflates, the single electrode basket moves between a flattened state (Figure 15A) and an expanded state (Figure 15B).

[0160] In a single catheter basket design, the handle may be secured by a spring as described herein.

[0161] In one embodiment, the number of splines may be two or more, and it should be noted that the width of the splines is sufficient to support one or more electrodes placed on one or more electrodes. As in other embodiments, each spline 875 may include one or more electrodes spaced along its longitudinal direction for tissue ablation (e.g., PFA).

[0162] The Nitinol tube 850 functions as an axial pressing / pulling rod in each of these embodiments, whether or not there are one or two electrode baskets 870, 880 surrounding the balloon 830. The movement of the Nitinol tube 850 is preferably controlled within a handle.

[0163] Furthermore, it should be understood that a visualization device, such as an endoscope as described herein, may be installed inside the balloon 830. Such a visualization device helps the user determine the degree and location of contact between the balloon and the tissue (as opposed to the presence of blood pools).

[0164] It should be understood that the same number in the drawings represents the same element across multiple drawings, and that not all components and / or steps described and illustrated with reference to the drawings are required for all embodiments or configurations.

[0165] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the invention. Where used herein, the singular forms "a," "an," and "the" are intended to also include the plural forms unless otherwise explicitly indicated in the context. Where used herein, the terms "comprises" and / or "comprising" indicate the presence of the features, integers, steps, actions, elements, and / or components mentioned, but should be further understood that they do not preclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof.

[0166] Furthermore, the words and terms used herein are for illustrative purposes only and should not be considered limiting. In this specification, the use of “includes,” “equips,” “has,” “contains,” “incorporates,” and variations thereof means to include the items listed thereafter and their equivalents, as well as any additional items.

[0167] The subject matter described above is provided for illustrative purposes only and should not be construed as limiting. Various modifications and changes can be made to the subject matter described herein without following the exemplary embodiments and uses, and without departing from the true spirit and scope of the invention as set forth in the following claims.

Claims

1. External catheter shaft, An inflatable balloon, the first end of which is connected to the outer catheter shaft, The second end of the inflatable balloon is connected to a posable nose tip, A first electrode basket having a plurality of first splines surrounding the balloon, with a first end connected to the outer catheter shaft and a second end connected to the nose tip, A second electrode basket having a plurality of second splines surrounding the balloon, with a first end connected to the outer catheter shaft and a second end connected to the nose tip, wherein the second electrode basket is positioned on the first electrode basket, the plurality of first splines are rotationally offset from the plurality of second splines, one or more of the first splines support one or more electrodes, and one or more of the second splines support one or more electrodes, The system includes an actuator that moves the nose tip in the axial direction to facilitate the transition of the first electrode basket and the second electrode basket to a folded state when the balloon is deflated, An ablation balloon catheter, wherein the plurality of first splines and the plurality of second splines are configured to expand radially when the inflatable balloon is inflated, with the plurality of first splines being interposed between the plurality of second splines.

2. The ablation balloon catheter according to claim 1, wherein the plurality of first splines include six splines, and the plurality of second splines include six splines.

3. The ablation balloon catheter according to claim 1, wherein the distal and proximal ends of the first electrode basket and the second electrode basket each include a solid cylindrical collar body, and the distal end of the second electrode basket covers the distal end of the first electrode basket in both the folded and extended states of the first spline and the second spline.

4. The ablation balloon catheter according to claim 1, wherein each of the first splines and each of the second splines has at least one electrode disposed on its outer surface.

5. The ablation balloon catheter according to claim 4, wherein each of the first splines and each of the second splines has a plurality of electrodes arranged at intervals on its outer surface.

6. The ablation balloon catheter according to claim 1, wherein the balloon includes a compliant balloon, and the first electrode basket and the second electrode basket are formed of a non-compliant material.

7. The ablation balloon catheter according to claim 6, wherein the first electrode basket and the second electrode basket are made of polyimide.

8. The ablation balloon catheter according to claim 1, wherein the actuator includes an elongated structure, the first end of which is connected to an axially movable portion housed within a handle, and the opposite second end of which is connected to the nose tip.

9. The ablation balloon catheter according to claim 8, wherein the elongated structure includes a tube.

10. The ablation balloon catheter according to claim 9, wherein the tube includes a nitinol tube.

11. The ablation balloon catheter according to claim 1, wherein the nose tip includes a flexible blunt tip.

12. The ablation balloon catheter according to claim 8, wherein the movable portion of the handle includes a slider housed within the handle and movable in the axial direction between an extended position and a retracted position.

13. The ablation balloon catheter according to claim 12, wherein the slider is in the deployed position when the balloon is deflated and the first spline and the second spline are in the folded state, and is in the retracted position when the balloon is inflated and the first spline and the second spline are in the expanded state.

14. The ablation balloon catheter according to claim 8, wherein the movable portion is spring-biased.

15. The ablation balloon catheter according to claim 12, wherein the slider is spring-biased, the movable portion takes the deployed position as the stationary position of the movable portion, and takes the retracted position when the balloon inflates and the force applied by the balloon to the first spline and the second spline exceeds the spring force of the spring.

16. The ablation balloon catheter according to claim 1, further comprising a visualization device disposed within the balloon.

17. The visualization device includes a movable endoscope, as described in claim 16, for the ablation balloon catheter.

18. The ablation balloon catheter according to claim 17, wherein the endoscope is rotatable and movable in the axial direction within the balloon.

19. The ablation balloon catheter according to claim 1, wherein the actuator includes an elongated nitinol tube that passes through the balloon, with a first end connected to an axially movable portion housed within a handle and a second end on the opposite side connected to the nose tip.

20. The ablation balloon catheter according to claim 1, wherein each electrode includes a conductive wire operably connected to an ablation energy source.

21. The ablation balloon catheter according to claim 20, wherein the ablation energy source includes PFA.

22. The ablation balloon catheter according to claim 1, wherein the distal and proximal ends of the first electrode basket and the second electrode basket each include a solid cylindrical collar body, the distal end of the second electrode basket covers the distal end of the first electrode basket in both the folded and extended states of the first and second splines, and the solid cylindrical collar body of the proximal end is at least partially positioned below the outer catheter shaft.

23. External catheter shaft, An inflatable balloon, the first end of which is connected to the outer catheter shaft, The second end of the inflatable balloon is connected to an axially movable nose tip, An electrode basket surrounds the balloon, has a plurality of first splines and a plurality of second splines, is connected to the outer catheter shaft and the nose tip, and moves between a flattened state and an expanded state, The actuator includes an actuator that moves the nose tip axially in parallel to facilitate the transition of the first and second electrode baskets to a folded state when the balloon is deflated, and moves axially between an deployed position and a retracted position. The plurality of first splines and the plurality of second splines are configured to unfold and expand radially when the inflatable balloon is inflated. An ablation balloon catheter wherein the actuator is spring-biased, takes the deployed position as the stationary position, and takes the retracted position when the balloon inflates and the force applied by the balloon to the plurality of first splines and the second splines exceeds the spring force of the spring.

24. External catheter shaft, An inflatable balloon, the first end of which is connected to the outer catheter shaft, A forward-viewing endoscope is placed inside the inflatable balloon, The second end of the inflatable balloon is connected to a posable nose tip, A first electrode basket having a plurality of first splines surrounding the outside of the balloon, with a first end connected to the outer catheter shaft and a second end connected to the nose tip, and one or more of the first splines supporting one or more electrodes, The actuator includes a component that moves the nose tip in the axial direction to facilitate the transition of the first electrode basket to a folded state when the balloon is deflated, An ablation balloon catheter wherein the plurality of first splines are configured to unfold and expand radially when the inflatable balloon is inflated.

25. The present invention further includes a second electrode basket having a plurality of second splines, the first end of which is connected to the outer catheter shaft and the second end of which is connected to the nose tip, wherein the second electrode basket is positioned on the first electrode basket, the plurality of first splines are rotationally offset from the plurality of second splines, and one or more of the second splines support one or more electrodes. The ablation balloon catheter according to claim 24, wherein the plurality of second splines are configured to unfold and expand radially when the inflatable balloon is inflated.

26. The actuator moves axially between the deployed position and the retracted position. The ablation balloon catheter according to claim 24, wherein the actuator is spring-biased, takes the deployed position as a stationary position, and takes the retracted position when the balloon inflates and the force applied by the balloon to the plurality of first splines exceeds the spring force of the spring.

27. The ablation balloon catheter according to claim 24, wherein the actuator is located within the handle of the catheter.

28. The ablation balloon catheter according to claim 24, wherein the actuator includes an elongated tube, the first end of which is connected to an axially movable portion housed in a handle, and the second end on the opposite side is connected to the nose tip.

29. The ablation balloon catheter according to claim 28, wherein the tube includes a nitinol tube.

30. The ablation balloon catheter according to claim 28, wherein the elongated tube is biased.

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