Expandable structure for providing electrodes for ablation and electrophysiological mapping at surface of endoscope guided laser ablation catheter

Abstract

An ablation balloon catheter includes an outer catheter shaft and an inflatable balloon coupled to the outer catheter shaft at a first end. The catheter includes a translatable nose end to which the second end of the inflatable balloon is coupled. The catheter has a first electrode basket having a plurality of first sample strips. A second electrode basket is provided, the second electrode basket having a plurality of second splines. The second electrode basket is disposed above the first electrode basket. The catheter has an actuator for axially translating the nasal end to cause the first and second electrode baskets to move to a collapsed state when the balloon is deflated. The plurality of first splines and the plurality of second splines are configured to deploy and radially expand with the inflatable balloon inflated, the plurality of first splines being interposed between the plurality of second splines.

Description

Cross-references to related applications

[0001] This application is based on and claims priority to U.S. Provisional Patent Application No. 63 / 504,465, filed May 26, 2023, the entire contents of which are incorporated herein by reference, as if their entire contents were expressly set forth herein. Technical Field

[0002] This disclosure relates to the ablation of atrial fibrillation, and more particularly to the ablation of atrial fibrillation using a device including an expandable structure to provide electrodes on the surface of an endoscopically guided laser ablation catheter for ablation and electrophysiological mapping. Background Technology

[0003] Balloon catheters configured to perform ablation of atrial fibrillation are well known and described in US9421066B2 by Melsky et al. and US9033961B2 by Melsky et al., the entire contents of which are expressly incorporated herein by reference. These patents treat atrial fibrillation by using an energy source to create non-conductive lesions in the atrial tissue in a circumferential ring-shaped injury in the left atrial region where the pulmonary veins connect to the atrium. This circumferential lesion prevents electrical signals originating from the veins from entering the atrium, and vice versa. In most cases, blocking the passage of these electrical signals restores sinus rhythm to the left atrium previously affected by fibrillation.

[0004] Typically, ablation for atrial fibrillation involves the following steps: introducing an ablation catheter into the left atrium, creating circumferential damage around the pulmonary veins, and then confirming that sufficient circumferential damage has been created to actually block the electrical signal. This confirmation step usually involves removing the ablation catheter and then introducing a catheter with multiple electrodes, which can be placed in the pulmonary veins away from the circumferential damage, and then using the electrodes to monitor the electrograms originating from the pulmonary veins. When the veins are electrically isolated from the atrium, the veins are silent, and only far-field electrical activity is seen in the veins. Occasional spikes may appear in the veins, but they do not conduct to the rest of the atrium. Pacing the atrium through a catheter with electrodes placed in the coronary sinus helps confirm that only far-field activity and random spikes are seen in the veins.

[0005] Currently, the devices described in US9421066B2 by Melsky et al. and US9033961B2 by Melsky et al. are effective ablation devices; however, like many other ablation devices, they do not include a means for quickly and easily confirming electrical isolation once venous ablation is completed. It is highly desirable to be able to ablate veins and then confirm that the ablation has resulted in the desired electrical isolation of the vein without having to replace the catheter. Therefore, one object of the present invention is to provide an ablation device that provides endoscopically guided laser ablation and a means for confirming that electrical isolation of the pulmonary vein has been achieved and performing this confirmation without removing or replacing the catheter. If performed incorrectly, catheter replacement carries the risk of introducing air into the left atrium. If air enters the capillary bed of an organ and obstructs blood flow there, air entering the left atrium can potentially cause damage to the brain, heart, or other organs. Therefore, catheter replacement is always performed slowly and methodically to minimize the risk of air introduction. However, slow and methodical catheter replacement increases the time required to complete the ablation process. Extended procedures pose additional risks to patients and increase the cost of the process; therefore, it is desirable to reduce the number of catheter changes during the procedure.

[0006] In addition to confirming the achievement of electrical isolation of the vein, the addition of electrodes in the ablation catheters described in Melsky et al. (US9421066B2) and Melsky et al. (US9033961B2) will also enable the delivery of ablation energy, which requires a conductive path from the energy source to the ablation area. The delivered ablation energy can be radiofrequency energy or electroporation energy (also known as pulsed field ablation energy) or other energy sources such as laser or microwave. Where one energy type is more preferred than another from an anatomical perspective, the ability to provide these other ablation energy types may be desirable. For example, laser energy is ideal because it produces damage penetrating the entire thickness of the atrial wall, thus ensuring that the electrical dissociation resulting from damage produced using laser energy will be robust and durable. However, in cases where the esophagus is located in an area close to the left atrium that must be ablated, it may be ideal to use electroporation energy in that specific area, since it has been proposed that electroporation energy produces differential damage in cardiac and esophageal tissues, thus opening up the possibility that cardiac tissue adjacent to the esophagus can be safely ablated by electroporation without the need for close monitoring of esophageal temperature and stopping ablation if the esophageal temperature rises too high. Summary of the Invention

[0007] In summary, one object of the present invention is to provide a device for rapidly and easily confirming electrical isolation of a pulmonary vein that has been isolated by endoscopic-guided laser ablation, using a device similar to those described in Melsky et al. (US9421066B2) and Melsky et al. (US9033961B2). Another object of the present invention is to provide such a device in a manner that does not require catheter replacement. Another object of the present invention is to provide a device for both confirming isolation and delivering other forms of ablation energy, which can be delivered via electrodes that contact or are in close proximity to tissue. Another object of the present invention is to provide electrodes for confirming isolation or ablation that can be visualized endoscopically using endoscopic devices already present in Melsky et al. (US9421066B2) and Melsky et al. (US9033961B2).

[0008] In one exemplary embodiment, the ablation balloon catheter includes: External catheter shaft; An inflatable balloon, the first end of which is connected to the external catheter shaft; A translatable nasal tip, with the second end of an inflatable balloon connected to the nasal tip; A first electrode basket having multiple first splines, the first electrode basket being connected at a first end to an external catheter shaft and at a second end to the nasal tip; and A second electrode basket having a plurality of second splines, the second electrode basket being connected at a first end to an external conduit shaft and at a second end to a nasal tip, wherein the second electrode basket is disposed above the first electrode basket, and the plurality of first splines are rotatably offset from the plurality of second splines, wherein one or more first splines support one or more electrodes and one or more second splines support one or more electrodes; An actuator is used to axially translate the nose tip to cause the first and second electrode baskets to move to a collapsed state when the balloon deflates. The plurality of first splines and the plurality of second splines are configured to deploy and expand radially when the inflatable balloon is inflated, with the plurality of first splines placed between the plurality of second splines. Attached Figure Description

[0009] Figure 1 An exemplary device of the present disclosure is shown in an deployed state, which is deployed on the surface of an inflatable balloon of an exemplary balloon catheter; Figure 2 It shows the retracted state. Figure 1 The device is prepared to be advanced on the deflation balloon of the balloon catheter; Figure 3 It shows Figure 1The device is in a state where it has been advanced onto the inflatable balloon of the balloon catheter and is in a partially deployed state, which is achieved by the expansion of the balloon; Figure 4 The PFA catheter installation basket is shown; Figure 5 An electrode catheter for use with a balloon catheter is shown; Figure 6 A dual transeptal / second catheter device is shown, comprising a device positioned on a balloon catheter. Figure 5 Electrode catheters; Figure 7 An embodiment of a retractable tine electrode array is shown; Figures 8A-8C The various states of the retractable fork electrode array are shown; Figure 9 A balloon catheter with a PFA braided wire mesh electrode array is shown; Figure 10 A balloon with an embedded electrode array is shown; Figure 11 A balloon catheter with micropores and an internal electrode array is shown; Figure 12 A balloon catheter with micropores and an internal electrode array is shown; Figure 13 Another balloon catheter with micropores and an internal electrode array is shown; Figure 14 This is a block diagram illustrating exemplary components of an endoscopic-guided cardiac ablation system according to the present invention; Figure 15A This is a perspective view of a translational distal balloon catheter according to one embodiment, shown in a collapsed state; Figure 15B yes Figure 15A A perspective view of the translational distal balloon catheter in an inflated state; Figure 16A It is suitable for and Figure 15A A perspective view of the handle used with a translational balloon catheter, shown in the extended position; and Figure 16B yes Figure 16A A perspective view of the handle in its retracted state. Detailed Implementation

[0010] Figure 1Exemplary balloon catheters are shown, such as those described in US9421066B2 by Melsky et al. and US9033961B2 by Melsky et al., each of which is incorporated herein by reference.

[0011] Exemplary ablation system Figure 14 This is an exemplary schematic block diagram of an ablation / endoscopic system according to the present invention, generally indicated by reference numeral 10. The ablation system 10 preferably includes a therapeutic ablation tool, such as one of those described herein, and more preferably includes an endoscope and ablation device as discussed below.

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

[0013] As will be understood from the following discussion, the endoscope is preferably housed within the ablation tool 100 and has the ability to capture both moving and recording images. Illumination light 24 is used to provide surgical light to the treatment site. The frequency of the illumination light allows the user to distinguish between different tissues present at the surgical site. Aiming light source 20 is used to visualize the location where the ablation tool 100 delivers energy to the tissue. It is conceivable that the wavelength of the aiming light 20 will be able to be recorded by the image capture device and visible on a monitor.

[0014] Processor 12 can be designed to process real-time visual data as well as data from the ablation tool controller and display. Processor 12 is configured to execute a series of software and / or hardware modules configured to interpret, manipulate, and record visual information received from the treatment site. Processor 12 can also be configured to manipulate and provide illustrative graphic overlays and synthesize or blend visual data to a display device.

[0015] like Figure 14 As shown, system 10 also 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 output of the illumination source 24 and excitation source 25 of the energy emitter, and is configured to determine the distance and movement of the energy emitter relative to the tissue at the ablation treatment site (as discussed further below). It will also be understood from the following discussion that the endoscope is preferably supported by the ablation tool and captures images that can be processed by the processor 12 to determine whether sufficient ablation energy has been delivered and directed to a specific area of ​​the treatment site. Data obtained from the endoscope includes real-time video or still images of the treatment site as seen from the ablation tool. As discussed herein, these images / videos can be stored in memory for later use.

[0016] A targeting light source 20 is used to visualize the location of the treatment site where energy will be delivered by the ablation tool to the target tissue. Preferably, the targeting light source 20 outputs light in the visible region of the electromagnetic spectrum. If the user sees a suitable ablation path, the controller 16 can transfer radiant energy from the ablation tool to the target tissue site via the energy source 18 to achieve ablation through lesions. It should be understood that the term "radiant energy" as used herein is intended to encompass energy sources that do not primarily rely on conductive or convective heat transfer. These sources include, but are not limited to, acoustic, laser, electroporation energy, and electromagnetic radiation sources, and more specifically include microwaves, X-rays, gamma rays, ultrasound, and radiation sources. Furthermore, the term "light" as used herein is intended to encompass electromagnetic radiation, including but not limited to visible light, infrared radiation, and ultraviolet radiation.

[0017] The illumination source 24 is a light source used to provide appropriate illumination to the treatment area. The illumination is configured so that natural biological hues and colors can be easily recognized by the operator.

[0018] Controller 16 provides the user with the ability to control the aiming light source, user input device, and ablation tool. Controller 16 serves as the primary control interface for the ablation system. Through controller 16, the user can turn the aiming light 20 and illumination light 24 on and off. Furthermore, controller 16 has the ability to change the intensity of the illumination and aiming light. The ability to switch user interfaces or display devices is also envisioned. Additionally, controller 16 provides access to the ablation tool, including controlling the discharge intensity, duration, and location of the ablation energy discharge. Controller 16 can also provide a safe shutdown of the system in the event of a loss of a clear transmission path between the radiation energy source and the target tissue during energy delivery (see, for example, U.S. Patent Application Serial No. 12 / 896,010, filed October 1, 2010, the entire contents of which are incorporated herein by reference).

[0019] The controller can be a single microprocessor based on control interface hardware, or it can be part of a module configured to run via a processor of a computer system configured to accept and control input from various physical devices.

[0020] Pulse electric field ablation energy While the technology of pulsed electric fields for tissue therapy continues to advance, it is generally understood that applying a brief high DC voltage to tissue can generate a localized high electric field, typically in the range of several hundred volts per centimeter, which disrupts the cell membrane by creating pores within it. Although the precise mechanisms of this electrically driven pore generation, or electroporation, are still under investigation, it is thought that applying a relatively brief and large electric field creates instability in the lipid bilayer of the cell membrane, leading to the distribution of localized gaps or pores within the cell membrane. If the electric field applied to the membrane exceeds a threshold, causing the pores to remain open and allowing for the exchange of biomolecules across the membrane, resulting in necrosis and / or apoptosis (cell death), this electroporation may be irreversible. Subsequently, the circumferential tissue can heal naturally.

[0021] Typically, systems such as those described herein for delivering pulsed waveforms to tissue include a signal generator configured to generate the pulsed waveform and an ablation device coupled 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. Therefore, the systems described herein for ablating tissue may include a signal generator and an ablation device having one or more electrodes and a expandable / expandable member (e.g., a balloon) for selectively and rapidly applying a DC voltage to drive electroporation.

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

[0023] The irreversible electroporation system described herein may include a signal generator and a processor configured to apply one or more voltage pulse waveforms to an electrode assembly to deliver energy to the region of interest. To transmit the pulse waveforms generated by the signal generator, one or more electrodes of the ablation device may have insulated conductors configured, in at least one embodiment, to maintain a voltage potential of at least about 2500 V without dielectric breakdown of their respective insulating portions. In some embodiments, at least some of the electrodes may be independently addressable, such that each electrode can be controlled (e.g., delivered energy) independently of any other electrode in the device.

[0024] like Figure 14As shown, the system may include a signal generator 29 configured to generate pulse waveforms for irreversible electroporation of tissue (e.g., pulmonary veins). For example, the signal generator 29 may be a voltage pulse waveform generator and configured to deliver the pulse waveforms to one of the ablation devices (ablation tools) described herein. The processor 12 may combine data received from memory to determine parameters of the pulse waveform to be generated by the signal generator 29, while some parameters, such as voltage, may be input by the user. The memory may also store instructions to cause the signal generator 29 to perform modules, processes, and / or functions associated with the system, such as pulse waveforms. For example, the memory may be configured to store pulse waveforms used for pulse waveform generation.

[0025] Some embodiments relate to pulsed high-voltage waveforms and sequential delivery schemes for delivering energy to tissue via an electrode array. The signal generator and processor can be configured to apply pulsed voltage waveforms to selected plurality of electrodes or subsets of electrodes of the ablation device.

[0026] In one application, the pulsed voltage waveform can be in the form of a two-pulse sequence, where each pulse, for example, is associated with a pulse width or duration. The pulse width / duration can 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, including all values ​​and sub-ranges therebetween. The pulse waveform can 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 baseline). In some embodiments, such as for irreversible electroporation applications, the height of each pulse or the voltage amplitude of the pulse can range from approximately 400 volts, approximately 1000 volts, approximately 5000 volts, approximately 10000 volts, approximately 15000 volts (e.g., in one application, a maximum amplitude of 2500 volts is used), including all values ​​and sub-ranges therebetween. This pulse is spaced apart from adjacent pulses by a certain time interval, sometimes referred to as a first time interval. As an example, the first time interval can be approximately 1 microsecond, approximately 50 microseconds, approximately 100 microseconds, approximately 200 microseconds, approximately 500 microseconds, approximately 800 microseconds, approximately 1 millisecond, including all values ​​and sub-ranges therein, to produce irreversible electroporation. It should be understood that the above values ​​are merely exemplary in nature and do not limit the scope of the invention, as values ​​outside the above ranges may exist for other applications.

[0027] Exemplary ablation catheter like Figures 1 to 3As shown, an exemplary ablation device involves a generally flexible and elongated structure 1 slidably disposed on an elongated axis 2 of a balloon ablation catheter. The elongated structure 1 can be considered as a longitudinally displaceable cannula on the balloon catheter. Although the term "elongated structure" is used herein, it should be understood that the term "cannula" is used interchangeably with it. As described herein, the elongated structure 1 is movable along the balloon catheter to cover different regions of the balloon catheter. As described herein, when the elongated structure at least partially covers the balloon, the elongated structure 1 is configured to respond to movement of the balloon ablation catheter, more specifically, to the expansion and contraction of the balloon.

[0028] The elongated structure 1 typically has several distinct portions, including a proximal portion and a distal portion. The proximal portion of the elongated structure 1 includes, for example: Figure 1 The first tubular portion 3 is shown. The proximal region is spaced posteriorly from the distal region by a distance of 2 cm to 4 cm; however, this is merely an exemplary value and not a limitation on the scope of the invention. The first tubular portion 3 is configured such that the axis 2 of the balloon ablation catheter passes through the lumen of the first tubular portion 3. In other words, the first tubular portion 3 completely surrounds the catheter axis 2 in at least one region of the first tubular portion 3.

[0029] The first tubular portion 3 can be formed of a flexible material.

[0030] The distal portion of the elongated structure 1 branches into two or more branches 4, but preferably six or more, and the branches 4 are also flexible. Each branch 4 contains one or more electrodes 5 on its outward-facing surface. Each electrode 5 is connected to an insulated wire embedded in the body of the elongated flexible structure 1, but such wire is not in the... Figure 1 As shown in the figure. For example, structure 1 can be overmolded onto the wire. As shown, when multiple electrodes 5 are used for each branch 4, the electrodes 5 are spaced apart longitudinally along the corresponding branch 4. It should also be understood that the electrodes 5 can be of the same type or can be of different types. In other words, the electrodes 5 can have different sizes and / or different shapes. The arrangement of the electrodes 5 can be asymmetrical, as the electrodes 5 can be concentrated on one or more regions of the branch 4. For example, the electrodes 5 can be positioned more centrally along the branch 4 and located at the distal end, rather than at the proximal end.

[0031] Therefore, branches 4 can be circumferentially spaced from each other and extend circumferentially around the balloon. Branches 4 can also be designed to have an asymmetrical appearance, i.e., an asymmetrical arrangement can be provided instead of symmetrical angular displacement between branches 4. In other words, within one half of the elongated structure 1, branches 4 can have one type of angular displacement, while in the other half, a different type of angular displacement can be provided. In other words, there can be more branches 4 in one half of structure 1 compared to the other half. For example, the first circumferential half can have a first number of electrodes, while the second circumferential half can 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 an opposite second end (distal end). The first end of the branch 4 is attached to the first tubular portion 3, and in one embodiment, the branch 4 is integrally formed with the first tubular portion 3.

[0033] Multiple flexible branches 4 recombine at their second ends to re-form a second tubular structure 6 at the distal end of the elongated structure 1. The second tubular structure 6 slidably (axially and rotatably) surrounds the distal end 7 of the balloon ablation catheter.

[0034] Typically, the multiple branches (branch 4) form an expandable cage-like structure that circumferentially surrounds the inflatable balloon 8 when the elongated structure is positioned on at least a portion of the balloon. The proximal portion of the elongated structure 1 can maintain a tubular shape from the rearward branching (branch 4), or alternatively, the proximal portion of the elongated structure 1 can consist only of the circumferential portion of the tubular portion shown in 9, thus being more flexible and occupying a smaller volume than when it is entirely tubular. The axis 2 is visible between the portions of the elongated structure 1.

[0035] It should be understood that the device 1 is preferably formed as a single elongated structure, wherein the tubular portions 3, 6 and the branch 4 located between the tubular portions 3, 6 are formed as a single integral component (e.g., a molded component).

[0036] Figure 2 The travel of the elongated structure 1 on the balloon catheter is shown. More specifically, the first tubular portion 3 and the branch 4 are shown in their relaxed state. This represents the normal resting state of the elongated structure 1. In this state, it is clear how this structure is fabricated by creating a series of longitudinal slits 10 in a generally thin, flat material that has already been formed into a tubular shape. In other words, the branch 4 is formed by incorporating longitudinal slits into the structure 1 to define a branch between two adjacent slits. A suitable thin, flat material is a polyimide film, such as the polyimide film commonly used in the production of flexible printed circuits or flexible circuits. It should be understood that other materials are also possible.

[0037] Figure 1 and Figure 2 Together, they illustrate how this device achieves the following objectives: to provide an apparatus for allowing pulmonary vein isolation using an endoscopically guided balloon catheter and, additionally, to confirm electrical isolation of the vein without requiring catheter replacement as is required in the prior art. As discussed in more detail below, the inner surface of the tubular structure may include endoscope-visible markings on its inner surface for indicating electrode positions.

[0038] Therefore, there can be two defined operational phases, including a first phase, which is an ablation phase in which the elongated structure 1 is not used. During this ablation phase, such as Figure 2 As shown, the elongated structure 1 resides at the proximal end of the balloon catheter and is in a collapsed state, tightly surrounding the axis 2 of the balloon catheter. As indicated by this stage and state, the entire elongated structure 1 is displaced from the balloon of the balloon catheter and located at the proximal end of the balloon catheter. Therefore, the distal second tubular axis portion 6 is located at the proximal end of the balloon.

[0039] In this state (first stage), the elongated structure 1 of the present invention allows the balloon of the ablation catheter to inflate and be placed in the pulmonary vein without obstruction by the elongated structure 1. The vein can be visualized endoscopically through the ablation catheter, and laser energy can be delivered to the vein, regardless of the present invention. In other words, as in the applicant's previous ablation catheter design, the energy emitted from the movable energy emitter 0 residing within the balloon ( Figure 2 The energy passes through the balloon to the target site without any obstruction from the elongated structure 1, because the elongated structure 1 is spaced apart from and does not contact the balloon's inflation operation area.

[0040] This would not be the case if the electrode (e.g., electrode 5) were placed directly on the surface of the balloon, because such an electrode would block the laser energy and the endoscope from observing the part of the balloon where such an electrode resides.

[0041] Once the vein ablation is complete (first stage), the balloon of the ablation catheter is deflated, but the elongated structure 1 of the ablation catheter is not repositioned relative to the vein. With the ablation catheter structure stationary relative to the ablated vein, the elongated structure 1 is advanced distally over the deflated balloon. The balloon is then re-inflated, and this re-inflation causes the branches (multi-branched) 4 of the elongated structure 1 to expand, forcing at least a number of electrodes 5 into contact with the lumen of the vein. Now, by extending the wires connected to the electrodes 5 proximally along the proximal portion of the elongated structure 1 until they appear outside the patient's body, they are connected to a known device capable of amplifying and displaying electrical activity emanating from the tissue in contact with the electrodes 5, which can be used to confirm electrical isolation.

[0042] It should also be noted that, while electrode 5 is in contact with pulmonary vein tissue (or other target tissue), ablation energy can be delivered by connecting an energy source such as radiofrequency energy, electroporation energy, or microwave energy to a wire attached to the electrode. It should also be noted that the position of the electrode is relevant to the endoscope 50 residing inside the balloon of the ablation catheter. Figure 2 The electrode 5 is visible. This visibility is achieved by fabricating the multi-branched structure 4 with a transparent material or by creating markings on the inner surface of the multi-branched structure directly adjacent to the electrode location. This endoscopic visualization of the electrode location allows for a visual assessment of the contact condition between the electrode and the tissue. For example, a given electrode may be in firm contact with venous tissue throughout the cardiac cycle. Alternatively, the electrode 5 may be in contact with the tissue during one part of the cardiac cycle, and with the blood during another part of the cycle, or it may not be in contact with the tissue during any part of the cardiac cycle. This visual assessment of the nature of contact between the tissue and the electrode is currently not possible in any known device. This assessment is valuable in helping to interpret electrographs measured by the electrodes. Furthermore, if the electrodes are used to apply radiofrequency or electroporation or microwave ablation energy, such visual information about the degree of tissue contact can be used to determine which of a number of electrodes are suitable for delivering ablation energy through the degree of tissue contact they provide. Additionally, if it is deemed necessary to better assess electrical activity in the vein or to improve electrode contact so that ablation can be performed via radiofrequency or electroporation energy application, endoscopic views can be used to guide the repositioning of the balloon in the vein to improve contact between the electrode and the venous tissue.

[0043] Sliding motion of slender structure 1 As discussed herein, the elongated member 1 is configured to move longitudinally along the balloon catheter, such as Figures 1 to 3 As shown. The elongated member also has rotational movement relative to the balloon. The elongated structure 1 can be moved manually, for example by grasping one end of the elongated structure 1 (e.g., the first tubular portion 3) and moving the entire structure 1 longitudinally in the distal or proximal direction. Alternatively, to move the elongated structure 1 in the proximal direction, the first tubular portion 3 can be grasped and pulled in the proximal direction. Preferably, the first tubular portion 3 extends proximally to the point where it leaves the body and can be directly grasped by the user. To assist the user in moving the structure 1, the proximal end of the structure 1 can have a grasping feature, such as an enlarged annular portion at the proximal end of the first tubular portion 3. Alternatively, a surface texture can be provided on one or more areas of the first tubular portion 3.

[0044] As the elongated member 1 retracts and moves proximally, it can enter the lumen formed within the catheter member, or the lumen within a guiding sheath or deflectable sheath typically used in atrial ablation, through which the balloon catheter and tubular member will pass. That is, the tubular structure can slide back into the catheter shaft or into the guiding or deflectable sheath, and this retraction will cause the elongated structure 1 to collapse and be removed from its surrounding relationship with the balloon. The retraction of structure 1 within the lumen of the catheter shaft causes the branches to collapse into a compact state. Note that when the tubular structure retracts into the guiding or deflectable sheath, the multiple branches of the tubular structure are supported by the inner surface of this sheath and prevented from expanding or deflecting outwards, and also prevented from deflecting inwards by the axis of the balloon catheter. In this state, the tubular structure is restricted from expanding or contracting, and therefore easier to reposition relative to the balloon catheter. In cases where the only ablation energy used by the device is delivered via electrodes, the elongated structure will not necessarily need to retract completely proximally to the balloon. In other words, the elongated structure 1 can move between multiple locations, one of which is where at least some electrodes at least partially cover the balloon.

[0045] Controllable electrode The entire ablation system described herein includes an elongated structure 1 and an ablation balloon catheter, which can communicate with various machines via a network. These machines are configured to send and receive content, data, and instructions, which, when executed, enable the operation of various connected components / mechanisms. Content and data can include information in various forms, including, as non-limiting examples, 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 can be of conventional construction, and although servers providing different content and services to other devices (such as mobile computing devices) are discussed, one or more server computing devices can include the same machine or can be distributed across multiple machines in a large-scale implementation, as understood by those skilled in the art. In the relevant sections, each computer server has one or more processors, a computer-readable storage device storing code that configures the processor to perform at least one function, and a communication port for connecting to a network. The code can include one or more programs, libraries, functions, or routines, which, for the purposes of this specification, can be described according to multiple modules residing in a representative code / instruction storage device that implement different parts of the process described herein. As described herein, each robotic device (tool) has a controller (processor), and therefore includes one form of the aforementioned computing device.

[0046] Furthermore, computer programs such as imaging or measurement software (also generally referred to herein as computer control logic or computer-readable program code) may be stored in main memory and / or auxiliary memory and implemented by one or more processors (controllers, etc.) to cause one or more processors to perform the functions of the invention as described herein. In this document, the terms “memory,” “machine-readable medium,” “computer program medium,” and “computer-usable medium” are used to generally refer to media such as random access memory (RAM); read-only memory (ROM); removable storage units (e.g., disks or optical discs, flash memory devices, etc.); hard disks; or similar devices. It should be understood that, for mobile computing devices (e.g., tablet computers), computer programs such as imaging software may be in the form of application programs that execute on the mobile computing device.

[0047] This system may include a graphical user interface (GUI), which can be provided to allow remote control of the system. As is known, a GUI is an interactive visual component system for computer software. A GUI displays objects that convey information and represent actions that a user can take. When a user interacts with an object, the object changes color, size, or visibility. GUI objects include icons, cursors, and buttons. These graphical elements are sometimes enhanced with sound or visual effects such as transparency and shadows.

[0048] A graphical user interface typically includes a display, such as a touchscreen display, to allow user input to be recorded, which is then processed by the main controller (main processor).

[0049] In one exemplary embodiment, a main controller can be used to control the operation of electrode 5. In other words, the main controller can be used to operate (activate) selected electrodes 5 at a given time. Those electrodes 5 that are activated are provided with ablation energy, while those electrodes 5 that are not activated are not provided with ablation energy. As described above, electrode 5 can be wired to an electrical connector, which itself is connected to a terminal (control console) or the like (e.g., its socket or plug), thereby providing power to electrode 5.

[0050] Depending on certain parameters, such as the location of the balloon catheter within the body, some electrodes 5 can be activated and turned on, while others can be turned off and deactivated. For example, if the balloon catheter and tubular structure are in contact with certain tissue, and this contact with the tissue is visualized via an endoscope inside the balloon, the user may only want the electrodes 5 in contact with the tissue to receive ablation energy, and therefore, based on endoscopic guidance, the operator can strategically select which branches 4 and electrodes 5 to activate.

[0051] The main controller can communicate with the display, and images and data can be displayed on the display.

[0052] Touchscreens and similar devices can be used to select which branches 4 and electrodes 5 to be activated (energized). For example, a graphic image of the elongated structure 1, and more specifically, graphic images of branches 4 and electrodes 5, can be displayed to the operator, who can then select which branches 4 / electrodes 5 to activate. When using a touchscreen, the operator can simply highlight and select which branches 4 / electrodes 5 to be activated with their finger. It should also be understood that artificial intelligence (AI) based software can be used to determine, and then, based on which electrodes are in contact with the tissue, recommend which electrodes should be activated to the user.

[0053] PFA conduit installation basket Figure 4 A balloon catheter 100 is shown, including a main catheter shaft 110 with a distal end. It should also be understood that the balloon catheter 100 typically includes more than one shaft, and typically includes an inner catheter shaft and an outer catheter shaft, or may otherwise include multiple concentric tubular structures. An inflatable balloon 120 is included in and coupled to the main catheter shaft 110, with the distal end of the inflatable balloon 120 proximal to the distal end of the main catheter shaft 110, and the proximal end of the inflatable balloon 120 spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main catheter shaft 110.

[0054] Figure 4 The inner axis 115 and the endoscope 125 are also shown. The endoscope 125 extends along the outside of the inner axis 115 and is generally located at one end of the forward-looking balloon because it faces the other end of the balloon.

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

[0056] The expandable balloon 120 also includes an endoscope 125 located within the compliant balloon. The endoscope allows the catheter operator to visualize the balloon surface, thereby aiming laser energy at portions of the balloon surface that come into contact with the atrial tissue desired to be treated with the laser energy. Such systems are described by Melsky et al. (U.S. Patent 9,421,066 ('066 Patent)) and Melsky et al. (U.S. Patent 9,033,961 ('961 Patent)), the entire contents of which are incorporated herein by reference. The endoscope is located close to the site of energy delivery to the tissue to allow the user to observe the energy delivery and the resulting tissue damage. The endoscope may be one of the endoscopes described herein or one of the endoscopes described in any of the documents cited herein.

[0057] exist Figure 4The diagram shows an energy emitter 127; however, it should be understood that in embodiments where the electrode array is intended to be held in position around the inflatable balloon 120, the energy emitter 127 may be removed or present but never used. The energy emitter 127 may be used where the electrode array can be removed from the balloon.

[0058] Endoscope 125 is anteriorly oriented and positioned adjacent to a catheter axis, such as a central tube typically formed of a transparent polymer material. As used herein, the term "anteriorly oriented" refers to the endoscope's view in the distal direction relative to the catheter body. Similarly, the term "lateral" refers to the endoscope's view in a radially outward direction from one side of the catheter body.

[0059] Endoscope 125 may be a fiber optic endoscope that is inserted through the lumen of a catheter and located in 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 providing direct visualization of the area to be treated, wherein the first imaging device is fixed relative 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, the entire contents of which are expressly incorporated herein by reference.

[0061] The balloon catheter 100 includes an expandable basket 130 surrounding an inflatable balloon 120 and configured to expand when the inflatable balloon 120 expands (inflates), and similarly, to contract when the inflatable balloon 120 contracts and collapses. The expandable basket 130 has a first loop (first ring) 132 at a first (proximal) end of the expandable basket 130 and a second loop (second ring) 134 at a second (distal) end of the expandable basket 130. The first loop 132 and the second loop 134 have annular shapes and can therefore have a continuous annular shape. The two loops 132, 134 can be different in size from each other; in the illustrated embodiment, the first loop 132 is larger than the second loop 134. The dimensions and construction of the two loops 132, 134 are designed to securely connect the expandable basket 130 to a main catheter shaft 110 (or one or more other catheter shafts), with the inflatable balloon 120 positioned between the two loops 132, 134. Therefore, the first ring 132 is preferably located at the proximal end of the inflatable balloon 120, while the second ring 134 is located at the distal end of the inflatable balloon 120.

[0062] The expandable basket 130 includes a plurality of splines 140, one end of which is attached to a first loop 132 and the other end to a second loop 134. The splines 140 extend longitudinally along the length of the inflatable balloon 120. The splines 140 are circumferentially offset from each other, forming open spaces between adjacent splines 140. The splines 140 are configured to expand and contract under the action of the underlying inflatable balloon 120. Specifically, when the inflatable balloon 120 expands, the splines 140 expand outwards; conversely, when the inflatable balloon 120 deflates, the splines 140 contract inwards. Thus, the splines 140 conform to the shape of the inflatable balloon 120.

[0063] Each spline 140 carries one or more electrodes 150. For example, each spline 140 may include a plurality of electrodes 150 that can be described as an electrode array. In the illustrated embodiment, three electrodes 150 are positioned along the length of the spline 140. The electrodes 150 are spaced apart (in series) along the longitudinal direction of 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 because, when the inflatable balloon 120 is inflated, as discussed herein, the electrodes 150 are positioned against the target tissue to be ablated using PFA technology.

[0064] The multiple electrodes 150 defining the electrodes can be of the same electrode type or they can be different. For example, the shape and size of the electrodes 150 can be the same as shown. The material of the expandable basket 130 is not elastic because the spline cannot stretch elastically in the longitudinal direction, but is instead able to expand and contract together with the underlying expandable balloon 120. Therefore, the longitudinal spacing between the electrodes 150 does not change as the expandable basket 130 moves between the expanded and retracted positions. Instead, this is an important fixed distance and is used during visualization and ablation procedures to form the desired lesion as discussed herein.

[0065] and Figures 1 to 3 Compared to the previous embodiment, Figure 4 A product is shown in which, in at least one embodiment, an expandable basket 130 is fixed.

[0066] In another aspect of this disclosure, the system may include electrode markers that mark the position of electrode 150 along a spline. Specifically, electrode 150 is located on the outer surface of spline 140, and the spline is typically formed of a non-transparent material, and therefore, electrode 150 is not visible in real-time endoscopic images. Since spline 140 is typically made of an opaque material, electrode 150 cannot be seen because endoscope 125 can only see the inner surface of spline 140. To determine the position of electrode 150 during visualization (i.e., using endoscope 125), markers may be placed along the inner surface of spline 140. Each marker is located on the inner surface of spline 140, directly opposite the position of electrode 150, to mark the position of electrode 150. The markers are visually identifiable in real-time endoscopic images and may therefore be in the form of visual markers formed along the inner surface of spline 140. For example, visual markers may be in the form of numbers and / or text markers. Furthermore, visual markers are selected such that one electrode can be distinguished from another. For example, each spline can be numbered, such as spline 1, and then each electrode 150 can be labeled with a letter, such as A, B, C, etc. Thus, in the illustrated embodiment, the farthest electrode of spline 1 can be identified by label 1A, the middle electrode by label 1B, and the nearest electrode by label 1C. Similarly, for adjacent splines 2, the labels can be 2A, 2B, and 2C. It should be understood that there are many different ways to visually identify one electrode on one spline from another electrode on another spline.

[0067] For example, color can be used to identify a spline 140 from other splines. For instance, the letters A, B, C or the numbers 1, 2, and 3 can be one color for one spline and another color for another. Symbols can also be used as markers.

[0068] It should be understood that not all electrodes 150 are visible in real-time endoscopic images because not all electrodes are in the desired contact with the tissue at the target site. Therefore, it is important to understand which electrodes are visible in real-time endoscopic images and in contact with the tissue so that these electrodes can be actuated (activated).

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

[0070] The movement of the expandable basket 130 relative to the catheter body and the inflatable balloon 120 can be an automated process, such as by using an electronic controller, or it can be a manual process that occurs at the user's action. The controller allows desired movement in the rotational and / or longitudinal directions.

[0071] Energy Delivery and Electrode Selection: In one embodiment, energy is delivered to two or more electrodes 150 positioned along identical splines 140. In this embodiment, since the distance between the electrodes 150 on a single spline 140 is fixed and does not change based on basket expansion, this allows for selection of the PFA dose because the distance between the electrodes 150 to be activated is known. In another embodiment, energy is delivered between two electrodes 150 positioned not along identical splines 140 but along adjacent splines 140. In this case, the distance between the splines 140 varies depending on the degree of basket expansion. For example, the greater the basket expansion, the greater the distance between the splines 140, and therefore the greater the distance between the electrodes 150. When the electrode spacing remains fixed, there is a greater degree of dose predictability.

[0072] Based on the visualization information and the location of the electrodes to be actuated to induce damage and the spacing between the electrodes, the (PFA) dose is selected. The correct (optimal) dose is one that provides good tissue isolation without adversely affecting tissue quality.

[0073] During tissue ablation, certain selected electrodes 150 are activated, rather than all electrodes 150. Only those electrodes 150 that are in direct contact with the tissue are activated to deliver energy and create tissue damage.

[0074] Based on the visualization information, basket 130 may need to be moved axially and / or rotationally to perform ablation. For example, if the electrode spacing is too large, energy may be delivered to form a first lesion segment, and then the basket may need to be moved relative to the balloon (axially and / or rotationally) to reposition the electrodes and deliver energy to form a second lesion segment, which combines with the first lesion segment to form a more complete lesion segment. Alternatively, the circumferential electrode spacing can be inferred from the endoscopic image, and the dose of PFA can be adjusted to compensate for the different electrode spacings.

[0075] The shape and size of the resulting damaged segment will depend on which electrodes are actuated and their location. For example, activating two electrodes 150 positioned along the same spline 140 will result in a more longitudinally extending shaped damage, while activating two electrodes 150 positioned along adjacent splines will result in a more circumferentially extending shaped damage.

[0076] Double diaphragm / secondary catheter Figure 5 and Figure 6A balloon catheter 200 similar to balloon catheter 100 is shown, except that balloon catheter 200 does not include an expandable basket 13. Therefore, Figure 4 The reference numerals used in the figures are also Figure 5 and 6 The components used in both embodiments are common to this. The inflatable balloon is typically transparent, therefore... Figure 6 The transparent nature of the balloon is shown.

[0077] The balloon catheter 200 includes a main tubular axis 110, which typically includes more than one axis and generally includes an inner catheter axis and an outer catheter axis, or may otherwise include multiple concentric tubular structures, as shown in the figure. An inflatable compliant balloon 120 is included in and coupled to the main tubular axis 110, wherein the distal end of the inflatable balloon 120 is proximal to the distal end of the main tubular axis 110, and the proximal end of the inflatable balloon 120 is spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main tubular axis 110.

[0078] In this embodiment, a second catheter is present, namely, an electrode catheter 210 used in conjunction with the balloon catheter 200. The electrode catheter 210 includes an elongated structure having an open distal end and a proximal region 220 and a distal electrode region 230. The proximal region 220 may include an elongated, arched body that is not entirely circumferential in shape. Conversely, the distal electrode region 230 may be a fully circumferential structure. The distal electrode region 230 includes a proximal collar 232 at the proximal end of the distal electrode region 230 and a distal collar 234 at the distal end of the distal electrode region 230. Between the two collars 232, 234, the body of the distal electrode region 230 includes a plurality of longitudinal slits 240 circumferentially spaced around the body. 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. Much like spline 140, spline 245 carries one or more, and preferably multiple, electrodes (e.g., electrode 150), positioned along the outer surface (outer side) of spline 245. Much like the foregoing embodiments, each spline 245 may carry multiple electrodes, such as three or more, arranged in series and spaced apart from each other in the longitudinal direction of spline 245.

[0079] Both ends of the distal electrode region 230 are open, thus representing a tubular structure with open ends as described herein, which is configured to receive a balloon catheter in its contracted (deflated) state in a quiescent state.

[0080] As in the foregoing embodiment, the spline 245 is not elastic and therefore cannot be stretched, but 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 based on whether the spline 245 expands or contracts. However, as in the foregoing embodiment, the distance between two electrodes on two different splines 245 does change based on the degree of expansion.

[0081] The balloon catheter is inserted and passes through the hollow interior (cavity) of the electrode catheter 210, such that the spline 245 surrounds the inflatable balloon 130. As the balloon inflates, the spline 245 expands radially outward and separates from each other.

[0082] In another embodiment, spline 245 can collapse by retracting it back into the main (outer) conduit shaft.

[0083] In this embodiment, visualization is also used to determine which electrodes are in contact with the tissue, and visualization can also guide the user in making any adjustments to the balloon catheter and / or electrode catheter to create a complete, continuous lesion.

[0084] Scalable fork electrode array Figure 7 and Figures 8A to 8C A balloon catheter 300 similar to balloon catheter 100 is shown, except that balloon catheter 300 does not include an expandable basket 130. Therefore, Figure 4 The reference numerals used in the figures are also Figure 7 and Figures 8A to 8C The components used in both embodiments are common to this embodiment.

[0085] The balloon catheter 300 includes a main tubular axis 110, which typically includes more than one axis and generally includes an inner catheter axis and an outer catheter axis, or may otherwise include multiple concentric tubular structures, as shown in the figure. An inflatable balloon 120 is included in and coupled to the main tubular axis 110 and / or the additional axes, wherein the distal end of the inflatable balloon 120 is proximal to the distal end of the main tubular axis 110, and the proximal end of the inflatable balloon 120 is spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main tubular axis 110.

[0086] The balloon catheter 300 also includes a retractable electrode sheath 310 configured to retract within the main guide 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 guide shaft 110, and more specifically, the retractable electrode sheath 310 can travel within the main guide shaft 110 to allow movement between a fully retracted position and a fully extended position. In the fully retracted position, at least a considerable length of the retractable electrode sheath 310 is contained within the main guide shaft 110, and in the fully extended position, a considerable length of the retractable electrode sheath 310 is positioned outside the main guide shaft 110 and surrounding the inflatable balloon 120 as described herein. As shown, in the fully extended position, the fork 320 can extend at least 75% of the length of the balloon 130 and can extend 90% of the balloon length. In another embodiment, the fork teeth 320 extend at least 50% of the length of the balloon 130 (e.g., they extend at least to the widest portion of the inflatable balloon 130).

[0087] The retractable electrode sheath 310 includes a proximal collar 312 and a plurality of expandable forks 320. The proximal collar 312 may be a continuous cylindrical structure, and the plurality of expandable forks 320 are integrally formed with the proximal collar 312 at their proximal ends. The forks 320 are cantilever structures because the distal end of each fork 320 is a free end and is not attached to other structures. When the forks are in the fully extended position, the forks 320 are spaced apart and extend circumferentially around the balloon 130.

[0088] As in other embodiments, the fork 320 is not elastic and does not stretch in any way; however, the fork 320 is capable of expanding (radially) outward as the inflatable balloon 130 inflates, and similarly, the fork 320 can contract when the inflatable balloon 130 deflates. Thus, the fork 320 can be aligned with the compliant balloon 130.

[0089] In order to cause the fork 320 to retract and fully collapse, the retractable electrode sheath 310 is pulled back in the proximal direction, and when the retractable electrode sheath 310 enters the master tube shaft 110, the master tube shaft 110, in a surrounding manner, applies an inward force to the fork 320, which causes the fork to collapse and allows the fork to travel within the master tube shaft 110 and retract from the balloon 130.

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

[0091] In other embodiments, visualization (e.g., endoscopy) is used to determine which electrodes 150 are in contact with the tissue, and those selected electrodes can then be activated (actuated) to create lesions. A user interface allows identification of those electrodes 150 in contact with the tissue and power to them. As previously described, the operating software can be programmed to calculate an appropriate dose based on the distance between the activated electrodes 150 and to deliver the necessary energy to the electrodes 150.

[0092] As in all embodiments, it is desirable to limit the activation of the electrodes to only those electrodes required to form damage (segments).

[0093] Figure 8A The inflatable balloon 130 is shown in a deflated state, with the fork 320 fully retracted and substantially within the main tube shaft 110 (e.g., only the ends of the fork 320 protrude outside the main tube shaft 110).

[0094] Figure 8B The diagram shows the inflatable balloon 130 still in its deflated state, but the fork 320 has deployed. As described above, the coverage of the fork 320 relative to the balloon 130 can vary.

[0095] Figure 8C An inflated balloon 130 is shown, which causes the deployed fork 320 to expand. In this figure, the fork 320 shown extends approximately 50% of the length of the balloon 130; however, this is merely exemplary in nature and it should be understood that the fork 320 may extend more or less along the length of the balloon.

[0096] therefore, Figure 7 and Figures 8A to 8C One embodiment includes semi-rigid, retractable forks 320 having one or more electrodes 150 along the outer surface of each fork 320. The forks are housed within a catheter (main guide shaft 110) and deploy before inflating a balloon 130 (by sliding a retractable electrode sheath 310 distally using a controller or similar means, manually or mechanically). When the balloon 130 inflates, the electrodes 150 are pressed against the inner surface of the vessel to achieve tissue contact. As in other embodiments, the endoscope in this embodiment, located within the balloon 130, allows for direct visualization and confirmation of tissue contact and electrode spacing. Once tissue contact and the desired electrode spacing are confirmed, energy is applied to the desired (selected) electrode 150 to induce lesion. This embodiment may include as few as four deployable forks 320, but a greater number of forks 320 may provide the user with an ideal number of electrodes 150 and electrode spacing for effective treatment.

[0097] In this embodiment, as in other embodiments, markings may be provided along the inner surface of the fork 320 to visually identify the position of the electrodes 150 along the fork 320. This allows the user to determine which electrodes 150 are in contact with tissue and then instruct the energy delivery module to deliver energy to those selected electrodes 150. Furthermore, in one embodiment, the system may include image recognition software that analyzes real-time images fed from the endoscope and identifies the present electrode markings. For example, if markings such as A1 and A2 are present, the image recognition module will identify these electrodes and provide the user with the option to confirm that the electrodes corresponding to markings A1 and A2 should be activated and energy delivered to the user.

[0098] This image recognition function can be implemented in any other embodiment described herein, wherein electrode markers are presented to provide the user with a suggested electrode activation plan.

[0099] balloon with PFA braided wire mesh electrode array Figure 9 A balloon catheter 400 similar to other balloon catheters described herein is shown. Therefore, Figure 4 The reference numerals used in the figures are also Figure 9 The component used in both embodiments.

[0100] The balloon catheter 400 includes a main tubular axis 110, which typically includes more than one axis and generally includes an inner catheter axis and an outer catheter axis, or may otherwise include multiple concentric tubular structures. An inflatable balloon 120 is included in and coupled to the main tubular axis 110, with the distal end of the inflatable balloon 120 proximal to the distal end of the main tubular axis 110, and the proximal end of the inflatable balloon 120 spaced apart from the distal end. Thus, the inflatable balloon 120 surrounds the main tubular axis 110.

[0101] The balloon catheter 400 includes a braided fabric 410 disposed on an inflatable balloon 120 and configured to expand radially when the inflatable balloon 120 is inflated. The braided fabric 410 may include a mesh-like braid as shown. This mesh can serve as a support structure for an electrode array formed by electrodes 150 and can be formed of an insulating material. The electrodes 150 are disposed along the outer surface of the braided fabric 410, and the coverage of the electrodes 150 can be uniform or non-uniform. In a non-uniform embodiment, the electrodes 150 may be more concentrated in one or more regions of the braided fabric 410. For example, the electrodes 150 may be primarily located in the central region of the braided fabric 410, where tissue contact is more likely.

[0102] Furthermore, the spacing between the electrodes can be the same along the entire electrode array, or the spacing can vary in one or more regions of the inlaid fabric 410. For example, the spacing can be closer in the central region of the inlaid fabric 410.

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

[0104] Alternatively, by incorporating an insulating coating into the conductive (metallic) braid, the braid 410 (support structure) itself can serve as and define an electrode array, with the insulating coating stripped at desired locations for energy transfer, defining discrete electrodes in those areas where the coating has been removed. The braid 410 will then be operatively connected to an energy source, and current (energy) will be transported through the braid 410, with the areas where the insulating coating has been removed defining the electrodes that define the electrode array.

[0105] The wire mesh can be formed from individual discrete insulated wires to define discrete paths along which electrodes are located. By defining discrete electrode paths, discrete regions of the wire mesh can be activated while other regions are not, allowing activation of those electrodes or electrode regions that come into contact with the tissue.

[0106] As shown in the figure, the braided fabric 410 can extend beyond the inflatable balloon 130 because one end of the braided fabric 410 extends to the proximal end of the inflatable balloon 130, while the other end of the braided fabric 410 extends to the distal end of the inflatable balloon 130.

[0107] As with other embodiments, this embodiment again uses an endoscope within the balloon 130 to confirm electrode placement and tissue contact. The number of electrodes 150 in the array can be varied with 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 with embedded electrode array Figure 10 A balloon catheter 500 is shown, comprising a main guide tube 110 and an inflatable balloon 510, which, as in other embodiments, is coupled to and extends along the main guide tube 110. The distal end of the inflatable balloon 510 is coupled to the distal end of the main guide tube 110, and the proximal end of the inflatable balloon 510 is coupled to the main guide tube 110 at a location spaced apart from the distal end of the main guide tube 110.

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

[0110] In this embodiment, the electrodes 150 may be disposed within and integrally formed with the balloon 510 as part of the molding process of the balloon 510. The electrodes 150 are spaced apart on the balloon 510 in a desired pattern. For example, the electrodes 150 are positioned circumferentially around the balloon 510. Alternatively, the electrodes 150 may be attached to the balloon 510 after the manufacturing process, rather than being positioned and attached to the balloon material during the manufacturing process. In particular, the electrodes 150 may be attached to the outer surface of the balloon 510, wherein the trace 151 is also attached to the outer surface of the balloon 510. Any number of conventional techniques can be used to attach these elements to the exterior of the balloon 510, such as using adhesives, bonding agents, etc.

[0111] Electrodes 150 are formed such that the outer surface of each electrode 150 is exposed along the surface of the balloon 150 for placement in contact with tissue. Each flexible trace 151 is formed with a zigzag pattern, which is intentionally designed to allow the flexible trace 151 to move with the compliant balloon during inflation / deflation and during placement against tissue. In other words, this zigzag pattern adapts to the flexible trace 151 during balloon expansion and contraction and prevents damage to the trace. Each flexible trace 151 is operatively coupled to an energy source such that energy can be delivered to selected electrodes among the electrodes 150.

[0112] As with other embodiments, this embodiment again uses an endoscope within balloon 510 to confirm electrode placement and tissue contact. Once the user determines which electrodes 150 are in contact with the tissue, the user can select those electrodes for activation.

[0113] Furthermore, electrode markers can be configured, as in other embodiments, to be visible inside the endoscope's balloon 510, allowing the user or image recognition software to determine which electrodes are clearly visible in the endoscope's field of view. Based on this information, energy is delivered to those selected electrodes 150 to create lesions. The user interface can be configured to easily allow the user to select which electrodes to deliver energy by presenting a touchscreen with an electrode map and / or having image recognition software pre-fill the screen with a suggested electrode activation map indicating which electrodes are visible in the endoscope and in contact with tissue.

[0114] balloon with micropores and internal electrode array Figure 11 and Figure 12A balloon catheter 600 is shown, comprising a main guide tube 110 and an inflatable compliant balloon 610, which is coupled to and extends along the main guide tube 110. An external catheter body or cannula 115 is also present, and as described above, the catheter 600 may include other axes, such as an external catheter axis and an internal catheter axis. The distal end of the inflatable balloon 610 is coupled to the distal end of the main guide tube 110, and the proximal end of the balloon 610 is coupled to the main guide tube 110 at a location spaced apart from the distal end.

[0115] As in another embodiment, an endoscope is positioned within balloon 610 and can be coupled to the main guide tube 110. The endoscope is forward-looking and allows observation of the transparent balloon 610 and its contact with surrounding tissues.

[0116] According to this embodiment, at least a portion of the balloon 610 has micropores 611 formed therein. The micropores 611 are preferably formed in one or more regions of the balloon 610 in which energy will be delivered to tissue. In the illustrated embodiment, the proximal and distal ends of the balloon 610 do not have micropores 611, while the central region includes micropores 611 because this central region contacts tissue during use.

[0117] For the sake of brevity, Figure 12 The micropores 611 in the middle are shown to have a higher density than those in the middle. Figure 11 The micropores in them are larger in size; however, it should be understood that Figure 11 and Figure 12 The micropores in the samples can be of the same size and the same number. However, Figure 12 This indeed shows that micropores 611 can be formed in different sizes and even different shapes.

[0118] The micropores 611 can have a uniform structure (i.e., the same size and shape), or they can have two or more types of micropores 611. The micropores 611 can be formed in a uniform pattern as shown, or they can be formed in a non-uniform pattern. For example, as shown, the micropores 611 can form a grid that extends circumferentially around the entire balloon 610.

[0119] The balloon catheter 600 also includes an electrode carrier 620 disposed within the balloon and, in at least one embodiment, movable within the balloon 610 (i.e., rotatably and / or longitudinally movable within the balloon 610). The electrode carrier 620 includes one or more electrodes 622 contained within a housing (shelter) 624. In the illustrated embodiment, a pair of electrodes 622 are present in the housing 624 (however, it is possible to use a single electrode in the shelter, which rotates within the porous balloon). The housing 624 is used to contain and direct the energy of the electrodes 622. The electrodes 622 are positioned in close proximity to the balloon itself, and the housing itself is positioned in direct contact with the inner surface of the balloon. The shelter 624 optimizes the proportion of ablation energy delivered to the tissue; however, the shelter 624 can be removed and is not required.

[0120] Therefore, the electrode array 622 is contained within a housing 624, which also encapsulates a conductive liquid medium, such as saline (e.g., physiological saline or hypertonic saline), allowing energy to flow directly into the tissue via micropores 611. In other words, the conductive liquid medium can be delivered to the housing 624, such as by using one or more conduits 626, the conduits 626 opening into the interior of the housing 624. When the electrode 622 is activated, energy is generated by the electrode (e.g., between the electrodes), and because the electrode 622 is immersed in the conductive liquid medium, the energy is used to heat the conductive liquid medium. The presence of micropores 611 allows the heated conductive liquid medium to permeate through the micropores 611 into the tissue, which, combined with the energy from the electrode 622 conducted through the balloon material, results in the formation of a targeted lesion. Specifically, the formation of a lesion segment. To form a complete lesion, the electrode carrier 620 can rotate and / or move along the inner surface of the balloon. The electrode carrier 620 maintains contact with the inner surface of the balloon 610 via a second balloon that can be inflated or deflated by the user to adjust the electrode contact pressure.

[0121] The combination of the electrode array and the conductive liquid medium defines the conductive path used to form the damaged segment. It should be understood that the expansion medium used to control the expansion or contraction of the balloon 610 may be the same as or different from the conductive liquid medium delivered into the housing 624.

[0122] In yet another embodiment, the balloon 610 does not include the micropores 611, but is formed of a conductive balloon material (e.g., a balloon material doped with carbon nanotubes). In this alternative embodiment, the shell (cover) may also be removed or may be retained. Thus, a non-conductive fluid can be used inside the balloon. The electrode array (or a single electrode) is still disposed within the balloon 610 and is movable therein by being able to rotate freely and / or move longitudinally within the balloon. Thus, the energy delivered to the electrode array is transferred to a localized region of the conductive balloon that is in close proximity to the electrode array to cause damage. In other words, the electrode array faces a localized region of the balloon, and the energy delivered to the electrode array is conducted to that localized region of the balloon to cause damage.

[0123] Now for reference 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; therefore, the same reference numerals are used for the same elements. Thus, the balloon includes micropores 611. Instead of the electrode carrier 620, the balloon catheter 700 includes an elongated structure 710, which may be similar to... Figure 1 The elongated structure 1, with several notable differences, is located inside the balloon, rather than as... Figure 1 Located outside the balloon as described above. The elongated structure 710 includes a first tubular portion 712 and a second tubular portion 714 surrounding the catheter axis. The elongated structure 710 branches into two or more, but preferably six or more, branches 720, each branch 720 containing one or more electrodes 715 on its outward-facing surface. The elongated structure 710 may be made of an elastic material pre-shaped to allow its expansion geometry and to remain in contact with the inner surface of the balloon when the balloon inflates. When the balloon is deflated by removing fluid from it under vacuum, the elongated structure 710 is compressed by the balloon. In other words, the elongated structure is configured to expand automatically and naturally as the balloon inflates, and similarly, it contracts due to the contraction of the balloon. This can occur naturally due to the memory properties of the elongated structure 710. Thus, the electrodes 715 on the outer surface of the elongated structure 710 contact the inner surface of the porous balloon. As in another embodiment, the balloon contains a conductive fluid passing through micropores. Therefore, energy from electrode 715 is conducted through the balloon itself and / or the conductive fluid inside the balloon through the micropores to reach the target tissue.

[0124] It should be understood that in all embodiments, the electrodes are connected to a controllable energy source using conventional techniques, including electrical wires, cables, conductive paths, etc. The energy source can be controlled using a conventional controller, such as a main controller, which may be part of a console. The user inputs input data into the console and can control and select different operating parameters, such as dose information (dose power (watts)).

[0125] Those embodiments that incorporate electrode arrays are particularly well-suited for delivering electroporation ablation energy (PFA).

[0126] Additional details regarding certain embodiments of this disclosure are as follows.

[0127] A device for altering tissue, the purpose of which is to change the tissue's conductive properties to achieve a desired result.

[0128] An external sheath located on an existing catheter system.

[0129] It consists of three distinct parts: a rigid positioning collar at the distal end; a balloon expansion section of softer, more flexible material (or an alternative arrangement) located near the main balloon; and an overcoat that extends from the catheter body to the proximal end.

[0130] Electrodes can be placed on the rigid collar portion for measuring remote electrical activity or for energy transfer.

[0131] Electrodes, in various configurations (another part), are placed on the expandable portion of the balloon to deliver energy to alter the properties of the target tissue.

[0132] The outer cladding of the body includes conductors for remote measurement and energy delivery, and terminates near a controller for rotation of another energy delivery source.

[0133] The electrodes on the collar can be of various configurations, including 2, 4 or 6 type square electrodes that are circumferentially spaced apart in the measurement area on the collar.

[0134] The balloon-inflated regional electrodes are intended to serve as the primary energy delivery (treatment) of the device. The most likely embodiment is a 16-electrode arrangement with equal spacing, positioned proximally to the primary treatment area, allowing slight deflation of the balloon to allow the electrode array to extend distally into the area to be treated, possibly, but not necessarily, within an arc similar to the location where the primary energy has been or will be delivered. This area will be aligned such that, at the inflation pressure specified for “PFA” treatment, the electrodes will be equally spaced and independent, allowing them to be used individually or in various groups.

[0135] The outer sheath of the conduit will have conductive elements for all sensing and energy delivery electrodes (some or all of which may have dual functions) to prevent any or at least minimal impact from bending or rotation of the main conduit. This could be helical wiring capable of using various helical pitches.

[0136] The inflatable part of the device's balloon can be a complete sheath made of a very elastic material with electrodes on its surface; or it can be more rigid, in which part of the device is removed so that the electrodes can be placed in the desired area by displacement of the structure.

[0137] Translational distal balloon catheter ( Figure 15A and Figure 15B ) Now for reference Figure 15A and Figure 15B The translational distal balloon catheter 800 is shown in the illustration. Figure 15A A collapsed catheter 800 for delivery to the target site is shown, while Figure 15B The catheter 800 is shown in an expanded state in use. The catheter 800 includes an elongated external catheter (shaft) 810 having a distal end 812 and an opposing proximal end 814. Figure 16A The external conduit 810 is a slender, hollow structure. The conduit 800 also includes a handle 820 for the user to grip. Figure 16A The handle 820 is attached to the proximal end 814 of the external catheter 810. Further details regarding the handle 820 will be described below.

[0138] The handle 820 can take any number of different forms, including being formed of two parts that are attached to each other to define a hollow interior that houses the working portion of the translational distal balloon catheter 800.

[0139] The catheter 800 also includes an inflatable balloon 830, which is coupled to the distal end 812 of the external catheter 810. The external catheter 810 may terminate proximally to the balloon 830, or the external catheter may extend partially into the balloon 830; however, the external catheter 810 does not extend fully to the distal end of the catheter 800.

[0140] Balloon 830 includes a compliant balloon. It should be understood that catheter 800 and balloon 830 have conventional inflatable and deflateable structures, such as an inflatable cavity and / or a deflateable cavity through which the inflatable medium flows into the balloon to inflate it. It is well known that the inflatable medium can be circulated using a pump or the like.

[0141] The catheter 800 is configured to deliver PFA energy using an expandable electrode basket structure surrounding the balloon 830 and an actuator or translation mechanism that allows the electrode basket structure to expand and collapse to a flatter state. More specifically, the translation mechanism may include an elongated structure, such as a tube or solid rod 850. Figure 16B It is connected to the handle at the first (proximal) end and to the flexible nose 860 at the opposite second (distal) end. Therefore, although element 850 is described as a tube, it should be understood that it does not necessarily have a tubular structure and can be solid.

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

[0143] The nasal tip 860 defines the distal end of the catheter 800. The nasal tip 860 is not directly attached to the external catheter 810, but is axially movable relative to the external catheter, providing axial translational capability for the catheter 800. Therefore, the distal end of the tube 850 is fixedly attached to the nasal tip 860 and passes through the interior of the balloon 830. Thus, when the tube 850 is driven forward, the nasal tip 860 is driven forward; conversely, when the tube 850 is driven backward, the nasal 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 herein. Each of the first electrode basket 870 and the second electrode basket 880 is coupled to the distal end 812 and the nasal tip 860 of the external catheter 810. As shown, the first electrode basket 870 and the second electrode basket 880 are layered, i.e., the first electrode basket 870 can be considered as the inner basket, and the second electrode basket 880 can be considered as the outer basket.

[0145] The first electrode basket 870 includes a distal portion and a proximal portion, both of which can be in the form of a solid cylindrical portion. Similarly, the second electrode basket 880 includes a distal portion and a proximal portion, both of which can be in the form of a solid cylindrical portion. The distal portion of the first electrode basket 870 is coupled to and can surround the nose tip 860, while the distal portion of the second electrode basket 880 (e.g., a collar) can be directly disposed above and thus surround (overlay) the distal portion of the first electrode basket 870. Similarly, the proximal portion of the second electrode basket 880 (e.g., a collar) can be disposed on and thus surround (overlay) the proximal portion of the first electrode basket 870. In other words, the first electrode basket can be a slit-tube structure with a solid end, and the second electrode basket can also be a slit-tube structure with a solid end. These two tube structures are superimposed, with the slit-tube structure of the second electrode basket directly disposed on the slit-tube structure of the first electrode basket, and the slits being circumferentially offset from each other.

[0146] Each of the first electrode basket 870 and the second electrode basket 880 carries one or more electrodes. As shown, the first electrode basket 870 and the second electrode basket 880 are spline structures because the first electrode basket 870 includes a plurality of longitudinal slits that create and define a plurality of first splines 875 extending circumferentially around the first electrode basket 870. The second electrode basket 880 includes a plurality of longitudinal slits that create and define a plurality of second splines 885 extending circumferentially around the second electrode basket 880. As described herein, the positions of the first splines 875 and the second splines 885 are intentionally selected by the orientation of the first electrode basket 870 and the second electrode basket 800 such that when the balloon 830 inflates and the first splines 875 and the second splines 885 move to their inflated state ( Figure 15B The first spline 875 and the second spline 885 do not overlap, but rather interweave. In other words, each second spline 885 lies between two adjacent first splines 885, and vice versa. This action achieves complete circumferential coverage around the balloon 830.

[0147] In one embodiment, each of the first electrode basket 870 and the second electrode basket 880 is configured such that they have six (6) splines, thus the superposition and offset nature of the first electrode basket 870 and the second electrode basket 880 defines twelve (12) splines. Therefore, the first electrode basket 870 and the second electrode basket 880 can have the same or very similar structure, one mounted on the other and rotated to cause each spline to be rotatably offset. Since each spline can carry one or more electrodes, when the balloon is inflated and the splines 875, 885 are in the expanded state, the 12 splines are circumferentially spaced along the outer side of the balloon, providing increased electrode coverage for tissue contact. If only one electrode basket (a sheath or collar) is used, including sufficient longitudinal slits to form 12 splines would result in each spline being insufficiently wide to carry the desired ablation electrode (e.g., for PFA). The current arrangement of two superimposed electrode baskets with rotational offset overcomes this deficiency and allows 12 splines, each with sufficient width to carry one or more electrodes of the desired size suitable for PFA.

[0148] In the initial collapsed state, the first strip 875 is at least substantially covered by the second electrode basket 880. Therefore, in this initial collapsed state, only the second electrode basket 880 is substantially visible because the first electrode basket 880 is covered.

[0149] In one embodiment, each spline 875, 885 carries one or more electrodes 890 (for ease of illustration, ...). Figure 15AElectrode 890 is omitted. In the illustrated embodiment, each spline 875, 885 includes four electrodes 890, which are spaced apart and arranged in series (longitudinally) along the spline. In one embodiment, each electrode 890 can be controlled independently, or in another embodiment, all electrodes 890 on a spline 875, 885 can be controlled together. It is well known that controllers are used to control the supply of ablation energy (e.g., PFA) to the electrodes 890, and in some embodiments, visualization can be used to detect which spline electrodes 890 are in contact with the target tissue. In one embodiment, instead of applying energy to all electrodes 890, energy can be supplied to selected spline electrodes 890 (e.g., those electrodes 890 in contact with the target tissue).

[0150] The first electrode basket 870 and the second electrode basket 880 are not compliant like the balloon 830. In one embodiment, the first electrode basket 870 and the second electrode basket 880 are formed of polyimide.

[0151] Electrode 890 is attached to the spline using conventional techniques, such as bonding. It is well known that each electrode 890 can be connected to an energy source using an electrical trace. For example, the electrical trace can be a copper trace, and electrode 890 can be a gold-plated electrode.

[0152] Now for reference Figures 15A to 16B The handle 820 includes a through-hole 821 in which an actuator 822 is movably disposed and housed. For example, the actuator 822 may be in the form of a slider, which can be approached and manipulated from opposite sides (faces) of the handle 820. The front end of the actuator 822 is fixedly coupled to the tube 850, so that when the actuator 822 moves axially, the tube 850 moves axially because they are fixed to each other (there is no relative movement between them). Therefore, when the actuator 822 moves forward, the tube 850 moves forward, and this translates to forward movement of the nose tip 860. Since the balloon 830 and each of the first electrode basket 870 and the second electrode basket 880 are fixedly attached to the nose tip 860, all these structures also move forward. This forward movement causes the balloon 830 and the first electrode basket 870 and the second electrode basket 880 to move towards the nose tip 860. Figure 15A The indicated position flattens (elongates) and reaches that position. Conversely, when actuator 822 moves rearward, tube 850 moves rearward, and this is translated into rearward movement of nose tip 860. Since balloon 830 and each of the first electrode basket 870 and the second electrode basket 880 are fixedly attached to nose tip 860, all these structures also move rearward. Rearward movement causes balloon 830 and the first electrode basket 870 and the second electrode basket 880 to face towards... Figure 15B The position shown expands (radially outward) and reaches that position.

[0153] When the balloon 830 inflates, it expands the splines 875 and 885 into a balloon shape, which pulls the nose tip 860 towards the proximal end.

[0154] Further details regarding actuator 822 can be found in U.S. Patent No. 11,389,236, the entire contents of which are incorporated herein by reference.

[0155] On another front, the handle 820 includes a biasing mechanism that operates on the tube 850. Specifically, the biasing mechanism can be in the form of a spring 890 contained within the handle and applying a biasing force to the rear of the actuator 822. The spring 890 can be a coil spring. One end of the spring 890 abuts against a fixed surface of the handle, while the opposite end abuts against the rear of the actuator 822. The spring 890 shown is designed to facilitate some of these movements. To deliver the catheter 800 to the target location, the catheter 800 can be delivered via a delivery sheath (not shown). As it passes through the sheath, the distal nasal tip 860 will be propelled in a proximal direction by the frictional force entering the sheath. Some force is required to resist this movement, and the spring 890 will provide this force. Once inside the patient and in place, the physician will inflate the balloon 830.

[0156] In one embodiment of this design, the spring 890 is designed such that the inflation of the balloon 830 is sufficient to overcome the spring 890 and pull the distal nasal tip 860 posteriorly, thereby allowing the splines 875, 885 to expand into the shape of the balloon 830. In another embodiment, there will be some type of removable locking element so that the spring 890 does not push the nitinol tube 850 or pushes it very little. This is now shown only by the removable block 900 proximal to the spring 890.

[0157] Figure 16A The handle and actuator 822 are shown in the extended position. Figure 16B yes Figure 16A A perspective view with the handle in the retracted state. When the balloon 830 deflates and the first electrode basket 870 and the second electrode basket 880 are in... Figure 15A When in a flat state, actuator 822 is in Figure 16A The position shown is opposite, when balloon 830 is in Figure 15B When in an expanded state, actuator 822 is in Figure 16B The position shown. Therefore, when the balloon 830 deflates, at a certain point, the elastic force of the spring 890 overcomes the force applied by the balloon 830, and the actuator 822 is driven to... Figure 16A The extended position shown is when the balloon 830 is deflated and the first electrode basket 870 and the second electrode basket 880 are in the extended position. Figure 15A The flattened state is the resting position of the catheter.

[0158] It should also be understood that, in another embodiment, the conduit 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 870 is omitted. In one embodiment, the plurality of first splines 875 comprises six or more splines spaced circumferentially apart. Therefore, the single-basket embodiment will be as follows: Figure 15A As shown, one of the electrode baskets is connected to the external catheter 810 and the nasal tip 860, as described herein. It should be understood that in Figure 15A The outermost second electrode basket 880 is shown in the diagram; however, in a single basket design, Figure 15A The second electrode basket will represent a single (unique) electrode basket that can be described as the first electrode basket, since there is only one.

[0159] The single-electrode basket design works in exactly the same way as the dual-electrode design, because the user manipulates the actuator 822 to cause axial movement of the nitinol tube 850, which in turn causes axial movement of the nose 860, resulting in the single electrode basket being in a flattened state. Figure 15A ) and expansion states (such as Figure 15B (When the balloon 830 inflates) moves between.

[0160] In a single-duct basket design, the handle can be spring-loaded, as described in this article.

[0161] It should be understood that in one embodiment, the number of splined electrodes may be more than two, and the width of the splined electrodes may be sufficient to support one or more electrodes disposed on one or more splined electrodes. As in other embodiments, each splined electrode 875 may include one or more electrodes spaced apart along its longitudinal direction for tissue ablation (e.g., PFA).

[0162] Whether or not one or two electrode baskets 870, 880 surround the balloon 830, the nitinol tube 850 serves as an axial push rod / pull rod in each of these embodiments. Movement of the nitinol tube 850 is preferably controlled within a handle.

[0163] It should also be understood that a visualization device, such as the endoscope described herein, may be present within the balloon 830. This visualization device helps the user determine the degree and location of contact between the balloon and the tissue (relative to the presence of the blood pool).

[0164] It should be understood that the same reference numerals in the accompanying drawings denote the same elements in several figures, and not all embodiments or arrangements require reference to all components and / or steps described and shown in the accompanying drawings.

[0165] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that when the terms “comprising” and / or “including” are used in this specification, they specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0166] Furthermore, the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including,” “comprising,” or “having,” “containing,” “involving,” and variations thereof in this document is intended to cover the items listed thereafter and their equivalents, as well as additional items.

[0167] The foregoing subject matter is provided by way of illustration only and should not be construed as limiting. Various modifications and changes may be made to the subject matter described herein without following the illustrated and described exemplary embodiments and applications and without departing from the true spirit and scope of the invention as set forth in the appended claims.

Claims

1. An ablation balloon catheter, comprising: External catheter shaft; An inflatable balloon, the inflatable balloon being connected at a first end to the external catheter shaft; A translatable nasal tip, with the second end of the inflatable balloon connected to the nasal tip; A first electrode basket having a plurality of first strips surrounding the balloon, the first electrode basket being connected at a first end to the external catheter shaft and at a second end to the nasal tip; and A second electrode basket having a plurality of second splines surrounding the balloon, the second electrode basket being connected at a first end to the external catheter shaft and at a second end to the nasal tip, wherein the second electrode basket is disposed above the first electrode basket, and the plurality of first splines are rotated away from the plurality of second splines, wherein one or more first splines support one or more electrodes, and one or more second splines support one or more electrodes; An actuator for axially translating the nose tip to cause the first and second electrode baskets to move to a collapsed state when the balloon deflates; The plurality of first splines and the plurality of second splines are configured to deploy and expand radially when the inflatable balloon is inflated, with the plurality of first splines positioned 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 each of the first and second electrode baskets 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 collapsed and expanded states of the first and second splines.

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

5. The ablation balloon catheter according to claim 4, wherein, Each first spline and each second spline have a plurality of electrodes arranged at intervals on their outer surface.

6. The ablation balloon catheter according to claim 1, wherein, The balloon includes a compliant balloon, and the first and second electrode baskets 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 that is coupled at a first end to an axially movable component contained in a handle, and at an opposite second end to the nose.

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 nickel-titanium tube.

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

12. The ablation balloon catheter according to claim 8, wherein, The movable component of the handle includes a slider contained within the handle and capable of axial movement between an extended position and a retracted position.

13. The ablation balloon catheter according to claim 12, wherein, When the balloon deflates and the first and second splines are in a collapsed state, the slider is in the extended position; when the balloon inflates and the first and second splines are in an expanded state, the slider is in the retracted position.

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

15. The ablation balloon catheter according to claim 12, wherein, The slider is spring-biased, the movable part is in the extended position when the movable part is in the stationary position, and is in the retracted position when the balloon inflates and the force of the balloon on the first and second splines overcomes the spring force.

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

17. The ablation balloon catheter according to claim 16, wherein, The visualization device includes a movable endoscope.

18. The ablation balloon catheter according to claim 17, wherein, The endoscope is rotatable and can move axially within the balloon.

19. The ablation balloon catheter according to claim 1, wherein, The actuator includes an elongated nitinol tube, which is connected at a first end to an axially movable component contained in a handle and at an opposite second end to the nasal tip, the tube passing through the balloon.

20. The ablation balloon catheter according to claim 1, wherein, Each electrode includes a conductive trace operatively coupled 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, Each of the first electrode basket and the second electrode basket includes a solid cylindrical collar body at its distal and proximal ends. The distal end of the second electrode basket covers the distal end of the first electrode basket in both the collapsed and expanded states of the first and second splines. The solid cylindrical collar body at the proximal end is at least partially disposed below the outer conduit shaft.

23. An ablation balloon catheter, comprising: External catheter shaft; An inflatable balloon, the inflatable balloon being connected at a first end to the external catheter shaft; A nose tip that can be translated axially, with the second end of the inflatable balloon connected to the nose tip; An electrode basket surrounding the balloon, the electrode basket having a plurality of first splines and a plurality of second splines, the electrode basket being connected to the external catheter shaft and the nasal tip, the electrode basket being movable between a flattened state and an inflated state; and An actuator for axially translating the nose tip to cause the first and second electrode baskets to move to a collapsed state when the balloon is deflated, the actuator being axially moved between an extended position and a retracted position; The plurality of first splines and the plurality of second splines are configured to deploy and expand radially when the inflatable balloon is inflated; The actuator is spring-biased, and is in the extended position when at rest, and is in the retracted position when the balloon inflates and the force of the balloon on the plurality of first and second splines overcomes the spring force.

24. An ablation balloon catheter, comprising: External catheter shaft; An inflatable balloon, the inflatable balloon being connected at a first end to the external catheter shaft; A forward-viewing endoscope, wherein the forward-viewing endoscope is disposed inside the inflatable balloon; A translatable nasal tip, with the second end of the inflatable balloon connected to the nasal tip; A first electrode basket having a plurality of first splines surrounding the outside of the balloon, the first electrode basket being coupled at a first end to the external catheter shaft and at a second end to the nasal tip, wherein one or more of the first splines support one or more electrodes; An actuator for axially translating the nose tip to cause the first electrode basket to move to a collapsed state when the balloon deflates; The plurality of first strips are configured to deploy and expand radially when the inflatable balloon is inflated.

25. The ablation balloon catheter of claim 24, further comprising a second electrode basket having a plurality of second splines, the second electrode basket being connected at a first end to the external catheter shaft and at a second end to the nasal tip, wherein, The second electrode basket is disposed above the first electrode basket, and the plurality of first splines are rotated away from the plurality of second splines, wherein one or more of the second splines support one or more electrodes; and The plurality of second splines are configured to deploy and expand radially when the inflatable balloon is inflated.

26. The ablation balloon catheter according to claim 24, wherein, The actuator moves axially between the extended position and the retracted position; and The actuator is spring-biased, and is in the extended position when at rest, and in the retracted position when the balloon inflates and the force of the balloon on the plurality of first strips overcomes the spring force.

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

28. The ablation balloon catheter according to claim 24, wherein, The actuator includes an elongated tube connected at a first end to an axially movable component contained in the handle, and at an opposite second end to the nose.

29. The ablation balloon catheter according to claim 28, wherein, The tube includes a nickel-titanium tube.

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

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