A catheter with electroporation and fluid delivery characteristics.

Abstract

To provide a catheter system. [Solution] The device includes a flexible catheter shaft, one or more electrodes, and one or more position sensors, at least one of the one or more position sensors being positioned on the distal portion of the catheter shaft, and the one or more position sensors being configured to provide a signal indicating the position of each of the one or more position sensors in three-dimensional space in response to a magnetic field. The flexible catheter shaft includes a lumen that is in fluid communication with the open distal end of the shaft. The lumen is configured to receive a guidewire and to communicate with the outside of the therapeutic fluid through the open distal end. The shaft has an outer diameter in the range of about 0.67 mm to about 1.33 mm. At least one of the one or more electrodes is operable to apply electrical energy to tissue.

Description

Background Art

[0001] Cardiac arrhythmias such as atrial fibrillation occur when regions of cardiac tissue conduct electrical signals abnormally. Treatments for arrhythmias include surgically disrupting such signal conduction pathways. By selectively applying electrical energy to cardiac tissue, it may be possible to stop or modify the propagation of unwanted electrical signals from one part of the heart to another. Some such ablation treatments may include radiofrequency (RF) ablation with alternating current (AC) electrical energy and / or irreversible electroporation (IRE) with pulsed field direct current (DC) electrical energy (e.g., pulsed field ablation (PFA)). The ablation process can provide a barrier to unwanted electrical pathways by creating an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across the ablated tissue.

[0002] In some procedures, a catheter having one or more electrodes can be used to provide ablation within a patient. The catheter can be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or in a structure adjacent to the heart (e.g., the pulmonary vein). One or more electrodes can be placed in contact with cardiac tissue or other vascular tissue and then activated with electrical energy to ablate the contacted tissue (e.g., via RF energy, IRE, etc.). In some cases, the electrodes may be bipolar. In some other cases, monopolar electrodes may be used in conjunction with a ground pad or in conjunction with another reference electrode in contact with the patient. Perfusion can be used to draw heat away from components of the ablation catheter and prevent the formation of blood clots near the treatment site of the tissue.

[0003] Examples of ablation catheters include U.S. Patent No. 8,747,351, issued June 10, 2014, entitled "Catheter with Multi-Functional Control Handle Having Linear Mechanism" (its disclosure is incorporated herein by reference in its entirety); U.S. Patent No. 8,956,353, issued February 17, 2015, entitled "Electrode Irrigation Using Micro-Jets" (its disclosure is incorporated herein by reference in its entirety); U.S. Patent No. 9,220,433, issued December 29, 2015, entitled "Catheter with Variable Arcuate Distal Section" (its disclosure is incorporated herein by reference in its entirety); and "Catheter with Soft Distal Tip for Mapping and Ablating Tubular" issued November 20, 2018. These are described in U.S. Patent No. 10,130,422, titled "Region" (the disclosure is incorporated in its entirety by reference), U.S. Patent No. 10,702,177, titled "Catheter with Bipole Electrode Spacer and Related Methods," issued on July 7, 2020 (the disclosure is incorporated in its entirety by reference), U.S. Patent No. 10,743,932, titled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens," issued on August 18, 2020 (the disclosure is incorporated in its entirety by reference), and U.S. Patent No. 11,559,349, titled "Ablation Catheter with a Flexible Printed Circuit Board," issued on January 24, 2023 (the disclosure is incorporated in its entirety by reference).

[0004] Some catheter ablation procedures may be performed after identifying the tissue area to be targeted for ablation using electrophysiological (EP) mapping. Such EP mapping may involve the use of a sensing electrode on a catheter (e.g., the same catheter used to perform the ablation, or a dedicated mapping catheter). Such a sensing electrode can monitor electrical signals emanating from conductive endocardial tissue to precisely pinpoint the location of abnormal conductive tissue sites causing arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, entitled "Cardiac Electromechanics," issued on April 14, 1998 (the disclosure thereof is incorporated herein by reference in its entirety). Examples of EP mapping catheters are described in U.S. Patent No. 9,907,480, “Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes,” issued on March 6, 2018 (the disclosure thereof is incorporated herein by reference in its entirety); U.S. Patent No. 10,130,422, “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region,” issued on November 20, 2018 (the disclosure thereof is incorporated herein by reference in its entirety); and U.S. Patent No. 10,702,177, “Catheter with Bipole Electrode Spacer and Related Methods,” issued on July 7, 2020 (the disclosure thereof is incorporated herein by reference in its entirety).

[0005] Some catheter ablation procedures can be performed using image-guided surgery (IGS) systems. IGS systems can enable physicians to visually track the position of the catheter within the patient in real time in relation to images of anatomical structures within the patient. Several systems, including the CARTO 3® system by Biosense Webster, Inc. (Irvine, California), may offer a combination of EP mapping and IGS capabilities. Examples of catheters configured for use with IGS systems are disclosed in U.S. Patent No. 9,480,416, “Signal Transmission Using Catheter Braid Wires,” published November 1, 2016 (the disclosure of which is incorporated herein by reference in its entirety), and in various other references cited herein.

[0006] Although several catheter systems and methods have been fabricated and used, it is believed that no one prior to the inventors had fabricated or used the invention described, illustrated, and claimed herein. [Brief explanation of the drawing]

[0007] The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as envisioned by the inventors. [Figure 1] This diagram shows a schematic representation of the medical procedure in which a catheter assembly catheter is inserted into a patient. [Figure 2] Figure 1 shows a perspective view of an example of a catheter assembly that may be used in the medical procedure. [Figure 3] Figure 2 shows a perspective view of the distal portion of the shaft assembly of the catheter assembly. [Figure 4] Figure 2 shows a perspective view of the distal portion of the flex circuit of the catheter assembly. [Figure 5] Figure 4 shows a perspective view of the proximal portion of the flex circuit. [Figure 6] Figure 2 shows a cross-sectional side view of the distal portion of the catheter assembly, with the outer layer omitted from the shaft assembly. [Figure 7] Figure 3 shows a cross-sectional end view of the shaft assembly. [Figure 8] Figure 4 shows a bottom view of the flex circuit, which has a flat configuration. [Figure 9] Figure 4 shows a top view of the distal portion of the flex circuit, which has a flat configuration. [Figure 10] Figure 4 shows a bottom view of the proximal portion of the flex circuit, which has a flat configuration. [Figure 11] Figure 4 shows a side and elevation view of the flex circuit, which is configured with a flex circuit wrapped around it. [Figure 12] Figure 4 shows a side elevation view of the distal portion of the flex circuit, which is configured with a flex circuit wrapped around it. [Figure 13] Figure 4 shows a top view of the distal portion of the flex circuit, which is configured with a flex circuit wrapped around it. [Figure 14] Figure 4 shows a side elevation view of the proximal portion of the flex circuit, which is configured with a flex circuit wrapped around it. [Figure 15] Figure 4 shows a top view of the proximal portion of the flex circuit, which is configured with a flex circuit wrapped around it. [Figure 16A] A schematic diagram of a catheter shaft having a first example of an elongated position sensor arrangement is shown, with the position sensor loop in an unbent state. [Figure 16B] A schematic diagram of the position sensor loop in the example of a bent state is shown in Figure 16A. [Figure 16C] Figure 16A shows a schematic top view of the position sensor loop in the non-bent state. [Figure 16D] Figure 16B shows a schematic top view of the position sensor loop in Figure 16A in the bent state. [Figure 17] A schematic diagram of a catheter shaft having a second example of an elongated position sensor arrangement is shown. [Figure 18]A bottom view of an example of a flex circuit that can be used to provide the elongated position sensor arrangement of FIG. 17 is shown. [Figure 19] A bottom view of an intermediate portion of the flex circuit of FIG. 18 is shown. [Figure 20] A schematic view of a catheter shaft having a third example of an elongated position sensor arrangement is shown. [Figure 21] A schematic view of a catheter shaft having a fourth example of an elongated position sensor arrangement is shown. [Figure 22] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used with a ground pad in a first example of an electrical path. [Figure 23] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used in a second example of an electrical path. [Figure 24] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used in a third example of an electrical path. [Figure 25] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used in a fourth example of an electrical path. [Figure 26] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used in a fifth example of an electrical path. [Figure 27] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used in a sixth example of an electrical path. [Figure 28] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used with a guide wire in a seventh example of an electrical path. [Figure 29] A schematic view of the end effector of the catheter assembly of FIG. 2 is shown, where the electrodes of the end effector are used with a guide wire in an eighth example of an electrical path. [Figure 30]Figure 2 shows a schematic diagram of the end effector of the catheter assembly, where the end effector electrodes are used together with the irrigation fluid from the catheter assembly in the ninth example of the electrical pathway. [Figure 31] Figure 2 shows a schematic diagram of the end effector of the catheter assembly, where the end effector electrode is used together with the irrigation fluid from the sheath in the tenth example of the electrical pathway. [Figure 32] Figure 2 shows a side elevation view of a modified end effector of the catheter assembly. [Figure 32A] Figure 32 shows a schematic cross-sectional side view of a portion of the end effector. [Figure 33] Figure 2 shows a schematic diagram of the end effector of the catheter assembly, where the end effector electrodes are used together with another ablation device in the 11th example of the electrical pathway. [Figure 34] Figure 2 shows a schematic diagram of the end effector of the catheter assembly, where the end effector electrodes are used together with another ablation device in the twelfth example of the electrical pathway. [Figure 35A] A schematic diagram shows another example of a catheter assembly coupled to a fluid source, with the catheter assembly balloon in a deflated state. [Figure 35B] Figure 35A shows a schematic diagram of the catheter assembly with the balloon in an inflated state. [Figure 35C] Figure 35B shows a cross-sectional view of the end effector of the catheter assembly shown in Figure 35A, taken along line 38C-38C, illustrating an example of a coaxial lumen. [Figure 36] Figure 35A shows a perspective view of the distal portion of the catheter assembly. [Figure 37A] This is a perspective view of the distal portion of the catheter assembly placed inside the sheath, with the sheath balloon in a deflated state. [Figure 37B] Figure 37A shows a perspective view of the catheter assembly and the distal portion of the sheath, with the balloon of the sheath inflated. [Figure 38A]This is a perspective view of a balloon device protruding distally from a catheter assembly, with the balloon of the balloon device in a deflated state. [Figure 38B] Figure 38A shows a perspective view of the catheter assembly and the distal portion of the balloon device, with the balloon of the balloon device in an inflated state. [Figure 39A] This shows a side elevation view of the distal portion of the catheter assembly with the balloon in a deflated state. [Figure 39B] Figure 39A shows a side elevation view of the distal portion of the catheter assembly with the balloon inflated. [Figure 40] A flowchart illustrating an example of a method that may be performed using the various catheter assemblies shown and described herein is provided. [Modes for carrying out the invention]

[0008] The following description of specific embodiments of the present invention should not be used to limit the scope of the invention. The drawings are not necessarily to scale, illustrate selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative, not limiting, and illustrates the principles of the invention as an example. Other embodiments, features, aspects, forms, and advantages of the invention will become apparent to those skilled in the art from the following description, which is one of the best modes intended to carry out the invention as an example. As will be recognized, the invention can be made into other different or equivalent embodiments without departing from the invention. Accordingly, the drawings and description should be considered illustrative, not limiting.

[0009] Any one or more of the teachings, expressions, modifications, or examples described herein may be combined with any one or more of the other teachings, expressions, modifications, or examples described herein. Therefore, the teachings, expressions, modifications, or examples described below should not be considered independent of each other. Various preferred ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0010] Where used herein, the terms “about” or “approximately” for any numerical value or range of numerical values ​​indicate a preferred dimensional tolerance that enables some or a set of components to function for the intended purpose described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the enumerated values; for example, “about 90%” may refer to a range of values ​​from 71% to 99%. In addition, where used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject, and while the use of the present invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0011] I. Examples of catheter systems Figure 1 shows an example of a medical procedure and associated components of a cardiac catheter system that may be used to provide the EP mapping and / or cardiac ablation described above. Specifically, Figure 1 shows a physician (PH) grasping the handle assembly (110) of a catheter assembly (100), and the end effector of the catheter (not shown) of the catheter assembly (100) is positioned within the patient (PA) to map the potentials of tissues within or near the patient's (PA) heart (H) and / or ablate the tissue. The catheter assembly (100) is coupled to a guide and drive system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A pair of field generators (20) are positioned beneath the patient (PA) and coupled to the guide and drive system (10) via another cable (22).

[0012] The induction and driving system (10) in this example includes a console (12) and a display (18). The console (12) includes a first driver module (14) and a second driver module (16). The first driver module (14) is coupled to a catheter assembly (100) via a cable (30). In some modifications, the first driver module (14) is operable to receive EP mapping signals acquired via the electrodes of the end effector. In such modifications, the console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping, as is known in the art. In some other modifications, the end effector does not provide EP mapping. In addition to receiving EP mapping signals acquired via the electrodes of the end effector, or instead of receiving EP mapping signals acquired via the electrodes of the end effector, the first driver module (14) may be operable to power the electrodes of the end effector and thereby ablate tissue. In such modifications, the console (12) includes a processor (not shown) that drives the generation of an appropriate electrical signal to provide ablation, as is well known in the art. In yet another modification, the end effector does not provide ablation.

[0013] A second driver module (16) is coupled to a field generator (20) via a cable (22). The second driver module (16) is operable to activate the field generator (20) to generate an alternating magnetic field around the patient's (PA) heart (H). For example, the field generator (20) may include a coil that generates an alternating magnetic field within a predetermined working volume including the heart (H).

[0014] The first driver module (14) may also be operable to receive position indicator signals from one or more position sensors (not shown) in the end effector and / or other locations within the catheter. In such modifications, the processor of the console (12) is operable to process the position indicator signals from one or more position sensors and thereby determine the position of the end effector within the patient (PA). In some modifications, each position sensor includes one or more coils operable to generate signals indicating the position and orientation of the end effector within the patient (PA). The coils are configured to generate electrical signals in response to the presence of an alternating electromagnetic field generated by a field generator (20). Other components and techniques that may be used to generate real-time position data associated with the end effector include radio triangulation, acoustic tracking, optical tracking, and inertial tracking. In some other modifications, the end effector and / or catheter lack position sensors.

[0015] The display (18) is coupled with the processor of the console (12) and is operable to render images of the patient's anatomical structure. Such images are obtained based on a set of images (e.g., CT scan or MRI scan, 3D map, etc.) acquired preoperatively or during surgery. The view of the patient's anatomical structure provided through the display (18) may also change dynamically based on signals from the end effector and / or catheter position sensor assembly. For example, as the catheter's end effector moves within the patient (PA), corresponding position data from one or more position sensors may cause the processor of the console (12) to update the view of the patient's anatomical structure on the display (18) in real time to depict the area of ​​the patient's anatomical structure around the end effector as the end effector moves within the patient (PA). Furthermore, the processor of the console (12) may drive the display (18) to indicate the location of abnormal conductive tissue sites, as detected by electrophysiological (EP) mapping using the end effector, or by other means (e.g., using a dedicated EP mapping catheter). As just one example, the processor of the console (12) may drive the display (18) to superimpose the location of abnormal conductive tissue areas onto an image of the patient's anatomical structure by superimposing an illuminated dot, crosshair, or any other form of visual representation of the abnormal conductive tissue areas.

[0016] The console (12) processor can also drive the display (18) to superimpose the current position of the end effector onto an image of the patient's anatomical structure, such as by superimposing an illuminated dot, crosshairs, a graphic representation of the end effector, or any other form of visual display. Such superimposed visual display can also move in real time within the image of the patient's anatomical structure on the display (18) as the physician moves the end effector within the patient (PA), thereby providing the operator with real-time visual feedback on the position of the end effector within the patient (PA) as the end effector moves within the patient (PA). Thus, the images provided through the display (18) can effectively provide video tracking the position of the end effector within the patient (PA) without necessarily having optical equipment (i.e., a camera) to view the end effector. In the same view, the display (18) can simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Therefore, the physician (PH) can view the display (18) and observe the real-time positioning of the end effector relative to the mapped abnormal conductive tissue area and to images of adjacent anatomical structures within the patient (PA).

[0017] The fluid source (42) in this example includes a bag containing saline solution or any other suitable irrigation fluid. The conduit (40) includes a flexible tube further coupled to a pump (44) that is operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). Such irrigation fluid can be discharged through an opening (not shown) of the end effector. Such irrigation may be provided in any preferred form that will be apparent to those skilled in the art in light of the teachings herein.

[0018] II. Examples of Catheter Assemblies As described above, the catheter assembly (100) may be used to perform diagnostic functions (e.g., EP mapping) and / or therapeutic functions (e.g., ablation) within the patient's cardiovascular system. In some cases, the end effector of the catheter assembly (100) may be positioned in anatomical spaces such as the cardiac chambers or pulmonary veins of the heart to provide diagnostic and / or therapeutic functions in those spaces. In addition, or instead, it may be desirable to advance the end effector into smaller anatomical spaces such as the Marshall's vein and / or other small vessels branching from the coronary sinus to provide diagnostic and / or therapeutic functions in those smaller spaces.

[0019] While some conventional EP mapping and / or ablation end effectors can be fitted into larger anatomical spaces such as the cardiac chambers and pulmonary veins, such end effectors may not be able to fit into smaller anatomical spaces such as other small vessels branching from the Marshall's vein and / or coronary sinus. Furthermore, simply reducing the size of such conventional end effectors to fit them into such smaller spaces may not be practical, and consequently, size reduction is not merely a design choice. For example, simply reducing the size of the electrodes and / or position sensors of such conventional end effectors to fit into smaller spaces may be physically impossible. Even if it is theoretically and physically possible to simply reduce the size of the electrodes and / or position sensors of such conventional end effectors to fit into smaller spaces, the reduction in size of the electrodes and / or position sensors may negatively affect the function of the electrodes and / or position sensors. For example, a reduced electrode may not be able to provide sufficient EP mapping and / or ablation function, and a reduced position sensor may not be able to provide sufficient position indication signal and accuracy. Therefore, it may be necessary to provide novel configurations and / or arrangements of electrodes and / or position sensors in order to provide desired functionality within relatively small spaces, such as other small vessels branching from the Marshall vein and / or coronary sinus.

[0020] Figure 2 shows an example of a catheter assembly (200) having an end effector (350) capable of providing desired EP mapping, ablation, and / or position-sensing functions within relatively small anatomical spaces, such as other small vessels branching from the Marshall vein and / or coronary sinus. The catheter assembly (200) in this example includes a handle assembly (210) and a shaft assembly (220) extending distally from the handle assembly (210).

[0021] The handle assembly (210) includes a body (212), a port (214), and a cable (216). The body (212) is configured to be grasped by the hand of a physician (PH). In some variations, the body (212) includes one or more actuators that can operate to drive movement (e.g., rotation, joint movement, helical contraction, etc.) and / or other functions of the shaft assembly (220). In some alternative variations, the body (212) is configured to engage with a robotic arm or other automated assembly rather than being operated by the hand of a physician (PH). The port (214) is positioned and configured to provide access to the lumen (236) (Figures 6-7) of the shaft assembly (220), thereby enabling the insertion of other components (e.g., a guidewire (250), etc.) into the shaft assembly (220) and / or communication of fluids (e.g., irrigation fluids such as saline, ethanol, or contrast agents) through the shaft assembly (220). For example, in some scenarios, a fluid conduit such as the fluid conduit (40) described above may be connected to the port (214). The cable (216) is configured to provide electrical communication between the electrical components of the catheter assembly (200) (e.g., the flexible circuit (300) described later) and the induction and drive system (10). Thus, the cable (216) may represent a modification of the cable (30) described above with reference to Figure 1.

[0022] The shaft assembly (220) in this example includes a proximal portion (222) and a distal portion (224), with an end effector (350) provided on the distal portion (224) and extending along the longitudinal axis (LA). The proximal portion (222) in this example includes a rigid shaft (223). For example, the proximal portion (222) may include a metal hypotube. Alternatively, the proximal portion (222) may include any other suitable material. The distal portion (224) includes a flexible catheter body (230). In some variations, the distal region of the proximal portion (222) includes laser cutting and / or other mechanisms that provide a gradual transition of rigidity between the proximal portion (222) and the distal portion (224). Examples of materials and configurations that may be used to form the distal portion (224) are described in more detail below.

[0023] The tip member (226) is fixed to the distal end of the distal portion (224) of the catheter body (230), distal to the end effector (350). As shown in Figure 2, the guidewire (250) may be slidably positioned within the lumen (236) of the catheter body (230) and extend distally from the tip member (226). In some variations, the guidewire (250) includes a non-ferrous material (e.g., nitinol, SS316, etc.), but the guidewire (250) may be formed using any suitable material. The guidewire (250) may be inserted into the catheter assembly (200) via the port (214). Similarly, the guidewire (250) may be removed from the catheter assembly (200) via the port (214). In some variations, at least a portion of the guidewire (250) has a predetermined shape, and the distal portion (224) of the shaft assembly (220) conforms to this predetermined shape of the guidewire (250) when the guidewire (250) is positioned within the lumen (236). Alternatively, the guidewire (250) may be flexible without having a predetermined shape, and as a result, the positioning of the guidewire (250) within the lumen (236) does not impart a predetermined shape to the distal portion (224) of the shaft assembly (220).

[0024] The shaft assembly (220) may have any suitable dimensions. As just one example, the shaft assembly (220) may have an outer diameter in the range of approximately 2 French (e.g., approximately 0.67 mm) to approximately 4 French (e.g., approximately 1.33 mm), or more specifically approximately 3 French (e.g., approximately 1.00 mm), or any other suitable outer diameter. As just another example, the shaft assembly (220) may have an inner diameter in the range of approximately 0.25 mm to approximately 0.45 mm, or any other suitable inner diameter. The shaft assembly (220) may also have any suitable length. For example, the shaft assembly (220) may have a length in the range of approximately 150 cm to approximately 200 cm, or more specifically approximately 173 cm, or any other suitable length. As just another example, the distal portion (224) may have a length in the range of approximately 30 cm to approximately 75 cm, or more specifically approximately 46 cm, or any other suitable length.

[0025] In some modifications, the distal portion (224) region is maneuverable or operable to articulate, and as a result, the end effector (350) can be controllably deflected laterally away from the central longitudinal axis. In some such modifications, such maneuverability is provided in accordance with at least some of the teachings of U.S. Patent No. 8,747,351, issued June 10, 2014, entitled “Catheter with multi-functional control handle having linear mechanism,” the disclosure of which is incorporated herein by reference. In some other modifications, the catheter assembly (200) lacks a mechanism to provide controlled deflection of the shaft assembly (220). As another example, the distal portion (224) region may be configured to be controllably deformable into a helical shape, with radius and / or pitch controllable by the physician (PH). In some such modifications, such controllable contraction of the distal portion (224) is provided in accordance with at least some of the teachings of U.S. Patent No. 9,220,433, “Catheter with Variable Arcuate Distal Section,” issued December 29, 2015, the disclosure thereof is incorporated herein by reference in its entirety. In some other modifications, the catheter assembly (100) lacks a mechanism to provide controlled contraction of the helical shape defined by the distal portion (224).

[0026] As shown in Figure 7, the catheter body (230) of this example includes a first layer (234), a second layer (232) positioned around the first layer (234), and a flexible circuit board (302) and a third layer (238) positioned around the second layer (232). The lumen (236) is defined by the first layer (234). In this embodiment, the first layer (234) includes a braided structure formed of fibers or wires (e.g., non-ferromagnetic material), but the first layer (234) may alternatively have any other suitable composition and / or configuration. In some variations, the inner sidewall of the first layer (234) (i.e., the sidewall of the lumen (236)) includes a lubricating coating or, in other ways, a low-friction material. This can facilitate the sliding of the guidewire (250) through the catheter body (230).

[0027] The second layer (232) in this example comprises a polymer material bonded around the first layer (234). As a mere example, the second layer (232) may include thermoplastic polyurethane (e.g., poly(ether urethane)) and / or any other suitable material. In some modifications, the second layer (232) is omitted. For example, in some modifications, the second layer (232) may be omitted if the first layer (234) has sufficient thickness or if there is sufficient structural integrity in the absence of the second layer (232) (e.g., due to material properties, etc.). In some modifications, the flexible circuit board (302) functions effectively as the second layer (232).

[0028] In this example, the tip member (226) includes a separate component fixed to the distal end of the distal portion (224) of the catheter body (230), but several other variations may include the tip member (226) as an integrally formed mechanism of the catheter body (230). For example, the tip member (226) may include a distal extension of the first layer (234), and the second layer (232) may or may not extend further into this distal extension of the first layer (234) to form the tip member (226). In such variations, the tip member (226) may (or may not) be formed in the same tapered shape as shown in Figure 6.

[0029] In this example, the flexible circuit board (302) effectively extends around the second layer (232) to an angular range of approximately 270 degrees around the central longitudinal axis. Alternatively, the flexible circuit board (302) may effectively extend around the second layer (232) to any other suitable angular range around the central longitudinal axis. For example, in some modifications, the flexible circuit board (302) may be wrapped around the entire perimeter of the second layer (232), and the flexible circuit board (302) may even overlap itself due to the angular range of the wrapping. It should also be understood that different regions of the flexible circuit board (302) may extend to different angular ranges at different longitudinal positions along the length of the distal portion (224) of the shaft assembly (220). In this example, the third layer (238) is applied around the outside of the flexible circuit board (302) through the reflow process, while the area of ​​the second layer (232) is left exposed to the flexible circuit board (302). As just a further example, the third layer (238) may include thermoplastic polyurethane (e.g., poly(ether urethane)), silicone, and / or any other suitable material that can be heated during the reflow process to provide the desired performance. Alternatively, the third layer (238) may include any suitable material and may be applied in any other suitable manner. In this example, the layers (232, 238) have substantially strong bonding properties with the first layer (234), with each other, and with the flexible circuit board (302). In some cases, such bonding may be achieved by the use of adhesives. In some other cases, such bonding is achieved by the application of heat and pressure (e.g., hot air reflow) and / or molding. Alternatively, any other suitable type of bonding may be used.

[0030] In Figure 7, the third layer (238) and the second layer (232) are depicted as being made of different materials, but in some variations, the third layer (238) and the second layer (232) may contain the same material. In other words, the layers (232, 238) may effectively contain a single layer in which the flexible circuit board (302) is embedded.

[0031] As shown in Figures 2-4 and 6, the tip member (226) in this example includes a lumen (227) and an open distal end (228). As a mere example, the openings of the lumen (227) and / or distal end (228) may have a diameter of about 0.3 mm or any other suitable diameter. The lumen (227) of the tip member (226) is aligned with the lumen (236) of the catheter body (230), allowing the guidewire (250) to pass through the catheter body (230) and the tip member (226). The lumens (236, 227) may also allow fluid (e.g., irrigation fluid such as saline, ethanol, or contrast agent) to be discharged through the open distal end (228). Although the tip member (226) has a tapered configuration in this example, the tip member (226) may alternatively have any other suitable configuration. Like the catheter body (230), the tip member (226) is flexible. In this example, the tip member (226) is more flexible than the catheter body (230). Increased flexibility of the tip member (226) may facilitate the navigation of the shaft assembly (220) into a narrow, meandering anatomical passage. In some variant forms, the tip member (226) is more flexible than the catheter body (230) because it lacks a braided core like the first layer (234) of the catheter body (230). In addition, or instead, the tip member (226) may contain a material that is more flexible than the material used to form the second layer (232) and / or third layer (238) of the catheter body (230). As merely an example, the tip member (226) may include any other polymer, including polyether block amides (e.g., PEBAX by Arkema (Colombes, France)), thermoplastic polyurethanes (e.g., TECOTHANE by Lubrizol Advanced Materials, Inc. (Cleveland, Ohio)), silicones, or combinations thereof. Alternatively, the tip member (226) may include any other suitable material.

[0032] The flex circuit (300) is positioned along the distal portion (224) of the shaft assembly (220) and forms part of the end effector (350), while extending proximal to the end effector (350). As shown in Figures 3 to 6, the flex circuit (300) in this example has a proximal portion (310), an intermediate portion (320), and a distal portion (330). Figures 8 to 10 show a flat configuration of the flex circuit (300), which is a configuration the flex circuit (300) may have before it is fixed to the catheter body (230). Figures 11 to 15 show a wrapped configuration of the flex circuit (300), which is a configuration the flex circuit (300) may have after it is fixed to the catheter body (230).

[0033] The flex circuit (300) includes a flexible substrate (302), traces (304), and electrodes (352). It should be understood that the flex circuit (300) may have substantially more traces (304) than those shown in the drawings, as the number of traces (304) depicted is minimized in the drawings for clarity. Where used herein, the singular term “trace” should be understood to include the plural term “trace.” In other words, the depiction of a single trace (304) in the drawings, and the description of “trace (304)” herein, are intended to include scenarios in which two or more traces are provided. Therefore, this disclosure should not be read as intended to mean that in each instance where a drawing shows a single trace (304) and the specification refers to “trace,” only a single trace is provided. The term “trace,” and the corresponding depiction of a single trace, are merely used as an abbreviation for one or more traces. The claims should also be understood to mean that the term "trace" may include "multiple traces."

[0034] The flexible substrate (302) may comprise polyimide and / or any other suitable material. The trace (304) may comprise any suitable conductive material. The trace (304) may be positioned on either or both surfaces of the flexible substrate (302). At least some of the traces (304) may be covered by the third layer (238) of the catheter body (230) as described above. The traces (304) may also be covered by another electrically insulating layer of plastic (e.g., polyimide) in front of the third layer (238) as part of the manufacturing process of the flexible circuit (300) before the third layer (238) is applied to the flexible circuit (300). In some such variations, the layers of the flexible circuit (300) may comprise a polyimide cover film, adhesive, conductive traces (e.g., traces (304)), a polyimide substrate (e.g., flexible substrate (302)), conductive traces (e.g., traces (304)), adhesive, and a polyimide cover film. Therefore, the trace (304) may be provided on both sides of the flexible substrate (302), and the adhesive and cover film layers are also provided on both sides of the flexible substrate (302) along both layers of the trace (304) and along the areas that remain exposed to the trace (304).

[0035] The electrodes (352) may remain uncovered by the third layer (238) of the catheter body (230), and as a result, the electrodes (352) may come into direct contact with tissue, conductive fluid, etc. The electrodes (352) may include a conductive material so that each electrode (352) is operable to apply electrical energy to tissue, as described above and in the various references cited herein. Just as an example, each electrode (352) may include a precious metal such as gold, platinum, ruthenium, rhodium, palladium, silver, osmium, or iridium. Alternatively, any other suitable conductive material may be used. In some variations, each electrode (352) is also operable to pick up potentials within tissue (e.g., as part of an EP mapping process), as described above and in the various references cited herein.

[0036] As also shown in Figures 3-6 and 8-15, the structural configuration of the flex circuit (300) differs between the proximal portion (310), the intermediate portion (320), and the distal portion (330). As best seen in Figures 4, 6, 9, and 12-13, the flexible substrate (302) in the distal portion (330) includes a circumferentially extending portion (332) and a longitudinally extending portion (334), the circumferentially extending portions (332) being longitudinally separated from each other by their respective pairs of longitudinally extending portions (334). Each circumferentially extending portion (332) has its own electrode (352) applied to the circumferentially extending portion (332). The trace (304) extends along the longitudinally extending portion (334). The trace (304) portion may also extend along the circumferentially extending portion (332). The flex circuit (300) in this example has six circumferentially extending portions (332) and their respective electrodes (352), but other modifications may have any other suitable number of circumferentially extending portions (332) and their respective electrodes (352). Just as an example, some modifications may have a number of electrodes (352) ranging from 2 to 20, or any other suitable number of electrodes (352).

[0037] As is most commonly seen in Figures 3, 5, and 8–15, the flexible substrate (302) within the proximal portion (320) has a circumferentially extending portion (312), a tail portion (314), and a plurality of contact pads (316). The circumferentially extending portion (312) may extend around the catheter body (230) along an angular range of approximately 270 degrees. Alternatively, the circumferentially extending portion (312) may extend around the catheter body (230) along any other preferred angular range. In the arrangements shown in Figures 3 and 5, the electrode (354) is positioned around the circumferentially extending portion (312). In some variations, the electrode (354) is used as a reference electrode. In some such variations, the electrode (354) is used during EP mapping procedures to pick up a reference potential from blood or saline passing along the end effector (350). Such reference potentials can be used to reduce noise or far-field signals, as is well known in the art. In addition, or instead, the electrode (354) can be used as an active or return electrode during ablation procedures such as RF ablation or PFA. In yet another modification, the electrode (354) may be omitted, as shown in Figures 14-15.

[0038] As is most commonly seen in Figures 8-10, when the flex circuit (300) is in a flat configuration, the tail (314) extends obliquely outward with respect to the central longitudinal axis (LA). As is most commonly seen in Figures 11-15, when the flex circuit (300) is in a wound configuration, the tail (314) is wound spirally around the catheter body (230). In this example, the underside of the tail (314) includes a contact pad (316). The contact pad (316) is in electrical communication with the trace (304) and the electrode (352). The contact pad (316) is configured to couple with a wire, a trace of another flex circuit, and / or other conductive mechanisms on or within the rigid shaft (223). In some variations of the tail section (314), it may be positioned inside the rigid shaft (223), so that the contact pad (316) is coupled to a wire, a trace of another flexible circuit, and / or other conductive mechanism located inside the rigid shaft (223). Such wires, flexible circuits, and / or other conductive mechanisms on or inside the rigid shaft (223) may be further electrically coupled to the cable (216). The tail section (314) may be incorporated into the shaft (230) via a third layer (238) which may be positioned around the outer surface of the tail section (314) along the entire length of the tail section (314). In some other variations, the tail section (314) may extend into the interior of the rigid shaft (223) and may extend into the handle assembly (210). Furthermore, it should be understood that, in addition to the contact pad (316) being positioned on the underside of the tail portion (314), or instead, the contact pad (316) may be positioned on the upper side of the tail portion (314). Alternatively, the flex circuit (300) may be electrically coupled to the mechanism of the cable (216) in any other preferred manner.

[0039] As best seen in Figures 3, 5, and 8-15, the intermediate portion (320) of the flexible substrate (302) has two legs (302a, 302b) that extend longitudinally and define a wavy or meandering configuration. As best seen in Figures 8-10, when the flex circuit (300) is in a flat configuration, the first meandering leg (302a) of the flexible substrate (302) is located on the first side of the central longitudinal axis (LA) (oriented along the x-dimension in Figures 8-10), while the second meandering leg (302b) of the flexible substrate (302) is located on the second side of the central longitudinal axis (LA). The meandering legs (302a, 302b) are spaced apart from each other along the y-dimension. The meandering legs (302a, 302b) are positioned relative to each other along the x-dimensional such that their respective peaks (303a, 303b) are aligned along the horizontal axis (TA) (oriented along the y-dimensional in Figures 8-10). In other words, if the meandering legs (302a, 302b) were viewed as waveforms plotted along the xy-plane in Figures 8-10, these waveforms would be 180 degrees out of phase with each other when the flex circuit (300) is in a flat configuration.

[0040] As is most commonly seen in Figures 11-15, when the flex circuit (300) is in a wound configuration, the meandering legs (302a, 302b) are positioned relative to each other along the x-dimensional such that the respective peaks (303a, 303b) of the meandering legs (302a, 302b) are aligned with each other along another horizontal axis (TA) (oriented along the z-dimensional in Figures 11-15). In other words, if the meandering legs (302a, 302b) are viewed as their respective waveforms plotted along the xz-plane in Figures 11-12 and 14, these waveforms are in phase with each other when the flex circuit (300) is in a wound configuration.

[0041] In this example, the trace (304) (which may actually include two or more traces, as described above) extends along the entire length of the meandering configuration of the flexible substrate (302), at least over the entire intermediate portion (320). This trace (304) continues along both of its meandering legs (302a, 302b), connecting the meandering legs (302a, 302b). For example, the trace may straddle the circumferentially extending portion (332) of the distal portion (330) of the flex circuit (300), thereby connecting the meandering legs (302a, 302b). The trace (304) may also straddle the circumferentially extending portion (312) of the proximal portion (320) of the flex circuit (300), thereby connecting the meandering legs (302a, 302b). By extending along both the meandering legs (302a, 302b) and the circumferentially extending portion (332), the trace (304) forms a loop configuration. If the trace (304) also straddles the circumferentially extending portion (312) of the proximal portion (320) of the flex circuit (300), thereby connecting the meandering legs (302a, 302b), the trace (304) may form a multi-winding coil loop configuration.

[0042] In some variations, the loop formed by the trace (304) extends only along the most proximal circumferential portion (332) of the distal portion (330) of the flexible circuit (300), and as a result, the loop does not extend along the length of the distal portion (330) of the flexible circuit, but only along the length of the intermediate portion (320) of the flexible circuit (300). In some other variations, the loop formed by the trace (304) extends along the most distal circumferential portion (332) of the distal portion (330) of the flexible circuit (300), and as a result, the loop extends along the length of the distal portion (330) of the flexible circuit, in addition to the length of the intermediate portion (320) of the flexible circuit (300).

[0043] In this example, the loop formed by the trace (304) along the intermediate portion (320) (and optionally along the distal portion (330)) provides a position sensor as described above. In other words, the loop formed by the trace (304) along the intermediate portion (320) (and optionally along the distal portion (330)) functions as an induction coil that provides electrical signals in response to the presence of an alternating electromagnetic field generated by the field generator (20). These electrical signals can indicate the real-time position and orientation of the end effector (350) within the patient (PA). The processor in the console (12) can receive these position indicator signals via the cable (216) and process them to determine the real-time position and orientation of the end effector (350) within the patient (PA). Accordingly, the processor of the console (12) may drive the display (18) to show the real-time position and orientation of the end effector (350) within the patient (PA), such as against preoperative images of the patient's anatomical structure or against a digital model of the patient's anatomical structure, as described above and in the various references cited herein.

[0044] In some modifications, the legs (302a, 302b) of the flexible substrate (302) along both sides of the central longitudinal axis (LA) are linear (for example, simply extending longitudinally) rather than having a meandering configuration. In such modifications, the loop formed by the trace (304) can still effectively provide a position sensor. In this example, the meandering configuration of the legs (302a, 302b) of the flexible substrate (302) along both sides of the central longitudinal axis (LA) allows the loop formed by the trace (304) to also effectively provide a position sensor; however, the meandering configuration of the legs (302a, 302b) of the flexible substrate (302) can further facilitate the bending of the flex circuit (300) along the intermediate portion (320). In some cases, the meandering configuration of the legs (302a, 302b) of the flexible substrate (302) does not affect the performance of the loop formed by the trace (304) as a position sensor, compared to the performance of the loop formed by the trace (304) as a position sensor in a modified example in which the legs (302a, 302b) are linear. Also, in some cases, the meandering configuration of the legs (302a, 302b) of the flexible substrate (302) does not create or enhance any bending bias in the distal portion (224) of the shaft assembly (220). In other words, the meandering configuration of the legs (302a, 302b) of the flexible substrate (302) does not provide an elastic bias that biases the distal portion (224) of the shaft assembly (220) toward a linear configuration along the central longitudinal axis (LA).

[0045] To the extent that some conventional catheter devices include a position sensor at the distal end of the shaft assembly in an end effector or otherwise, the catheter assembly (200) in this example may differ substantially from such conventional catheter devices in that the position sensor provided by a loop formed by a trace (304) along the middle portion (320) (and possibly along the distal portion (330)) extends along a substantial portion of the entire length of the shaft assembly (220). For example, the position sensor provided by the loop formed by the trace (304) may have a length of at least about 5 cm, at least about 10 cm, in the range of about 5 cm to about 20 cm, in the range of about 10 cm to about 15 cm, or about 13 cm. Alternatively, the position sensor provided by the loop formed by the trace (304) may have any other preferred length.

[0046] With respect to the entire length of the shaft assembly (220), the position sensor provided by the loop formed by the trace (304) may extend along at least about 2.5% of the total length of the shaft assembly (220), along at least about 3% of the total length of the shaft assembly (220), along at least about 5% of the total length of the shaft assembly (220), along at least about 6.5% of the total length of the shaft assembly (220), along at least about 7.5% of the total length of the shaft assembly (220), along at least about 8.5% of the total length of the shaft assembly (220), along at least about 10% of the total length of the shaft assembly (220), along at least about 11.5% of the total length of the shaft assembly (220), along at least about 13% of the total length of the shaft assembly (220), along at least about 15% of the total length of the shaft assembly (220), or along at least about 20% of the total length of the shaft assembly (220). Alternatively, the length of the position sensor provided by the loop formed by the trace (304) may have any other preferred relationship with the total length of the shaft assembly (220).

[0047] With respect to the outer diameter of the shaft assembly (220), the length of the position sensor provided by the loop formed by the trace (304) may be more than 10 times the outer diameter of the shaft assembly (220), more than 20 times the outer diameter of the shaft assembly (220), more than 25 times the outer diameter of the shaft assembly (220), more than 50 times the outer diameter of the shaft assembly (220), more than 75 times the outer diameter of the shaft assembly (220), more than 100 times the outer diameter of the shaft assembly (220), more than 125 times the outer diameter of the shaft assembly (220), more than 145 times the outer diameter of the shaft assembly (220), more than 200 times the outer diameter of the shaft assembly (220), more than 250 times the outer diameter of the shaft assembly (220), or more than 300 times the outer diameter of the shaft assembly (220). Alternatively, the length of the position sensor provided by the loop formed by the trace (304) may have any other preferred relationship with the outer diameter of the shaft assembly (220).

[0048] Regardless of whether the length of the position sensor provided by the loop formed by the trace (304) is compared to the total length of the shaft assembly (220) or the outer diameter of the shaft assembly (220), the relative length of the position sensor provided by the loop formed by the trace (304) may be considered substantial, particularly compared to a similar relative length provided by a conventional position sensor. This substantial relative length of the position sensor may be counterintuitive, as conventional fixture design considerations may tend to focus on minimizing the size of the components. In other words, conventional position sensors may tend to be as compact as possible, and as a result, the position sensor provided by the loop formed by the trace (304) may be substantially larger than that of a conventional position sensor. Similarly, the surface area bounded by the trace (304) may be substantially larger than the surface area bounded by a conventional position sensor. Conventional position sensor designs may also indicate that the position sensor should not bend during use, whereas a position sensor provided by a loop formed by trace (304) may be substantially prone to bending during use, and this bending may be even more likely due to the substantial length of the position sensor provided by the loop formed by trace (304). In other words, the substantial length of the position sensor provided by the loop formed by trace (304) may facilitate bending of the position sensor during use.

[0049] In another respect, the catheter assembly (200) in this example may differ substantially from conventional catheter instruments having a position sensor in that the position sensor provided by the loop formed by the trace (304) may be substantially bent during the operation of the catheter assembly (200). This bending may be facilitated by the meandering configuration of the flexible substrate (302) along the middle portion (320) of the flex circuit (300). This bending of the position sensor may be partially attributable to the substantial length of the position sensor in this example. In contrast, conventional position sensors may be substantially shorter and / or be longitudinally constrained to components of a catheter assembly that do not bend. In other words, conventional position sensors may be substantially impervious to bending during use, or bend minimally during use, and as a result, conventional position sensors may be substantially impervious to bending as much as the position sensor provided by the loop formed by the trace (304).

[0050] III. Example of a long, narrow position sensor configuration As described above, the loop formed by the trace (304) along the intermediate portion (320) (and possibly along the distal portion (330)) can provide a position sensor that provides a position indicator signal in the presence of an alternating electromagnetic field. Also, as described above, the loop formed by the trace (304) can be considered to form a substantially rectangular shape that extends longitudinally along a portion of the length of the catheter body (230) and covers the periphery of the catheter body (230). This arrangement is schematically shown in Figure 16A. Specifically, Figure 16A shows a first example of an elongated position sensor arrangement (400) in which the loop (404) covers the upper part of the catheter body (402). Thus, the loop (404) schematically represents the loop formed by the trace (304) within the flex circuit (300). The length of the rectangle defined by the loop (404) is determined by the length of the flexible circuit into which the loop (404) is incorporated, and the width of the rectangle defined by the loop is determined by the diameter of the catheter body (402).

[0051] The arrow (405) indicates the direction of the current that may be generated in the loop (404) by an alternating electromagnetic field (e.g., one generated by the field generator (20)). The direction indicated by the arrow (405) in Figure 16A is illustrative only, and the current may actually flow in the opposite direction depending on the orientation of the field. In the example shown in Figure 16A, each of the circumferential segments of the loop (404) has an angular range of approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (402), and as a result, the longitudinal segments of the loop (404) are angularly offset from each other by approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (402). This relative positioning of the longitudinal segments of the loop (404) may tend to maximize the sensitivity of the position sensor provided by the loop (404). Alternatively, the segments extending circumferentially from the loop (404) may have any other preferred angular range, and the segments extending longitudinally from the loop (404) may be angularly offset from each other by any other preferred angular distance.

[0052] In the operating state shown in Figure 16A, the catheter body (402) is in an unbent state, and as a result, the loop (404) is also in an unbent state. During normal operation, the catheter body (402) may bend in a number of different directions as it traverses a meandering anatomical passage, as described herein. The loop (404) bends together with the catheter body (402). Figure 16B shows an example of the loop (404) in such a bent state. As shown, in this example, the loop (404) is bent along the xz plane, and the loop (404) extends longitudinally along the x direction. Also as shown, when the loop (404) is bent in this manner, it defines a saddle-shaped plane or extends along a saddle-shaped plane. In some other scenarios (for example, when the catheter body (402) and loop (404) are bent along the xy-plane), the loop (404) may define different shapes when it is in a bent state.

[0053] As schematically shown in Figure 16C, the loop (404) may have a first effective length (L1) and a first effective width (W1) when the loop (404) is in an unbent state (e.g., the state shown in Figure 16A). In this unbent state, the loop (404) may effectively boundary a first area (i.e., L1 × W1) along a particular two-dimensional plane (e.g., the xy-plane as shown in Figure 16C). As schematically shown in Figure 16D, the loop (404) may have a second effective length (L2) while maintaining the first effective width (W1) when the loop (404) is in a bent state (e.g., the state shown in Figure 16B). In this bent state, the loop (404) may effectively boundary a second area (i.e., L2 × W1) along the same two-dimensional plane (e.g., the xy-plane as shown in Figure 16D). In this example, the second effective length (L2) is smaller than the first effective length (L1). As a result, the second area along the two-dimensional plane (i.e., L2 × W1) is smaller than the first area along the two-dimensional plane (i.e., L1 × W1). In other words, the area defined by the effective length (L) and effective width (W) of the loop (404) along the two-dimensional reference plane may tend to be smaller when the catheter body (402) and loop (404) are bent, especially when the catheter body (402) and loop (404) are bent.

[0054] In some other scenarios, the effective width (W) of the loop (404) may change when the catheter body (402) and loop (404) bend, and in addition, or instead, the effective length (L) of the loop (404) may change when the catheter body (402) and loop (404) bend. This may depend on the direction in which the catheter body (402) and loop (404) bend. In any of these cases, the area defined by the effective length and width of the loop (404) along a given two-dimensional plane may change when the catheter body (402) and loop (404) bend, for example, by becoming smaller when the catheter body (402) and loop (404) bend. In some variants, the catheter assembly (200) has an area defined by the effective length (L) and effective width (W) of the loop (404) along a two-dimensional reference plane (including when the catheter body (402) and loop (404) are bent) of at least approximately 150 mm². 2 at least approximately 175mm 2 , at least about 200mm 2 , at least about 225mm 2 , at least about 250mm 2 , at least about 275mm 2 , or at least about 300 mm 2 It is constructed in such a manner. Alternatively, the loop (404) may define any other suitable area along the two-dimensional reference plane when the loop (404) is in an unbent or bent state.

[0055] Figure 17 shows a second example of an elongated position sensor arrangement (410). In this arrangement (410), the first loop (414) covers the top of the catheter body (412) at a first angular position and a first longitudinal position, and the second loop (416) covers the side of the catheter body (412) at a second angular position and a second longitudinal position. In this example, the loops (414, 416) are electrically insulated from each other. The second angular position is angularly offset by approximately 90 degrees from the first angular position with respect to the central longitudinal axis (LA) of the catheter body (412). The second longitudinal position is distal to the first longitudinal position. The arrangement of the loops (414, 416) is such that no part of loop (414) overlaps with any part of loop (416). This longitudinal spacing of the loops (414, 416) can maximize the flexibility of the arrangement (410).

[0056] The arrow (415) indicates the direction of any current that may be generated within the loop (414) by an alternating electromagnetic field (e.g., one generated by the field generator (20)). In the example shown in Figure 17, each circumferential segment of the loop (414) has an angular range of approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (412), and as a result, the longitudinal segments of the loop (414) are angularly offset from each other by approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (412). This relative positioning of the longitudinal segments of the loop (414) may tend to maximize the sensitivity of the position sensor provided by the loop (414). Alternatively, the circumferential segments of the loop (414) may have any other preferred angular range, and the longitudinal segments of the loop (414) may be angularly offset from each other by any other preferred angular distance.

[0057] The arrow (417) indicates the direction of any current that may be generated within the loop (416) by an alternating electromagnetic field (e.g., one generated by the field generator (20)). In the example shown in Figure 17, each circumferential segment of the loop (416) has an angular range of approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (412), and as a result, the longitudinal segments of the loop (416) are angularly offset from each other by approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (412). This relative positioning of the longitudinal segments of the loop (416) may tend to maximize the sensitivity of the position sensor provided by the loop (416). Alternatively, the circumferential segments of the loop (416) may have any other preferred angular range, and the longitudinal segments of the loop (416) may be angularly offset from each other by any other preferred angular distance.

[0058] The presence of two loops (414, 416) and an angular offset of approximately 90 degrees between them can provide a position-sensitive arrangement (410) with two degrees of freedom, and thus can provide enhanced real-time position information compared to the real-time position information provided by arrangement (400). Although only two loops (414, 416) are provided for arrangement (410), variations of arrangement (410) may include three or more loops, each providing its own respective position indicator signal.

[0059] Figures 18-19 show an example of a flexible circuit (500) that may be used to provide the arrangement (410) of Figure 17. Although the flexible circuit (500) is shown in a planar configuration, it should be understood that the flexible circuit (500) may be wrapped around the catheter body, as described above in the context of the flexible circuit (300). The flexible circuit (500) in this example includes a flexible substrate (502) having a proximal portion (510), a first intermediate portion (520), a transition portion (530), a second intermediate portion (540), and a distal portion (550). The proximal portion (510) of the flexible circuit (500) may be configured and operable in the same way as the proximal portion (310) of the flexible circuit (300) described above. Similarly, the distal portion (550) of the flex circuit (500) may be configured and operable in the same way as the distal portion (330) of the flex circuit (300) described above.

[0060] Similar to the intermediate portion (320) of the flexible circuit (300), the first intermediate portion (520) of the flexible circuit (500) has two legs, each defining a wavy or meandering configuration. Also similar to the intermediate portion (320) of the flexible circuit (300), the second intermediate portion (540) of the flexible circuit (500) has two legs, each defining a wavy or meandering configuration. Unlike the intermediate portion (320) of the flexible circuit (300), each intermediate portion (520, 540) of the flexible circuit (500) includes a plurality of transversely oriented webs (508) that join the meandering legs of the flexible substrate (502). The webs (508) are spaced longitudinally apart from each other along the length of each intermediate portion (520, 540). The web (508) may prevent the meandering legs of the flexible substrate (502) from moving further away from each other along the transverse axis, and as a result, the web (508) may provide a consistent spacing between the meandering legs of the flexible substrate (502) along the length of each intermediate section (520, 540). In this example, there are no electrical traces extending across the web (508), but in other modifications, electrical traces spanning the web (508) may be provided.

[0061] The transition portion (530) of the flexible substrate (502) is joined together with the intermediate portions (520, 540). In the flat configuration shown in Figures 18-19, the transition portion (530) is oriented laterally, but in the wrapped configuration (when the flexible circuit (500) is wrapped around the catheter body), the transition portion extends along a circumferential path.

[0062] The first intermediate portion (520) includes a trace (504) that extends along the entire length of the first intermediate portion (520) along both of its meandering legs of the flexible substrate (502). The trace (504) also straddles the transition portion (530). Thus, the trace (504) forms a loop that provides a position sensor, as schematically represented by the first loop (414) in the position sensor arrangement of Figure 17. The second intermediate portion (540) includes a trace (506) that extends along the entire length of the second intermediate portion (540) along both of its meandering legs of the flexible substrate (502). The trace (506) also straddles the transition portion (530). Thus, the trace (506) forms a loop that provides a position sensor, as schematically represented by the second loop (416) in the position sensor arrangement of Figure 17. In this example, the traces (504, 506) are electrically isolated from each other. Nevertheless, it should be understood that a portion of the trace (506) extends along the first intermediate portion (520) and reaches a corresponding pair of contact pads on the proximal portion (510), thereby enabling the communication of position indicator signals from the loop formed by the trace (506) to a processor (e.g., the processor of console (12)).

[0063] As described above with respect to the loops (414, 416) of arrangement (410), the intermediate portions (520, 540) are positioned relative to each other such that when the flex circuit (500) is wrapped around the catheter body, the loops formed by the traces (504, 506) are angularly offset from each other by approximately 90 degrees around the central longitudinal axis of the catheter body. This offset is provided in this example by the configuration of the transition portion (530). If three or more loops are provided, the flex circuit may include modified variations of the transition portion (530) and / or two or more transition portions to accommodate any desired number of angular offsets corresponding to the number of loops.

[0064] Figure 20 shows a third example of an elongated position sensor arrangement (600). In this arrangement (600), the first loop (604) covers the top of the catheter body (602) at a first angular position and a first longitudinal position, and the second loop (606) covers the top of the catheter body (602) at a second angular position and a first longitudinal position. In this example, the loops (604, 606) are electrically insulated from each other. The second angular position is angularly offset by approximately 90 degrees from the first angular position with respect to the central longitudinal axis (LA) of the catheter body (602). In this example, the loops (604, 606) have the same longitudinal spread relative to each other. The arrangement of the loops (604, 606) is such that the angular segment of loop (604) overlaps with the angular segment of loop (606). In this example, this angular overlap extends along approximately 90 degrees of the angular range of each loop (604, 606). This relative spacing of loops (604, 606) can minimize the overall length of arrangement (600).

[0065] The arrow (605) indicates the direction of any current that may be generated within the loop (604) by an alternating electromagnetic field (e.g., one generated by the field generator (20)). In the example shown in Figure 20, each circumferential segment of the loop (604) has an angular range of approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (602), and as a result, the longitudinal segments of the loop (602) are angularly offset from each other by approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (602). This relative positioning of the longitudinal segments of the loop (604) may tend to maximize the sensitivity of the position sensor provided by the loop (604). Alternatively, the circumferential segments of the loop (604) may have any other preferred angular range, and the longitudinal segments of the loop (604) may be angularly offset from each other by any other preferred angular distance.

[0066] The arrow (607) indicates the direction of any current that may be generated within the loop (606) by an alternating electromagnetic field (e.g., one generated by the field generator (20)). In the example shown in Figure 20, each circumferential segment of the loop (606) has an angular range of approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (602), and as a result, the longitudinal segments of the loop (606) are angularly offset from each other by approximately 180 degrees around the central longitudinal axis (LA) of the catheter body (602). This relative positioning of the longitudinal segments of the loop (606) may tend to maximize the sensitivity of the position sensor provided by the loop (606). Alternatively, the circumferential segments of the loop (606) may have any other preferred angular range, and the longitudinal segments of the loop (606) may be angularly offset from each other by any other preferred angular distance.

[0067] The presence of two loops (604, 606) and an angular offset of approximately 90 degrees between them can provide a position-sensitive arrangement (600) with two degrees of freedom, and thus can provide enhanced real-time position information compared to the real-time position information provided by arrangement (400). Although only two loops (604, 606) are provided for arrangement (600), variations of arrangement (600) may include three or more loops, each providing its own respective position indicator signal.

[0068] Figure 21 shows a fourth example of an elongated position sensor arrangement (610). In this arrangement (610), a pair of first loop segments (614a, 614b, 614c) cover the upper part of the catheter body (612) at a first angular position around the central longitudinal axis (LA), and a pair of second loop segments (616a, 616b, 616c) cover the side of the catheter body (612) at a second angular position about the central longitudinal axis (LA). The second angular position is angularly offset by approximately 90 degrees from the first angular position about the central longitudinal axis (LA) of the catheter body (412). The combination of angles and longitudinal positioning of loop segments (614a, 614b, 614c) relative to loop segments (616a, 616b, 616c) is such that the areas of loop segments (614a, 614b, 614c) alternate with those of loop segments (616a, 616b, 616c). However, no portion of any loop segment (614a, 614b, 614c) from the first set overlaps with any portion of any loop segment (616a, 616b, 616c) from the second set.

[0069] In this example, the first set of loop segments (614a, 614b, 614c) are joined together in series (e.g., by a shared set of traces). Similarly, the second set of loop segments (616a, 616b, 616c) are joined together in series (e.g., by a shared set of traces). In this example, the first set of loop segments (614a, 614b, 614c) are electrically isolated from the second set of loop segments (616a, 616b, 616c). Figure 21 does not include arrows indicating the direction of currents that may be generated in each loop segment (614a, 614b, 614c, 616a, 616b, 616c) by an alternating electromagnetic field (e.g., generated by the field generator (20)), but such currents may be generated in the same way as described above with respect to the arrangement (400, 410, 600).

[0070] With the first set of loop segments (614a, 614b, 614c) joined together in series, the first set of loop segments (614a, 614b, 614c) cooperate to effectively provide a first single loop, thereby providing a real-time position indication signal with a first degree of freedom. Similarly, with the second set of loop segments (616a, 616b, 616c) joined together in series, the second set of loop segments (616a, 616b, 616c) cooperate to effectively provide a second single loop, thereby providing a real-time position indication signal with a second degree of freedom. Thus, arrangement (610) can provide enhanced real-time position information compared to the real-time position information provided by arrangement (400). Although only active loops are provided by the loop segments (614a, 614b, 614c, 616a, 616b, 616c) in arrangement (610), variations of arrangement (610) may include additional loop segments that effectively provide three or more active loops, each active loop providing its own position indicator signal.

[0071] IV. Examples of Electrical Paths As described above, the electrodes (352) of the end effector (350) can be used in a number of ways. For example, the electrodes (352) can be used to provide EP mapping and / or other diagnostic functions. In addition, or instead, the electrodes (352) may be used to provide ablation and / or other therapeutic functions. In the context of ablation, the electrodes (352) can be used to apply RF energy to tissue to ablate the tissue. In addition, or instead, the electrodes (352) may be used to ablate tissue by applying PFA or any other form of electrical energy. Regardless of whether the electrodes (352) are used to provide RF ablation, PFA, or any other form of electrical ablation, there are a number of permutations in which one or more different electrodes (352) can be operated with different polarities to apply electrical energy to tissue. Various examples of how the electrodes (352) can be used to apply electrical energy to tissue, either through direct or indirect contact with the tissue, are described in more detail below.

[0072] A. Example of an electrical path between an electrode and a grounding pad Figure 22 shows the electrodes (352) of an end effector (350) used with a grounding pad (700) to provide a first example of an electrical pathway. In this example, the end effector (350) is used as a unipolar instrument, so that one or more of the electrodes (352) may be activated, while the grounding pad (700) provides a return pathway. The grounding pad (700) can take any preferred form, including, but not limited to, a pad on which the patient (PA) lies, or a patch adhered to the patient's (PA) skin. Once the end effector (350) is positioned within the anatomical space of the target (e.g., Marshall's vein or other small vessels branching from the coronary sinus), one or more of the electrodes (352) may be positioned in contact with the tissue and then activated with unipolar electrical energy. The electrical energy can flow through the adjacent tissue between the activated electrode (352) and the grounding pad (700), which may result in tissue ablation.

[0073] B. Example of an electrical path between electrode combinations In some scenarios, the use of a grounding pad (700) may be undesirable, and therefore, it may be more desirable to apply bipolar electrical energy to the tissue using electrodes (352). This may allow the physician (PH) to ablate the tissue in a more precisely targeted manner. While a variant of the end effector (350) with only one electrode (352) can apply bipolar electrical energy to the tissue, a variant of the end effector (350) with three or more electrodes (352) may provide even better control over the formation of damage and / or other ablation outcomes by allowing the physician (PH) to make ad hoc individual combinations of which electrodes (352) act as active electrodes and which electrodes (352) act as return electrodes at a given point in time during the ablation procedure. Such control over the bipolar assignment between electrodes (352) may allow the physician to fine-tune the shape, gradient, and / or other characteristics of the damage formed by the ablation process (and / or other outcomes of the ablation process). This, in turn, can minimize the risk of undesirable gaps remaining between or within the ablated areas of the tissue.

[0074] Figures 23–27 provide examples of different cases in which electrodes (352) can function as the active electrode and which electrodes (352) can function as the return electrode at a given point in time during an ablation procedure. The examples shown in Figures 23–27 are illustrative examples only. One or more of the electrodes (352) can be used to establish an electrical bipolarity with any other electrode (352) or any other group of electrodes (352) to deliver electrical energy. The following examples are not intended to be exhaustive.

[0075] Figure 23 shows the electrodes (352) of an end effector (350) used together to provide a second example of an electrical path. In this example, the most distal electrodes (352, 352e, 352f) function as active electrodes, while the nearest electrodes (352a, 352b, 352c) function as return electrodes. In some such variations, the most distal electrodes (352d, 352e, 352f) are acted simultaneously, while the nearest electrodes (352a, 352b, 352c) function simultaneously as return electrodes. In some other variations, the most distal electrodes (352d, 352e, 352f) are acted sequentially, while the nearest electrodes (352a, 352b, 352c) function sequentially as return electrodes. In some such variations, electrode (352a) acts as a return electrode while electrode (352d) is activated, electrode (352b) acts as a return electrode while electrode (352e) is activated, and electrode (352c) acts as a return electrode while electrode (352f) is activated. Such sequences can occur in any suitable order or arrangement. Furthermore, a pair of bipolars can be formed at any point in time between any suitable electrode pairs (352a, 352b, 352c, 352d, 352e, 352f).

[0076] Figure 24 shows the electrodes (352) of an end effector (350) used together to provide a third example of an electrical path. In this example, the most distal electrode (352f) functions as the active electrode, while the nearest electrode (352a) functions as the return electrode.

[0077] Figure 25 shows the electrodes (352) of an end effector (350) used together to provide a fourth example of an electrical path. In this example, electrodes (352e, 352f) function together / simultaneously as the active electrode, while electrodes (352a, 352b, 352c) function together / simultaneously as the return electrode. Therefore, there does not need to be a 1:1 parity between the number of electrodes (352) functioning as the active electrode and the number of electrodes (352) functioning as the return electrode at a given time.

[0078] Figure 26 shows the electrodes (352) of the end effector (350) used together to provide a fifth example of an electrical path. In this example, electrodes (352e, 352f) function together / simultaneously as the active electrode, while electrodes (352a, 352b) function together / simultaneously as the return electrode.

[0079] Figure 27 shows the electrodes (352) of the end effector (350) used together to provide a sixth example of an electrical path. In this example, electrodes (352d, 352e, 352f) function together / simultaneously as the active electrode, while electrodes (352a, 352b) function together / simultaneously as the return electrode.

[0080] The bipolar assignments between electrodes (352) shown in Figures 23 to 27 and described above are not intended to be exhaustive, as any other suitable bipolar assignments may be used. It should also be understood that the bipolar assignments may change during the ablation procedure. For example, the bipolar assignment shown in Figure 23 may be used at some point during the ablation procedure, and then the bipolar assignment shown in Figure 24 may be used at another point during the same ablation procedure on the same area of ​​tissue. Alternatively, the bipolar assignments of electrodes (352) may change in any other suitable way during the same ablation procedure on the same area of ​​tissue. In some cases, the bipolar assignments of electrodes (352) may change during the same ablation procedure according to a predetermined assignment sequence. In some other cases, the bipolar assignments of electrodes (352) may change on an ad-hoc basis during the same ablation procedure based on real-time feedback. For example, the electrode (352) may provide tissue impedance sensing, and a control algorithm may be used to change the bipolar assignment of the electrode (352) on an ad-hoc basis based on real-time tissue impedance data. In addition, or alternatively, the end effector (350) may include one or more thermocouples and / or other temperature sensing mechanisms, and a control algorithm may be used to change the bipolar assignment of the electrode (352) on an ad-hoc basis based on real-time temperature data. Alternatively, the bipolar assignment of the electrode (352) may be changed on an ad-hoc basis during the same ablation procedure based on any other preferred criteria. In any of the above scenarios, additional factors that may influence the bipolar assignment of the electrode (352) include, among other things, the intended tissue target (e.g., the anatomical structure of the target), the intended depth or shallowness of the injury, the geometric configuration of the injury, and / or other factors.

[0081] C. Example of an electrical path between an electrode and a guide wire As described above with respect to the grounding pad (700) in the electrical path shown in Figure 22, it is possible to use a second device to provide a return to the electrical path including the active electrode (352). Also as described above, the use of the grounding pad (700) may come at the cost of reduced precision and control of the damage provided via ablation using the electrode (352). This may be partly due to the distance the current must travel from the electrode (352) to the grounding pad (700).

[0082] Therefore, it may be desirable to use a second device to provide a return path within the electrical path including the active electrode (352), the second device being substantially closer to the electrode (352), thereby reducing the distance the current must travel. For this purpose, Figure 28 shows the electrode (352) of an end effector (350) used with a guidewire (250) to provide a seventh example of an electrical path. In this example, the guidewire (250) is positioned within a lumen (236, 227) and protrudes distally from the open distal end (228) of the tip member (226). The guidewire (250) is also conductive in this example. Thus, the guidewire (250) may provide a return path, while one or more electrodes (352) are actuated with unipolar electrical energy. The electrical energy can flow between the actuated electrode (352) and the guidewire (250) through adjacent tissue, which may result in tissue ablation. Although Figure 28 shows only the electrode (352a) that functions as the active electrode, an active electrode that works in cooperation with the guide wire (250) as a return electrode can be provided using any suitable number or position of electrodes (352).

[0083] Figure 29 shows the electrodes (352) of an end effector (350) used with a guidewire (250) to provide an eighth example of an electrical pathway. In this example, the guidewire (250) is not located within a lumen (236, 227) but instead located elsewhere within the patient (PA). For example, the guidewire (250) may be located within any other blood vessel, a cardiac chamber of the heart (H), or any other suitable location within the patient (PA). Nevertheless, the guidewire (250) may also be used to provide a return pathway, while one or more electrodes (352) are activated with unipolar electrical energy. The electrical energy can flow between the activated electrode (352) and the guidewire (250) through adjacent tissue, which may result in tissue ablation.

[0084] D. Example of an electrical path between an electrode and an irrigation fluid. In some scenarios, it may be beneficial to introduce an irrigation fluid (e.g., saline solution) into communication with the ablation device and / or ablation site during the ablation procedure. For example, the irrigation fluid may prevent arc discharge during ablation, prevent the accumulation of lumps, promote conductivity, prevent overheating, and / or provide other benefits. The irrigation fluid may also function as a virtual electrode. When saline solution is used as the irrigation fluid providing a virtual electrode, the salt content of the saline solution can be varied to alter its conductivity, which in turn can affect the performance of the irrigation fluid as a virtual electrode.

[0085] Figures 30-31 illustrate an example of how irrigation fluid may be used to provide a virtual electrode that serves as a return path for one or more activated electrodes (352) of an end effector (350). Specifically, Figure 30 shows an electrode (352) of an end effector (350) used with irrigation fluid (702) to provide a ninth example of an electrical path. In this example, the end effector (350) is located within a lumen (L) defined by tissue (T). As a mere example, the lumen (L) may be within some other small vessel branching from Marshall's vein or coronary sinus. The irrigation fluid (702) is discharged into the lumen (L) through the lumen (236, 227) and the open distal end (228) of the tip member (226). As described above, the irrigation fluid (702) can be supplied from the fluid source (42) to the lumens (236, 227) via the pump (44), conduit (40), and port (214).

[0086] As a mere example, the irrigation fluid (702) may be discharged through the open distal end (228) at a flow rate of approximately 3 mL / min, at a flow rate greater than approximately 3 mL / min, or at any other suitable flow rate. Discharge of the irrigation fluid (702) into the lumen (L) may ultimately result in a backflow of the irrigation fluid (702) toward the electrodes (352). When the irrigation fluid (702) has sufficiently reached the electrodes (352), one or more electrodes (352) may be activated to provide an active electrode, while the irrigation fluid (702) acts as a virtual return electrode. The resulting flow of electrical energy may result in ablation of the adjacent region of tissue (T) defining the lumen (L).

[0087] The irrigation fluid (702) can communicate with the lumen (L) via the tubular lumen (236, 227) and the open distal end (228) of the tip member (226), but it may be preferable to communicate the irrigation fluid (702) with the lumen (L) via some other route. For example, this may be desirable if the physician (PH) wishes to maintain some other device (e.g., a guidewire (250)) inside the lumen (236, 227), in which case the presence of the other device inside the lumen (236, 227) may negatively affect the ability of the irrigation fluid (702) to communicate adequately through the lumen (236, 227). Figure 31 shows the electrode (352) of an end effector (350) used with an irrigation fluid (702) to provide a tenth example of an electrical path, the irrigation fluid (702) being communicated through an open distal end (712) of a sheath (710) in which a shaft assembly (220) is located. In this example, the open distal end (712) is located proximal to the end effector (350). In some modifications, the sheath (710) is in fluid communication with a fluid source (42) via a pump (44) and a conduit (40).

[0088] As a mere example, the irrigation fluid (702) may be discharged through the open distal end (712) at a flow rate of approximately 10 mL / min, at a flow rate greater than approximately 10 mL / min, or at any other suitable flow rate. Discharge of the irrigation fluid (702) into the lumen (L) may ultimately result in a backflow of the irrigation fluid (702) toward the electrodes (352). When the irrigation fluid (702) has sufficiently reached the electrodes (352), one or more electrodes (352) may be activated to provide an active electrode, while the irrigation fluid (702) acts as a virtual return electrode. The resulting flow of electrical energy may result in ablation of the adjacent region of tissue (T) defining the lumen (L). Figures 30 and 31 show the irrigation fluid (702) being discharged through either the open distal end (228) of the tip member (226) or the open distal end (712) of the sheath (710), although some modifications may provide discharge of the irrigation fluid (702) through both the open distal end (228) of the tip member (226) and the open distal end (712) of the sheath (710) (for example, simultaneously).

[0089] Furthermore, in addition to discharging the irrigation fluid (702) through the open distal end (228) of the tip member (226) or through the open distal end (712) of the sheath (710), or as an alternative to discharging the irrigation fluid (702) through the open distal end (228) of the tip member (226) or through the open distal end (712) of the sheath (710), it may be desirable to discharge the irrigation fluid (702) through the end effector (350). For this purpose, Figure 32 shows an end effector (720) representing a modified version of the end effector (350), and as a result, the end effector (720) can be provided as a substitute for the end effector (350). The end effector (720) in this example is configured and operable in the same way as the end effector (350), except for the differences described below. The end effector (720) is configured as the tip member (226) described above and is positioned proximal to the movable tip member (724). The end effector (720) includes a flexible circuit (730) having a flexible substrate (732) wrapped around the catheter body (722). The flexible circuit (730) also includes a plurality of electrodes (740) on the flexible substrate (732).

[0090] Unlike the electrode (352) of the end effector (350), the electrode (740) of the end effector (720) includes an irrigation opening (742). Similarly, unlike the flexible substrate (302) of the flex circuit (300), the flexible substrate (732) of the flex circuit (730) includes an irrigation opening (734) positioned between the electrodes (740). An irrigation opening (723) is also formed through the catheter body (722) in this example. The irrigation opening (723) may be provided in addition to, or instead of, the irrigation openings (734, 742). Similarly, the irrigation opening (734) and the irrigation opening (742) are optional. If irrigation openings (723) and / or irrigation openings (734) are provided, such irrigation openings (723, 734) may be positioned adjacent to the electrode (740) to facilitate contact between the irrigation fluid discharged through the irrigation openings (723, 734) and the electrode (740). Any suitable number of irrigation openings (723, 734, 742) may be provided, such as 70 irrigation openings (723, 734, 742) or any other suitable number of irrigation openings (723, 734, 742).

[0091] The irrigation openings (723, 734, 742) can be in fluid communication with a lumen (not shown) within the catheter body (722). This lumen within the catheter body (722) can be further in fluid communication with a fluid source (42) via a pump (44), a conduit (40), and a port (214).

[0092] As a mere example, the irrigation fluid (702) may be discharged through the irrigation openings (723, 734, 742) at a flow rate of approximately 3 mL / min, at a flow rate greater than approximately 3 mL / min, or at any other suitable flow rate. As a mere further example, the irrigation openings (723, 734, 742) may have a diameter of approximately 0.1 mm, or any other suitable diameter. When the discharged irrigation fluid (702) comes into contact with the electrodes (740), one or more electrodes (740) may be activated to provide an active electrode, while the irrigation fluid (702) functions as a virtual return electrode. The resulting flow of electrical energy may result in ablation of the adjacent region of tissue (T) defining the lumen (L).

[0093] It should be understood that the irrigation fluid (702) can also be discharged through the open distal end of the tip member (724) as well as through the irrigation openings (723, 734, 742). In addition, or alternatively, the irrigation fluid (702) can also be discharged through the open distal end (712) of the sheath (710) as well as through the irrigation openings (723, 734, 742). Some variations of the end effector (720) may include one or more types of irrigation openings (723, 734, 742), while omitting one or more other types of irrigation openings (723, 734, 742).

[0094] In some variations, the material defining the irrigation openings (723, 734, 742) is configured such that the irrigation fluid discharged through the irrigation openings (723, 734, 742) is discharged along a path oriented obliquely to the central longitudinal axis (LA). This example is schematically shown in Figure 32A. As shown, the irrigation openings (723) adjacent to the electrode (740) are oriented obliquely to the central longitudinal axis (LA) along their respective axes oriented toward each other, such that one irrigation opening (723) discharges a jet of irrigation fluid (J1) along a path having a distal side, while the other irrigation opening (723) discharges a jet of irrigation fluid (J2) along a path having a proximal side. The jets (J1, J2) converge to form a vortex (V) of irrigation fluid, which is adjacent to the electrode (740). Although only one pair of irrigation openings (723) and adjacent electrodes (740) are shown, a similar arrangement may be provided between additional electrodes (740) of the same end effector (720) (if not all of the electrodes (740)), so that each electrode (740) receives its own local vortex (V) of the irrigation fluid. Such local vortices (V) of the irrigation fluid can promote the cooling of the electrodes, particularly at the edges of the electrodes (740). In some other modifications, the irrigation fluid at each electrode (740) is discharged only in the direction of jet (J1) or jet (J2), so that the jets (J1, J2) do not converge. Alternatively, the irrigation fluid may be discharged in any other preferred manner.

[0095] E. Example of an electrical path between electrodes and other ablation devices There may be several scenarios in which two different types of ablation devices are positioned simultaneously in the same patient (PA). This may include a catheter assembly (200) and another device having at least one ablation electrode. In such scenarios, it may be desirable to provide a bipolar coupling between at least one electrode (352) of an end-effector (350) and at least one electrode of the other ablation device. For this purpose, Figure 33 shows the electrode (352) of an end-effector (350) used with another ablation device (750) to provide an eleventh example of an electrical pathway. In this example, the end-effector (350) is positioned in a lumen (L) defined by tissue (T). As merely an example, the lumen (L) may be in some other small vessel branching off from the Marshall vein or coronary sinus.

[0096] The other ablation device (750) is positioned within a larger cavity (C), such as a cardiac chamber of the heart (H) or a space outside the heart (H). The device (750) may include a sheath or any other delivery device, another catheter, and / or any other suitable type of device. In this example, the device (750) includes a shaft (752) with a distal tip electrode (754). Alternatively, the device (750) may have any other suitable type of conductive mechanism at any other suitable position along the shaft (752). In the example shown in Figure 33, the electrode (754) of the device (750) is used to provide a return path, while one or more electrodes (352) are actuated with unipolar electrical energy. The electrical energy can flow between the actuated electrode (352) and electrode (754) through adjacent tissue (T), which may result in ablation of the tissue (T). Although not shown in Figure 33, the irrigation fluid (702) may be provided intraluminal (L) and / or intracardiac chamber (C) during this process. In some cases, the instrument (750) may also be used to ablate tissue and / or to provide EP mapping via the electrode (754) and / or via other mechanisms in intracardiac chamber (C). Such ablation by the intracardiac instrument (750) may be provided within the same procedure in which an ablation is provided intraluminal (L) using the end effector (350).

[0097] Figure 34 shows the electrodes (352) of an end effector (350) used with another ablation device (760) to provide a twelfth example of an electrical pathway. In this example, the shaft assembly (220) is positioned within the lumen of the device (760), and the end effector (350) is positioned distal to the device (760). The device (760) may include a sheath or any other delivery device, another catheter, and / or any other suitable type of device. The device (760) in this example includes a shaft (762) having a pair of ring electrodes (764). Alternatively, the device (760) may have any other suitable type of conductive mechanism at any other suitable position along the shaft (762). In the example shown in Figure 33, one or more electrodes (764) of the device (760) are used to provide a return pathway, while one or more electrodes (352) are actuated with unipolar electrical energy. Electrical energy can flow between the activated electrode (352) and electrode (764) through adjacent tissue, which can result in tissue ablation.

[0098] In some cases, the instrument (760) is advanced along a larger lumen (e.g., within the coronary sinus) and used to ablate tissue defining the larger lumen (e.g., via the action of an electrode (764)). While the instrument (760) is held in place within its larger lumen, the end effector (350) may be advanced into a smaller lumen branching off from the larger lumen (e.g., within Marshall's vein). One or more electrodes (352) are then used together with one or more electrodes (764) to form a bipolar pair, thereby ablating tissue defining the smaller lumen. Alternatively, the end effector (350) may be used with another instrument (760) in any other preferred manner.

[0099] V. Examples of devices and procedures for administering therapeutic fluids A. Example of a catheter assembly having an integrated distal occlusion balloon and a proximal occlusion balloon. As described above, variations of the catheter assembly (200) may be used to communicate a fluid (e.g., an irrigation fluid such as saline, ethanol, or a contrast agent) through the shaft assembly (220). In some cases, it may be desirable for such a fluid to contain a therapeutic agent. Such uses may be particularly beneficial when it is desired to deliver a therapeutic agent to the coronary sinus, blood vessels branching from the coronary sinus (e.g., Marshall's vein), other veins or arteries, the tissues forming these anatomical structures, and / or tissues adjacent to these anatomical structures (e.g., muscle tissue, adipose tissue). The terms “therapeutic agent” and “therapeutic fluid” may be read interchangeably herein, but it should be understood that some variations of “therapeutic agent” may not necessarily be in fluid form, and “therapeutic fluid” may constitute a fluid containing a therapeutic agent.

[0100] Figures 35A-35B and 36 show an example of a configuration that may provide the operability described above. Specifically, Figures 35A-35B show a modified catheter assembly (800) in the form of a catheter assembly (200) coupled with an inflation fluid source (812) and a therapeutic fluid source (820). The catheter assembly (800) in this example is configured and operable in the same way as the catheter assembly (200), except that the catheter assembly (800) in this example includes a proximal balloon (802) and a distal balloon (804). In other respects, the 200 and 300 series reference numerals shown in Figures 35A-35B and 36 indicate the same components of the catheter assembly (200) as indicated by the 200 and 300 series reference numerals described above. As shown in Figure 36, the end effector (350) of the catheter assembly (800) further includes a number of openings (824). These openings (824) of the catheter assembly (800) may be configured and operable in the same way as the irrigation openings (723, 734) of the end effector (720) described above in the context of Figure 32, unless otherwise described below.

[0101] The catheter assembly (800) is connected to an inflation fluid source (812) via a port (810) of a flexible conduit (814) and a handle assembly (210) to provide inflation and deflation of balloons (802, 804). In some modifications, the inflation fluid source (812) contains saline solution, but any other suitable inflation fluid may be used. The flexible conduit (814) may include a flexible tube such as a fluid conduit (40) and / or any other suitable structure. The shaft assembly (220) includes a lumen (not shown) that provides a path for the inflation fluid to communicate from the port (810) to the balloons (802, 804). In some modifications, the balloons (802, 804) are in fluid communication with a shared inflation lumen such that both balloons (802, 804) are always inflated and deflated simultaneously. In some other variations, each balloon (802, 804) has its own dedicated expansion lumen, and as a result, the balloons (802, 804) can be inflated independently of each other. In some such variations, two separate conduits (814) and ports (810) are provided. In some other variations where a single conduit (814) and port (810) are provided, a manifold and valve assembly interposes in the fluid path between the port (810) and the dedicated expansion lumen to which the balloons (802, 804) are respectively coupled. In any of these scenarios, the lumen providing communication of the expansion fluid to the balloons (802, 804) may be coaxial with the central longitudinal axis of the shaft assembly (220) or may be laterally offset from it.

[0102] Figure 35A shows the deflated balloons (802, 804), while Figure 35B shows the inflated balloons (802, 804). Either or both of the balloons (802, 804) can be inflated to temporarily occlude a blood vessel or other anatomical structure, as will be described in more detail below. In this embodiment, the distal balloon (804) is located on the tip member (226), while the proximal balloon (802) is located proximal to the flex circuit (300). In some other variations, the distal balloon (804) is located distal or proximal to the position shown in Figures 35A-35B and Figure 36. Similarly, the proximal balloon (802) may be located distal or proximal to the position shown in Figures 35A-35B. In this example, each balloon (802, 804) is fixedly positioned relative to the catheter body (230), but other variations may exist in which one or both of the balloons (802, 804) are not fixedly positioned relative to the catheter body (230). Fluids such as saline, therapeutic agents, or biologics can be delivered through the lumen (227) of the tip member (226). Alternatively, as shown in Figure 35C, a coaxial lumen (which may be concentric as shown) may be provided to allow a guidewire to move through the lumen (227), while the fluid can be pumped through the lumen (229) with the guidewire in place. In yet another alternative, an opening (824) can be provided that communicates with a lumen (227), and the second lumen (229) is a dead hole (blocking the flow of fluid at the tip) so that the guidewire may occlude an anatomical passage, while the opening (824) allows the flow of therapeutic fluid from the second lumen (229).

[0103] The catheter assembly (800) is further coupled to a therapeutic fluid source (820) via a flexible conduit (822) and a port (214) of the handle assembly (210) to provide communication of the therapeutic fluid from the catheter assembly (800). In some modifications, the therapeutic fluid is discharged from the catheter assembly (800) through an opening (824) of the end effector (350). In addition, or instead, the therapeutic fluid may be discharged through an open distal end (228) of the tip member (226). The flexible conduit (822) may include a flexible tube such as a fluid conduit (40), and / or any other suitable structure.

[0104] The therapeutic fluid source (820) may contain any preferred type of therapeutic fluid. As just one example, the therapeutic fluid source (820) may contain a fluid configured to provide chemical ablation of tissue (e.g., ethyl alcohol). As yet another example, the therapeutic fluid source (820) may contain a chemotherapeutic fluid, such as a fluid containing a small molecule drug. As yet another exemplary example, the therapeutic fluid source (820) may contain a biological therapeutic fluid, such as a fluid containing a large molecule drug (e.g., stem cells, gene therapy, therapeutic mRNA, etc.) and / or other biologics. Alternatively, the therapeutic fluid source (820) may contain any other preferred type of therapeutic fluid. The term “therapeutic” should be read broadly so as not to be understood as limiting these terms to only certain types of therapeutics.

[0105] The therapeutic fluid source (820) may also contain one or more fluids that are not configured to provide a therapeutic effect on their own. Such other fluids may include, but are not limited to, irrigation fluids such as the irrigation fluid (702) described above, contrast agents used in imaging processes, etc. In some cases, the therapeutic fluid source (820) may contain several different types of fluids, and one or more pumps, valves, and / or other components of the therapeutic fluid source (820) may be operated to selectively communicate a particular fluid to the catheter assembly (200) based on selection by the operator and / or other criteria (e.g., the stage of the procedure at hand).

[0106] B. Examples of catheter assemblies with integrated distal occlusion balloons and outer sheaths with occlusion balloons. As described above, either or both of the balloons (802, 804) may be incorporated into some other mechanism such that the balloons (802, 804) do not necessarily need to be fixedly positioned relative to the catheter body (230). Examples of such alternative configurations are shown in Figures 37A-37B, which may be considered variations of the catheter assembly (200). In this example, the shaft assembly (910) of the alternative catheter assembly is located within the outer sheath (900). The shaft assembly (910) in this example is configured and operable similarly to the shaft assembly (220) of the catheter assembly (800), except that the shaft assembly (910) lacks a proximal balloon (802) but includes a distal balloon (912) such as the distal balloon (804). The reference numerals in the 200 and 300 series shown in Figures 37A and 37B are used to illustrate the shaft assembly (910) and indicate the same components of the shaft assembly (220) as indicated by the aforementioned reference numerals in the 200 and 300 series.

[0107] The outer sheath (900) in this example includes a shaft (902) having a balloon (904) positioned near the open distal end (906). The balloon (904) is operable to function as a substitute for the proximal balloon (802) during operation, as described below. The shaft assembly (910) in this example is slidably positioned within the outer sheath (900), and as a result, the shaft assembly (910) can be selectively advanced or retracted relative to the outer sheath (900). In the depictions shown in Figures 37A and 37B, only a portion of the end effector (350) of the shaft assembly (910) protrudes distally from the open distal end (906), but there may be operating states in which the entire end effector (350) is proximal to the open distal end (906), and operating states in which the entire end effector (350) is distal to the open distal end (906).

[0108] In some variations, the outer sheath (900) and the shaft assembly (910) are both coupled to the same handle assembly, resulting in the outer sheath (900) and the shaft assembly (910) forming a telescopic arrangement of a single instrument. In some other variations, the shaft assembly (910) is part of one catheter instrument, while the outer sheath (900) is part of another separate instrument (e.g., a guide sheath assembly). In any situation, the balloon (904) can be inflated (Figure 37B) and deflated (Figure 37A) in any preferred manner using any preferred structure and technique. In addition to, or instead of, discharging the therapeutic fluid through the opening (824), the therapeutic fluid can be discharged through a gap (G) defined between the inner diameter of the shaft (902) and the outer diameter of the shaft assembly (910) in the configurations shown in Figures 37A and 37B. The therapeutic fluid can be connected to this gap (G) from a source of the therapeutic fluid using any suitable structure and technique.

[0109] C. Example of a catheter assembly having a balloon device that provides distal vascular occlusion balloons. Figures 38A and 38B show another example of an alternative configuration that may be considered a variation of the catheter assembly (200). In this example, the balloon device (930) is located within the shaft assembly (920) of the alternative catheter assembly. The shaft assembly (920) in this example is configured and operable similarly to the shaft assembly (220) of the catheter assembly (800), except that the shaft assembly (920) lacks the distal balloon (804). In some variations, the shaft assembly (920) includes an integrated proximal balloon (not shown), such as the proximal balloon (802). In some other variations, the shaft assembly (920) is used with an outer sheath (900) to provide a functional equivalent of the proximal balloon (802) via the balloon (904). Thus, in some variations, the shaft assembly (920) may lack the integrated proximal balloon. The reference numerals in the 200 and 300 series shown in Figures 37A and 37B are used to illustrate the shaft assembly (910) and indicate the same components of the shaft assembly (220) as indicated by the aforementioned reference numerals in the 200 and 300 series.

[0110] The balloon device (930) in this example includes a shaft (932) having a balloon (934) positioned near a closed distal end (936). In this variant, the distal end (936) is closed, but in other variants, the distal end (936) may be open. The balloon (934) is operable to function as a substitute for the distal balloon (804) during operation, as described below. In this example, the balloon device (930) is slidably positioned within the shaft assembly (920), and as a result, the balloon device (930) can be selectively advanced or retracted relative to the shaft assembly (920). In the depictions shown in Figures 38A and 38B, the entire balloon (934) and the adjacent proximal portion of the shaft (932) protrude distally from the open distal end (228), but there may be operating states in which the entire shaft (932) and balloon (934) are proximal to the open distal end (228).

[0111] In some variations, the balloon device (930) and the shaft assembly (920) are both coupled to the same handle assembly, resulting in the balloon device (930) and the shaft assembly (920) forming a nested arrangement of a single device. In some other variations, the shaft assembly (920) is part of one catheter device, while the balloon device (930) is part of another separate device. In any situation, the balloon (934) can be inflated (Figure 38B) and deflated (Figure 38A) in any preferred manner using any preferred structure and technique.

[0112] D. Example of a catheter assembly with a porous balloon between electrodes. Figures 39A and 39B show another example of an alternative configuration that may be considered a modification of the catheter assembly (200). In this example, the shaft assembly (940) includes a shaft body (942) having an integrated balloon (944) longitudinally interposed between a pair of proximal electrodes (352a, 352b) and a pair of distal electrodes (352c, 352d). The shaft body (942) may be configured and operable like the catheter body (230), but with the addition of a lumen for communicating fluid to the balloon (944). The shaft assembly (940) may provide inflation and deflation of the balloon (944) using any preferred mechanism and technique.

[0113] The balloon (944) in this example has multiple holes (946), and as a result, the balloon (944) is a porous balloon. The holes (946) are of a size such that the balloon (944) can transition from a deflated state (Figure 39A) to an inflated state (Figure 39B) despite the presence of the holes (946), however the same pressurized fluid that inflates the balloon (944) can also leak out of the balloon (944) through the holes (946). In some variants, the balloon (944) is inflated with a therapeutic fluid (e.g., from a therapeutic fluid source (820)). Thus, the therapeutic fluid may be discharged from the balloon (944) through the holes (946) while inflating the balloon (944). Thus, the balloon (944) can simultaneously occlude a blood vessel and simultaneously deliver a therapeutic fluid to the tissue of the blood vessel.

[0114] The electrodes (352a, 352b, 352c, 352d) may be configured and operable as various electrodes (352, 740) described herein, including being positioned along the same flexible circuit board (302). In this example, two electrodes (352a, 352b) are positioned proximal to the balloon (944) and two electrodes (352c, 352d) are positioned distal to the balloon (944), but there may be variations in which only one electrode (352) is located proximal to the balloon (944) and only one electrode (352) is located distal to the balloon (944). In another variation, three or more electrodes (352a, 352b) may be positioned proximal to the balloon (944), and / or three or more electrodes (352c, 352d) may be positioned distal to the balloon (944). In any of these scenarios, one or more electrodes (352) distal to the balloon (944) may provide a first polarity, while one or more electrodes (352) proximal to the balloon (944) may provide a second polarity, so that the electrodes (352) can work together to generate an electric field through the tissue in contact with the balloon (944) when the balloon (944) is inflated. This may result in tissue perforation (or tissue excision), as described herein. In some cases, the perforation is irreversible. In some other cases, the perforation is reversible.

[0115] Although not shown in Figures 39A and 39B, several variations of the shaft assembly (940) may include openings formed through the shaft body (942) and / or through the electrode (352). These openings may also discharge the therapeutic agent, similar to the openings (723, 734, 742, 824) described herein. This may complement the communication of the therapeutic agent through the hole (946). Several variations of the shaft assembly (940) may provide an open distal end of the tip member (226). In some such variations, the therapeutic agent may be discharged through the open distal end of the tip member (226). In some other variations, the therapeutic agent is not discharged through the open distal end of the tip member (226). In yet another variation, the tip member (226) may have a closed distal end. In some such variations, the shaft assembly (940) may have only one single lumen through which the therapeutic agent communicates with the balloon (944).

[0116] E. Example of a process for administering therapeutic fluid using reversible electroporation. As described above, electrodes (352, 740) can be operated to apply electrical energy to tissue. Similarly, one or more electrodes (352, 740) of the first device can work in conjunction with one or more other conductive mechanisms (e.g., a grounding pad (700), a guide wire (250), an irrigation fluid (702), an electrode (754) of the device (750), one or more electrodes (764) of the device (760), etc.) to apply electrical energy to tissue. In some cases, electrodes (352, 740) can be operated to provide electroporation of cells in cardiac tissue and / or other vascular tissue. Such electroporation can facilitate the passage of therapeutic fluid from a therapeutic fluid source (820) through the walls of such cells and thus into the cells of cardiac / vascular tissue. In some cases, such electroporation may be reversible, and as a result, the holes formed in the walls of cardiac / vascular tissue cells can close after the therapeutic agent has been delivered to the cells.

[0117] Figure 400 shows an example of a process (1000) that may be carried out using a catheter assembly, such as any of the modifications of the catheter assembly (200) described herein, in combination with a therapeutic fluid source, such as the therapeutic fluid source (820) described above. The process (1000) in this example begins with positioning the distal portion of the catheter (e.g., the distal portion (224) of the shaft assembly (220, 910, 920, 940)) within the patient's blood vessels (block 1010). In some cases, the distal portion of the catheter is positioned within a venous vessel (block 1010). In some other cases, the distal portion of the catheter is positioned within an arterial vessel (block 1010). In only further examples, the distal portion of the catheter may be positioned within the coronary sinus of the heart (block 1010). In yet another case, the distal portion of the catheter is positioned within a vessel branching off from the coronary sinus (e.g., Marshall's vein) (block 1010). In yet another variation, the distal portion of the catheter may be positioned within the heart cavity (block 1010). Alternatively, the distal portion of the catheter may be positioned in any other suitable location (block 1010).

[0118] Once the distal portion of the catheter is suitably positioned (block 1010), one or more balloons may be inflated (block 1020) to at least partially occlude the blood vessel or other lumen into which the catheter is positioned. For example, when a catheter assembly (800) is used, the proximal balloon (802) and / or distal balloon (804) may be inflated (block 1020). As yet another example, when the shaft assembly (220) of the catheter assembly (800) is positioned in a venous vessel, the proximal balloon (802) may be inflated (block 1020), while the distal balloon (804) is not inflated (however, if desired, both balloons (802, 804) may be inflated when the shaft assembly (220) is positioned in a venous vessel (block 1020)). When the shaft assembly (220) of the catheter assembly (800) is positioned within an arterial vessel, the distal balloon (804) may be inflated (block 1020), while the proximal balloon (802) is not inflated (however, if desired, both balloons (802, 804) may be inflated when the shaft assembly (220) is positioned within an arterial vessel (block 1020)).

[0119] When the shaft assembly (910) and external sheath (900) are positioned within a venous vessel, the balloon (904) may be inflated (block 1020), while the distal balloon (912) may not be inflated (however, if desired, both balloons (904, 912) may be inflated when the shaft assembly (910) and external sheath (900) are positioned within a venous vessel (block 1020)). When the shaft assembly (910) and external sheath (900) are positioned within an arterial vessel, the distal balloon (912) may be inflated (block 1020), while the balloon (904) may not be inflated (however, if desired, both balloons (904, 912) may be inflated when the shaft assembly (910) and external sheath (900) are positioned within an arterial vessel (block 1020)).

[0120] When the shaft assembly (920) and balloon device (930) are positioned within a venous vessel, the proximal balloon (e.g., an equivalent of balloon (802) or balloon (904)) may be inflated (block 1020), while balloon (934) may not be inflated (however, if desired, both balloons (804 / 904, 934) may be inflated when the shaft assembly (920) and balloon device (930) are positioned within a venous vessel (block 1020)). When the shaft assembly (920) and balloon device (930) are positioned within an arterial vessel, the balloon (934) may be inflated (block 1020), while the balloons (804 / 904) may not be inflated (however, if desired, when the shaft assembly (920) and balloon device (930) are positioned within an arterial vessel, both balloons (804 / 904, 934) may be inflated (block 1020)).

[0121] When a shaft assembly (940) is used, the balloon (946) may be inflated regardless of whether the shaft assembly (940) is located in a venous or arterial vessel (block 1020). In some cases, a distal balloon may also be inflated with the balloon (946) (block 1020), and the distal balloon may be integrated with the shaft assembly (942) or provided by a separate component (e.g., a balloon device (930)). In addition, or instead, a proximal balloon may also be inflated with the balloon (946) (block 1020), and the proximal balloon may be integrated with the shaft assembly (942) or provided by a separate component (e.g., an outer sheath (900)). Alternatively, the balloon (946) may be inflated without inflating an additional balloon (block 1020) (block 1020).

[0122] Once one or more balloons are properly inflated (block 1020), a therapeutic agent can be delivered (block 1030). For example, the therapeutic agent may be supplied from a therapeutic fluid source (820) but may be discharged through the open distal end (228), gap (G), openings (723, 734, 742, 824), and / or holes (946) of the tip members (226, 724).

[0123] Once a suitable amount of therapeutic agent is delivered (block 1030), energy is applied (block 1040) to perforate cells in the tissue adjacent to the distal portion of the catheter. As merely an example, the perforation energy may be applied at less than 600 volts / cm (block 1040). The perforation energy may be applied via an electrode (352, 740) (block 1040). In some such cases, the electrode (352, 740) is activated to apply short high-voltage electrical pulses to the cell membranes of tissue in the heart, coronary sinus, or blood vessels branching from the coronary sinus (block 1040), thereby increasing the permeability of the cell membranes. In some scenarios, one or more electrodes of the catheter (352, 740) may work in conjunction with one or more other conductive mechanisms (e.g., grounding pad (700), guidewire (250), irrigation fluid (702), electrode (754) of instrument (750), one or more electrodes (764) of instrument (760), etc.) to apply energy to perforate tissue (block 1040). Regardless of the combination and positioning of the electrical features used to apply energy to perforate tissue (block 1040), the enhanced permeability of the cell membrane may facilitate the passage of the delivered therapeutic agent into the perforated cells. While cell membrane permeability is thus increased, the therapeutic agent can be delivered to the perforated cells (block 930). In other words, electroporation with applied energy (block 1040) can facilitate the passage of the delivered (block 1030) therapeutic agent through the membrane of such cells, which in turn can enhance the therapeutic effect of the drug on cardiovascular tissue.

[0124] Although the delivery of therapeutic agents (block 1030) and the application of energy (block 1040) are shown as separate steps in the sequence, it should be understood that these steps may be performed in the reverse sequence. In addition, or instead, the steps may be performed at least partially simultaneously. For example, in some modifications, the therapeutic agent is delivered over a period of time (block 1030) (e.g., to perfuse tissue). Then, energy is applied (block 1040) to provide tissue perforation, while an additional therapeutic agent is delivered simultaneously (block 1030). Thus, the therapeutic agent may be delivered before and during the application of energy (block 1040) to provide perforation (block 1030). Similarly, in some modifications, the application of energy may be provided (block 1040) immediately before the delivery of the therapeutic agent (block 1030) to provide perforation, and the therapeutic agent may be delivered (block 1030) while the energy is being applied (block 1040).

[0125] In some variations, a catheter used to deliver a therapeutic agent (block 1030) and apply energy (block 1040) is transitioned longitudinally between these two steps (blocks 1030, 1040). For example, the fluid delivery region of the catheter's end-effector may be positioned within a target region of a blood vessel to deliver a therapeutic agent (block 1030), and then the catheter may be transitioned longitudinally to position the energy delivery region of the end-effector within a target region of a blood vessel to apply energy (block 1040).

[0126] After a suitable amount of time has elapsed and a suitable amount of therapeutic agent has reached the perforated cells, the perforation of the cells may be reversed (block 1050). In some cases, this reversal (1050) may simply involve the cessation of energy delivery (block 1040). In other words, the cell membrane may eventually tend to return to its pre-perforation state after the cell membrane is no longer receiving electrical energy from the electrodes (352, 740) and / or other conductive features.

[0127] In another variation of process (1000), the energy applied to perforate the cells of cardiac tissue (block 1040) may be configured to provide an irreversible method of tissue perforation. In some such cases, the perforation energy may be applied at 600 volts per cm or more (block 1040). In the variation where the perforation is irreversible, the step of reversing the perforation (block 1050) may be omitted. In some of these variations of process (1000), the therapeutic agent may still be delivered via a catheter to the irreversibly perforated cells and / or other areas of cardiac tissue (block 1030). Similarly, other variations of process (1000) may include any preferred combination of applying any preferred type of energy, including non-penetrating energy, to the tissue (e.g., via electrodes (352, 740) and / or other conductive features) and delivering a therapeutic agent to the tissue (e.g., via the open distal end (228), gap (G), openings (723, 734, 742, 824), and / or holes (946), etc., of the tip members (226, 724).

[0128] In some scenarios, process (1000) is performed only once, with the catheter or other device being removed after process (1000) is performed in a single target area. In some other scenarios, process (1000) is repeated, with the catheter or other device being repositioned to perform process (1000) in two or more target areas, without the need to remove the catheter or other device from the patient between each process (1000).

[0129] VI. Examples of combinations The following examples relate to various non-exclusive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit any claims that may be presented at any point in this application or any subsequent application. No waiver of rights is intended. The following examples are provided solely for illustrative purposes. Various teachings herein are intended to be arranged and applied in many other ways. Some variations may also omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered important unless they are subsequently expressed as such by the inventors or their heirs. If any claims presented in this application or any subsequent application relating to this application include additional features other than those mentioned below, those additional features should not be considered added for any patentability reason.

[0130] Example 1 A device comprising: (a) an elongated shaft assembly having a proximal portion and a distal portion, the distal portion having a distal end, the distal portion being flexible, the shaft assembly having an outer diameter; (b) an end effector positioned at the distal end of the shaft assembly, the end effector including one or more electrodes; and (c) a flexible circuit comprising: (i) a flexible substrate, the flexible substrate comprising: (A) a proximal portion, the proximal portion of the flexible substrate being positioned proximal to the end effector; and (B) an intermediate portion, the intermediate portion extending along the distal portion of the shaft assembly, the intermediate portion Apparatus comprising: a flexible substrate including (c) an intermediate portion and a distal portion located proximal to an end effector; and a flexible circuit including (ii) a first trace extending along at least the intermediate portion of the flexible substrate, wherein a portion of the first trace defines a first position sensor having a first position sensor length extending along a first portion of the length of the distal portion of the shaft assembly, the first position sensor being configured to generate a signal in the presence of an alternating magnetic field, the first position sensor being further configured to bend together with the distal portion of the shaft assembly, the first position sensor length being at least about 10 times greater than the outer diameter of the shaft assembly.

[0131] Example 2 The proximal portion of the shaft assembly is rigid, as described in Example 1.

[0132] Example 3 The apparatus according to Example 2, further comprising an intermediate portion that provides a gradual transition of flexibility from a rigid proximal portion to a flexible distal portion.

[0133] Example 4 The apparatus according to any one of Examples 1 to 3, wherein the end effector includes multiple electrodes, the electrodes being spaced longitudinally apart from one another along the distal end of the shaft assembly.

[0134] Example 5 The apparatus according to Example 4, wherein the electrodes are operable to apply electrical energy to tissue, thereby ablating the tissue.

[0135] Example 6 The apparatus according to Example 5, wherein the electrodes are operable to deliver pulsed-field ablation to the tissue.

[0136] Example 7 The apparatus according to any one of Examples 1 to 6, wherein one or more electrodes are positioned on the distal portion of a flexible substrate.

[0137] Example 8 The apparatus according to any one of Examples 1 to 7, wherein the intermediate portion includes a segment extending in a first longitudinal direction and a segment extending in a second longitudinal direction, and the segment extending in the first longitudinal direction is angularly spaced apart from the segment extending in the second longitudinal direction.

[0138] Example 9 The apparatus according to Example 8, wherein the first longitudinally extending segment is angularly separated by approximately 180 degrees from the second longitudinally extending segment with respect to the central longitudinal axis.

[0139] Example 10 The apparatus according to any one of Examples 8 to 9, wherein the first longitudinally extending segment has a meandering configuration.

[0140] Example 11 The apparatus according to Example 10, wherein the second longitudinally extending segment has a meandering configuration.

[0141] Example 12 The apparatus according to any one of Examples 8 to 11, wherein a portion of the first trace defines a first position sensor extending along a first longitudinally extending segment and along a second longitudinally extending segment.

[0142] Example 13 The apparatus according to Embodiment 12, wherein the flexible substrate further comprises an angled segment that joins a first longitudinally extending segment with a second longitudinally extending segment, and a portion of the first trace defining the first position sensor further extends along the angled segment.

[0143] Example 14 An apparatus according to any one of Examples 1 to 13, wherein a portion of the first trace defines a first position sensor that defines the coil shape.

[0144] Example 15 The apparatus according to any one of Examples 1 to 14, wherein the proximal portion of the flexible substrate includes a tail portion configured to spirally wrap around the distal portion of the shaft assembly.

[0145] Example 16 The apparatus according to any one of Examples 1 to 15, further comprising one or more electrical contact pads positioned on the proximal portion of the flexible substrate.

[0146] Example 17 The apparatus according to any one of Examples 1 to 16, wherein a portion of the first trace defines a position sensor that further extends along the distal portion of the flexible substrate.

[0147] Example 18 The apparatus according to any one of Examples 1 to 16, wherein a portion of the first trace defines a position sensor that further extends along the end effector.

[0148] Example 19 The apparatus according to any one of Examples 1 to 18, further comprising a tip member fixed to the distal portion of the shaft assembly at the distal end of the end effector.

[0149] Example 20 The apparatus according to Example 19, wherein the tip member has higher flexibility than the distal portion of the shaft assembly.

[0150] Example 21 The apparatus according to Example 21, wherein the distal portion of the shaft assembly includes a braided internal structure, while the tip member lacks a braided internal structure, and as a result, the absence of the braided internal structure provides greater flexibility to the tip member compared to the flexibility of the distal portion of the shaft assembly.

[0151] Example 22 The apparatus according to any one of Examples 19 to 21, wherein the shaft assembly and tip member together define a lumen, and the lumen terminates distally at the open distal end of the tip member.

[0152] Example 23 The apparatus as described in Example 22, wherein the lumen is sized to receive a guidewire.

[0153] Example 24 The apparatus according to any one of Examples 22 to 23, wherein the lumen is configured to allow fluid to flow outward through an elongated shaft assembly and through the open distal end of the tip member.

[0154] Example 25 The apparatus according to any one of Examples 1 to 24, wherein the shaft assembly has a total length extending from the proximal end to the distal end of the shaft assembly, and the first position sensor is defined by a portion of the first trace and has a total length extending from the proximal end to the distal end of the first position sensor, and the total length of the first position sensor is at least about 5% of the total length of the shaft assembly.

[0155] Example 26 The apparatus according to any one of Examples 1 to 25, wherein the flexible circuit further includes a second trace extending along at least the middle portion of the flexible substrate, a portion of which defines a second position sensor extending along a second portion of the length of the distal portion of the shaft assembly, and the second position sensor is configured to generate a signal in the presence of an alternating magnetic field.

[0156] Example 27 The apparatus according to Example 26, wherein the second position sensor is positioned distal to the first position sensor.

[0157] Example 28 The apparatus according to Example 26, wherein the second position sensor has the same longitudinal extent as the first position sensor.

[0158] Example 29 The apparatus according to any one of Examples 26 to 28, wherein the second position sensor is angularly offset from the first position sensor with respect to the central longitudinal axis.

[0159] Example 30 The apparatus according to Example 29, wherein the second position sensor is angularly offset by approximately 90 degrees from the first position sensor with respect to the central longitudinal axis.

[0160] Example 31 The apparatus according to any one of Examples 26 to 30, wherein the first position sensor includes a first set of loop segments, and the second position sensor includes a second set of loop segments.

[0161] Example 32 The apparatus according to Example 31, wherein the first set of loop segments of the loop segments are arranged alternately with the second set of loop segments.

[0162] Example 33 The apparatus according to any one of Examples 26 to 32, wherein the second trace is electrically insulated from the first trace.

[0163] Example 34 The apparatus according to any one of Examples 26 to 33, further comprising a flexible substrate with angled segments that provide an angular offset and a longitudinal offset between a first position sensor and a second position sensor.

[0164] Example 35 The apparatus according to any of Examples 1 to 34, wherein the outer diameter of the shaft assembly is in the range of approximately 0.67 mm to approximately 1.33 mm.

[0165] Example 36 The apparatus is one of the apparatuses described in any of Examples 1 to 35, having an inner diameter in the range of approximately 0.25 mm to approximately 0.45 mm.

[0166] Example 37 The apparatus according to any of Examples 1 to 36, wherein the shaft assembly has a length ranging from approximately 150 cm to approximately 200 cm.

[0167] Example 38 The distal portion of the shaft assembly has a length ranging from approximately 30 cm to approximately 75 cm, as described in any of Examples 1 to 37.

[0168] Example 39 The end effector is sized to fit into a blood vessel branching from the patient's coronary sinus, as described in any of Examples 1 to 28.

[0169] Example 40 The apparatus according to Example 39, wherein the end effector is sized to fit into the patient's Marshall vein.

[0170] Example 41 The apparatus comprises (a) an elongated shaft assembly having a total length extending from the proximal end to the distal end of the shaft assembly, (b) an end effector positioned at the distal end of the shaft assembly and including one or more electrodes, and (c) a flexible circuit comprising (i) a flexible substrate, the flexible substrate having (A) a proximal portion, the proximal portion of the flexible substrate being positioned proximal to the end effector, and (B) an intermediate portion, the intermediate portion extending along the distal portion of the shaft assembly, and An apparatus comprising a flexible circuit including (i) a middle portion and (c) a distal portion, the intermediate portion being located proximal to the end effector, and (ii) a trace extending along at least the middle portion of the flexible circuit, wherein a portion of the trace defines a position sensor having a position sensor length extending along a portion of the length of the distal portion of the shaft assembly, the position sensor being configured to generate a signal in the presence of an alternating magnetic field and further configured to bend together with the distal portion of the shaft assembly, the position sensor length being at least about 5% of the total length of the shaft assembly.

[0171] Example 42 The apparatus according to Example 41, wherein the shaft assembly has an outer diameter, and the position sensor length is at least about 25 times greater than the outer diameter of the shaft assembly.

[0172] Example 43 Apparatus, (a) an elongated shaft assembly having an entire length extending from the proximal end to the distal end of the shaft assembly, (b) an end effector positioned at the distal end of the shaft assembly, including one or more electrodes, and (c) a flexible circuit, (i) a flexible substrate, the flexible substrate comprising (A) a proximal portion, the proximal portion of the flexible substrate being positioned proximal to the end effector, (B) an intermediate portion extending along the distal portion of the shaft assembly and positioned proximal to the end effector, and (C) a distal portion, and (ii) an intermediate portion extending along at least the intermediate portion of the flexible substrate A trace is provided, wherein a portion of the trace defines a position sensor having an effective position sensor length extending along a portion of the length of the distal portion of the shaft assembly, the position sensor having an effective position sensor width extending transversely with respect to the length of the distal portion of the shaft assembly, the position sensor is configured to generate a signal in the presence of an alternating magnetic field, and is further configured to bend together with the distal portion of the shaft assembly, the effective position sensor length and effective position sensor width together define an area along a two-dimensional plane, the area is configured to change along with either or both the effective position sensor length or effective position sensor width as the position sensor bends together with the distal portion of the shaft assembly, and the area of ​​the position sensor is approximately 150 mm² when the position sensor bends together with the distal portion of the shaft assembly. 2 A device comprising a flexible circuit including a trace, which is further configured so as not to become smaller than a certain size.

[0173] Example 44 The apparatus according to Example 43, wherein the effective length of the position sensor is at least about 5% of the total length of the shaft assembly.

[0174] Example 45 The apparatus according to any one of Examples 43 to 44, wherein the shaft assembly has an outer diameter, and the effective length of the position sensor is at least about 25 times greater than the outer diameter of the shaft assembly.

[0175] Example 46 The apparatus comprises: (a) an elongated shaft assembly having a proximal portion and a distal portion, the distal portion having a distal end and the distal portion being flexible; (b) an end effector positioned at the distal end of the shaft assembly, the end effector comprising one or more electrodes; and (c) a flexible circuit comprising: (i) a flexible substrate, the flexible substrate having (A) a proximal portion positioned proximal to the end effector and (B) an intermediate portion, the intermediate portion extending along the distal portion of the shaft assembly, the intermediate portion positioned proximal to the end effector, and A flexible substrate comprising (c) a distal portion and (ii) a trace extending along the first longitudinal segment and the second longitudinal segment, wherein the first longitudinal segment is angularly spaced apart from the second longitudinal segment, and (ii) a flexible circuit comprising (c) a trace extending along the first longitudinal segment and the second longitudinal segment, wherein the trace defines a position sensor extending along a portion of the length of the distal portion of the shaft assembly, the position sensor being configured to generate a signal in the presence of an alternating magnetic field.

[0176] Example 47 The apparatus according to Embodiment 46, wherein the position sensor is further configured to bend together with the distal portion of the shaft assembly.

[0177] Example 48 The apparatus according to any one of Examples 46 to 47, wherein the first longitudinally extending segment is angularly separated by approximately 180 degrees from the second longitudinally extending segment with respect to the central longitudinal axis.

[0178] Example 49 The apparatus according to any one of Examples 46 to 48, wherein the first longitudinally extending segment has a meandering configuration.

[0179] Example 50 The apparatus according to Example 49, wherein the second longitudinally extending segment has a meandering configuration.

[0180] Example 51 The apparatus according to Example 50, wherein the meandering configuration of the first longitudinally extending segment defines a first plurality of peaks, and the meandering configuration of the first longitudinally extending segment defines a second plurality of peaks.

[0181] Example 52 The apparatus according to Example 51, wherein the peaks of the first set of peaks are positioned to coincide with the peaks of the second set of peaks along a dimension oriented transversely with respect to the longitudinal dimension.

[0182] Example 53 The apparatus according to any one of Examples 46 to 52, wherein the flexible substrate further comprises an angled segment that joins a segment extending in a first longitudinal direction with a segment extending in a second longitudinal direction, and a portion of the trace defining the first position sensor further extends along the angled segment.

[0183] Example 54 The apparatus according to any one of Examples 46 to 53, wherein a portion of the trace defines a position sensor that defines the coil shape.

[0184] Example 55 The apparatus according to any one of Examples 46 to 54, wherein the intermediate portion further comprises a plurality of web segments, the web segments being spaced apart from each other in the longitudinal direction, and the web segments joining a segment extending in a first longitudinal direction with a segment extending in a second longitudinal direction.

[0185] Example 56 A method comprising inserting an elongated shaft assembly into an anatomical structure within the cardiovascular system of a patient, wherein the elongated shaft assembly has a distal portion with an end effector, the end effector having a plurality of electrodes that extend at an angle around the distal portion of the shaft assembly and are longitudinally spaced apart from one another along the distal portion of the shaft assembly, and the shaft assembly further includes a tip member positioned distal to the end effector, the tip member being more flexible than the distal portion of the shaft assembly; selecting one or more electrodes from the plurality to be activated; and activating the one or more selected electrodes to apply electrical energy to tissue, thereby ablating the tissue.

[0186] Example 57 The anatomical passage includes blood vessels branching from the coronary sinus, as described in Example 56.

[0187] Example 58 The anatomical passage is the Marshall vein, as described in Example 57.

[0188] Example 59 Inserting an elongated shaft assembly into an anatomical structure involves advancing the elongated shaft assembly along a guide wire, the guide wire being slidably positioned within the elongated shaft assembly, as described in any of Examples 56-58.

[0189] Example 60 The method according to Example 59, wherein activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue includes utilizing a guidewire as a return path for the electrical energy.

[0190] Example 61 The method according to any one of Examples 56 to 60, which includes activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue, and utilizing a grounding pad as a return path for the electrical energy.

[0191] Example 62 The method according to Example 61, wherein the grounding pad includes a patch adhered to the patient.

[0192] Example 63 The method according to any one of Examples 56 to 62, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first single electrode from the plurality of electrodes to function as an active electrode.

[0193] Example 64 The method according to any of Examples 56 to 62, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first set of electrodes from a plurality of electrodes so that they function collectively as an active electrode.

[0194] Example 65 The method according to any one of Examples 56 to 64, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first single electrode from a plurality of electrodes to function as a return electrode.

[0195] Example 66 The method according to any of Examples 56 to 64, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first set of electrodes from a plurality of electrodes so that they function collectively as a return electrode.

[0196] Example 67 The method according to any one of Examples 56 to 66, comprising activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue, utilizing a separate instrument to provide a return pathway for the electrical energy, the separate instrument being positioned within the patient.

[0197] Example 68 The method according to Example 67, wherein a separate device includes a guide wire.

[0198] Example 69 The method according to Example 68, wherein the guidewire is positioned at different locations within the patient so that the guidewire is not positioned within an anatomical structure where the elongated shaft assembly is located.

[0199] Example 70 The method of Example 67, wherein the separate instrument includes an ablation instrument having electrodes.

[0200] Example 71 The method according to Example 70, wherein the ablation device is positioned at different locations within the patient so that the ablation device is not positioned within an anatomical structure where the elongated shaft assembly is located.

[0201] Example 72 The method according to Example 71, wherein the ablation device is positioned within the cardiac chambers or pulmonary veins of the heart.

[0202] Example 73 The ablation device defines a lumen, and the elongated shaft assembly is slidably positioned within the lumen of the ablation device, according to any one of Examples 71 to 72.

[0203] Example 74 The method according to Example 73, wherein the ablation device is positioned within the coronary sinus and the elongated shaft assembly is positioned within a blood vessel branching from the coronary sinus.

[0204] Example 75 The method according to any one of Examples 56 to 74, further comprising communicating the irrigation fluid with an anatomical structure.

[0205] Example 76 The method according to Example 75, further comprising activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue, and using an irrigation fluid to provide a return pathway for the electrical energy.

[0206] Example 77 The method according to any one of Examples 74 to 76, wherein the irrigation fluid is connected to an anatomical structure, and the irrigation fluid is discharged through the open distal end of the tip member.

[0207] Example 78 The method according to any one of Examples 76-77, wherein an elongated shaft assembly is positioned within a sheath, and the irrigation fluid is communicated with an anatomical structure, and the irrigation fluid is discharged through the open distal end of the sheath.

[0208] Example 79 The method according to Example 78, wherein the open distal end of the sheath is positioned proximal to the end effector.

[0209] Example 80 Communicating the irrigation fluid to an anatomical structure is the method according to any one of Examples 76-79, which includes draining the irrigation fluid through a lateral opening formed in the end effector.

[0210] Example 81 The method according to Example 75, wherein at least one of the lateral openings is located within at least one electrode of a plurality of electrodes.

[0211] Example 82 The method according to any one of Examples 80 to 81, wherein the lateral opening is oriented obliquely with respect to the central longitudinal axis of the shaft assembly, and as a result, the discharged irrigation fluid is discharged in a jet oriented obliquely with respect to the central longitudinal axis of the shaft assembly.

[0212] Example 83 The method according to Example 82, wherein at least some of the jets form vortices of the irrigation fluid adjacent to multiple electrodes.

[0213] Example 84 The method according to Example 83, wherein at least some of the jets are oriented toward each other to form vortices of the irrigation fluid adjacent to multiple electrodes.

[0214] Example 85 The method according to any one of Examples 56 to 84, wherein activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue includes applying high-frequency energy to the tissue.

[0215] Example 86 The method according to any one of Examples 56 to 84, which includes activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue, thereby providing pulsed-field ablation to the tissue.

[0216] Example 87 The method according to any of Examples 56 to 86, further comprising processing a signal from a position sensor, the signal indicating the real-time position of the end effector.

[0217] Example 88 The position sensor includes a coil formed by a portion of a flexible circuit, the coil bending together with the distal portion of the elongated shaft assembly while the elongated shaft assembly is inserted into an anatomical structure, as described in Example 87.

[0218] Example 89 Apparatus comprising: (a) an elongated shaft assembly having a proximal portion and a distal portion, the distal portion having a distal end, and the distal portion being flexible; (b) an end effector positioned at the distal end of the shaft assembly; (c) a flexible circuit, the flexible circuit including (i) a flexible substrate; (ii) at least one position sensor supported by the flexible substrate and configured to provide a signal indicating the position of the end effector; and (iii) a plurality of electrodes supported by the flexible substrate, the electrodes of the plurality of electrodes spaced apart from each other longitudinally along the end effector; and (d) a processor electrically coupled to the flexible circuit, the processor configured to (i) determine the arrangement of a pair of bipolar electrodes based on one or more criteria; (ii) select one or more electrodes from the plurality of electrodes based on the determination; and (iii) activate the one or more selected electrodes to apply electrical energy to tissue, thereby ablating the tissue.

[0219] Example 90 The apparatus according to Example 89, wherein one or more criteria include one or more criteria selected from the group consisting of the anatomical structure of the target, the depth of the intended injury, and the geometric configuration of the intended injury.

[0220] Example 91 A method comprising inserting an elongated shaft assembly of a first instrument into a first anatomical structure within a patient's cardiovascular system, the elongated shaft assembly having a distal portion with an end effector, the end effector extending at an angle around the distal portion of the shaft assembly and having a plurality of electrodes longitudinally spaced apart from each other along the distal portion of the shaft assembly, the shaft assembly further including a tip member positioned distally of the end effector, the tip member being more flexible than the distal portion of the shaft assembly; inserting a second instrument having at least one conductive mechanism into a second anatomical structure within the patient; selecting one or more of the plurality of electrodes to activate; activating the one or more selected electrodes to apply electrical energy to tissue, thereby ablating the tissue, wherein at least one conductive mechanism of the second instrument provides a return path for the electrical energy.

[0221] Example 92 The method according to Example 91, wherein the second anatomical structure is within the patient's cardiovascular system.

[0222] Example 93 The method according to Example 92, wherein the second anatomical structure includes a cardiac chamber of the patient's heart.

[0223] Example 94 The method according to any one of Examples 91 to 93, wherein the first anatomical structure includes a blood vessel branching from the patient's coronary sinus.

[0224] Example 95 The method according to any one of Examples 91 to 94, wherein the second instrument includes a guide wire.

[0225] Example 96 The method according to any one of Examples 91 to 94, wherein the second instrument includes an ablation catheter.

[0226] Example 97 At least one conductive mechanism of the second instrument is the method according to any one of Examples 91 to 96, including a distal tip electrode.

[0227] Example 98 The first instrument and the second instrument are separated by tissue between the first anatomical structure and the second anatomical structure, according to the method according to any one of Examples 91 to 97.

[0228] Example 99 The first anatomical structure includes a first blood vessel, the second anatomical structure includes a second blood vessel, and the first blood vessel branches from the second blood vessel, according to the method according to any one of Examples 91 to 98.

[0229] Example 100 The first instrument is slidably disposed within the second instrument, according to the method described in Example 99.

[0230] Example 101 An apparatus comprising: a flexible catheter shaft having a distal portion including an open distal end; a lumen in fluid communication with the open distal end, configured to receive a guidewire and further configured to communicate a therapeutic fluid therethrough to the outside; a flexible catheter shaft having an outer diameter ranging from about 0.67 mm to about 1.33 mm; one or more electrodes, at least one of the one or more electrodes being positioned on the distal portion of the catheter shaft, at least one of the one or more electrodes being operable to apply electrical energy to tissue; and one or more position sensors, at least one of the one or more position sensors being positioned on the distal portion of the catheter shaft, the one or more position sensors being configured to provide a signal indicative of the respective position of the one or more position sensors in three-dimensional space in response to a magnetic field.

[0231] Example 102 The apparatus according to Example 101, further comprising a source of therapeutic fluid in fluid communication with the lumen.

[0232] Example 103 The apparatus according to Example 102, wherein the therapeutic fluid is configured to provide chemical ablation.

[0233] Example 104 The apparatus described in Example 103 contains ethyl alcohol as the therapeutic fluid.

[0234] Example 105 The therapeutic fluid is an apparatus as described in any of Examples 102 to 104, including biological treatments.

[0235] Example 106 The biological therapy is performed using the apparatus described in Example 105, which includes stem cells.

[0236] Example 107 The therapeutic fluid is an apparatus according to any one of Examples 102 to 106, including a chemotherapy.

[0237] Example 108 The apparatus according to any one of Examples 101 to 107, further comprising a flexible circuit positioned along the distal portion of the catheter shaft, the flexible circuit including one or more position sensors.

[0238] Example 109 The apparatus according to any one of Examples 101 to 108, further comprising an electric generator configured to communicate with one or more electrodes.

[0239] Example 110 The apparatus according to Example 109, wherein the electrogenerator is operable to drive one or more electrodes to provide electroperforation of tissue.

[0240] Example 111 The apparatus according to Example 110, wherein the electrogenerator is operable to drive one or more electrodes to provide reversible electroperforation of tissue.

[0241] Example 112 The electrical generator is the device according to any one of Examples 109 to 111, operable to drive one or more electrodes to provide pulsed field ablation of tissue.

[0242] Example 113 The electrical generator is the device according to any one of Examples 109 to 112, operable to drive one or more electrodes to provide radiofrequency ablation of tissue.

[0243] Example 114 The distal portion of the catheter shaft is configured to fit into a blood vessel branching from the coronary sinus of a patient, the device according to any one of Examples 101 to 113.

[0244] Example 115 The distal portion of the catheter shaft is configured to fit into the Marshall vein of a patient, the device according to Example 114.

[0245] Example 116 A device comprising a flexible catheter shaft, the catheter shaft having a distal portion including an open distal end, the distal portion being sized to fit within the coronary sinus of a patient, a lumen in fluid communication with the open distal end, the lumen being configured to receive a guide wire and further configured to communicate a therapeutic fluid out through the open distal end, a flexible catheter shaft including the lumen, one or more electrodes, at least one of the one or more electrodes being positioned on the distal portion of the catheter shaft, at least one of the one or more electrodes being operable to apply electrical energy to tissue, one or more position sensors, at least one of the one or more position sensors being positioned on the distal portion of the catheter shaft, the one or more position sensors being configured to provide a signal indicative of the respective position of each of the one or more position sensors in three-dimensional space in response to a magnetic field.

[0246] Example 117 The device described in Example 116, wherein the distal portion is sized to fit into a blood vessel branching from the patient's coronary sinus.

[0247] Example 118 The distal portion has an outer diameter in the range of approximately 0.67 mm to approximately 1.33 mm, as described in any of Examples 116 to 117.

[0248] Example 119 A device comprising: a flexible catheter shaft, the catheter shaft comprising: a distal portion including an open distal end; a first lumen fluidly communicating with the open distal end, the first lumen configured to receive a guidewire; and a second lumen configured to communicate therapeutic fluid to the outside through the open distal end; one or more position sensors, at least one of which is positioned on the distal portion of the catheter shaft, and which is configured to provide a signal indicating the position of each of the one or more position sensors in three-dimensional space in response to a magnetic field; and a source of therapeutic fluid fluidly communicating with the second lumen, the source of therapeutic fluid fluid configured to provide one or more of chemical ablation, biological treatment, or chemotherapy.

[0249] Example 120 The device described in Example 119, wherein the distal portion is sized to fit into the patient's coronary blood vessel.

[0250] Example 121 The distal portion is sized to fit into a blood vessel branching from the patient's coronary sinus, as described in any of Examples 119 to 120.

[0251] Example 122 The distal portion has an outer diameter in the range of approximately 0.67 mm to approximately 1.33 mm, as described in any of Examples 119 to 121.

[0252] Example 123 The apparatus according to any one of Examples 119 to 122, further comprising one or more electrodes, at least one of which is positioned on the distal portion of the catheter shaft, and at least one of which is operable to apply pulsed electroelectric energy to induce reversible electroperforation of tissue.

[0253] Example 124 A device comprising: a flexible catheter shaft, the catheter shaft comprising: a distal portion including an open distal end; a first lumen fluidly communicating with the open distal end, the lumen configured to receive a guidewire; and a second lumen configured to communicate therapeutic fluid to the outside through the open distal end; one or more electrodes, at least one of which is positioned on the distal portion of the catheter shaft; one or more position sensors, at least one of which is positioned on the distal portion of the catheter shaft, and the one or more position sensors are configured to provide signals indicating the position of each of the one or more position sensors in three-dimensional space in response to a magnetic field; and an electric generator configured to communicate with one or more electrodes, the electric generator being operable to drive one or more electrodes to provide reversible electroperforation of tissue.

[0254] Example 125 The device described in Example 124, wherein the distal portion is sized to fit into the patient's coronary sinus.

[0255] Example 126 The apparatus according to any one of Examples 124 to 125, wherein the electrical generator is further operable to drive one or more electrodes to provide pulsed-field ablation of tissue.

[0256] Example 127 The apparatus according to any one of Examples 124 to 126, wherein the electrical generator is further operable to drive one or more electrodes to provide high-frequency ablation of tissue.

[0257] Example 128 A method comprising: advancing the distal portion of a catheter into the patient's heart; tracking the position of the distal portion in the heart using one or more position sensors; further advancing the distal portion into the patient's coronary sinus; preventing the flow of a fluid containing blood from flowing proximal; delivering a therapeutic fluid through the distal portion of the catheter; and applying pulsed-field energy to induce reversible electroperforation of the tissue surrounding the distal portion of the catheter.

[0258] Example 129 The method according to Example 128, further comprising generating a magnetic field, wherein one or more position sensors provide information indicating the position of a distal portion in response to the magnetic field.

[0259] Example 130 The method according to any one of Examples 128 to 129, wherein the therapeutic fluid is delivered into the blood vessels of the heart.

[0260] Example 131 The method according to any one of Examples 128 to 130, further comprising advancing the distal portion into a vessel branching from the coronary sinus.

[0261] Example 132 The therapeutic fluid is delivered into the blood vessels branching from the coronary sinus, as described in Example 131.

[0262] Example 133 The method according to any one of Examples 128 to 132, wherein the therapeutic fluid provides chemical ablation of the patient's tissue.

[0263] Example 134 The therapeutic fluid is a method according to any of Examples 128 to 133, including biological treatment.

[0264] Example 135 The method according to Example 134, wherein the biological treatment includes stem cells.

[0265] Example 136 The therapeutic fluid is a method according to any of Examples 128 to 135, including chemotherapy.

[0266] Example 137 The method according to any one of Examples 128 to 136, further comprising advancing a guidewire into the patient's heart.

[0267] Example 138 The catheter is advanced along the guidewire, as described in Example 137.

[0268] Example 139 Electroporation facilitates the entry of therapeutic fluids into tissue cells, as described in any of Examples 128-138.

[0269] Example 140 The method according to Example 139, wherein the act of applying pulsed field energy includes activating one or more electrodes on the distal portion of the catheter.

[0270] Example 141 The method according to Example 140, wherein the act of applying pulsed field energy involves using a separate feature distinct from the catheter to provide a return pathway for the pulsed field energy.

[0271] Example 142 A device comprising: (a) an elongated shaft assembly having a proximal portion and a distal portion, the distal portion having a distal end, the distal portion being flexible, and the shaft assembly having an outer diameter; (b) an elongated end effector positioned at the distal end of the shaft assembly, the elongated end effector extending along a longitudinal axis, the end effector defining a lumen extending through a portion of the end effector, a plurality of openings disposed on the end effector and communicating with the lumen to allow fluid to flow from the lumen, the end effector including one or more electrodes disposed on the surface of the end effector, the one or more electrodes configured to deliver sufficient electrical energy for reversible electroporation in target living cells; and (c) a flexible circuit including a magnetic position sensor disposed along the elongated end effector to enable the positioning of the end effector within a patient.

[0272] Example 143 The apparatus according to Example 142, wherein the shaft assembly is configured to deliver the therapeutic agent flowing from the lumen of the end effector to the opening.

[0273] Example 144 The apparatus according to Example 143, further comprising an intermediate portion that provides a gradual transition of flexibility from a rigid proximal portion to a flexible distal portion.

[0274] Example 145 The apparatus according to any one of Examples 142 to 144, wherein the end effector includes multiple electrodes, the electrodes being spaced longitudinally apart from one another along the distal end of the shaft assembly.

[0275] Example 146 The apparatus according to Example 145, wherein the electrodes are operable to transmit pulses of electrical energy to generate an electric field that enables reversible electroporation on tissue cells surrounding the end effector.

[0276] Example 147 The apparatus according to any one of Examples 145 to 146, wherein the end effector further includes an inflatable balloon, the balloon being longitudinally interposed between a first electrode of a plurality of electrodes and a second electrode of a plurality of electrodes.

[0277] Example 148 The apparatus according to Example 147, wherein the balloon includes multiple holes, and the multiple holes are configured to allow the balloon to inflate while providing the discharge of therapeutic agents through the holes.

[0278] Example 149 The apparatus according to Example 148, wherein the balloon is configured to be inflated by a therapeutic agent discharged through a hole.

[0279] Example 150 The apparatus according to any one of Examples 142 to 149, wherein one or more electrodes are positioned on the distal portion of a flexible substrate.

[0280] Example 151 The apparatus according to any one of Examples 142 to 150, wherein the elongated end effector includes a tip member that together defines a lumen, and the lumen terminates distally at the open distal end of the tip member.

[0281] Example 152 The apparatus according to Example 151, wherein the lumen comprises a first lumen and a second lumen, the first lumen being sized to receive a guidewire, and the second lumen being coaxial with the first lumen, allowing a therapeutic fluid to be delivered through the second lumen.

[0282] Example 153 The apparatus according to any one of Examples 142 to 152, wherein the lumen is configured to communicate fluid to the outside through an elongated member, through an opening and an open distal end of the tip member, and the fluid comprises one or more of physiological saline or therapeutic agents.

[0283] Example 154 The apparatus according to any one of Examples 142 to 153, further comprising a first balloon positioned on an elongated end effector, the first balloon being inflatable to a size configured to occlude a blood vessel.

[0284] Example 155 The apparatus according to Example 154, wherein the first balloon is positioned distal to at least one of one or more electrodes.

[0285] Example 156 The apparatus according to any one of Examples 154 to 155, wherein the first balloon is positioned proximal to at least one of one or more electrodes.

[0286] Example 157 The apparatus according to any one of Examples 154 to 156, wherein the first balloon is integrated with the shaft assembly.

[0287] Example 158 The apparatus according to any one of Examples 154 to 156, further comprising a sheath, wherein the shaft assembly is insertable into the sheath, and the first balloon is integrated with the tip of the sheath to occlude a blood vessel.

[0288] Example 159 The apparatus according to any one of Examples 154 to 156, further comprising a balloon device, the balloon device being insertable into the lumen of the shaft assembly, and the first balloon being integrated with the balloon device.

[0289] Example 160 The apparatus according to any one of Examples 154 to 159, wherein the first balloon is porous.

[0290] Example 161 The apparatus according to Example 160, wherein the first balloon is configured to discharge the expansion fluid through a hole in the first balloon when the first balloon is inflated with the expansion fluid.

[0291] Example 162 The apparatus according to any one of Examples 154 to 151, further comprising a second balloon, the second balloon being inflatable to a size configured to occlude a blood vessel.

[0292] Example 163 The apparatus according to Example 162, wherein the first balloon is distal to the multiple electrodes and the second balloon is proximal to the multiple electrodes.

[0293] Example 164 The apparatus according to any one of Examples 162 to 163, wherein at least one of the first balloon or the second balloon is porous.

[0294] Example 165 The apparatus according to Example 164, wherein at least one porous balloon is configured to discharge the expansion fluid through the holes of at least one porous balloon when at least one porous balloon is inflated with the expansion fluid.

[0295] Example 166 Apparatus comprising: (a) an elongated shaft assembly having a proximal portion and a distal portion, the distal portion having a distal end, and the distal portion being flexible; and (b) an elongated end effector positioned at the distal end of the shaft assembly, extending along a longitudinal axis, and including (i) at least one distal electrode; (ii) at least one proximal electrode, the at least one proximal electrode and the at least one distal electrode configured to deliver sufficient electrical energy for reversible electroporation in target living cells; and (iii) a porous balloon interposed longitudinally between the at least one distal electrode and the at least one proximal electrode, configured to inflate with an expansion fluid and release the expansion fluid through a hole in the balloon.

[0296] Example 167 The apparatus according to Example 166 further comprises a flexible circuit including a magnetic position sensor positioned along an elongated end effector to enable the positioning of the end effector within the patient.

[0297] Example 168 The apparatus according to any one of Examples 166 to 167, further comprising a source of therapeutic fluid, wherein the therapeutic fluid is configured to function as a source of inflating fluid such that a balloon inflates with the therapeutic fluid and releases the therapeutic fluid through a hole in the balloon.

[0298] Example 169 The apparatus according to any of Examples 166 to 168, wherein the balloon is configured to inflate to a size that provides contact between the balloon and the wall of the blood vessel.

[0299] Example 170 The apparatus according to Example 169, wherein at least one proximal electrode and at least one distal electrode are configured to deliver sufficient electrical energy to reversibly electroperforate living cells in the tissue of the blood vessel wall in contact with the inflated balloon.

[0300] Example 171 A method comprising inserting an elongated shaft assembly into an anatomical structure within the cardiovascular system of a patient, wherein the elongated shaft assembly has a distal portion with an end effector, the end effector has a plurality of electrodes that extend at an angle around the distal portion of the shaft assembly and are longitudinally spaced apart from one another along the distal portion of the shaft assembly, and the shaft assembly further includes a tip member positioned distal to the end effector, the tip member being more flexible than the distal portion of the shaft assembly, the method comprising insertion, occluding an anatomical passage into which the end effector is inserted, administering a therapeutic agent through the shaft assembly, selecting one or more electrodes from a plurality of electrodes to transmit pulses of electrical energy, and activating one or more selected electrodes to transmit pulses of electrical energy sufficient to induce electroperforation of cells in the anatomical tissue of the anatomical passage.

[0301] Example 172 Electroporation is reversible, as described in Example 171.

[0302] Example 173 The method according to any of Examples 171-172, wherein the pulse of electrical energy is applied at less than 600 volts / cm².

[0303] Example 174 The therapeutic agent is the method described in any of Examples 171 to 173, including a biological agent.

[0304] Example 175 The method according to any one of Examples 171 to 174, further comprising moving the catheter longitudinally between the act of administering a therapeutic agent and the act of activating one or more selected electrodes.

[0305] Example 176 The method according to any of Examples 171 to 175, wherein the act of administering the therapeutic agent results in perfusion of the anatomical tissue with the therapeutic agent.

[0306] Example 177 The anatomical structure includes venous or arterial vessels, as described in any of Examples 171 to 176.

[0307] Example 178 The anatomical passage includes blood vessels branching from the coronary sinus, as described in Example 177.

[0308] Example 179 The anatomical passage is the Marshall vein, as described in Example 178.

[0309] Example 180 Inserting an elongated shaft assembly into an anatomical structure involves advancing the elongated shaft assembly along a guide wire, the guide wire being slidably positioned within the elongated shaft assembly, as described in any of Examples 171 to 179.

[0310] Example 181 The method according to Example 180, which includes activating one or more selected electrodes to apply a pulse of electrical energy, using a guidewire as a return path for the electrical energy.

[0311] Example 182 The method according to any one of Examples 171 to 181, which includes activating one or more selected electrodes to apply a pulse of electrical energy, using a grounding pad as a return path for the electrical energy.

[0312] Example 183 The method according to Example 182, wherein the grounding pad includes a patch adhered to the patient.

[0313] Example 184 The method according to any one of Examples 171 to 183, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first single electrode from the plurality of electrodes to function as an active electrode.

[0314] Example 185 The method according to any one of Examples 171 to 183, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first set of electrodes from a plurality of electrodes so that they function collectively as an active electrode.

[0315] Example 186 The method according to any one of Examples 171 to 185, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first single electrode from the plurality of electrodes to function as a return electrode.

[0316] Example 187 The method according to any of Examples 171 to 185, wherein selecting one or more electrodes from a plurality of electrodes includes selecting a first set of electrodes from a plurality of electrodes so that they function collectively as a return electrode.

[0317] Example 188 The method according to any of Examples 171-187, comprising activating one or more selected electrodes to apply electrical energy to tissue and thereby ablate the tissue, utilizing a separate instrument to provide a return pathway for the electrical energy, the separate instrument being positioned within the patient.

[0318] Example 189 The method according to Example 188, wherein a separate device includes a guide wire.

[0319] Example 190 The method according to Example 189, wherein the guidewire is positioned at different locations within the patient so that the guidewire is not positioned within an anatomical structure where the elongated shaft assembly is located.

[0320] Example 191 The method according to Example 188, wherein the separate instrument includes an ablation instrument having electrodes.

[0321] Example 192 The method according to Example 191, wherein the ablation device is positioned at different locations within the patient so that the ablation device is not positioned within an anatomical structure where the elongated shaft assembly is located.

[0322] Example 193 The ablation device is positioned within the cardiac chambers or pulmonary veins of the heart, as described in Example 192.

[0323] Example 194 The ablation device defines a lumen, and the elongated shaft assembly is slidably positioned within the lumen of the ablation device, according to any one of Examples 192 to 193.

[0324] Example 195 The method according to Example 194, wherein the ablation device is positioned within the coronary sinus and the elongated shaft assembly is positioned within a blood vessel branching from the coronary sinus.

[0325] Example 196 The occlusion act is the method according to any one of Examples 171 to 195, which includes inflating a first balloon to occlude an anatomical structure.

[0326] Example 197 The method according to Example 196, wherein the first balloon is integrated with the shaft assembly.

[0327] Example 198 The anatomical structure, including venous blood vessels, is as described in any of Examples 196 to 197.

[0328] Example 199 The first balloon is located proximal to multiple electrodes, as described in Example 198.

[0329] Example 200 The anatomical structure, including arterial vessels, is as described in any of Examples 196 to 197.

[0330] Example 201 The first balloon is located distal to multiple electrodes, as described in Example 200.

[0331] Example 202 The method according to any one of Examples 196 to 201, further comprising inserting the shaft assembly through the sheath.

[0332] Example 203 The first balloon is integrated with the sheath, as described in Example 202.

[0333] Example 204 The method according to any one of Examples 196 to 201, further comprising inserting a balloon device through a shaft assembly.

[0334] Example 205 The method according to Example 204, wherein the first balloon is integrated with the balloon device.

[0335] Example 206 The method according to any one of Examples 196 to 205, further comprising inflating a second balloon to occlude an anatomical structure.

[0336] Example 207 The method according to Example 206, wherein multiple electrodes are positioned longitudinally between the first balloon and the second balloon.

[0337] Example 208 The method according to any one of Examples 206 to 207, wherein the therapeutic agent is administered through one or more openings in a shaft assembly longitudinally positioned between a first balloon and a second balloon.

[0338] Example 209 The first balloon is porous, as described in any of Examples 196 to 208.

[0339] Example 210 The therapeutic agent is administered through the hole in the balloon, as described in Example 209.

[0340] Example 211 The first balloon is inflated with a therapeutic agent, according to any of the methods in Examples 209-210.

[0341] VII. Others Any of the instruments described herein may be cleaned and sterilized before and / or after treatment. One sterilization technique involves placing the device in a sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electron beams. The radiation may kill bacteria on the device and within the container. The sterilized device may then be stored in a sterilized container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma rays, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization with or without gas plasma or water vapor.

[0342] It should be understood that any of the embodiments described herein may include a variety of other features in addition to or instead of those described herein. For example, any of the embodiments described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0343] It should be understood that one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various preferred ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0344] Any patent, publication, or other disclosure material that is said to be incorporated herein by reference will be incorporated herein only to the extent that the incorporated material does not contradict existing definitions, views, or other disclosure materials contained herein, in whole or in part. Any disclosure expressly stated herein, either by itself or to the extent necessary, shall take precedence over any conflicting material incorporated herein by reference. Any material, or any part thereof, that is said to be incorporated herein by reference but contradicts existing definitions, views, or other disclosure materials contained herein will be incorporated only to the extent that it does not create a conflict between the incorporated material and the existing disclosure materials.

[0345] While various modifications of the present invention have been illustrated and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some of such possible modifications have been mentioned, but others will be obvious to those skilled in the art. For example, the embodiments, modifications, geometric shapes, materials, dimensions, proportions, processes, etc., discussed above are illustrative and not essential. Therefore, it should be understood that the scope of the invention is to be considered with respect to the following claims and is not limited to the structural and operational details shown and described herein and in the drawings.

[0346] [Implementation Method] (1) A device, A flexible catheter shaft, The distal portion including the open distal end, A lumen that is in fluid communication with the open distal end, configured to receive a guidewire, and further configured to allow therapeutic fluid to be communicated to the outside through the open distal end, Outer diameter in the range of approximately 0.67 mm to approximately 1.33 mm, A flexible catheter shaft, including One or more electrodes, wherein at least one of the one or more electrodes is positioned on the distal portion of the catheter shaft, and at least one of the one or more electrodes is operable to apply electrical energy to tissue, An apparatus comprising one or more position sensors, at least one of which is positioned on the distal portion of the catheter shaft, and which is configured to provide a signal indicating the position of each of the one or more position sensors in three-dimensional space in response to a magnetic field. (2) The apparatus according to Embodiment 1, further comprising a therapeutic fluid source in fluid communication with the lumen. (3) The apparatus according to Embodiment 2, wherein the therapeutic fluid is configured to provide chemical ablation. (4) The apparatus according to Embodiment 3, wherein the therapeutic fluid contains ethyl alcohol. (5) The apparatus according to Embodiment 2, wherein the therapeutic fluid includes biological treatment.

[0347] (6) The apparatus according to Embodiment 5, wherein the biological treatment includes stem cells. (7) The apparatus according to Embodiment 2, wherein the therapeutic fluid includes chemical treatment. (8) The apparatus according to Embodiment 1, further comprising a flexible circuit positioned along the distal portion of the catheter shaft, wherein the flexible circuit includes one or more position sensors. (9) The apparatus according to Embodiment 1, further comprising an electric generator configured to communicate with one or more electrodes. (10) The apparatus according to Embodiment 9, wherein the electricity generator is operable to drive one or more electrodes to provide electroporation of tissue.

[0348] (11) The apparatus according to embodiment 10, wherein the electric generator is operable to drive one or more electrodes to provide reversible electroperforation of tissue. (12) The apparatus according to Embodiment 9, wherein the electrical generator is operable to drive one or more electrodes to provide pulsed-field ablation of tissue. (13) The apparatus according to Embodiment 9, wherein the electrical generator is operable to drive one or more electrodes to provide radiofrequency ablation of tissue. (14) The apparatus according to Embodiment 1, wherein the distal portion of the catheter shaft is configured to fit into a blood vessel branching from the patient's coronary sinus. (15) The apparatus according to embodiment 14, wherein the distal portion of the catheter shaft is configured to be fitted into the Marshall vein of a patient.

[0349] (16) A method, The distal portion of the catheter is advanced into the patient's heart, Tracking the position of the distal portion of the heart using one or more position sensors, Further advancing the distal portion into the patient's coronary sinus, To prevent the flow of fluids, including blood, from flowing proximal, Delivering therapeutic fluid through the distal portion of the catheter, A method comprising applying pulsed-field energy to induce reversible electroperforation of the tissue surrounding the distal portion of the catheter. (17) The method according to Embodiment 16, further comprising generating a magnetic field, wherein one or more position sensors provide information indicating the position of the distal portion in response to the magnetic field. (18) The method according to embodiment 16, wherein the therapeutic fluid is delivered into the blood vessels of the heart. (19) The method according to embodiment 16, further comprising advancing the distal portion into a blood vessel branching from the coronary sinus. (20) A method, The invention involves inserting an elongated shaft assembly into an anatomical structure within the cardiovascular system of a patient, wherein the elongated shaft assembly has a distal portion with an end effector, the end effector extends at an angle around the distal portion of the shaft assembly and has a plurality of electrodes spaced longitudinally apart from each other along the distal portion of the shaft assembly, and the shaft assembly further includes a tip member positioned distal to the end effector, the tip member being more flexible than the distal portion of the shaft assembly. The anatomical passage into which the end effector is inserted is to be closed, Administering the therapeutic agent via the aforementioned shaft assembly, Selecting one or more electrodes from the plurality of electrodes in order to transmit a pulse of electrical energy, A method comprising activating one or more selected electrodes to transmit pulses of electrical energy sufficient to induce electroperforation of cells in the anatomical tissue of the anatomical passage.

Claims

1. It is a device, A flexible catheter shaft, The distal portion including the open distal end, A lumen that is in fluid communication with the open distal end, configured to receive a guidewire, and further configured to allow therapeutic fluid to be communicated to the outside through the open distal end, Outer diameter in the range of approximately 0.67 mm to approximately 1.33 mm, A flexible catheter shaft, including One or more electrodes, at least one of which is positioned on the distal portion of the catheter shaft, and at least one of which is operable to apply electrical energy to tissue, An apparatus comprising one or more position sensors, wherein at least one of the one or more position sensors is positioned on the distal portion of the catheter shaft, and the one or more position sensors are configured to provide a signal indicating the position of each of the one or more position sensors in three-dimensional space in response to a magnetic field.

2. The apparatus according to claim 1, further comprising a therapeutic fluid source in fluid communication with the lumen.

3. The apparatus according to claim 2, wherein the therapeutic fluid is configured to provide chemical ablation.

4. The apparatus according to claim 3, wherein the therapeutic fluid contains ethyl alcohol.

5. The apparatus according to claim 2, wherein the therapeutic fluid includes biological treatment.

6. The apparatus according to claim 5, wherein the biological treatment includes stem cells.

7. The apparatus according to claim 2, wherein the therapeutic fluid includes chemical treatment.

8. The apparatus according to claim 1, further comprising a flexible circuit positioned along the distal portion of the catheter shaft, wherein the flexible circuit includes one or more position sensors.

9. The apparatus according to claim 1, further comprising an electric generator configured to communicate with one or more electrodes.

10. The apparatus according to claim 9, wherein the electricity generator is operable to drive one or more electrodes to provide electroporation of tissue.

11. The apparatus according to claim 10, wherein the electricity generator is operable to drive one or more electrodes to provide reversible electroperforation of tissue.

12. The apparatus according to claim 9, wherein the electrical generator is operable to drive one or more electrodes to provide pulsed-field ablation of tissue.

13. The apparatus according to claim 9, wherein the electrical generator is operable to drive one or more electrodes to provide high-frequency ablation of tissue.

14. The apparatus according to claim 1, wherein the distal portion of the catheter shaft is configured to fit into a blood vessel branching from the patient's coronary sinus.

15. The apparatus according to claim 14, wherein the distal portion of the catheter shaft is configured to be fitted into the Marshall vein of a patient.

16. It is a method, The distal portion of the catheter is advanced into the patient's heart, Tracking the position of the distal portion of the heart using one or more position sensors, Further advancing the distal portion into the patient's coronary sinus, To prevent the flow of fluids, including blood, from flowing proximal, Delivering therapeutic fluid through the distal portion of the catheter, A method comprising applying pulsed-field energy to induce reversible electroperforation of the tissue surrounding the distal portion of the catheter.

17. The method according to claim 16, further comprising generating a magnetic field, wherein one or more position sensors provide information indicating the position of the distal portion in response to the magnetic field.

18. The method according to claim 16, wherein the therapeutic fluid is delivered into the blood vessels of the heart.

19. The method according to claim 16, further comprising advancing the distal portion into a blood vessel branching from the coronary sinus.

20. It is a method, The invention involves inserting an elongated shaft assembly into an anatomical structure within the cardiovascular system of a patient, wherein the elongated shaft assembly has a distal portion with an end effector, the end effector extends at an angle around the distal portion of the shaft assembly and has a plurality of electrodes spaced longitudinally apart from each other along the distal portion of the shaft assembly, and the shaft assembly further includes a tip member positioned distal to the end effector, the tip member being more flexible than the distal portion of the shaft assembly. The anatomical passage into which the end effector is inserted is to be closed, Administering the therapeutic agent via the aforementioned shaft assembly, Selecting one or more electrodes from the plurality of electrodes in order to transmit an electrical energy pulse, A method comprising activating one or more selected electrodes to transmit pulses of electrical energy sufficient to induce electroperforation of cells in the anatomical tissue of the anatomical passage.

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