Catheter with thin film electrodes on deployable mechanical structure

Abstract

The present invention discloses a device, which includes a catheter and an end effector. The size and structure of at least a portion of the catheter are configured to be assembled in the inner cavity of the cardiovascular system. The end effector is positioned at the distal end of the catheter. The end effector includes a panel, a plurality of mapping electrodes positioned on a first surface of the panel, and a plurality of ablation electrodes positioned on the first surface of the panel. The mapping electrodes are configured to sense the potential in the tissue contacting the mapping electrodes. The ablation electrodes are operable to ablate the tissue contacting the ablation electrodes.

Description

Background Art

[0001] When electrical signals are abnormally conducted in a region of heart tissue, arrhythmias such as atrial fibrillation occur. Procedures for treating arrhythmias include surgically interrupting the conduction pathways for such signals. Selectively ablating heart tissue by applying energy (e.g., alternating current electrical energy or direct current electrical energy) may stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across the tissue.

[0002] In some procedures, a catheter having one or more electrodes can be used to provide ablation within the cardiovascular system. 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 cardiovascular structure adjacent to the heart (e.g., the pulmonary vein). The electrodes can be placed in contact with heart tissue or other vascular tissue and then activated with electrical energy to ablate the contacted tissue. In some cases, the electrodes can be bipolar. In some other cases, monopolar electrodes can be used in combination with a ground pad or other reference electrode that contacts the patient.

[0003] Examples of ablation catheters are described in the following documents: US Publication 2013 / 0030426, titled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens", published on January 31, 2013, the disclosure of which is incorporated herein by reference in its entirety; US Publication 2017 / 0312022, titled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly", published on November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety; US Publication 2018 / 0071017, titled "Ablation Catheter with a Flexible Printed Circuit Board", published on March 15, 2018, the disclosure of which is incorporated herein by reference in its entirety; US Publication 2018 / 0056038, titled "Catheter with Bipole Electrode Spacer and Related Methods", published on March 1, 2018, the disclosure of which is incorporated herein by reference in its entirety; US Patent 10,130,422, titled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region", published on November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; US Patent 8,956,353, titled "Electrode Irrigation Using Micro-Jets", published on February 17, 2015, the disclosure of which is incorporated herein by reference in its entirety; and US Patent 9,801,585, titled "Electrocardiogram Noise Reduction", published on October 31, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0004] Some catheter ablation procedures may be performed after using electrophysiological (EP) mapping to identify tissue regions that should be targeted for ablation. Such EP mapping may include using sensing electrodes on a catheter (e.g., the same catheter used to perform ablation or a dedicated mapping catheter). Such sensing electrodes may monitor electrical signals emitted from conductive endocardial tissue to precisely locate the position of abnormal conductive tissue sites that cause arrhythmias. Examples of EP mapping systems are described in U.S. Patent 5,738,096, entitled "Cardiac Electromechanics," published on April 14, 1998, the disclosure of which is incorporated herein by reference in its entirety. Examples of EP mapping catheters are described in the following documents: U.S. Patent 9,907,480, entitled "Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes," published on March 6, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent 10,130,422, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," published on November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Publication 2018 / 0056038, entitled "Catheter with Bipole Electrode Spacer and Related Methods," published on March 1, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0005] In addition to using EP mapping, some catheter ablation procedures may also be performed using an image-guided surgery (IGS) system. The IGS system may enable a physician to visually track the position of a catheter within a patient in real time relative to an image of the anatomical structures within the patient. Some systems may provide a combination of EP mapping and IGS functionality, including the system of Biosense Webster, Inc., of Irvine, California. Examples of catheters configured for use with an IGS system are disclosed in the following documents: U.S. Patent 9,480,416, entitled "Signal Transmission Using Catheter Braid Wires," published on November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety; and various other references cited herein.

[0006] Although several surgical systems and methods have been made and used, it is believed that no one prior to the present inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The following drawings and detailed embodiments are intended to be exemplary only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0008] Figure 1 A schematic diagram showing a medical procedure of inserting a catheter of a catheter assembly into a patient;

[0009] Figure 2A Shows Figure 1 A perspective view of the distal portion of the catheter assembly of , where the end effector is in the undeployed state;

[0010] Figure 2B Shows Figure 1 A perspective view of the distal portion of the catheter assembly of , where the end effector is in the deployed state;

[0011] Figure 3 Shows Figure 2A A top plan view of the panel assembly of the end effector of ;

[0012] Figure 4 Shows Figure 3 A bottom plan view of the panel assembly of ;

[0013] Figure 5 Shows Figure 3 A cross-sectional view of the panel assembly of ;

[0014] Figure 6 Shows an example of a reference electrode feature structure that can be incorporated into the panel assembly of Figure 3 A perspective view;

[0015] Figure 7 Shows an example of another reference electrode feature structure that can be incorporated into the panel assembly of Figure 3 A perspective view;

[0016] Figure 8 Shows Figure 2A A top plan view of another example of the panel assembly that can be incorporated into the end effector of ;

[0017] Figure 9 Shows Figure 2A A top plan view of another example of the panel assembly that can be incorporated into the end effector of ;

[0018] Figure 10 Shows Figure 1 A perspective view of another example of the end effector that can be incorporated into the catheter assembly of ;

[0019] Figure 11 Shows Figure 1Perspective view of another example of an end effector in a catheter assembly;

[0020] Figure 12 Schematic end view showing an example of a panel assembly having a lateral edge that is angled over the entire thickness of the panel assembly;

[0021] Figure 13 Schematic end view showing an example of a panel assembly that is laterally offset from the longitudinal axis of the shaft assembly;

[0022] Figure 14 Schematic end view showing an example of a panel assembly that is aligned with the longitudinal axis of the shaft assembly;

[0023] Figure 15 Top plan view showing another example of a panel member that can be incorporated into any of the panel assemblies described herein;

[0024] Figure 16 Showing in a rolled-up configuration Figure 15 Perspective view of the proximal portion of the panel member;

[0025] Figure 17 Top plan view showing another example of a panel member that can be incorporated into any of the panel assemblies described herein;

[0026] Figure 18 Showing in a rolled-up configuration Figure 17 Perspective view of the proximal portion of the panel member;

[0027] Figure 19 Top plan view showing another example of a panel member that can be incorporated into any of the panel assemblies described herein; and

[0028] Figure 20 Showing in an unfolded configuration Figure 19 Side elevation view of the panel member. Detailed Description

[0029] The following description of certain examples of the present invention is not intended to limit the scope of the present invention. The drawings (not necessarily to scale) illustrate selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principles of the present invention in an illustrative rather than a restrictive manner. Other examples, features, aspects, embodiments, and advantages of the present invention will be apparent to those skilled in the art from the following description, which is presented by way of example. A best mode is contemplated for practicing the present invention. As will be recognized, the present invention is capable of having other different or equivalent aspects, all of which do not depart from the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature rather than restrictive.

[0030] Any one or more of the teachings, expressions, forms, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, forms, examples, etc. described herein. Thus, the following teachings, expressions, forms, examples, etc. should not be regarded as separate from each other. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0031] As used herein, the term “about” or “approximately” with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a set of components or elements to achieve its intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of values of ±20% of the recited value; for example, “about 90%” can refer to a range of values from 71% to 99%. Additionally, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject, and are not intended to limit the system or method to human use, although use of the subject invention in human patients represents a preferred embodiment.

[0032] I. Overview of Examples of Catheter Systems

[0033] Figure 1 An example of a medical procedure and associated components of a cardiac mapping and ablation system is shown. Specifically, Figure 1 it is shown that a physician (PH) grasps the handle (110) of a catheter assembly (100), wherein the end effector (200) of the flexible catheter (120) of the catheter assembly (100) (shown in Figures 2A - 2B but not shown in Figure 1 ) is positioned within a patient (PA) to map or ablate tissue in or near the patient's (PA) heart (H). As Figures 2A - 2B shown, the catheter (120) includes an outer sheath (122) and an inner shaft (130), wherein the end effector (200) is disposed at the distal end (132) of the inner shaft (130). The catheter assembly (100) is coupled to a guidance and drive system (10) via a cable (30). The catheter assembly (100) is also optionally connected to a fluid source (42) via a fluid conduit (40). A set of field generators (20) are positioned beneath the patient (PA) and are also coupled to the guidance and drive system (10) via a cable (22).

[0034] The guiding and driving system (10) of 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 the catheter assembly (100) via a cable (30). In some variations, the first driver module (14) is operable to receive EP mapping signals obtained via the electrodes of the end effector (200), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals to provide EP mapping as known in the art. Additionally or alternatively, the first driver module (14) is operable to supply power to the electrodes of the end effector (200) to ablate tissue. In some forms, the first driver module (14) is also operable to receive position indication signals from one or more position sensors (290) in the end effector (200), as will be described in more detail below. In this type of form, the processor of the console (12) is also operable to process the position indication signals from the position sensors (290) to determine the position of the end effector (200) of the catheter (120) within the patient (PA).

[0035] The second driver module (16) is coupled to the 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 heart (H) of the patient (PA). For example, the field generator (20) may include a coil that generates an alternating magnetic field in a pre-determined working volume that houses the heart (H).

[0036] The display (18) is coupled to the processor of the console (12) and is operable to present an image of a patient's anatomy. Such an image can be based on a set of pre-operative or intra-operative acquired images (e.g., CT or MRI scans, 3D maps, etc.). The view of the patient's anatomy provided by the display (18) can also be dynamically changed based on signals from the position sensor (290) of the end effector (200). For example, as the end effector (200) of the catheter (120) moves within the patient (PA), the corresponding position data from the position sensor (290) can cause the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to show the area of the patient's anatomy around the end effector (200) as the end effector (200) moves within the patient (PA). Additionally, the processor of the console (12) can drive the display (18) to show the location of abnormal conductive tissue sites detected by performing EP mapping with the end effector (200). By way of example only, the processor of the console (12) can drive the display (18) to superimpose the location of the abnormal conductive tissue sites on the image of the patient's anatomy, such as by overlaying illuminated points, crosshairs, or some other form of visual indication of the abnormal conductive tissue sites.

[0037] The processor of the console (12) can also drive the display (18) to superimpose the current position of the end effector (200) on the image of the patient's anatomy, such as by overlaying illuminated points, crosshairs, a graphical representation of the end effector (200), or some other form of visual indication. As the physician moves the end effector (200) within the patient (PA), this superimposed visual indication can also move in real time within the image of the patient's anatomy on the display (18), thereby providing real-time visual feedback to the operator regarding the position of the end effector (200) within the patient (PA) as the end effector (200) moves within the patient (PA). Thus, the image provided by the display (18) can effectively provide a video tracking the position of the end effector (200) within the patient (PA) without having to have any optical means (i.e., a camera) for viewing the end effector (200). In the same view, the display (18) can simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping as described herein. Thus, the physician (PH) can view the display (18) to observe the real-time positioning of the end effector (200) relative to the mapped abnormal conductive tissue sites and relative to the image of adjacent anatomy within the patient (PA).

[0038] The fluid source (42) of this example includes a bag containing saline or some other suitable flushing fluid. The conduit (40) includes a flexible tube that is also coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). In some variations, the conduit (40), fluid source (42), and pump (44) are completely omitted. In configurations that include these components, the end effector (200) can be configured to transfer the flushing fluid from the fluid source (42) to a target site within a patient's body. Such flushing can be provided in accordance with the teachings of any one of the various patent references cited herein; or in any other suitable manner that would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0039] Figures 2A - 2B The catheter (120) is shown in more detail. As shown, the outer sheath (122) is configured to translate relative to the end effector (200) and to translate between a distal position ( Figure 2A ) and a proximal position ( Figure 2B ) relative to the inner shaft (130). When the outer sheath (122) is in the distal position as shown in Figure 2A , the distal end (124) of the outer sheath (122) is positioned distally relative to the distal end (202) of the end effector (200) such that the end effector (200) is fully received within the interior of the outer sheath (122). In some configurations, the end effector (200) is configured to have a size less than or equal to approximately 6 French when in the Figure 2A shown un-deployed configuration. When the outer sheath (122) is in the proximal position as shown in Figure 2B , the distal end (124) of the outer sheath (122) is positioned proximally relative to the end effector (200) such that the end effector (200) and the distal portion of the inner shaft (130) are exposed relative to the outer sheath (122). As shown in the transition of Figures 2A through 2B and as will be described in more detail below, the end effector (200) is operable to transition from an un-deployed state to a deployed state after being exposed by the outer sheath (122).

[0040] II. Examples of End Effectors with Deployable Panel Assemblies

[0041] As shown in Figure 2B , the end effector (200) of the example of the present invention is formed by a panel assembly (210) and the exposed distal portion of the inner shaft (130). As shown in Figure 2AAs shown, the panel assembly (210) is configured to be in a rolled-up state so as to achieve an un-deployed configuration within the hollow interior of the outer sheath (122). In this example, when the panel assembly (210) is received within the outer sheath (122), the panel assembly (210) is rolled up around the central longitudinal axis (LA) of the end effector (200) and the catheter (120). However, as Figure 2B shown, once the panel assembly (210) is exposed by the outer sheath (122) that is retracted proximally, the panel assembly (210) unfolds and elastically returns to a flat state. To provide an elastic bias towards the flattened configuration, the panel assembly (210) may incorporate an elastic material, as will be described in more detail below. In the deployed flat state (or flattened configuration), the panel assembly (210) is generally planar. By way of example only, in the deployed flat state, the distal portion (212) of the panel assembly (210) may have a length of approximately 2 cm to approximately 3 cm; and a width of approximately 1 cm to approximately 2 cm.

[0042] During use of the catheter assembly (100), as the catheter (120) is advanced into the patient (PA), the outer sheath (122) may be held in a distal position, as Figure 2A shown. Once the distal portion of the catheter (120) reaches the targeted anatomical region, the outer sheath (122) may be retracted proximally relative to the end effector (200) and the inner shaft (130) to achieve the Figure 2B state shown. Alternatively, once the distal portion of the catheter (120) reaches the targeted anatomical region, the end effector (200) and the inner shaft (130) may be advanced distally relative to the outer sheath (122) to achieve the Figure 2B state shown.

[0043] After the end effector (200) has been used to provide EP mapping or ablation as described herein and before the end effector (200) is withdrawn from the patient, the outer sheath (122) may return to the Figure 2A distal position shown to cover the end effector (200) during withdrawal of the catheter (120) from the patient (PA). When the outer sheath (122) is advanced distally relative to the end effector (200) and relative to the inner sheath (or when the end effector (200) and the inner sheath are retracted proximally relative to the outer sheath (122)), the distal end (124) of the outer sheath (122) may interact with the proximally facing edge (222) at the proximal end (220) of the panel assembly (210).

[0044] In an example of the present invention, the edge (222) tapers to provide a cam interaction with the distal end (124) of the outer sheath (122), thereby facilitating the return of the panel assembly (210) to Figure 2A the rolled-up state shown as the outer sheath (122) is advanced distally relative to the end effector (200). In some forms, the edge (222) may also include a three-dimensional curved profile that further facilitates the return of the panel assembly (210) to Figure 2A the rolled-up state shown as the outer sheath (122) is advanced distally relative to the end effector (200). For example, the panel assembly (210) may have a preformed concave curvature in the region of the panel assembly (210) near the edge (222), where the concave curvature is configured to define a cam surface that engages the distal end (124) of the outer sheath (122), such that as the outer sheath (122) transitions from a proximal position to a distal position, the panel assembly (210) is moved from Figure 2B a flattened configuration to Figure 2B a rolled-up (or otherwise undeployed) configuration. In addition to or as an alternative to having the above-described features, the panel assembly (210) may be configured such that the longitudinally extending lateral edges (228) of the panel assembly (210) have an angled profile through the thickness of the panel assembly (210). In some such forms, and as Figure 11 shown, the angle of one lateral edge (228) is opposite the angle of the other lateral edge (228). Such an opposite angle configuration can facilitate the lateral edges sliding away from each other if they begin to contact as the panel assembly (210) transitions to the Figure 2B rolled-up (or otherwise undeployed) configuration shown as the outer sheath (122) transitions from a proximal position to a distal position. Such an angled profile may be defined in the film body that defines the panel assembly (210); may be constructed as a separate buffer or attached to other structures that define the film body of the panel assembly (210); or may be otherwise constructed.

[0045] Additionally, in some forms, the panel assembly (210) is positioned laterally offset (but parallel to) the longitudinal axis (LA) of the outer sheath (122), as Figure 12 shown. By positioning with such an offset, the edge (222) can further cooperate with the distal end (124) of the outer sheath (122), such that as the outer sheath (122) transitions from a proximal position to a distal position, the panel assembly (210) is moved from Figure 2B a flattened configuration to Figure 2B a rolled-up (or otherwise undeployed) configuration. However, other forms may provide a panel assembly (210) that is aligned with the longitudinal axis (LA) of the outer sheath (122), asFigure 13 as shown; and as the outer sheath (122) transitions from the proximal position to the distal position, the panel assembly remains convertible from Figure 2B a flattened configuration to Figure 2B a rolled-up (or otherwise unrolled) configuration. In any case, once the outer sheath (122) returns to Figure 2A its distal position, in which the end effector (200) is received within the outer sheath (122), the catheter (120) can be removed from the patient (PA).

[0046] As Figures 3 - 5 shown, the panel assembly (210) of this example includes a distal portion (212) having a distal end (218), a proximal portion (220), a first surface (214), and a second surface (216) opposite the first surface (214). The distal portion (212) of the example of the present invention is generally square, but the distal portion (212) can alternatively be shaped as any other type of rectangle or have any other suitable type of shape. The first surface (214) includes a plurality of mapping electrodes (230), a plurality of ablation electrodes (232), a plurality of temperature sensors (240), and a plurality of position sensors (290). The second surface (216) includes a plurality of reference electrodes (234). The proximal portion (220) includes the proximally facing edge (222) and the tab portion (224) as described above. The tab portion (224) includes a pair of outwardly extending ears (226). The tab portion (224) is configured to be rolled up and inserted into the distal end (132) of the inner shaft (130); and then be securely fixed within the inner shaft (130), as Figure 2B shown. By way of example only, the tab portion (224) can be fixed to the inner shaft (130) using an adhesive or using any other suitable technique, as will be apparent to those skilled in the art in view of the teachings herein. In addition to providing the structure by which the panel assembly (210) is fixed to the inner shaft (130), the tab portion (224) can also provide sufficient surface area for electrical connection between the wires (not shown) in the inner shaft (130) and the various electrical feature structures (e.g., mapping electrodes (230), ablation electrodes (232), temperature sensors (240), position sensors (290), and reference electrodes (234), etc.) on the panel assembly (210).

[0047] In some configurations, the distal end (132) of the inner shaft (130) includes an opening that is in fluid communication with a fluid source (42) via a fluid conduit (40). In this type of configuration, the inner shaft (130) can discharge flushing fluid through the distal end (132) to a targeted site within the patient (PA). The rolled-up configuration of the tab portion (224) at the proximal portion (220) of the panel assembly (210) can readily permit such fluid to be conveyed outwardly through the distal end (132). Alternatively, the flushing fluid can be conveyed to the target site within the patient (PA) in any other suitable manner. As another alternative, in some configurations, the flushing fluid can be omitted.

[0048] The mapping electrodes (230) are configured to provide EP mapping (e.g., to provide an electrocardiogram signal) by contacting tissue and picking up potentials from the contacted tissue. In some configurations, the mapping electrodes (230) cooperate in bipolar pairs during such mapping procedures. Thus, the mapping electrode pairs (230) can be considered to jointly form a single "sensor". Each mapping electrode (230) can be coupled to a corresponding trace (not shown) or other electrical conduit such that the signals picked up by the mapping electrodes (230) can be transmitted back to the console (12) through the electrical conduits (not shown) in the catheter (120), and the console can process the signals to provide EP mapping to identify the location of abnormal electrical activity within the cardiac anatomy. This, in turn, can allow the physician (PH) to identify the most suitable regions of cardiac tissue to ablate (e.g., with electrical energy, cryoablation, etc.) to prevent or at least reduce the propagation of abnormal electrical activity across the cardiac tissue.

[0049] In an example of the present invention, the mapping electrodes (230) are arranged in a grid or matrix form on the entire first surface (214) of the panel assembly (210). By way of further example only, the mapping electrodes (230) can be spaced apart and arranged in accordance with at least some of the teachings in the following patent applications: U.S. Provisional Patent Application No. 62 / 819,738, entitled "Electrode Configurations for Diagnosis of Arryhtmias", filed on March 18, 2019, the disclosure of which is incorporated herein by reference in its entirety. For example, the mapping electrodes (230) can be spaced apart and arranged in accordance with Figure 13 A, Figure 13 B, Figure 13 C, and Figure 13 D.

[0050] As Figures 2B - 3As shown, in this example, the ablation electrode (232) is larger than the mapping electrode (230). The ablation electrode (232) can be used to apply electrical energy to tissue in contact with the electrode, thereby ablating the tissue. As used herein, the term "ablation" is intended to encompass radiofrequency ablation or irreversible electroporation. Each ablation electrode (232) can be coupled to a corresponding trace (not shown) or other electrical conduit such that the console (12) can transmit electrical energy through the electrical conduit (not shown) in the catheter (120) to the trace or other conduit to reach the ablation electrode (232). In some cases, only one, only two, or some other relatively small number of ablation electrodes (232) will be activated to apply electrical energy to the tissue at any given moment. In the example of the present invention, the ablation electrodes (232) are arranged in a grid or matrix form over the entire first surface (214) of the panel assembly (210). This grid or matrix of ablation electrodes (232) is offset from the grid or matrix of the mapping electrodes (230). Like the mapping electrodes (230), as Figures 2B - 3 shown, the number and positioning of the ablation electrodes (232) are merely exemplary. Any other suitable number or positioning can be used for the ablation electrodes (232). As yet another merely illustrative variation, the ablation electrodes (232) can be omitted from the end effector (200). In some such variations, the mapping electrodes (230) are still included on the end effector (200).

[0051] Also as Figures 2B - 3 shown, the temperature sensors (240) are arranged in a grid or matrix form over the entire first surface (214) of the panel assembly (210). This grid or matrix of temperature sensors (240) is offset from the grid or matrix of the mapping electrodes (230) and the ablation electrodes (232). Like the mapping electrodes (230) and the ablation electrodes (232), as Figures 2B - 3 shown, the number and positioning of the temperature sensors (240) are merely exemplary. In some configurations, the temperature sensors (240) can be operative to sense the temperature of the tissue in contact with the temperature sensors (240). In some other configurations, the temperature sensors (240) can be operative to sense the temperature of the ablation electrodes (232). Whether the temperature sensors (240) sense the temperature of the tissue in contact or the temperature of the ablation electrodes (232), the console (12) can track the sensed tissue temperature in real time and adjust the delivery of electrical energy to the ablation electrodes (232) to prevent overheating of the tissue caused by the ablation electrodes (232). By way of example only, the temperature sensors (240) can be in the form of a thermocouple, such as a negative temperature coefficient (NTC) thermistor or a positive temperature coefficient (PTC) thermistor. Other suitable forms that the temperature sensors (240) can take and other suitable uses of the temperature sensors (240) in the end effector (200) will be apparent to those skilled in the art in view of the teachings herein.

[0052] As described above and as Figure 4 shown, a set of reference electrodes (234) are positioned on a second side (216) of the panel assembly (210). Such reference electrodes (234) can be used in combination with the mapping electrodes (230) during an EP mapping procedure. For example, during an EP mapping procedure, the mapping electrodes (230) can be placed in contact with tissue in a cardiovascular structure, whereas the reference electrodes (234) only contact blood or saline in the cardiovascular structure (i.e., such that the reference electrodes (234) do not contact tissue). When the mapping electrodes (230) pick up potentials from the contacted tissue, the reference electrodes (234) can pick up a reference potential from the blood or saline passing through the cardiovascular structure. As is known in the art, such reference potentials can be used to reduce noise or far-field signals. In an example of the present invention, because the reference electrodes (234) are only positioned on the side (216) of the panel assembly (210) that is opposite the side (214) on which the mapping electrodes (230) are positioned, the reference electrodes (234) should not contact tissue, whereas the mapping electrodes (230) contact tissue.

[0053] In some cases, the reference electrodes (234) can be used as EP mapping electrodes by applying reference electrodes (234) that are in direct contact with tissue. In such cases, the mapping electrodes (230) can only contact blood or saline in the cardiovascular structure (i.e., such that the mapping electrodes (230) do not contact tissue), whereas the reference electrodes (234) contact tissue to pick up potentials from the contacted tissue.

[0054] In an example of the present invention, the reference electrodes (234) are positioned in a grid or matrix pattern over the entire second surface (216) of the panel assembly (210). Alternatively, the number and positioning of the reference electrodes (234) on the second surface (216) can vary in any suitable manner. In some configurations, annular reference electrodes (140) are coaxially positioned around a distal portion of the inner shaft (130), as Figure 2BAs shown. The reference electrode (140) can function only as the reference electrode (234) described above; and can form part of the end effector (200). Some forms of the end effector (200) can include the reference electrode (140) instead of including the reference electrode (234). Other forms of the end effector (200) can include the reference electrode (234) instead of including the reference electrode (140). As yet another variant, each surface (214, 216) of the panel assembly (210) can be configured identically. In some forms of this type, the system does not necessarily need to distinguish between a set of mapping electrodes (230) and a set of reference electrodes (234). As described above, the electrodes (230, 234) on either surface (214, 216) of the panel assembly (210) can be used as mapping electrodes, whereas the electrodes (230, 234) on the other surface (214, 216) of the panel assembly (210) can be used as reference electrodes, depending on which surface (214, 216) contacts the tissue. In cases where the system needs to determine which surface (214, 216) of the panel assembly (210) contacts the tissue, this can be achieved using tissue proximity indication (e.g., impedance measurement at the electrodes (230, 234), etc.). Other forms of the end effector (200) can include the reference electrode (140) and the reference electrode (234).

[0055] As Figure 5 As shown, the panel assembly (210) of an example of the present invention is formed of a plurality of layers (250, 252, 254). In this example, the intermediate layer (250) is formed of an elastic material that provides a bias toward a flattened configuration or a deployed configuration. By way of example only, the intermediate layer (250) can be formed of nitinol. Alternatively, any other suitable material can be used to form the intermediate layer (250). In some forms, the intermediate layer (250) is in the form of a single solid sheet spanning the entire length and width of the distal portion (212) of the panel assembly (210). In some other forms, the intermediate layer (250) is provided in the form of one or more strips, grids, or some other structure.

[0056] The first outer layer (252) is positioned on one side of the intermediate layer (250), whereas the second outer layer (254) is positioned on the other side of the intermediate layer (250). As Figure 5As shown, the first outer layer (252) presents a first surface (214); however, the second outer layer (254) presents a second surface (216). The outer layers (252, 254) are formed of a flexible, non-conductive material in this example. By way of example only, the outer layer may be formed of a conventional flexible circuit substrate material, such as polyimide, polyetheretherketone, polyester, or any other suitable material, as will be apparent to those skilled in the art in view of the teachings herein. The electrodes (230, 232) and the temperature sensor (240) (and their corresponding traces) may be applied to the first outer layer (252) using any one of the techniques described herein; or using any other suitable technique, as will be apparent to those skilled in the art in view of the teachings herein. Similarly, the electrode (234) (and its corresponding trace) may be applied to the second outer layer (254) using any one of the techniques described herein; or using any other suitable technique, as will be apparent to those skilled in the art in view of the teachings herein.

[0057] By way of example only, the electrodes (140, 230, 232, 234) may be formed of nitinol, platinum, gold, or any other suitable material. In some variations of the panel assembly (210), where the intermediate layer (250) is formed of a conductive material (e.g., nitinol, etc.), the intermediate layer (250) itself may effectively form the ablation electrode (232). In this type of configuration, the outer layers (252, 254) may be omitted. Alternatively, one or both of the outer layers (252, 254) may form one or more openings that expose one or more corresponding regions of the intermediate layer (250), where such exposed regions of the intermediate layer (250) effectively form one or more corresponding ablation electrodes (232).

[0058] The electrodes (140, 230, 232, 234) can be directly applied to the inner shaft (130), the first outer layer (252), or the second outer layer (254) using a physical vapor deposition (PVD) process. By way of example only, such PVD processes can be carried out in accordance with at least some of the teachings of the following patents: at least some of the teachings in the International Patent Publication WO 2015 / 117908, published on August 13, 2015, entitled "Medical Device for Ablating Tissue Cells and System Comprising a Device of This Type", the disclosure of which is incorporated herein by reference in its entirety; at least some of the teachings in the German Patent Publication 102017130152, published on January 3, 2019, entitled "Method for Operating a Multi-Layer Structure", the disclosure of which is incorporated herein by reference in its entirety; or at least some of the teachings in the United States Patent 10,061,198, published on August 28, 2018, entitled "Method for Producing a Medical Device or a Device with Structure Elements, Method for Modifying the Surface of a Medical Device or of a Device with Structure Elements, Medical Device and Laminated Composite with a Substrate", the disclosure of which is incorporated herein by reference in its entirety. Other methods can also be used to deposit the electrodes (140, 230, 232, 234), including but not limited to sputter deposition, chemical vapor deposition (CVD), thermal deposition, etc.

[0059] If desired, the electrodes (140, 230, 232, 234) may include various coatings. For example, the electrodes may include coatings selected to improve the signal-to-noise ratio of the signals from the electrodes. Such coatings may include, but are not limited to, iridium oxide (IrOx) coatings, poly(3,4-ethylenedioxythiophene) (PEDOT) coatings, electrodeposited iridium oxide (EIROF) coatings, platinum iridium (PtIr) coatings, or any other suitable coatings. With reference to the teachings herein, various suitable types of coatings for the electrodes (128, 230, 232, 230) will be apparent to those skilled in the art. The electrodes (230, 232) may be arranged on the entire first surface (214) at any suitable density. By way of example only, the first surface (214) may include from about 20 electrodes to about 200 electrodes. Similarly, the first surface (214) may include from about 20 electrodes to about 200 electrodes. Alternatively, any other suitable number of electrodes (230, 232) may be provided. The electrodes (140, 230, 232, 234) may be further constructed and operated in accordance with at least some of the teachings of U.S. Publication 2017 / 0312022, entitled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly", published on November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0060] As described above, the end effector (200) of the example of the present invention further includes a set of position sensors (290) located at the distal end (218) of the panel assembly (210). The position sensors (290) may be applied to the first outer surface (252) using any one of the processes described herein for the application electrodes (140, 230, 232, 234); or using any other suitable process. Although four position sensors (290) are shown, any other suitable number of position sensors (290) may be provided. By way of example only, some other configurations may have only a single position sensor (290). In addition, the position sensors (290) may be located at any other suitable location on the end effector (200). In addition to or instead of providing the position sensors (290) on the panel assembly (210), some variations may also provide the position sensors (290) on one or both of the outer sheath (122) or the inner shaft (130). In some configurations, the position sensors (290) may be completely omitted from the end effector (200).

[0061] Each position sensor (290) of an example of the present invention is operable to generate a signal indicative of the position and orientation of the end effector (200) within a patient (PA). By way of example only, the position sensor (290) can be in the form of one coil or multiple coils (e.g., three orthogonal coils) configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). Each position sensor (290) can be coupled along or otherwise through the catheter (120) to a wire, trace, or any other suitable electrical conduit such that the signal generated by the position sensor (290) can be transmitted back to the console (12) through the electrical conduit (not shown) within the catheter (120). The console (12) can process the signals from each position sensor (290) to identify the position of the end effector (200) within the patient (PA). Other components and techniques that can be used to generate real-time position data associated with the end effector (200) can include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, and the like.

[0062] During use of the ablation catheter assembly (100), when the end effector (200) is in the undeployed configuration as Figure 2A shown, the catheter (120) can be advanced to position the end effector (200) near a targeted cardiovascular structure (e.g., ventricle (H), pulmonary vein, etc.). The outer sheath (122) can then be converted to Figure 2Ba proximal position as shown, thereby allowing the panel assembly (210) to elastically expand to an expanded state. The physician (PH) can then manipulate the catheter assembly (100) to press at least a portion of the first surface (214) against the tissue of the cardiovascular structure, thereby placing the electrodes (230, 232) (and in some cases, the temperature sensor (240)) in contact with the tissue. The physician (PH) can use the mapping electrode (230) to map the location of abnormal electrical activity within the heart tissue, where the location is tracked by the position sensor (290). These mapped sites can be displayed on the display (18). The physician (PH) can then push the ablation electrode (232) against the tissue at these sites, thereby using the ablation electrode (232) to ablate the sites within the heart tissue having abnormal electrical activity. In some cases, the mapping procedure and the ablation procedure can be performed during separate patient (PA) visits. In such cases, real-time data from the position sensor (290) can be used to guide the ablation electrode (232) back to the initially mapped sites within the heart tissue having abnormal electrical activity. In some other cases, the mapping procedure and the ablation procedure can be performed during the same patient (PA) visit without removing the catheter (120) from the patient (PA) body between the mapping procedure and the ablation procedure. Even in these cases, real-time data from the position sensor (290) can be used to help properly position the ablation electrode (232) at the mapped sites within the heart tissue having abnormal electrical activity.

[0063] III. Examples of Alternative End Effector Configurations

[0064] The above-described configuration of the end effector (200) is merely an illustrative example. The end effector (200) can be modified in a variety of ways. Several examples of such modifications will be described in more detail below with reference to Figures 6 - 11 more detail.

[0065] As described above, it may be desirable to avoid contact between each reference electrode (234) and the tissue during the EP mapping procedure. Avoiding such contact will cause the reference electrode (234) to pick up the reference potential only from the blood or saline passing through the targeted cardiovascular structure, thereby allowing the signal from the reference electrode (234) to be used to reduce noise or far-field signals, which in turn can provide better resolution for the electrocardiogram signals picked up by the mapping electrode (230).

[0066] Figure 6 An example of a feature structure that can be used to reduce the risk of unintentional contact between the reference electrode (234) and the tissue is shown. Specifically, Figure 6A wall (270) surrounding the reference electrode (234) is shown. Each electrode (234) may have an associated wall (270). By way of example only, the wall (270) may protrude from the second surface (216) by a height of from about 20 microns to about 2 mm. The wall (270) can be formed in a variety of different ways. For example, additive manufacturing (e.g., lithography, etc.) or subtractive manufacturing (e.g., etching into a substrate, etc.) can be used.

[0067] Figure 7 Another example of a feature structure that can be used to reduce the risk of inadvertent contact between the reference electrode (234) and tissue is shown. Specifically, Figure 7 A reference electrode (234) positioned within a groove (280) formed in the second surface (216) is shown. Such a groove (280) can position the reference electrode (234) at a depth of from about 20 microns to about 2 mm relative to the second surface (216). The groove (280) can be formed in a variety of different ways. For example, additive manufacturing (e.g., lithography, etc.), subtractive manufacturing (e.g., etching into a substrate, etc.), or overmolding of a flexible polymer (e.g., silicone) can be used.

[0068] In some cases, it may be desirable to allow fluid to be conveyed through the panel assembly (210). By way of example only, providing an opening through the panel assembly (210) can prevent the naturally flowing blood from causing the panel assembly (210) to flex undesirably when the panel assembly (210) is positioned within a targeted anatomical region of the cardiovascular system. Additionally or alternatively, such an opening can facilitate the flushing fluid reaching the interface between the tissue and the ablation electrode (232). Referring to the foregoing, Figure 8 An example of an alternative panel assembly (310) is shown, which is substantially similar to the panel assembly (210), except that the panel assembly (310) of this example includes a plurality of openings (370) formed therethrough. Like the panel assembly (210), the panel assembly (310) of this example includes a distal portion (312) and a proximal portion (320), wherein the distal portion (312) includes mapping electrodes (330), ablation electrodes (332), and temperature sensors (340). The panel assembly (310) may also include a reference electrode, such as the reference electrode (234); and a position sensor, such as the position sensor (290). The openings (370) of this example are formed through two opposing surfaces of the distal portion (312), thereby allowing fluid to pass through the distal portion (312). Although the shape of the openings (370) is shown as rectangular, the openings (370) can alternatively have any other suitable shape. The openings (370) can also be positioned at any other suitable location along the panel assembly (310).

[0069] As another merely exemplary variant, the panel assembly (210) can be formed as a grid defining an opening therethrough such that the grid material can serve as a substrate for the electrodes (230, 232, 234) and the temperature sensor (240). Such a grid can allow fluid to pass through the panel assembly (210); and can also provide an elastic bias to urge the panel assembly (210) to assume Figure 2B the flattened configuration shown. In some forms in which the panel assembly (210) is formed of a grid, such a grid can be extensible to allow the panel assembly (210) to further deploy beyond Figure 2B the configuration shown, as described below. Such a grid can also be contractible to allow the panel assembly (210) to contract in lateral dimensions when collapsing into the outer sheath (122).

[0070] In some cases, it may be desirable to configure the panel assembly (210) such that the panel assembly (210) further deploys beyond Figure 2B the configuration shown. This can include cases where the panel assembly (210) is mounted to an actively deployable body (e.g., as described below with reference to Figures 10 - 11 ) and other cases where the panel assembly (210) is not mounted to an actively deployable body. For example, allowing the panel assembly (210) to further deploy beyond Figure 2B the configuration shown can allow the panel assembly to more easily conform to the contour of the anatomical structure; or can otherwise facilitate better contact between the electrodes (230, 232) and the tissue. Referring to the foregoing, Figure 9 an example of an alternative panel assembly (410) is shown, which is substantially similar to the panel assembly (210), except that the example panel assembly (410) includes a plurality of incisions (470) formed therethrough. Like the panel assembly (210), the example panel assembly (410) includes a distal portion (412) and a proximal portion (420), where the distal portion (412) includes mapping electrodes (430), ablation electrodes (432), and a temperature sensor (440). The panel assembly (410) can also include a reference electrode, such as the reference electrode (234); and a position sensor, such as the position sensor (290). The incisions (470) of this example are formed through two opposing surfaces of the distal portion (412) such that the distal portion (312) is allowed to form strips (472) that fan out from each other or are otherwise separated from each other along various dimensions. Although the incisions (470) are shown as having a zigzag shape, the incisions (470) can alternatively have any other suitable shape. Similarly, while the incisions (470) are shown as being generally longitudinally oriented along the distal portion (412), the incisions (470) can be instead generally laterally oriented; or can be positioned and oriented in any other suitable manner along the panel assembly (410).

[0071] In some cases, it may be desirable to secure a panel component, such as any of the panel components (210, 310, 410) described above, to an inflatable body. Such an inflatable body may assist in deploying the panel component (210, 310, 410) after the panel component (210, 310, 410) is exposed from the outer sheath (122). Such an inflatable body may also provide additional structural integrity to the panel component (210, 310, 410), thereby assisting in ensuring proper contact between the electrodes (230, 232, 330, 332, 430, 432) and the tissue when the panel component (210, 310, 410) is pressed against the tissue. Figures 10 - 11 Two examples of ways in which an end effector (500, 600) may be formed by securing a panel component (210) to an inflatable body (510, 610) are shown. The end effectors (500, 600) of these examples are secured to the distal end of a catheter (120) and may generally operate as the end effector (200) described above. Although the panel component (210) is shown and described in these examples, the panel components (310, 410) and their variations may be used in place of the panel component (210). Additionally, although the inflatable bodies (510, 610) are shown and described in these examples, other variations may utilize a mechanically deployable body that does not require inflation for deployment.

[0072] As Figure 10 shown, the end effector (500) is formed by a panel component (210) and an inflatable body (510). The inflatable body (510) is in the form of a membrane that defines a plurality of openings (512). The inflatable body (510) of this example has a cylindrical shape in the deployed state, where the panel component (210) wraps around a longitudinally extending portion (514) of the inflatable body (510). The openings (512) are large enough to allow fluid to pass through the openings (512), while being small enough to allow the inflatable body to achieve and maintain a deployed state when the inflatable body (510) is filled with an inflation fluid (e.g., saline, etc.). In some configurations, the same fluid used to inflate the inflatable body (510) is discharged through the openings (512) to provide irrigation at a targeted site within the patient (PA)'s body. For example, fluid from a fluid source (42) may be discharged through the openings (512). Additionally or alternatively, the patient (PA)'s blood may enter the interior of the end effector (500) via the openings (512) to reach a reference electrode (234) that may be exposed within the interior of the inflatable body (510).

[0073] As another merely exemplary alternative, the inflatable body (510) can include two layers, wherein a fluid-sealed space between the layers receives inflation fluid such that the inflation fluid does not discharge through the opening (512). In some such configurations, flush fluid from the fluid source (42) is conveyed via the fluid conduit (40) to the interior of the inflatable body (510); and discharges through the opening (512). It should also be understood that the opening (512) can be omitted in some configurations. By way of further example only, the inflatable body (510) can be made of a non-extensible material. Alternatively, the inflatable body (510) can be made of an extensible material. In some variations, the body (510) does not include the opening (512). In such configurations (and in configurations where the opening (512) is present), the flush fluid can be discharged from the end effector (500) via one or more flush ports provided by the conduit (120).

[0074] In some cases, when the end effector (500) is positioned within a generally tubular anatomical structure such as a pulmonary vein, the cylindrical configuration of the inflatable body (510) can be particularly useful. For example, the curvature of the longitudinally extending portion (514) of the inflatable body (510) can facilitate contact between the electrodes (230, 232) and the curved inner wall of the pulmonary vein.

[0075] Figure 11 Another end effector (600) is shown, which is formed by a panel assembly (210) and an inflatable body (610). The inflatable body (610) is in the form of a membrane defining a plurality of openings (612). The inflatable body (610) of this example has a generally flat rectangular shape in the deployed state, with one panel assembly (210) positioned on one broad face (620) of the inflatable body (610). In some configurations, another panel assembly (210) is positioned on the other opposing broad face (622) of the inflatable body (610). The openings (612) are large enough to allow fluid to pass through the openings (612), while being small enough to allow the inflatable body to achieve and maintain the deployed state when the inflatable body (610) is filled with inflation fluid (e.g., saline, etc.). In some configurations, the same fluid used to inflate the inflatable body (610) discharges through the openings (612) to provide flushing at the targeted site within the patient (PA). For example, fluid from the fluid source (42) can discharge through the openings (612). Additionally or alternatively, blood of the patient (PA) can enter the interior of the end effector (600) via the openings (612) to reach the reference electrode (234), which can be exposed within the interior of the inflatable body (610).

[0076] As another merely exemplary alternative, the inflatable body (610) can include two layers, wherein a fluid-sealed space between the layers receives inflation fluid such that the inflation fluid does not discharge through the opening (612). In some such configurations, flushing fluid from the fluid source (42) is conveyed via the fluid conduit (40) to the interior of the inflatable body (610); and discharged through the opening (612). It should also be understood that in some configurations the opening (612) can be omitted. By way of further example only, the inflatable body (610) can be made of non-extensible material. Alternatively, the inflatable body (610) can be made of extensible material. In some variations, the body (610) does not include the opening (612). In such configurations (as well as in configurations where the opening (612) is present), the flushing fluid can be discharged from the end effector (600) via one or more flushing ports provided by the conduit (120).

[0077] In some cases, when the end effector (600) is positioned within an anatomical structure having a generally flat inner wall, such as the ventricle (H), the generally flat rectangular configuration of the inflatable body (610) can be particularly useful. For example, the flatness of the broad face (620) of the inflatable body (610) can facilitate contact between the electrodes (230, 232) and the generally flat inner wall of the ventricle (H).

[0078] Although the end effectors (500, 600) are shown as having inflatable bodies (510, 610) that have cylindrical and generally flat rectangular configurations, the panel assemblies (210, 310, 410) can alternatively be secured to inflatable bodies having various other types of configurations, as will be apparent to those skilled in the art in light of the teachings herein.

[0079] Although the panel assembly (210) was described above as incorporating the position sensor (290) in the distal portion (212) of the panel assembly (210), other variations can alternatively incorporate the position sensor (290) in the proximal end (220) of the panel assembly (210). Figures 15 - 18 An example of a manner in which this can be accomplished is shown. Specifically, Figures 15 - 16 A panel assembly (700) is shown that includes a distal portion (710) and a proximal tab portion (720), and a narrow region (712) separating the distal portion (710) from the proximal tab portion (720). The distal portion (710) can be configured and operated as the distal portions (212, 312, 412) described above; and thus can include electrodes (230, 232, 234, 330, 332, 430, 432), temperature sensors (240, 340, 440), openings (370), incisions (470), and the like.

[0080] Figures 15 - 16 The panel assembly (700) includes a biaxial (CA 1 ,CA 2 ) position sensor assembly integrated into the proximal tab portion (720). The proximal tab portion (720) includes a first laterally extending tab (722) and a second laterally extending tab (724). The first coil (730) and the second coil (732) are positioned on the second laterally extending tab (724). In some other configurations, at least one of the coils (730, 732) is positioned on the first laterally extending tab (722) or elsewhere on the proximal tab portion (720). By way of example only, the coils (730, 732) can be printed onto the proximal tab portion (720) as part of a flexible circuit configuration or otherwise integrated into the proximal tab portion (720) using any suitable technique, as will be apparent to those skilled in the art in light of the teachings herein.

[0081] Each coil (730, 732) surrounds its respective axis (CA 1 ,CA 2 ) at the center of the corresponding coil (730, 732). Each coil (730, 732) is operable to generate a signal indicative of the position and orientation of the panel assembly (700) within a patient (PA). By way of example only, the coils (730, 732) can be configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by a field generator (20). Each coil (730, 732) can be coupled along or otherwise through the catheter (120) to a wire, trace, or any other suitable electrical conduit such that the signal generated by the coil (730, 732) can be transmitted back to the console (12) through the electrical conduit (not shown) in the catheter (120). The console (12) can process the signals from each coil (730, 732) to identify the position of the panel assembly (700) within the patient (PA).

[0082] Figure 16 An example of a manner in which the proximal tab portion (720) can be rolled up to facilitate securing the panel assembly (700) to the distal end (132) of the inner shaft (130) is shown, as described above. In an example of the present invention, when the proximal tab portion (720) is in this rolled-up configuration, the tabs (722, 724) overlap. In the case where the proximal tab portion (720) is in the rolled-up configuration, the axes (CA 1 ,CA 2 ) of both coils (730, 732) are orthogonal to the longitudinal axis (LA) of the end effector incorporating the panel assembly (700). The axes (CA 1 ,CA 2Neither aligned with each other nor parallel to each other. In some configurations, when the proximal tab portion (720) is in the Figure 16 rolled-up configuration shown and is secured to the distal end (132) of the inner shaft (130), the axes (CA 1 , CA 2 ) of the coils (730, 732) are orthogonal to each other, although such an orthogonal relationship is not necessarily required.

[0083] Also as Figure 16 shown, when the proximal tab portion (720) is in the rolled-up configuration, the proximal tab portion (720) defines a channel (740). By way of example only, such a channel (740) can accommodate other instruments, such as guide wires, another catheter, etc. By way of further example only, the channel (740) can provide a path for draining flushing fluid (e.g., saline, etc.). Other suitable ways of using the channel (740) will be apparent to those skilled in the art in light of the teachings herein. Alternatively, not all objects necessarily require the use of the channel (740).

[0084] In some variations of the panel assembly (700), it may be desirable to provide additional position-sensing coil axes (CA 3 ). Figures 17 - 18 An example of a way to implement such a variation is shown. Specifically, Figures 17 - 18 a panel assembly (800) is shown that includes a distal portion (810) and a proximal tab portion (820), and a narrow region (812) separating the distal portion (810) from the proximal tab portion (820). The distal portion (810) can be configured and operated as the distal portions (212, 312, 412) described above; and can thus include electrodes (230, 232, 234, 330, 332, 430, 432), temperature sensors (240, 340, 440), openings (370), incisions (470), etc.

[0085] Figures 17 - 18 The panel assembly (800) of 1 , CA 2 , CA 3)Position sensor assembly. The proximal tab portion (820) includes a first laterally extending tab (822), a second laterally extending tab (824), and a distal extending tab (826) protruding from the second laterally extending tab (824). The first coil (830) and the second coil (832) are positioned on the second laterally extending tab (824). The third coil (834) is positioned on the distal extending tab (826). In some other configurations, at least one coil (830, 832, 834) is positioned on the first laterally extending tab (822) or elsewhere on the proximal tab portion (820). By way of example only, the coils (830, 832, 834) can be printed onto the proximal tab portion (820) as part of a flexible circuit configuration or can be otherwise integrated onto the proximal tab portion (820) using any suitable technique, as will be apparent to those skilled in the art in light of the teachings herein.

[0086] Each coil (830, 832, 834) surrounds its respective axis (CA 1 , CA 2 , CA 3 ) at the center of the corresponding coil (830, 832, 834). Each coil (830, 832, 834) is operable to generate a signal indicative of the position and orientation of the panel assembly (800) within the patient (PA). By way of example only, the coils (830, 832, 834) can be configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by a field generator (20). Each coil (830, 832, 834) can be coupled along or otherwise through the catheter (120) to a wire, trace, or any other suitable electrical conduit such that the signal generated by the coil (830, 832, 834) can be transmitted back to the console (12) through the electrical conduit (not shown) within the catheter (120). The console (12) can process the signals from each coil (830, 832, 834) to identify the position of the panel assembly (800) within the patient (PA).

[0087] Figure 18 An example of the manner in which the proximal tab portion (820) can be rolled up to facilitate securing the panel assembly (800) to the distal end (132) of the inner shaft (130) is shown, as described above. In the example of the present invention, when the proximal tab portion (820) is in this rolled-up configuration, the tabs (822, 824) overlap. In the case where the proximal tab portion (820) is in the rolled-up configuration, the axes (CA 1 , CA 2 ) of the coils (830, 832) are each orthogonal to the longitudinal axis (LA) of the end effector incorporating the panel assembly (800). The axes (CA 1,CA 2 ) are neither aligned with each other nor parallel to each other. In some configurations, when the proximal tab portion (820) is in the Figure 18 rolled-up configuration shown and is secured to the distal end (132) of the inner shaft (130), the axes (CA 1 ,CA 2 ) of the coils (830, 832) are orthogonal to each other, but such an orthogonal relationship is not necessarily required.

[0088] Also as Figure 18 shown, the distal extension tab (826) is folded over the channel (840) defined by the rolled-up lateral extension tabs (822, 824). This positions the axis (CA 3 ) of the coil (834) parallel to the longitudinal axis (LA) of the end effector of the bonding panel assembly (800). This also positions the axis (CA 3 ) of the coil (834) orthogonal to the axes (CA 1 ,CA 2 ) of the coils (830, 832). Compared with the position data generated by the biaxial (CA 1 ,CA 2 ) sensing assembly defined by the coils (730, 732) of the panel assembly (700), the additional sensing axis (CA 3 ) provided by the coil (834) can generate additional position and orientation data associated with the panel assembly (800).

[0089] In some configurations, the distal extension tab (826) defines an opening (not shown) within the central region of the coil (834). Such an opening can accommodate other instruments, such as guide wires, another catheter, etc. By way of further example only, an opening formed through the distal extension tab (826) within the central region of the coil (834) can provide a path for draining flushing fluid (e.g., saline, etc.). Other suitable ways of using such an opening will be apparent to those skilled in the art in light of the teachings herein. Alternatively, the opening does not necessarily need to be formed through the distal extension tab (826).

[0090] Even though the panel assemblies (700, 800) include coils (730, 732, 830, 832, 834) to provide position sensing, the distal portions (710, 810) can also include one or more position sensors (e.g., as the position sensor (290) of the panel assembly (210)).

[0091] In some variations, a pull wire or other actuator can be utilized to further deploy the panel assembly. Figures 19 - 20 An example of a way in which this can be achieved is shown. Specifically, Figures 19 - 20A panel assembly (900) is shown, which includes a distal portion (910) and a proximal tab portion (920), as well as a narrow region (912) separating the distal portion (910) from the proximal tab portion (920). The distal portion (910) can be configured and operated as the distal portions (212, 312, 412) described above; and thus can include electrodes (230, 232, 234, 330, 332, 430, 432), temperature sensors (240, 340, 440), openings (370), cuts (470), etc. The proximal tab portion (920) includes a pair of laterally extending tabs (922). By way of example only, the tabs (922) can be configured and operated as the tabs (722, 724, 822, 824, 826).

[0092] The panel assembly (900) of this example further includes a plurality of slits (914) formed through the distal portion (910). The slits (914) effectively define a plurality of strap regions (916) between the slits (914). Although the slits (914) are shown as straight lines in this example, the slits (914) can alternatively have a zigzag configuration, a wavy configuration, or any other suitable configuration. A pull wire (930) is fixed to the distal region of the distal portion (910) via an anchor (932). In some other forms, a belt, strip, or other actuating member is used instead of the pull wire (930).

[0093] The panel assembly (900) is configured to transition from a flat configuration as shown Figure 19 to an additional deployed configuration as shown Figure 20 in response to proximal retraction of the pull wire (930). When the pull wire (930) is retracted proximally, the strap regions (916) can bend outwardly in the opposite direction as the proximal regions of the strap regions (916) are effectively mechanically grounded, as shown Figure 20 in. In some forms, the panel assembly (900) can include reinforcing features selectively configured and positioned that allow such outward bending of the strap regions (916) while preventing the remainder of the panel assembly (900) from simply collapsing proximally when the pull wire (930) is retracted proximally.

[0094] Thus, the panel assembly (900) can be operated to transition from an undeployed configuration (e.g., similar to the configuration shown Figure 2A ) when the panel assembly (900) is housed within an outer sheath (122); to a first deployed configuration (e.g., as shown Figure 19 ) when the panel assembly (900) is exposed relative to the outer sheath (122); and then to a second deployed configuration (e.g., as shown Figure 20As shown). In this second deployed configuration, the panel assembly (900) may be more inclined to facilitate contact between the electrodes (230, 232, 234, 330, 332, 430, 432) on the panel assembly (900) and adjacent tissue.

[0095] IV. Examples of Combinations

[0096] The following embodiments relate to various non - exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following embodiments are not intended to limit the scope of any claims that may be provided at any time in this patent application or in subsequent filings of this patent application. There is no intended disclaimer. The following embodiments are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also envisioned that some variations may omit certain features mentioned in the following embodiments. Thus, none of the aspects or features mentioned below should be considered decisive, unless otherwise expressly indicated as such, for example, by the inventors or their successors in interest at a later date. If any claims presented in this patent application or in subsequent filings related to this patent application include additional features beyond those mentioned below, these additional features should not be assumed to have been added for any reason related to patentability.

[0097] Example 1

[0098] An apparatus, the apparatus comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) a panel biased to assume a deployed configuration, (ii) a plurality of mapping electrodes positioned on a first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, and (iii) a plurality of ablation electrodes positioned on the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes.

[0099] Example 2

[0100] The apparatus according to Embodiment 1, wherein the panel includes a distal portion biased to assume a generally flat shape in the deployed configuration.

[0101] Example 3

[0102] The apparatus according to any one or more of Embodiments 1 to 2, wherein the panel includes a distal portion having a generally rectangular shape.

[0103] Example 4

[0104] The device according to any one or more of embodiments 1 to 3, wherein the catheter includes an outer sheath, and the outer sheath and the end effector are configured to transition between a first state and a second state, the end effector being received within the outer sheath in the first state and being exposed relative to the outer sheath in the second state.

[0105] Example 5

[0106] The device according to embodiment 4, wherein the panel is configured to be in an undeployed configuration within the outer sheath in the first state.

[0107] Example 6

[0108] The device according to embodiment 5, wherein the panel is configured to be in a rolled-up undeployed configuration within the outer sheath in the first state.

[0109] Example 7

[0110] The device according to any one or more of embodiments 4 to 6, wherein the panel includes a proximal portion having a convex feature configured to mate with a distal end of another sheath so as to push the panel from the deployed configuration to the undeployed configuration in response to the outer sheath and the end effector transitioning from the second state to the first state.

[0111] Example 8

[0112] The device according to embodiment 7, wherein the cam feature includes a tapered proximally-facing edge of the panel.

[0113] Example 9

[0114] The device according to any one or more of embodiments 7 to 8, wherein the cam feature includes a concave curved portion of a proximal region of the panel.

[0115] Example 10

[0116] The device according to any one or more of embodiments 1 to 9, wherein the panel is elastically biased to assume the deployed configuration.

[0117] Example 11

[0118] The device according to Embodiment 10, wherein the panel comprises an elastic material that biases the panel to assume the deployed configuration.

[0119] Example 12

[0120] The device according to Embodiment 11, wherein the elastic material comprises nitinol.

[0121] Example 13

[0122] The device according to any one or more of Embodiments 11 to 12, wherein the panel comprises a plurality of layers, and at least one of the layers comprises the elastic material.

[0123] Example 14

[0124] The device according to Embodiment 13, wherein the layer further comprises a non-conductive layer, and at least one of the mapping electrodes and at least one of the ablation electrodes are positioned on a first side of the non-conductive layer, and the elastic material is positioned on a second side of the non-conductive layer.

[0125] Example 15

[0126] The device according to any one or more of Embodiments 1 to 14, wherein the end effector further comprises an inflatable member to which the panel is secured.

[0127] Example 16

[0128] The device according to Embodiment 15, wherein the inflatable member is configured to bias the panel to assume the deployed configuration.

[0129] Example 17

[0130] The device according to any one or more of Embodiments 15 to 16, wherein the inflatable member defines a plurality of openings configured to permit fluid communication between an interior region and an exterior region of the inflatable member.

[0131] Example 18

[0132] The device according to any one or more of Embodiments 15 to 17, wherein the inflatable member is configured to define a cylindrical shape in an inflated state.

[0133] Example 19

[0134] The device according to any one or more of embodiments 15 to 17, wherein the expandable member is configured to define a substantially flat rectangular shape in the expanded state.

[0135] Example 20

[0136] The device according to any one or more of embodiments 1 to 19, wherein the end effector further comprises at least one reference electrode.

[0137] Example 21

[0138] The device according to embodiment 20, wherein the at least one reference electrode comprises one or more reference electrodes positioned on a second surface of the panel, the second surface being opposite the first surface.

[0139] Example 22

[0140] The device according to embodiment 21, wherein the second surface of the panel comprises features for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface.

[0141] Example 23

[0142] The device according to embodiment 22, wherein the features for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface comprise one or more walls surrounding the one or more reference electrodes, the one or more walls protruding from the second surface.

[0143] Example 24

[0144] The device according to any one or more of embodiments 22 to 23, wherein the features for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface comprise one or more grooves formed in the second surface, each of the one or more reference electrodes being positioned in a corresponding one of the one or more grooves.

[0145] Example 25

[0146] The device according to any one or more of embodiments 20 to 24, wherein the catheter comprises a shaft, and the at least one electrode comprises one or more electrodes positioned on the shaft.

[0147] Example 26

[0148] The device according to any one or more of embodiments 1 to 25, wherein the mapping electrodes are arranged in a matrix of rows and columns along the first surface.

[0149] Example 27

[0150] The device according to any one or more of Embodiments 1 to 26, wherein the ablation electrodes are arranged in a matrix of rows and columns along the first surface.

[0151] Example 28

[0152] The device according to any one or more of Embodiments 1 to 25, wherein the mapping electrodes are arranged in a first matrix of rows and columns along the first surface, and the ablation electrodes are arranged in a second matrix of rows and columns along the first surface, and the second matrix is offset from the first matrix.

[0153] Example 29

[0154] The device according to any one or more of Embodiments 1 to 28, wherein the end effector further comprises a plurality of temperature sensors.

[0155] Example 30

[0156] The device according to Embodiment 29, wherein the temperature sensor comprises a thermocouple.

[0157] Example 31

[0158] The device according to Embodiment 30, wherein the thermocouple comprises a thermistor.

[0159] Example 32

[0160] The device according to any one or more of Embodiments 1 to 31, wherein the panel further defines a plurality of openings therethrough.

[0161] Example 33

[0162] The device according to Embodiment 32, wherein the openings are arranged in a matrix.

[0163] Example 34

[0164] The device according to any one or more of Embodiments 1 to 33, wherein the panel defines a plurality of cuts separating a plurality of strips, and the strips are movable relative to each other at the cuts.

[0165] Example 35

[0166] The device according to Embodiment 34, wherein the cuts define a zigzag pattern.

[0167] Example 36

[0168] An apparatus, the apparatus comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) a panel defining a first surface and a second surface opposite the first surface, (ii) a plurality of mapping electrodes arranged in a first grid pattern along the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, and (iii) a plurality of ablation electrodes arranged in a second grid pattern along the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, the second grid being offset from the first grid.

[0169] Example 37

[0170] The apparatus according to embodiment 36, wherein the end effector further comprises at least one reference electrode positioned on the second surface.

[0171] Example 38

[0172] The apparatus according to embodiment 37, wherein the at least one reference electrode comprises a plurality of reference electrodes arranged in a grid pattern along the second surface.

[0173] Example 39

[0174] An apparatus, the apparatus comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) a panel defining a first surface and a second surface opposite the first surface, (ii) a plurality of mapping electrodes positioned along the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, (iii) a plurality of ablation electrodes positioned along the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, a second grid being offset from a first grid, and (iv) one or more reference electrodes positioned on the second surface of the panel.

[0175] Example 40

[0176] An apparatus, the apparatus comprising: (a) a catheter, at least a portion of the catheter being sized and configured to fit within a lumen of a cardiovascular system, the catheter including an outer sheath; and (b) an end effector positioned at a distal end of the catheter, the outer sheath being operable to transition between a distal position and a proximal position, the end effector including: (i) a panel defining a first surface and a second surface opposite the first surface, the panel being configured to assume a rolled-up configuration within the outer sheath when the outer sheath is in the distal position and to assume a generally flat configuration when the outer sheath is in the proximal position, (ii) a plurality of mapping electrodes positioned along the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, (iii) a plurality of ablation electrodes positioned along the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, a second grid being offset from a first grid.

[0177] V. Miscellaneous

[0178] Any of the instruments described herein may be cleaned and sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and the device may then be placed in a radiation field that penetrates the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. Any other technique known in the art may also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization (with or without gas plasma or vapor).

[0179] It should be understood that any example described herein may also include various other features in addition to or in place of those described above. By way of example only, any example described herein may also include one or more of the various features disclosed in any one of the various references incorporated herein by reference in their entirety.

[0180] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be regarded as being isolated from one another. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0181] It should be understood that any patent, patent publication, or other published material that is alleged to be incorporated by reference in its entirety herein, whether in whole or in part, is incorporated herein only to the extent that such incorporated material does not conflict with the existing definitions, statements, or other published material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure set forth herein expressly supersedes any conflicting material incorporated by reference herein. Any material or portion thereof that is alleged to be incorporated by reference in its entirety herein but conflicts with the existing definitions, statements, or other published material set forth herein will be incorporated only to the extent that it does not create a conflict with the existing published material.

[0182] Having shown and described various forms of the present invention, further improvements to the methods and systems described herein can be achieved by those of ordinary skill in the art through appropriate modifications without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, forms, geometries, materials, dimensions, ratios, steps, and the like discussed above are exemplary and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood to be not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A device comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at the distal end of the catheter, the end effector comprising: (i) a panel biased to assume a deployed configuration, (ii) a plurality of mapping electrodes positioned on the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, and (iii) a plurality of ablation electrodes positioned on the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, The end actuator further comprises one or more reference electrodes positioned on a second surface of the panel, the second surface being opposite to the first surface, and the second surface of the panel comprises a feature structure for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface.

2. The device of claim 1, the panel comprising a distal portion biased to assume a flat shape in the expanded configuration.

3. The device of claim 1, the panel comprising a distal portion having a rectangular shape.

4. The device according to claim 1, wherein the catheter includes an outer sheath, and the outer sheath and the end actuator are configured to convert between a first state and a second state, wherein the end actuator is accommodated within the outer sheath in the first state and is exposed relative to the outer sheath in the second state.

5. According to the device according to claim 4, the panel includes a proximal portion having a convex feature structure, which is configured to cooperate with the distal end of another sheath, thereby pushing the panel from the expanded configuration to the non-expanded configuration in response to the outer sheath and the end actuator being transformed from the second state to the first state.

6. The apparatus of claim 1, said panel being resiliently biased to assume said expanded configuration.

7. The apparatus of claim 6, the panel comprising an elastic material, the elastic material biasing the panel to assume the expanded configuration.

8. The apparatus of claim 7, the panel comprising a plurality of layers, at least one of the layers comprising the elastic material.

9. According to the device according to claim 8, the layer also includes a non-conductive layer, at least one of the mapping electrodes and at least one of the ablation electrodes are positioned on the first side of the non-conductive layer, and the elastic material is positioned on the second side of the non-conductive layer.

10. The apparatus of claim 1, the end effector further comprising an expandable member to which the panel is secured, the expandable member being configured to bias the panel to assume the deployed configuration.

11. The apparatus of claim 10, the expandable member being configured to define a cylindrical shape in an expanded state.

12. The apparatus of claim 10, the expandable member being configured to define a flat rectangular shape in an expanded state.

13. The apparatus of claim 1, wherein the mapping electrodes are arranged in a first matrix of rows and columns along the first surface, and the ablation electrodes are arranged in a second matrix of rows and columns along the first surface, the second matrix being offset from the first matrix.

14. The apparatus of claim 1, the end effector further comprising a plurality of temperature sensors.

15. The apparatus of claim 1, the panel further defining a plurality of openings therethrough.

16. The apparatus of claim 1, the panel defining a plurality of cutouts separating a plurality of strips, the strips being movable relative to one another at the cutouts.

17. A device comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at the distal end of the catheter, the end effector comprising: (i) a panel, the panel defining a first surface and a second surface, the second surface being opposite to the first surface, (ii) a plurality of mapping electrodes arranged in a first grid along the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, and (iii) a plurality of ablation electrodes arranged in a second grid along the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, the second grid being offset from the first grid, The end actuator further comprises one or more reference electrodes positioned on a second surface of the panel, the second surface being opposite to the first surface, and the second surface of the panel comprises a feature structure for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface.

18. A device comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of a cardiovascular system; and (b) an end effector positioned at the distal end of the catheter, the end effector comprising: (i) a panel, the panel defining a first surface and a second surface, the second surface being opposite to the first surface, (ii) a plurality of mapping electrodes positioned along the first surface of the panel, the mapping electrodes being configured to sense electrical potentials in tissue contacting the mapping electrodes, (iii) a plurality of ablation electrodes positioned along the first surface of the panel, the ablation electrodes being operable to ablate tissue contacting the ablation electrodes, the second grid being offset from the first grid, and (iv) one or more reference electrodes, said one or more reference electrodes being positioned on said second surface of said panel, The second surface is opposite to the first surface, and the second surface of the panel includes a feature structure for preventing the one or more reference electrodes from contacting tissue adjacent to the second surface.

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