Catheter with thin film electrodes on an expandable membrane

Abstract

The present invention discloses a device comprising a catheter and an end effector. The end effector comprises an expandable body and a plurality of electrodes deposited on the outer surface of the expandable body. The expandable body is configured to transition between a non-expanded state and an expanded state. The expandable body has an inner surface and an outer surface. The expandable body defines a plurality of openings extending from the inner surface to the outer surface. The electrode is configured to expand from the non-expanded state to the expanded state together with the expandable body. The electrode comprises one or more electrodes selected from the following: a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and an ablation electrode operable to ablate tissue contacting the ablation electrode.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 900,749, filed on September 16, 2019, entitled “Catheter with Thin-Film Electrodes on Expandable Membrane,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Arrhythmias, such as atrial fibrillation, occur when an area of ​​cardiac tissue conducts electrical signals abnormally. Procedures for treating arrhythmias include surgically interrupting the conduction pathways for such signals. By applying energy (e.g., alternating current or direct current energy) to selectively ablate cardiac tissue, it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a block to the unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissue.

[0004] In some procedures, a catheter with 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 cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). The electrodes can be placed in contact with cardiac 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, a monopolar electrode can be used in conjunction with a ground pad or other reference electrode in contact with the patient.

[0005] Examples of ablation catheters are described in U.S. Publication 2013 / 0030426, entitled “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; 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; U.S. Publication 2018 / 0071017, entitled “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; and U.S. Publication 2018 / 0071017, entitled “Catheter with Bipole Electrode Spacer and Related Methods”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,130,422, published on November 20, 2018, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,956,353, published on February 17, 2015, entitled “Electrode Irrigation Using Micro-Jets”, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 9,801,585, published on October 31, 2017, entitled “Electrocardiogram Noise Reduction”, the disclosure of which is incorporated herein by reference in its entirety.

[0006] Some catheter ablation procedures may be performed after using electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may include the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). Such sensing electrodes can monitor electrical signals emanating from the conductive endocardial tissue to precisely locate the location of abnormal conductive tissue sites that cause arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, entitled "Cardiac Electromechanics," issued on April 14, 1998, the disclosure 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.

[0007] In addition to using EP mapping, some catheter ablation procedures can also be performed using image-guided surgery (IGS) systems. An IGS system can enable a physician to visually track the position of a catheter within a patient relative to an image of the patient's anatomy in real time. Some systems offer a combination of EP mapping and IGS functionality, including the CARTO Examples of catheters configured for use with the IGS system are disclosed in U.S. Patent No. 9,480,416, entitled “Signal Transmission Using Catheter Braid Wires,” issued November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety, and various other references cited herein.

[0008] While several surgical systems and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0010] Figure 1 A schematic diagram illustrating a medical procedure for inserting a catheter of a catheter assembly into a patient;

[0011] Figure 2A Shown Figure 1 a top plan view of a catheter assembly with the end effector in a non-expanded state;

[0012] Figure 2B Shown Figure 1 a top plan view of a catheter assembly with the end effector in an expanded state;

[0013] Figure 3 Shown in expanded state Figure 2A An enlarged perspective view of an end effector;

[0014] Figure 4 Shown Figure 2A An enlarged perspective view of an example of a variation of an end effector of wherein an integral resilient element assists in urging the end effector to an expanded state;

[0015] Figure 5 Shown Figure 2A a cross-sectional view of a portion of an end effector;

[0016] Figure 6 Shown can be combined with Figure 1 An enlarged perspective view of an example of an alternative end effector in a catheter assembly;

[0017] Figure 7 Shown can be combined with Figure 1 An enlarged perspective view of another example of an alternative end effector in a catheter assembly;

[0018] Figure 8 Shown can be combined with Figure 1 An enlarged perspective view of another example of an alternative end effector in a catheter assembly;

[0019] Figure 9 Shown can be combined with Figure 1 A top plan view of a flattened body of another example of an alternative end effector in a catheter assembly;

[0020] Figure 10 Shown in conjunction with Figure 1 The end effector of the catheter assembly Figure 9 an enlarged perspective view of the subject; and

[0021] Figure 11 Shown Figure 10 A cross-sectional view of a portion of an end effector. DETAILED DESCRIPTION

[0022] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. The accompanying drawings (not necessarily drawn to scale) illustrate selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principle of the present invention by way of example and not by way of limitation. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best approach is envisioned for implementing the present invention. As will be appreciated, the present invention can have other different or equivalent aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and not restrictive in nature.

[0023] Any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. described herein. Therefore, the following teachings, expressions, versions, examples, etc. should not be considered separate from one another. Various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art with reference to the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0024] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows the part or collection of elements to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of ±10% of the recited value, for example, "about 90%" can refer to a range of values ​​from 81% 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 systems or methods to human use, although use of the subject invention in human patients represents a preferred embodiment.

[0025] I. Overview of Examples of Catheter Systems

[0026] Figure 1 An example of a medical procedure and associated components of a cardiac ablation system is shown. Specifically, Figure 1 A physician (PH) is shown grasping the handle (110) of the catheter assembly (100) wherein the flexible catheter (120) of the catheter assembly (100) ( Figures 2A to 3 Shown but not in Figure 1The end effector (200) is positioned within a patient (PA) to map or ablate tissue in or near a heart (H) of the patient (PA). Figures 2A to 3 As shown, the catheter (120) includes an outer sheath (122), wherein the end effector (200) is disposed at or near the distal end (124) of the outer sheath (122). The catheter assembly (100) is coupled to the guidance and drive system (10) via a cable (30). The catheter assembly (100) is also connected to a fluid source (42) via a fluid conduit (40), but this is only optional. A set of field generators (20) are positioned below the patient (PA) and are also coupled to the guidance and drive system (10) via a cable (22).

[0027] The guidance and drive system (10) of the present 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 electrodes (250) of an 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. In addition or in an alternative, the first driver module (14) can be operable to provide electrical power to the electrodes (260) of the end effector (200) to ablate tissue. In some versions, the first driver module (14) can also be operable to receive position indication signals from one or more position sensors (270) in the end effector (200), as described in more detail below. In this type of arrangement, the processor of the console (12) is further operable to process the position-indicative signal from the position sensor (270) to determine the position of the end effector (200) of the catheter (120) within the patient (PA).

[0028] 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 the alternating magnetic field in a predetermined working volume that accommodates the heart (H).

[0029] The display (18) is coupled to the processor of the console (12) and is operable to present an image of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D maps, etc.). The view of the patient's anatomy provided by the display (18) may also be dynamically changed based on a signal from a position sensor (270) 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 (270) may cause the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to depict the area of ​​the patient's anatomy around the end effector (200) as the end effector (200) moves within the patient (PA). In addition, the processor of the console (12) may drive the display (18) to display the location of abnormal conductive tissue sites detected by EP mapping using the end effector (200). By way of example only, the processor of console (12) may drive display (18) to superimpose the location of the abnormal conductive tissue site on an image of the patient's anatomy, such as by superimposing an illuminated dot, crosshairs, or some other form of visual indication of the abnormal conductive tissue site.

[0030] 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 superimposing an illuminated dot, a crosshair, 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 the operator with real-time visual feedback 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 that tracks the position of the end effector (200) within the patient (PA) without having to have any optical instrument (i.e., a camera) to view 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) may view the display (18) to observe the real-time positioning of the end effector (200) relative to the mapped abnormal conductive tissue site and relative to an image of adjacent anatomical structures within the patient (PA).

[0031] The fluid source (42) of this example comprises a bag containing saline or some other suitable irrigation fluid. The conduit (40) comprises a flexible tube that is also coupled to a pump (44) that is 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 omitted entirely. In versions that include these components, the end effector (200) can be configured to deliver irrigation fluid from the fluid source (42) to a target site within the patient's body. Such irrigation can be provided in accordance with the teachings of any of the various patent references cited herein; or in any other suitable manner that would be apparent to one skilled in the art having reference to the teachings herein.

[0032] Figures 2A to 2B The ablation catheter assembly (100) is shown in more detail. As shown, the catheter (120) extends distally from the handle (110); and the fluid connector assembly (130) extends proximally from the handle (110). The fluid connector assembly (130) is configured to couple with the tubing (40) to provide a path for delivering irrigation fluid from the fluid source (42) to the end effector (200). Since fluid irrigation is merely an optional feature of the ablation catheter assembly (100), the fluid connector assembly (130) may be omitted if desired. The handle (110) of this example also includes a socket (112) configured to receive a plug (not shown) on the distal end of the cable (30), thereby providing a path for electrical communication between the console (12) and the end effector (200). In view of the teachings herein, various suitable components and configurations that can be used to form these components will be apparent to those skilled in the art.

[0033] II. Examples of End Effectors Having Expandable Bodies Including Flexible Circuits

[0034] like Figures 2A to 2B and Figure 3 As shown, the end effector (200) is positioned at the distal end (124) of the catheter (120). Figures 2A to 2B The end effector (200) is shown in schematic form, and Figure 3 The end effector (200) is shown in more detail. The end effector (200) is configured to be in a non-expanded configuration ( Figure 2A ) and the expanded configuration ( Figure 2B). In some versions, the end effector (200) is configured to have a size less than or equal to about a 6 French catheter diameter when in the non-expanded configuration. As the catheter (120) is inserted into the patient (PA), the end effector (200) can remain in the non-expanded configuration. Once the end effector (200) reaches the target site in the patient, the end effector (200) can be transformed into the expanded configuration. In some versions, the end effector (200) is positioned within a sheath (not shown) during transport toward the target site in the patient (PA) while the end effector (200) is in the non-expanded configuration. The sheath can be slidably disposed over the catheter (120). Once the distal end (124) reaches the target site, the end effector (200) can be positioned distally relative to the distal end of the sheath and can then be transformed into the expanded configuration. Some examples of how end effector (200) may transition between a non-expanded configuration and an expanded configuration are described in greater detail below, while other examples will be apparent to those skilled in the art in view of the teachings herein.

[0035] The end effector (200) is positioned distal to the distal end (124) of the outer sheath (122). In some cases, the end effector (200) is slidably disposed within the outer sheath (122); and the end effector (200) and the outer sheath (122) are advanced together into a lumen (e.g., an artery, a vein, etc.) of a patient (PA) until the distal end (124) is proximal to a target site within the patient (PA). As the end effector (200) and the outer sheath (122) combination are advanced into position, the end effector (200) can initially be retracted proximally relative to the distal end (124). Once the target site is reached, the end effector (200) can be advanced distally while the outer sheath (120) remains stationary, thereby advancing the end effector (200) from the distal end (124). Alternatively, end effector (200) may remain stationary as outer sheath (122) is retracted proximally to reveal end effector (200).

[0036] like Figure 3As shown, the end effector (200) in this example includes an inflatable body (210), a plurality of mapping electrodes (220), a plurality of ablation electrodes (222), a central axis (126) and a distal hub (270). The inflatable body (210) is in the form of a membrane that defines a plurality of openings (212). The openings (212) are large enough to allow fluid to pass through the openings (212), while being small enough to allow the inflatable body (210) to achieve and maintain an expanded state when filled with an inflation fluid (e.g., saline, etc.). In some versions, the same fluid used to inflate the inflatable body (210) is discharged through the openings (212) to provide flushing at a target site in the patient (PA). For example, fluid from a fluid source (42) can be discharged through the openings (212). Additionally or alternatively, blood from the patient (PA) may enter the interior of the end effector (200) via opening (212) to a reference electrode (128) coaxially mounted to the central shaft (126). Such a reference electrode (128) will be described in greater detail below.

[0037] As another merely illustrative alternative, the inflatable body (210) may comprise two layers with a fluid-tight space between the layers for receiving the inflation fluid, such that the inflation fluid does not exit through the opening (212). In some such versions, irrigation fluid from the fluid source (42) is delivered to the interior of the inflatable body (210) via the fluid conduit (40); and exits through the opening (212). It should also be understood that in some versions, the opening (212) may be omitted. By way of further example only, the inflatable body (210) may be made of a non-extensible material. Alternatively, the inflatable body (210) may be made of an extensible material. In some variations, the body (210) lacks the opening (212). In this version (and in versions in which the opening (212) is present), the irrigation fluid may exit the end effector (200) via the central shaft (126). For example, the central shaft (126) may include at least one distal opening or a lateral opening configured to discharge an irrigation fluid.

[0038] Figure 4 An example of a variation of the end effector (200) is shown. In this example, the end effector (200') includes a plurality of elastic strips (290) fixed to (or otherwise coupled to) the body (210). For simplicity, Figure 4 The depiction of the end effector (200') in FIG. 2 omits other components of the end effector (200), but it should be understood that the only difference between the end effector (200) and the end effector (200') is the inclusion of the elastic strip (290) in the end effector (200'). The elastic strip (290) is configured to cause the body (210) to move toward Figure 4The expanded configuration shown in FIG. 2 is elastically biased. In some such versions, body (210) is not filled with any type of fluid to drive expansion, such that elastic strip (290) alone provides sufficient bias (200) for end effector to achieve the expanded state. In some other versions, elastic strip (290) cooperates with the inflation fluid to supplement the inflation of body (210) caused by the inflation fluid.

[0039] By way of example only, the elastic strip (290) may comprise Nitinol. By way of further example only, the elastic strip (290) may be deposited directly on the inner or outer surface of the body (210). For example, the elastic strip (290) may be formed from Nitinol that is vapor deposited onto the inflatable body (210) as a thin film (e.g., by a physical vapor deposition (PVD) process). By way of example only, such a PVD process may be performed in accordance with at least some of the teachings of 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 of 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 German Patent Publication 102017130152, 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 The present invention relates to a composite material comprising at least some of the teachings of U.S. Patent No. 10,061,198, entitled "Substrate", the disclosure of which is incorporated herein by reference in its entirety. Other methods may also be used to deposit the elastic strip (290), including but not limited to sputtering deposition, chemical vapor deposition (CVD), thermal deposition, etc. It should also be understood that the elastic strip (290) may be formed of other materials in addition to or instead of being formed of Nitinol.

[0040] exist Figure 3In the example shown, the mapping electrodes (220) are arranged in a generally circumferential array extending along respective latitudinal paths, wherein such latitudinal paths are longitudinally spaced apart from one another. Figure 3 In the example shown, ablation electrodes (222) are arranged in a generally longitudinal array extending along respective longitudinal paths, wherein such longitudinal paths are angularly spaced from one another. Of course, these arrangements of electrodes (220, 222) are merely illustrative examples. It will be apparent to those skilled in the art in view of the teachings herein that electrodes (220, 222) may be positioned in any other suitable locations and arrangements.

[0041] The electrodes (220, 222) may each be printed directly on or otherwise applied directly to the body (210). Figure 5 An example is shown in which electrodes (220) and corresponding conductive traces (221) are applied directly to the body (210). By way of example only, the electrodes (220) and traces (221) may be applied to the body (210) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process. For example, any of the processes described above with respect to applying the elastic strip (290) to the body (210) may also be used to apply the electrodes (220, 222) to the body (210). Each electrode (220, 222) may be similarly applied to the body (210) with a corresponding trace. In some versions, a layer of electrically insulating material is further applied on or between the traces (221) of the electrodes (220, 222).

[0042] In versions of the end effector (200') that include a resilient strip (290), the electrodes (220, 222) may be applied separately from the resilient strip (290). In other words, the electrodes (220, 222) may be spaced apart from the resilient strip (290) on the surface of the body (210). In some other versions of the end effector (200') that include a resilient strip (290), the electrodes (220, 222) may be applied directly to the concave resilient strip (290). In some such versions, the electrodes (642, 644) may be applied to the concave resilient strip (290) in a manner similar to that described below in the context of applying the electrodes (642, 644) to the strip body (610), as shown in FIG. Figure 11 As shown, electrodes (220, 222) are applied to the elastic strip (290).

[0043] The mapping electrodes (220) are configured to provide EP mapping (e.g., to provide an electrocardiogram signal) by contacting tissue and picking up electrical potentials from the contacted tissue. In some versions, the mapping electrodes (220) cooperate in bipolar pairs during such a mapping procedure. Thus, the pair of mapping electrodes (220) can be considered to collectively form a single "sensor." Each mapping electrode (220) can be connected to a corresponding trace (221) ( Figure 5 ) or other electrical conduits so that the signals picked up by the mapping electrodes (220) can be transmitted back to the console (12) through the electrical conduits (not shown) in the catheter (120), which 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 appropriate area of ​​cardiac tissue to be ablated (e.g., with electrical energy, cryoablation, etc.) to prevent or at least reduce the spread of abnormal electrical activity on the cardiac tissue.

[0044] As mentioned above and as Figure 3 As shown, the end effector (200) also includes a pair of reference electrodes (128) coaxially mounted to the central shaft (126). Such reference electrodes (128) can be used in conjunction with the electrode (220) during the EP mapping procedure. For example, the reference electrodes (128) can be used to pick up a reference potential from blood or saline passing through the interior of the end effector (200) via the opening (212) during the EP mapping procedure. As is known in the art, such reference potentials can be used to reduce noise or far-field signals. In the present example, since the reference electrodes (128) are effectively housed within the interior of the inflatable body (210), the inflatable body (210) will prevent tissue from contacting the reference electrodes (128) during the use of the end effector (200) during the EP mapping procedure; while still allowing blood and saline to flow freely through the end effector (200) to reach the reference electrodes (128). Alternatively, the reference electrodes (128) can be positioned at any other suitable location; and any other suitable number of reference electrodes (128) can be provided.

[0045] Figure 5Another example is shown in which a reference electrode (230) is positioned on the inside of the inflatable body (210), opposite the electrode (220). In this example, the reference electrode (230) and corresponding traces (231) can be applied directly to the inflatable body (210), such as by using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process. In some versions, a layer of electrically insulating material is further applied on or between the traces (231) of the reference electrode (230). The reference electrode (230) can operate similarly to the reference electrode (128) described above, such that the reference electrode (230) can be used to pick up a reference potential from blood or saline passing through the interior of the end effector (200) via the opening (212) during an EP mapping procedure. Because the reference electrode (230) will be positioned within the interior of the end effector (200), the body (210) will prevent tissue from contacting the reference electrode (230) during use of the end effector (200) in an EP mapping procedure; while still allowing blood and saline to flow freely through the end effector (200) to reach the reference electrode (230). The trace (231) forms part of the path that the signal picked up by the reference electrode (230) takes to reach the console (12). In some versions, only a single reference electrode (230) is positioned opposite each mapping electrode (220). Alternatively, the reference electrode (230) may have any other suitable spatial or structural relationship to the mapping electrodes (230).

[0046] In such Figure 3 In the example of the present invention shown, the ablation electrodes (222) are larger than the mapping electrodes (220) in this example. The ablation electrodes (222) can be used to apply electrical energy to tissue in contact with the electrodes (222), thereby ablating the tissue. Each ablation electrode (222) can be connected to a corresponding trace (e.g., similar to Figure 5 The arrangement shown) or other electrical conduits are coupled to the catheter (120) so that the console (12) can transmit electrical energy through the electrical conduits (not shown) in the catheter (120) to the traces or other conduits to reach the ablation electrodes (222). In some cases, only one, only two, or some other relatively small number of ablation electrodes (222) are activated at any given moment to apply electrical energy to the tissue. As with the mapping electrodes (220), as Figure 3 The number and positioning of ablation electrodes (222) shown are merely illustrative. Any other suitable number or positioning of ablation electrodes (222) may be used. As yet another merely illustrative variation, ablation electrodes (222) may be omitted from end effector (200). In some such variations, mapping electrodes (220) are still included on end effector (200). As used herein, the term "ablation" is intended to encompass radiofrequency ablation or irreversible electroporation.

[0047] By way of example only, the electrodes (128, 220, 222, 230) may be formed of nitinol, platinum, gold, or any other suitable biocompatible material. In some versions, the electrodes (128, 220, 222, 230) are formed of a ductile material and are thus configured to expand with the body (210). The electrodes (220, 222, 230) may be applied directly to the body (210) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process. If desired, the electrodes (128, 220, 222, 230) may include various coatings. For example, the electrode (220) may include a coating selected to improve the signal-to-noise ratio of the signal from the electrode (220). Such coatings may include, but are not necessarily 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. Various suitable types of coatings that can be used for electrodes (128, 220, 222, 230) will be apparent to those skilled in the art in view of the teachings herein.

[0048] By way of further example only, the electrodes (220) may be spaced and arranged according to at least some of the teachings of U.S. Provisional Patent Application 62 / 819,738, filed on March 18, 2019, entitled "Electrode Configurations for Diagnosis of Arryhtmias," the disclosure of which is incorporated herein by reference in its entirety. For example, the electrodes (220) may be spaced and arranged according to Figures 13A, 13B, 13C, and 13D of U.S. Provisional Patent Application 62 / 819,738. The electrodes (226, 230, 232) may be further constructed and operated according to at least some of the teachings of U.S. Publication 2017 / 0312022, published on November 2, 2017, entitled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly," the disclosure of which is incorporated herein by reference in its entirety.

[0049] The end effector (200) of the present invention also includes a position sensor (270) located at the hub (226) at the distal end of the end effector (200). The position sensor (270) is operable to generate a signal indicating the position and orientation of the end effector (200) within the patient (PA). By way of example only, the position sensor (270) may be in the form of a coil or multiple coils (e.g., three orthogonal coils) that are configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). The position sensor (270) may be coupled to a wire, trace, or any other suitable electrical conduit along the catheter (120) or otherwise through the catheter, so that the signal generated by the position sensor (270) can be transmitted back to the console (12) through the electrical conduit (not shown) in the catheter (120). The console (12) may process the signal from the position sensor (270) to identify the position of the end effector (200) within the patient (PA). Other components and techniques that may be used to generate real-time position data associated with end effector (200) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc. While position sensor (270) is shown in this example as being located on hub (226), one or more position sensors (270) may be incorporated elsewhere into or onto body (210) in addition to or instead of being incorporated into hub (226). In some versions, position sensor (270) may be omitted entirely from end effector (200).

[0050] During use of the ablation catheter assembly (100), when the end effector (200) is in a non-expanded configuration, the catheter (120) can be advanced to position the end effector (200) near a target cardiovascular structure (e.g., a chamber of the heart (H), a pulmonary vein, etc.). The end effector (200) can then be expanded to bring the electrodes (220, 222) into contact with tissue of the target cardiovascular structure. In some versions, the operator can selectively inflate the end effector (200) to provide a desired degree of expansion, wherein the degree of expansion is selected in the following manner: based on the size or structural configuration of the specific anatomical structure being targeted; or based on whether the end effector (200) is being used in a mapping procedure or in an ablation procedure. For example, the physician (PH) can provide a greater expansion of the end effector (200) when the end effector (200) is located in a chamber of the heart (H); and provide a lesser expansion of the end effector (200) when the end effector (200) is located in a pulmonary vein. As another merely illustrative example, a physician (PH) may provide a greater expansion of end effector (200) when end effector (200) is used to perform EP mapping (e.g., expanding the end effector to a diameter of approximately 2.5 cm to approximately 3 cm), and a lesser expansion of end effector (200) when end effector (200) is used to perform ablation (e.g., expanding the end effector to a diameter of approximately 5 mm to approximately 9 mm). Other suitable ways of employing end effector (200) will be apparent to those skilled in the art in view of the teachings herein.

[0051] III. Examples of Alternative End Effector Membrane Shapes

[0052] While the above-described examples of end effector (200) exhibit a generally spherical or ball-like shape when end effector (200) is in an expanded state, variations of end effector (200) may exhibit other types of shapes when in an expanded state. Several examples of alternative shapes are described in greater detail below.

[0053] A. Example of an end effector having a cylindrical shape

[0054] Figure 6An example of an end effector (300) is shown positioned at the distal end (124) of a catheter (120), replacing end effector (200). The end effector (300) of this example can be constructed and operated like the end effector (200) described above, except for the differences described below. Like end effector (200), the end effector (300) of this example includes an inflatable body (310) (e.g., in the form of an expandable membrane), a set of mapping electrodes (320), and a set of ablation electrodes (322). Although not shown, the end effector (300) can also include a central axis, such as central axis (126); and in some versions, a reference electrode, such as reference electrodes (128, 230). The mapping electrodes (320) are arranged in a generally circumferential array extending along respective latitudinal paths, wherein such latitudinal paths are longitudinally spaced apart from one another; and are otherwise constructed and operated like the mapping electrode (220). The ablation electrodes (322) are arranged in a generally longitudinal array extending along respective longitudinal paths, wherein such longitudinal paths are angularly spaced from one another; and are otherwise constructed and operated like the ablation electrodes (222).

[0055] By way of example only, electrodes (320, 322) may be formed of nitinol, platinum, gold, or any other suitable material. In some versions, electrodes (320, 322) are formed of a ductile material and are thus configured to expand with body (310). Electrodes (320, 322) may be applied directly to body (310) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process.

[0056] Like the inflatable body (210), the inflatable body (310) includes an opening (312) and is operable to transition between a non-expanded state and an expanded state. However, unlike the inflatable body (210), the inflatable body (310) has a cylindrical shape when in the expanded state. In this example, the electrodes (320, 322) are located only on the longitudinally extending portion (314) of the inflatable body (310), such that the electrodes (320, 322) do not extend along the flat distal surface (316) of the inflatable body (310). In some other versions, the electrodes (320, 322) extend across at least a portion of the distal surface (316). Alternatively, the distal surface (316) may incorporate the electrodes (320, 322) in any other suitable manner. In some cases, the cylindrical shape of end effector (300) may make end effector (300) particularly suitable for use with the pulmonary veins, such as, for example, isolating the pulmonary veins or performing focused ablation on only a portion of the vein, as well as other suitable anatomical structures of the organ.

[0057] B. Example of an end effector having a frustoconical shape

[0058] Figure 7 Another example of an end effector (400) is shown at the distal end (124) of the catheter (120), which replaces the end effector (200). Except for the differences described below, the end effector (400) of this example can be constructed and operated like the end effector (200) described above. As with the end effector (200), the end effector (400) of this example includes an inflatable body (410) (e.g., in the form of an expandable membrane), a set of mapping electrodes (420), and a set of ablation electrodes (422). Although not shown, the end effector (400) can also include a central axis, such as the central axis (126); and in some versions, a reference electrode, such as the reference electrodes (128, 230). The mapping electrodes (420) are arranged in a generally circumferential array extending along respective latitudinal paths, wherein such latitudinal paths are longitudinally spaced apart from each other; and are otherwise constructed and operated like the mapping electrode (220). The ablation electrodes (422) are arranged in a generally longitudinal array extending along respective longitudinal paths, wherein such longitudinal paths are angularly spaced from one another; and are otherwise constructed and operated like the ablation electrodes (222).

[0059] By way of example only, electrodes (420, 422) may be formed of nitinol, platinum, gold, or any other suitable material. In some versions, electrodes (420, 422) are formed of a ductile material and are thus configured to expand with body (410). Electrodes (420, 422) may be applied directly to body (410) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process.

[0060] Like the inflatable body (210), the inflatable body (410) includes an opening (412) and is operable to transition between a non-expanded state and an expanded state. However, unlike the inflatable body (210), the inflatable body (410) has a frusto-conical shape when in the expanded state. In this example, the electrodes (420, 422) are located only on the tapered portion (414) of the inflatable body (410), such that the electrodes (420, 422) do not extend along the flat distal surface (416) of the inflatable body (410). In some other versions, the electrodes (420, 422) extend across at least a portion of the distal surface (416). Alternatively, the distal surface (416) may incorporate the electrodes (420, 422) in any other suitable manner. In some cases, the frusto-conical shape of end effector ( 400 ) may make end effector ( 400 ) particularly suitable for adapting to changing pulmonary vein geometries and diameters.

[0061] C. Example of an end effector having a generally flat rectangular shape

[0062] Figure 8 Another example of an end effector (500) is shown at the distal end (124) of a catheter (120), replacing end effector (200). This example end effector (500) can be constructed and operated like end effector (200) described above, except for the differences described below. Like end effector (200), this example end effector (500) includes an inflatable body (510) (e.g., in the form of an expandable membrane), a set of mapping electrodes (520), and a set of ablation electrodes (522). Although not shown, end effector (500) can also include a central axis, such as central axis (126), and, in some versions, a reference electrode, such as reference electrodes (128, 230). The mapping electrodes (520) are arranged in a generally lateral array extending along respective laterally oriented paths, wherein such laterally oriented paths are longitudinally spaced apart from one another, and are otherwise constructed and operated like mapping electrode (220). The ablation electrodes (522) are arranged in a generally longitudinal array extending along respective longitudinal paths, wherein such longitudinal paths are laterally spaced apart from one another; and are otherwise constructed and operated like the ablation electrodes (222).

[0063] By way of example only, electrodes (520, 522) may be formed of nitinol, platinum, gold, or any other suitable material. In some versions, electrodes (520, 522) are formed of a ductile material and are thus configured to expand with body (510). Electrodes (520, 522) may be applied directly to body (510) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process.

[0064] Like the inflatable body (510), the inflatable body (510) includes an opening (512) and is operable to transition between a non-expanded state and an expanded state. However, unlike the inflatable body (210), the inflatable body (510) has a generally flat rectangular shape when in the expanded state. In this example, the electrodes (520, 522) are located only on the widest face (514) of the inflatable body (510), such that the electrodes (520, 522) do not extend along the flat distal face (516) or side face (518) of the inflatable body (510). In some other versions, the electrodes (520, 522) extend across at least a portion of the distal face (516) or side face (518). Alternatively, the distal face (516) or side face (518) may incorporate the electrodes (520, 522) in any other suitable manner. In some cases, the generally flat rectangular shape of end effector (500) can make end effector (500) particularly suitable for recording signals along chamber walls, where the geometry allows for a grid-like pattern of electrodes on the widest face. The grid-like pattern of electrodes can enable bipolar signal recording in two orthogonal directions.

[0065] IV. Example of an End Effector with a Metal Grid Structure

[0066] Figures 9 and 10 Another example of a lattice structure (600) is shown, which can be combined with a membrane (e.g., such as the inflatable body (210)) to form an end effector; or it can form an end effector by itself. The lattice structure (600) of this example is configured to be initially constructed in a flat configuration, such as Figure 9 and then folded into a ball or roughly spherical shape, as shown. Figure 10 In the combination of the grid structure (600) and the membrane, the membrane may be positioned on the interior of the generally spherical shape that is formed when the grid structure (600) is in the Figure 10 The folded configuration shown is formed by the lattice structure (600). Alternatively, the membrane may be provided in discrete segments (630) positioned in each opening defined by the lattice structure (600). In either case, the membrane may function like an inflatable body such that the membrane may assist in driving the lattice structure from a non-expanded state (e.g., similar to a lattice structure) to a collapsed state (e.g., similar to a lattice structure) by inflation. Figure 2A ) to an expanded state (e.g., to achieve Figure 10 In versions that include a membrane, the membrane may further include openings, such as openings (212) described above; or such openings may be omitted.

[0067] Some versions of the lattice structure (600) may omit the membrane entirely. In this version, and in some versions that include a membrane, the lattice structure (600) may be resiliently biased to present Figure 10For example, the lattice structure (600) may include nitinol or some other elastic material to bias the lattice structure (600) into a generally spherical configuration. Figure 10 In either case, however, the grid structure (600) may be compressible to achieve a configuration similar to Figure 2A By way of example only, lattice structure (600) may be compressible to achieve a size less than or equal to approximately a 6 Fr catheter diameter when in the non-expanded configuration.

[0068] The grid structure (600) is formed by a plurality of curved strip bodies (610). Each strip body (610) has an undulating curved configuration. The proximal end (612) of each strip body (610) contacts the proximal end (612) of the adjacent strip body (610), such as Figure 9 The proximal ends (612) secure the lattice structure (600) to the catheter (120), as best seen in FIG. Figure 10 As shown. Adjacent strip bodies (610) also contact each other at the node area (620). In some versions, adjacent strip bodies (610) overlap each other at the node area (620). Openings (630) are defined between adjacent strip bodies (610). The distal ends of the strip bodies (610) converge at the distal end (614) of the grid structure (600). When the grid structure (600) is in the Figure 9 By way of example only, the distal end (614) and / or other portions of the grid structure (600) may be constructed and operated in accordance with at least some of the teachings of U.S. Publication No. 2015 / 0342532, entitled "High Electrode Density Basket Catheter," published on December 3, 2015, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2017 / 0071543, entitled "Convertible Basket Catheter," published on March 16, 2017, the disclosure of which is incorporated herein by reference in its entirety; or U.S. Publication No. 2017 / 0347959, entitled "Spine Construction for Basket Catheter," published on December 7, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0069] like Figure 10As shown, each node region (620) includes an electrode pair (640). Each electrode pair (640) includes a first electrode (642) and a second electrode (644). The electrodes (642, 644) can be printed on the strip body (610) or otherwise integrated into the strip body (610). The electrodes (642, 644) are configured to provide EP mapping (e.g., to provide an electrocardiogram signal) by contacting the tissue and picking up a potential from the contacted tissue. In other words, each electrode pair (640) is configured to provide bipolar sensing of the electrocardiogram signal when the electrode pair (640) is placed in contact with cardiovascular tissue. Therefore, each electrode pair (640) can be considered to collectively form a single "sensor." Each electrode (642, 644) can be coupled to a corresponding trace or other electrical conduit on the grid structure (600), so that the signal picked up by the electrode pair (640) can be transmitted back to the console (12) through the electrical conduit (not shown) in the catheter (120), which can process the signal 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 appropriate area of ​​cardiac tissue to be ablated (e.g., with electrical energy, cryoablation, etc.), thereby preventing or at least reducing the spread of abnormal electrical activity to the cardiac tissue.

[0070] Figure 11 Another example of an arrangement is shown in which the reference electrode (646) is positioned in an opposing manner relative to the mapping electrode (642). Figure 11 Only the mapping electrode (642) is shown, but a similar arrangement can be provided for the mapping electrode (644). As shown, the mapping electrode (642) is applied to the dielectric layer (650). The dielectric layer (650) is applied to the biocompatible structural layer (652). By way of example only, the biocompatible structural layer (652) may include platinum or any other suitable biocompatible metal. The biocompatible structural layer (652) is applied to the dielectric insulating layer (654). The conductive layer trace (656) is positioned below the dielectric insulating layer (654). The through hole (660) provides a path for the signal from the mapping electrode (642) to be transmitted to the conductive layer trace (656). The conductive layer trace (656) can form part of the path through which the potential (642) picked up by the mapping electrode is transmitted back to the console (12). The mapping electrode (644) can have its own dedicated area of ​​the conductive trace layer (656), which is insulated from the area of ​​the conductive trace layer (656) dedicated to the mapping electrode (644), so that the mapping electrodes (642, 644) have their own respective discrete areas of the conductive trace layer (656). Another dielectric layer (658) is positioned below the conductive trace layer (656). The dielectric layer (658) is positioned on the strip body (610). As described above, the strip body (610) can be in the form of a nitinol film.

[0071] Also like Figure 11 As shown, the underside of the strip body (610) (which will face the interior area of ​​the end effector (600)) includes a dielectric layer (674), a conductive trace layer (672), a dielectric insulation layer (670), and a reference electrode (646). The reference electrode (646) can operate similarly to the reference electrodes (128, 230) described above, such that the reference electrode (646) can be used to pick up a reference potential from blood or saline passing through the interior of the end effector (600) via the opening (630) during an EP mapping procedure. Since the reference electrode (646) will be positioned within the interior of the end effector (600), the strip body (610) will prevent tissue from contacting the reference electrode (646) during use of the end effector (600) during an EP mapping procedure; while still allowing blood and saline to flow freely through the end effector (600) to reach the reference electrode (646). The through-hole (676) provides a path for the signal from the reference electrode (646) to be transmitted to the conductive trace layer (672). The conductive trace layer (672) forms part of the path for the signal picked up by the reference electrode (646) to reach the console (12). In some versions, only a single reference electrode (646) is positioned opposite each electrode pair (640). Alternatively, the reference electrode (646) may have any other suitable spatial or structural relationship with the electrodes (642, 644).

[0072] In versions where the end effector (600) includes ablative capabilities, the biocompatible structural layer (652) can effectively form an ablation electrode. By providing a majority of the exposed surface area of ​​the end effector (600), the layer (652) can create larger lesions than would otherwise be created using a small, single electrode.

[0073] exist Figure 11 In the example shown, all layers (642, 650, 652, 654, 656, 658, 660) shown on the outside of the strip body (610) may be applied to the strip body (610) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process. Similarly, all layers (646, 670, 672, 674, 676) shown on the inside of the strip body (610) may be applied to the strip body (610) using a physical vapor deposition (PVD) process, sputter deposition, chemical vapor deposition (CVD), thermal deposition, or any other suitable process.

[0074] In some variations of the end effector (600), an insulating layer may be provided over the entire exposed surface of each strip body (610), wherein cutouts are formed in the insulating layer to expose the electrodes (642, 644, 646). Such an insulating layer may effectively form a recess at the cutout, with the electrodes (642, 644, 646) disposed in the recess. By forming such recesses for the electrodes (642, 644, 646), the insulating layer may mechanically protect the electrodes (642, 644, 646). Furthermore, in some such embodiments, it may not be necessary to form any through-holes for coupling the electrodes (642, 644, 646) with corresponding traces. In other words, each electrode (642, 644, 646) and its corresponding trace may be located on the same layer.

[0075] V. Combined Examples

[0076] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided solely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise expressly indicated as such by the inventor or the inventor's successor at a later date, for example. If any claim set forth in this patent application or subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.

[0077] Example 1

[0078] A device comprising: (a) a catheter, at least a portion of which is sized and constructed to fit within an inner lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) an expandable body configured to transition between a non-expanded state and an expanded state, the expandable body having an inner surface and an outer surface, the expandable body defining a plurality of openings extending from the inner surface to the outer surface, and (ii) a plurality of electrodes deposited on the outer surface of the expandable body, the electrodes configured to expand from the non-expanded state to the expanded state with the expandable body, the electrodes comprising one or more electrodes selected from the group consisting of: (A) a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and (B) an ablation electrode operable to ablate tissue contacting the ablation electrode.

[0079] Example 2

[0080] Embodiment 1 : The device of embodiment 1 , wherein the expandable body comprises a membrane.

[0081] Example 3

[0082] According to the device of embodiment 2, the membrane is extensible.

[0083] Example 4

[0084]

[0014] According to the apparatus of any one or more of embodiments 1 to 3, the opening is configured to discharge irrigation fluid from the interior region defined by the expandable body.

[0085] Example 5

[0086]

[0046] The apparatus of any one or more of embodiments 1 to 4, wherein the opening is configured to allow fluid to flow into the interior region defined by the expandable body.

[0087] Example 6

[0088] According to the apparatus of any one or more of embodiments 1 to 5, the expandable body is configured to define a spherical shape in the expanded state.

[0089] Example 7

[0090] According to the apparatus of embodiment 6, the spherical shape is a substantially spherical shape.

[0091] Example 8

[0092]

[0014] According to the apparatus of any one or more of embodiments 1 to 5, the expandable body is configured to define a cylindrical shape in the expanded state.

[0093] Example 9

[0094]

[0014] According to the apparatus of any one or more of embodiments 1 to 5, the expandable body is configured to define a frusto-conical shape in the expanded state.

[0095] Example 10

[0096]

[0014] According to the apparatus of any one or more of embodiments 1 to 5, the expandable body is configured to define a rectangular shape in the expanded state.

[0097] Example 11

[0098] In accordance with the apparatus of any one or more of Examples 1-10, the end effector further comprises one or more resilient members configured to urge the expandable body toward the expanded state.

[0099] Example 12

[0100]

[00116] According to the device of Example 11, the one or more elastic members include one or more elastic strips.

[0101] Example 13

[0102] In accordance with the apparatus of any one or more of Examples 11-12, the one or more elastic members comprise Nitinol.

[0103] Example 14

[0104] According to the device of any one or more of embodiments 11 to 13, one or more elastic members are deposited on the inner surface or the outer surface of the expandable body.

[0105] Example 15

[0106] According to the apparatus of any one or more of embodiments 1 to 14, the plurality of electrodes comprises a plurality of mapping electrodes and a plurality of ablation electrodes.

[0107] Example 16

[0108] In the apparatus of any one or more of embodiments 1 to 15, the end effector further comprises at least one reference electrode.

[0109] Example 17

[0110] According to the apparatus of embodiment 16, at least one reference electrode is disposed on an inner surface of the expandable body.

[0111] Example 18

[0112] According to the device of embodiment 16, the end actuator further includes a central shaft, and the at least one reference electrode is disposed on the central shaft.

[0113] Example 19

[0114]

[00146] The device of any one or more of embodiments 1 to 18, wherein the expandable body comprises an elastic lattice structure.

[0115] Example 20

[0116] According to the device of embodiment 19, the elastic grid structure is formed by a plurality of bent elastic strips.

[0117] Example 21

[0118] According to the device of embodiment 20, the curved elastic strips include areas overlapping each other.

[0119] Example 22

[0120] According to the apparatus of embodiment 21, at least some of the plurality of electrodes are located at regions of the elastic strip that overlap each other.

[0121] Example 23

[0122] The device of any one or more of Examples 19 to 22, wherein the elastic lattice structure comprises Nitinol.

[0123] Example 24

[0124]

[00146] The apparatus of any one or more of embodiments 1-23, further comprising a processor in communication with the electrodes.

[0125] Example 25

[0126] In accordance with the device of Example 24, the electrodes include mapping electrodes configured to sense electrical potentials in tissue contacting the mapping electrodes, and the processor is operable to process the electrical potentials picked up by the mapping electrodes.

[0127] Example 26

[0128] According to the apparatus of Example 25, the processor is operable to provide an electrocardiogram reading based on the potentials picked up by the mapping electrodes.

[0129] Example 27

[0130] In accordance with the apparatus of any one or more of Examples 24 to 26, the electrode comprises an ablation electrode operable to ablate tissue contacting the ablation electrode, and the processor is operable to drive activation of the ablation electrode using electrical energy.

[0131] Example 28

[0132] The apparatus of any one or more of embodiments 1-27 further comprises a position sensor operable to generate a signal indicative of a position of the end effector in three-dimensional space.

[0133] Example 29

[0134] In the apparatus of embodiment 28, the position sensor is located on the end effector.

[0135] Example 30

[0136]

[00106] In the apparatus of Example 29, the position sensor is located on the expandable body.

[0137] Example 31

[0138] A device comprising: (a) a catheter, at least a portion of which is sized and constructed to fit within an inner lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) an inflatable membrane configured to transition between a non-inflated state and an inflated state, the inflatable membrane having an inner surface and an outer surface, the inflatable membrane defining a plurality of openings extending from the inner surface to the outer surface, and (ii) a plurality of electrodes deposited on the outer surface of the inflatable membrane, the electrodes configured to expand from the non-inflated state to the inflated state together with the inflatable membrane, the electrodes comprising one or more electrodes selected from the group consisting of: (A) a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and (B) an ablation electrode operable to ablate tissue contacting the ablation electrode.

[0139] Example 32

[0140] A device comprising: (a) a catheter, at least a portion of which is sized and constructed 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) an expandable lattice structure configured to transition between a non-expanded state and an expanded state, the expandable lattice structure comprising a plurality of strips and defining a plurality of openings between the strips, and (ii) a plurality of electrodes deposited on an outer surface of the expandable lattice structure, the electrodes comprising one or more electrodes selected from the group consisting of: (A) a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and (B) an ablation electrode operable to ablate tissue contacting the ablation electrode.

[0141] Example 33

[0142] A method comprises: (a) providing an expandable body configured to transition between an expanded state and a non-expanded state, the expandable body configured to fit within an inner cavity of a cardiovascular system in the non-expanded state; (b) depositing a plurality of electrodes on a surface of the expandable body, the electrodes and the expandable body together defining an end effector, the electrodes being configured to expand from the non-expanded state to the expanded state together with the expandable body, the electrodes comprising one or more electrodes selected from the group consisting of: (i) a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and (ii) an ablation electrode operable to ablate tissue contacting the ablation electrode; and (c) securing the end effector to a distal end of a catheter shaft assembly.

[0143] Example 34

[0144] In accordance with the method of Example 33, the expandable body is initially formed into a planar structure that is folded into a non-planar shape to further define the end effector.

[0145] Example 35

[0146] According to the method of embodiment 34, the electrodes are deposited on the planar structure before the planar structure is folded into the non-planar shape.

[0147] Example 36

[0148] According to the method of embodiment 33, the expandable body includes a membrane and the electrodes are deposited directly on the membrane.

[0149] Example 37

[0150] The method of any one or more of embodiments 33 to 36, wherein depositing the plurality of electrodes on the surface of the expandable body comprises utilizing a vapor deposition process.

[0151] Example 38

[0152] According to the method of embodiment 37, the vapor deposition process includes a physical vapor deposition process.

[0153] Example 39

[0154] The method of any one or more of embodiments 37 to 38, wherein the vapor deposition process comprises a chemical vapor deposition process.

[0155] Example 40

[0156] The method of any one or more of embodiments 33 to 39, wherein depositing the plurality of electrodes on the surface of the expandable body comprises utilizing a sputtering deposition process.

[0157] Example 41

[0158] The method of any one or more of embodiments 33 to 40, depositing the plurality of electrodes on the surface of the expandable body comprises utilizing a thermal deposition process.

[0159] Example 42

[0160] The method of any one or more of embodiments 33 to 41, wherein the deposited electrode is formed of an elastic material.

[0161] Example 43

[0162] The method of any one or more of embodiments 33 to 42, wherein the deposited electrode is formed from a ductile material.

[0163] Example 44

[0164] The method of any one or more of Examples 33 to 43, wherein the deposited electrode is formed of Nitinol.

[0165] Example 45

[0166] According to the method described in any one or more of Examples 33 to 44, the expandable body includes a first surface and a second surface, the second surface is opposite to the first surface, and depositing multiple electrodes onto the surface of the expandable body includes: (i) depositing at least one electrode on the first surface of the expandable body, and (ii) depositing at least one electrode on the second surface of the expandable body.

[0167] Example 46

[0168] According to the method of embodiment 45, the end actuator includes an inner region and an outer region, the first surface is located on the inner region of the end actuator, and the second surface is located on the outer region of the end actuator.

[0169] Example 47

[0170] A device comprising: (a) a catheter, at least a portion of which is sized and constructed to fit within an inner lumen of a cardiovascular system; and (b) an end effector positioned at a distal end of the catheter, the end effector comprising: (i) an inflatable membrane configured to transition between a non-inflated state and an inflated state, the inflatable membrane having an inner surface and an outer surface, the inflatable membrane defining a plurality of openings extending from the inner surface to the outer surface, the openings configured to allow fluid to flow through the membrane, and (ii) a plurality of electrodes deposited on the outer surface of the inflatable membrane, the electrodes configured to expand from the non-inflated state to the inflated state together with the inflatable membrane, the electrodes comprising one or more electrodes selected from the group consisting of: (A) a mapping electrode configured to sense an electrical potential in tissue contacting the mapping electrode, and (B) an ablation electrode operable to ablate tissue contacting the ablation electrode.

[0171] VI. Miscellaneous

[0172] Any of the instruments described herein can be cleaned and sterilized before and / or after the 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 device can then be placed in a field of radiation that can penetrate 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 can then be stored in a sterile container for later use. Any other technique known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and vapor phase sterilization (with or without gas plasma or steam).

[0173] It should be understood that any examples described herein may also include various other features in addition to or in place of those described above. By way of example only, any examples described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference in their entireties.

[0174] 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. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art with reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0175] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, that is stated to be incorporated herein by reference in its entirety is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is stated to be incorporated herein by reference in its entirety but that conflicts with existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.

[0176] While various versions of the present invention have been shown and described, further improvements to the methods and systems described herein may be achieved by appropriate modifications by one of ordinary skill in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, versions, 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 not to be limited to the details of construction and operation shown and described in the specification and drawings.

Claims

1. A mapping and ablation device comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of the cardiovascular system; and (b) an end effector positioned at the distal end of the catheter, the end effector comprising: (i) an expandable body configured to transition between a non-expanded state and an expanded state, the expandable body having an inner surface and an outer surface, the expandable body defining a plurality of openings extending from the inner surface to the outer surface, and (ii) a plurality of electrodes deposited on the outer surface of the expandable body, the electrodes configured to expand together with the expandable body from the non-expanded state to the expanded state, the plurality of electrodes comprising: (A) a plurality of mapping electrodes configured to sense electrical potentials in tissue contacting the mapping electrodes, the plurality of mapping electrodes being arranged on the outer surface of the expandable body in generally circumferential mapping arrays extending along respective latitudinal mapping paths longitudinally spaced apart from one another, each generally circumferential mapping array including a plurality of the plurality of mapping electrodes extending along each respective latitudinal mapping path, and (B) a plurality of ablation electrodes operable to ablate tissue contacting the ablation electrodes, the plurality of ablation electrodes being arranged in generally longitudinal ablation arrays extending along respective longitudinal ablation paths angularly spaced apart from one another, each generally longitudinal ablation array comprising a plurality of the plurality of ablation electrodes extending along each respective longitudinal ablation path, The end effector further comprises at least one reference electrode mounted to a central axis of the end effector, and the at least one reference electrode is used to pick up a reference potential from blood or saline passing through the interior of the end effector through the plurality of openings during an electrophysiological mapping procedure.

2. The mapping and ablation device of claim 1, the expandable body comprising a membrane.

3. The mapping and ablation device of claim 1, the opening being configured to discharge irrigation fluid from an interior region defined by the expandable body.

4. The mapping and ablation device of claim 1, the opening being configured to allow fluid to flow into an interior region defined by the expandable body.

5. The mapping and ablation device of claim 1, the expandable body being configured to define a spherical shape in the expanded state.

6. The mapping and ablation device of claim 1, the expandable body being configured to define a cylindrical shape in the expanded state.

7. The mapping and ablation device of claim 1, the expandable body being configured to define a frusto-conical shape in the expanded state.

8. The mapping and ablation device of claim 1, the expandable body being configured to define a rectangular shape in the expanded state.

9. The mapping and ablation device of claim 1, the end effector further comprising one or more elastic members configured to urge the expandable body toward the expanded state.

10. The mapping and ablation device of claim 9, the one or more elastic members comprising one or more elastic strips.

11. The mapping and ablation device of claim 9, the one or more elastic members being deposited on the inner surface or the outer surface of the expandable body.

12. The mapping and ablation device of claim 1, the expandable body comprising an elastic lattice structure.

13. The mapping and ablation device of claim 12, wherein the elastic grid structure is formed by a plurality of curved elastic strips. The mapping and ablation device of claim 13 , wherein the curved elastic strips include regions that overlap each other.

15. The mapping and ablation device of claim 14, at least some of the plurality of electrodes being located at regions of the elastic strip that overlap one another.

16. A mapping and ablation device comprising: (a) a catheter, at least a portion of which is sized and configured to fit within a lumen of the cardiovascular system; and (b) an end effector positioned at the distal end of the catheter, the end effector comprising: (i) an inflatable membrane configured to transition between a non-inflated state and an inflated state, the inflatable membrane having an inner surface and an outer surface, the inflatable membrane defining a plurality of openings extending from the inner surface to the outer surface, the openings configured to allow fluid to flow through the membrane, and (ii) a plurality of electrodes deposited on the outer surface of the expandable membrane, the electrodes being configured to expand together with the expandable membrane from the non-expanded state to the expanded state, the plurality of electrodes comprising: (A) a plurality of mapping electrodes configured to sense electrical potentials in tissue contacting the mapping electrodes, the plurality of mapping electrodes being arranged on the outer surface of the expandable membrane in generally circumferential mapping arrays extending along respective latitudinal mapping paths longitudinally spaced apart from one another, each generally circumferential mapping array including a plurality of the plurality of mapping electrodes extending along each respective latitudinal mapping path, and (B) a plurality of ablation electrodes operable to ablate tissue contacting the ablation electrodes, the plurality of ablation electrodes being arranged in generally longitudinal ablation arrays extending along respective longitudinal ablation paths angularly spaced apart from one another, each generally longitudinal ablation array comprising a plurality of the plurality of ablation electrodes extending along each respective longitudinal ablation path, The end effector further comprises at least one reference electrode mounted to a central axis of the end effector, and the at least one reference electrode is used to pick up a reference potential from blood or saline passing through the interior of the end effector through the plurality of openings during an electrophysiological mapping procedure.

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