Catheter with integrated thin film microsensor

Abstract

The present invention relates to an apparatus comprising a catheter body and an end effector. The catheter body has a distal end and is sized and configured to fit within a region of a cardiovascular system. The end effector is at the distal end of the catheter body and is sized and configured to fit within a region of the cardiovascular system. The end effector comprises an end effector body, an electrode, and a sensor. The end effector body has an outer surface. The electrode has a tissue contact surface. The sensor has a tissue contact surface. The sensor is configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor. The tissue contact surface of the sensor is configured to protrude relative to one or both of the outer surface of the end effector body member or the tissue contact surface of the electrode.

Description

BACKGROUND

[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when regions of heart tissue abnormally conduct electrical signals. Procedures for treating cardiac arrhythmias include surgically interrupting the conduction pathways for such signals. By selectively ablating heart tissue with the application of energy (e.g., radiofrequency (RF) energy), the propagation of unwanted electrical signals from one part of the heart to another can be stopped or altered. The ablation process can provide a block to the unwanted electrical pathway by creating an electrically insulative lesion or scar tissue that effectively blocks the communication of aberrant electrical signals across the tissue.

[0002] Cardiac arrhythmias, such as atrial fibrillation, occur when regions of heart tissue abnormally conduct electrical signals. Procedures for treating cardiac arrhythmias include surgically interrupting the conduction pathways for such signals. By selectively ablating heart tissue with the application of energy (e.g., radiofrequency (RF) energy), the propagation of unwanted electrical signals from one part of the heart to another can be stopped or altered. The ablation process can provide a block to the unwanted electrical pathway by creating an electrically insulative lesion or scar tissue that effectively blocks the communication of aberrant electrical signals across the tissue.

[0003] In some procedures, a catheter having one or more RF 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 in a cardiovascular structure within or adjacent to the heart (e.g., a pulmonary vein). The one or more electrodes can be placed in contact with heart tissue or other vascular tissue and then activated with RF energy, thereby ablating 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. Irrigation can be used to draw heat away from the ablation components of the ablation catheter; and to prevent the formation of blood clots near the ablation site.

[0004] Examples of ablation catheters are described in U.S. Pub. No. 2013 / 0030426, entitled “Integrated Ablation System using Catheter with Multiple Irrigation Lumens,” published January 31, 2013, the disclosure of which is incorporated by reference herein in its entirety; U.S. Pub. No. 2018 / 0071017, entitled “Ablation Catheter with a Flexible Printed Circuit Board,” published March 15, 2018, the disclosure of which is incorporated by reference herein in its entirety; and U.S. Pat. No. 8,956,353, entitled “Electrode Irrigation Using Micro-Jets,” published February 17, 2015, the disclosure of which is incorporated by reference herein in its entirety.

[0005] Some catheter ablation procedures can be performed after the use of electrophysiology (EP) mapping to identify regions of tissue that should be targeted for ablation. Such EP mapping can include the use of sensing electrodes on a catheter (e.g., the same catheter used to perform ablation or a dedicated mapping catheter). Such sensing electrodes can monitor electrical signals emanating from conductive endocardial tissue to precisely locate the position of abnormal conductive tissue sites that cause arrhythmias.

[0006] When using an ablation catheter, it can be desirable to ensure that one or more electrodes of the ablation catheter are in sufficient contact with the target tissue. For example, it can be desirable to ensure that the one or more electrodes are in contact with the target tissue with sufficient force to effectively apply RF ablation energy to the tissue; but not apply a degree of force that can tend to undesirably damage the tissue. To this end, it can be desirable to include one or more force sensors or pressure sensors for detecting sufficient contact between the one or more electrodes of the ablation catheter and the target tissue.

[0007] In addition to the use of force sensing or EP mapping, some catheter ablation procedures can also be performed using an image-guided surgery (IGS) system. IGS systems can enable a physician to visually track the location of a catheter within a patient’s body in real-time with respect to an image of the anatomy within the patient’s body. Some systems can provide a combination of EP mapping and IGS functionality, including the CARTO® system by Biosense Webster, Inc. of Irvine, California. Examples of catheters constructed for use with an IGS system are disclosed in the following documents: U.S. Patent No. 9,480,416, entitled “Signal Transmission Using Catheter Braid Wires,” published November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety; and various other references cited herein.

[0008] Although several catheter systems and methods have been manufactured and used, it is believed that no one had manufactured or used the inventions described, shown and claimed herein before the inventors. Attached Figure Description

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

[0010] FIG. 1 A schematic diagram depicts a medical procedure for inserting a catheter assembly into a patient's body.

[0011] FIG. 2 Depicting FIG. 1 A perspective view of the catheter assembly, with additional components shown schematically;

[0012] FIG. 3 Depicting FIG. 1 A perspective view of the distal portion of the catheter, with additional components shown schematically;

[0013] FIG. 4 Depicting FIG. 1 A perspective view of the distal portion of the catheter, with the outer sheath omitted to show the internal components;

[0014] FIG. 5 Depicting FIG. 1 Exploded perspective view of the distal portion of the catheter;

[0015] FIG. 6 Depicting what can be combined with FIG. 1 An example of electrodes and sensor components in the end actuator of a conduit;

[0016] FIG. 7 Depicting along FIG. 6 The line 7-7 was cut FIG. 6 A cross-sectional view of the electrode and sensor assembly;

[0017] FIG. 8 Depicting what can be combined with FIG. 6 A side sectional view of an example force sensor in an electrode and sensor assembly;

[0018] FIG. 9 Depicting what can be combined withFIG. 6 top plan view of another example of a force sensor in an electrode and sensor assembly of the present disclosure;

[0019] FIG. 10 depicts FIG. 9 side cross-sectional view of a force sensor of the present disclosure;

[0020] FIG. 11 depicts FIG. 9 side elevation view of a force sensor of the present disclosure, with the mass of the force sensor encountering a vertically oriented force; and

[0021] FIG. 12 depicts FIG. 9 side elevation view of a force sensor of the present disclosure, with the mass of the force sensor encountering a laterally oriented force. DETAILED DESCRIPTION

[0022] The following description of certain examples of the application should not be used to limit the scope of the present application. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the application. The detailed description illustrates by way of example, not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the application will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best ways contemplated for carrying out the application. As will be realized, the application is capable of other different and equivalent aspects, all without departing from the application. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0023] Any one or more of the teachings, expressions, versions, examples, etc. described herein can be combined with any one or more of the other teachings, expressions and / or versions described herein. The description herein of any particular aspect, embodiment, example, etc. does not inherently imply that the aspect, embodiment, example and / or description is preferred over other aspects, embodiments, examples and / or descriptions. Various modifications and changes can be made as would be obvious to a person of ordinary skill in the art having the benefit of this disclosure, once informed of the present disclosure, without departing from the spirit and scope of the description. It is, therefore, desired to be secured to whoever has whatever right, including assignees and successors in title, to this application or of patent issuing thereon to practice this application or claimed combination. It is intended to cover by this patent wherever possible, without limitation, all practical, equivalents and substitutions known now or developed in the future for any stated term irrespective of

[0024] As used herein, the terms "about" or "approximately," with reference to any numerical or range of values, indicate suitable dimensional tolerances that allow the components or elements, within set ranges, to perform their intended objectives as described herein. More specifically, "about" or "approximately" can refer to a range of values ±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 the systems or methods to human use, but the use of the subject application with human patients is a preferred embodiment.

[0025] I. Overview of an exemplary ablation catheter system

[0026] FIG. 1 An exemplary medical protocol and associated components are shown for a cardiac ablation catheter system that can be used to deliver the cardiac ablation procedures mentioned above. Specifically, FIG. 1 The image shows the handle (110) of the catheter assembly (100) being gripped by a physician (PH), wherein the end actuator (140) of the catheter (120) of the catheter assembly (100) is located in... FIGS. 2-3 Shown but not in FIG. 1 (As shown) is placed inside the patient (PA) to ablate tissue in or near the patient's (PA) heart (H). FIG. 2 As shown, the catheter assembly (100) includes a handle (110), a catheter (120) extending distally from the handle (110), an end actuator (140) located at the distal end of the catheter (120), and a deflection drive assembly (112) associated with the handle (110).

[0027] As will be described in more detail below, the end effector (140) includes various components configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140), and disperse flushing fluid. Also as will be described in more detail below, the deflection drive assembly (112) is configured to deflect the distal portion of the end effector (140) and the catheter (120) away from the central longitudinal axis (LL) defined by the proximal portion of the catheter (120). FIGS. 3-5 ).

[0028] like FIG. 3 As shown, the catheter (120) includes an elongated flexible sheath (122) with an end effector (140) positioned at the distal end of the elongated flexible sheath (122). The end effector (140) and various components housed within the elongated flexible sheath (122) will be described in more detail below. The catheter assembly (100) is coupled to the guidance and actuation system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of field generators (20) is positioned below the patient (PA) and coupled to the guidance and actuation system (10) via another cable (22). The field generators (20) are optional only.

[0029] The guidance and drive system (10) of the present example includes a console (12) and a display (18). The console (12) includes a first drive module (14) and a second drive module (16). The first drive module (14) is coupled with the catheter assembly (100) via a cable (30). In some variations, the first drive module (14) is operable to receive EP mapping signals obtained via microelectrodes (138) of an end effector (140), as described in greater detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals, and thereby provides EP mapping as is known in the art.

[0030] The first drive module (14) of the present example is also operable to provide RF power to a distal tip member (142) of the end effector (140), as will be described in greater detail below, to ablate tissue. The second drive module (16) is coupled with a field generator (20) via a cable (22). The second drive 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) can include a coil that generates an alternating magnetic field in a predetermined working volume that houses the heart (H).

[0031] The first drive module (14) is also operable to receive position indicating signals from a position sensor assembly (150) in the end effector (140). In this type, the processor of the console (12) is also operable to process the position indicating signals from the position sensor assembly (150) to determine the position of the end effector (140) within the patient (PA). As will be described in greater detail below, the position sensor assembly (150) includes a pair of coils on respective panels (151) that are operable to generate signals indicative of the position and orientation of the end effector (140) within the patient (PA). The coils are configured to generate electrical signals in response to the presence of the alternating electromagnetic field generated by the field generator (20). Other components and techniques that can be used to generate real-time position data associated with the end effector (140) can include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc. Alternatively, the end effector (140) can not have a position sensor assembly (150).

[0032] The display (18) is coupled with the processor of the console (12) and is operable to present images of the patient anatomy. Such images can be based on a set of preoperative or intraoperative acquired images (e.g., CT or MRI scans, 3D maps, etc.). The view of the patient anatomy provided through the display (18) can also be dynamically changed based on signals from the position sensor assembly (150) of the end effector (140). For example, as the end effector (140) of the catheter (120) is moved within the patient (PA), corresponding position data from the position sensor assembly (150) can cause the processor of the console (12) to update the view of the patient anatomy in the display (18) in real-time to depict the area of the patient anatomy around the end effector (140) as the end effector (140) is moved within the patient (PA). Further, the processor of the console (12) can drive the display (18) to show the location of abnormal conductive tissue sites detected via electrophysiological (EP) mapping with the end effector (140) or otherwise (e.g., using a dedicated EP mapping catheter, etc.). 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 anatomy such as by superimposing illuminated dots, crosshairs, or some other form of visual indication of the abnormal conductive tissue sites.

[0033] The processor of the console (12) can also drive the display (18) to superimpose the current location of the end effector (140) on the image of the patient anatomy such as by superimposing illuminated dots, crosshairs, a graphical representation of the end effector (140), or some other form of visual indication. As the physician moves the end effector (140) within the patient (PA), such superimposed visual indication can also move within the image of the patient anatomy on the display (18) in real-time, thereby providing real-time visual feedback to the operator regarding the location of the end effector (140) within the patient (PA) as the end effector (140) is moved within the patient (PA). Thus, the image provided through the display (18) can effectively provide a video that tracks the location of the end effector (140) within the patient (PA) without having to have any optical instrument (i.e., camera) that views the end effector (140). In the same view, the display (18) can simultaneously visually indicate the location of the abnormal conductive tissue sites detected by EP mapping. Thus, the physician (PH) can view the display (18) to observe the real-time positioning of the end effector (140) relative to the mapped abnormal conductive tissue sites and relative to the image of the adjacent anatomy within the patient (PA).

[0034] The fluid source (42) of the present example includes a bag containing saline or some other suitable irrigation fluid. The tubing (40) includes a flexible tube that is further coupled with a pump (44) that is operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). As described in greater detail below, such irrigation fluid can be expelled through the openings (158) of the distal tip member (142) of the end effector (140). Such irrigation can be provided in any suitable manner as will be apparent to those of skill in the art in view of the teachings herein.

[0035] II. Examples of end effectors for catheter assemblies

[0036] As noted above, the end effector (140) includes various components that are configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied on the end effector (140), track the location of the end effector (140) within the patient (PA), and disperse irrigation fluid. FIGS. 3-5 An example of the components of the end effector (140) and other components of the distal portion of the catheter (120) are shown in greater detail. The end effector (140) includes a distal tip member (142), a distal tip base (144), a distal circuit board (146), a force sensor assembly (148), a position sensor assembly (150), a distal spacer stack (152), and a pair of proximal spacers (154). The distal tip member (142), the distal tip base (144), the distal circuit board (146), the force sensor assembly (148), the position sensor assembly (150), the distal spacer stack (152), and the proximal spacers (154) are coaxially aligned with one another and longitudinally stacked such that these components (144-154) define a stacked circuit. A pair of push-pull cables (160, 170) and an irrigation tube (180) extend along the length of the catheter (120) to reach the end effector (140). Each of the foregoing components will be described in greater detail below. The flexible sheath (122) surrounds all of the foregoing components except the distal tip member (142).

[0037] As FIGS. 4-5As shown, the distal end member (142) of this example includes a cylindrical body (156) with a domed end. The cylindrical body (156) and the domed end may be formed of a conductive material, such as metal. A plurality of openings (158) are formed through the cylindrical body (156) and communicate with the hollow interior of the distal end member (142). Thus, the openings (158) allow flushing fluid to be delivered from the interior of the distal end member (142) through the cylindrical body (156). The cylindrical body (156) and the domed end are also operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy may be delivered from the first driver module (14) to the proximal spacer (154) via a cable (30). The distal end member (142) may also include one or more thermocouples configured to provide temperature sensing capability.

[0038] like FIGS. 3-4 As shown, the distal end member (142) of this example also includes one or more EP mapping microelectrodes (138) mounted to the cylindrical body (156). The EP mapping microelectrodes (138) are configured to pick up potentials from tissues in contact with the EP mapping microelectrodes (138). Thus, the EP mapping microelectrodes (138) can be used to determine the location of abnormal electrical activity in tissues within cardiovascular anatomy structures (e.g., pulmonary veins, etc.). The signals picked up by the EP mapping microelectrodes (138) can be transmitted via through-holes or other structures located in layers proximal to the force sensor assembly (148), ultimately reaching the first driver module (14) of the console (12) via cable (30). Based on the teachings of the various references cited herein, the first driver module (14) can process the EP mapping signals and provide corresponding feedback to the physician (PH) indicating the location of abnormal electrical activity.

[0039] In a configuration where the cylindrical body (156) is formed of a conductive material to provide RF power for tissue ablation, an electrically insulating material may be inserted between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically isolating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operated in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal end member (142) may include two or more EP mapping microelectrodes (138). Alternatively, the distal end member (142) may be completely devoid of EP mapping microelectrodes (138).

[0040] The distal tip base (144) defines a central bore configured to provide a path for delivery of irrigation fluid to the hollow interior of the distal tip member (142). The distal tip base 144 forms an annular shoulder against which a proximal edge of the distal tip member (142) can abut. The distal tip member (142) also defines a transverse notch configured to receive a proximally extending tab of the distal tip member (142). As FIGS. 3-4 shown, the distal circuit board (146) is positioned proximal of the distal tip base (144). The distal circuit board (146) includes circuitry operable to deliver RF electrical energy to the distal tip member (142) via the proximally extending tab of the distal tip member (142). In versions in which one or more EP mapping electrodes (138) are included, the distal circuit board (146) can also include circuitry operable to deliver EP mapping signals from the EP mapping electrodes (138).

[0041] In some versions, the distal circuit board (146) also includes one or more transmit coils. Such transmit coils can provide wireless communication of signals (e.g., EP mapping signals from the microelectrodes (138)) to one or more complementary coils located proximal of the distal circuit board (146). Additionally or alternatively, such transmit coils can provide wireless communication of RF electrical energy from one or more complementary coils located proximal of the distal circuit board (146) to the distal tip member (142). In versions in which coils are incorporated into the distal circuit board (146) and one or more other layers proximal of the force sensor assembly (148), such coils can thus enable wireless communication of electrical signals across the force sensor assembly (148) without the need for wires, vias, or other electrically conductive structures to pass longitudinally through the force sensor assembly (148).

[0042] In some versions, the distal circuit board (146) includes at least one transmit coil (TX) paired with a receive coil (RX) of the position sensor assembly (150) to detect strain applied to the force sensor assembly (148) in order to determine a contact force applied to the distal tip (142). Some other versions of the distal circuit board (146) can simply omit the TX coil.

[0043] The force sensor assembly (148) is positioned proximal to the distal circuit board (146) and is configured to sense external forces impinging on the distal tip member (142). When the distal tip (142) encounters external forces (e.g., when the distal tip (142) is pressed against tissue), those external forces are transmitted from the distal tip (142) to the distal tip base (144), to the distal circuit board (146), and to the force sensor assembly (148) such that the strain gauges can generate appropriate signals corresponding to the magnitude and direction of the external forces. Signals from the force sensor assembly (148) can be transmitted through vias or other structures in the layers proximal to the force sensor assembly (148) and ultimately via the cable (30) to the first driver module (14) of the console (12). The first driver module (14) can process the strain signals in accordance with any suitable manner that will be apparent to those of ordinary skill in the art in view of the teachings herein. By way of example only, when the force sensor assembly (148) indicates that the distal tip member (142) is encountering forces that exceed a predetermined threshold, the console (12) can provide audible feedback to alert the physician (PH) so as to prevent the physician (PH) from inadvertently damaging the cardiovascular anatomy with the distal tip member (142).

[0044] The position sensor assembly (150) can generate signals indicative of the position and orientation of the end effector (140) in three-dimensional space with substantial accuracy. The position sensor assembly (150) includes a plurality of panels (151), each panel including an RX coil operable to generate electrical signals indicative of position in response to an alternating magnetic field generated by the field generator (20). Each RX coil can be formed from electrical traces to define an electrical coil or antenna to receive radio frequency signals transmitted by an external transmitter TX coil (e.g., three TX coils provided by the field generator (20) positioned external to the patient (PA) body and transmitting discrete radio frequencies) such that the position and orientation of each RX coil can be determined relative to the TX coils provided by the field generator (20). Signals from the position sensor assembly (150) can be transmitted through vias or other structures in the layers proximal to the strain position sensor assembly (150) and ultimately via the cable (30) to the first driver module (14) of the console (12).

[0045] The central annular body of the position sensor assembly (150) defines a central aperture configured to provide a pathway for the transmission of irrigation fluid to the hollow interior of the distal tip member (142). In versions in which the central annular body of the position sensor assembly includes wireless communication coils, such wireless communication coils can also be coupled with vias or other structures in the layers proximal to the strain position sensor assembly (150) to provide a pathway for electrical communication with the first driver module (14) of the console (12) via the cable (30).

[0046] In the present example, each distal spacer (153) is generally shaped as a disk with a pair of spinal cord incisions angularly offset 90 degrees from one another. The incisions are sized and configured to accommodate a corresponding faceplate (151) of the position sensor assembly (150), thereby allowing the faceplate (151) to be radially interposed between the distal spacer stack (152) and the sheath (122). Each distal spacer (153) also includes a pair of cable notches angularly offset 180 degrees from one another. The cable notches are configured to receive respective distal end portions (174, 164) of the push-pull cables (170, 172). Each distal spacer (153) also includes a central aperture configured to provide a path for the transmission of irrigation fluid to the hollow interior of the distal tip member (142).

[0047] Each proximal spacer 154 is shaped as a disk with three apertures formed therethrough. A central aperture is configured to provide a path for the transmission of irrigation fluid to the hollow interior of the distal tip member (142). Side apertures are sized and configured to receive proximal portions (162, 172) of respective push-pull cables (160, 170).

[0048] As described above and as shown in FIG. 1, the distal tip member (142) is coupled to the distal end of the catheter (120). The distal tip member (142) is configured to be received within the distal end of the catheter (120) and to be coupled to the distal end of the catheter (120) in a manner that allows the distal tip member (142) to be rotated relative to the catheter (120). In the present example, the distal tip member (142) is coupled to the distal end of the catheter (120) in a manner that allows the distal tip member (142) to be rotated relative to the catheter (120) by 360 degrees. FIG. 1 and FIG. 3 As shown in FIG. 1, the catheter assembly (100) is coupled to the drive system (10) by a cable (30). As shown in FIG. 1, a wire (32) of the cable (30) extends along the length of the catheter (120) to reach the proximal-most proximal spacer (154). Thus, the wire (32) can be housed within the sheath (122). The wire (32) can be physically and electrically coupled to the proximal-most proximal spacer (154) in any suitable manner. FIG. 4

[0049] As also described above, the catheter assembly (100) is configured to enable the transmission of irrigation fluid from the fluid source (42) to the catheter (120) via the fluid conduit (40), thereby providing the discharge of irrigation fluid via the opening (158) of the distal tip member (142). In the present example, the fluid path for the irrigation fluid includes an irrigation tube (180), which is shown in FIG. 1. A proximal end of the irrigation tube (180) is coupled to the fluid conduit (40) (e.g., at the handle (110) of the catheter assembly (100)). The irrigation tube (180) extends along the length of the catheter (120) to reach the end effector (140). In some versions, irrigation fluid can be transmitted from a distal end of the irrigation tube (180) through a central passageway formed by the aforementioned central apertures of the aligned proximal spacers (154), ultimately reaching the interior of the distal tip member (142) via the aperture (218) of the distal tip base (144). FIGS. 4-5

[0050] ​​III. Examples of electrode and sensor assemblies for end effectors of catheter assemblies

[0051] The end effector of an EP mapping or ablation catheter can include various types of sensors configured to sense conditions associated with tissue contacted by the end effector. Such sensors can include force sensors, temperature sensors, impedance sensors, or other types of sensors. In conventional EP mapping or ablation catheters, such sensors can be spaced apart from the EP mapping electrodes (e.g., microelectrodes (138)) or ablation electrodes. By being spaced apart from the EP mapping electrodes or ablation electrodes, the data obtained via such sensors can not necessarily provide a fully accurate representation of the conditions associated with the precise location of tissue contacted by a given electrode. Accordingly, it would be desirable to provide an end effector in which sensors are positioned and operable to provide data that is actually an accurate representation of the conditions associated with the precise location of tissue contacted by a given electrode. To this end, FIGS. 6-7 An example of an electrode and sensor assembly (200) that can be incorporated into an end effector, such as end effector (140), is shown.

[0052] As FIGS. 6-7 shown, the electrode and sensor assembly (200) of this example includes a base structure (210) that defines a recess (220) in an outer surface (212). By way of example only, the base structure (210) can form a portion of the structure of the cylindrical body (156) that replaces the distal tip member (142) of the end effector (140). While the base structure (210) is shown as being substantially flat, the base structure (210) can instead have a curvature (e.g., to form a domed tip or other non-flat shape). While only one recess (220) is shown in the base structure (210) in FIGS. 6-7 While only one recess (220) is shown in the base structure (210) in

[0053] The recess (220) includes a sidewall (222). While the recess (220) is circular in this example, the recess (220) can instead have any other suitable shape, including but not limited to square, hexagonal, etc. The electrode (230) is positioned at the bottom of the recess (220) such that the electrode (230) is recessed relative to the outer surface (212) of the base structure (210). In some cases, the electrode (230) is an EP mapping electrode (e.g., like the EP mapping microelectrode (138)) such that the electrode (230) is configured to pick up electrical potentials from tissue in contact with the electrode (230). Additionally or alternatively, the electrode (230) can be used as an ablation electrode such that the electrode (230) is configured to ablate tissue in contact with the electrode (230) when the electrode (230) is activated with RF energy. Some versions of the electrode and sensor assembly (200) can include a combination of one or more electrodes (230) for EP mapping and one or more electrodes (230) for ablation.

[0054] In this example, the sensor (240) is positioned at the center of the electrode (230). The sensor (240) is offset from the electrode (230) via the sidewall (224) such that the sensor (240) is elevated above the electrode (240). In some versions, the sensor (240) is at the same height as the outer surface (212) of the base structure (210). In some other versions, the sensor (240) is recessed relative to the outer surface (212) of the base structure (210) but not as much as the electrode (230). In other versions, the sensor (240) is protruding outward relative to the outer surface (212) of the base structure (210). While the sensor (240) is shown as being positioned entirely at the top of the sidewall (224), some versions of the sensor (240) can include at least a portion of the sensor (240) positioned along the sidewall (224) (e.g., such that a portion of the sensor (240) faces the sidewall (222) of the recess (220)). In this type of version, even the portion of the sensor (240) positioned along the sidewall (224) can still be in contact with tissue.

[0055] In this example, the recess (220) is circular and the sensor (240) and the sidewall (224) are positioned at the axial center of the recess (220) and the electrode (230), which has a ring shape in this example, such that the electrode (230) surrounds the outer perimeter of the sidewall (224). As another merely illustrative example, the sensor (240) can be positioned immediately adjacent to the outside of the electrode (230). Alternatively, any other suitable positioning and relationship can be used.

[0056] During use of an end effector incorporating an electrode and sensor assembly (200) as described herein, the electrode and sensor assembly (200) can be pressed against tissue (e.g., in a heart (H) chamber, a pulmonary vein, etc.) such that the electrode (230) and sensor (240) simultaneously contact the tissue. In this example, the tissue contact surface of the electrode (230) is recessed relative to the outer surface (212) of the base structure (210), allowing the tissue to protrude into or otherwise enter the recess (220) to contact the electrode (230). In some other embodiments, the tissue contact surface of the electrode (230) is substantially flush with the outer surface (212) of the base structure (210). In this embodiment, the tissue contact surface of the sensor (240) may be flush with the tissue contact surface of the electrode (230); or raised relative to the tissue contact surface of the electrode (230). As another example, which is merely illustrative, the tissue contact surface of the electrode (230) may be raised relative to the outer surface (212) of the base structure (210). Similarly, in this type, the tissue contact surface of the sensor (240) may be flush with or raised relative to the tissue contact surface of the electrode (230). However, it should be understood that the tissue does not necessarily need to contact the electrode (230) in order for the electrode (230) to pick up a signal from the tissue. For example, when the tissue is brought close enough to the electrode (230), the signal can be transmitted by a fluid (e.g., blood, saline, etc.) inserted between the tissue and the electrode (230).

[0057] like FIG. 7 As shown, the conduit (232) is coupled to the electrode (230); simultaneously, two conduits (242, 244) are coupled to the sensor (240). In some other configurations, the electrode (230) has two conduits (232). The conduits (232, 242, 244) can take various forms, including but not limited to wires, conductive traces, etc. The conduits (232, 242, 244) can ultimately communicate with the console (12) via a cable (30). Thus, the console (12) is operable to receive EP mapping signals from the electrode (230) via the conduits (232) and cable (30), to supply RF energy to the electrode (230) via the conduits (232) and cable (30), or to receive data from the sensor (240) via the conduits (242, 244) and cable (30). Based on the teachings herein, various suitable ways in which the conduits (232, 242, 244) can be integrated into or otherwise supported by the base structure (210) will be apparent to those skilled in the art.

[0058] The sensor (240) can be operable to sense various conditions. By way of example only, the sensor (240) can be operable to sense a temperature of tissue contacted by the sensor (240). In this type, the sensor (240) can be thermally isolated from the electrode (230) such that the sensor (240) only measures the temperature of tissue contacted by the sensor (240) and not the temperature of the electrode (230). By way of example only, a type of sensor (240) operable to sense temperature can include a thermocouple or any other suitable type of temperature sensor as will be apparent to those of ordinary skill in the art in view of this disclosure. In a type where the electrode (230) is used to apply RF ablation energy to tissue, temperature data picked up by the sensor (240) can be processed by the console (12) to modulate the delivery of RF energy by the electrode (230) in real time. For example, such temperature data can be used to determine when tissue has been sufficiently ablated to prevent overheating of the tissue during ablation. In this case, the console (12) can track tissue impedance data from the sensor (240) in real time during the delivery of RF energy by the electrode (230). Once the tissue temperature data indicates that a particular threshold has been reached, the console (12) can stop or otherwise reduce the delivery of RF energy by the electrode (230). Additionally or alternatively, the console (12) can use tissue temperature data from the sensor (240) for other purposes as will be apparent to those of ordinary skill in the art in view of this disclosure.

[0059] By way of further example only, the sensors (230, 240) can be used together to sense an impedance of tissue contacted by both sensors (230, 240) at the same time. Such impedance values can be used to identify contact between tissue and the sensors (230, 240). For example, prior to the sensors (230, 240) contacting tissue, and when one or both of the sensors (230, 240) are in contact with blood, the sensed impedance values can be relatively low. Once the sensors (230, 240) contact tissue, the sensed impedance values can increase significantly. Thus, a peak in the impedance sensed by the sensors (230, 240) can indicate contact between the sensors (230, 240) and tissue. This can be further understood to indicate contact between tissue and the electrode (230) adjacent to the sensor (240). In contrast to an end effector that senses impedance by using one electrode on the end effector in cooperation with an external electrode (e.g., a patch adhered to the skin of a patient), the end effector (140) having the electrode and sensor assembly (200) can provide significantly greater sensitivity to detecting tissue contact by utilizing sensors (230, 240) that are closely positioned relative to each other.

[0060] In cases where the impedance of the tissue varies based on the RF ablation energy delivered to the tissue, in versions where the electrode (230) is used to apply RF ablation energy to the tissue, the tissue impedance data can be processed by the console (12) to modulate the delivery of RF energy by the electrode (230) in real time. For example, such tissue impedance data can be used to determine when the tissue has been sufficiently ablated to prevent overheating of the tissue during the ablation. In this case, the console (12) can track the tissue impedance data from the sensor (240) in real time during the delivery of RF energy by the electrode (230). Once the tissue impedance data indicates that a particular threshold has been reached, the console (12) can stop the delivery of RF energy by the electrode (230). Similarly, the console (12) can change the frequency, amplitude, or other characteristics of the RF energy delivery based on real-time tissue impedance data from the sensor (240) before stopping a suitable form of energy, such as a form of direct current (DC) or alternating current (AC) such as a form of pulsed direct current bipolar ablation (e.g., irreversible energy ablation or pulsed field ablation) or RF energy delivery. Additionally or alternatively, the console (12) can use the tissue impedance data from the sensor (240) for other purposes that will be apparent to those of skill in the art in view of the teachings herein.

[0061] As another example, the sensor (240) can be operable to sense tissue contact force (e.g., a normal force exerted by tissue pressed against the sensor (240)). Such force sensors can take a variety of different forms. FIG. 8 One example of a form that the sensor (240) can take is shown. FIGS. 8-12 Some examples of forms that the force sensing version of the sensor (240) can take are shown, and will be described in greater detail below. Other examples can include a capacitive film construction or any other suitable type of force sensing construction that will be apparent to those of skill in the art in view of the teachings herein.

[0062] FIG. 8 A force sensor (300) is shown that operates using piezoelectric principles and includes a first electrode layer (310) and a second electrode layer (320). By way of example only, the electrode layers (310, 320) can include copper or any other suitable material. The first electrode layer (310) can be positioned to contact tissue (e.g., similar to the sensor (240) described above); while the second electrode layer (320) can be positioned at the top of the sidewall (224) to provide a base support (i.e., mechanical ground) to the force sensor (300). In some versions, the second electrode layer (320) provides an additional sensing element similar to the sensor (230) described above.

[0063] A pair of dielectric layers (330, 340) is interposed between corresponding regions of the electrode layers (310, 320); wherein the electrode layers (310, 320) are oriented parallel to one another. In particular, a first dielectric layer (330) is positioned directly below the first electrode layer (310), and a second dielectric layer (340) is positioned directly above the second electrode layer (320), with the dielectric layers (330, 340) directly opposite one another. By way of example only, each dielectric layer (330, 340) can comprise a polyimide material. By way of further example only, each dielectric layer (330, 340) can comprise Kapton® by DuPont of Wilmington, Delaware. While a pair of dielectric layers (330, 340) is provided in the present example, some other versions can have only a single dielectric layer (330, 340). It will also be appreciated that in versions where the first electrode layer (310) is similar in structure and function to the sensor (240) and the second electrode layer (320) is similar in structure and function to the sensor (230), the structure provided by the dielectric layers (330, 340) can provide structure and function similar to the sidewall (224) of the electrode and sensor assembly (200). As another example only, the first electrode layer (310) can be similar in structure and function to the sensor (240), and the second electrode layer (320) can cooperate with the dielectric layers (330, 340) to provide structure and function similar to the sidewall (224) (e.g., such that a separate electrode similar to the electrode (230) is provided).

[0064] A piezoelectric element (350) is interposed between another region of the electrode layers (310, 320), laterally adjacent to the dielectric layers (330, 340). An upper portion of the piezoelectric element (350) is bonded to an underside of the first electrode layer (310) by a conductive adhesive (352); while a lower portion of the piezoelectric element (350) is bonded to a top side of the second electrode layer (310) by a conductive adhesive (354).

[0065] In use, the force sensor (300) can generate a variable voltage based on a force exerted on the sensor (300) by tissue. In other words, the greater the force exerted on the sensor (300) by tissue, the greater the voltage generated by the force sensor (300). In some variations of the force sensor (300), both electrode layers (310, 320) can be positioned to contact tissue; and the electrode layers (310, 320) can also be operable to sense tissue temperature or tissue impedance. Thus, some versions of the sensor (300) can be operable to sense any combination of tissue contact force, tissue temperature, and tissue impedance. As another example only, either or both of the electrode layers (310, 320) can be operable to provide one or both of EP mapping or ablation functionality, similar to the electrode (230).

[0066] FIGS. 9-12 Another example of a form that a sensor (240) can take is shown. In particular, FIGS. 9-12 A force sensor (400) is shown that includes a first body (410) having a first pair of opposing arms (412) and a second pair of opposing arms (414). The arms (412) are angularly spaced 90 degrees from the arms (414). In this example, the length of the arms (412) is greater than the length of the arms (414). By way of example only, the first body (410) can include gold or chromium. A cubic mass (440) is positioned on top of and bonded to a central region of the first body (410). The mass (440) is positioned to contact tissue such that the mass (440) will directly receive a force applied by the contacted tissue; and the force sensor (400) will generate a signal indicative of the force applied on the mass (440). While the mass (440) is shown and described as cubic in this example, the mass (440) can have any other suitable shape that will be apparent to those of skill in the art in view of the teachings herein.

[0067] A first layer (430) is positioned underneath at least a portion of the first body (410). The first layer (430) includes a first arm region (450) that is convex outward relative to one arm (414) of the first body (410); and a second arm region (452) that is convex outward relative to the other arm (414) of the first body (410). The arm regions (450, 452) are thus exposed relative to the arms (414). By way of example only, the first layer (430) can include doped silicon. A second layer (432) is positioned underneath the first layer (430). For example, the second layer (432) can span the entire underside of the first layer (430). By way of example only, the second layer (432) can include silicon.

[0068] As FIGS. 11-12As shown, the layers (430, 432) can be secured to two support structures (500, 502) such that the first arm region (450) is positioned adjacent to the first support structure (500) and the second arm region (452) is positioned adjacent to the second support structure (502). The support structures (500, 502) can be supported on top of the sidewalls (224) such that the support structures (500, 502) provide a base support (i.e., mechanical ground) for the force sensor (400). Alternatively, the support structures (500, 502) can be positioned on the outer surface (212) of the base structure (210) somewhere near the electrodes (230) but not on the sidewalls (224). By way of further example only, the support structures (500, 502) can be defined by the outer surface (212) of the base structure (210) (e.g., such that the support structures (500, 502) are not separate components secured to the outer surface (212) of the base structure (210)); the mass (440) can be positioned over the center region of the electrodes (230) (e.g., in place of the sensor (240)); and the arms (412, 414) can span the space over the electrodes (230) to support the mass (440) over the center region of the electrodes (230). With reference to the teachings herein, the force sensor (400) can be integrated into the electrode and sensor assembly (200) or in other manners apparent to those of skill in the art into the end effector (140).

[0069] FIG. 11 The force sensor (400) is shown receiving a generally vertical force, deforming the center region and the two arm regions (450, 452) of the first body (410) downward. In other words, the force sensor (400) is experiencing a normal deflection in the z-direction. FIG. 11 The vertically oriented force (p) can be measured using the following equation:

[0070] p = (AR1 / R1 + AR2 / R2) / k p

[0071] where p = the magnitude of the vertically oriented force;

[0072] R1 = the resistance of the first layer (430) at the first arm region (450);

[0073] R2 = the resistance of the first layer (430) at the second arm region (452); and

[0074] k p = the conversion constant for normal force.

[0075] FIG. 12A force sensor (400) is shown that receives a generally lateral directed force, deforming a first arm region (450) upward and a second arm region (452) downward. In other words, the force sensor (400) encounters FIG. 12 a shear deflection in the x-y plane. The lateral directed force (T) can be measured using the following equation:

[0076] T = (AR1 / R1 - AR2 / R2) / k s

[0077] where T = the magnitude of the lateral directed force;

[0078] R1 = the resistance of the first layer (430) at the first arm region (450);

[0079] R2 = the resistance of the first layer (430) at the second arm region (452); and

[0080] k s = the conversion constant for shear force.

[0081] Of course, in a real-world scenario, the force applied to the sensor (400) can include a combination of vertically directed and laterally directed components. It should be appreciated that the sensor (400) can detect both axial forces to derive a force direction vector. Other variations can be simplified to measure only the normal force (e.g., not measure shear / lateral forces).

[0082] In versions in which the sensor (240) is used to measure force (e.g., in versions in which the sensor (240) is in the form of the sensor (300), in the form of the sensor (400), or in some other form), force data from the sensor (240) can be used in various ways. For example, the console (12) can drive the display (18) to provide visual feedback to the physician (PH) to indicate the amount of force encountered by the sensor (240), which can reflect the force with which the corresponding electrode (230) is pressed against tissue. In cases in which the force exceeds a threshold (e.g., a value associated with causing undesired trauma to tissue due to pressing against the tissue with too much force), the console (12) can also provide audible or visual indications to the physician (PH) to warn the physician (PH) that they are applying too much force to the tissue. Additionally or alternatively, force data from the sensor (240) can be processed by the console (12) to modulate the delivery of RF energy to the electrode (230) in real time. For example, the console (12) can prevent the electrode (230) from being activated by RF energy until force data from the corresponding sensor (240) indicates that the sensor (240) and electrode (230) are being pressed against tissue with sufficient force. As another example, force data from the sensor (240) can be used (e.g., in combination with other measurements such as power and duration of RF application) to estimate the size of a lesion formed by an ablation procedure with the electrode (230). Alternatively, force data from the sensor (240) can be used for any other suitable purpose that will be apparent to those skilled in the art in view of the teachings herein, including but not limited to providing a warning when the force exceeds a threshold (e.g., to avoid accidentally puncturing tissue with the end effector (140)). In versions in which the end effector (140) is used to measure temperature, temperature measurements can be used to provide error correction for force measurements due to the fact that readings from force measurement sensors can be affected by temperature (e.g., due to expansion / contraction of elements, etc.).

[0083] In the present example, the electrode (230) and sensor (240) are integrally constructed together. In other words, the electrode (230) and sensor (240) can be simultaneously constructed together in the same process. In some other versions, the electrode (230) and sensor (240) can be separately constructed and subsequently assembled together (e.g., through a lamination process or other process).

[0084] It will be appreciated from the foregoing that the configuration of the electrode and sensor assembly (200) allows each sensor (240) to provide spatially highly localized data related to the corresponding electrode (230). Such highly localized data can be more meaningful than data acquired from sensors that are spatially further removed from the electrode (230). For example, where a conventional ablation catheter can provide a single contact force sensor that provides contact force data indicative of contact force across the entire tip of an end effector (which can include more than one ablation electrode), an ablation catheter that includes the electrode and sensor assembly (200) on the end effector can provide several separate contact force data measurements based on each electrode (230). It will also be appreciated that the relatively small size of each sensor (240) can facilitate full contact between the sensor (240) and the tissue; this is in contrast to conventional catheters having large sensors that, during use of such catheters, the tissue only contacts a portion of the sensor due to the sensor being so large. Full contact between the sensor (240) and the tissue can provide more reliable and more meaningful data than data acquired by a larger sensor that only has a portion in contact with the tissue.

[0085] IV. Examples of combinations

[0086] The following examples relate to various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that can be presented at any time in this application or in subsequent filings of this application. No admission is made that any aspect or feature of the following examples is essential to practicing the application. The following examples are provided merely as an exemplification of the various teachings herein. It is contemplated that various teachings herein can be arranged and applied in numerous other ways. It is also contemplated that some variations can omit certain features referred to in the following examples. Therefore, none of the aspects or features of the following examples should be deemed critical, essential, or required. If any of the following examples are presented as claims, they should be interpreted to exclude any feature that is not recited in the claims. If any of the following examples are presented as claims, they should be interpreted to exclude any feature that is not recited in the claims.

[0087] EMBODIMENT 1

[0088] An apparatus comprising: (a) a catheter body having a distal end, the catheter body sized and configured to fit within a region of a cardiovascular system; and (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region of a cardiovascular system, the end effector comprising: (i) an end effector body member having an outer surface, (ii) an electrode having a tissue contact surface, and (iii) a sensor having a tissue contact surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, the tissue contact surface of the sensor configured to protrude relative to one or both of the outer surface of the end effector body member or the tissue contact surface of the electrode.

[0089] EMBODIMENT 2

[0090] The apparatus of any one or more of embodiments 1, the end effector defines a dome-shaped tip.

[0091] EMBODIMENT 3

[0092] The apparatus of any one or more of embodiments 1-2, the electrode is operable to pick up an electrical potential from tissue contacting the tissue contact surface of the electrode.

[0093] EMBODIMENT 4

[0094] The apparatus of any one or more of embodiments 1-3, the electrode is operable to ablate tissue contacting the tissue contact surface of the electrode.

[0095] EMBODIMENT 5

[0096] The apparatus of embodiment 4, the electrode is operable to apply one or more of pulsed direct current bipolar ablation or radiofrequency energy to tissue contacting the tissue contact surface of the electrode, thereby ablating tissue contacting the tissue contact surface of the electrode.

[0097] EMBODIMENT 6

[0098] The apparatus of any one or more of embodiments 1-5, the end effector body member defines a recess.

[0099] EMBODIMENT 7

[0100] The apparatus of embodiment 6, the electrode is positioned in the recess.

[0101] EMBODIMENT 8

[0102] The apparatus according to any one or more of embodiments 7, the tissue-contacting surface of the electrode is recessed relative to the outer surface of the end effector body.

[0103] EMBODIMENT 9

[0104] The apparatus according to any one or more of embodiments 1-8, the electrode has an annular shape defining a radial center.

[0105] EMBODIMENT 10

[0106] The apparatus according to embodiment 9, the electrode is positioned at the radial center of the electrode.

[0107] EMBODIMENT 11

[0108] The apparatus according to any one or more of embodiments 1-10, the sensor has a circular shape.

[0109] EMBODIMENT 12

[0110] The apparatus according to any one or more of embodiments 1-11, the end effector body further comprises a first sidewall and a second sidewall, the electrode is positioned between the first sidewall and the second sidewall.

[0111] EMBODIMENT 13

[0112] The apparatus according to embodiment 12, the second sidewall faces the first sidewall.

[0113] EMBODIMENT 14

[0114] The apparatus according to any one or more of embodiments 12-13, the first sidewall and the second sidewall each have a cylindrical outer shape.

[0115] EMBODIMENT 15

[0116] The apparatus according to any one or more of embodiments 12-14, the sensor is positioned at a top of the second sidewall, the second sidewall being an inner sidewall.

[0117] EMBODIMENT 16

[0118] The apparatus according to any one or more of embodiments 1-15, the sensor is configured to sense a temperature of tissue contacting the tissue-contacting surface of the sensor.

[0119] EMBODIMENT 17

[0120] The apparatus of example 16, the electrode operable to apply radiofrequency energy to tissue contacting the tissue contact surface of the electrode.

[0121] EMBODIMENT 18

[0122] The apparatus of example 17, further comprising a control module in communication with the sensor and with the electrode, the control module operable to modulate delivery of radiofrequency energy to the electrode based on temperature data from the sensor.

[0123] EMBODIMENT 19

[0124] The apparatus of example 18, the control module operable to stop delivery of radiofrequency energy to the electrode in response to a sensed temperature value that exceeds a threshold value.

[0125] EMBODIMENT 20

[0126] The apparatus of any one or more of examples 1-19, the sensor configured to sense impedance of tissue contacting the tissue contact surface of the sensor.

[0127] EMBODIMENT 21

[0128] The apparatus of example 20, the electrode operable to apply one or more of pulsed direct current bipolar ablation or radiofrequency energy to tissue contacting the tissue contact surface of the electrode.

[0129] EMBODIMENT 22

[0130] The apparatus of example 21, further comprising a control module in communication with the sensor and with the electrode, the control module operable to modulate delivery of one or more of pulsed direct current bipolar ablation or radiofrequency energy to the electrode based on impedance data from the sensor.

[0131] EMBODIMENT 23

[0132] The apparatus of example 22, the control module operable to stop delivery of radiofrequency energy to the electrode in response to a sensed impedance that reaches a threshold value.

[0133] EMBODIMENT 24

[0134] The apparatus of any one or more of embodiments 22-23, the control module operable to change one or both of a voltage and a duration of one or more pulses of direct current bipolar ablation to the electrode, or change one or both of a frequency or an amplitude of radiofrequency energy based on impedance data from the sensor.

[0135] EMBODIMENT 25

[0136] The apparatus of any one or more of embodiments 20-22, further comprising a control module in communication with the sensor, the control module configured to: (i) determine whether the sensor is in contact with tissue based on impedance data from the sensor, and (ii) indicate that the sensor is in contact with tissue in response to determining that the sensor is in contact with tissue based on impedance data from the sensor.

[0137] EMBODIMENT 26

[0138] The apparatus of any one or more of embodiments 1-25, the sensor configured to detect a force between the tissue contact surface of the sensor and adjacent tissue.

[0139] EMBODIMENT 27

[0140] The apparatus of embodiment 26, further comprising a control module in communication with the sensor, the control module configured to determine whether the sensor is in contact with tissue based on force data from the sensor.

[0141] EMBODIMENT 28

[0142] The apparatus of embodiment 27, the electrode operable to apply one or more of pulsed direct current bipolar ablation or radiofrequency energy to tissue contacting the tissue contact surface of the electrode.

[0143] EMBODIMENT 29

[0144] The apparatus of embodiment 28, the control module operable to modulate delivery of one or more of pulsed direct current bipolar ablation or radiofrequency energy to the electrode until force data from the sensor indicates contact between the sensor and tissue.

[0145] EMBODIMENT 30

[0146] The apparatus of any one or more of embodiments 28-29, the control module operable to prevent delivery of one or more of pulsed direct current bipolar ablation or radiofrequency energy to the electrode until force data from the sensor indicates contact between the sensor and tissue.

[0147] EMBODIMENT 31

[0148] The apparatus of any one or more of embodiments 26-30, the force sensor comprises a piezoelectric element.

[0149] EMBODIMENT 32

[0150] The apparatus of embodiment 31, the force sensor further comprises a first electrode layer and a second electrode layer, the piezoelectric element being interposed between the first electrode layer and the second electrode layer at a first associated region.

[0151] EMBODIMENT 33

[0152] The apparatus of embodiment 32, the force sensor further comprises a pair of dielectric layers adjacent to the piezoelectric element, the dielectric layers being interposed between the first electrode layer and the second electrode layer at a second associated region.

[0153] EMBODIMENT 34

[0154] The apparatus of any one or more of embodiments 26-33, the force sensor comprises a pair of arms fixed to a corresponding pair of support structures, the force sensor being configured to sense a force based on deformation of the arms.

[0155] EMBODIMENT 35

[0156] The apparatus of any one or more of embodiments 1-34, further comprising a position sensor operable to generate a signal indicative of a real-time position of the end effector in three-dimensional space.

[0157] EMBODIMENT 36

[0158] The apparatus of embodiment 35, the position sensor is located in the end effector.

[0159] EMBODIMENT 37

[0160] The apparatus of any one or more of embodiments 1-36, the end effector further comprises (i) a plurality of electrodes comprising the electrode, and (ii) a plurality of sensors comprising the sensor.

[0161] EMBODIMENT 38

[0162] An apparatus comprising: (a) a catheter body having a distal end, the catheter body sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region of the cardiovascular system, the end effector comprising: (i) an end effector body member having an outer surface, (ii) an electrode having a tissue contact surface, the tissue contact surface recessed relative to the outer surface of the end effector body member, the electrode operable to perform one or both of: (A) pick up an electrical potential from tissue contacting the tissue contact surface of the ring electrode, or (B) ablate tissue contacting the tissue contact surface of the ring electrode, and (iii) a sensor having a tissue contact surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, the tissue contact surface of the sensor configured to protrude relative to the tissue contact surface of the electrode.

[0163] EMBODIMENT 39

[0164] An apparatus comprising: (a) a catheter body having a distal end, the catheter body sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region of the cardiovascular system, the end effector comprising: (i) an end effector body member having an outer surface, (ii) an electrode having a tissue contact surface and a central region, the tissue contact surface of the electrode exposed relative to the outer surface of the end effector body member, the electrode operable to perform one or both of: (A) pick up an electrical potential from tissue contacting the tissue contact surface of the ring electrode, or (B) ablate tissue contacting the tissue contact surface of the ring electrode, and (iii) a sensor positioned in the central region of the electrode, the sensor having a tissue contact surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, the tissue contact surface of the sensor exposed relative to the outer surface of the end effector body member and relative to the tissue contact surface of the electrode.

[0165] EMBODIMENT 40

[0166] An apparatus comprising: (a) a catheter body having a distal end, the catheter body sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region of the cardiovascular system, the end effector comprising: (i) an end effector body member having an outer surface, (ii) a ring electrode, the electrode having a tissue contact surface, the electrode operable to perform one or both of: (A) pick up an electrical potential from tissue contacting the tissue contact surface of the ring electrode, or (B) ablate tissue contacting the tissue contact surface of the ring electrode, and (iii) a sensor positioned in a radially central region of the ring electrode, the sensor having a tissue contact surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, the tissue contact surface of the sensor being exposed relative to the tissue contact surface of the electrode.

[0167] V. Miscellaneous

[0168] Any of the instruments described herein can be cleaned and / or sterilized prior to and / or following a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or 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 the sterile container for later use. A device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas plasma (with or without vapor).

[0169] It should be understood that any of the examples described herein can include various other features in addition to or in place of those described above. By way of example only, any of the examples described herein can include one or more of the various features disclosed in any of the various references incorporated by reference herein in their entireties.

[0170] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable methods, features, components, and / or functions described herein can be employed in conjunction with each other in various suitable combinations. Various modifications and changes can be made as would be obvious to a person of ordinary skill in the art having the benefit of this disclosure, once informed of the teachings contained herein. Any and all such modifications or changes are intended to fall within the scope of the claims.

[0171] It should be understood that any patents, patent publications, or other publications referred to herein are incorporated by reference in their entirety only to the extent that the incorporated material is not inconsistent with existing definitions, statements, or other disclosure material set forth in the present disclosure. Thus, and to the extent necessary, the disclosure herein expressly incorporates by reference the entire text of any and all patents, patent publications, or other disclosure materials for all purposes. Any material, or portion thereof, that is said to be incorporated by reference herein but which contradicts the present disclosure or which has been previously filed a priority document outside the United States will only be incorporated to the extent that the material is not contradictory.

[0172] Having shown and described various modes of the present application, further modifications and improvements will occur to persons of ordinary skill in the art. Several of such possible modifications and improvements have been mentioned, and others will occur to those persons. For example, the examples, modes, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not essential. Accordingly, the scope of the present application should be considered in terms of the following claims and any equivalents thereof, and should be understood not to be limited to the details of structure and operation shown and described herein.

Claims

1. An apparatus comprising: (a) A catheter body having a distal end, the size and configuration of which are configured to fit within a region of the cardiovascular system; and (b) An end effector located at the distal end of the catheter body, the end effector being sized and configured to fit within a region of the cardiovascular system, the end effector comprising: (i) An end effector body member having an outer surface and a recess, wherein the recess includes a bottom surface and a sidewall extending from the bottom surface to the outer surface. (ii) An electrode having a tissue contact surface, wherein the electrode is positioned in the recess such that the tissue contact surface of the electrode is recessed relative to the outer surface of the end effector body member, and (iii) A sensor having a tissue contact surface, the sensor being configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, wherein the sensor is positioned at the center of the electrode such that the tissue contact surface of the sensor protrudes relative to the tissue contact surface of the electrode.

2. The device of claim 1, wherein the electrode is operable to pick up a potential from the tissue contact surface in contact with the electrode.

3. The device according to claim 1, wherein the electrode is operable to ablate tissue on the tissue contact surface in contact with the electrode.

4. The device according to claim 1, wherein the electrode has an annular shape defining a radial center, and the electrode is positioned at the radial center of the electrode.

5. The device of claim 1, wherein the sensor is configured to sense the temperature of tissue contacting the tissue contact surface of the sensor.

6. The device of claim 5, further comprising a control module in communication with the sensor and the electrode, the electrode being operable to apply radio frequency energy to tissue contacting the tissue contact surface of the electrode, the control module being operable to modulate the delivery of radio frequency energy to the electrode based on temperature data from the sensor.

7. The device of claim 6, wherein the control module is operable to stop delivering radio frequency energy to the electrode in response to a sensed temperature value exceeding a threshold value.

8. The device of claim 1, wherein the sensor is configured to sense the impedance of tissue contacting the tissue contact surface of the sensor.

9. The device of claim 8, further comprising a control module in communication with the sensor and the electrode, the electrode operable to apply one or more of pulsed DC bipolar ablation or radio frequency energy to tissue contacting the tissue contact surface of the electrode, the control module operable to modulate the delivery of one or more of the pulsed DC bipolar ablation or radio frequency energy to the electrode based on impedance data from the sensor.

10. The device of claim 9, wherein the control module is operable to stop delivering radio frequency energy to the electrode in response to a sensed impedance reaching a threshold.

11. The device of claim 9, wherein the control module is operable to change the voltage and duration of one or more pulses of DC bipolar ablation to the electrode, or to change the frequency or amplitude of radio frequency energy to the electrode, based on impedance data from the sensor.

12. The device of claim 8, further comprising a control module communicating with the sensor, the control module being configured to: (i) Determine whether the sensor is in contact with tissue based on impedance data from the sensor, and (ii) In response to determining that the sensor is in contact with tissue based on impedance data from the sensor, indicating that the sensor is in contact with tissue.

13. The device of claim 1, further comprising a control module communicating with the sensor, the sensor being configured to detect forces between the tissue contact surface of the sensor and adjacent tissue, the control module being configured to determine whether the sensor is in contact with tissue based on force data from the sensor.

14. The device of claim 13, wherein the electrode is operable to apply one or more of pulsed DC bipolar ablation or radiofrequency energy to tissue contacting the tissue contact surface of the electrode, and the control module is operable to perform one or both of the following operations: (i) The delivery of one or more of modulated pulsed DC bipolar ablation or radio frequency energy to the electrode continues until force data from the sensor indicates contact between the sensor and the tissue, or (ii) Prevent the delivery of one or more of pulsed DC bipolar ablation or radio frequency energy to the electrode until force data from the sensor indicates contact between the sensor and the tissue.

15. The device of claim 1, wherein the sensor comprises a force sensor configured to detect forces between the tissue contact surface of the sensor and adjacent tissue, the force sensor comprising a piezoelectric element.

16. The device according to claim 15, wherein the force sensor further comprises: (i) a first electrode layer and a second electrode layer, wherein the piezoelectric element is inserted between a first associated region between the first electrode layer and the second electrode layer, and (ii) A pair of dielectric layers adjacent to the piezoelectric element, the dielectric layers being interposed between a second associated region between the first electrode layer and the second electrode layer.

17. The device of claim 1, wherein the sensor includes a force sensor configured to detect forces between the tissue contact surface of the sensor and adjacent tissue, the force sensor including a pair of arms fixed to a corresponding pair of support structures, the force sensor being configured to sense forces based on deformation of the arms.

18. An apparatus comprising: (a) A catheter body having a distal end, the size and configuration of which are configured to fit within a region of the cardiovascular system; and (b) An end effector located at the distal end of the catheter body, the end effector being sized and configured to fit within a region of the cardiovascular system, the end effector comprising: (i) An end effector body member having an outer surface and a recess, wherein the recess includes a bottom surface and a sidewall extending from the bottom surface to the outer surface. (ii) An annular electrode having a tissue contact surface recessed relative to the outer surface of the end effector body member, the annular electrode being operable to perform one or both of the following operations: (A) Picking up potential from the tissue contact surface of the annular electrode, or (B) Ablation of the tissue contact surface of the annular electrode, and (iii) A sensor having a tissue contact surface, the sensor being configured to sense at least one condition associated with tissue contacting the tissue contact surface of the sensor, wherein the sensor is positioned entirely on the top surface of a protrusion extending through a central opening of the annular electrode such that the tissue contact surface of the sensor protrudes relative to the tissue contact surface of the annular electrode, wherein the inner diameter of the central opening matches the outer diameter of the protrusion.

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