CATHETER WITH INTEGRATED THIN FILM MICRO-SENSOR - Patent application

Abstract

A device is provided that includes 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 the 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 includes an end effector body, an electrode, and a sensor. The end effector body has an outer surface. The electrode has a tissue-contacting surface. The sensor has a tissue-contacting surface. The sensor is configured to sense at least one condition associated with tissue contacting the tissue-contacting surface of the sensor. The tissue-contacting 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-contacting surface of the electrode.

Description

[Background technology]

[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when an area of ​​cardiac tissue abnormally conducts electrical signals. Procedures for treating arrhythmias include surgically disrupting the conduction pathways of such signals. By selectively ablating cardiac tissue by applying energy (e.g., radiofrequency (RF) energy), it may be possible to stop or modify the propagation of undesired electrical signals from one part of the heart to another. The ablation process can provide a barrier to the undesired electrical pathways by forming electrically insulating lesions or scar tissue that effectively block communication of the abnormal electrical signals across the tissue.

[0002] Cardiac arrhythmias, such as atrial fibrillation, occur when an area of ​​cardiac tissue abnormally conducts electrical signals. Procedures for treating arrhythmias include surgically disrupting the conduction pathways of such signals. By selectively ablating cardiac tissue by applying energy (e.g., radiofrequency (RF) energy), it may be possible to stop or modify the propagation of undesired electrical signals from one part of the heart to another. The ablation process can provide a barrier to the undesired electrical pathways by forming electrically insulating lesions or scar tissue that effectively block communication of the abnormal electrical signals across the tissue.

[0003] In some procedures, a catheter with one or more RF electrodes can be used to perform 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 within a cardiovascular structure adjacent to the heart (e.g., the pulmonary veins). One or more electrodes can be placed in contact with cardiac tissue or other vascular tissue and then activated with RF energy, thereby ablating the contacted tissue. In some cases, the electrodes may be bipolar. In some other cases, a monopolar electrode may be used in combination with a ground pad in contact with the patient or other reference electrode in contact with the patient. Irrigation can be used to draw heat from the ablation component of the ablation catheter and prevent blood clots from forming near the ablation site.

[0004] Examples of ablation catheters are described in U.S. Patent Application Publication No. 2013 / 0030426, published on January 31, 2013, entitled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens," the disclosures of which are incorporated by reference in their entirety into this specification, U.S. Patent Application Publication No. 2018 / 0071017, published on March 15, 2018, entitled "Ablation Catheter with a Flexible Printed Circuit Board," the disclosures of which are incorporated by reference in their entirety into this specification, and U.S. Patent No. 8,956,353, published on February 17, 2015, entitled "Electrode Irrigation Using Micro-Jets," the disclosures of which are incorporated by reference in their entirety into this specification.

[0005] Some catheter ablation procedures may be performed after using electrophysiology (EP) mapping to identify tissue regions to be targeted for ablation. Such EP mapping may involve 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 conductive endocardial tissue to identify the location of abnormal conductive tissue sites responsible for arrhythmias.

[0006] When using an ablation catheter, it may be desirable to ensure that one or more electrodes of the ablation catheter are in sufficient contact with the target tissue. For example, it may be desirable to ensure that one or more electrodes contact the target tissue with sufficient force to effectively apply RF ablation energy to the tissue, while avoiding applying a degree of force that would tend to unnecessarily damage the tissue. To that end, it may be desirable to include one or more force or pressure sensors to detect sufficient contact between one or more electrodes of the ablation catheter and the target tissue.

[0007] In addition to using force sensing or EP mapping, some catheter ablation procedures may be performed using an image guided surgery (IGS) system. An IGS system may allow a physician to visually track the position of the catheter within the patient in real time in conjunction with an image of the patient's anatomy. Some systems, including the CARTO 3® system by Biosense Webster, Inc. of Irvine, California, may provide a combination of EP mapping and IGS functionality. Examples of catheters configured for use with IGS systems 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] Although several catheter systems and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention as described, illustrated and claimed herein. [Brief description of the drawings]

[0009] The drawings and detailed description which follow are intended to be merely illustrative and are not intended to limit the scope of the invention as contemplated by the inventors. [Figure 1] 1 is a schematic diagram of a medical procedure in which a catheter of a catheter assembly is inserted into a patient. [Diagram 2] FIG. 2 is a perspective view of the catheter assembly of FIG. 1, with additional components shown in schematic form. [Diagram 3] FIG. 2 is a perspective view of a distal portion of the catheter of FIG. 1, with additional components shown in schematic form. [Figure 4] FIG. 2 is a perspective view of a distal portion of the catheter of FIG. 1 with the outer sheath omitted to reveal the internal components. [Diagram 5] FIG. 2 is an exploded perspective view of a distal portion of the catheter of FIG. 1. [Figure 6] 2A-2C show examples of electrode and sensor assemblies that may be incorporated into the end effector of the catheter of FIG. 1. [Figure 7] 7 is a cross-sectional view of the electrode and sensor assembly of FIG. 6 taken along line 7-7 of FIG. 6. [Figure 8] 7 is a side cross-sectional view of an example of a force sensor that can be incorporated into the electrode and sensor assembly of FIG. [Figure 9] 7 is a top view of another example of a force sensor that can be incorporated into the electrode and sensor assembly of FIG. 6. [Figure 10] FIG. 10 is a side cross-sectional view of the force sensor of FIG. [Figure 11] FIG. 10 is a side view of the force sensor of FIG. 9, with the mass of the force sensor experiencing a vertically oriented force. [Figure 12] FIG. 10 is a side view of the force sensor of FIG. 9, with the mass of the force sensor experiencing a laterally oriented force. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principles of the present invention by way of example and not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is by way of example one of the best modes contemplated for carrying out the invention. As will be appreciated, the present invention is capable of other different or equivalent aspects, all without departing from the present invention. The drawings and description should therefore be regarded as illustrative in nature and not restrictive.

[0011] Any one or more of the teachings, expressions, variations, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, variations, examples, etc. described herein. Thus, the teachings, expressions, variations, examples, etc. described below should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0012] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±10% of the stated value, e.g., "about 90%" may refer to a range of values ​​of 81% to 99%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in human patients represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0013] I. Overview of Exemplary Ablation Catheter Systems FIG 1 illustrates an exemplary medical procedure and associated components of a cardiac ablation catheter system that may be used to perform cardiac ablation as described above. In particular, FIG 1 illustrates a physician (PH) grasping the handle (110) of the catheter assembly (100) while an end effector (140) of a catheter (120) (shown in FIGS. 2-3, but not shown in FIG 1) of the catheter assembly (100) is positioned in a patient (PA) to ablate tissue in or near the patient's (PA) heart (H). As shown in FIG 2, the catheter assembly (100) includes the handle (110), a catheter (120) extending distally from the handle (110), an end effector (140) located at a distal end of the catheter (120), and a deflection drive assembly (112) associated with the handle (110).

[0014] As 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 distribute irrigation fluid. As described in more detail below, the deflection drive assembly (112) is configured to deflect the end effector (140) and a distal portion of the catheter (120) away from a central longitudinal axis (LL) (FIGS. 3-5) defined by a proximal portion of the catheter (120).

[0015] As shown in FIG. 3, the catheter (120) includes an elongated flexible sheath (122) with an end effector (140) disposed at a distal end of the 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 a guided drive system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of magnetic field generators (20) are positioned below the patient (PA) and are coupled to the guided drive system (10) via another cable (22). The magnetic field generators (20) are merely optional.

[0016] The guidance drive system (10) of this example includes a console (12) and a display (18). The console (12) includes a first driver module (14) and a second driver module (16). The first driver module (14) is coupled to the catheter assembly (100) via a cable (30). In some variations, the first driver module (14) is operable to receive EP mapping signals acquired via microelectrodes (138) of the end effector (140), as described in more detail below. The console (12) includes a processor (not shown) to process such EP mapping signals, thereby performing EP mapping, as is known in the art.

[0017] The first driver module (14) of this embodiment is further operable to provide RF power to a distal tip member (142) of the end effector (140) to ablate tissue, as described in more detail below. The second driver module (16) is coupled to a magnetic field generator (20) via a cable (22). The second driver module (16) is operable to activate the magnetic field generator (20) to generate an alternating magnetic field around the heart (H) of the patient (PA). For example, the magnetic field generator (20) may include a coil that generates an alternating magnetic field within a predetermined working volume that includes the heart (H).

[0018] The first driver module (14) is also operable to receive a position-indicating signal from a position sensor assembly (150) in the end effector (140). In such a variation, the processor of the console (12) is also operable to process the position-indicating signal from the position sensor assembly (150) and thereby determine the position of the end effector (140) in the patient (PA). As described in more detail below, the position sensor assembly (150) includes a pair of coils on each panel (151) operable to generate a signal indicative of the position and orientation of the end effector (140) in the patient (PA). The coils are configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the magnetic field generator (20). Other components and techniques that may be used to generate real-time position data associated with the end effector (140) may include radio triangulation, acoustic tracking, optical tracking, inertial tracking, and the like. Alternatively, the end effector (140) may lack a position sensor assembly (150).

[0019] The display (18) is coupled to the processor of the console (12) and is operable to render an image of the patient's anatomy. Such an image may be based on a set of images (e.g., CT or MRI scans, 3D maps, etc.) acquired pre-operatively or intra-operatively. The view of the patient's anatomy provided through the display (18) may also change dynamically based on signals from a position sensor assembly (150) of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), corresponding position data from the position sensor assembly (150) 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 show the area of ​​the patient's anatomy surrounding the end effector (140) as it moves within the patient (PA). Additionally, the processor of the console 12 may drive the display 18 to indicate the location of the abnormal conductive tissue site, as detected by electrophysiological (EP) mapping with the end effector 140, or as otherwise detected (e.g., using a specialized EP mapping catheter). By way of example only, the processor of the console 12 may drive the display 18 to superimpose the location of the abnormal conductive tissue site onto an image of the patient's anatomy, such as by superimposing an illuminated dot, crosshairs, or some other type of visual indication of the abnormal conductive tissue site.

[0020] The processor of the console 12 can also drive the display 18 to superimpose the current position of the end effector 140 onto the image of the patient's anatomy, such as by superimposing an illuminated dot, crosshairs, a graphical representation of the end effector 140, or some other form of visual indication. Such a superimposed visual indication can also move within the image of the patient's anatomy on the display 18 in real time as the physician moves the end effector 140 within the patient, thereby providing the operator with real-time visual feedback regarding the position of the end effector 140 within the patient as it moves within the patient. Thus, the image provided via the display 18 can effectively provide a video that tracks the position of the end effector 140 within the patient without necessarily having any optics (i.e., a camera) observing 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, such that the physician PH can view the display 18 and observe the real-time position of the end effector 140 in relation to the images of the mapped abnormal conductive tissue sites and adjacent anatomical structures within the patient PA.

[0021] The fluid source (42) in this example comprises a bag containing saline or some other suitable irrigation fluid. The conduit (40) comprises a flexible tube that is further coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). As described in more detail below, such irrigation fluid may be exhausted through an opening (158) in the distal tip member (142) of the end effector (140). Such irrigation may be accomplished in any suitable manner, as will be apparent to those of skill in the art in light of the teachings herein.

[0022] II. Example End Effectors for Catheter Assemblies As described above, 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) within the patient (PA), and distribute irrigation fluid. Figures 3-5 show exemplary components of the end effector (140) and other components of the distal portion of the catheter (120) in greater detail. The end effector (140) includes a distal tip member (142), a distal tip base (144), a distal circuit disk (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), distal tip base (144), distal circuit disk (146), force sensor assembly (148), position sensor assembly (150), distal spacer stack (152), and proximal spacer (154) are coaxially aligned with one another and stacked longitudinally such that these components (144-154) define a stacked circuit. A pair of push-pull cables (160, 170) and an irrigation tube (180) run along the length of the catheter (120) and terminate at the end effector (140). Each of the aforementioned components is described in more detail below. A flexible sheath (122) surrounds all of the aforementioned components, except for the distal tip member (142).

[0023] As shown in FIGS. 4-5, the distal tip member (142) of this embodiment includes a cylindrical body (156) having a dome tip. The cylindrical body (156) and the dome tip may be formed of an electrically conductive material, such as metal. A plurality of openings (158) are formed through the cylindrical body (156) and are in communication with the hollow interior of the distal tip member (142). The openings (158) thus allow irrigation fluid to communicate from the interior of the distal tip member (142) out through the cylindrical body (156). The cylindrical body (156) and the dome tip are also operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy may be communicated from the first driver module (14) to the proximal-most spacer (154) via the cable (30). The distal tip member (142) may also include one or more thermocouples configured to provide a temperature sensing function.

[0024] As shown in FIGS. 3-4, the distal tip member (142) of this embodiment also includes one or more EP mapping microelectrodes (138) mounted on the cylindrical body (156). The EP mapping microelectrodes (138) are configured to pick up electrical potentials from tissue 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 tissue within a cardiovascular anatomical structure (e.g., a pulmonary vein, etc.). Signals picked up by the EP mapping microelectrodes (138) may be communicated through vias or other structures in layers proximal to the force sensor assembly (148) and ultimately reach the first driver module (14) of the console (12) via the cable (30). The first driver module (14) can process the EP mapping signals and provide corresponding feedback to the physician (PH) indicative of the location of the abnormal electrical activity in accordance with the teachings of the various references cited herein.

[0025] In variations in which the cylindrical body (156) is formed of an electrically conductive material to deliver RF electrical energy for tissue ablation, an electrically insulating material may be interposed between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically insulating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operative in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal tip member (142) may include two or more EP mapping microelectrodes (138). Alternatively, the distal tip member (142) may be completely devoid of an EP mapping microelectrode (138).

[0026] The distal tip base (144) defines a central opening configured to provide a path for communicating irrigation fluid to the hollow interior of the distal tip member (142). The distal tip base (144) forms an annular shoulder against which the proximal end of the distal tip member (142) may abut. The distal tip member (142) also defines a lateral notch configured to receive a proximally extending tab of the distal tip member (142). As shown in FIGS. 3-4, the distal circuit disk (146) is disposed proximally of the distal tip base (144). The distal circuit disk (146) includes circuitry operable to communicate RF electrical energy to the distal tip member (142) via the proximally extending tab of the distal tip member (142). In variations in which one or more EP mapping electrodes (138) are included, the distal circuit disk (146) may also include circuitry operable to communicate EP mapping signals from the EP mapping electrodes (138).

[0027] In some variations, the distal circuit disk (146) further 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 proximal to the distal circuit disk (146). Additionally or alternatively, such transmit coils can provide wireless communication of RF electrical energy from one or more complementary coils proximal to the distal circuit disk (146) to the distal tip member (142). In variations in which coils are incorporated into the distal circuit disk (146) and one or more other layers proximal to 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 conductive structures passing longitudinally across the force sensor assembly (148).

[0028] In some variations, the distal circuit disk (146) includes at least one transmitting coil (transmission, TX) that is paired with a receiving coil (RX) of the position sensor assembly (150) to detect strain applied to the force sensor assembly (148) to determine the contact force applied to the distal tip (142). Some other variations of the distal circuit disk (146) may simply omit the TX coil.

[0029] The force sensor assembly (148) is positioned proximal to the distal circuit disk (146) and is configured to sense external forces impinging against 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 disk (146), and to the force sensor assembly (148) so that the strain gauges can generate a suitable signal corresponding to the magnitude and direction of the external force. Signals from the force sensor assembly (148) may be communicated through vias or other structures in layers proximal to the force sensor assembly (148), and ultimately to the first driver module (14) of the console (12) via the cable (30). The first driver module (14) can process the strain signal according to any suitable method as would be apparent to one of ordinary skill in the art in light of the teachings herein. By way of example only, the console (12) may provide audible feedback to alert the physician (PH) when the force sensor assembly (148) indicates that the distal tip member (142) is experiencing a force that exceeds a predetermined threshold, thereby preventing the physician (PH) from unintentionally damaging cardiovascular anatomical structures with the distal tip member (142).

[0030] The position sensor assembly (150) may 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 including an RX coil operable to generate a position-indicating electrical signal in response to an alternating magnetic field generated by the magnetic field generator (20). Each RX coil may be formed by electrical traces defining an electrical coil or antenna for receiving a radio frequency signal emitted by a TX coil of an external transmitter (e.g., three TX coils provided by the magnetic field generator (20) that are positioned outside the body of the patient (PA) and emit individual radio frequencies), such that the position and orientation of each RX coil can be determined with respect to the TX coil provided by the magnetic field generator (20). Signals from the position sensor assembly (150) may be communicated through vias or other structures in layers proximate to the strain position sensor assembly (150) and ultimately reach the first driver module (14) of the console (12) via the cable (30).

[0031] The central annulus of the position sensor assembly (150) defines a central opening configured to provide a path for communication of irrigation fluid into the hollow interior of the distal tip member (142). In variations in which the central annulus of the position sensor assembly includes a wireless communication coil, such wireless communication coil may be further coupled to vias or other structures in a proximal layer of the strain position sensor assembly (150), thereby providing a path for electrical communication with the first driver module (14) of the console (12) via the cable (30).

[0032] In this embodiment, each distal spacer (153) is generally disk-like shaped with a pair of chordal notches angularly offset from one another by 90 degrees. The notches are sized and configured to accommodate a respective panel (151) of the position sensor assembly (150), thereby allowing the panel (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 from one another by 180 degrees. The cable notches are configured to receive the respective distal end portions (174, 164) of the push-pull cables (170, 172). Each distal spacer (153) further includes a central opening configured to provide a path for communicating irrigation fluid to the hollow interior of the distal tip member (142).

[0033] Each proximal spacer (154) is disc-like in shape and has three openings formed therethrough. The central opening is configured to provide a path for communicating irrigation fluid to the hollow interior of the distal tip member (142). The side openings are sized and configured to receive the proximal portions (162, 172) of the respective push-pull cables (160, 170).

[0034] As discussed above and shown in Figures 1 and 3, a cable (30) couples the catheter assembly (100) to the drive system (10). As shown in Figure 4, the wires (32) of the cable (30) extend along the length of the catheter (120) to the proximal-most proximal spacer (154). Thus, the wires (32) may be housed within the sheath (122). The wires (32) may be physically and electrically coupled to the proximal-most proximal spacer (154) in any suitable manner.

[0035] As also described above, the catheter assembly (100) is configured to allow irrigation fluid to be communicated from the fluid source (42) to the catheter (120) via the fluid conduit (40), thereby providing for evacuation of the irrigation fluid via the opening (158) in the distal tip member (142). In this embodiment, the fluid path for the irrigation fluid includes an irrigation tube (180) shown in Figures 4-5. The 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 the end effector (140). In some variations, irrigation fluid may be communicated from the distal end of the irrigation tube (180) through a central passage aligned with the above-mentioned central opening, and ultimately reach the interior of the distal tip member (142) through an opening (218) in the distal tip base (144).

[0036] III. EXAMPLES OF ELECTRODE AND SENSOR ASSEMBLY FOR END EFFECTOR OF CATHETER ASSEMBLY An end effector of an EP mapping or ablation catheter may include various types of sensors configured to sense conditions associated with tissue being contacted by the end effector. Such sensors may include force sensors, temperature sensors, impedance sensors, or other types of sensors. In conventional EP mapping or ablation catheters, such sensors may be spaced apart from the EP mapping electrodes (e.g., microelectrodes (138)) or ablation electrodes. By being spaced apart from the EP mapping or ablation electrodes, data acquired through such sensors may not necessarily provide a completely accurate representation of conditions associated with the exact location where tissue is being contacted by a given electrode. It may therefore be desirable to provide an end effector in which sensors are positioned and operable to provide data that is, in fact, an accurate representation of conditions associated with the exact location where tissue is being contacted by a given electrode. To that end, FIGS. 6-7 show examples of electrode and sensor assemblies (200) that may be incorporated into an end effector, such as end effector (140).

[0037] As shown in FIGS. 6-7, the electrode and sensor assembly (200) of this example includes a base structure (210) defining a recess (220) in an outer surface (212). By way of example only, the base structure (210) may form part of a structure that is a replacement for the cylindrical body (156) of the distal tip member (142) of the end effector (140). Although the base structure (210) is shown as being substantially flat, the base structure (210) may alternatively have curvature (e.g., to form a dome tip or other non-flat shape). Although only one recess (220) is shown in the base structure (210) in FIGS. 6-7, the base structure (210) may have several recesses (220) and associated features, as described in more detail below. Base structure (210) may also define a number of openings, similar to openings (158), to allow communication of irrigation fluid, blood, or other fluids through base structure (210). By way of example only, base structure (210) may comprise a conventional flex circuit material (e.g., polyimide), Nitinol or other metallic material, or any other suitable type of material as would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0038] The recess (220) includes a sidewall (222). In this embodiment, the recess (220) is circular, but may alternatively 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 (such as, for example, the EP mapping microelectrode (138)) such that the electrode (230) is configured to pick up an electrical potential from tissue in contact with the electrode (230). Additionally or alternatively, the electrode (230) may function 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 variations of the electrode and sensor assembly (200) may include a combination of one or more electrodes (230) used for EP mapping and one or more electrodes (230) used for ablation.

[0039] In this example, the sensor (240) is centered on 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 variations, the sensor (240) is flush with the outer surface (212) of the base structure (210). In some other variations, the sensor (240) is recessed relative to the outer surface (212) of the base structure (210), but not as recessed as the electrode (230). In still other variations, the sensor (240) protrudes outward relative to the outer surface (212) of the base structure (210). Although the sensor (240) is shown as being disposed completely on the sidewall (224), some variations of the sensor (240) may 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 such variations, a uniform portion of the sensor (240) disposed along the sidewall (224) may still contact tissue.

[0040] In this embodiment, recess 220 is circular, and electrode 230 has an annular shape, in this example, such that electrode 230 surrounds the outer periphery of sidewall 224, with sensor 240 and sidewall 224 disposed axially at the center of recess 220 and electrode 230. As another merely illustrative example, sensor 240 may be disposed immediately adjacent the exterior of electrode 230. Alternatively, any other suitable arrangement and relationship may be utilized.

[0041] During use of an end effector incorporating the electrode and sensor assembly (200) described herein, the electrode and sensor assembly (200) may be pressed against tissue (e.g., in a chamber of the heart (H), in a pulmonary vein, etc.) such that the electrode (230) and the sensor (240) simultaneously contact the tissue. In this embodiment, the tissue contacting surface of the electrode (230) is recessed relative to the outer surface (212) of the base structure (210) such that the tissue may escape or otherwise enter the recess (220) to contact the electrode (230). In some other variations, the tissue contacting surface of the electrode (230) is substantially flush with the outer surface (212) of the base structure (210). In such variations, the tissue contacting surface of the sensor (240) may be flush with the tissue contacting surface of the electrode (230) or may be elevated relative to the tissue contacting surface (230) of the electrode. As another merely illustrative example, the tissue contacting surface of the electrode (230) may be elevated relative to the outer surface (212) of the base structure (210). Again, in such variations, the tissue contacting surface of the sensor (240) may be flush with or elevated relative to the tissue contacting surface of the electrode (230). However, it should be understood that the tissue does not necessarily have to contact the electrode (230) for the electrode (230) to pick up a signal from the tissue. For example, the signal may be transmitted via a fluid (e.g., blood, saline, etc.) interposed between the tissue and the electrode (230) when the tissue is in sufficient proximity to the electrode (230).

[0042] As shown in FIG. 7, the conduit (232) is coupled to the electrode (230) and two conduits (242, 244) are coupled to the sensor (240). In some other variations, the electrode (230) has two conduits (232). The conduits (232, 242, 244) can take various forms, including but not limited to wires, conductive traces, and the like. The conduits (232, 242, 244) can ultimately communicate with the console (12) via the cable (30). Thus, the console (12) can be operable to receive EP mapping signals from the electrode (230) via the conduit (232) and the cable (30) and provide RF energy to the electrode (230) via the conduit (232) and the cable (30) or receive data from the sensor (240) via the conduits (242, 244) and the cable (30). A variety of suitable ways in which the conduits (232, 242, 244) may be integrated into or otherwise supported by the base structure (210) will be apparent to those of skill in the art in light of the teachings herein.

[0043] The sensor (240) may be operable to sense various types of conditions. By way of example only, the sensor (240) may be operable to sense the temperature of tissue contacted by the sensor (240). In such variations, the sensor (240) may be thermally isolated with respect to the electrode (230) so as to measure only the temperature of the tissue contacted by the sensor (240) without measuring the temperature of the electrode (230). By way of example only, variations of the sensor (240) operable to sense temperature may include a thermocouple or any other suitable type of temperature sensor, as would be apparent to one of ordinary skill in the art in light of the teachings herein. In variations in which the electrode (230) is operable to apply RF ablation energy to tissue, temperature data picked up by the sensor (240) may be processed by the console (12) to adjust the delivery of RF energy by the electrode (230) in real time. For example, such temperature data may be used to determine when tissue has been sufficiently ablated to prevent the tissue from overheating during ablation. In such a case, the console 12 may track tissue impedance data from the sensor 240 in real time during delivery of RF energy by the electrodes 230. If the tissue temperature data indicates that a certain threshold has been reached, the console 12 may stop or otherwise reduce delivery of RF energy by the electrodes 230. Additionally or alternatively, the console 12 may utilize the tissue temperature data from the sensor 240 for other purposes, as will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0044] As a further example only, the sensors (230, 240) may be utilized together to sense the impedance of tissue that is simultaneously contacted by the sensors (230, 240). Such impedance value may be used to identify contact between the tissue and the sensors (230, 240). For example, the sensed impedance value may be relatively low before the sensors (230, 240) contact the tissue and while one or both of the sensors (230, 240) are in contact with blood. Once the sensors (230, 240) contact the tissue, the sensed impedance value may increase substantially. Thus, a spike in the impedance sensed by the sensors (230, 240) may indicate contact between the sensors (230, 240) and the tissue. This may be further understood to indicate contact between the tissue and the electrode (230) adjacent to the sensor (240). By utilizing sensors (230, 240) spaced closely together, an end effector (140) having an electrode and sensor assembly (200) can provide substantially greater sensitivity for detecting tissue contact compared to end effectors that sense impedance by using a single electrode on the end effector in cooperation with an external electrode (e.g., a patch adhered to the patient's skin).

[0045] In variations in which the electrode (230) is operable to apply RF ablation energy to tissue, so long as the tissue impedance changes based on the delivery of RF ablation energy to the tissue, the tissue impedance data can be processed by the console (12) to adjust 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 the tissue from overheating during ablation. In such cases, 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). When the tissue impedance data indicates that a certain threshold has been reached, the console (12) can stop the delivery of RF energy by the electrode (230). Similarly, the console (12) may vary the frequency, amplitude, or other characteristics of the RF energy delivery based on real-time tissue impedance data from the sensor (240) before terminating a suitable form of energy, such as alternating current (AC) in the form of pulsed direct current bipolar ablation (e.g., irreversible energy ablation or pulsed field ablation) or direct current (DC) in the form of RF energy delivery. Additionally or alternatively, the console (12) may utilize the tissue impedance data from the sensor (240) for other purposes, as will be apparent to those of skill in the art in light of the teachings herein.

[0046] As another example, the sensor (240) may be operable to sense tissue contact forces (e.g., normal forces imposed by tissue against which the sensor (240) is pressed). Such force sensors may take a variety of different forms. FIG. 8 illustrates one example of a form the sensor (240) may take. FIGS. 8-12 illustrate some examples of forms the force sensing variations of the sensor (240) may take, which are described in more detail below. Other examples may include capacitive membrane structures or any other suitable type of force sensing structure, as would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0047] FIG. 8 illustrates a force sensor (300) 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) may include copper or any other suitable material. The first electrode layer (310) may be positioned to contact tissue (e.g., like sensor (240) described above). The second electrode layer (320) may be positioned on top of the sidewall (224) to provide a basic support (i.e., mechanical ground) for the force sensor (300). In some variations, the second electrode layer (320) provides an additional sensing element, like sensor (230) described above.

[0048] A pair of dielectric layers (330, 340) are interposed between corresponding regions of the electrode layers (310, 320), the electrode layers (310, 320) being oriented parallel to one another. In particular, the first dielectric layer (330) is disposed directly below the first electrode layer (310), the second dielectric layer (340) is disposed directly above the second electrode layer (320), and the dielectric layers (330, 340) are directly juxtaposed to one another. By way of example only, each dielectric layer (330, 340) may comprise a polyimide material. As a further example, each dielectric layer (330, 340) may comprise KAPTON® from DuPont de Nemours, Wilmington, Delaware. Although a pair of dielectric layers (330, 340) is provided in this embodiment, some other variations may have only a single dielectric layer (330, 340). It should also be appreciated that in variations in which the first electrode layer (310) is structurally and functionally similar to the sensor (240) and the second electrode layer (320) is structurally and functionally similar to the sensor (230), the structure provided by the dielectric layers (330, 340) may provide a structural and functional analogy to the electrodes and sidewalls (224) of the sensor assembly (200). As another merely illustrative example, the first electrode layer (310) may be structurally and functionally similar to the sensor (240) and the second electrode layer (320) may cooperate with the dielectric layers (330, 340) to provide a structural and functional analogy to the sidewalls (224) (e.g., such that a separate electrode is provided as an analog of the electrode (230)).

[0049] The piezoelectric element (350) is interposed between distinct regions of the electrode layers (310, 320) that are laterally adjacent to the dielectric layers (330, 340). An upper portion of the piezoelectric element (350) is bonded to the underside of the first electrode layer (310) by a conductive adhesive (352) and a lower portion of the piezoelectric element (350) is bonded to the top side of the second electrode layer (310) by a conductive adhesive (354).

[0050] In use, the force sensor (300) may generate a variable voltage based on the force applied by the tissue to the sensor (300). In other words, the greater the force imposed by the tissue on the sensor (300), the greater the voltage generated by the force sensor (300). In some variations of the force sensor (300), both electrode layers (310, 320) may be positioned to contact tissue, and the electrode layers (310, 320) may also be operable to sense tissue temperature or tissue impedance. Thus, some variations of the sensor (300) may be operable to sense any combination of tissue contact force, tissue temperature, and tissue impedance. As yet another merely exemplary variation, either or both layers (310, 320) may be operable to provide one or both of EP mapping or ablation functions, such as the electrode (230).

[0051] 9-12 show another example of a form that the sensor (240) may take. In particular, FIGS. 9-12 show a force sensor (400) including a first body (410) having a first pair of opposing arms (412) and a second pair of opposing arms (414). The arms (412) are spaced 90 degrees from the arms (414). The arms (412) have a longer length than the arms (414) in this example. By way of example only, the first body (410) may include gold or chrome. A cube-shaped mass (440) is disposed on top of and coupled to a central region of the first body (410). The mass (440) is disposed in contact with tissue such that the mass (440) directly receives a force applied by the contacting tissue, and the force sensor (400) generates a signal indicative of the force imposed on the mass (440). Although mass (440) is shown and described as a cube in this example, mass (440) may have any other suitable shape, as will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0052] The first layer (430) is disposed beneath at least a portion of the first body (410). The first layer (430) includes a first arm region (450) that projects outwardly relative to one arm (414) of the first body (410) and a second arm region (452) that projects outwardly relative to the other arm (414) of the first body (410). Thus, the arm regions (450, 452) are exposed to the arm (414). By way of example only, the first layer (430) may include doped silicon. The second layer (432) is disposed beneath the first layer (430). For example, the second layer (432) may extend across the entire underside of the first layer (430). By way of example only, the second layer (432) may include silicon.

[0053] As shown in Figures 11-12, the layers (430, 432) may be secured to two support structures (500, 502) such that the first arm region (450) is disposed adjacent to the first support structure (500) and the second arm region (452) is disposed adjacent to the second support structure (502). The support structures (500, 502) may 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) may be disposed on the outer surface (212) of the base structure (210) near the electrodes (230) but not on the sidewalls (224). As a further example, the support structures (500, 502) may 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 fixed to the outer surface (212) of the base structure (210), the mass (440) may be disposed over a central region of the electrode (230) (e.g., in place of the sensor (240)), and the arms (412, 414) may span a space above the electrode (230) to support the mass (440) over the central region of the electrode (230). Other suitable manners in which the force sensor (400) may be integrated into the electrode and sensor assembly (200) or otherwise integrated into the end effector (140) will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0054] Figure 11 shows the force sensor (400) subjected to a generally vertical force, deforming the central region of the first body (410) and causing both arm regions (450, 452) to deform downwards. In other words, the force sensor (400) experiences a normal deflection in Figure 11. The vertical orientation force (p) can be measured using the following equation: p = (ΔR1 / R1 + ΔR2 / R2) / k p In the formula, p is the magnitude of the vertical alignment force, R1 is the resistance of the first layer (430) in the first arm region (450); R2 is the resistance of the first layer (430) in the second arm region (452), and k pis the normal force conversion constant.

[0055] Figure 12 shows the force sensor (400) subjected to a generally laterally oriented force, deforming the first arm region (450) upward and the second arm region (452) downward. In other words, the force sensor (400) experiences a shear deflection in Figure 12. The laterally oriented force (T) may be measured using the following equation: T = (ΔR1 / R1-ΔR2 / R2) / k s where T is the magnitude of the laterally oriented force; R1 is the resistance of the first layer (430) in the first arm region (450); R2 is the resistance of the first layer (430) in the second arm region (452), and k s is the shear force conversion constant.

[0056] Of course, in real-world scenarios, the forces imposed on the sensor (400) may include a combination of vertically and laterally oriented components. It should be understood that the sensor (400) may detect two axial forces to derive a force direction vector. Other variations may be simplified to measure only vertical forces (e.g., without measuring shear / lateral forces).

[0057] In variations in which the sensor (240) is operable to measure force (e.g., where the sensor (240) is in the form of sensor (300), in the form of sensor (400), or in some other form), the force data from the sensor (240) may be used in a variety of ways. For example, the console (12) may drive the display (18) to provide visual feedback to the physician (PH) indicative of the amount of force encountered by the sensor (240), which may reflect the force with which the corresponding electrode (230) is pressing against tissue. If the force exceeds a threshold value (e.g., a value associated with undesirable trauma to tissue by compressing the tissue with too much force), the console (12) may further provide an audible or visual indication to the physician (PH) to alert the physician (PH) that too much force is being applied against the tissue. Additionally or alternatively, the force data from the sensor (240) may be processed by the console (12) to adjust the delivery of RF energy by the electrode (230) in real time. For example, the console 12 may prevent an electrode 230 from being activated with RF energy until force data from a corresponding sensor 240 indicates that the sensor 240 and electrode 230 are being pressed against tissue with sufficient force. As yet another example, the force data from the sensor 240 may be used (e.g., in combination with other measurements such as the power and duration of RF application) to estimate the size of a lesion created by an ablation procedure using the electrode 230. Alternatively, the force data from the sensor 240 may be used for any other suitable purpose, as would be apparent to one of ordinary skill in the art in light of the teachings herein, including, but not limited to, providing a warning when a force exceeds a threshold value (e.g., to avoid inadvertent perforation of tissue by the end effector 140). In variations in which the end effector 140 is operable to measure temperature, the temperature measurements may be used to provide error correction for the force measurements, since the readings of the force measuring sensor may be affected by temperature (e.g., due to expansion / contraction of elements, etc.).

[0058] In this embodiment, the electrodes 230 and the sensors 240 are integrally constructed. In other words, the electrodes 230 and the sensors 240 may be constructed together at the same time in the same process. In some other variations, the electrodes 230 and the sensors 240 may be constructed separately and then assembled together (e.g., through a lamination process or other process).

[0059] From the above, it should be appreciated that the configuration of the electrode and sensor assembly (200) allows each sensor (240) to provide highly localized data spatially related to its corresponding electrode (230). Such highly localized data may be more meaningful than data obtained from a sensor that is spatially displaced further from the electrode (230). For example, to the extent that a conventional ablation catheter may provide a single contact force sensor that provides contact force data indicative of the contact force of the entire tip of the end effector (which may include two or more ablation electrodes), an ablation catheter including multiple electrode and sensor assemblies (200) on the end effector may provide several separate measurements of contact force data for each electrode (230). It should also be appreciated that the relatively small size of each sensor (240) may facilitate complete contact between the sensor (240) and tissue, in contrast to conventional catheters having sensors that are so large that the tissue only contacts a portion of the sensor during use. Complete contact between the sensor (240) and tissue may provide more reliable and meaningful data than data obtained by a larger sensor that only partially contacts the tissue.

[0060] IV. Combination Examples The following examples relate to various non-exhaustive methods in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of the claims that may be presented at any time in this application or any subsequent application of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Thus, none of the aspects or features referred to below should be considered critical unless later expressly so indicated by the inventors or their successors. If the claims presented in this application or any subsequent application related to this application include additional features other than those referred to below, those additional features should not be considered added for any reason regarding patentability. EXAMPLES

[0061] 1. An apparatus comprising: (a) a catheter body having a distal end, the catheter body being 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 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; (ii) an electrode having a tissue contacting surface; and (iii) a sensor having a tissue contacting surface, the sensor being configured to sense at least one condition associated with tissue in contact with the tissue contacting surface of the sensor, the tissue contacting surface of the sensor being configured to protrude relative to one or both of the outer surface of the end effector body member or the tissue contacting surface of the electrode. EXAMPLES

[0062] The apparatus of example 1, wherein the end effector defines a dome tip. EXAMPLES

[0063] 3. The device of any one or more of Examples 1-2, wherein the electrode is operable to pick up an electrical potential from tissue in contact with the tissue contacting surface of the electrode. EXAMPLES

[0064] The device of any one or more of Examples 1 to 3, wherein the electrode is operable to ablate tissue in contact with the tissue contacting surface of the electrode. EXAMPLES

[0065] The device of Example 4, wherein the electrode is operable to apply one or more of pulsed direct current bipolar ablation or radio frequency energy to tissue in contact with the tissue contact surface of the electrode, thereby ablating tissue in contact with the tissue contact surface of the electrode. EXAMPLES

[0066] The device of any one or more of examples 1-5, wherein the end effector body member defines a recess. EXAMPLES

[0067] The device of example 6, wherein the electrode is disposed within the recess. EXAMPLES

[0068] The device of Example 7, wherein the tissue contacting surface of the electrode is recessed relative to the outer surface of the end effector body. EXAMPLES

[0069] The apparatus of any one or more of examples 1-8, wherein the electrode has an annular shape defining a radial center. EXAMPLES

[0070] The apparatus of example 9, wherein the electrode is disposed at the radial center of the electrode. EXAMPLES

[0071] The device of any one or more of examples 1-10, wherein the sensor has a circular shape. EXAMPLES

[0072] The device of any one or more of Examples 1-11, wherein the end effector body further includes a first sidewall and a second sidewall, and the electrode is disposed between the first sidewall and the second sidewall. EXAMPLES

[0073] 13. The device of example 12, wherein the second sidewall faces the first sidewall. EXAMPLES

[0074] 14. The device of any one or more of examples 12-13, wherein the first and second side walls each have a cylindrical profile. EXAMPLES

[0075] The device of any one or more of examples 12-14, wherein the sensor is disposed on the second sidewall, and the second sidewall is an inner sidewall. EXAMPLES

[0076] 16. The device of any one or more of examples 1-15, wherein the sensor is configured to sense a temperature of tissue in contact with the tissue contacting surface of the sensor. EXAMPLES

[0077] The device of Example 16, wherein the electrode is operable to apply radio frequency energy to tissue in contact with the tissue contact surface of the electrode. EXAMPLES

[0078] The device of Example 17, further comprising a control module, the control module in communication with the sensor and the electrode, the control module operable to adjust delivery of high frequency energy to the electrode based on temperature data from the sensor. EXAMPLES

[0079] The device of Example 18, wherein the control module is operable to stop delivery of high frequency energy to the electrode in response to the sensed temperature value exceeding a threshold value. EXAMPLES

[0080] 20. The device of any one or more of examples 1-19, wherein the sensor is configured to sense impedance of tissue in contact with the tissue contacting surface of the sensor. EXAMPLES

[0081] The device of Example 20, wherein the electrode is operable to apply one or more of pulsed direct current bipolar ablation or radio frequency energy to tissue in contact with the tissue contact surface of the electrode. EXAMPLES

[0082] The device of Example 21, further comprising a control module in communication with the sensor and the electrodes, the control module operable to adjust the delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes based on impedance data from the sensor. EXAMPLES

[0083] 23. The device of example 22, wherein the control module is operable to stop delivery of radio frequency energy to the electrode in response to the sensed impedance reaching a threshold value. EXAMPLES

[0084] The device of any one or more of Examples 22 to 23, wherein the control module is operable to vary one or both of the voltage and duration of one or more of the direct current bipolar ablation pulses, or the frequency or amplitude of the radio frequency energy to the electrodes, based on impedance data from the sensor. EXAMPLES

[0085] The device of any one or more of Examples 20 to 22, further comprising a control module in communication 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) indicate that the sensor is in contact with tissue in response to determining that the sensor is in contact with tissue based on the impedance data from the sensor. EXAMPLES

[0086] 26. The device of any one or more of examples 1-25, wherein the sensor is configured to detect a force between a tissue contacting surface of the sensor and adjacent tissue. EXAMPLES

[0087] 27. The device of Example 26, further comprising a control module, the 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. EXAMPLES

[0088] The device of Example 27, wherein the electrode is operable to apply one or more of pulsed direct current bipolar ablation or radio frequency energy to tissue in contact with the tissue contact surface of the electrode. EXAMPLES

[0089] The device of Example 28, wherein the control module is operable to adjust the delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue. EXAMPLES

[0090] 30. The device of any one or more of Examples 28 to 29, wherein the control module is operable to prevent delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue. EXAMPLES

[0091] 31. The apparatus of any one or more of examples 26 to 30, wherein the force sensor comprises a piezoelectric element. EXAMPLES

[0092] The apparatus of Example 31, wherein the force sensor further includes a first electrode layer and a second electrode layer, and the piezoelectric element is interposed between the first associated region between the first electrode layer and the second electrode layer. EXAMPLES

[0093] The device of example 32, wherein the force sensor further includes a pair of dielectric layers adjacent to the piezoelectric element, the dielectric layers being interposed between the second associated region between the first electrode layer and the second electrode layer. EXAMPLES

[0094] 34. The device of any one or more of examples 26 to 33, wherein the force sensor includes a pair of arms fixed to a corresponding pair of support structures, the force sensor configured to sense force based on deformation of the arms. EXAMPLES

[0095] 35. The apparatus of any one or more of the preceding examples, further comprising a position sensor, the position sensor operable to generate a signal indicative of a real-time position of the end effector in three dimensional space. EXAMPLES

[0096] The apparatus of example 35, wherein the position sensor is located within the end effector. EXAMPLES

[0097] 37. The device of any one or more of the preceding claims, wherein the end effector further comprises: (i) a plurality of electrodes including the electrode; and (ii) a plurality of sensors including the sensor. EXAMPLES

[0098] 1. An apparatus comprising: (a) a catheter body having a distal end, the catheter body being sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at a 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; (ii) an electrode, the electrode having a tissue contacting surface, the tissue contacting surface being recessed relative to the outer surface of the end effector body member, the electrode operable to do one or both of: (A) pick up an electrical potential from tissue in contact with the tissue contacting surface of the annular electrode; or (B) ablate tissue in contact with the tissue contacting surface of the annular electrode; and (iii) a sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue in contact with the tissue contacting surface of the sensor, the tissue contacting surface of the sensor being configured to protrude relative to the tissue contacting surface of the electrode. EXAMPLES

[0099] 1. An apparatus comprising: (a) a catheter body having a distal end, the catheter body being sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at a 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; (ii) an electrode, the electrode having a tissue contacting surface and a central region, the tissue contacting surface of the electrode being exposed to an outer surface of the end effector body member, the electrode being operable to do one or both of: (A) pick up an electrical potential from tissue in contact with the tissue contacting surface of the annular electrode; or (B) ablate tissue in contact with the tissue contacting surface of the annular electrode; and (iii) a sensor positioned in the central region of the electrode, the sensor having a tissue contacting surface, the sensor being configured to sense at least one condition associated with tissue in contact with the tissue contacting surface of the sensor, the tissue contacting surface of the sensor being exposed to the outer surface of the end effector body member and to the tissue contacting surface of the electrode. EXAMPLES

[0100] 1. An apparatus comprising: (a) a catheter body having a distal end, the catheter body being sized and configured to fit within a region of the cardiovascular system; and (b) an end effector at a distal end of the catheter body, the end effector being sized and configured to fit within a region of the cardiovascular system and comprising: (i) an end effector body member having an outer surface; (ii) an annular electrode, the electrode having a tissue contacting surface, the electrode being operable to do one or both of: (A) pick up an electrical potential from tissue in contact with the tissue contacting surface of the annular electrode; or (B) ablate tissue in contact with the tissue contacting surface of the annular electrode; and (iii) a sensor disposed in a radially central region of the annular electrode, the sensor having a tissue contacting surface, the sensor being configured to sense at least one condition associated with tissue in contact with the tissue contacting surface of the sensor, the tissue contacting surface of the sensor being exposed to the tissue contacting surface of the electrode.

[0101] V.Other Any of the instruments described herein can be cleaned and sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electron beams. 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. The 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 phase sterilization with or without gas plasma or water vapor.

[0102] It should be understood that any of the embodiments described herein may include various other features in addition to or in place of those described above. By way of example only, any of the embodiments described herein may further include one or more of the various features disclosed in any of the various references incorporated herein by reference in their entireties.

[0103] 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. Thus, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation with respect to each other. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0104] Any patent, publication, or other disclosure whose disclosure is referred to as being incorporated herein by reference in its entirety should be understood to be incorporated herein in whole or in part only to the extent that the incorporated content does not contradict the current definitions, opinions, or other disclosures set forth in this disclosure. Thus, to the extent necessary, the disclosures expressly set forth herein shall prevail over any conflicting content incorporated herein by reference. Although the disclosure is referred to as being incorporated herein by reference in its entirety, any content, or portions thereof, that contradicts the current definitions, opinions, or other disclosures set forth herein shall be incorporated only to the extent that no conflict occurs between the incorporated content and the current disclosure.

[0105] Although various versions of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Although some of such possible modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the above-mentioned embodiments, variations, geometries, materials, dimensions, ratios, steps, etc. are exemplary and not required. Thus, it is understood that the scope of the present invention should be considered in relation to the following claims and is not limited to the details of construction and operation shown and described in the specification and drawings.

[0106] [Embodiment] (1) An apparatus comprising: (a) a catheter body having a distal end and sized and configured to fit within a region of the cardiovascular system; (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region within the cardiovascular system; (i) an end effector body member having an outer surface; (ii) an electrode having a tissue contacting surface; (iii) an end effector comprising: a sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contacting surface of the sensor, the tissue contacting 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 contacting surface of the electrode. (2) The device of embodiment 1, wherein the electrode is operable to pick up an electrical potential from tissue in contact with the tissue contact surface of the electrode. (3) The device of embodiment 1, wherein the electrode is operable to ablate tissue in contact with the tissue contact surface of the electrode. (4) The device of embodiment 1, wherein the end effector body member defines a recess, the electrode is positioned within the recess, and the tissue contacting surface of the electrode is recessed relative to the outer surface of the end effector body. (5) The device of embodiment 1, wherein the electrode has an annular shape defining a radial center, and the electrode is positioned at the radial center of the electrode.

[0107] (6) The device of embodiment 1, wherein the sensor is configured to sense the temperature of tissue contacting the tissue contact surface of the sensor. (7) The device of embodiment 6, further comprising a control module, the control module in communication with the sensor and the electrode, the electrode operable to apply radio frequency energy to tissue in contact with the tissue contact surface of the electrode, and the control module operable to adjust delivery of radio frequency energy to the electrode based on temperature data from the sensor. (8) The device of embodiment 7, wherein the control module is operable to stop delivery of radio frequency energy to the electrode in response to a sensed temperature value exceeding a threshold value. (9) The device of embodiment 1, wherein the sensor is configured to sense impedance of tissue in contact with the tissue contact surface of the sensor. (10) The device of embodiment 9, further comprising a control module, the control module in communication with the sensor and the electrode, the electrode operable to apply one or more of pulsed direct current bipolar ablation or radiofrequency energy to tissue in contact with the tissue contacting surface of the electrode, and the control module operable to adjust the delivery of one or more of pulsed direct current bipolar ablation or radiofrequency energy to the electrode based on impedance data from the sensor.

[0108] (11) The device of embodiment 10, wherein the control module is operable to stop delivery of radio frequency energy to the electrode in response to the sensed impedance reaching a threshold. (12) The device of embodiment 10, wherein the control module is operable to vary one or both of the voltage and duration of one or more of the direct current bipolar ablation pulses, or the frequency or amplitude of radio frequency energy to the electrodes based on impedance data from the sensor. (13) A control module in communication with the sensor, the control module comprising: (i) determining whether the sensor is in contact with tissue based on impedance data from the sensor; and The device of embodiment 9, wherein the device is configured to: (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. (14) The device of embodiment 1, further comprising a control module, the control module in communication with the sensor, the sensor configured to detect a force between the tissue contact surface of the sensor and adjacent tissue, and the control module configured to determine whether the sensor is in contact with tissue based on force data from the sensor. (15) The electrode is operable to apply one or more of pulsed direct current bipolar ablation or radio frequency energy to tissue contacting the tissue contacting surface of the electrode, and the control module is further configured to: (i) adjusting the delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue; or (ii) preventing delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue.

[0109] (16) The device of claim 1, wherein the sensor includes a force sensor configured to detect a force between the tissue contact surface of the sensor and adjacent tissue, the force sensor including a piezoelectric element. (17) The force sensor, (i) a first electrode layer and a second electrode layer, the piezoelectric element being interposed between a first associated region of the first electrode layer and the second electrode layer; (ii) a pair of dielectric layers adjacent the piezoelectric element, the dielectric layers being interposed between a second associated region between the first electrode layer and the second electrode layer. (18) The device of embodiment 1, wherein the sensor includes a force sensor configured to detect a force 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, and the force sensor configured to sense a force based on a deformation of the arms. (19) An apparatus comprising: (a) a catheter body having a distal end and sized and configured to fit within a region of the cardiovascular system; (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region within the cardiovascular system; (i) an end effector body member having an outer surface; (ii) an electrode, the electrode having a tissue contacting surface, the tissue contacting surface being recessed relative to the outer surface of the end effector body member; (A) picking up an electrical potential from tissue contacting the tissue contacting surface of the ring electrode; or (B) ablating tissue in contact with the tissue contacting surface of the annular electrode; and (iii) an end effector comprising: a sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contacting surface of the sensor, the tissue contacting surface of the sensor configured to protrude relative to the tissue contacting surface of the electrode. (20) An apparatus comprising: (a) a catheter body having a distal end and sized and configured to fit within a region of the cardiovascular system; (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region within the cardiovascular system; (i) an end effector body member having an outer surface; (ii) an electrode having a tissue contacting surface and a central region, the tissue contacting surface of the electrode being exposed to the exterior surface of the end effector body member; (A) picking up an electrical potential from tissue contacting the tissue contacting surface of the ring electrode; or (B) ablating tissue in contact with the tissue contacting surface of the annular electrode; and (iii) a sensor positioned in the central region of the electrode, the sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contacting surface of the sensor, the tissue contacting surface of the sensor exposed to the outer surface of the end effector body member and to the tissue contacting surface of the electrode.

Claims

1. An apparatus comprising: (a) a catheter body having a distal end and sized and configured to fit within a region of the cardiovascular system; (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region within the cardiovascular system; (i) an end effector body member having an outer surface and a recess, the recess including a bottom surface and a sidewall extending from the bottom surface to the outer surface; (ii) an electrode having a tissue contacting surface, the electrode being positioned within the recess such that the tissue contacting surface of the electrode is recessed relative to the outer surface of the end effector body member; (iii) an end effector comprising: a sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contacting surface of the sensor, the sensor positioned at a center of the electrode such that the tissue contacting surface of the sensor protrudes relative to the tissue contacting surface of the electrode; the end effector body member defining a protrusion positioned within the recess, the protrusion having a top surface and a sidewall, the sidewall of the protrusion extending from the bottom surface of the recess, the sensor positioned over the entire top surface, and the electrode extending from the sidewall of the recess to the sidewall of the protrusion.

2. The device of claim 1 , wherein the electrode is operable to pick up an electrical potential from tissue contacting the tissue contacting surface of the electrode.

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

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

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

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

7. The apparatus of claim 6 , wherein the control module is operable to cease delivery of 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 impedance of tissue in contact with the tissue contacting surface of the sensor.

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

10. 10. The apparatus of claim 9, wherein the control module is operable to cease delivery of radio frequency energy to the electrodes in response to a sensed impedance reaching a threshold value.

11. 10. The device of claim 9, wherein the control module is operable to vary one or both of the voltage and duration of one or more of the pulses of direct current bipolar ablation, or the frequency or amplitude of radio frequency energy to the electrodes based on impedance data from the sensor.

12. and a control module in communication with the sensor, the control module comprising: (i) determining whether the sensor is in contact with tissue based on impedance data from the sensor; and 10. The apparatus of claim 8, configured to: (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.

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

14. the electrodes are operable to apply one or more of pulsed direct current bipolar ablation or radio frequency energy to tissue contacting the tissue contacting surface of the electrodes, and the control module is further configured to: (i) adjusting the delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue; or 14. The device of claim 13, wherein the device is operable to one or both of: (ii) prevent delivery of one or more of pulsed direct current bipolar ablation or radio frequency energy to the electrodes until force data from the sensor indicates contact between the sensor and tissue.

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

16. The force sensor is (i) a first electrode layer and a second electrode layer, the piezoelectric element being interposed between a first associated region of the first electrode layer and the second electrode layer; 16. The apparatus of claim 15, further comprising: (ii) a pair of dielectric layers adjacent the piezoelectric element, the pair of dielectric layers being interposed between a second associated region between the first electrode layer and the second electrode layer.

17. 10. The device of claim 1, wherein the sensor comprises a force sensor configured to detect a force between the tissue contacting surface of the sensor and adjacent tissue, the force sensor comprising a pair of arms fixed to a corresponding pair of support structures, the force sensor configured to sense a force based on deformation of the arms.

18. An apparatus comprising: (a) a catheter body having a distal end and sized and configured to fit within a region of the cardiovascular system; (b) an end effector at the distal end of the catheter body, the end effector sized and configured to fit within a region within the cardiovascular system; (i) an end effector body member having an outer surface and a recess; (ii) a ring electrode having a tissue contacting surface and positioned within the recess, the tissue contacting surface being recessed relative to the outer surface of the end effector body member, the ring electrode comprising: (A) picking up an electrical potential from tissue contacting the tissue contacting surface of the ring electrode; or (B) ablating tissue in contact with the tissue contacting surface of the annular electrode; and (iii) a sensor having a tissue contacting surface, the sensor configured to sense at least one condition associated with tissue contacting the tissue contacting surface of the sensor, the sensor being positioned over an upper surface of a protrusion extending through a central opening of the annular electrode such that the tissue contacting surface of the sensor protrudes relative to the tissue contacting surface of the annular electrode; The device, wherein an inner diameter of the central opening and an outer diameter of the protrusion are coincident.

19. the tissue contacting surface of the ring electrode is exposed to the exterior surface of the end effector body member; The device of claim 18 , wherein the tissue contacting surface of the sensor is exposed to the outer surface of the end effector body member and to the tissue contacting surface of the ring electrode.

20. The device of claim 1 , wherein the electrode has an annular shape defining a central opening, the protrusion extending through the central opening.

21. The device described in claim 20, wherein the inner diameter of the central opening and the outer diameter of the protrusion are the same.

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