Catheter deflection control assembly

Abstract

The device includes a handle, a catheter, an end effector, and a deflection drive assembly. The end effector includes at least one electrode. The deflection drive assembly includes an input member, a translation assembly coupled to the end effector, and a rack and pinion assembly. The rack and pinion assembly is configured to drive the translation assembly to deflect the end effector away from the longitudinal axis at an angle, and is configured to convert rotational motion of the pinion from the input member into linear motion of the rack to either push the translation member distally or pull it proximally, or convert linear motion of the rack from the input member into rotational motion of the pinion to move a first end of the translation member proximally and a second end of the translation member distally.

Description

Background Art

[0001] Cardiac arrhythmias such as atrial fibrillation occur when regions of heart tissue conduct electrical signals abnormally. Treatments for arrhythmias include surgically disrupting such signal conduction pathways. By selectively excising heart tissue by applying energy (e.g., radiofrequency (RF) energy), it may be possible to stop or modify the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a barrier to unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across the tissue.

[0002] In some procedures, ablation can be performed within the cardiovascular system using a catheter having one or more RF electrodes. The catheter can be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrode within the heart or within a cardiovascular structure adjacent to the heart (e.g., the pulmonary vein). One or more electrodes can be arranged to contact heart tissue or other vascular tissue and then activated with RF energy, thereby excising the contacted tissue. In some cases, the electrodes may be bipolar. In some other cases, monopolar electrodes can be used in conjunction with a ground pad or in conjunction with another reference electrode in contact with the patient. Irrigation can be used to draw heat away from the ablation components of the ablation catheter and prevent the formation of thrombi near the ablation site.

[0003] Examples of ablation catheters include U.S. Patent Application Publication No. 2013 / 0030426, “Integrated Ablation System using Catheter with Multiple Irrigation Lumens,” published on January 31, 2013 (its disclosure is incorporated herein by reference in its entirety); U.S. Patent Application Publication No. 2017 / 0312022, “Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly,” published on November 2, 2017 (its disclosure is incorporated herein by reference in its entirety); U.S. Patent Application Publication No. 2018 / 0056038, “Catheter with Bipole Electrode Spacer and Related Methods,” published on March 1, 2018 (its disclosure is incorporated herein by reference in its entirety); and “Catheter with Soft Distal Tip for Mapping and Ablating Tubular” issued on November 20, 2018. This is described in U.S. Patent No. 10,130,422, titled "Region" (the disclosure thereof is incorporated in its entirety by reference), and U.S. Patent No. 9,801,585, titled "Electrocardiogram Noise Reduction," issued on 31 October 2017 (the disclosure thereof is incorporated in its entirety by reference).

[0004] Some catheter ablation procedures may be performed after identifying the tissue area to be targeted for ablation using electrophysiological (EP) mapping. Such EP mapping may include the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation, or a dedicated mapping catheter). Such sensing electrodes can monitor electrical signals emanating from conductive endocardial tissue to pinpoint the location of abnormal conductive tissue sites causing arrhythmias. Examples of EP mapping systems and catheters are described in various references cited herein.

[0005] 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 are in contact with the target tissue with sufficient force to effectively apply RF ablation energy to the tissue, without applying a force that may be likely to cause undesirable tissue damage. To this end, it may be desirable to include one or more force sensors or pressure sensors to detect sufficient contact between one or more electrodes of the ablation catheter and the target tissue.

[0006] In addition to using force sensing or EP mapping, some catheter ablation procedures may be performed using image-guided surgery (IGS) systems. IGS systems can enable physicians to visually track the position of the catheter within the patient in real time in relation to images of anatomical structures within the patient. Some systems, including the CARTO 3® system by Biosense Webster, Inc. of Irvine, California, can offer a combination of EP mapping and IGS capabilities. Examples of catheters configured for use with IGS systems are disclosed in U.S. Patent No. 9,480,416, “Signal Transmission Using Catheter Braid Wires,” published November 1, 2016 (the disclosure of which is incorporated herein by reference in its entirety), and in various other references cited herein.

[0007] Although several catheter systems and methods have been implemented and used, it is believed that no one prior to the present inventors has implemented or used the invention described, illustrated, and claimed herein. [Brief explanation of the drawing]

[0008] The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as envisioned by the inventors. [Figure 1] This is a schematic diagram of the medical procedure of inserting a catheter assembly catheter into a patient. [Figure 2] Figure 1 is a perspective view of the catheter assembly, with additional components shown in schematic form. [Figure 3] Figure 1 is a perspective view of the distal portion of the catheter, with additional components shown in schematic form. [Figure 4] Figure 1 is a perspective view of the distal portion of the catheter, with the outer sheath omitted to reveal the internal components. [Figure 5] Figure 1 is an exploded perspective view of the distal portion of the catheter. [Figure 6] Figure 1 is a perspective view of the handle and deflection drive assembly of the catheter assembly, the deflection drive assembly including a rocker arm. [Figure 7] Figure 6 is a perspective view of the handle and deflection drive assembly, with a portion of the handle omitted to reveal the internal components, including the rack and pinion assembly. [Figure 8A] Figure 6 is a schematic top view of the deflection drive assembly, in which the rocker arm and the rack of the rack and pinion assembly are in a neutral position for bidirectional deflection, and the first exemplary lock assembly is in an unlocked configuration. [Figure 8B] Figure 8A is a schematic top view of the deflection drive assembly, where the rocker arm is in the first position, the rack is in the first longitudinal position, and the lock assembly is in the first lock configuration. [Figure 8C] Figure 8A is a schematic top view of the deflection drive assembly, where the rocker arm is in the second position, the rack is in the second longitudinal position, and the lock assembly is in the second lock configuration. [Figure 9A] Figure 1 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components. The distal portion of the catheter is in a neutral position relative to the neutral position of the rocker arm in Figure 8A. [Figure 9B] Figure 1 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components, and the distal portion of the catheter is in a first deflection position related to the first position of the rocker arm in Figure 8B. [Figure 9C] Figure 1 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components. The distal portion of the catheter is in a second deflection position, related to the second position of the rocker arm in Figure 8C. [Figure 10A]Figure 6 is a schematic top view of the deflection drive assembly, in which the rocker arm and the rack of the rack and pinion assembly are in the neutral position for unidirectional deflection, and the lock assembly is in the first lock configuration. [Figure 10B] Figure 10A is a schematic top view of the deflection drive assembly, where the rocker arm is in the first rotational position, the rack is in the first longitudinal position, and the lock assembly is in the second lock configuration. [Figure 11A] Figure 1 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components. The distal portion of the catheter is in a non-deflected position relative to the rocker arm in the neutral position in Figure 10A. [Figure 11B] Figure 1 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components, and the distal portion of the catheter is in a deflected position related to the first position of the rocker arm in Figure 10B. [Figure 12] This is a top schematic view of a second exemplary deflection drive assembly, in which the second exemplary lock assembly is in an unlock configuration. [Figure 13] This is a perspective view of a second exemplary catheter assembly, similar to the catheter assembly in Figure 1 and including a second exemplary catheter, and a third exemplary deflection drive assembly, with additional components shown in schematic form. [Figure 14] Figure 13 is a perspective view of the deflection drive assembly, which includes a third exemplary rack and pinion assembly, a push-pull cable, and a third exemplary lock assembly. [Figure 15A] Figure 14 is a schematic top view of the deflection drive assembly, in which the linear slider is in a first longitudinal position, the rack of the rack and pinion assembly is in a first longitudinal position, and the lock assembly is in an unlocked configuration. [Figure 15B]Figure 15A is a schematic top view of the deflection drive assembly, where the linear slider is in the second longitudinal position, the rack of the rack and pinion assembly is in the second longitudinal position, and the lock assembly is in the first lock configuration. [Figure 15C] Figure 15A is a schematic top view of the deflection drive assembly, where the linear slider is in the third longitudinal position, the rack and pinion assembly is in the third longitudinal position, and the lock assembly is in the second lock configuration. [Figure 16A] Figure 13 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components. The distal portion of the catheter is in a non-deflected position related to the first longitudinal position of the linear slider in Figure 15A. [Figure 16B] Figure 13 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components, and the distal portion of the catheter is in a first deflection position related to the second longitudinal position of the linear slider in Figure 15B. [Figure 16C] Figure 13 is a top view of the distal portion of the catheter, with a portion of the outer sheath omitted to reveal the internal components, and the distal portion of the catheter is in a second deflection position related to the third longitudinal position of the linear slider in Figure 15C. [Figure 17] This is a top schematic view of a fourth exemplary deflection drive assembly, in which a fourth exemplary lock assembly is located in the lock configuration. [Figure 18] Figure 1 is a schematic diagram illustrating an exemplary method for operating the catheter assembly. [Modes for carrying out the invention]

[0009] The following description of specific embodiments of the invention should not be used to limit the scope of the invention. The drawings are not necessarily to scale, show selected embodiments, and are not intended to limit the scope of the invention. The detailed description shows, by way of example and not limitation, the principles of the invention. Other embodiments, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for carrying out the invention by way of illustration. As will be recognized, the invention is capable of other different aspects or equivalent aspects without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0010] Any one or more of the teachings, expressions, variations, embodiments, etc. described herein can be combined with any one or more of the other teachings, expressions, variations, embodiments, etc. described herein. Accordingly, the teachings, expressions, variations, embodiments, etc. described below should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0011] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a component or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values that are ±10% of the recited value; for example, "about 90%" may refer to a range of values from 81% to 99%. Further, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and while the use of the invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0012] I. Overview of an Exemplary Ablation Catheter System Figure 1 shows 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, Figure 1 shows a physician (PH) grasping the handle (110) of the catheter assembly (100) with the end effector (140) of the catheter (120) (shown in Figures 2A-3, but not in Figure 1) positioned on the patient (PA) to excise tissue in or near the patient's (PA) heart (H). As shown in Figure 2, the catheter assembly (100) includes the handle (110), the catheter (120) extending distally from the handle (110), the end effector (140) located at the distal end of the catheter (120), and a deflection drive assembly (200) associated with the handle (110).

[0013] 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 the irrigation fluid. As will be described in more detail below, the deflection drive assembly (200) is configured to deflect the end effector (140) and the distal portion of the catheter (120) away from the central longitudinal axis (LL) (Figures 3-5) defined by the proximal portion of the catheter (120).

[0014] As shown in Figure 3, the catheter (120) includes an elongated flexible sheath (122), and the end effector (140) is located at the distal end of the outer sheath (122). The various components housed within the end effector (140) and the outer sheath (122) are described in more detail below. The catheter assembly (100) is coupled to the induction drive system (10) via a cable (30). The catheter assembly (100) is also coupled to the fluid source (42) via a fluid conduit (40). A pair of magnetic field generators (20) are located below the patient (PA) and coupled to the induction drive system (10) via another cable (22). The magnetic field generators (20) are simply optional.

[0015] The induction drive system (10) of this embodiment includes a console (12) and a display (18). The console (12) includes a first driver module (14) and a second driver module (16). The first driver module (14) is coupled to a catheter assembly (100) via a cable (30). In some modifications, the first driver module (14) is operable to receive EP mapping signals acquired via a microelectrode (138) of an end effector (140), as will be described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby performs EP mapping known in the art.

[0016] The first driver module (14) in this embodiment is further operable to supply RF power to the distal tip member (142) of the end effector (140), as will be described in more detail below, thereby excising tissue. The second driver module (16) is coupled to the 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 including the heart (H). The first driver module (14) is also operable to receive position indication signals from a navigation sensor assembly (150) in the end effector (140). In such a modification, the processor of the console (12) is also operable to process the position indication signals from the navigation sensor assembly (150), thereby determining the position of the end effector (140) in the patient (PA).

[0017] The navigation sensor assembly (150) includes a pair of coils on each panel (151), which are operable to generate signals indicating 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 an alternating electromagnetic field generated by a magnetic field generator (20). Other components and techniques that may be used to generate real-time position data related to the end effector (140) include wireless triangulation, acoustic tracking, optical tracking, and inertial tracking. Alternatively, the end effector (140) may lack the navigation sensor assembly (150).

[0018] The display (18) is coupled with the processor of the console (12) and is operable to render images of the patient's anatomical structure. Such images can be obtained based on a set of images (e.g., CT scan or MRI scan, 3D map, etc.) acquired before or during surgery. The view of the patient's anatomical structure provided through the display (18) can also change dynamically based on signals from the navigation sensor assembly (150) of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), the corresponding position data from the navigation sensor assembly (150) allows the processor of the console (12) to update the view of the patient's anatomical structure in the display (18) in real time, depicting the area of ​​the patient's anatomical structure around the end effector (140) as the end effector (140) moves within the patient (PA). Furthermore, the console (12) processor may drive the display (18) to indicate the location of abnormal conductive tissue sites, as detected by electrophysiological (EP) mapping using an end effector (140) or by other means (e.g., by using a dedicated EP mapping catheter). As just one example, the console (12) processor may drive the display (18) to superimpose the location of abnormal conductive tissue sites onto an image of the patient's anatomical structure, such as by superimposing illumination dots, crosshairs, or some other form of visual indication of abnormal conductive tissue sites.

[0019] The console (12) processor can also drive the display (18) to superimpose the current position of the end effector (140) onto an image of the patient's anatomical structure, for example, by superimposing illumination dots, crosshairs, a graphic representation of the end effector (140), or some other form of visual indication. Such superimposed visual indication can also move in real time within the image of the patient's anatomical structure on the display (18) as the physician (PH) moves the end effector (140) within the patient (PA), thereby providing the operator with real-time visual feedback on the position of the end effector (140) within the patient (PA) as the end effector (140) moves within the patient (PA). Thus, the images provided via the display (18) can effectively perform video tracking of the position of the end effector (140) within the patient (PA) without necessarily having any optical equipment (i.e., a camera) to view the end effector (140). In the same view, the display (18) can simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Thus, the physician (PH) can look at the display (18) and observe the real-time location of the end effector (140) in relation to the mapped abnormal conductive tissue sites and images of adjacent anatomical structures within the patient (PA).

[0020] The fluid source (42) in this embodiment includes a bag containing saline solution or some other suitable irrigation fluid. The conduit (40) includes a flexible tube further coupled to a pump (44) that is operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). As will be described in more detail below, such irrigation fluid may be discharged through an opening (158) in the distal tip member (142) of the end effector (140). Such irrigation can be carried out in any preferred manner that will be apparent to those skilled in the art in light of the teachings herein.

[0021] II. Exemplary End Effector of Catheter Assembly Figures 3 to 5 show exemplary components of the end effector (140) and other components of the distal portion of the catheter (120) in more detail. 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 disperse the irrigation fluid. For example, the end effector (140) includes a distal tip member (142), a distal tip base (144), a distal circuit disk (146), a strain gauge assembly (148), a navigation 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), strain gauge assembly (148), navigation sensor assembly (150), distal spacer stack (152), and proximal spacer (154) are aligned coaxially with each other, and these components (144-154) are stacked longitudinally to define a stacked circuit. The push-pull cable (160) and irrigation tube (180) extend along the length of the catheter (120) to reach the end effector (140). Each of the aforementioned components is described in more detail below. The outer sheath (122) may be flexible and surrounds all of the aforementioned components except the distal tip member (142).

[0022] As shown in Figures 3 to 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 a conductive material such as metal. Multiple openings (158) are formed through the cylindrical body (156) and communicate with the hollow interior of the distal tip member (142). Thus, the openings (158) allow the irrigation fluid to communicate from the inside of the distal tip member (142) through the cylindrical body (156) to the outside. The cylindrical body (156) and the dome tip are also operable to apply RF electrical energy to tissue, thereby excising the tissue. Such RF electrical energy may be communicated via a cable (30) from the first driver module (14) to the most proximal spacer (154). The distal tip member (142) may also include one or more thermocouples configured to provide a temperature sensing function.

[0023] As shown in Figures 3 and 4, the distal tip member (142) of this embodiment also includes one or more EP mapping microelectrodes (138) mounted on a cylindrical body (156). The EP mapping microelectrodes (138) are configured to pick up potentials from the 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 cardiovascular anatomical structures (e.g., pulmonary veins). The signals picked up by the EP mapping microelectrodes (138) may be communicated via vias or other structures in a layer proximal to the strain gauge assembly (148) and ultimately reach a first driver module (14) of the console (12) via a cable (30). The first driver module (14) processes the EP mapping signals and can provide the physician (PH) with corresponding feedback indicating the location of abnormal electrical activity, in accordance with the teachings of various references cited herein.

[0024] In a modified configuration in which the cylindrical body (156) is formed of a conductive material to supply RF electrical energy for tissue ablation, an electrically insulating material can be inserted between the cylindrical body (156) and the EP mapping microelectrode (138) to electrically isolate the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operable according to the teachings of 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 EP mapping microelectrodes (138). The distal tip base (144) defines a central opening configured to provide a path for communicating an irrigation fluid into the hollow interior of the distal tip member (142). The distal tip base (144) forms an annular shoulder to which the proximal end of the distal tip member (142) can abut. The distal tip member (142) also defines a lateral notch configured to receive a tab extending proximal to the distal tip member (142).

[0025] As shown in Figures 3 and 4, the distal circuit disk (146) is located proximal to 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 a tab extending proximal to the distal tip member (142). In modifications including one or more EP mapping electrodes (138), the distal circuit disk (146) may also include circuitry operable to communicate EP mapping signals from the EP mapping electrodes (138). In some modifications, the distal circuit disk (146) further includes one or more transmitting coils. Such transmitting coils can provide wireless communication of signals (e.g., EP mapping signals from microelectrodes (138)) to one or more complementary coils located proximal to the distal circuit disk (146). Furthermore, or alternatively, such a transmitting coil can provide wireless communication of RF electrical energy from one or more complementary coils located proximal to the distal end member (142) of the distal circuit disk (146).

[0026] In modifications in which the coil is incorporated into one or more other layers proximal to the distal circuit disk (146) and strain gauge assembly (148), such a coil may enable wireless communication of electrical signals across the strain gauge assembly (148) without requiring wires, vias, or other conductive structures to pass longitudinally across the strain gauge assembly (148). In some modifications, the distal circuit disk (146) includes at least one transmission coil (TX) paired with a receiving coil (RX) of a navigation sensor assembly (150) to detect the strain applied to the strain gauge assembly (148) and determine the contact force applied to the distal tip member (142). Some other modifications of the distal circuit disk (146) may simply omit the TX coil.

[0027] The strain gauge assembly (148) is positioned proximal to the distal circuit disk (146) and is configured to sense external forces impacting the distal tip member (142). When the distal tip (142) encounters an external force (for example, when the distal tip (142) is pressed against tissue), these external forces are communicated from the distal tip (142) to the distal tip base (144), to the distal circuit disk (146), and to the strain gauge assembly (148), so that the strain gauge can generate a suitable signal corresponding to the magnitude and direction of the external force. The signal from the strain gauge assembly (148) may also be communicated via vias or other structures in a layer proximal to the strain gauge assembly (148), and ultimately reaches a first driver module (14) of the console (12) via a cable (30). The first driver module (14) can process the strain signal in any preferred manner that will be apparent to those skilled in the art in light of the teachings herein. As a simple example, the console (12) could provide audible feedback to alert the physician (PH) when the strain gauge assembly (148) indicates that the distal tip member (142) is encountering a force exceeding a predetermined threshold, thereby preventing the physician (PH) from inadvertently damaging cardiovascular anatomical structures with the distal tip member (142).

[0028] The navigation sensor assembly (150) can generate signals indicating the position and orientation of the end effector (140) in three-dimensional space with substantial accuracy. The navigation sensor assembly (150) includes a plurality of panels (151), each panel including an RX coil operable to generate a position-indicating electrical signal in response to an alternating magnetic field generated by a magnetic field generator (20). Each RX coil may be formed by an electrical trace defining an electrical coil or antenna for receiving radio frequency signals emitted by the TX coils of an external transmitter (e.g., three TX coils provided by the magnetic field generator (20) located outside the patient's (PA) body and emitting individual radio frequencies), thereby allowing the position and orientation of each RX coil to be determined with respect to the TX coils provided by the magnetic field generator (20). Signals from the navigation sensor assembly (150) may be communicated via vias or other structures in layers near the strain navigation sensor assembly (150) and eventually reach a first driver module (14) of the console (12) via a cable (30).

[0029] The central annular body of the navigation sensor assembly (150) defines a central opening configured to provide a path for irrigation fluid to communicate with the hollow interior of the distal tip member (142). In a variation in which the central annular body of the navigation sensor assembly includes a radio communication coil, such radio communication coil may be further coupled to vias or other structures in a proximal layer of the strained navigation sensor assembly (150) thereby providing a path for electrical communication with the first driver module (14) of the console (12) via a cable (30).

[0030] In this embodiment, each distal spacer (153) is generally disc-shaped, with a pair of chord-shaped notches that are angularly offset by 90 degrees from each other. These notches are sized and configured to accommodate each panel (151) of the navigation sensor assembly (150), thereby allowing the panel (151) to be radially sandwiched between the distal spacer stack (152) and the outer sheath (122). Each distal spacer (153) also includes at least one cable notch, and two or more notches may be angularly offset by 180 degrees from each other. This cable notch is configured to receive the distal end portion (164) of a push-pull cable (160). Each distal spacer (153) further includes a central opening configured to provide a path for irrigation fluid to communicate with the hollow interior of the distal tip member (142). Each proximal spacer (154) is disc-shaped, with two or more openings formed through it. The central opening is configured to provide a path for irrigation fluid to communicate with the hollow interior of the distal tip member (142). The side openings are sized and configured to receive the proximal portion (162) of the push-pull cable (160). A second side opening may also be included.

[0031] As described above and as shown in Figures 1 and 3, the cable (30) connects the catheter assembly (100) to the drive system (10). As shown in Figure 4, the wire (32) of the cable (30) extends along the length of the catheter (120) to reach the most proximal proximal spacer (154). Thus, the wire (32) may be housed within the outer sheath (122). The wire (32) can be physically and electrically coupled to the most proximal proximal spacer (154) in any preferred manner. The catheter assembly (100) is configured to allow irrigation fluid to communicate from the fluid source (42) to the catheter (120) via the fluid conduit (40), thereby allowing the irrigation fluid to be discharged through the opening (158) of the distal tip member (142). In this embodiment, the fluid path for the irrigation fluid includes the irrigation tube (180) shown in Figures 4-5. The proximal end of the irrigation tube (180) is connected to a fluid conduit (40) (for example, 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 modifications, the irrigation fluid may also be transmitted from the distal end of the irrigation tube (180) through a central passage and eventually reach the interior of the distal tip member (142) through an opening (218) at the distal tip base (144).

[0032] As best shown in Figure 5, each distal end portion (164) has a larger outer diameter than each intermediate portion (162). The distal end portion (174) is coupled to the end effector (140) to prevent the push-pull cable (160) from being pulled proximal to the end effector (140). A preferred method for coupling the push-pull cable (160) to the end effector (140) will be apparent to those skilled in the art in light of the teachings herein.

[0033] III. A catheter with a bias drive In some cases, multiple production lines are used to construct catheters. For example, a first production line may produce only unidirectional catheters, while a second production line may produce only bidirectional catheters. A unidirectional catheter is one that deflects in only one direction (e.g., up, down, left, or right) away from the longitudinal axis (LL). A bidirectional catheter is one that deflects in two directions (e.g., up and down or left and right) away from the longitudinal axis (LL). Multiple production lines can be used because there are several structural differences between unidirectional and bidirectional catheters to achieve this difference in deflection. These differences may include the handle (110) and the deflection mechanism (e.g., the deflection drive assembly).

[0034] It may be advantageous to use some of the same components for both unidirectional and bidirectional catheters. This is also advantageous because both unidirectional and bidirectional catheters can be produced using the same production line. Using the same production line can save the time required to train assembly operators, reduce the possibility of mixing components on the production line, ensure interoperability of assembly operators between the unidirectional and bidirectional catheter lines, and may also generate larger quantity discounts during component procurement.

[0035] Furthermore, using the same or similar handle (110) for both unidirectional and bidirectional catheters may provide greater reassurance to physicians (PHs) as they may find the user interface more comfortable. The catheter assembly (100) captures the modification of the bidirectional deflection mechanism to enable unidirectional use. Conversely, the second exemplary catheter assembly (500) captures the modification of the bidirectional deflection mechanism to enable unidirectional use.

[0036] As will be described in more detail below, the exemplary deflection drive assemblies (300, 400, 508, 608) incorporate exemplary rack and pinion assemblies (304, 404, 518, 618) to (1) convert the rotational motion of pinions (308, 408) from rocker arms (230, 501) into linear motion of racks (306, 406), or (2) convert the linear motion of racks (524, 624) from linear sliders (514, 614) into rotational motion of pinions (526, 626). As shown in the figure, a single rack (306, 406, 524, 624) interacts with pinions (308, 408, 526, 626). The input members are shown as rocker arms (230, 501) in Figures 2 and 6-12, but are shown and described as linear sliders (514, 614) of the catheter assembly (500, 600) in Figures 13-17. Other suitable input members are also conceivable, as will be apparent to those skilled in the art in light of the teachings herein.

[0037] A. First exemplary catheter assembly for bidirectional end-effector deflection Figure 7 shows a schematic perspective view of the handle (110) and deflection drive assembly (300) of Figure 6, with a portion of the handle (110) omitted to reveal the internal components. As described above, the catheter assembly (100) includes the handle (110), the catheter (120), the end effector (140), and the deflection drive assembly (300). The catheter (120) extends distally from the handle (110). As shown in Figure 6, the handle (110) includes a first casing portion (112) and a second casing portion (114) that together define the internal cavity (102). The rocker arm (230) includes an elongated body (232) for enhancing the physician's (PH) grip. One such preferred example of a rocker arm (230) for rotatably operating a bidirectional catheter is shown and described in U.S. Provisional Patent Application No. 62 / 866,109, filed June 25, 2019, entitled “Catheter Deflection System with Deflection Load Limiter,” the disclosure of which is incorporated herein by reference in its entirety.

[0038] The deflection drive assembly (300) is configured to deflect the end effector (140) away from the longitudinal axis (LL) defined by the proximal portion of the catheter (120). The deflection drive assembly (300) in this embodiment includes a rocker arm (230) associated with a handle (110), a translation assembly (302), and a rack and pinion assembly (304) coupled to the rocker arm (230). The translation assembly (302) is indirectly or directly coupled to the rack and pinion assembly (304) and the end effector (140). As shown, the translation assembly (302) includes a push-pull cable (160). As will be described in more detail below, the physician (PH) may actuate the rocker arm (230) relative to the handle (110), thereby actinguating the rack and pinion assembly (304) to actuate the push-pull cable (160) to selectively deflect the end effector (140) laterally away from the longitudinal axis (LL), thereby allowing the physician (PH) to actively manipulate the end effector (140) within the patient (PA). The rocker arm (230) can drive the translation assembly (302) to deflect the end effector (140) away from the longitudinal axis (LL) at a certain angle (A) in two directions (up and down or left and right). The rocker arm (230) is configured to rotate relative to the handle (110) about a drive axis (DD) without translating along the longitudinal axis (LL). As shown in the figure, the drive axis (DD) is perpendicular to the longitudinal axis (LL).

[0039] The rack and pinion assembly (304) has a rack (306) and a pinion (308). Figures 7 to 11B show only a single rack (306). The rack and pinion assembly (304) converts the rotational motion of the pinion (308) from the rocker arm (230) to the linear motion of the rack (306). The rack and pinion assembly (304) is coupled to the rocker arm (230) and the translation assembly (302) using a shaft (310). As shown, the rocker arm (230) and the pinion (308) are coaxial with respect to the drive shaft (DD). The rack (306) is operably coupled to the distal end member (142) via a push-pull cable (160) or using another suitable translation member that drives the unidirectional deflection of the distal end member (142). The rack (306) includes multiple teeth (312). Similarly, the pinion (308) includes a plurality of teeth (314) configured to selectively engage with the teeth (312) of the rack (306). As will be described in more detail with reference to Figures 8A–8C, the deflection drive assembly (300) may optionally include a locking assembly (316). Several preferred examples of locking assemblies will be described, but other preferred locking assemblies are also conceivable.

[0040] As shown in the figure, the translational assembly (302) has a single push-pull cable (160) coupled to a rack (306) and an end effector (140). In particular, the push-pull cable (160) is coupled to the rack (306) at a proximal mounting point (318) using one of a variety of preferred mounting methods. Similarly, the push-pull cable (160) is coupled to the end effector (140) at a distal mounting point (321) using one of a variety of preferred mounting methods. Generally, the push-pull cable (160) is coupled to the rack (306) after the rack (306) engages with the pinion (308), although it is also conceivable that the push-pull cable (160) may be coupled to the rack (306) before the rack (306) engages with the pinion (308). The deflection drive assembly (300) alters the linear motion of the rack (306) to either push the push-pull cable (160) distally (see Figure 9B) or pull the push-pull cable (160) proximal (see Figure 9C). In particular, the rack and pinion assembly (304) is configured to drive a single push-pull cable (160) in both directions using input from the rocker arm (230). The push-pull cable (160) is shown as a stainless steel rod, but other suitable push-pull cables with sufficient flexibility and column strength are also conceivable.

[0041] Figures 8A to 8C show exemplary use of a deflection drive assembly (300) for deflecting the distal portions of the end effector (140) and catheter (120) around the longitudinal axis (LL). Figures 8A and 9A show the catheter assembly (100) when the end effector (140) is in a neutral, non-deflected position. In particular, Figure 8A shows a schematic top view of the deflection drive assembly (300) of Figure 6 with the rocker arm (230) in a neutral position. The rocker arm (230) is rotatable around a pivot point (319). When the rocker arm (230) is in a neutral position, the rack (306) of the rack and pinion assembly (304) is in a neutral, non-deflected position.

[0042] Figure 9A shows a top view of the distal portion of the catheter (120) of Figure 1, with a portion of the outer sheath (122) omitted to reveal the internal components. The push-pull cable (160) is in a neutral, non-deflected position relative to the end effector (140), which is in a neutral, non-deflected position. As shown in Figures 9A–9C, the intermediate portion (162) extends proximal from the distal end portion (164) through the outer sheath (122) of the catheter (120). The intermediate portion (162) may include various segments coupled together to extend to the distal end portion (164). The various segments of the intermediate portion (162) may be coupled by any preferred means as will be apparent to those skilled in the art in light of the teachings herein.

[0043] As shown in Figures 8A and 8C, the lock assembly (316) is sandwiched between the rocker arm (230) and the translation assembly (302). Figure 8A shows the lock assembly (316) in an unlocked configuration, allowing the end effector (140) to move along a range of angles. In the lock configurations shown in Figures 8B and 8C, the lock assembly (316) locks the end effector (140) at a desired angle with respect to the longitudinal axis (LL). In particular, in Figure 9B, the lock assembly (316) prevents the rack (306) from moving further distally. The lock assembly (316) includes lock features (320, 322, 324) that define the lock and unlock configurations. As shown in Figure 8A, the pinion (308) includes the lock feature (320). Although the pinion (308) is shown as having only a single locking feature (320), the pinion (308) may have two or more locking features spaced apart around the pinion (308). Similarly, the rack (306) has locking features (322, 324) spaced apart from each other along the longitudinal axis (LL). As shown, the locking features (322, 324) of the rack (306) are located at either end of the working length of the rack (306). The rack (306) may have more or fewer locking features. The locking features (322, 324) of the rack (306) are complementary to the locking feature (320) of the pinion (308). The locking feature (320) is configured to engage with one of the locking features (322, 324) in the lock configuration.

[0044] The locking features (322, 324) are positioned at a distance from the locking feature (320) in the unlocking configuration. As shown in the figure, the locking features (320, 322, 324) are cylindrical in shape. In particular, the locking feature (320) of the pinion (308) is a cylindrical pin (326), and the locking features (322, 324) of the rack (306) are cylindrical retaining elements (328, 330). The cylindrical pin (326) of the locking feature (320) of the pinion (308) is configured to be detachably coupled (e.g., fitted into) the cylindrical retaining elements (328, 330) of the locking features (322, 324) of the rack (306) in the locking configuration. The cylindrical pin (326) protrudes downward and integrally from the rocker arm (230) adjacent to the pinion (308). The cylindrical pin (326) may be positioned adjacent to the tooth tip of the gear. The cylindrical retainers (328, 330) may be formed within the gear tooth grooves of the rack (306).

[0045] When the resistance using the rocker arm (230) is the same or less, the cylindrical pin (326) of the pinion (308) is detachable from one of the cylindrical retainers (328, 330) of the rack (306) to unlock the deflection of the end effector (140). The cylindrical pin (326) and cylindrical retainers (328, 330) provide a coupling that is strong enough to resist unintended longitudinal movement of the rack (306) when the lock assembly (316) is in the state shown in Figure 10B or Figure 10C (for example, in response to lateral forces applied to the end effector by the patient's anatomical structure), but weak enough to allow the operator to intentionally move the assembly between the states shown in Figures 10A and 10C without requiring excessive torque on the rocker arm (230). The lock assembly (316) can provide tactile indication when entering or exiting the locked or unlocked configuration. Although not shown in the illustration, various non-cylindrical shapes are also conceivable for the lock feature parts (320, 322, 324), including spherical lock feature parts.

[0046] Figure 8B shows a schematic top view of the deflection drive assembly (300) of Figure 8A, where the rocker arm (230) is in a second position (rotated 180 degrees clockwise), the rack (306) is in a first longitudinal position, and the lock assembly (316) is in a first lock configuration. As shown in Figure 8B, the first lock configuration is the most distal position of the rack (306). Figure 9B shows a top view of the distal portion of the catheter (120) of Figure 1, with a portion of the outer sheath (122) omitted to reveal the internal components, where the distal portion of the catheter (120) is in a first deflection position related to the first position of the rocker arm (230) in Figure 8B. As best illustrated in Figure 9B, when the rocker arm (230) is rotated to the first position shown in Figure 8B, the rack and pinion assembly (304) is driven to the corresponding longitudinal position, thereby driving the push-pull cable (160) distally. As shown in Figure 8B, in the first locking configuration, the cylindrical pin (326) of the locking feature (320) is located within the cylindrical retaining element (330) of the locking feature (324).

[0047] If the physician (PH) wishes to deflect the end effector (140) relative to the central longitudinal axis (LL) to the deflection position shown in Figure 9C, the physician (PH) can rotate the rocker arm (230) relative to the handle (110) to the position shown in Figure 8C. In particular, Figure 8C shows a schematic top view of the deflection drive assembly (300) of Figure 8A, where the rocker arm (230) is in the second position, the rack and pinion assembly (304) is in the second longitudinal position, and the lock assembly (316) is in the second lock configuration. As shown in Figure 8B, the second lock configuration is the most proximal position of the rack (306). Figure 9C shows a top view of the distal portion of the catheter (120) of Figure 1, with a portion of the outer sheath (122) omitted to reveal the internal components. The distal portion of the catheter (120) includes the irrigation tube (180) and is in a deflected position related to the second position of the rocker arm (230). As shown in Figure 8C, when the rocker arm (230) is rotated to the rotational position shown in Figure 8C, the pinion (308) of the rack and pinion assembly (304) is driven to the corresponding rotational position, resulting in the rack (306) and push-pull cable (160) moving proximal. As shown in Figure 8C, in the second locking configuration, the cylindrical pin (326) of the locking feature (320) is located within the cylindrical retaining element (328) of the locking feature (322). It is assumed that the physician (PH) may rotate the rocker arm (230) to move the end effector (140) from the position shown in Figure 8A to the position shown in Figure 8C without rotating the rocker arm (230) to the position shown in Figure 8B.

[0048] B. First exemplary catheter assembly for unidirectional end effector deflection It may be desirable to modify the deflection drive assembly (300), which is configured to provide bidirectional deflection to the end effector (140) as shown in Figures 8A to 9C, to instead provide unidirectional deflection to the end effector (140), as shown in Figures 10A to 11B. This switch from bidirectional to unidirectional deflection of the end effector (140) can be achieved by modifying the neutral position of the deflection drive assembly (300) while it is being manufactured (e.g., while it is being assembled). For example, as shown in Figures 10A to 11B, this can be achieved by modifying the initial position of the rack and pinion assembly (304) and the longitudinal position to which the translation assembly (302) is coupled with the rack and pinion assembly (304).

[0049] Figure 10A shows a schematic top view of the deflection drive assembly (300) of Figure 8A, where the rocker arm (230) is in a neutral, non-deflected position, the rack (306) is in a first longitudinal position, and the lock assembly (316) is in a first lock configuration. Figure 11A shows a top view of the distal portion of the catheter (120) of Figure 1, with a portion of the outer sheath (122) omitted to reveal the internal components, where the distal portion of the catheter (120) is in a neutral, non-deflected position. As shown in Figure 10A, the rack and pinion assembly (304) is adjusted from the neutral configuration shown in Figure 8A to the neutral configuration shown in Figure 10A, and the longitudinal position in which the push-pull cable (160) is firmly fixed to the rack (306) is adjusted from the neutral position shown in Figure 8A to the neutral position shown in Figure 10A. As shown in Figure 10A, the lock assembly (316) in the first lock configuration prevents the rack (306) from being driven distally. In the first lock configuration, the cylindrical pin (326) of the lock feature (320) is located within the cylindrical retaining element (330) of the lock feature (324).

[0050] Figure 10B shows a schematic top view of the deflection drive assembly (300) of Figure 10A, where the rocker arm (230) is in a first rotational position, the rack (306) is in a first longitudinal position, and the lock assembly (316) is in a second lock configuration. Figure 11B shows a top view of the distal portion of the catheter (120) of Figure 1, with a portion of the outer sheath (122) omitted to reveal the internal components, where the distal portion of the catheter (120) is in a deflection position related to the first position of the rocker arm (230) in Figure 10B. As shown in Figure 11B, when the rocker arm (230) is rotated from the position shown in Figure 10A to the position shown in Figure 10B, the rack and pinion assembly (304) is driven to the corresponding rotational position, and as a result the push-pull cable (160) is driven proximal. Although not necessarily shown in these drawings, please understand that the distal portion of the catheter (120) can achieve a greater degree of lateral deflection (i.e., a greater bending angle) in the configuration shown in Figures 10A to 11B than in the configuration shown in Figures 8A to 9C.

[0051] C. Second exemplary lock assembly Figure 12 shows a schematic top view of a second exemplary deflection drive assembly (400) in which a second exemplary lock assembly (416) is in an unlocked configuration. The deflection drive assembly (400) includes a rocker arm (401) similar to the rocker arm (230), a translation assembly (402) similar to the translation assembly (302), and a rack and pinion assembly (404) similar to the rack and pinion assembly (304). The rack and pinion assembly (404) includes a rack (406) and a pinion (408). The rack (406) includes teeth (412), and the pinion (408) includes teeth (414). The rack (406) is coupled to a push-pull cable (434) of the translation assembly (402) at a mounting point (418) similar to the proximal mounting point (318). The locking assembly (416) includes a locking feature (420) on the pinion (408) and locking features (422, 424) on the rack (406). For example, the locking feature (422) is shown as a cylindrical pin (426) adjacent to the pinion (408) and projecting downward and integrally from the rocker arm (230). The cylindrical pin (426) may be positioned adjacent to the tooth tip of the gear. The locking features (422, 424) are cylindrical retainers (428, 430) formed in the tooth grooves of the gear, respectively. The rocker arm (401) may be coupled to the pinion (408) using a shaft (410). The shaft (410) may be fixedly coupled to one or both of the rocker arm (401) and the pinion (408).

[0052] The lock assembly (416) may include a biasing member (438) configured to bias the rack (406) away from the pinion (408), thereby converting the lock assembly (416) from a locked configuration to an unlocked configuration. For example, the rack (406) may be formed from a flexible material (e.g., a polymer material). As shown, the biasing member (438) protrudes outward from the handle (411), and as a result, the biasing member (438) can be manually actuated by a physician (PH). It is envisioned that the latch pin (436) or the biasing member (438) may be used alone or in combination.

[0053] D. Exemplary catheter assembly for bidirectional end effector deflection with a third exemplary locking assembly A catheter assembly including a translationable actuator (e.g., a linear slider) may typically be configured to provide only unidirectional deflection of the end effector (140). It may be desirable to manufacture a catheter assembly including a linear slider that can provide bidirectional deflection of the end effector (140). Furthermore, it may be desirable to produce both unidirectional catheters including a linear slider and bidirectional catheters including a linear slider using the same production line. As mentioned above, using the same production line for unidirectional and bidirectional catheters can save the time required to train assembly operators, reduce the possibility of mixing components on the production line, ensure interoperability of assembly operators between unidirectional and bidirectional catheter production lines, and also generate greater quantity discounts during component procurement. For at least these reasons, the second exemplary catheter assembly (500) includes an input member (indicated as a linear slider (514)) that can provide bidirectional deflection to the end effector (504). Bidirectional deflection provides a wider range of deflection angles for the end effector (504) compared to unidirectional deflection.

[0054] Figure 13 shows a perspective view of a catheter assembly (500) similar to the catheter assembly (100) in Figure 1, with additional components shown in schematic form. The catheter assembly (500) includes a second exemplary catheter (502) similar to the catheter (120), an end effector (504) similar to the end effector (140), a handle (506) similar to the handle (110), and a third exemplary deflection drive assembly (508). The handle (506) includes a first casing portion (510) and a second casing portion (512). The deflection drive assembly (508) includes a linear slider (514), a translation assembly (516), and a rack and pinion assembly (518). The linear slider (514) is slidable by the physician (PH) along the longitudinal axis (LL) between the distal most position (DP), indicated by a dashed line, and the proximal most position (PP), also indicated by a dashed line, and between any position between the distal most position (DP) and the proximal most position (PP). As shown in the figure, the linear slider (514) translates along the longitudinal axis (LL) without rotation.

[0055] The translational assembly (516) includes a push-pull cable (520). The push-pull cable (520) and an irrigation tube (521) similar to the irrigation tube (180) can extend along the length of the catheter (120) to reach the end effector (504). The cable (30) connects the catheter assembly (500) to the drive system (10) described above. Similar to the wire (32) in Figure 3, the wire of the cable (30) extends along the length of the catheter (502) to reach the most proximal proximal spacer. The wire (32) may be housed within an outer sheath (522) similar to the outer sheath (122). The wire (32) can be physically and electrically coupled to the most proximal proximal spacer in any preferred manner.

[0056] The catheter assembly (500) is configured to allow irrigation fluid to communicate with the catheter (502) from a fluid source similar to the fluid source (42) in Figure 3 via a fluid conduit (40), thereby allowing the irrigation fluid to be discharged through an opening in the distal tip member (523) similar to the opening (158) in Figure 3. Similar to the distal tip member (142), the distal tip member (523) includes a cylindrical body (540) (see Figures 16A-16C) having a dome tip. In this embodiment, the fluid path for the irrigation fluid includes an irrigation tube (521). The proximal end of the irrigation tube (521) is coupled to the fluid conduit (40) (for example, at the handle (506) of the catheter assembly (500)). The irrigation tube (541) extends along the length of the catheter (502) to reach the end effector (504). In some variations, the irrigation fluid may be routed from the distal end of the irrigation tube (541) through the central passage and eventually reach the interior of the distal tip member (523) through an opening similar to the opening (218).

[0057] Figure 14 shows a perspective view of the deflection drive assembly (508) of Figure 13. The rack and pinion assembly (518), similar to the rack and pinion assembly (304), includes a rack (524) and a pinion (526). As shown, the linear slider (514) is fixedly coupled to the rack (524). The rack and pinion assembly (518) converts the linear motion of the rack (524), obtained from the linear motion of the linear slider (514), into the rotational motion of the pinion (526). The pinion (526) extends from the shaft (528). The rack (524) includes a plurality of teeth (530). Similarly, the pinion (308) includes a plurality of teeth (532) configured to selectively engage with the teeth (530) of the rack (524). The push-pull cable (520) has portions (536, 538). The rack (524) is connected to the distal end member (523) via the push-pull cable (520) or via another suitable translational member that drives the bidirectional deflection of the distal end member (523).

[0058] Continuing to refer to Figure 14, the deflection drive assembly (508) includes a pulley wheel (542) coaxial with the pinion (526) of the rack and pinion assembly (518). The pulley wheel (542) is rotatably coupled to the pinion (526) using a shaft (528). The pulley wheel (542) includes an interface surface (544) configured to frictionally engage with the push-pull cable (520). As will be described in more detail with reference to Figures 15A to 16C, the handle (110) uses the rack and pinion assembly (518) to deflect the distal tip member (523) by converting the linear motion of the linear slider (514) into the rotational motion of the pinion (526) synchronized with the push-pull cable (520) via the pulley wheel (542). The distal tip member (523) deflects in multiple directions while applying tension to one portion (536, 538) of the push-pull cable (520) and releasing tension to the other portion (536, 538) of the push-pull cable (520).

[0059] Figures 15A to 16C illustrate exemplary use of a deflection drive assembly (508) for deflecting the distal portions of the end effector (504) and catheter (502) around the central longitudinal axis (LL). Figure 15A shows a schematic top view of the deflection drive assembly (508) of Figure 14. As shown, the linear slider (514) is in a first longitudinal position (i.e., neutral position), the rack and pinion assembly (304) is in a first longitudinal position (i.e., neutral position), and the third exemplary lock assembly (534) is in an unlock configuration. The shown neutral position has a pinion (526) positioned in the center of the rack (524), but the neutral position may have a pinion (526) positioned more proximal or more distal along the rack (524). As shown in Figure 15A, the pinion (526) and the pulley wheel (542) are coaxial with each other and laterally offset from each other. The pinion (526) and the pulley wheel (542) may be rotatably coupled together via a shaft (528), or they may be formed together as a single part. For example, the pinion (526), ​​shaft (528), and pulley wheel (542) may be formed of plastic, metal, or another suitable material or combination of materials. The push-pull cable (520) is shown as being wound around the pulley wheel (542). The distal portion of the rack (524) may be coupled with the wire (546) at the mounting point (548) for unidirectional deflection of the end effector (504), which is generally not omitted for unidirectional deflection of the end effector (504).

[0060] As shown in Figures 15A to 15C, the deflection drive assembly (300) may optionally include a lock assembly (534) similar to the lock assembly (316). The lock assembly (534) includes lock features (552, 554, 556) that define the lock and unlock configurations. As shown in Figure 15A, the pinion (526) includes a lock feature (552). Although the pinion (526) is shown as including only a single lock feature (552), the pinion (526) may include two or more lock features. Similarly, the rack (524) includes lock features (554, 556) spaced apart from each other along the longitudinal axis (LL). As shown, the lock features (554, 556) of the rack (524) are located at either end of the working length of the rack (524). The rack (524) may include more or fewer locking features. The locking features (554, 556) of the rack (524) are complementary to the locking features (552) of the pinion (526). The locking feature (552) is configured to engage with one of the locking features (554, 556) in the lock configuration.

[0061] The locking features (554, 556) are positioned at a distance from the locking feature (552) in the unlocked configuration. In other words, in the unlocked position shown in Figure 15A, the locking features (554, 556) of the rack (524) are not engaged with the locking feature (552) of the pinion (526). As shown in the figure, the locking features (552, 554, 556) are cylindrical in shape. In particular, the locking feature (552) of the pinion (526) is a cylindrical pin (558), and the locking features (554, 556) of the rack (524) are cylindrical retainers (560, 562). The cylindrical pin (558) of the locking feature (552) of the pinion (526) is configured to be removably coupled (e.g., fitted into) the cylindrical retainers (560, 562) of the locking features (554, 556) of the rack (524) in the locking configuration. The cylindrical pin (558) may be positioned adjacent to the teeth of the gear. Alternatively, the cylindrical pin (558) may protrude integrally from the pulley wheel (542) which is rotatably coupled to the pinion (526). The cylindrical retainers (560, 562) may be formed within the tooth grooves of the gear of the rack (524). When the resistance using the linear slider (514) is the same or less, the cylindrical pin (558) of the pinion (526) is detachable from one of the cylindrical retainers (560, 562) of the rack (524) to unlock the deflection of the end effector (504). Thus, the lock assembly (534) can provide tactile indication when entering or exiting the locked or unlocked configuration. Although not shown, various non-cylindrical shapes are also conceivable for the lock features (552, 554, 556).

[0062] Figure 16A shows a top view of the distal portion of the catheter of Figure 13, with a portion of the outer sheath (522) omitted to reveal the internal components, and the distal portion of the catheter (502) is in a neutral, unbiased position related to the first longitudinal position of the linear slider (514) of Figure 15A. Thus, Figure 16A shows the catheter assembly (500) when the end effector (504) is in a neutral, unbiased position. Similarly, the push-pull cable (520) is in a first position related to the end effector (504) in an unbiased position. A portion (536) of the push-pull cable (520) is coupled to the distal tip member (523) of the end effector (504) at the attachment point (564). Similarly, a portion (538) of the push-pull cable (520) is coupled at the mounting point (566) to the distal end member (523) of the end effector (504). Since the end effector (504) is shown to be in a neutral, non-deflected position, the mounting point (564) is positioned longitudinally along the same longitudinal axis (LL) as the mounting point (566).

[0063] Figure 15B shows a schematic top view of the deflection drive assembly (508) of Figure 15A. As shown, the linear slider (514) is in the second longitudinal position, the rack and pinion assembly (304) is in the second longitudinal position, and the lock assembly (534) is in the first lock configuration. As shown in Figure 15B, the linear slider (514) is actuated distally (indicated by arrow (568)), thereby driving the rack (524) distally along the longitudinal axis (LL). As shown in Figure 15B, the first lock configuration is the most proximal position of the rack (524). Since the teeth (530) of the rack (524) engage with the teeth (532) of the pinion (526), ​​longitudinal movement of the rack (524) causes the pinion (526) to rotate clockwise (indicated by arrow (570)). Since the pinion (526) and the pulley wheel (542) are rotatably coupled, the clockwise rotation of the pinion (526) drives the pulley wheel (542) to rotate clockwise. For example, the pinion (526) and the pulley wheel (542) may be integral with each other or may be fixed together integrally in other ways. The clockwise rotation of the pulley wheel (542) drives the push-pull cable (520) to rotate clockwise. In particular, a portion (536) of the push-pull cable (520) is pushed distally (indicated by arrow (572)), and a portion (538) of the push-pull cable (520) is pulled proximal (indicated by arrow (574)). As shown in Figure 15B, in the first locking configuration, the cylindrical pin (558) of the locking feature (552) is located within the cylindrical retaining element (562) of the locking feature (556).

[0064] Alternatively, it is conceivable that a sprocket could be used instead of the pulley wheel (542), and a chain instead of at least a portion of the push-pull cable (520) (e.g., the portion that directly engages with the sprocket during operation), with the chain wrapped around the sprocket and the first and second push-pull cables joined to the respective ends of the chain. In such an alternative configuration utilizing a chain and sprocket, the first and second push-pull cables move in opposite directions along the longitudinal axis (LL) in a manner similar to that of a bidirectional catheter as shown and described in U.S. Provisional Patent Application No. 62 / 866,109, “Catheter Deflection System with Deflection Load Limiter,” filed June 25, 2019 (the disclosure thereof is incorporated herein by reference in its entirety).

[0065] Figure 16B shows a top view of the distal portion of the catheter (502) of Figure 13, with a portion of the outer sheath (522) omitted to reveal the internal components. As shown, the distal portion of the catheter (502) is in a first deflection position relative to the second longitudinal position of the linear slider (514) in Figure 15B. If the physician (PH) wishes to deflect the end effector (504) in a first direction with respect to the central longitudinal axis (LL) to the first deflection position shown in Figure 16B, the physician (PH) can translate the linear slider (514) to the position shown in Figure 15B relative to the handle (506). Since the end effector (504) is shown in the first deflection position, the mounting point (564) is positioned distal to the mounting point (566) along the longitudinal axis (LL).

[0066] Figure 15C shows a schematic top view of the deflection drive assembly (508) of Figure 15A, where the linear slider (514) is in a third longitudinal position, the rack and pinion assembly (518) is in a third longitudinal position, and the lock assembly (534) is in a second lock configuration. As shown in Figure 15C, the linear slider (514) is actuated proximal (indicated by arrow (576)), thereby driving the rack (524) proximal along the longitudinal axis (LL). Since the teeth (530) of the rack (524) engage with the teeth (532) of the pinion (526), ​​longitudinal movement of the rack (524) causes the pinion (526) to rotate counterclockwise (indicated by arrow (578)). Since the pinion (526) and the pulley wheel (542) are rotatably coupled, the rotation of the pinion (526) drives the pulley wheel (542) to rotate counterclockwise. The counterclockwise rotation of the pulley wheel (542) drives the push-pull cable (160) to rotate counterclockwise. In particular, a portion (536) of the push-pull cable (520) is pulled proximally (indicated by arrow (580)), and a portion (538) of the push-pull cable (520) is pushed distally (indicated by arrow (582)). As shown in Figure 15C, in the second lock configuration, the cylindrical pin (558) of the lock feature (552) is located within the cylindrical retaining element (560) of the lock feature (554). As shown in Figure 15C, the second lock configuration is the most proximal position of the rack (524).

[0067] Figure 16C shows a top view of the distal portion of the catheter (502) of Figure 13, with a portion of the outer sheath omitted to reveal the internal components, and the distal portion of the catheter (502) is in a second deflection position related to the third longitudinal position of the linear slider (514) of Figure 15C. Since the end effector (504) is shown to be in the second deflection position, the mounting point (564) is positioned proximal to the mounting point (566) along the longitudinal axis (LL).

[0068] E. Fourth exemplary lock assembly Figure 17 shows a top schematic view of a fourth exemplary deflection drive assembly (608) in which a fourth exemplary lock assembly (634) is in an unlock configuration. The deflection drive assembly (608) includes a linear slider (614) similar to that of a linear slider (514), a translation assembly (616) similar to that of a translation assembly (516), and a rack and pinion assembly (618) similar to that of a rack and pinion assembly (518). The rack and pinion assembly (618) includes a rack (624) having teeth (630) and a pinion (626) having teeth (632). The rack (624) is coupled to the linear slider (614). The lock assembly (634) includes a lock feature (652) on the pinion (626) and lock features (654, ​​656) on the rack (624). For example, the locking feature (652) is shown as a cylindrical pin (658), and the locking features (654, ​​656) are cylindrical retainers (660, 662) formed in the tooth grooves of the gear, respectively. The cylindrical pin (658) may be formed together with the pulley wheel (642).

[0069] The linear slider (614) is configured to translate along the longitudinal axis (LL) relative to the handle (606). The linear slider (614) is coupled to the pinion (626) using a shaft (628). The shaft (628) rotatably couples the pinion (626) to the pulley wheel (642). The deflection drive assembly (608) includes a pulley wheel (642) that is coaxial with the pinion (626) of the rack and pinion assembly (618). The pulley wheel (642) is rotatably coupled to the pinion (626) using a shaft (628). The pulley wheel (642) includes an interface surface (644) configured to contact the push-pull cable (620). The distal portion of the rack (524) may be coupled to the wire (546) at the mounting point (548). The push-pull cable (620) has the same parts (636, 638) as the push-pull cable (520). Part (636) of the push-pull cable (620) is connected to the distal end member (523) of the end effector (504) at the same mounting point as the mounting point (564). Part (638) of the push-pull cable (620) is connected to the distal end member (523) of the end effector (504) at the same mounting point as the mounting point (566).

[0070] Instead of or in addition to the locking features (652, 654, 656), the locking assembly (634) may include a locking feature (indicated as a latch pin (668)) that selectively connects with the teeth (670) of a linear slider (614) to maintain the deflection angle of the end effector (504) (see Figures 16A to 16C). The latch pin (668) selectively maintains the linear slider (614) in the locked position. Instead of or in addition to the locking features (652, 654, 656) or the latch pin (668), the locking assembly (634) may include a locking feature (indicated as a latch pin (672)) that selectively connects with the teeth (674) of a rack (624) to maintain the deflection angle of the end effector (504) (see Figures 16A to 16C).

[0071] F. Exemplary Methods Figure 18 shows a method (700) for operating a catheter assembly (100, 500). Step (702a) of method (700) includes manually operating the rocker arms (230, 401) using rotational motion. Step (702b) of method (700) includes manually operating the linear sliders (514, 614) using linear motion. Step (704a) of method (700) includes transmitting the rotational motion of the rocker arms (230, 401) to the pinions (308, 408). Step (704b) of method (700) includes transmitting the linear motion of the linear sliders (514, 614) to the racks (524, 624).

[0072] Step (706a) of Method (700) includes using a rack and pinion assembly (304, 404) to convert the rotational motion of a pinion (308, 408) to the subsequent rotational motion of a rack (306, 406). Step (706b) of Method (700) includes using a rack and pinion assembly (518, 618) to convert the linear motion of a rack (524, 624) to the subsequent rotational motion of a pinion (526, 626). Step (708a) of Method (700) includes transmitting the subsequent linear motion of the rack (306, 406) to a translational assembly (302, 402). Step (708b) of Method (700) includes transmitting the subsequent rotational motion of a pinion (526, 626) to a translational assembly (516, 616).

[0073] Step (710) of method (700) includes deflecting the end effector (140) at an angle away from the longitudinal axis (LL) using translation assemblies (302, 402), or deflecting the end effector (504) at an angle away from the longitudinal axis (LL) using translation assemblies (516, 616). Step (712) of method (700) includes locking the end effectors (140, 504, 604) at a desired angle away from the longitudinal axis (LL) in a locked configuration using lock assemblies (316, 416, 534, 634).

[0074] IV. Exemplary Combinations The following embodiments relate to various non-exclusive methods by which the teachings herein can be combined or applied. It should be understood that the following embodiments are not intended to limit the claims that may be presented at any point in this application or any subsequent application thereof. No waiver of any rights is intended. The following embodiments are provided solely for illustrative purposes. Various teachings herein are intended to be constructed and applied in many other ways. In addition, some modifications may omit certain features mentioned in the following embodiments. Accordingly, none of the embodiments or features mentioned below should be considered important unless they are subsequently expressly indicated so by the inventors or their heirs. If the claims presented in this application or any subsequent application relating to this application include additional features other than those mentioned below, those additional features should not be considered added for any patentability reason. [Examples]

[0075] A device comprising: (a) a handle; (b) a catheter extending distally from the handle, the proximal portion of which defines a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; and (iii) a rack and pinion assembly coupled to the input member and the translation assembly. A deflection drive assembly and apparatus comprising a rack and pinion assembly, the on-assembly is configured to drive a translation assembly to deflect an end effector away from the longitudinal axis at a certain angle, the rack and pinion assembly comprising a rack and a pinion, the rack and pinion assembly being configured to (1) convert the rotational motion of the pinion from an input member into the linear motion of the rack to push the translation member distally or pull it proximally, or (2) convert the linear motion of the rack from an input member into the rotational motion of the pinion to move a first end of the translation member proximally and a second end of the translation member distally. [Examples]

[0076] The apparatus according to Embodiment 1, wherein the input member includes a rocker arm configured to rotate relative to a handle about a drive shaft, and the rack and pinion assembly is configured to convert the rotational motion of the pinion from the rocker arm into the linear motion of the rack, thereby pushing the translational member distally or pulling it proximally. [Examples]

[0077] The apparatus according to Embodiment 2, wherein the translational assembly further includes a push-pull cable coupled to a rack, and the deflection drive assembly is configured to transmit the linear motion of the rack to push the push-pull cable distally or pull the push-pull cable proximal. [Examples]

[0078] The apparatus according to one or more of Examples 2 to 3, wherein the rocker arm and pinion are coaxial with respect to the drive shaft. [Examples]

[0079] The apparatus according to Embodiment 1, wherein the input member includes a linear slider configured to move longitudinally along a longitudinal axis, and the rack and pinion assembly is configured to convert the linear motion of the rack from the linear slider into rotational motion of the pinion, thereby moving a first end of the translational member proximal and a second end of the translational member distally. [Examples]

[0080] The apparatus according to Embodiment 1, wherein the translational assembly further includes a push-pull cable having a first portion and a second portion, and the deflection drive assembly is configured to transmit the rotational motion of a pinion to push the first portion of the push-pull cable distally and pull the second portion of the push-pull cable proximal. [Examples]

[0081] The apparatus according to Embodiment 6, wherein the deflection drive assembly further includes a pulley wheel coaxial with the pinion of a rack and pinion assembly, the pulley wheel including an interface surface configured to contact a push-pull cable. [Examples]

[0082] The apparatus according to any one or more of Examples 5 to 7, wherein a linear slider is fixedly coupled to a rack and a pulley wheel is rotatably coupled to a pinion. [Examples]

[0083] The apparatus according to any one of Examples 1 to 8, further comprising a locking assembly sandwiched between an input member and a translational assembly, wherein the locking assembly is movable between a locked configuration and an unlocked configuration, and the locking assembly is configured to lock the end effector at an angle with respect to the longitudinal axis in the locked configuration. [Examples]

[0084] The apparatus according to Embodiment 9, wherein the lock assembly includes a first lock feature portion and a second lock feature portion configured to transition between a locked configuration and an unlocked configuration, and the lock assembly is configured to prevent the translational assembly from translating along the longitudinal axis in the locked configuration. [Examples]

[0085] The apparatus according to Embodiment 10, wherein a first locking feature is located on a pinion, a second locking feature is located on a rack, the second locking feature is complementary to the first locking feature, the first and second locking features are configured to engage with each other in a locking configuration, and the first and second locking features are configured to be located at a certain distance from each other in an unlocking configuration. [Examples]

[0086] The apparatus according to Example 10 or 11, wherein the first locking feature and the second locking feature are cylindrical. [Examples]

[0087] The apparatus according to Embodiment 12, wherein the first locking feature includes a cylindrical pin, and the second locking feature includes a cylindrical retaining element configured to receive the cylindrical pin in the locking configuration. [Examples]

[0088] The apparatus according to Example 13, wherein the cylindrical pin protrudes integrally from the input member, and the cylindrical retainer is formed within the tooth groove of the rack gear. [Examples]

[0089] The apparatus according to any one of Examples 9 to 14, further comprising a biasing member configured to bias the rack away from the pinion and switch to an unlocked configuration. [Examples]

[0090] The apparatus according to any one or more of Examples 1 to 8, further comprising a locking assembly, the locking assembly including a first locking feature portion and a second locking feature portion configured to transition between a locked configuration and an unlocked configuration, wherein the first locking feature portion is located on a translational assembly and the second locking feature portion is selectively located on a handle. [Examples]

[0091] The apparatus according to Embodiment 10, wherein the input member includes a rocker arm configured to rotate relative to the handle about a drive shaft, a first locking feature is located on the rocker arm, and a second locking feature is movable on the handle. [Examples]

[0092] The apparatus according to Embodiment 17, wherein the drive shaft is perpendicular to the longitudinal axis. [Examples]

[0093] The apparatus according to Embodiment 10, wherein the input member includes a linear slider configured to translate relative to the handle along a longitudinal axis, a first locking feature portion is located on the linear slider, and a second locking feature portion is movable on the handle. [Examples]

[0094] The apparatus according to Embodiment 1, wherein the translational assembly consists of a single push-pull cable, and the rack and pinion assembly is configured to drive the single push-pull cable in both directions. [Examples]

[0095] A single push-pull cable is included in the apparatus described in Example 20, which includes a stainless steel rod. [Examples]

[0096] The apparatus according to one or more of Examples 1 to 21, wherein at least one electrode is configured to emit RF energy. [Examples]

[0097] The apparatus according to one or more of Examples 1 to 22, wherein at least one electrode is configured to perform electrophysiological mapping. [Examples]

[0098] The end effector is the apparatus described in one or more of Examples 1 to 23, including a strain gauge assembly. [Examples]

[0099] The apparatus according to one or more of Examples 1 to 24, wherein the end effector is configured to discharge the irrigation fluid. [Examples]

[0100] The end effector is the apparatus described in one or more of Examples 1 to 25, including a position sensor. [Examples]

[0101] A device comprising: (a) a handle; (b) a catheter extending distally from the handle, the proximal portion of which defines a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode; (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector, the input member configured to drive the translation assembly to deflect the end effector away from the longitudinal axis at a certain angle; and (iii) a rack and pinion assembly coupled to the input member and the translation assembly, the rack and pinion assembly comprising a rack and a pinion, the rack and pinion assembly comprising: (1) an input section A deflection drive assembly comprising: (2) a rack and pinion assembly configured to convert the rotational motion of a pinion from a material into the linear motion of a rack to push a translation member distally or pull it proximally, or (3) a rack and pinion assembly configured to convert the linear motion of a rack from an input member into the rotational motion of a pinion to move a first end of a translation member proximally and a second end of a translation member distally; and (4) a lock assembly configured to transition between a locked configuration and an unlocked configuration, the lock assembly comprising a first lock feature portion and a second lock feature portion, the first and second lock feature portions configured to lock an end effector at an angle away from the longitudinal axis in the locked configuration, and the first and second lock feature portions configured to allow the end effector to move along a range of angles in the unlocked configuration. [Examples]

[0102] The apparatus according to Embodiment 27, wherein the locking assembly is sandwiched between the input member and the translational assembly, and the locking assembly is configured to prevent the translational assembly from translating along the longitudinal axis in the locking configuration. [Examples]

[0103] The apparatus according to Embodiment 28, wherein a first locking feature is located on a pinion, a second locking feature is located on a rack, the second locking feature is complementary to the first locking feature, the first and second locking features are configured to engage with each other in a locking configuration, and the first and second locking features are configured to be located at a certain distance from each other in an unlocking configuration. [Examples]

[0104] The apparatus according to one or more of Examples 27 to 30, wherein the first locking feature and the second locking feature are cylindrical. [Examples]

[0105] The apparatus according to Embodiment 30, wherein the first locking feature is a cylindrical pin, and the second locking feature is a cylindrical retaining element configured to receive the cylindrical pin in the locking configuration. [Examples]

[0106] A method for manufacturing a device, the device comprising: (a) a handle; (b) a catheter extending distally from the handle, the proximal portion of which defines a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector including at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, wherein the deflection drive assembly comprises: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; and (iii) a rack and pinion assembly coupled to the input member and the translation assembly, the rack and pinion assembly A method comprising a rack and pinion assembly comprising a rack and a pinion, the method comprising (a) manually acting an input member using rotational or linear motion, (b) transmitting the rotational motion of the input member to the pinion, or transmitting the linear motion of the input member to the rack, (c) using the rack and pinion assembly to convert the rotational motion of the pinion to subsequent linear motion of the rack, or converting the linear motion of the rack to subsequent rotational motion of the pinion, (d) transmitting the subsequent linear motion to a translational assembly, or transmitting the subsequent rotational motion to a translational assembly, and (e) using the translational assembly to deflect the end effector at a certain angle away from the longitudinal axis. [Examples]

[0107] The method according to Embodiment 32, further comprising locking the end effector at an angle such that it is away from the longitudinal axis in the locking configuration. [Examples]

[0108] A method for manufacturing a device, the device comprising: (a) a handle; (b) a catheter extending distally from the handle, the proximal portion of which defines a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; and (iii) a rack and pinion assembly coupled to the input member and the translation assembly. The rack and pinion assembly comprises a rack and a pinion, and the method comprises (a) inserting a pinion to engage with the rack at a first position configured for unidirectional end effector deflection, which is longitudinally spaced from a second position along the rack for bidirectional end effector deflection, or inserting a pinion to engage with the rack at a third position configured for bidirectional end effector deflection, which is longitudinally spaced from a fourth position along the rack for unidirectional end effector deflection, and (b) attaching a translation assembly to the rack and pinion assembly.

[0109] V. Others Any of the instruments described herein can be cleaned and sterilized before and / or after treatment. One sterilization technique involves placing the device in a sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electron beams. The radiation may kill bacteria on the device and within the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma rays, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization with or without gas plasma or steam.

[0110] It should be understood that any of the embodiments described herein may include a variety of other features in addition to or instead of those described above. For example, any of the embodiments described herein may include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0111] It should be understood that one or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the above teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various preferred ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included in the claims.

[0112] Any patents, publications, or other disclosures, in whole or in part, that are referred to as being incorporated by reference herein are incorporated only to the extent that the incorporated content does not conflict with any existing definitions, views, or other disclosures contained herein. Therefore, to the extent necessary, any disclosures expressly contained herein supersede any conflicting content incorporated by reference herein. Any content or part thereof that is referred to as being incorporated by reference but conflicts with any existing definitions, views, or other disclosures contained herein is incorporated only to the extent that it does not create a conflict between the incorporated content and the existing disclosures.

[0113] While various modifications of the present invention have been illustrated and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some of such possible modifications have been described, but other modifications will be obvious to those skilled in the art. For example, the embodiments, modifications, geometric shapes, materials, dimensions, proportions, steps, etc. described above are illustrative and not essential. Accordingly, it should be understood that the scope of the invention should be considered with respect to the following claims and is not limited to the details of the structure and operation shown and described herein and in the drawings.

[0114] [Implementation Method] (1) A device, (a) the handle and (b) A catheter extending distally from the handle, wherein the proximal portion of the catheter defines a longitudinal axis, (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode, (d) A deflection drive assembly configured to deflect the end effector away from the longitudinal axis, wherein the deflection drive assembly (i) an input member associated with the handle, (ii) A translation assembly coupled to the end effector, (iii) A rack and pinion assembly coupled to the input member and the translation assembly, wherein the rack and pinion assembly is configured to drive the translation assembly to deflect the end effector away from the longitudinal axis at a certain angle, and the rack and pinion assembly consists of a rack and a pinion, (1) Convert the rotational motion of the pinion from the input member into the linear motion of the rack, so as to push the translation member distally or pull it proximally, (2) The linear motion of the rack from the input member is converted into the rotational motion of the pinion, so that the first end of the translation member moves proximal and the second end of the translation member moves distal. The rack and pinion assembly is configured as follows: A deflection drive assembly including, A device that includes this. (2) The apparatus according to Embodiment 1, wherein the input member includes a rocker arm configured to rotate with respect to the handle about a drive shaft, and the rack and pinion assembly is configured to convert the rotational motion of the pinion from the rocker arm into the linear motion of the rack, thereby pushing the translational member distally or pulling it proximally. (3) The apparatus according to Embodiment 2, wherein the translational assembly further includes a push-pull cable coupled to the rack, and the deflection drive assembly is configured to transmit the linear motion of the rack to push the push-pull cable distally or pull the push-pull cable proximal. (4) The apparatus according to Embodiment 2, wherein the rocker arm and the pinion are coaxial with respect to the drive shaft. (5) The apparatus according to Embodiment 1, wherein the input member includes a linear slider configured to move longitudinally along the longitudinal axis, and the rack and pinion assembly is configured to convert the linear motion of the rack from the linear slider into the rotational motion of the pinion, thereby moving the first end of the translational member proximal and the second end of the translational member distal.

[0115] (6) The apparatus according to embodiment 5, wherein the linear slider is fixedly coupled to the rack and the pulley wheel is rotatably coupled to the pinion. (7) The apparatus according to Embodiment 1, wherein the translational assembly further includes a push-pull cable having a first portion and a second portion, and the deflection drive assembly is configured to transmit the rotational motion of the pinion to push the first portion of the push-pull cable distally and pull the second portion of the push-pull cable proximal. (8) The apparatus according to Embodiment 7, wherein the deflection drive assembly further includes a pulley wheel coaxial with the pinion of the rack and pinion assembly, the pulley wheel including an interface surface configured to contact the push-pull cable. (9) The apparatus according to Embodiment 1, further comprising a locking assembly sandwiched between the input member and the translational assembly, wherein the locking assembly is movable between a locked configuration and an unlocked configuration, and the locking assembly is configured to lock the end effector at the angle with respect to the longitudinal axis in the locked configuration. (10) The apparatus according to Embodiment 9, wherein the lock assembly includes a first lock feature portion and a second lock feature portion configured to transition between a locked configuration and an unlocked configuration, and the lock assembly is configured to prevent the translation assembly from translating along the longitudinal axis in the locked configuration.

[0116] (11) The apparatus according to Embodiment 10, wherein the first locking feature is located on the pinion, the second locking feature is located on the rack, the second locking feature is complementary to the first locking feature, the first locking feature and the second locking feature are configured to engage with each other in the lock configuration, and the first locking feature and the second locking feature are configured to be located at a certain distance from each other in the unlock configuration. (12) The apparatus according to embodiment 10, wherein the input member includes a rocker arm configured to rotate with respect to the handle about a drive shaft, the first locking feature is located on the rocker arm, and the second locking feature is movable on the handle. (13) The apparatus according to embodiment 10, wherein the input member includes a linear slider configured to translate relative to the handle along the longitudinal axis, the first locking feature being located on the linear slider, and the second locking feature being movable on the handle. (14) The apparatus according to embodiment 9, wherein the lock assembly further includes a biasing member configured to bias the rack away from the pinion and switch to the unlocked configuration. (15) The apparatus according to Embodiment 1, further comprising a locking assembly, the locking assembly including a first locking feature portion and a second locking feature portion configured to transition between a locked configuration and an unlocked configuration, wherein the first locking feature portion is located on the translational assembly and the second locking feature portion is selectively located on the handle.

[0117] (16) The apparatus according to Embodiment 1, wherein the translational assembly consists of a single push-pull cable, and the rack and pinion assembly is configured to drive the single push-pull cable in both directions. (17) The apparatus according to Embodiment 1, wherein the at least one electrode is configured to emit RF energy. (18) The apparatus according to Embodiment 1, wherein the at least one electrode is configured to perform electrophysiological mapping. (19) A device, (a) the handle and (b) A catheter extending distally from the handle, wherein the proximal portion of the catheter defines a longitudinal axis, (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode, (d) A deflection drive assembly configured to deflect the end effector away from the longitudinal axis, wherein the deflection drive assembly (i) an input member associated with the handle, (ii) A translation assembly coupled to the end effector, wherein the input member is configured to drive the translation assembly to deflect the end effector at an angle away from the longitudinal axis, (iii) A rack and pinion assembly coupled with the input member and the translation assembly, wherein the rack and pinion assembly consists of a rack and a pinion, (1) Convert the rotational motion of the pinion from the input member into the linear motion of the rack, so as to push the translation member distally or pull it proximally, (2) The linear motion of the rack from the input member is converted into the rotational motion of the pinion, so that the first end of the translation member moves proximal and the second end of the translation member moves distal. The rack and pinion assembly is configured as follows: A deflection drive assembly including, (e) A lock assembly configured to transition between a locked configuration and an unlocked configuration, the lock assembly comprising a first lock feature portion and a second lock feature portion, the first lock feature portion and the second lock feature portion configured to lock the end effector at an angle such that it is away from the longitudinal axis in the locked configuration, and the first lock feature portion and the second lock feature portion configured to allow the end effector to move along a range of angles in the unlocked configuration, A device equipped with the following features. (20) A method for manufacturing an apparatus, wherein the apparatus is (a) the handle and (b) A catheter extending distally from the handle, wherein the proximal portion of the catheter defines a longitudinal axis, (c) an end effector extending distally from the catheter, the end effector comprising at least one electrode, (d) A deflection drive assembly configured to deflect the end effector away from the longitudinal axis, wherein the deflection drive assembly (i) an input member associated with the handle, (ii) A translation assembly coupled to the end effector, (iii) A rack and pinion assembly coupled with the input member and the translation assembly, wherein the rack and pinion assembly comprises a rack and a pinion, The aforementioned method, (a) Inserting the pinion so as to engage with the rack at a first position configured for unidirectional end effector deflection, which is longitudinally spaced from a second position along the rack for bidirectional end effector deflection, or inserting the pinion so as to engage with the rack at a third position configured for bidirectional end effector deflection, which is longitudinally spaced from a fourth position along the rack for unidirectional end effector deflection, (b) attaching the translation assembly to the rack and pinion assembly, Methods that include...

Claims

1. 1. An apparatus comprising: (a) a handle; (b) a catheter extending distally from the handle, a proximal portion of the catheter defining a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector including at least one electrode; (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; (iii) a rack and pinion assembly coupled to the input member and the translation assembly, the rack and pinion assembly configured to drive the translation assembly to deflect the end effector away from the longitudinal axis at an angle, the rack and pinion assembly comprising a rack and a pinion, the rack and pinion assembly comprising: (1) converting rotational motion of the pinion from the input member into linear motion of the rack to push the translation member distally or pull it proximally; or (2) converting linear motion of the rack from the input member into rotational motion of the pinion to move a first end of the translation member proximally and a second end of the translation member distally; a rack and pinion assembly comprising: a deflection drive assembly including: An apparatus comprising:

2. 2. The device of claim 1, wherein the input member includes a rocker arm configured to rotate relative to the handle about a drive axis, and the rack and pinion assembly is configured to translate the rotational motion of the pinion from the rocker arm into the linear motion of the rack to push distally or pull proximally the translation member.

3. 3. The device of claim 2, wherein the translation assembly further includes a push-pull cable coupled to the rack, and the deflection drive assembly is configured to transfer the linear motion of the rack to either push the push-pull cable in a distal direction or pull the push-pull cable in a proximal direction.

4. The apparatus of claim 2 , wherein the rocker arm and the pinion are coaxial about the drive shaft.

5. 2. The device of claim 1, wherein the input member includes a linear slider configured to move longitudinally along the longitudinal axis, and the rack and pinion assembly is configured to translate the linear motion of the rack from the linear slider into the rotational motion of the pinion to move the first end of the translation member proximally and the second end of the translation member distally.

6. 6. The apparatus of claim 5, wherein the linear slider is fixably coupled to the rack and the pulley wheel is rotatably coupled to the pinion.

7. 2. The device of claim 1, wherein the translation assembly further includes a push-pull cable having a first portion and a second portion, and the deflection drive assembly is configured to transfer the rotational motion of the pinion to push the first portion of the push-pull cable in a distal direction and pull the second portion of the push-pull cable in a proximal direction.

8. 8. The apparatus of claim 7, wherein the deflection drive assembly further includes a pulley wheel coaxial with the pinion of the rack and pinion assembly, the pulley wheel including an interface surface configured to contact the push-pull cable.

9. 2. The apparatus of claim 1, further comprising a locking assembly interposed between the input member and the translating assembly, the locking assembly movable between a locked configuration and an unlocked configuration, the locking assembly configured to lock the end effector at the angle relative to the longitudinal axis in the locked configuration.

10. 10. The device of claim 9, wherein the locking assembly includes a first locking feature and a second locking feature configured to transition between a locked configuration and an unlocked configuration, the locking assembly configured to prevent the translating assembly from translating along the longitudinal axis in the locked configuration.

11. 11. The apparatus of claim 10, wherein the first locking feature is disposed on the pinion and the second locking feature is disposed on the rack, the second locking feature is complementary to the first locking feature, the first locking feature and the second locking feature are configured to engage one another in the locked configuration, and the first locking feature and the second locking feature are configured to be disposed a distance from one another in the unlocked configuration.

12. 11. The device of claim 10, wherein the input member includes a rocker arm configured to rotate relative to the handle about a drive axis, the first locking feature disposed on the rocker arm, and the second locking feature movable on the handle.

13. 11. The device of claim 10, wherein the input member includes a linear slider configured to translate relative to the handle along the longitudinal axis, the first locking feature disposed on the linear slider, and the second locking feature movable on the handle.

14. 10. The apparatus of claim 9, wherein the locking assembly further comprises a biasing member configured to bias the rack away from the pinion to the unlocked configuration.

15. 10. The device of claim 1, further comprising a locking assembly, the locking assembly including a first locking feature and a second locking feature configured to transition between a locked configuration and an unlocked configuration, the first locking feature being disposed on the translating assembly and the second locking feature being selectively disposed on the handle.

16. 2. The apparatus of claim 1, wherein the translation assembly comprises a single push-pull cable, and the rack and pinion assembly is configured to drive the single push-pull cable in both directions.

17. The device of claim 1 , wherein the at least one electrode is configured to emit RF energy.

18. The device of claim 1 , wherein the at least one electrode is configured to perform electrophysiological mapping.

19. 1. An apparatus comprising: (a) a handle; (b) a catheter extending distally from the handle, a proximal portion of the catheter defining a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector including at least one electrode; (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector, the input member configured to drive the translation assembly to deflect the end effector at an angle away from the longitudinal axis; and (iii) a rack and pinion assembly coupled to the input member and the translation assembly, the rack and pinion assembly comprising a rack and a pinion, the rack and pinion assembly comprising: (1) converting rotational motion of the pinion from the input member into linear motion of the rack to push the translation member distally or pull it proximally; or (2) converting linear motion of the rack from the input member into rotational motion of the pinion to move the first end of the translation member proximally and the second end of the translation member distally; a rack and pinion assembly comprising: a deflection drive assembly including: (e) a lock assembly configured to transition between a locked configuration and an unlocked configuration, the lock assembly including a first locking feature and a second locking feature configured to lock the end effector at the angle away from the longitudinal axis in the locked configuration, and the first locking feature and the second locking feature configured to allow the end effector to move along a range of angles in the unlocked configuration; and An apparatus comprising:

20. 1. A method of manufacturing a device, the device comprising: (a) a handle; (b) a catheter extending distally from the handle, a proximal portion of the catheter defining a longitudinal axis; (c) an end effector extending distally from the catheter, the end effector including at least one electrode; (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; (iii) a rack and pinion assembly coupled to the input member and the translation assembly, the rack and pinion assembly comprising a rack and a pinion; The method comprises: (a) inserting the pinion to engage the rack at a first position configured for unidirectional end effector deflection, longitudinally spaced from a second position along the rack for bidirectional end effector deflection, or inserting the pinion to engage the rack at a third position configured for bidirectional end effector deflection, longitudinally spaced from a fourth position along the rack for unidirectional end effector deflection; (b) attaching the translation assembly to the rack and pinion assembly; A method comprising:

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