Joint movement status indicator for maneuverable catheters

Abstract

To provide a guide sheath assembly. [Solution] The guide sheath assembly includes an elongated shaft and a control handle proximal to the elongated shaft. The control handle has a longitudinal axis and includes a control handle housing and at least one shuttle configured to translate along the longitudinal axis. The guide sheath assembly also includes at least one actuator element extending along at least one side of the elongated shaft and having a proximal end portion that responds to translation of at least one shuttle in at least the proximal direction. The guide sheath assembly further includes at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the articulation state of the elongated shaft based on the longitudinal position of at least one shuttle.

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 applying electrical energy to heart tissue, it may be possible to stop or modify the propagation of unwanted electrical signals from one part of the heart to another. Some such ablation treatments may include radiofrequency (RF) ablation with alternating current (AC) electrical energy and / or irreversible electroporation (IRE) with pulsed field direct current (DC) electrical energy. The ablation process can provide a barrier to unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the transmission of abnormal electrical signals across the ablated tissue.

[0002] In some procedures, a catheter having one or more electrodes can be used to provide ablation within a patient's body. The catheter can be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or within a structure adjacent to the heart (e.g., the pulmonary vein). One or more electrodes can be placed in contact with heart tissue or other vascular tissue and then activated with electrical energy to ablate the contacted tissue (e.g., via RF energy, IRE, etc.). 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. Perfusion can be used to draw heat away from components of the ablation catheter and prevent the formation of blood clots near the treatment site of the tissue.

[0003] Examples of ablation catheters include U.S. Patent No. 10,743,932, issued on August 18, 2020, entitled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens" (the disclosure thereof is incorporated herein by reference in its entirety); U.S. Patent No. 10,660,700, issued on May 26, 2020, entitled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly" (the disclosure thereof is incorporated herein by reference in its entirety); U.S. Patent No. 11,559,349, issued on January 24, 2023, entitled "Ablation Catheter with a Flexible Printed Circuit Board" (the disclosure thereof is incorporated herein by reference in its entirety); and "Catheter with Bipole Electrode Spacer and Related" issued on July 7, 2020. These methods are described in U.S. Patent No. 10,702,177, entitled “Methods” (the entire disclosure of which is incorporated herein by reference); U.S. Patent No. 10,130,422, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region,” issued on 20 November 2018 (the entire disclosure of which is incorporated herein by reference); U.S. Patent No. 8,956,353, entitled “Electrode Irrigation Using Micro-Jets,” issued on 17 February 2015 (the entire disclosure of which is incorporated herein by reference); and U.S. Patent No. 9,801,585, entitled “Electrocardiogram Noise Reduction,” issued on 31 October 2017 (the entire disclosure of which is incorporated herein 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 a sensing electrode on a catheter (e.g., the same catheter used to perform the ablation, or a dedicated mapping catheter). Such a sensing electrode can monitor electrical signals emanating from conductive endocardial tissue to pinpoint the location of abnormal conductive tissue sites causing arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, entitled "Cardiac Electromechanics," issued on April 14, 1998 (the disclosure thereof is incorporated herein by reference in its entirety). Examples of EP mapping catheters are described in U.S. Patent No. 9,907,480, entitled "Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes," issued on March 6, 2018 (the disclosure thereof is incorporated herein by reference in its entirety); U.S. Patent No. 10,130,422, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," issued on November 20, 2018 (the disclosure thereof is incorporated herein by reference in its entirety); and U.S. Patent No. 10,702,177, entitled "Catheter with Bipole Electrode Spacer and Related Methods," issued on July 7, 2020 (the disclosure thereof is incorporated herein by reference in its entirety).

[0005] Some catheter ablation procedures may be performed using image-guided surgery (IGS) systems. IGS systems may allow physicians to visually track the position of the catheter in 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 provide 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, and in various other references cited herein, the entire disclosure of which is incorporated herein by reference.

[0006] 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]

[0007] 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 diagram illustrates a schematic representation of the medical procedure involving the insertion of a catheter assembly into a patient. [Figure 2] A top view of an example of a guide sheath including a control handle is shown. [Figure 3] Figure 2 shows a longitudinal cross-sectional view of the control handle. [Figure 4] Figure 2 shows an exploded perspective view of the control handle with the housing removed. [Figure 5A]Figure 2 shows a longitudinal side cross-sectional view of another embodiment of a control handle having a push-button switch to indicate the articulated state of the guide sheath, which can be used with the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 5B] Figure 5A shows a longitudinal side cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 5C] Figure 5A shows a longitudinal side cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 6A] Figure 2 shows a longitudinal side cross-sectional view of another embodiment of a control handle having a double push-button switch to indicate the articulated state of the guide sheath, which can be used with the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 6B] Figure 6A shows a longitudinal side cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 6C] Figure 6A shows a longitudinal side cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 7] Figure 6A shows a perspective view of the shuttle. [Figure 8A] Figure 2 shows a longitudinal top cross-sectional view of another embodiment of a control handle having an optical proximity sensor for indicating the articulated movement state of the guide sheath, which may be used with the guide sheath, and shows the first shuttle of the control handle positioned to place the guide sheath in a neutral configuration (the second shuttle of the control handle is omitted). [Figure 8B] Figure 8A shows a longitudinal top cross-sectional view of the control handle, illustrating the first shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 8C]Figure 8A shows a longitudinal top cross-sectional view of the control handle, illustrating the first shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 9A] Figure 2 shows a longitudinal top cross-sectional view of another embodiment of a control handle, which may be used with the guide sheath and has a dual optical proximity sensor to indicate the articulated state of the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 9B] Figure 9A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 9C] Figure 9A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 10A] Figure 2 shows a longitudinal top cross-sectional view of another embodiment of a control handle having a reed switch to show the articulated state of the guide sheath, which can be used with the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 10B] Figure 10A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 10C] Figure 10A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 11A] Figure 2 shows a longitudinal top cross-sectional view of another embodiment of a control handle, which may be used with the guide sheath and has a dual reed switch to show the articulated state of the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 11B] Figure 11A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 11C] Figure 11A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 12A] Figure 2 shows a partial perspective view of another embodiment of a control handle having a dual stop contact sensor to indicate the articulated state of the guide sheath, which can be used with the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 12B] Figure 12A shows a partial perspective view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 12C] Figure 12A shows a partial perspective view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 13A] Figure 2 shows a longitudinal top cross-sectional view of another embodiment of a control handle, which may be used with the guide sheath and has a flexible sensor assembly for indicating the articulated state of the guide sheath, and shows the shuttle of the control handle positioned to place the guide sheath in a neutral configuration. [Figure 13B] Figure 13A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the first deflection configuration. [Figure 13C] Figure 13A shows a longitudinal top cross-sectional view of the control handle, illustrating the shuttle of the control handle positioned to place the guide sheath in the second deflection configuration. [Figure 14A] A schematic diagram of a graphical user interface that may be presented by the display in Figure 1 is shown, based on one or more signals generated using any of the control handles in Figures 5A to 13C, when the guide sheath is in a neutral configuration. [Figure 14B]Depict a schematic diagram of a graphical user interface that can be presented by the display of FIG. 1 based on one or more signals generated using any of the control handles of FIGS. 5A to 13C when the guide sheath is in a deflected configuration.

Best Mode for Carrying Out the Invention

[0008] The following description of specific embodiments of the present invention should not be used to limit the scope of the present invention. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the present invention. The detailed description is illustrative, not limiting, and is presented by way of example to illustrate the principles of the present invention. Other embodiments, features, aspects, embodiments, and advantages of the present 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 present invention by way of illustration. As will be recognized, the present invention is capable of other different aspects or equivalent aspects without departing from the present invention. Therefore, the drawings and description should be regarded as illustrative in nature and not limiting.

[0009] Any one or more of the teachings, expressions, variations, embodiments, etc. described herein may be combined with any one or more of the other teachings, expressions, variations, embodiments, etc. described herein. Therefore, the teachings, expressions, variations, embodiments, etc. described below should not be considered in isolation from one another. 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.

[0010] Where used herein, the terms “about” or “approximately” for any numerical value or range of numerical values ​​indicate a preferred dimensional tolerance that enables some or a set of components to function for the intended purpose described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the enumerated values; for example, “about 90%” may refer to a range of values ​​between 71% and 99%. In addition, where used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject, and while the use of the present invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0011] I. Overview of Catheter System Implementation Examples Figure 1 shows an exemplary medical procedure and associated components of a cardiac catheter system that can be used to perform EP mapping or cardiac ablation as described above. Specifically, Figure 1 shows a physician (PH) grasping the handle assembly (110) of a catheter assembly (100), and the end effector of the catheter (not shown) of the catheter assembly (100) is positioned within the patient (PA) to map the potentials of tissues within or near the heart (H) of the patient (PA) and / or ablate the tissues.

[0012] The catheter assembly (100) is connected to the induction drive system (10) via a cable (30). The catheter assembly (100) is also connected to the fluid source (42) via a fluid conduit (40). A pair of magnetic field generators (20) are positioned below the patient (PA) and connected to the induction drive system (10) via another cable (22). The magnetic field generators (20) are simply optional.

[0013] 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 electrodes of an end effector. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby performs EP mapping known in the art. In some other modifications, the end effector includes other electrodes configured to provide EP mapping signals. In yet another modification, the end effector does not provide EP mapping.

[0014] The first driver module (14) of this embodiment is further operable to supply power to the electrodes of the end effector, as will be described in more detail below, thereby ablating tissue. In some other modifications, the end effector includes other electrodes configured to provide ablation. In yet another modification, the end effector does not provide ablation.

[0015] A second driver module (16) is coupled to a magnetic field generator (20) via a cable (22). The second driver module (16) is operable to activate the magnetic field generator (20) to generate an alternating magnetic field around the patient's (PA) heart (H). 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).

[0016] The first driver module (14) is also operable to receive position indication signals from a catheter navigation sensor assembly (not shown) near the end effector. In such a modification, the console (12) processor is also operable to process the position indication signals from the navigation sensor assembly and thereby determine the position of the end effector within the patient (PA). In some modifications, the navigation sensor assembly includes two or more coils operable to generate signals indicating the position and orientation of the end effector 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 associated with the end effector include radio triangulation, acoustic tracking, optical tracking, and inertial tracking. Although the navigation sensor assembly is shown as being located at the distal end of the catheter, the navigation sensor assembly may instead be located at the end effector. Alternatively, the catheter and end effector may lack a navigation sensor assembly.

[0017] The display (18) is coupled to the processor of the console (12) and is operable to render images of the patient's anatomical structure. Such images are obtained based on a set of images (e.g., CT scan or MRI scan, 3D map, etc.) acquired preoperatively or during surgery. The view of the patient's anatomical structure provided through the display (18) may also change dynamically based on signals from the end effector's navigation sensor assembly. For example, as the catheter's end effector moves within the patient (PA), the corresponding position data from the navigation sensor assembly may cause the console (12) processor to update the view of the patient's anatomical structure on the display (18) in real time to depict the area of ​​the patient's anatomical structure around the end effector as the end effector moves within the patient (PA). Furthermore, the console (12) processor can drive the display (18) to indicate the location of abnormal conductive tissue sites, as detected by electrophysiological (EP) mapping using the end effector, or by other means (e.g., using a dedicated EP mapping catheter). As just one example, the processor of the console (12) 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 representation of abnormal conductive tissue sites.

[0018] The console (12) processor also drives the display (18) to overlay the current position of the end effector onto an image of the patient's anatomical structure by superimposing an illuminated point, crosshairs, a graphic representation of the end effector, or other form of visual display. Such superimposed visual display can also move in real time within the image of the patient's anatomical structure on the display (18) as the physician moves the end effector within the patient (PA), thereby providing the operator with real-time visual feedback on the position of the end effector within the patient (PA) as the end effector moves within the patient (PA). Thus, the images provided via the display (18) can effectively provide video tracking the position of the end effector within the patient (PA) body without necessarily having optical equipment (i.e., a camera) to view the end effector. In the same view, the display (18) can simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Therefore, the physician (PH) can view the display (18) and observe the real-time positioning of the end effector in relation to the mapped abnormal conductive tissue area and images of adjacent anatomical structures within the patient (PA).

[0019] 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). Such irrigation fluid may be discharged through an opening (not shown) in the end effector. Such irrigation can be carried out in any preferred manner that is apparent to those skilled in the art in light of the teachings herein.

[0020] II. Examples of Guide Sheath Assemblies In some procedures, the physician (PH) may wish to introduce the catheter into the patient (PA) via a delivery sheath (also called a guide sheath). In some such procedures, the delivery sheath may be inserted into the patient (PA) (e.g., through the patient's leg or groin) and then advanced along a vein or artery to reach a position within or near the heart (H). Once the delivery sheath is suitably positioned within the patient (PA), the physician (PH) may then advance the end effector and catheter into the delivery sheath. Once the end effector is suitably positioned near the target structure, the delivery sheath may be retracted relative to the end effector (or the end effector may be advanced relative to the delivery sheath). In some examples, the end effector may then be expanded by inflating the balloon of the end effector to bring the electrode into contact with the tissue of the target structure. In addition to or instead of this, one or more elastic mechanisms of the end effector may bias the end effector from a non-expanded state to an expanded state. Once the end effector is in the expanded state, the physician (PH) may then manipulate the catheter assembly (100) to perform EP mapping, ablation, or any other type of operation within or near the heart (H) of the patient (PA). The end effector may then be folded into a non-expanded configuration by compressing the balloon and / or otherwise deflating the end effector in order to retract it through the delivery sheath.

[0021] Figures 2–4 show an example of a guide sheath assembly (210) that may be used in such a procedure. The guide sheath assembly (210) includes an elongated flexible sheath (212) and a control handle (216) proximal to the sheath (212). The sheath (212) includes a proximal portion (213) and a distal deflection portion (214). The control handle (216) may be connected to an electrical connector (217) for transmitting electrical signals sensed by one or more ring electrodes supported on the sheath (212), for example, including the deflection portion (214). As shown in Figure 2, the control handle (216) is also fitted with a hemostatic valve (218) configured to receive a catheter (not shown) that can be advanced through the central lumen (222) of the guide sheath assembly (210) (Figure 2). The hemostatic valve (218) also has a side port (221) that terminates with a Luer hub, such as a two-way stopcock (223), for connecting to one or more fluid sources (not shown) to supply fluid through the lumen (222) into the lumen (222) of the guide sheath assembly (210).

[0022] As shown in Figures 3 and 4, the control handle (216) includes an elongated, substantially cylindrical body (224) having a narrower distal portion, i.e., a shaft portion (225), and a distal rotation control knob (226) attached to the distal shaft portion (225). The body (224) has an outer shell half-member formed to define an internal volume (V), the edges (251) of which are aligned along a longitudinal seam. The distal shaft portion (225) of the body (224) has a smaller outer diameter (D1) compared to the outer diameter (D2) of the proximal portion of the body (224). The control knob (226) is configured to be rotated by the user's thumb and index finger when the user grasps the body (224) of the control handle (216). To enable deflection of the deflection portion (214) of the guide sheath (212) by the first puller wire (230A) and the second puller wire (230B), the control handle (216) includes a rotary shaft (231), a first shuttle (232A), a second shuttle (232B), and a pinion (234) within its internal volume (V). The rotary shaft (231) drives the first shuttle (232A) in response to the control knob (226) to move linearly in a first direction along the longitudinal axis (255), and the pinion (234) connects the second shuttle (232B) to the first shuttle (232A), so that the second shuttle (232B) moves linearly along the longitudinal axis in a second direction opposite to the first direction. Since the proximal ends of the first puller wire (230A) and the second puller wire (230B) are fixed to, or at least coupled to, the first shuttle (232A) and the second shuttle (232B), respectively, the linked, opposite translational motion of the first and second shuttles acts on the first puller wire (230A) and the second puller wire (230B) to cause bidirectional deflection of the deflection portion (214) of the guide sheath (212).

[0023] The rotary shaft (231) has a main proximal portion (236) having an outer diameter (D3), a shorter distal portion (237) having an outer diameter (D4), and a stepped connection portion (J) between the proximal portion (236) and the distal portion (237). At its proximal end, the rotary shaft (231) is connected to and fixed to the body (224) by a proximal-outer circumferential lip (238) that engages with an inner circumferential slot defined between circumferential flanges (240) formed within the internal volume (V) of the body 224. The rotary shaft (231) is hollow and has an internal passage (242). The passage (242) is threaded and has a diameter such that it accommodates both the guide sheath (212) and the shuttles (232A, 232B) that circumferentially surround the guide sheath (212), as will be described in more detail below.

[0024] The control knob (226) is attached to the distal shaft portion (225) and the rotary shaft (231) of the body (224) of the control handle (216), and has a main proximal portion (246) and a short distal end portion (247). The control knob (226) is substantially cylindrical in shape, having a hollow interior in the longitudinal direction that extends throughout its entire length.

[0025] To rotatably couple the rotary shaft (231) to the control knob (226) (for the common rotational motion of the rotary shaft (231) and the control knob (226)), the outer surface of the distal portion of the shaft (231) has a longitudinal protrusion (270) (Figure 4) that is received into and engages with a corresponding longitudinal recess (271) (Figure 3) formed on the inner surface of the control knob (226). To fix the control knob (226) to the rotary shaft (231) and therefore to the body (224) in a translationally symmetric manner (for the common translational motion of the control knob (226) and the rotary shaft (231)), the outer surface of the shaft (231) also has one or more linear slots (274) oriented perpendicular to the longitudinal axis of the rotary shaft (231). Each slot (274) may be aligned with a hole (276) (Figure 4) formed through the side of the distal end portion (247) of the control knob (226), thereby connecting the control knob (226) and the rotary shaft (231) for common translational motion by inserting each pin (277) into the hole (276) and slot (274).

[0026] As shown in Figure 4, the shuttles (232A, 232B) have similar structures to each other and can be understood as being approximately mirror images of the other. The first shuttle (232A) is driven by a rotary shaft (231), and the second shuttle (232B) is driven by the first shuttle (232A) via a pinion (234) positioned between the shuttles. Each shuttle (232A, 232B) has an elongated body with a distal portion (280A, 280B) having a C-shaped end cross-section, and a proximal rack portion (290A, 290B) with multiple teeth (292) arranged longitudinally. The first shuttle (232A) and the second shuttle (232B) are configured to face each other and engage with a pinion (234), so that the distal portion (280A) and distal portion (280B) can form a cylindrical shape with an outer surface that fits into the screw passage (242) and an inner surface that defines a passage (293) through which the guide sheath (212) passes. The rack portions (290A, 290B) of each shuttle (232A, 232B) face each other with a pinion (234) in between, so that the teeth (292) of each rack portion (290A, 290B) can engage with the teeth of the pinion (234), which is mounted to rotate about an axis perpendicular to the longitudinal axis (255) of the control handle (216).

[0027] Referring to Figures 3 and 4, the outer surface of the distal portion (280A) of the first shuttle (232A) is provided with an outer or male threaded surface (285). The inner circumferential surface of the rotary shaft (231) is provided with an inner or female threaded surface (286) that receives the male threaded surface (285) of the first shuttle (232A) (Figure 3), thereby coupling the first shuttle (232A) and the rotary shaft (231), and converting the rotational motion of the rotary shaft (231) into the translational motion of the first shuttle (232A). Therefore, when the user rotates the control knob (226) in the first direction, the rotary shaft (231), which is rotatably coupled to the control knob (226) via the longitudinal ridge (270) (for common rotational motion), also rotates. With the rotary shaft (231) rotatably and translatably locked to a control knob (226) via longitudinal protrusions (270) and one or more pins (277) (for common rotational and common translational motion), the rotation of the shaft (231) drives a first shuttle (232A) to translate along the longitudinal axis in a first direction (e.g., proximal direction). As the first shuttle (232A) translates, its teeth (292) drive a pinion (234) to rotate in a first direction (e.g., clockwise), and the pinion (234) drives a second shuttle (232B) to translate along the longitudinal axis (255) in a second direction opposite to the first direction (e.g., distal direction). In this configuration, the male threaded surface (285) and the female threaded surface (286) convert the rotational motion of the control knob (226) into the linear motion of the shuttles (232A, 232B). The proximal ends of the first puller wire (230A) and the second puller wire (230B) are fixed, coupled to, or otherwise responsive to, the first shuttle (232A) and the second shuttle (232B), respectively, so that the linear and reverse motion of the shuttles (232A, 232B) acts on the puller wires (230A, 230B) to cause bidirectional deflection of the deflection portion (214) of the guide sheath (212). In the shown embodiment, the proximal ends of the puller wires (230A, 230B) are coupled to the rack portions (290A, 290B) of the shuttles (232A, 232B), respectively.Therefore, when one puller wire (230A, 230B) is pulled proximal under tension by its respective shuttle (232A, 232B), the other puller wire (230A, 230B) is simultaneously released from tension by its respective shuttle (232A, 232B) moving distally.

[0028] As shown in Figure 3, the proximal end portions of each puller wire (230A, 230B) extend outside the sheath (212) within the respective longitudinal channels (288A, 288B) formed in the proximal rack portions (290A, 290B) of each shuttle (232A, 232B). As shown in Figure 4, each puller wire (230A, 230B) has a stopper (289A, 289B), such as a hypotube, fixed to its proximal end. By positioning these stoppers proximal to the proximal ends (287A, 287B) of the respective rack sections (290A, 290B), when the shuttle (232A, 232B) moves proximal, each rack section (290A, 290B) pushes or otherwise acts on its respective stopper (289A, 289B), allowing each puller wire (230A, 230B) to be pulled proximal. When the shuttle (232A, 232B) moves distal, the proximal ends of the respective rack sections (290A, 290B) disengage from their respective stoppers (289A, 289B), releasing each puller wire (230A, 230B) from tension. It will be understood that each stopper (289A, 289B) may be embedded in or otherwise fixed to any part of each rack section (290A, 290B) or each shuttle (232A, 232B) in order to deflect the sheath (212).

[0029] Since the first shuttle (232A) and the second shuttle (232B) move in opposite directions along the longitudinal axis (255), the initial positioning of the shuttles (232A, 232B) relative to each other and to the passage (242) is performed when the control handle (216) is assembled. For example, as shown in Figure 3, when the shuttles (232A, 232B) are positioned in the passage (242) of the rotary shaft (231) such that they are at the same height as each other along the longitudinal axis (255), the distal end of each shuttle is positioned approximately midway along the passage (242), so that each shuttle (232A, 232B) has enough space to move in the proximal or distal direction within the rotary shaft (231). In a nearly neutral guide sheath with little deflection, the stop sections (289A, 289B) may be positioned relative to each shuttle (232A, 232B) such that the tension acting on each puller wire (230A, 230B) is minimized or uniform. In such a configuration, the shuttles (232A, 232B) have a "neutral" initial configuration, meaning that the user may uniformly deflect the guide sheath (212) from there in two directions.

[0030] As merely a further example, the guide sheath assembly (210) may be constructed and made operational in accordance with at least a portion of the teachings of U.S. Patent No. 10,653,860, published May 19, 2020, entitled “Steerable Guiding Sheath with Rack and Pinion Deflection Mechanism,” the disclosure of which is incorporated herein by reference. In some modifications, the guide sheath assembly (210) may be configured and made operational as the CARTO VIZIGO® two-way delivery sheath by Biosense Webster, Inc. (Irvine, California).

[0031] IV. Example of a control handle with a joint movement state indicator In some procedures, it may be desirable to provide the operator with a real-time display of the articular movement (e.g., deflection) of the guide sheath (212) (and / or the catheter placed therein). For example, to avoid trauma to the patient's heart (H) that could be caused by retracting the guide sheath (212) while it is deflected, it may be desirable for the operator to confirm that the guide sheath (212) is in a neutral configuration before retracting it from the patient's heart (H) (e.g., from the fossa ovale of the patient's heart (H) and / or from the transseptal foramen of the patient's heart (H)). However, during some procedures, the operator may want to continuously view the display (18) to continuously observe the real-time positioning of the end effector, catheter, and / or guide sheath (212) in relation to mapped abnormal conductive tissue sites and / or images of adjacent anatomical structures within the patient (PA). Therefore, it may be desirable to provide the operator with a real-time display of the joint movement state of the guide sheath (212) via the display (18), enabling the operator to observe the real-time display of the joint movement state of the guide sheath (212) substantially simultaneously with observing the real-time positioning of the end effector, catheter, and / or guide sheath (212). In this regard, it will be understood that by providing the operator with a real-time display of the joint movement state of the guide sheath (212) via the display (18), it may be possible for the operator to observe the real-time display of the joint movement state of the guide sheath (212) without having to divert their attention from the display (18).

[0032] A. Embodiment of a control handle having a single push-button switch Figures 5A to 5C show an example of a control handle (310) that may be incorporated into the guide sheath assembly (210) instead of the control handle (216) and may provide at least some, if not all, of the features and functions described above. The control handle (310) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (310) in this embodiment includes an elongated, substantially cylindrical body (312) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal axis of the body (312). As shown, the control handle (310) also includes a pair of shuttles (314) (one shown) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of one shuttle (314) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (314) to each other via their respective teeth (316), thereby driving the longitudinal translation of the other shuttle (314) in the opposite direction.A stopper (also called a ferrule) (318) (one shown), similar to the stoppers (289A, 289B) described above, is fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., a band, rod, etc.), and the proximal end (319) of the corresponding shuttle (314) is positioned so that when each shuttle (314) moves proximal from the neutral position (Figure 5A) toward the proximal position (Figure 5B), each shuttle (314) pushes or acts on its respective stopper (318) to pull its respective puller wire in the proximal direction. Positioned in the direction of the shuttle (314), as the shuttle (314) is moved distally from the proximal position (Figure 5B) toward the neutral position (Figure 5A), each stop (318) may move distally with the shuttle (314) as tension is released in its respective puller wire. As the shuttle (314) is moved distally from the neutral position (Figure 5A) toward the distal position (Figure 5C), the proximal end (319) of the shuttle (314) disengages from contact with its respective stop (318), releasing tension in its respective puller wire, and as a result, each stop (318) may remain stationary in its own neutral position. Thus, the control handle (310) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0033] The control handle (310) in this embodiment further includes a deflection sensor assembly (320) configured to generate one or more signals indicating the joint movement state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (320) includes a printed circuit board (PCB) (322) securely fixed to the body (312), and a tactile switch (323) including a push button (324) movably mounted on the PCB (322) such that the push button (324) can be operated from a non-operated state (Figures 5B-5C) to an operated state (Figure 5A). In this regard, one shuttle (314) (for example, a shuttle (314) directly driven by a rotary shaft) includes an actuation member in the form of a projection (330), and a push button (324) is positioned along the translational path of the projection (330), so that the projection (330) selectively acts on the push button (324) by selectively engaging with it.

[0034] More specifically, the projection (330) in this embodiment is positioned at a predetermined location along the length of the shuttle (314), so that when the shuttles (314) are at the same height relative to each other in the longitudinal direction, the projection (330) aligns with (for example, vertically) the push button (324) and engages with it to position the guide sheath (212) in a neutral configuration, so that when the shuttles (314) are moved proximal and distal relative to each other, the projection (330) shifts (for example vertically) from the push button (324), disengages, and positions the guide sheath (212) in a deflected configuration. Thus, one or more signals generated by the deflection sensor assembly (320) may indicate whether the guide sheath (212) is in a neutral configuration or a deflected configuration. In some cases, the engagement and / or disengagement of the projection (330) and the push button (324) may generate tactile and / or audible feedback (e.g., a "click" sound) indicating the articulation state of the guide sheath (212).

[0035] The deflection sensor assembly (320) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (320). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (320) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of the console (12) may be operable to determine that the guide sheath (212) is currently in a neutral configuration in response to receiving a signal from the deflection sensor assembly (320) indicating that the push button (324) is currently engaged by the projection (330), and may be operable to determine that the guide sheath (212) is currently in a deflected configuration in response to not receiving a signal from the deflection sensor assembly (320) (indicating that the push button (324) is currently disengaged from the projection (330)). The processor of the console (12) may further be operable to provide a real-time visual display of the joint movement state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0036] In one example of use, the guide sheath (212) may initially be in a neutral configuration, resulting in the projection (330) aligning with and engaging with the push button (324), as shown in Figure 5A, and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration. Subsequently, the guide sheath (212) may be articulated to a first deflected configuration, as shown in Figure 5B, such that the projection (330) is near the push button (324) and disengaged from the push button (324), and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is deflected. In addition, or alternatively, the guide sheath (212) may be articulated to a second deflection configuration, as shown in Figure 5C, such that the projection (330) is distal to the push button (324) and disengaged from the push button (324), and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is deflected. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, as shown in Figure 5A, so that the projection (330) is aligned with and engaged with the push button (324), and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0037] B. Embodiment of a control handle having a double push-button switch Figures 6A to 7 show an example of a control handle (410) that may be incorporated into the guide sheath assembly (210) instead of the control handle (216) and may provide at least some, if not all, of the features and functions described above. The control handle (410) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (410) in this embodiment includes an elongated, substantially cylindrical body (412) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal axis of the body (412). As shown, the control handle (410) also includes a pair of shuttles (414) (one shown) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of one shuttle (414) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (414) to each other via their respective teeth (416), thereby driving the longitudinal translation of the other shuttle (414) in the opposite direction.A stopper (also called a ferrule) (418) (one shown), similar to the stoppers (289A, 289B) described above, is fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., a band, rod, etc.), and is positioned proximal to the proximal end (419) of each shuttle (414) so ​​that when the corresponding shuttle (414) moves proximal from the neutral position (Figure 6A) toward the proximal position (Figure 6B), each shuttle (414) pushes or otherwise acts on its respective stopper (418) so that the respective puller wire can be pulled in the proximal direction. As the shuttle (414) is positioned and moved distally from a proximal position (Figure 6B) toward a neutral position (Figure 6A), each stop (418) may move distally with the shuttle (414) as tension is released in its respective puller wire. When the shuttle (414) is moved distally from a neutral position (Figure 6A) toward a distal position (Figure 6C), the proximal end (419) of the shuttle (414) disengages from contact with its respective stop (418), releasing tension in its respective puller wire, and as a result, each stop (418) may remain stationary in its own neutral position. Thus, the control handle (410) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0038] The control handle (410) in this embodiment further includes a deflection sensor assembly (420) configured to generate one or more signals indicating the joint motion state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (420) includes a printed circuit board (PCB) (422) securely fixed to the body (412), and first and second lateral adjacent tactile switches (423a, 423b) including a first lateral adjacent push button (424a, 424b) movably mounted on the PCB (422), thereby enabling the first push button (424a) to be actuated from a non-actuated state (Figures 6B-6C) to an actuated state (Figure 6A), and the second push button (424b) to be actuated from a non-actuated state (Figure 6C) to an actuated state (Figures 6A-6B). In this regard, one shuttle (414) (for example, a shuttle (414) directly driven by a rotary shaft) includes a first actuation member in the form of a projection (430) and a second actuation member in the form of an elongated ridge (432), wherein a first push button (424a) is positioned along the translational path of the projection (430) such that the projection (430) selectively engages with the push button (424a) to selectively actuate the first push button (424a), and a second push button (424b) is positioned along the translational path of the elongated ridge (432) such that the elongated ridge (432) selectively engages with the second push button (424b) to selectively actuate the second push button (424b).

[0039] More specifically, the projection (430) in this embodiment is positioned at a predetermined location along the length of the shuttle (414), so that when the shuttles (414) are at the same height relative to each other in the longitudinal direction, the projection (430) aligns with (e.g., vertically) the first push button (424a) and engages with it to position the guide sheath (212) in a neutral configuration, so that when the shuttles (414) are moved proximal and distal to each other, the projection (430) shifts (e.g., vertically) from the first push button (424a) and disengages with it to position the guide sheath (212) in a deflected configuration. In some cases, the engagement and / or disengagement of the projection (430) with the first push button (424a) may generate tactile and / or audible feedback (e.g., a "click" sound) indicating the articulation state of the guide sheath (212).

[0040] Furthermore, the elongated protrusion (432) of this embodiment is positioned at a predetermined location along the length of the shuttle (414), so that at least a portion of the elongated protrusion (432) engages with the second push button (424b) when the shuttles (414) are at the same height to each other in the longitudinal direction, positioning the guide sheath (212) in a neutral configuration, so that the first shuttle of the shuttle (414) moves proximal and the second shuttle of the shuttle (414) moves distal. The guide sheath (212) is configured to be positioned in a deflection configuration deflected in a first direction (e.g., to the right), and the elongated protrusion (432) is configured to disengage (e.g., vertically) from the second push button (424b) when the first shuttle of the shuttle (414) is moved distally and the second shuttle of the shuttle (414) is moved proximal to position the guide sheath (212) in a deflection configuration deflected in a second direction (e.g., to the left). Thus, in addition to indicating whether the guide sheath (212) is in a neutral configuration or a deflection configuration, one or more signals generated by the deflection sensor assembly (420) may indicate the direction of deflection when the guide sheath (212) is in a deflection configuration. In some cases, the engagement and / or disengagement of the elongated protrusion (432) and the second push button (424b) may generate tactile and / or audible feedback (e.g., a "click" sound) indicating the articulation state of the guide sheath (212).

[0041] The deflection sensor assembly (420) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (420). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (420) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of the console (12) may be able to operate to determine that the guide sheath (212) is currently in a neutral configuration in response to receiving signals from the deflection sensor assembly (420) indicating that the push buttons (424a, 424b) are currently engaged by the projection (430) and the elongated ridge (432), respectively, from the deflection sensor assembly (420) that the first push button (424a) is currently disengaged from the projection (430) and the second push button (424b) is currently engaged by the elongated ridge (432). In response to receiving a signal indicating engagement, the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a first direction (e.g., to the right), and in response to not receiving a signal from the deflection sensor assembly (420) (indicating that the push buttons (424a, 424b) are currently disengaged from the projection (430) and the elongated protrusion (432), respectively), the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a second direction (e.g., to the left). The processor of the console (12) may further be operable to provide a real-time visual display of the joint movement state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0042] In one example of use, the guide sheath (212) may initially be in a neutral configuration, resulting in the projection (430) aligning and engaging with the first push button (424a), and at least a portion of the elongated ridge (432) aligning and engaging with the second push button (424b), as shown in Figure 6A, allowing the operator to observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration. The guide sheath (212) can then be articulated into a first deflection configuration in which the guide sheath (212) is deflected in a first direction (e.g., to the right), so that the projection (430) is proximal to and disengaged from the first push button (424a), and at least a portion of the elongated protrusion (432) is aligned with and engaged with the second push button (424b), as shown in Figure 6B, so that the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the first direction. In addition, or alternatively, the guide sheath (212) may be articulated into a second deflection configuration in which the guide sheath (212) is deflected in a second direction (e.g., to the left), as shown in Figure 6C, such that the projection (430) is distal to the first push button (424a) and disengaged from there, and the elongated ridge (432) is distal to the second push button (424b) and disengaged from there, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the second direction. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, so that, as shown in Figure 6A, the projection (430) is aligned and engages with the first push button (424a), and at least a portion of the elongated protrusion (432) is aligned and engages with the second push button (424b), allowing the operator to observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0043] C. Example of a control handle having a single optical proximity sensor Figures 8A to 8C show an example of a control handle (510) that may be incorporated into the guide sheath assembly (210) instead of the control handle (216) and may provide at least some, if not all, of the features and functions described above. The control handle (510) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (510) in this embodiment includes an elongated, substantially cylindrical body (512) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal shaft of the body (512). As shown, the control handle (510) also includes a pair of shuttles (514) (one shown) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of one shuttle (514) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (514) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the other shuttle (514) in the opposite direction.A stopper (also called a ferrule) (518) (one shown), similar to the stoppers (289A, 289B) described above, is fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., a band, rod, etc.), and the proximal end (519) of each shuttle (514) is positioned so that when the corresponding shuttle (514) moves proximal from the neutral position (Figure 8A) toward the proximal position (Figure 8B), each shuttle (514) pushes or acts on its respective stopper (518) in any way, thereby pulling its respective puller wire in the proximal direction. Positioned in the direction of the shuttle (514), as the shuttle (514) is moved distally from the proximal position (Figure 8B) toward the neutral position (Figure 8A), each stop (518) may move distally with the shuttle (514) as tension is released in its respective puller wire. As the shuttle (514) is moved distally from the neutral position (Figure 8A) toward the distal position (Figure 8C), the proximal end (519) of the shuttle (514) disengages from contact with its respective stop (518), releasing tension in its respective puller wire, and as a result, each stop (518) may remain stationary in its own neutral position. Thus, the control handle (510) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0044] The control handle (510) in this embodiment further includes a deflection sensor assembly (520) configured to generate one or more signals indicating the joint motion state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (520) includes a proximity sensor in the form of an optical proximity sensor (524) that is firmly fixed to the body (512). In this regard, one shuttle (514) (e.g., a shuttle (514) directly driven by a rotary shaft) includes a marker member in the form of a projection (530), the field of view of the optical proximity sensor (524) intersects (e.g., is perpendicular) with the translational path of the projection (530), and as a result the projection (530) is configured to selectively trigger the optical proximity sensor (524) by selectively crossing the field of view of the optical proximity sensor (524).

[0045] More specifically, the projection (530) in this embodiment is positioned at a predetermined location along the length of the shuttle (514), so that when the shuttles (514) are at the same height relative to each other in the longitudinal direction, the projection (530) aligns with the optical proximity sensor (524) (for example, laterally) and triggers it to position the guide sheath (212) in a neutral configuration, and when the shuttles (514) are moved proximal and distal relative to each other to position the guide sheath (212) in a deflected configuration, the projection (530) is offset (for example, laterally) from the optical proximity sensor (524) and is outside its field of view. Thus, one or more signals generated by the deflection sensor assembly (520) can indicate whether the guide sheath (212) is in a neutral configuration or a deflected configuration, and can be generated without requiring physical contact between the deflection sensor assembly (520) and either shuttle (514).

[0046] The deflection sensor assembly (520) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (520). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (520) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of the console (12) may be operable to determine that the guide sheath (212) is currently in a neutral configuration in response to receiving a signal from the deflection sensor assembly (520) indicating that the optical proximity sensor (524) is currently triggered by the projection (530), and may be operable to determine that the guide sheath (212) is currently in a deflected configuration in response to not receiving a signal from the deflection sensor assembly (520) (indicating that the optical proximity sensor (524) is not currently triggered by the projection (530)). The processor of the console (12) may further be operable to provide a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0047] In one example of use, the guide sheath (212) may initially be in a neutral configuration, resulting in the projection (530) aligning with the optical proximity sensor (524) and triggering it, as shown in Figure 8A, and the operator can observe a real-time display on the display (18) indicating that the guide sheath (212) is in a neutral configuration. Subsequently, the guide sheath (212) may be articulated into a first deflected configuration, as shown in Figure 8B, such that the projection (530) is near the optical proximity sensor (524) and outside its field of view, and the operator can observe a real-time display on the display (18) indicating that the guide sheath (212) is deflected. In addition, or alternatively, the guide sheath (212) may be articulated to a second deflection configuration, as shown in Figure 8C, such that the projection (530) is distal to the optical proximity sensor (524) and outside its field of view, allowing the operator to observe a real-time indication on the display (18) that the guide sheath (212) is deflected. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, so that the projection (530) aligns with the optical proximity sensor (524), as shown in Figure 8A, triggering it, and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0048] D. Embodiment of a control handle with dual optical proximity sensors Figures 9A to 9C show an example of a control handle (610) that can be incorporated into the guide sheath assembly (210) instead of the control handle (216) and can provide at least some, if not all, of the features and functions described above. The control handle (610) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (610) in this embodiment includes an elongated, substantially cylindrical body (612) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal shaft portion of the body (612). As shown, the control handle (610) also includes a pair of shuttles (614a, 614b) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of the first shuttle (614a) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (614a, 614b) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the second shuttle (614b) in the opposite direction.The stoppers (also called ferrules) (618a, 618b), similar to the stoppers (289A, 289B) described above, are fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., band, rod, etc.), and are positioned proximal to the proximal end (619a, 619b) of the corresponding shuttles (614a, 614b), so that each shuttle (614a, 614b) is... When each shuttle (614a, 614b) is moved proximal from a neutral position (for example, both shuttles (614a, 614b) in Figure 9A) toward a proximal position (for example, the first shuttle (614a) in Figure 9B, the second shuttle (614b) in Figure 9C), the respective stoppers (618a, 618b) can be pushed or acted upon in any other way to pull out the respective puller wires proximal, and the shuttles (614a, 614b) toward a proximal position (for example If the first shuttle (614a) in Figure 9B and the second shuttle (614b) in Figure 9C are moved distally toward a neutral position (for example, both shuttles (614a, 614b) in Figure 9A), then the respective stopping points (618a, 618b) may move distally with the shuttles (614a, 614b) once the tension is released in their respective puller wires, and the shuttles (614a, 614b) are moved distally toward a neutral position (for example, both shuttles (614a, 614b) in Figure 9A). When the shuttles (614a, 614b) are moved distally from their respective ends toward a distal position (e.g., the first shuttle (614a) in Figure 9C, the second shuttle (614b) in Figure 9B), the proximal ends (619a, 619b) of the shuttles (614a, 614b) disengage from contact with their respective stops (618a, 618b), releasing their respective puller wires from tension, and as a result, the respective stops (618a, 618b) may remain stationary in their own neutral positions. Thus, the control handle (610) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0049] The control handle (610) in this embodiment further includes a deflection sensor assembly (620) configured to generate one or more signals indicating the joint movement state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (620) includes a first laterally opposed proximity sensor and a second laterally opposed proximity sensor in the form of optical proximity sensors (624a, 624b) that are firmly fixed to the body (612). In this regard, the first shuttle (614a) includes a first marker member in the form of a projection (630), and the second shuttle (614b) includes a second marker member in the form of an elongated ridge (632), and the field of view of the first optical proximity sensor (624a) intersects (e.g., perpendicularly) with the translational path of the first projection (630a), and as a result, the first projection (630a) selectively targets the field of view of the first optical proximity sensor (624a). The field of view of the second optical proximity sensor (624b) is configured to selectively trigger the second optical proximity sensor (624a) by crossing over the field of view of the elongated protrusion (632), such that the field of view of the second optical proximity sensor (624b) intersects (for example, is perpendicular) with the translational path of the elongated protrusion (632), and as a result, the elongated protrusion (632) is configured to selectively trigger the second optical proximity sensor (624b) by selectively crossing over the field of view of the second optical proximity sensor (624b).

[0050] More specifically, the projection (630) of this embodiment is positioned at a predetermined location along the length of the first shuttle (614a), so that when the shuttles (614a, 614b) are at the same height relative to each other in the longitudinal direction, the projection (630) aligns with the first optical proximity sensor (624a) (for example, laterally) and triggers it to position the guide sheath (212) in a neutral configuration. The projection (630) is also configured to be offset (for example, laterally) from the first optical proximity sensor (624a) and outside its field of view when the shuttles (614a, 614b) are moved proximal and distal relative to each other to position the guide sheath (212) in a deflected configuration.

[0051] Furthermore, in this embodiment, the elongated protrusion (632) aligns with the second optical proximity sensor (624b) (for example, horizontally) when the shuttles (614a, 614b) are at the same height longitudinally and the guide sheath (212) is positioned in a neutral configuration, and when the second shuttle (614b) is moved proximal and the first shuttle (614a) is moved distally and the guide sheath (212) is positioned in a deflection configuration deflected in a first direction (for example, to the left). Positioned along the length of the second shuttle (614b) to be configured to trigger it in the direction of the deflection, the elongated protrusion (632) is positioned so as to be offset (e.g. laterally) from the field of view of the second optical proximity sensor (624b) and outside its field of view when the second shuttle (614b) is moved distally and the first shuttle (614a) is moved proximal to position the guide sheath (212) in a deflection configuration in which the guide sheath is deflected in a second direction (e.g., to the right). Thus, in addition to indicating whether the guide sheath (212) is in a neutral configuration or a deflection configuration, one or more signals generated by the deflection sensor assembly (620) may indicate the direction of deflection when the guide sheath (212) is in a deflection configuration, and may be generated without requiring physical contact between the deflection sensor assembly (620) and either shuttle (614a, 614b).

[0052] The deflection sensor assembly (620) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (620). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (620) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of console (12) may be able to operate to determine that the guide sheath (212) is currently in a neutral configuration in response to receiving signals from the deflection sensor assembly (620) indicating that the optical proximity sensors (624a, 624b) are currently triggered by the protrusion (630) and the elongated ridge (632), respectively, and receive signals from the deflection sensor assembly (620) indicating that the first optical proximity sensor (624a) is not currently triggered by the protrusion (630) and the second optical proximity sensor (624b) is currently triggered by the elongated ridge (632). In response to a signal received from the sensor assembly (620), the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a first direction (e.g., to the left), and in response to no signal being received from the deflection sensor assembly (620) (indicating that the optical proximity sensors (624a, 624b) are not currently triggered by the projection (630) and the elongated protrusion (632), respectively), the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a second direction (e.g., to the right). The processor of the console (12) may further be operable to provide a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0053] In one example of use, the guide sheath (212) may initially be in a neutral configuration, and as a result, as shown in Figure 9A, the projection (630) aligns with and triggers the first optical proximity sensor (624a), and at least a portion of the elongated ridge (632) aligns with and triggers the second optical proximity sensor (624b), allowing the operator to observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration. The guide sheath (212) may then be articulated into a first deflection configuration in which the guide sheath (212) is deflected in a first direction (e.g., to the left), so that the projection (630) is distal to and outside the field of view of the first optical proximity sensor (624a), and at least a portion of the elongated protrusion (632) aligns with the second optical proximity sensor (624b), as shown in Figure 9C, triggering it, and the operator can observe a real-time display on the display (18) that the guide sheath (212) is deflected in the first direction. In addition, or alternatively, the guide sheath (212) may be articulated into a second deflection configuration in which the guide sheath (212) is deflected in a second direction (e.g., to the right), as shown in Figure 9B, with the projection (630) located proximal to and outside the field of view of the first optical proximity sensor (624a), and the elongated ridge (632) located distal to and disengaged from the second optical proximity sensor (624b), allowing the operator to observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the second direction. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, so that, as shown in Figure 9A, the projection (630) aligns with and triggers the first optical proximity sensor (624a), and at least a portion of the elongated protrusion (632) aligns with and triggers the second optical proximity sensor (624b), allowing the operator to observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0054] E. Embodiment of a control handle having a single reed switch Figures 10A to 10C show an example of a control handle (710) that may be incorporated into the guide sheath assembly (210) instead of the control handle (216) and may provide at least some, if not all, of the features and functions described above. The control handle (710) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (710) in this embodiment includes an elongated, substantially cylindrical body (712) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal shaft portion of the body (712). As shown, the control handle (710) also includes a pair of shuttles (714a, 714b) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of one shuttle (714a, 714b) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (714a, 714b) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the other shuttle (714a, 714b) in the opposite direction.Stops (also called ferrules) (718a, 718b) similar to the stoppers (289A, 289B) described above are fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., band, rod, etc.), and are positioned proximal to the proximal ends (719a, 719b) of the corresponding shuttles (714a, 714b), so that each shuttle (714a, 714b) is, When the shuttles (714a, 714b) move proximal from a neutral position (e.g., both shuttles (714a, 714b) in Figure 10A) toward a proximal position (e.g., the first shuttle (714a) in Figure 10B, the second shuttle (714b) in Figure 10C), their respective stops (718a, 718b) can be pushed or acted upon in any other way to pull out their respective puller wires proximal, and the shuttles (714a, 714b) toward a proximal position (e.g., When the first shuttle (714a) in Figure 10B and the second shuttle (714b) in Figure 10C are moved distally toward a neutral position (for example, both shuttles (714a, 714b) in Figure 10A), the respective stopping parts (718a, 718b) may move distally with the shuttles (714a, 714b) when the tension is released in their respective puller wires, and the shuttles (714a, 714b) are moved distally toward a neutral position (for example, both shuttles (714a, 714b) in Figure 10A). When the shuttles (714a, 714b) are moved distally from their respective stops (718a, 718b), the proximal ends (719a, 719b) of the shuttles (714a, 714b) disengage from their respective stops (718a, 718b), releasing their respective puller wires from tension, and as a result, the respective stops (718a, 718b) may remain stationary in their own neutral positions. Thus, the control handle (710) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0055] The control handle (710) in this embodiment further includes a deflection sensor assembly (720) configured to generate one or more signals indicating the joint motion state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (720) includes a proximity sensor in the form of a reed switch (724) that is firmly fixed to the body (712). In this regard, the first shuttle (714a) includes a magnetic member in the form of an embedded permanent magnet (730), the operating zone of the reed switch (724) intersects (e.g., perpendicularly) with the translational path of the magnet (730), and as a result, the magnet (730) is configured to selectively trigger the reed switch (724) by selectively crossing the operating zone of the reed switch (724).

[0056] More specifically, the magnet (730) in this embodiment is positioned at a predetermined location along the length of the first shuttle (714a) such that the magnet (730) triggers the reed switch (724) when the shuttles (714a, 714b) are at the same height relative to each other longitudinally, thereby positioning the guide sheath (212) in a neutral configuration, and that the magnet (730) is outside the operating zone of the reed switch (724) when the shuttles (714a, 714b) are moved proximal and distal relative to each other, positioning the guide sheath (212) in a deflected configuration. Thus, one or more signals generated by the deflection sensor assembly (720) can indicate whether the guide sheath (212) is in a neutral configuration or a deflected configuration, and can be generated using relatively low current and without requiring physical contact between the deflection sensor assembly (720) and either shuttle (714). In some variations, the magnet (730) may be oriented perpendicular to the longitudinal axis through which the shuttles (714a, 714b) translate, thereby improving the resolution of the reed switch (724).

[0057] The deflection sensor assembly (720) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (720). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (720) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of the console (12) may be operable to determine that the guide sheath (212) is currently in a neutral configuration in response to receiving a signal from the deflection sensor assembly (720) indicating that the reed switch (724) is currently triggered by the magnet (730), and may be operable to determine that the guide sheath (212) is currently in a deflected configuration in response to not receiving a signal from the deflection sensor assembly (720) (indicating that the reed switch (724) is not currently triggered by the magnet (730)). The processor of the console (12) may further be operable to provide a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0058] In one example of use, the guide sheath (212) may initially be in a neutral configuration, resulting in the magnet (730) triggering the reed switch (724) as shown in Figure 10A, and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration. The guide sheath (212) may then be articulated to a first deflection configuration, as shown in Figure 10B, such that the magnet (730) is proximal to and outside the operating zone of the reed switch (724), and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is deflected. In addition, or alternatively, the guide sheath (212) may be articulated to a second deflection configuration, as shown in Figure 10C, such that the magnet (730) is distal and lateral to the operating zone of the reed switch (724), and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is deflected. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, as a result of the magnet (730) triggering the reed switch (724), as shown in Figure 10A, and the operator can observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0059] F. Example of a control handle with a dual reed switch Figures 11A to 11C show an example of a control handle (810) that may be incorporated into the guide sheath assembly (210) instead of the control handle (216) and may provide at least some, if not all, of the features and functions described above. The control handle (810) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (810) in this embodiment includes an elongated, substantially cylindrical body (812) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal shaft portion of the body (812). As shown, the control handle (810) also includes a pair of shuttles (814a, 814b) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of the first shuttle (814a) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (814a, 814b) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the second shuttle (814b) in the opposite direction.Stops (also called ferrules) (818a, 818b) similar to the stops (289A, 289B) described above are fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., band, rod, etc.), and are positioned proximal to the proximal ends (819a, 819b) of the corresponding shuttles (814a, 814b), so that each shuttle (814a, 814b) is, When the shuttles (814a, 814b) are moved proximal from a neutral position (e.g., both shuttles (814a, 814b) in Figure 11A) toward a proximal position (e.g., the first shuttle (814a) in Figure 11B, the second shuttle (814b) in Figure 11C), their respective stops (818a, 818b) can be pushed or acted upon in any other way to pull out their respective puller wires proximal, and the shuttles (814a, 814b) toward a proximal position (e.g., When the first shuttle (814a) in Figure 11B and the second shuttle (814b) in Figure 11C are moved distally toward a neutral position (for example, both shuttles (814a, 814b) in Figure 11A), the respective stopping points (818a, 818b) may move distally with the shuttles (814a, 814b) when the tension is released in their respective puller wires, and the shuttles (814a, 814b) are moved distally toward a neutral position (for example, both shuttles (814a, 814b) in Figure 11A). When the shuttles (814a, 814b) are moved distally from their respective ends toward a distal position (e.g., the first shuttle (814a) in Figure 11C, the second shuttle (814b) in Figure 11B), the proximal ends (819a, 819b) of the shuttles (814a, 814b) disengage from contact with their respective stops (818a, 818b), releasing their respective puller wires from tension, and as a result, the respective stops (818a, 818b) may remain stationary in their own neutral positions. Thus, the control handle (810) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0060] The control handle (810) in this embodiment further includes a deflection sensor assembly (820) configured to generate one or more signals indicating the articular motion state of the guide sheath (212). In the shown embodiment, the deflection sensor assembly (820) includes a first longitudinally adjacent proximity sensor and a second longitudinally adjacent proximity sensor in the form of reed switches (824a, 824b) that are firmly fixed to the body (812). In this regard, the first shuttle (814a) includes a magnetic member in the form of an embedded permanent magnet (830), the operating zones of the reed switches (824a, 824b) each intersect (e.g., perpendicular) with the translational path of the magnet (830), and as a result, the magnet (830) is configured to selectively trigger the reed switches (824a, 824b) by selectively traversing the operating zones of the reed switches (824a, 824b).

[0061] More specifically, the magnet (830) in this embodiment is positioned at a predetermined location along the length of the first shuttle (814a) such that the magnet (830) is outside (e.g., between) both operating zones of the reed switches (824a, 824b) when the shuttles (814a, 814b) are at the same height relative to each other in the longitudinal direction, and the magnet (830) is positioned so that the guide sheath (212) is in a neutral configuration when the first shuttle (814a) moves proximal and the second shuttle (814b) moves distal, and the magnet (830) moves in the first direction (e.g., to the right). The magnet (830) is configured to trigger the second reed switch (824b) when the guide sheath (212) is positioned in a deflection configuration where it is deflected in a second direction (e.g., left), and is configured to be positioned outside the operating zone of the first reed switch (824a). Therefore, in addition to indicating whether the guide sheath (212) is in a neutral or deflected configuration, one or more signals generated by the deflection sensor assembly (820) can indicate the direction of deflection when the guide sheath (212) is in a deflected configuration, and can be generated using relatively low current and without requiring physical contact between the deflection sensor assembly (820) and either shuttle (814a, 814b). In some modifications, the magnet (830) can be oriented perpendicular to the longitudinal axis through which the shuttles (814a, 814b) translate to improve the resolution of the reed switches (824a, 824b).

[0062] The deflection sensor assembly (820) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (820). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (820) and thereby determine the current joint motion state of the guide sheath (212). For example, the console (12) processor may be able to operate to determine that the guide sheath (212) is currently in a neutral configuration in response to the fact that it has not received a signal from the deflection sensor assembly (820) (indicating that the reed switches (824a, 824b) are not currently triggered by the magnet (830)). In response to the above, the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a first direction (e.g., to the right), and in response to receiving a signal from the deflection sensor assembly (820) indicating that the first reed switch (824a) is not currently triggered by the magnet (830) and the second reed switch (824b) is currently triggered by the magnet (830), the guide sheath (212) may be operable to determine that it is currently in a deflection configuration deflected in a second direction (e.g., to the left). The processor of the console (12) may further be operable to provide a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0063] In one example of use, the guide sheath (212) may initially be in a neutral configuration, as shown in Figure 11A, with the magnet (830) distal and outside the operating zone of the first reed switch (824a) and the magnet (830) proximal and outside the operating zone of the second reed switch (824b). The operator can then observe a real-time indication on the display (18) that the guide sheath (212) is in a neutral configuration. The guide sheath (212) may then be articulated into a first deflection configuration in which the guide sheath (212) is deflected in a first direction (e.g., to the right), as a result of the magnet (830) triggering a first reed switch (824a), and the magnet (830) is located near the second reed switch (824b) and outside its operating zone, as shown in Figure 11B, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the first direction. In addition, or alternatively, the guide sheath (212) may be articulated into a second deflection configuration in which the guide sheath (212) is deflected in a second direction (e.g., to the left), as a result of the magnet (830) triggering a second reed switch (824b), and the magnet (830) is distal to the first reed switch (824a) and outside its operating zone, as shown in Figure 11C, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the second direction. In some cases, the guide sheath (212) may eventually be returned to a neutral configuration, resulting in the magnet (830) being distal and lateral to the operating zone of the first reed switch (824a), as shown in Figure 11A, and the magnet (830) being proximal and lateral to the operating zone of the second reed switch (824b), allowing the operator to observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0064] G. Embodiment of a control handle with a dual stop contact sensor Figures 12A to 12C show an example of a control handle (910) that can be incorporated into the guide sheath assembly (210) instead of the control handle (216) and can provide at least some, if not all, of the features and functions described above. The control handle (910) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (910) in this embodiment includes an elongated, substantially cylindrical body (912) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal axis of the body (912). As shown, the control handle (910) also includes a pair of shuttles (914a, 914b) similar to the shuttles (232A, 232B) described above. A rotary shaft (not shown), such as the rotary shaft (231) described above, is configured to drive the longitudinal translation of the first shuttle (914a) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (914a, 914b) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the second shuttle (914b) in the opposite direction. The stoppers (also called ferrules) (918a, 918b), similar to the stoppers (289A, 289B) described above, are fixed to the proximal ends of each actuator element in the form of puller wires (921a, 921b), similar to the puller wires (230A, 230B) described above, and are positioned proximal to the proximal ends (919a, 919b) of the corresponding shuttles (914a, 914b), so that each shuttle (914a, 914b) is in a neutral position. When moving proximal from a position (for example, both shuttles (914a, 914b) in Figure 12A) toward a proximal position (for example, the first shuttle (914a) in Figure 12B, the second shuttle (914b) in Figure 12C), each stop (918a, 918b) can be pushed or acted upon in any other way to pull out each puller wire (921a, 921b) in the proximal direction, so that the shuttles (914a, 914b) toward a proximal position (for example, the first shuttle (914a) in Figure 12B),As the second shuttle (914b) in Figure 12C is moved distally toward a neutral position (for example, both shuttles (914a, 914b) in Figure 12A), each stop (918a, 918b) moves distally with the shuttle (914a, 914b) until the tension in each puller wire (921a, 921b) is released, releasing the tension in each puller wire (921a, 921b) until each stop (918a, 918b) reaches its own neutral position where the proximal end (919a, 919b) of the shuttle (914a, 914b) is no longer in contact with the respective stop (918a, 918b), thereby releasing the tension in each puller wire (921a, 921b) when the shuttle (914a, 914b) is in the neutral position. A small spatial gap may be provided between the proximal end (919a, 919b) of each shuttle (914a, 914b) and their respective stop (918a, 918b) so as to prevent contact between 9b) and their respective stop (918a, 918b). When the shuttles (914a, 914b) are moved distally from a neutral position (e.g., both shuttles (914a, 914b) in Figure 12A) toward a distal position (e.g., the first shuttle (914a) in Figure 12C, the second shuttle (914b) in Figure 12B), the proximal ends (919a, 919b) of the shuttles (914a, 914b) remain in no contact with their respective stop (918a, 918b), and as a result, each stop (918a, 918b) may remain stationary in its own neutral position. Therefore, the control handle (910) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0065] The control handle (910) in this embodiment further includes a first deflection sensor assembly (920a) and a second deflection sensor assembly (920b), each configured to generate one or more signals indicating the articular motion state of the guide sheath (212). In the shown embodiment, each deflection sensor assembly (920a, 920b) includes a printed circuit board (PCB) (922a, 922b) securely fixed to the body of each shuttle (914a, 914b) such that the proximal surface of each PCB (922a, 922b) defines the proximal end (919a, 919b) of each shuttle (914a, 914b). Each PCB (922a, 922b) includes a corresponding pair of electrical contact members in the form of electrical contact traces (924a, 924b, 925a, 925b) spaced apart from each other around corresponding openings for corresponding puller wires (921a, 921b), each pair of electrical contact traces (924a, 924b, 925a, 925b) is electrically insulated from each other on each PCB (922a, 922b) and is configured to be selectively electrically coupled to each other by corresponding stoppers (918a, 918b). In this regard, each stop (918a, 918b) may include a conductive material and / or metallic material such as stainless steel, and as a result, each stop (918a, 918b) is configured to selectively contact the corresponding pair of electrical contact traces (924a, 924b, 925a, 925b) and selectively electrically couple the corresponding pair of electrical contact traces (924a, 924b, 925a, 925b), and each electrical contact trace (924a, 924b, 925a, 925b) may include a conductive material and / or metallic material such as copper.

[0066] More specifically, the stoppers (918a, 918b) of this embodiment are configured not to contact the corresponding pairs of electrical contact traces (924a, 924b, 925a, 925b) so that when the shuttles (914a, 914b) are at the same height relative to each other in the longitudinal direction, the corresponding pairs of electrical contact traces (924a, 924b, 925a, 925b) are electrically insulated from each other, and the guide sheath (212) is positioned in a neutral configuration. The first stopper (918a) is configured to contact and electrically couple with the first pair of electrical contact traces (924a, 925a), while the second stopper (918b) is configured not to contact the second pair of electrical contact traces (924b, 925b). When the first shuttle (914a) moves in the proximal direction and the second shuttle (914b) moves in the distal direction... When the first shuttle (914a) moves in the distal direction and the second shuttle (914b) moves in the proximal direction to position the guide sheath (212) in a deflection configuration deflected in a first direction (e.g., to the right), the second pair of electrical contact traces (924b, 925b) are electrically insulated from each other. When the first shuttle (914a) moves distally and the second shuttle (914b) moves proximal to position the guide sheath (212) in a deflection configuration deflected in a second direction (e.g., to the left), the first stop (918a) is configured not to contact the first pair of electrical contact traces (924a, 925a), and as a result, the first pair of electrical contact traces (924a, 925a) are electrically insulated from each other. The second stop (918b) is configured to contact and electrically couple the second pair of electrical contact traces (924b, 925b). Therefore, in addition to indicating whether the guide sheath (212) is in a neutral configuration or a deflected configuration, one or more signals generated by the deflection sensor assemblies (920a, 920b) may indicate the direction of deflection when the guide sheath (212) is in a deflected configuration.

[0067] Each deflection sensor assembly (920a, 920b) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (e.g., via a wired connection through an electrical connector, such as the electrical connector (217) described above), to transmit one or more signals thereto. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assemblies (920a, 920b). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assemblies (920a, 920b) and thereby determine the current joint motion state of the guide sheath (212).For example, the processor of console (12) may be able to operate to determine that the guide sheath (212) is currently in a neutral configuration in response to the fact that it is not receiving signals from any of the deflection sensor assemblies (920a, 920b) (indicating that each pair of electrical contact traces (924a, 924b, 925a, 925b) is not currently in contact by its respective stopper (918a, 918b), while receiving signals from the first deflection sensor assembly (920a) indicating that the first electrical contact traces (924a, 925a) are currently in contact and electrically coupled by the first stopper (918a), while not receiving signals from the second deflection sensor assembly (920b) (indicating that the second electrical contact traces (924b, 925b) are not currently in contact by the second stopper (918b) In response to a signal indicating that the first electrical contact traces (924a, 925a) are not currently in contact with the first stop (918a), the guide sheath (212) may be operable to determine that the guide sheath is currently in a deflection configuration in which it is deflected in a first direction (e.g., to the right), and in response to receiving a signal from the second deflection sensor assembly (920b) indicating that the second electrical contact traces (924b, 925b) are currently in contact with and electrically coupled with the second stop (918b) while the first electrical contact traces (924a, 925a) are not currently in contact with the first stop (918a), the guide sheath (212) may be operable to determine that the guide sheath is currently in a deflection configuration in which it is deflected in a second direction (e.g., to the left). The processor in the console (12) may be further capable of providing a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0068] In one example of use, the guide sheath (212) may initially be in a neutral configuration, and as a result, as shown in Figure 12A, the stop sections (918a, 918b) are each near and not in contact with the corresponding pair of electrical contact traces (924a, 924b, 925a, 925b), and the operator can observe on the display (18) in real time that the guide sheath (212) is in a neutral configuration. Next, the guide sheath (212) can be articulated into a first deflection configuration, as shown in Figure 12B, such that the first stop (918a) contacts and electrically couples the first pair of electrical contact traces (924a, 925a), and the second stop (918b) is located near the second pair of electrical contact traces (924b, 925b) but does not contact them, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the first direction. In addition, or alternatively, the guide sheath (212) may be articulated into a second deflection configuration in which the guide sheath (212) is deflected in a second direction (e.g., to the left), so that the second stop (918b) contacts and electrically couples with the second pair of electrical contact traces (924b, 925b), while the first stop (918a) is located near and not in contact with the first pair of electrical contact traces (924a, 925a), as shown in Figure 12C, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the second direction. In some cases, the guide sheath (212) may eventually be returned to a neutral configuration, so that, as shown in Figure 12A, the stop portions (918a, 918b) are each near and not in contact with the corresponding pair of electrical contact traces (924a, 924b, 925a, 925b), and the operator can observe on the display (18) in real time that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0069] H. Example of a control handle with a flexible sensor assemblyFigures 13A to 13C show an example of a control handle (1010) that can be incorporated into a guide sheath assembly (210) instead of the control handle (216) and can provide at least some, if not all, of the features and functions described above. The control handle (1010) may be the same as the control handle (216) described above, except as described below. In this regard, the control handle (1010) in this embodiment includes an elongated, substantially cylindrical body (1012) similar to the body (224) described above, and a distal rotation control knob (not shown), such as the distal rotation control knob (226) described above, mounted on the distal shaft portion of the body (1012). As shown, the control handle (1010) also includes a pair of shuttles (1014a, 1014b) similar to the shuttles (232A, 232B) described above. A rotary shaft (1013), similar to the rotary shaft (231) described above, is connected to and fixed to the body (1012) at its proximal end by a proximal-outer circumferential lip (1015) that engages with an inner circumferential slot defined between circumferential flanges (1017), and is configured to drive the longitudinal translation of the first shuttle (1014a) in response to the rotation of the control knob, and a pinion (not shown), such as the pinion (234) described above, connects the shuttles (1014a, 1014b) to each other via their respective teeth (not shown), thereby driving the longitudinal translation of the second shuttle (1014b) in the opposite direction.The stoppers (also called ferrules) (1018a, 1018b), similar to the stoppers (289A, 289B) described above, are fixed to the proximal end of each actuator element (not shown), such as the puller wires (230A, 230B) described above or any other suitable actuator element (e.g., band, rod, etc.), and are positioned proximal to the proximal ends (1019a, 1019b) of the corresponding shuttles (1014a, 1014b), so that each shuttle (1014a, 1014b) is positioned As the shuttles (1014a, 1014b) move proximal from a neutral position (e.g., both shuttles (1014a, 1014b) in Figure 13A) toward a proximal position (e.g., the first shuttle (1014a) in Figure 13B, the second shuttle (1014b) in Figure 13C), their respective stops (1018a, 1018b) can be pushed or acted upon in any other way to pull out their respective puller wires proximal, allowing the shuttles (1014a, 1014b) to move toward a proximal position (e.g., Figure 1 When the first shuttle (1014a) in Figure 3B and the second shuttle (1014b) in Figure 13C are moved distally toward a neutral position (for example, both shuttles (1014a, 1014b) in Figure 13A), the respective stopping points (1018a, 1018b) may move distally with the shuttles (1014a, 1014b) when the tension is released in their respective puller wires, and the shuttles (1014a, 1014b) are moved distally toward a neutral position (for example, both shuttles (1014a, 1014b) in Figure 13A). When the shuttles (1014a, 1014b) are moved distally from their respective stops (1018a, 1018b) toward a distal position (for example, the first shuttle (1014a) in Figure 13C, the second shuttle (1014b) in Figure 13B), the proximal ends (1019a, 1019b) of the shuttles (1014a, 1014b) disengage from contact with their respective stops (1018a, 1018b), releasing their respective puller wires from tension, and as a result, the respective stops (1018a, 1018b) may remain stationary in their own neutral positions. Thus, the control handle (1010) can provide bidirectional deflection of the deflection portion (214) of the guide sheath (212) in a manner similar to that described above in relation to the control handle (216).

[0070] The control handle (1010) in this embodiment further includes a deflection sensor assembly (1020) configured to generate one or more signals indicating the joint motion state of the guide sheath (212). In the embodiment shown, the deflection sensor assembly (1020) includes a flexible printed circuit board (PCB) (1022) having a variable length and a proximal end (1026) firmly fixed to a first shuttle (1014a) (e.g., on the distal-facing surface of the first shuttle (1014a) near the shaft (1013) and a distal end (1028) firmly fixed to a body (1012) (e.g., on the proximal flange of the flange (1017), so that the flexible PCB (1022) is configured to bend (e.g., stretch and / or compress) between at least one extended state (Figure 13B), at least one shortened state (Figure 13C), and an intermediate state (Figure 13A). In this regard, the flexible PCB (1022) may have at least one electrical trace (not shown) having a variable electrical resistance that changes based on the length of the flexible PCB (1022) (for example, based on the longitudinal distance between the proximal end (1026) and the distal end (1028).

[0071] More specifically, the flexible PCB (1022) of this embodiment is configured such that the shuttles (1014a, 1014b) are at the same height to each other in the longitudinal direction and the guide sheath (212) is positioned in a neutral configuration, at least one electrical trace of the flexible PCB (1022) has a first resistance, and the flexible PCB (1022) is configured such that when the first shuttle (1014a) is moved proximal and the second shuttle (1014b) is moved distally, the guide sheath (212) is positioned in a deflected configuration in which the guide sheath is deflected in a first direction (e.g., to the right), the flexible PCB (1022) The flexible PCB (1022) is configured to be in at least one extended state such that at least one electrical trace of the flexible PCB (1022) has at least one second resistance greater than a first resistance, and the flexible PCB (1022) is configured to be in at least one shortened state such that at least one electrical trace of the flexible PCB (1022) has at least one third resistance less than a first resistance when the first shuttle (1014a) is moved distally and the second shuttle (1014b) is moved proximal to position the guide sheath (212) in a deflected configuration in which the guide sheath is deflected in a second direction (e.g., to the left).

[0072] In some cases, the flexible PCB (1022) may be configured to take on multiple extended states, such as between the intermediate state shown in Figure 13A and the extended state shown in Figure 13B, and at least one second resistor of at least one electrical trace of the flexible PCB (1022) may include a plurality of different second resistors for each extended state. Similarly, the flexible PCB (1022) may be configured to take on multiple shortened states, such as between the intermediate state shown in Figure 13A and the shortened state shown in Figure 13C, and at least one third resistor of at least one electrical trace of the flexible PCB (1022) may include a plurality of different third resistors for each extended state. In such a case, a specific resistance of at least one electrical trace of the flexible PCB (1022) at a given moment may indicate the current length of the flexible PCB (1022), which may correlate with the longitudinal position of the first shuttle (1014a) relative to the body (1012), and thus may further correlate with a specific degree of deflection of the guide sheath (212). Thus, in addition to indicating whether the guide sheath (212) is in a neutral configuration or a deflected configuration, and also indicating the direction of deflection when the guide sheath (212) is in a deflected configuration, one or more signals generated by the deflection sensor assembly (1020) may indicate a specific degree of deflection when the guide sheath (212) is in a deflected configuration.

[0073] The deflection sensor assembly (1020) may be operable to communicate with an inductive drive system (not shown), such as the inductive drive system (10) described above (for example, via a wired connection through an electrical connector, such as the electrical connector (217) described above), in order to transmit one or more signals. For example, the first driver module (14) of the console (12) of the inductive drive system (10) may be operable to receive joint motion indicator signals from the deflection sensor assembly (1020). In such a modification, the processor of the console (12) may be operable to process the joint motion indicator signals from the deflection sensor assembly (1020) and thereby determine the current joint motion state of the guide sheath (212). For example, the processor of the console (12) may be operable to determine, in response to receiving a signal from the deflection sensor assembly (1020) based on a first resistance of at least one electrical trace of the flexible PCB (1022), that the guide sheath (212) is currently in a neutral configuration and the flexible PCB (1022) is in an intermediate state, and in response to receiving a signal from the deflection sensor assembly (1020) based on a second resistance of at least one electrical trace of the flexible PCB (1022), the guide sheath (212) is currently The guide sheath (212) may be operable to determine that it is in a deflection configuration deflected in a first direction (e.g., to the right) and that the flexible PCB (1022) is in at least one extended state, and in response to receiving a signal from the deflection sensor assembly (1020) based on at least one third resistance of at least one electrical trace of the flexible PCB (1022), it may be operable to determine that it is currently in a deflection configuration deflected in a second direction (e.g., to the left) and that the flexible PCB (1022) is in at least one shortened state. In some cases, the processor of the console (12) may be operable to determine a particular degree of deflection of the guide sheath (212) by correlating at least one second resistance or at least one third resistance of at least one electrical trace of the flexible PCB (1022) with the longitudinal position of the first shuttle (1014a) relative to the body (1012).The processor in the console (12) may be further capable of providing a real-time visual display of the joint motion state of the guide sheath (212) via the display (18), as will be described in more detail below.

[0074] In one example of use, the guide sheath (212) may initially be in a neutral configuration, resulting in the flexible PCB (1022) being in an intermediate state as shown in Figure 13A, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration. The guide sheath (212) may then be articulated into a first deflection configuration in which the guide sheath (212) is deflected in a first direction (e.g., to the right), resulting in the flexible PCB (1022) being in an extended state as shown in Figure 13B, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the first direction, and / or a real-time indication of a specific degree of deflection of the guide sheath (212) in the first direction. In addition, or alternatively, the guide sheath (212) may be articulated into a second deflection configuration in which the guide sheath (212) is deflected in a second direction (e.g., to the left), resulting in the flexible PCB (1022) being in a shortened state as shown in Figure 13C, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is deflected in the second direction, and / or a real-time indication of a specific degree of deflection of the guide sheath (212) in the second direction. In some examples, the guide sheath (212) may eventually be returned to a neutral configuration, resulting in the flexible PCB (1022) being in an intermediate state as shown in Figure 13A, and the operator can observe on the display (18) a real-time indication that the guide sheath (212) is in a neutral configuration before retracting the guide sheath (212) from the patient's heart (H).

[0075] V. Example of a graphical user interface having a representation of joint movement states Figure 14 shows an example of a graphical user interface (GUI) (1110) that can be rendered by a display of the induction drive system, such as the display (18) of the induction drive system (10) described above, to enable the operator to observe a real-time display of the joint motion state of the guide sheath (212) substantially simultaneously with observing the real-time positioning of the guide sheath (212). The GUI (1110) of this embodiment includes a first window (1111a) and a second window (1111b). The processor of the console (12) can drive the display (18) to superimpose a graphic representation (1112) of the guide sheath (212) onto an image (1114) of the patient's heart (H) in the first window (1111a). The image (1114) of the heart (H) may be based on a set of images (e.g., a CT scan or MRI scan, a 3D map, etc.) acquired before or during surgery. The view of the heart (H) provided via the display (18) may also change dynamically based on signals from the navigation sensor assembly of the guide sheath (212). The graphic representation (1112) of the guide sheath (212) may also move in real time within the image (1114) of the heart (H) in the first window (1111a) as the physician moves the guide sheath (212) within the patient (PA), thereby providing the operator with real-time visual feedback on the position of the guide sheath (212) within the patient (PA) as the guide sheath (212) moves within the patient (PA). In the first window (1111a), the display (18) may simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Therefore, the physician (PH) can observe the real-time positioning of the sheath (212) in relation to the mapped abnormal conductive tissue sites and the image (1114) of the heart (H) in the patient (PA) by looking at the first window (1111a) of the GUI (1110) on the display (18).

[0076] The console (12) processor may drive the display (18) to render one or more graphic displays (1120) showing the joint motion state of the guide sheath (212) in a second window (1111b) based on one or more signals received by the processor from the deflection sensor assemblies (320, 420, 520, 620, 720, 820, 920a, 920b, 1020) of the control handles for the guide sheath (212), such as one of the deflection sensor assemblies (320, 420, 520, 620, 720, 820, 920a, 920b, 1020) of the control handles (310, 410, 510, 610, 710, 810, 910, 1010) described above. In the embodiment shown, the graphic display (1120) includes a graphic representation (1122) of a guide sheath (212) superimposed on a generally circular scale (1124), such that the graphic representation (1122) of the guide sheath (212) enters the circular scale (1124) at the 6 o'clock position relative to the circular scale (1124). The graphic display (1120) in this embodiment also includes an "N" marker (1126) at the 12 o'clock position relative to the circular scale (1124).

[0077] If the processor determines that the guide sheath (212) is in a neutral configuration, the processor may drive the display (18) to show the graphic representation (1122) in a linear configuration so that the graphic representation (1122) aligns with the "N" marker (1126), as shown in Figure 14A. If the processor determines that the guide sheath (212) is in a deflected configuration, the processor may drive the display (18) to show the graphic representation (1122) in a curved configuration so that the graphic representation (1122) is deflected away from the "N" marker (1126), as shown in Figure 14B. In some variations, such as when the guide sheath (212) is in a deflection configuration, the processor may drive the display (18) to display the graphic representation (1122) in a curved configuration so that the graphic representation (1122) is deflected away from the "N" marker (1126) in the same direction (e.g., to the right or to the left). In addition, or alternatively, in variations where, when the guide sheath (212) is in a deflection configuration, one or more signals received by the processor from the deflection sensor assembly indicate a specific degree of deflection, the processor may drive the display (18) to display the graphic representation (1122) in a curved configuration so that the graphic representation (1122) is deflected to the same degree as the "N" marker (1126).

[0078] VI. Examples of combinations The following embodiments relate to various non-exclusive ways in which the teachings herein may be combined or applied. It should be understood that the following embodiments are not intended to limit any claims that may be presented at any point in this application or any subsequent application. No waiver of 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. Furthermore, some modifications may omit certain features mentioned in the following embodiments. Therefore, none of the embodiments or features mentioned below should be considered important unless they are subsequently explicitly indicated as such by the inventors or their heirs. If 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]

[0079] A guide sheath assembly comprising: (a) an elongated shaft; (b) a control handle located proximal to the elongated shaft, the control handle having a longitudinal axis and including (i) a control handle housing and (ii) at least one shuttle configured to translate along the longitudinal axis; (c) at least one actuator element extending along at least one side of the elongated shaft and having a proximal end portion that responds to translation of at least one shuttle in at least the proximal direction; and (d) at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the articular motion state of the elongated shaft based on the longitudinal position of at least one shuttle. [Examples]

[0080] The guide sheath assembly according to Embodiment 1, wherein at least one deflection sensor assembly includes at least one tactile switch fixed to a control handle housing, and at least one shuttle is configured to selectively activate at least one tactile switch. [Examples]

[0081] The guide sheath assembly according to Embodiment 2, wherein at least one tactile switch includes a first tactile switch and a second tactile switch, and at least one shuttle includes a first actuating member and a second actuating member configured to selectively actuate the first tactile switch and the second tactile switch, respectively. [Examples]

[0082] A guide sheath assembly according to any one of Examples 1 to 3, wherein at least one deflection sensor assembly includes at least one optical proximity sensor fixed to a control handle housing, and at least one shuttle is configured to selectively trigger at least one optical proximity sensor. [Examples]

[0083] The guide sheath assembly according to Embodiment 4, wherein at least one optical proximity sensor includes a first optical proximity sensor and a second optical proximity sensor, and at least one shuttle includes a first shuttle and a second shuttle configured to selectively trigger the first optical proximity sensor and the second optical proximity sensor, respectively. [Examples]

[0084] A guide sheath assembly according to any one of Examples 1 to 5, wherein at least one deflection sensor assembly includes at least one reed switch fixed to a control handle housing, and at least one shuttle includes at least one magnetic member configured to selectively trigger at least one reed switch. [Examples]

[0085] The guide sheath assembly according to Embodiment 6, wherein at least one reed switch comprises a first reed switch and a second reed switch, and at least one magnetic member is configured to selectively trigger each of the first reed switch and the second reed switch. [Examples]

[0086] A guide sheath assembly according to any one of Examples 1 to 7, wherein the proximal end portion of at least one actuator element is fixed to a conductive ferrule, and at least one deflection sensor assembly includes at least one pair of conductive contact members positioned on the proximal end of at least one shuttle, and the conductive ferrule is configured to selectively electrically couple the at least one pair of conductive contact members. [Examples]

[0087] A guide sheath assembly according to any one of Examples 1 to 8, wherein at least one deflection sensor assembly includes at least one flexible sensor assembly having variable resistance based on the length of at least one flexible sensor assembly. [Examples]

[0088] A guide sheath assembly according to any one of Examples 1 to 9, wherein one or more signals indicate that the elongated shaft is in a neutral configuration or in at least one deflection configuration. [Examples]

[0089] The guide sheath assembly according to Example 10, wherein one or more signals indicate the direction of deflection of the elongated shaft when the elongated shaft is in at least one deflection configuration. [Examples]

[0090] A guide sheath assembly according to Example 10 or 11, wherein one or more signals indicate the degree of deflection of an elongated shaft when the elongated shaft is in at least one deflection configuration. [Examples]

[0091] A guide sheath assembly according to any one of Examples 1 to 12, wherein at least one shuttle includes (A) a first shuttle configured to translate along the longitudinal axis in a first direction, and (B) a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction. [Examples]

[0092] The guide sheath assembly according to Embodiment 13, wherein at least one actuator element includes (i) a first actuator element extending along a first side of an elongated shaft and having a proximal end portion that responds at least to the translation of a first shuttle in the proximal direction, and (ii) a second actuator element extending along a second side of an elongated shaft and having a proximal end portion that responds at least to the translation of a second shuttle in the proximal direction. [Examples]

[0093] A guide sheath assembly according to Embodiment 13 or 14, wherein a first shuttle has a first plurality of teeth, and a control handle further includes a pinion that engages with the first plurality of teeth, the pinion being configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to the translation of the first shuttle in a first direction, and a second shuttle has a second plurality of teeth that engage with the pinion, the second shuttle being configured to translate in a second direction along the longitudinal axis in response to the rotation of the pinion. [Examples]

[0094] A guide sheath assembly according to any one of embodiments 1 to 15, wherein the control handle is located inside the control handle housing and includes a rotary shaft configured to rotate about the longitudinal axis of the control handle, and at least one shuttle is configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft. [Examples]

[0095] The guide sheath assembly according to Embodiment 16 includes a control handle, which is a control knob coupled to a rotary shaft for common translational and rotational motion. [Examples]

[0096] A guide sheath assembly according to Embodiment 16 or 17, wherein at least one shuttle comprises a first shuttle and a second shuttle, and a rotating shaft is provided with an internal passage, configured such that at least a portion of the first shuttle extends into the internal passage of the rotating shaft, and at least a portion of the second shuttle extends into the internal passage of the rotating shaft. [Examples]

[0097] A system comprising: (a) a guide sheath assembly according to any one of Examples 1 to 18; and (b) a processor operably communicating with at least one deflection sensor assembly to receive one or more signals from at least one deflection sensor assembly, and configured to determine the joint motion state of an elongated shaft based on the one or more signals. [Examples]

[0098] A guide sheath assembly comprising (a) an elongated shaft, (b) a control handle located proximal to the elongated shaft, the control handle having a longitudinal axis, (i) a control handle housing, (ii) a control knob configured to rotate about the longitudinal axis, (iii) a rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, the rotary shaft being coupled to the control knob for common translational and common rotational motion, (iv) a first shuttle configured to translate along the longitudinal axis in a first direction in response to the rotation of the rotary shaft, and (v) a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction. A guide sheath assembly comprising: a control handle, including a second shuttle configured to translate in the longitudinal direction along the longitudinal axis; (c) a first puller wire extending along a first side of an elongated shaft, having a proximal end portion that responds to at least the proximal translation of the first shuttle; (d) a second puller wire extending along a second side of an elongated shaft, having a proximal end portion that responds to at least the proximal translation of the second shuttle; and (e) at least one proximity sensor fixed to the control handle housing and configured to generate one or more signals indicating the articular motion state of the elongated shaft based on the longitudinal position of at least one of the first or second shuttles. [Examples]

[0099] The guide sheath assembly according to Example 20, wherein at least one proximity sensor includes at least one of an optical proximity sensor or a reed switch. [Examples]

[0100] A guide sheath assembly according to any one of Examples 20 to 21, wherein at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and the first shuttle and the second shuttle are configured to selectively trigger the first proximity sensor and the second proximity sensor, respectively. [Examples]

[0101] A guide sheath assembly according to any one of Examples 20 to 22, wherein at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and one of the first shuttle or the second shuttle is configured to selectively trigger each of the first and second proximity sensors. [Examples]

[0102] A control handle used to control the deflection of a medical guide sheath shaft, the control handle having a longitudinal axis and comprising: (a) a control handle housing; (b) a control knob configured to rotate about the longitudinal axis; (c) a rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, the rotary shaft being coupled to the control knob for common translational and common rotational motion; (d) a first shuttle configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft; and (e) the first shuttle A control handle comprising: (f) a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to translation of the first shuttle in a first direction, the first shuttle and the second shuttle configured to act on a first puller wire and a second puller wire extending along a medical guide sheath shaft, respectively; and at least one deflection sensor assembly fixed to a control handle housing and configured to generate one or more signals indicating the joint motion state of the medical guide sheath shaft based on the longitudinal position of at least one of the first shuttle or the second shuttle.

[0103] VII. Others Any of the instruments described herein may be cleaned and sterilized before and / or after a procedure. 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 sterilized 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 water vapor.

[0104] 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.

[0105] It should be understood that one or more of the teachings, expressions, embodiments, examples, etc. described herein may 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 may 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.

[0106] Any patents, publications, or other disclosures, in whole or in part, that are referred to as being incorporated herein by reference are incorporated herein only to the extent that the incorporated content does not conflict with the current definitions, views, or other disclosures contained herein. Any disclosure expressly contained herein, either in itself or to the extent necessary, takes precedence over any conflicting statements incorporated herein by reference. Any content, or any portion thereof, that is referred to as being incorporated herein by reference but conflicts with the current 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 current disclosures.

[0107] 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 these possible modifications have been mentioned, but others will be obvious to those skilled in the art. For example, the embodiments, modifications, geometric shapes, materials, dimensions, proportions, processes, etc., discussed above are illustrative and not essential. Therefore, it should be understood that the scope of the invention is to be considered with respect to the following claims and is not limited to the details of structures and operations shown and described herein and in the drawings.

[0108] [Implementation Method] (1) A guide sheath assembly, (a) A long, slender shaft, (b) A control handle located near the elongated shaft, the control handle having a longitudinal axis and, (i) Control handle housing and (ii) A control handle including at least one shuttle configured to translate along the longitudinal axis, (c) at least one actuator element extending along at least one side of the elongated shaft and having a proximal end portion that responds at least to the translation of the at least one shuttle in the proximal direction, (d) A guide sheath assembly comprising: at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the articular motion state of the elongated shaft based on the longitudinal position of the at least one shuttle. (2) The guide sheath assembly according to Embodiment 1, wherein the at least one deflection sensor assembly includes at least one tactile switch fixed to the control handle housing, and the at least one shuttle is configured to selectively activate the at least one tactile switch. (3) The guide sheath assembly according to Embodiment 2, wherein the at least one tactile switch includes a first tactile switch and a second tactile switch, and the at least one shuttle includes a first actuating member and a second actuating member configured to selectively actuate the first tactile switch and the second tactile switch, respectively. (4) The guide sheath assembly according to Embodiment 1, wherein the at least one deflection sensor assembly includes at least one optical proximity sensor fixed to the control handle housing, and the at least one shuttle is configured to selectively trigger the at least one optical proximity sensor. (5) The guide sheath assembly according to Embodiment 4, comprising a first shuttle and a second shuttle, wherein the at least one optical proximity sensor includes a first optical proximity sensor and a second optical proximity sensor, and the at least one shuttle is configured to selectively trigger the first optical proximity sensor and the second optical proximity sensor, respectively.

[0109] (6) The guide sheath assembly according to Embodiment 1, wherein the at least one deflection sensor assembly includes at least one reed switch fixed to the control handle housing, and the at least one shuttle includes at least one magnetic member configured to selectively trigger the at least one reed switch. (7) The guide sheath assembly according to Embodiment 6, wherein the at least one reed switch includes a first reed switch and a second reed switch, and the at least one magnetic member is configured to selectively trigger each of the first reed switch and the second reed switch. (8) The guide sheath assembly according to Embodiment 1, wherein the proximal end portion of the at least one actuator element is fixed to a conductive ferrule, the at least one deflection sensor assembly includes at least one pair of conductive contact members positioned on the proximal end of the at least one shuttle, and the conductive ferrule is configured to selectively electrically couple the at least one pair of conductive contact members. (9) The guide sheath assembly according to Embodiment 1, wherein the at least one deflection sensor assembly includes at least one flexible sensor assembly, the at least one flexible sensor assembly having a variable resistance based on the length of the at least one flexible sensor assembly. (10) The guide sheath assembly according to Embodiment 1, wherein one or more signals indicate whether the elongated shaft is in a neutral configuration or in at least one deflection configuration.

[0110] (11) The guide sheath assembly according to Embodiment 10, wherein the one or more signals indicate the direction of deflection of the elongated shaft when the elongated shaft is in the at least one deflection configuration. (12) The guide sheath assembly according to Embodiment 10, wherein the one or more signals indicate the degree of deflection of the elongated shaft when the elongated shaft is in the at least one deflection configuration. (13) The at least one shuttle is (A) A first shuttle configured to translate along the longitudinal axis in a first direction, (B) A guide sheath assembly according to Embodiment 1, comprising: a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction. (14) The at least one actuator element is (i) A first actuator element extending along the first side of the elongated shaft and having a proximal end portion that responds at least to the translation of the first shuttle in the proximal direction, (ii) A guide sheath assembly according to Embodiment 13, comprising: a second actuator element extending along the second side of the elongated shaft and having a proximal end portion that responds at least to the translation of the second shuttle in the proximal direction. (15) A system, (a) A guide sheath assembly as described in Embodiment 1, (b) A system comprising: a processor operably communicating with the at least one deflection sensor assembly in order to receive the one or more signals from the at least one deflection sensor assembly, the processor configured to determine the joint motion state of the elongated shaft based on the one or more signals.

[0111] (16) A guide sheath assembly, (a) A long, slender shaft, (b) A control handle located near the elongated shaft, the control handle having a longitudinal axis and, (i) Control handle housing and (ii) A control knob configured to rotate about the longitudinal axis, (iii) A rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, wherein the rotary shaft is coupled to the control knob for common translational motion and common rotational motion, (iv) A first shuttle configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft, (v) A control handle including a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction, (c) A first puller wire extending along the first side of the elongated shaft, having at least a proximal end portion that responds to the translation of the first shuttle in the proximal direction, (d) A second puller wire extending along the second side of the elongated shaft, having at least a proximal end portion that responds to the translation of the second shuttle in the proximal direction, (e) A guide sheath assembly comprising: at least one proximity sensor fixed to the control handle housing and configured to generate one or more signals indicating the articulation state of the elongated shaft based on the longitudinal position of at least one of the first shuttle or the second shuttle. (17) The guide sheath assembly according to Embodiment 16, wherein the at least one proximity sensor includes at least one of an optical proximity sensor or a reed switch. (18) The guide sheath assembly according to Embodiment 16, wherein the at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and the first shuttle and the second shuttle are configured to selectively trigger the first proximity sensor and the second proximity sensor, respectively. (19) The guide sheath assembly according to Embodiment 16, wherein the at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and one of the first shuttle or the second shuttle is configured to selectively trigger each of the first proximity sensor and the second proximity sensor. (20) A control handle used to control the deflection of a medical guide sheath shaft, having a longitudinal axis and, (a) Control handle housing and (b) A control knob configured to rotate about the longitudinal axis, (c) A rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, wherein the rotary shaft is coupled to the control knob for common translational motion and common rotational motion, (d) A first shuttle configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft, (e) A second shuttle configured to translate in a second direction opposite to the first direction along the longitudinal axis in response to the translation of the first shuttle in the first direction, wherein the first shuttle and the second shuttle are configured to act on a first puller wire and a second puller wire, respectively, extending along the medical guide sheath shaft, (f) A control handle comprising at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the joint motion state of the medical guide sheath shaft based on the longitudinal position of at least one of the first shuttle or the second shuttle.

Claims

1. A guide sheath assembly, (a) A long, slender shaft, (b) A control handle located near the elongated shaft, the control handle having a longitudinal axis and, (i) Control handle housing and (ii) A control handle including at least one shuttle configured to translate along the longitudinal axis, (c) at least one actuator element extending along at least one side of the elongated shaft and having a proximal end portion that responds at least to the translation of the at least one shuttle in the proximal direction, (d) A guide sheath assembly comprising: at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the articulation state of the elongated shaft based on the longitudinal position of the at least one shuttle.

2. The guide sheath assembly according to claim 1, wherein the at least one deflection sensor assembly includes at least one tactile switch fixed to the control handle housing, and the at least one shuttle is configured to selectively activate the at least one tactile switch.

3. The guide sheath assembly according to claim 2, wherein the at least one tactile switch includes a first tactile switch and a second tactile switch, and the at least one shuttle includes a first actuator and a second actuator configured to selectively actuate the first tactile switch and the second tactile switch, respectively.

4. The guide sheath assembly according to claim 1, wherein the at least one deflection sensor assembly includes at least one optical proximity sensor fixed to the control handle housing, and the at least one shuttle is configured to selectively trigger the at least one optical proximity sensor.

5. The guide sheath assembly according to claim 4, wherein the at least one optical proximity sensor includes a first optical proximity sensor and a second optical proximity sensor, and the at least one shuttle includes a first shuttle and a second shuttle, each configured to selectively trigger the first optical proximity sensor and the second optical proximity sensor, respectively.

6. The guide sheath assembly according to claim 1, wherein the at least one deflection sensor assembly includes at least one reed switch fixed to the control handle housing, and the at least one shuttle includes at least one magnetic member configured to selectively trigger the at least one reed switch.

7. The guide sheath assembly according to claim 6, wherein the at least one reed switch includes a first reed switch and a second reed switch, and the at least one magnetic member is configured to selectively trigger each of the first reed switch and the second reed switch.

8. The guide sheath assembly according to claim 1, wherein the proximal end portion of the at least one actuator element is fixed to a conductive ferrule, the at least one deflection sensor assembly includes at least one pair of conductive contact members positioned on the proximal end of the at least one shuttle, and the conductive ferrule is configured to selectively electrically couple the at least one pair of conductive contact members.

9. The guide sheath assembly according to claim 1, wherein the at least one deflection sensor assembly includes at least one flexible sensor assembly, the at least one flexible sensor assembly having a variable resistance based on the length of the at least one flexible sensor assembly.

10. The guide sheath assembly according to claim 1, wherein one or more signals indicate whether the elongated shaft is in a neutral configuration or in at least one deflection configuration.

11. The guide sheath assembly according to claim 10, wherein the one or more signals indicate the direction of deflection of the elongated shaft when the elongated shaft is in the at least one deflection configuration.

12. The guide sheath assembly according to claim 10, wherein the one or more signals indicate the degree of deflection of the elongated shaft when the elongated shaft is in the at least one deflection configuration.

13. The at least one shuttle is (A) A first shuttle configured to translate along the longitudinal axis in a first direction, (B) A guide sheath assembly according to claim 1, comprising: (B) a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction.

14. The at least one actuator element is (i) A first actuator element extending along the first side of the elongated shaft and having a proximal end portion that responds at least to the translation of the first shuttle in the proximal direction, (ii) The guide sheath assembly according to claim 13, comprising: (ii) a second actuator element extending along a second side of the elongated shaft and having a proximal end portion that responds at least to the translation of the second shuttle in the proximal direction.

15. It is a system, (a) The guide sheath assembly according to claim 1, (b) A system comprising: a processor operably communicating with the at least one deflection sensor assembly in order to receive the one or more signals from the at least one deflection sensor assembly, the processor configured to determine the joint motion state of the elongated shaft based on the one or more signals.

16. A guide sheath assembly, (a) A long, slender shaft, (b) A control handle located near the elongated shaft, the control handle having a longitudinal axis and, (i) Control handle housing and (ii) A control knob configured to rotate about the longitudinal axis, (iii) A rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, wherein the rotary shaft is coupled to the control knob for common translational motion and common rotational motion, (iv) A first shuttle configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft, (v) A control handle including a second shuttle configured to translate along the longitudinal axis in a second direction opposite to the first direction in response to the translation of the first shuttle in the first direction, (c) A first puller wire extending along the first side of the elongated shaft, having at least a proximal end portion that responds to the proximal translation of the first shuttle, (d) A second puller wire extending along the second side of the elongated shaft, having at least a proximal end portion that responds to the translation of the second shuttle in the proximal direction, (e) A guide sheath assembly comprising: at least one proximity sensor fixed to the control handle housing and configured to generate one or more signals indicating the articulation state of the elongated shaft based on the longitudinal position of at least one of the first shuttle or the second shuttle.

17. The guide sheath assembly according to claim 16, wherein the at least one proximity sensor includes at least one of an optical proximity sensor or a reed switch.

18. The guide sheath assembly according to claim 16, wherein the at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and the first shuttle and the second shuttle are configured to selectively trigger the first proximity sensor and the second proximity sensor, respectively.

19. The guide sheath assembly according to claim 16, wherein the at least one proximity sensor includes a first proximity sensor and a second proximity sensor, and one of the first shuttle or the second shuttle is configured to selectively trigger each of the first proximity sensor and the second proximity sensor.

20. A control handle used to control the deflection of a medical guide sheath shaft, having a longitudinal axis, (a) Control handle housing and (b) A control knob configured to rotate about the longitudinal axis, (c) A rotary shaft located within the control handle housing and configured to rotate about the longitudinal axis in response to the rotation of the control knob, wherein the rotary shaft is coupled to the control knob for common translational motion and common rotational motion, (d) A first shuttle configured to translate in a first direction along the longitudinal axis in response to the rotation of the rotary shaft, (e) A second shuttle configured to translate in a second direction opposite to the first direction along the longitudinal axis in response to the translation of the first shuttle in the first direction, wherein the first shuttle and the second shuttle are configured to act on a first puller wire and a second puller wire, respectively, extending along the medical guide sheath shaft, (f) A control handle comprising at least one deflection sensor assembly fixed to the control handle housing and configured to generate one or more signals indicating the joint motion state of the medical guide sheath shaft based on the longitudinal position of at least one of the first shuttle or the second shuttle.

Images