Catheter deflection control assembly

Abstract

An apparatus includes a handle, a catheter, an end effector, and a deflection drive assembly. The end effector includes at least one electrode. The deflection drive assembly includes an input member, a translation assembly coupled to the end effector, and a rack and pinion assembly. The rack and pinion assembly is configured to drive the translation assembly to deflect the end effector by an angle relative to a longitudinal axis and is comprised of the rack and pinion. The rack and pinion assembly is configured to transfer rotational motion of the pinion from the input member into linear motion of the rack to push distally or pull proximally the translation member; or transfer linear motion of the rack from the input member into rotational motion of the pinion to move a first end of the translation member proximally and a second end of the translation member distally.

Description

Background Technology

[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when areas of cardiac tissue abnormally conduct electrical signals. Treatment protocols for these arrhythmias involve surgically disrupting the conduction pathways used for such signals. By selectively ablating cardiac tissue with energy (e.g., radiofrequency (RF) energy), it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissues.

[0002] In some procedures, catheters with one or more RF electrodes can be used to deliver ablation within the cardiovascular system. The catheter may be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or in cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). One or more electrodes may be positioned to contact cardiac or other vascular tissue and then activated using RF energy to ablate the contacted tissue. In some cases, the electrodes may be bipolar. In other cases, a monopolar electrode may be used in conjunction with a grounding pad or other reference electrode in contact with the patient. Flushing may be used to absorb heat from the ablation components of the ablation catheter and to prevent blood clots from forming near the ablation site.

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

[0004] Some catheter ablation procedures can be performed after electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may involve the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). These sensing electrodes monitor electrical signals emanating from conductive endocardial tissue to precisely locate the site of abnormally conductive tissue leading to arrhythmias. Examples of EP mapping systems and catheters are described in the various references cited herein.

[0005] When using an ablation catheter, it may be desirable to ensure that one or more electrodes of the ablation catheter make adequate contact with the target tissue. For example, it may be desirable to ensure that one or more electrodes contact the target tissue with sufficient force to effectively apply RF ablation energy to the tissue; but not to apply a force that may tend to undesirably damage the tissue. For this purpose, it may be desirable to include one or more force sensors or pressure sensors for detecting adequate contact between one or more electrodes of the ablation catheter and the target tissue.

[0006] In addition to force sensing or EP mapping, some catheter ablation procedures can be performed using image-guided surgery (IGS) systems. IGS systems allow physicians to visually track the catheter's position within the patient's body in real time, relative to images of the patient's anatomy. Some systems offer a combination of EP mapping and IGS functionality, including CARTO from Biosense Webster, Inc., Irvine, California. Examples of catheters constructed for use with IGS systems are disclosed in the following documents: U.S. Patent No. 9,480,416, entitled “Signal Transmission Using Catheter Braid Wires,” published November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety; and various other references cited herein.

[0007] Although several catheter systems and methods have been manufactured and used, it is believed that no one had manufactured or used the inventions described, shown and claimed herein before the inventors. Attached Figure Description

[0008] The following figures and detailed descriptions are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0009] Figure 1 A schematic perspective view depicting a medical procedure for inserting a catheter assembly into a patient's body;

[0010] Figure 2 Depicting Figure 1 A perspective view of the catheter assembly, with accessory components shown schematically;

[0011] Figure 3 Depicting Figure 1 A perspective view of the distal portion of the catheter, with additional components shown schematically;

[0012] Figure 4 Depicting Figure 1 A perspective view of the distal portion of the catheter, with the outer sheath omitted to show the internal components;

[0013] Figure 5 Depicting Figure 1 Exploded perspective view of the distal portion of the catheter;

[0014] Figure 6 Depicting Figure 1 A perspective view of the handle of the conduit assembly and the deflection drive assembly, wherein the deflection drive assembly includes a rocker arm;

[0015] Figure 7 Depicting Figure 6A schematic perspective view of the shank and deflection drive assembly, with a portion of the shank omitted to show internal components including the rack and pinion assembly;

[0016] Figure 8A Depicting Figure 6 A top view of the deflection drive assembly, wherein the rack of the rocker arm and rack and pinion assembly is in a neutral position for bidirectional deflection, and the first exemplary locking assembly is in an unlocked configuration;

[0017] Figure 8B Depicting Figure 8A The top view of the deflection drive assembly shows the rocker arm in a first position, the rack in a first longitudinal position, and the locking assembly in a first locking configuration.

[0018] Figure 8C Depicting Figure 8A The top view of the deflection drive assembly shows the rocker arm in the second position, the rack in the second longitudinal position, and the locking assembly in the second locking configuration.

[0019] Figure 9A Depicting Figure 1 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 8A The neutral position associated with the neutral position of the rocker arm;

[0020] Figure 9B Depicting Figure 1 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 8B The first deflection position associated with the first position of the rocker arm;

[0021] Figure 9C Depicting Figure 1 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 8C The second deflection position associated with the second position of the rocker arm;

[0022] Figure 10A Depicting Figure 6 A top view of the deflection drive assembly, wherein the rack of the rocker arm and rack and pinion assembly is in a neutral position for unidirectional deflection, and the locking assembly is in a first locking configuration.

[0023] Figure 10B Depicting Figure 10AThe top view of the deflection drive assembly shows the rocker arm in a first rotational position, the rack in a first longitudinal position, and the locking assembly in a second locking configuration.

[0024] Figure 11A Depicting Figure 1 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, wherein the distal portion of the catheter is positioned relative to the portion in the... Figure 10A The neutral position of the rocker arm is associated with the non-deflection position;

[0025] Figure 11B Depicting Figure 1 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 10B The deflection position associated with the first position of the rocker arm;

[0026] Figure 12 A top schematic of a second exemplary deflection drive component is depicted, wherein the second exemplary locking component is in an unlocked configuration;

[0027] Figure 13 A perspective view depicts a second exemplary catheter assembly and a third exemplary deflection drive assembly having additional components shown schematically. The second exemplary catheter assembly is similar to... Figure 1 The catheter assembly includes a second exemplary catheter;

[0028] Figure 14 Depicting Figure 13 A perspective view of a deflection drive assembly, which includes a third exemplary rack and pinion assembly, a push-pull cable, and a third exemplary locking assembly;

[0029] Figure 15A Depicting Figure 14 A top view of the deflection drive assembly, wherein the linear slider is in a first longitudinal position, the rack of the rack and pinion assembly is in a first longitudinal position, and the locking assembly is in an unlocked configuration;

[0030] Figure 15B Depicting Figure 15A The top view of the deflection drive assembly shows the linear slider in the second longitudinal position, the rack and pinion assembly in the second longitudinal position, and the locking assembly in the first locking configuration.

[0031] Figure 15C Depicting Figure 15A The top view of the deflection drive assembly shows the linear slider in the third longitudinal position, the rack and pinion assembly in the third longitudinal position, and the locking assembly in the second locking configuration.

[0032] Figure 16A Depicting Figure 13 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 15A The non-deflection position associated with the first longitudinal position of the linear slider;

[0033] Figure 16B Depicting Figure 13 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 15B The second longitudinal position of the linear slider is associated with the first deflection position;

[0034] Figure 16C Depicting Figure 13 A top plan view of the distal portion of the catheter, where a portion of the outer sheath is omitted to show the internal components, with the distal portion of the catheter positioned relative to... Figure 15C The second deflection position associated with the third longitudinal position of the linear slider;

[0035] Figure 17 A top schematic diagram of a fourth exemplary deflection driver is depicted, wherein a fourth exemplary locking component is in a locked configuration; and

[0036] Figure 18 The operation is described Figure 1 A schematic view of an exemplary method for constructing a conduit assembly; Detailed Implementation

[0037] The following description of certain examples of the invention is not intended to limit the scope of the invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a best mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different or equivalent aspects, all of which do not depart from the invention. Therefore, the drawings and descriptions should be considered substantially illustrative and not restrictive.

[0038] Any one or more of the teachings, expressions, types, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, types, examples, etc. Therefore, the following teachings, expressions, types, examples, etc., should not be considered separate from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art, referring to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0039] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or elements to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​±10% of the listed values; for example, “about 90%” may refer to a range of values ​​from 81% to 99%. Additionally, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the system or method to human use, but the use of the subject matter invention in human patients represents a preferred embodiment.

[0040] I. Overview of Exemplary Ablation Catheter Systems

[0041] Figure 1 An exemplary medical protocol and associated components are shown for a cardiac ablation catheter system that can be used to deliver the cardiac ablation procedures mentioned above. Specifically, Figure 1 The image shows the handle (110) of the catheter assembly (100) being gripped by a physician (PH), wherein the end actuator (140) of the catheter (120) of the catheter assembly (100) is located in... Figures 2 to 3 Shown but not in Figure 1 (As shown) is placed inside the patient (PA) to ablate tissue in or near the patient's (PA) heart (H). Figure 2 As shown, the catheter assembly (100) includes a handle (110), a catheter (120) extending distally from the handle (110), an end actuator (140) located at the distal end of the catheter (120), and a deflection drive assembly (200) associated with the handle (110).

[0042] As will be described in more detail below, the end effector (140) includes various components configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140), and disperse flushing fluid. Also as will be described in more detail below, the deflection drive assembly (200) is configured to deflect the distal portion of the end effector (140) and the catheter (120) away from the central longitudinal axis (LL) defined by the proximal portion of the catheter (120). Figures 3 to 5 ).

[0043] like Figure 3 As shown, the catheter (120) includes an elongated flexible sheath (122), with an end effector (140) positioned at the distal end of the outer sheath (122). The end effector (140) and various components housed within the outer sheath (122) will be described in more detail below. The catheter assembly (100) is connected to the guidance and actuation system (10) via a cable (30). The catheter assembly (100) is also connected to a fluid source (42) via a fluid conduit (40). A set of field generators (20) is positioned below the patient (PA) and is connected to the guidance and actuation system (10) via another cable (22). The field generators (20) are optional only.

[0044] The boot and drive system (10) of this example includes a console (12) and a display (18). The console (12) includes a first drive module (14) and a second drive module (16). The first drive module (14) is coupled to the conduit assembly (100) via a cable (30). In some variations, the first drive module (14) is operable to receive EP mapping signals obtained via microelectrodes (138) of an end effector (140), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping as known in the art.

[0045] The first driver module (14) of this example is also operable to provide RF power (as will be described in more detail below) to the distal end member (142) of the end effector (140) to ablate tissue. The second driver module (16) is coupled to the field generator (20) via a cable (22). The second driver module (16) is operable to activate the field generator (20) to generate an alternating magnetic field around the heart (H) of the patient (PA). For example, the field generator (20) may include coils that generate the alternating magnetic field in a predetermined working volume containing the heart (H). The first driver module (14) is also operable to receive a position indication signal from a navigation sensor assembly (150) in the end effector (140). In this type, the processor of the console (12) is also operable to process the position indication signal from the navigation sensor assembly (150) to thereby determine the position of the end effector (140) within the patient (PA).

[0046] The navigation sensor assembly (150) includes a pair of coils located on a respective panel (151) operable to generate signals indicating the position and orientation of the end effector (140) within the patient's (PA) body. The coils are configured to generate electrical signals in response to the presence of an alternating electromagnetic field generated by a field generator (20). Other components and techniques that may be used to generate real-time position data associated with the end effector (140) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc. Alternatively, the end effector (140) may not have the navigation sensor assembly (150).

[0047] The display (18) is coupled to the processor of the console (12) and is operable to present images of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping, etc.). The view of the patient's anatomy provided by the display (18) may also be dynamically changed based on signals from the navigation sensor assembly (150) of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), corresponding positional data from the navigation sensor assembly (150) may cause the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to depict the area of ​​the patient's anatomy around the end effector (140) as the end effector (140) moves within the patient (PA). Furthermore, the processor of the console (12) can drive the display (18) to show the location of abnormally conductive tissue sites detected via electrophysiological (EP) mapping using an end effector (140) or otherwise (e.g., using a dedicated EP mapping catheter). By way of example only, the processor of the console (12) can drive the display (18) to overlay the location of the abnormally conductive tissue sites onto an image of the patient's anatomy with some other form of visual indication, such as by overlaying illuminated points, crosshairs, or other forms of visual indication of the abnormally conductive tissue sites.

[0048] The processor of the console (12) can also drive the display (18) to overlay the current position of the end effector (140) onto an image of the patient's anatomy in a manner such as by overlaying illuminated points, crosshairs, a graphical representation of the end effector (140), or some other form of visual indication. As the physician (PH) moves the end effector (140) within the patient (PA), this overlaid visual indication can also move in real time within the image of the patient's anatomy on the display (18), thus providing the operator with real-time visual feedback on the position of the end effector (140) within the patient (PA) as it moves within the patient (PA). Therefore, the image provided by the display (18) can effectively provide video tracking of the position of the end effector (140) within the patient (PA) without requiring any optical instruments (i.e., cameras) for viewing the end effector (140). In the same view, the display (18) can simultaneously visually indicate the location of abnormally conductive tissue sites detected by EP mapping. Therefore, the physician (PH) can view the display (18) to observe the real-time positioning of the end effector (140) relative to the mapped abnormal conductive tissue sites and relative to images of adjacent anatomical structures within the patient (PA).

[0049] The fluid source (42) in this example comprises a bag containing brine or some other suitable flushing fluid. The conduit (40) includes a flexible tube further coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the conduit assembly (100). As described in more detail below, such flushing fluid may be discharged through an opening (158) in the distal end member (142) of the end actuator (140). Such flushing can be provided in any suitable manner that will be apparent to those skilled in the art, taking into account the teachings herein.

[0050] II. Exemplary end actuator of the catheter assembly

[0051] Figures 3 to 5Exemplary components of the end effector (140) and other components of the distal portion of the catheter (120) are shown in more detail. As described above, the end effector (140) includes various components configured to deliver RF energy to target tissue sites, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140) within the patient (PA), and disperse flushing fluid. For example, the end effector (140) includes a distal end member (142), a distal end base (144), a distal circuit disc (146), a strain gauge assembly (148), a navigation sensor assembly (150), a distal spacer stack (152), and a pair of proximal spacers (154). The distal end member (142), distal end base (144), distal circuit disk (146), strain gauge assembly (148), navigation sensor assembly (150), distal spacer stack (152), and proximal spacer (154) are coaxially aligned and longitudinally stacked, such that these components (144-154) define a stacked circuit. A push-pull cable (160) and a flushing tube (180) may extend along the length of the conduit (120) to reach the end effector (140). Each of the aforementioned components will be described in more detail below. An outer sheath (122) surrounds all the aforementioned components except for the distal end member (142), and this outer sheath may be flexible.

[0052] like Figures 3 to 5 As shown, the distal end member (142) of this example includes a cylindrical body (156) with a domed end. The cylindrical body (156) and the domed end may be formed of a conductive material, such as a metal. A plurality of openings (158) are formed through the cylindrical body (156) and communicate with the hollow interior of the distal end member (142). Thus, the openings (158) allow flushing fluid to be delivered from the interior of the distal end member (142) through the cylindrical body (156). The cylindrical body (156) and the domed end are also operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy may be delivered from the first driver module (14) to the nearest-side spacer (154) via a cable (30). The distal end member (142) may also include one or more thermocouples configured to provide temperature sensing capability.

[0053] like Figures 3 to 4As shown, the distal end member (142) of this example also includes one or more EP mapping microelectrodes (138) mounted to the cylindrical body (156). The EP mapping microelectrodes (138) are configured to pick up potentials from tissues in contact with the EP mapping microelectrodes (138). Thus, the EP mapping microelectrodes (138) can be used to determine the location of abnormal electrical activity in tissues within cardiovascular anatomy structures (e.g., pulmonary veins, etc.). The signals picked up by the EP mapping microelectrodes (138) can be transmitted via through-holes or other structures in layers proximal to the strain gauge assembly (148), ultimately reaching the first actuator module (14) of the console (12) via cable (30). Based on the teachings of the various references cited herein, the first actuator module (14) can process the EP mapping signals and provide corresponding feedback to the physician (PH) indicating the location of abnormal electrical activity.

[0054] In a configuration where the cylindrical body (156) is formed of a conductive material to provide RF power for tissue ablation, an electrically insulating material may be inserted between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically isolating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operated in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal end member (142) may include two or more EP mapping microelectrodes (138). Alternatively, the distal end member (142) may be completely devoid of EP mapping microelectrodes (138). The distal end base (144) defines a central aperture configured to provide a path for delivering flushing fluid into the hollow interior of the distal end member (142). The distal end base 144 forms an annular shoulder that is adjacent to the proximal edge of the distal end member (142). The distal end member (142) also defines a transverse notch configured to receive a proximally extending tab of the distal end member (142).

[0055] like Figures 3 to 4As shown, the distal circuit disk (146) is positioned proximal to the distal end base (144). The distal circuit disk (146) includes circuitry operable to transfer RF power to the distal end member (142) via a proximal tab extending from the distal end member (142). In a configuration that includes one or more EP mapping electrodes (138), the distal circuit disk (146) may also include circuitry operable to transmit EP mapping signals from the EP mapping electrodes (138). In some configurations, the distal circuit disk (146) also includes one or more transmit coils. Such transmit coils can provide wireless communication of signals (e.g., EP mapping signals from the microelectrodes (138)) to one or more complementary coils located proximal to the distal circuit disk (146). Additionally or alternatively, such transmit coils can provide wireless communication of RF power from one or more complementary coils located proximal to the distal end member (142).

[0056] In some designs where the coil is incorporated into the distal circuit disk (146) and one or more other layers located near the strain gauge assembly (148), such coils enable wireless communication of electrical signals across the strain gauge assembly (148) without requiring wires, vias, or other conductive structures to longitudinally traverse the strain gauge assembly (148). In some designs, the distal circuit disk (146) includes at least one transmitting coil (TX) paired with the receiving coil (RX) of the navigation sensor assembly (150) to detect the strain applied to the strain gauge assembly (148) in order to determine the contact force applied to the distal end (142). Some other designs of the distal circuit disk (146) may simply omit the TX coil.

[0057] The strain gauge assembly (148) is positioned proximal to the distal circuit disk (146) and is configured to sense external forces impacting the distal end member (142). When the distal end (142) encounters an external force (e.g., when the distal end (142) presses against tissue), those forces are transmitted from the distal end (142) to the distal end base (144), to the distal circuit disk (146), and to the strain gauge assembly (148), enabling the strain gauge to generate a suitable signal corresponding to the magnitude and direction of the external force. The signal from the strain gauge assembly (148) can be transmitted through vias or other structures in a layer proximal to the strain gauge assembly (148), ultimately reaching the first actuator module (14) of the control console (12) via a cable (30). Referring to the teachings herein, the first actuator module (14) can process the strain signal in any suitable manner that will be apparent to a person skilled in the art. By way of example only, when the strain gauge assembly (148) indicates that the distal end member (142) has encountered a force exceeding a predetermined threshold, the console (12) can provide auditory feedback to alert the physician (PH) to prevent the physician (PH) from unintentionally damaging the cardiovascular anatomy with the distal end member (142).

[0058] The navigation sensor assembly (150) can generate signals indicating the position and orientation of the end effector (140) in three-dimensional space with substantially accurate precision. The navigation sensor assembly (150) includes a plurality of panels (151), each panel including an RX coil operable to generate an electrical signal indicating position in response to an alternating magnetic field generated by a field generator (20). Each RX coil may be formed by an electrical trace to define an electrical coil or antenna to receive radio frequency signals emitted by an external transmitter TX coil (e.g., three TX coils provided by a field generator (20) positioned outside the patient's (PA) body and emitting discrete radio frequencies), such that the position and orientation of each RX coil can be determined relative to the TX coil provided by the field generator (20). Signals from the navigation sensor assembly (150) can be transmitted through vias or other structures in a layer located proximal to the strain navigation sensor assembly (150), ultimately reaching the first driver module (14) of the console (12) via a cable (30).

[0059] The central annular body of the navigation sensor assembly (150) defines a central aperture configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142). In a configuration where the central annular body of the navigation sensor assembly includes a wireless communication coil, such coil may also be coupled to a through-hole or other structure in a layer proximal to the strain navigation sensor assembly (150), thereby providing a path for electrical communication with the first driver module (14) of the console (12) via a cable (30).

[0060] In this example, each distal spacer (153) is generally shaped as a disc, with a pair of chord cutouts offset at an angle of 90 degrees from each other. The size and configuration of these cutouts are set to accommodate a corresponding panel (151) of the navigation sensor assembly (150), thereby allowing the panel (151) to be radially inserted between the distal spacer stack (152) and the outer sheath (122). Each distal spacer (153) also includes at least one cable recess, wherein two or more recesses may be offset at an angle of 180 degrees from each other. Such cable recesses are configured to receive the distal end portion (164) of a push-pull cable (160). Each distal spacer (153) also includes a central aperture configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142). Each proximal spacer (154) is shaped as a disc, having two or more holes formed therethrough. The central aperture is configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142). The side apertures are sized and configured to receive the proximal portion (162) of the push-pull cable (160). A second side aperture may also be included.

[0061] As stated above and as Figure 1 and Figure 3 As shown, cable (30) connects the conduit assembly (100) to the drive system (10). Figure 4 As shown, the cable (30) has a wire (32) extending along the length of the conduit (120) to reach the proximal spacer (154) on the nearest side. Therefore, the wire (32) can be housed within the outer sheath (122). The wire (32) can be physically and electrically connected to the proximal spacer (154) on the nearest side in any suitable manner. The conduit assembly (100) is configured such that flushing fluid can be delivered from the fluid source (42) to the conduit (120) via a fluid conduit (40), thereby providing drainage of the flushing fluid through an opening (158) in the distal end member (142). In this example, the fluid path for the flushing fluid includes a flushing tube (180) which... Figures 4 to 5 As shown in the diagram. The proximal end of the flushing tube (180) is connected to a fluid conduit (40) (e.g., at the handle (110) of the conduit assembly (100). The flushing tube (180) extends along the length of the conduit (120) to reach the end actuator (140). In some configurations, flushing fluid may be delivered from the distal end of the flushing tube (180) through a central passage and ultimately reach the interior of the distal end member (142) via a hole (218) in the distal end base (144).

[0062] like Figure 5As best shown, the corresponding distal end portion (164) has a larger outer diameter than the corresponding intermediate portion (162). The distal end portion (174) is coupled to the end effector (140) to prevent the push-pull cable (160) from being pulled proximally out of the end effector (140). A suitable manner in which the push-pull cable (160) can be coupled to the end effector (140) will be apparent to those skilled in the art from the teachings herein.

[0063] III. Exemplary conduit assembly with an exemplary deflection drive component

[0064] In some cases, multiple production lines are used to manufacture conduits. For example, a first production line may produce only unidirectional conduits, and a second production line may produce only bidirectional conduits. A unidirectional conduit is one that deflects away from its longitudinal axis (LL) in only a single direction (e.g., up, down, left, or right). A bidirectional conduit is one that deflects away from its longitudinal axis (LL) in two directions (e.g., up and down or left and right). Multiple production lines can be used because there are several structural differences between unidirectional and bidirectional conduits to achieve this deflection difference. These differences may include a handle (110) and a deflection mechanism (e.g., a deflection drive assembly).

[0065] Using some of the same components for both unidirectional and bidirectional conduits can be beneficial. This can be advantageous because the same production line can then be used to produce both unidirectional and bidirectional conduits. Using the same production line can also save time required to train component operators, reduce the possibility of mixing parts on the production line, ensure cross-compatibility between unidirectional and bidirectional conduit lines for component operators, and generate larger volume discounts during component procurement.

[0066] Using the same or similar handle (110) for both unidirectional and bidirectional catheters can also reassure physicians (PHs) because they may feel more comfortable with the user interface. The catheter assembly (100) captures a modified bidirectional deflection mechanism for unidirectional use. Conversely, the second exemplary catheter assembly (500) captures a modified bidirectional deflection mechanism for unidirectional use.

[0067] As will be described in more detail below, the exemplary deflection drive assembly (300, 400, 508, 608) incorporates an exemplary rack and pinion assembly (304, 404, 518, 618) to (1) transmit rotational motion of the pinion (308, 408) from the rocker arm (230, 501) to linear motion of the rack (306, 406), or (2) transmit linear motion of the rack (524, 624) from the linear slider (514, 614) to rotational motion of the pinion (526, 626). As shown, a single rack (306, 406, 524, 624) interacts with the pinion (308, 408, 526, 626). Although the input member is in Figure 2 and Figures 6 to 12 The input component is shown as a rocker arm (230, 501), but it is shown and described as such. Figures 13 to 17 The linear sliders (514, 614) of the catheter assembly (500, 600). In light of the teachings herein, other suitable input components are also contemplated to be apparent to those skilled in the art.

[0068] A. A first exemplary conduit assembly for bidirectional end effector deflection

[0069] Figure 7 It shows Figure 6 A schematic perspective view of the handle (110) and deflection drive assembly (300), wherein a portion of the handle (110) is omitted to show internal components; as described above, the catheter assembly (100) includes the handle (110), catheter (120), end actuator (140), and deflection drive assembly (300). The catheter (120) extends distally from the handle (110). Figure 6 As shown, the handle (110) includes a first housing portion (112) and a second housing portion (114) that together define an internal cavity (102). The rocker arm (230) includes an elongated body (232) for enhancing the physician's (PH) grip. A suitable example of such a rocker arm (230) for rotatably actuating a bidirectional catheter is shown and described in U.S. Provisional Patent Application No. 62 / 866,109, filed June 25, 2019, entitled "Catheter Deflection System with Deflection Load Limiter," the disclosure of which is incorporated herein by reference in its entirety.

[0070] The deflection drive assembly (300) is configured to deflect the end effector (140) away from the longitudinal axis (LL) defined by the proximal portion of the conduit (120). The deflection drive assembly (300) of this example includes a rocker arm (230) associated with a shank (110), a translation assembly (302), and a rack and pinion assembly (304) coupled to the rocker arm (230). The translation assembly (302) is indirectly or directly coupled to the rack and pinion assembly (304) and the end effector (140). As shown, the translation assembly (302) includes a push-pull cable (160). As will be described in more detail below, the physician (PH) can actuate the rocker arm (230) relative to the handle (110), causing the rack and pinion assembly (304) to actuate the push-pull cable (160) to selectively deflect the end effector (140) laterally away from the longitudinal axis (LL), thereby enabling the physician (PH) to actively steer the end effector (140) within the patient's (PA) body. The rocker arm (230) can drive the translation assembly (302) to deflect the end effector (140) relative to the longitudinal axis (LL) by an angle (A) in two directions (up and down or left and right). The rocker arm (230) is configured to rotate relative to the handle (110) about the drive axis (DD) without translating along the longitudinal axis (LL). As shown, the drive axis (DD) is perpendicular to the longitudinal axis (LL).

[0071] The rack and pinion assembly (304) has a rack (306) and a pinion (308). Figures 7 to 11B Only a single rack (306) is shown. A rack and pinion assembly (304) converts the rotational motion of the pinion (308) from the rocker arm (230) into linear motion of the rack (306). The rack and pinion assembly (304) is connected to the rocker arm (230) and a translational assembly (302) via a shaft (310). As shown, the rocker arm (230) and the pinion (308) are coaxial about a drive axis (DD). The rack (306) is operably connected to the distal end member (142) via a push-pull cable (160) or another suitable translational member that drives unidirectional deflection of the distal end member (142). The rack (306) includes a plurality of teeth (312). Similarly, the pinion (308) includes a plurality of teeth (314) configured to selectively mesh with the teeth (312) of the rack (306). (See reference...) Figures 8A to 8C In more detail, the deflection drive component (300) may optionally include a locking component (316). Several examples of suitable locking components will be described; however, other suitable locking components may also be envisioned.

[0072] As shown, the translation assembly (302) has a single push-pull cable (160) connected to the rack (306) and the end effector (140). Specifically, the push-pull cable (160) is connected to the rack (306) at a proximal attachment point (318) using any of a variety of suitable attachment methods. Similarly, the push-pull cable (160) is connected to the end effector (140) at a distal attachment point (321) using any of a variety of suitable attachment methods. Although the push-pull cable (160) is generally connected to the rack (306) after the rack (306) engages with the pinion (308), it is also conceivable that the push-pull cable (160) may be connected to the rack (306) before the rack (306) engages with the pinion (308). The deflection drive assembly (300) transmits linear motion of the rack (306) to push the push-pull cable (160) in the distal direction (see) Figure 9B Or pull the push-pull cable along the proximal direction (160) (see) Figure 9C Specifically, the rack and pinion assembly (304) is configured to drive a single push-pull cable (160) in opposite directions using input from the rocker arm (230). Although the push-pull cable (160) is shown as a stainless steel rod, other suitable push-pull cables with sufficient flexibility and column strength are also conceivable.

[0073] Figures 8A to 8C An exemplary use of the deflection drive assembly (300) is shown to deflect the distal portion of the end effector (140) and the conduit (120) about the longitudinal axis (LL). Figure 8A and Figure 9A The conduit assembly (100) is shown when the end effector (140) is in a neutral, non-deflection position. Specifically, Figure 8A It shows Figure 6 A top view of the deflection drive assembly (300) is shown, with the rocker arm (230) in a neutral position. The rocker arm (230) is pivotable about a pivot point (319). When the rocker arm (230) is in the neutral position, the rack (306) of the rack and pinion assembly (304) is in a neutral, non-deflection position.

[0074] Figure 9A It shows Figure 1 A top plan view of the distal portion of the conduit (120), omitting a portion of the outer sheath (122) to show the internal components. The push-pull cable (160) is in a neutral, non-deflected position associated with the end effector (140) in a neutral, non-deflected position. Figures 9A to 9CAs shown, the intermediate portion (162) extends proximally from the distal end portion (164) through the outer sheath (122) of the catheter (120). The intermediate portion (162) may include various segments connected to each other to extend to the distal end portion (164). Referring to the teachings herein, the various segments of the intermediate portion (162) may be connected in any suitable manner that will be apparent to those skilled in the art.

[0075] like Figures 8A to 8C As shown, the locking component (316) is inserted between the rocker arm (230) and the translation component (302). Figure 8A A locking component (316) is shown in an unlocked configuration, allowing the end effector (140) to move within a range of angles. Figure 8B and 8C In the locking configuration shown, the locking component (316) locks the end effector (140) at a desired angle relative to the longitudinal axis (LL). Specifically, in Figure 9B In this configuration, the locking assembly (316) prevents the rack (306) from moving further distally. The locking assembly (316) includes locking features (320, 322, 324) defining the locking and unlocking mechanisms. Figure 8A As shown, the pinion (308) includes a locking feature (320). Although the pinion (308) is shown as including only a single locking feature (320), the pinion (308) may include two or more locking features spaced apart circumferentially around the pinion (308). Similarly, the rack (306) includes locking features (322, 324) spaced apart from each other along the longitudinal axis (LL). As shown, the locking features (322, 324) of the rack (306) are located at either end of the working length of the rack (306). The rack (306) may include more or fewer locking features. The locking features (322, 324) of the rack (306) are complementary to the locking features (320) of the pinion (308). The locking feature (320) is configured in the locking configuration to engage one of the locking features (322, 324).

[0076] In the unlocking configuration, the locking features (322, 324) are spaced apart from the locking feature (320). As shown, the locking features (320, 322, 324) are cylindrical in shape. Specifically, the locking feature (320) of the pinion (308) is a cylindrical pin (326), while the locking features (322, 324) of the rack (306) are cylindrical pawls (328, 330). The cylindrical pin (326) of the locking feature (320) of the pinion (308) is configured in the locking configuration to be removably engaged (e.g., snapped into) the cylindrical pawls (328, 330) of the locking features (322, 324) of the rack (306). The cylindrical pin (326) protrudes downward and integrally from the rocker arm (230); adjacent to the pinion (308). A cylindrical pin (326) may be positioned adjacent to the tip of a gear tooth. Cylindrical pawls (328, 330) may be formed into the gear tooth groove of a rack (306).

[0077] Using a rocker arm (230) with the same or less resistance, the cylindrical pin (326) of the pinion (308) can be removed from one of the cylindrical pawls (328, 330) of the rack (306) to unlock the deflection of the end actuator (140). The cylindrical pin (326) and the cylindrical pawls (328, 330) provide a connection that is strong enough to resist deflection when the locking assembly (316) is in position. Figure 10B or Figure 10A The state shown is characterized by unintended longitudinal movement of the rack (306) (e.g., unintended longitudinal movement in response to lateral forces applied to the end effector by the patient's anatomy, etc.); but weak enough to allow the operator to intentionally move the assembly in... Figures 10A to 10B The states shown transition between each other without applying excessive torque to the rocker arm (230). The locking assembly (316) can provide tactile indication when entering or exiting the locking or unlocking configuration. Although not shown, various non-cylindrical shapes are envisioned for the locking features (320, 322, 324), including spherical locking features.

[0078] Figure 8B It shows Figure 8A A top view of the deflection drive assembly (300), but the rocker arm (230) is in the second position (rotated 180 degrees clockwise), the rack (306) is in the first longitudinal position, and the locking assembly (316) is in the first locking configuration. Figure 8B As shown, the first locking configuration is the farthest position of the rack (306). Figure 9B It shows Figure 1Top plan view of the distal portion of the catheter (120), wherein a portion of the outer sheath (122) is omitted to show the internal components, wherein the distal portion of the catheter (120) is positioned relative to... Figure 8B The first deflection position associated with the first position of the rocker arm (230). For example... Figure 9B As shown in the optimal diagram, the rocker arm (230) moves towards... Figure 8B The rotation of the shown rotational position drives the rack and pinion assembly (304) to the corresponding longitudinal position, causing the push-pull cable (160) to be driven further away. Figure 8B As shown, in the first locking configuration, the cylindrical pin (326) of the locking feature (320) is disposed in the cylindrical pawl (330) of the locking feature (324).

[0079] When the physician (PH) desires to deflect the end effector (140) relative to the central longitudinal axis (LL) to Figure 9C When the deflection position is shown, the physician (PH) can rotate the rocker arm (230) relative to the handle (110) to the indicated position. Figure 8C The location shown. Specifically, Figure 8C It shows Figure 8A A top view of the deflection drive assembly (300), but the rocker arm (230) is in a second position, the rack and pinion assembly (304) is in a second longitudinal position; and the locking assembly (316) is in a second locking configuration. Figure 8C As shown, the second locking configuration is the closest side position of the rack (306). Figure 9C It shows Figure 1 A top plan view of the distal portion of the catheter (120), with a portion of the outer sheath (122) omitted to show the internal components, including the flushing tube (180). The distal portion of the catheter (120) is in a deflected position associated with the second position of the rocker arm (230). Figure 8C As shown, the rocker arm (230) moves towards Figure 8C The rotation of the rotational position shown drives the pinion (308) of the rack and pinion assembly (304) to the corresponding rotational position, causing the rack (306) and push-pull cable (160) to move closer to the side. Figure 8C As shown, in the second locking configuration, the cylindrical pin (326) of the locking feature (320) is disposed in the cylindrical pawl (328) of the locking feature (322). It is envisioned that a physician (PH) can move the rocker arm (230) for moving the end effector (140) from... Figure 8A Rotate to the position shown Figure 8C The position shown is achieved without rotating the rocker arm (230) to the indicated position. Figure 8B The location shown.

[0080] B. First exemplary conduit assembly for unidirectional end effector deflection

[0081] It may be necessary to modify the structure to be as follows Figures 8A to 9C The deflection drive assembly (300) shown provides bidirectional deflection to the end effector (140), instead as... Figure 10A-11B The end effector (140) is shown to provide unidirectional deflection. This switching of the end effector (140) from bidirectional to unidirectional deflection can be achieved during the manufacturing (e.g., assembly) of the deflection drive assembly (300) by modifying the neutral position of the deflection drive assembly (300). For example, as Figures 10A to 11B As shown, this can be achieved by modifying the initial position of the rack and pinion assembly (304) and translating the longitudinal position of the connection between the translation assembly (302) and the rack and pinion assembly (304).

[0082] Figure 10A It shows Figure 8A The top view of the deflection drive assembly (300) is shown, but the rocker arm (230) is in a neutral, non-deflection position, the rack (306) is in a first longitudinal position, and the locking assembly (316) is in a first locking configuration. Figure 11A It shows Figure 1 Top plan view of the distal portion of the catheter (120), with a portion of the outer sheath (122) omitted to show the internal components, wherein the distal portion of the catheter (120) is in a neutral, undeflected position. Figure 10A As shown, the rack and pinion assembly (304) from Figure 8A The neutral structure shown is adjusted to Figure 10A The neutral structure shown; and the push-pull cable (160) is fixedly fastened to the longitudinal position of the rack (306) by... Figure 8A The neutral position shown has been adjusted to Figure 10A The neutral position shown. Figure 10A As shown, the locking assembly (316) in the first locking configuration prevents the rack (306) from being driven distally. In the first locking configuration, the cylindrical pin (326) of the locking feature (320) is disposed in the cylindrical pawl (330) of the locking feature (324).

[0083] Figure 10B It shows Figure 10A The top view of the deflection drive assembly (300) is shown, but the rocker arm (230) is in a first rotational position, the rack (306) is moved to a first longitudinal position, and the locking assembly (316) is in a second locking configuration. Figure 11B It shows Figure 1 Top plan view of the distal portion of the catheter (120), wherein a portion of the outer sheath (122) is omitted to show the internal components, wherein the distal portion of the catheter (120) is positioned relative to... Figure 10BThe deflection position associated with the first position of the rocker arm (230). For example... Figure 11B As shown, the rocker arm (230) from Figure 10A The position shown is towards Figure 10B Rotation at the indicated position drives the rack and pinion assembly (304) to the corresponding rotational position, causing the push-pull cable (160) to be driven proximally. Although not necessarily shown in this figure, it should be understood that the distal portion of the conduit (120) can be utilized Figures 10A to 11B The arrangement shown achieves a greater degree of lateral deflection (i.e., bending angle) than can be utilized Figures 8A to 9C The arrangement shown achieves a large degree of lateral deflection (i.e., bending angle).

[0084] C. Second exemplary locking component

[0085] Figure 12 A top schematic diagram of a second exemplary deflection drive assembly (400) is shown, wherein a second exemplary locking assembly (416) is in an unlocked configuration. The deflection drive assembly (400) includes a rocker arm (401) similar to a rocker arm (230), a translation assembly (402) similar to a translation assembly (302), and a rack and pinion assembly (404) similar to a rack and pinion assembly (304). The rack and pinion assembly (404) includes a rack (406) and a pinion (408). The rack (406) includes teeth (412), and the pinion (408) includes teeth (414). The rack (406) is connected to a push-pull cable (434) of the translation assembly (402) at an attachment point (418) similar to a proximal attachment point (318). The locking assembly (416) includes a locking feature (420) on the pinion (408) and locking features (422, 424) on the rack (406). For example, the locking feature (422) is shown as a cylindrical pin (426) that projects downward and integrally from the rocker arm (230) and is adjacent to the pinion (408). The cylindrical pin (426) may be positioned adjacent to the tip of a gear tooth. The locking features (422, 424) are cylindrical pawls (428, 430) respectively formed in the gear tooth grooves. The rocker arm (401) may be connected to the pinion (408) using a shaft (410). The shaft (410) may be fixedly connected to one or both of the rocker arm (401) and the pinion (408).

[0086] The locking assembly (416) may include a biasing member (438) configured to bias the rack (406) away from the pinion (408) to switch the locking assembly (416) from a locked configuration to an unlocked configuration. For example, the rack (406) may be formed of a flexible material, such as a polymer. As shown, the biasing member (438) projects outward from the shank (411) such that it can be manually actuated by a physician (PH). It is envisioned that the locking pin (436) or the biasing member (438) may be used alone or in combination.

[0087] D. An exemplary conduit assembly for bidirectional end effector deflection with a third exemplary locking component. Example catheter assembly

[0088] A conduit assembly including a translational actuator (e.g., a linear slider) can typically be configured to provide only unidirectional deflection of the end effector (140). It may be necessary to manufacture conduit assemblies that include a linear slider capable of providing bidirectional deflection of the end effector (140). Furthermore, it may be necessary to use the same production line to produce both unidirectional conduits including linear sliders and bidirectional conduits including linear sliders. As described above, using the same production line for both unidirectional and bidirectional conduits can also save time required to train component operators, reduce the likelihood of components being mixed on the production line, ensure cross-compatibility between component operators on unidirectional and bidirectional conduit production lines, and generate greater volume discounts during component procurement. For at least these reasons, a second exemplary conduit assembly (500) includes an input member (shown as a linear slider (514)) capable of providing bidirectional deflection to the end effector (504). Bidirectional deflection provides a wider range of deflection angles to the end effector (504) compared to unidirectional deflection.

[0089] Figure 13 It shows something similar to Figure 1A perspective view of a catheter assembly (500) of a catheter assembly (100), wherein additional components are shown schematically; the catheter assembly (500) includes a second exemplary catheter (502) similar to a catheter (120), an end actuator (504) similar to an end actuator (140), a handle (506) similar to a handle (110), and a third exemplary deflection drive assembly (508). The handle (506) includes a first housing portion and a second housing portion (510, 512). The deflection drive assembly (508) includes a linear slider (514), a translation assembly (516), and a rack and pinion assembly (518). The linear slider (514) is slidable by a physician (PH) along the longitudinal axis (LL) between the distal position (DP) shown in dashed lines and the proximal position (PP), also shown in dashed lines, and at any position between the distal position (DP) and the proximal position (PP). As shown, the linear slider (514) translates without rotating along the longitudinal axis (LL).

[0090] The translation assembly (516) includes a push-pull cable (520). The push-pull cable (520) and a flushing tube (521) similar to a flushing tube (180) extend along the length of the conduit (120) to reach the end actuator (504). A cable (30) connects the conduit assembly (500) to the aforementioned drive system (10). The cable (30) is similar to... Figure 3 The wire (32) extends along the length of the conduit (502) to reach the proximal spacer on the nearest side. The wire (32) may be contained within an outer sheath (522) similar to an outer sheath (122). The wire (32) may be physically and electrically connected to the proximal spacer on the nearest side in any suitable manner.

[0091] The conduit assembly (500) is configured to allow flushing fluid to flow through the fluid conduit (40) from a similar... Figure 3 The fluid source (42) delivers fluid to the conduit (502), thereby providing flushing fluid via the distal end member (523) similar to... Figure 3 The opening (158) discharges. Similar to the distal end member (142), the distal end member (523) includes a cylindrical body (540) with a domed end (see...). Figures 16A to 16C In this example, the fluid path for the flushing fluid includes a flushing tube (521). The proximal end of the flushing tube (521) is connected to a fluid conduit (40), for example, at the handle (506) of the conduit assembly (500). The flushing tube (541) extends along the length of the conduit (502) to reach the end actuator (504). In some configurations, the flushing fluid may be delivered from the distal end of the flushing tube (541) through a central passage and ultimately reach the interior of the distal end member (523) via an orifice similar to a hole (218).

[0092] Figure 14 It shows Figure 13 A perspective view of the deflection drive assembly (508). Similar to the rack and pinion assembly (304), the rack and pinion assembly (518) includes a rack (524) and a pinion (526). As shown, a linear slider (514) is fixedly coupled to the rack (524). The rack and pinion assembly (518) converts the linear motion of the rack (524), obtained from the linear motion of the linear slider (514), into the rotational motion of the pinion (526). The pinion (526) extends from a shaft (528). The rack (524) includes a plurality of teeth (530). Similarly, the pinion (308) includes a plurality of teeth (532) configured to selectively mesh with the teeth (530) of the rack (524). A push-pull cable (520) has portions (536, 538). The rack (524) is connected to the distal end member (523) via a push-pull cable (520) or another suitable translation member that drives the distal end member (523) to deflect bidirectionally.

[0093] Continue to refer to Figure 14 The deflection drive assembly (508) includes a pulley (542) coaxial with a pinion (526) of the rack and pinion assembly (518). The pulley (542) is rotatably coupled to the pinion (526) via a shaft (528). The pulley (542) includes an interface surface (544) configured to frictionally engage a push-pull cable (520). See reference... Figures 15A to 16C In more detail, the handle (110) uses a rack and pinion assembly (518) to convert the linear motion of the linear slider (514) into the rotational motion of the pinion (526) synchronized with the push-pull cable (520) via a pulley (542), thereby deflecting the distal end member (523). The distal end member (523) deflects in multiple directions while providing tension on one portion of the push-pull cable (520) (536, 538) and releasing tension on another portion of the push-pull cable (520) (536, 538).

[0094] Figures 15A to 16C An exemplary use of the deflection drive assembly (508) is shown to deflect the distal portion of the end effector (504) and the conduit (502) about a central longitudinal axis (LL). Figure 15A It shows Figure 14A top schematic diagram of the deflection drive assembly (508). As shown, the linear slider (514) is in a first longitudinal position (i.e., a neutral position), the rack and pinion assembly (304) is in a first longitudinal position (i.e., a neutral position), and the third exemplary locking assembly (534) is in an unlocked configuration. Although the shown neutral position has a pinion (526) disposed in the center of the rack (524), this neutral position may have a pinion (526) disposed along the rack (524) towards the proximal side or towards the distal side. Figure 15A As shown, the pinion (526) and pulley (542) are coaxial with each other and laterally offset from each other. The pinion (526) and pulley (542) may be rotatably connected together via a shaft (528) or formed as a single piece. For example, the pinion (526), ​​shaft (528), and pulley (542) may be formed of plastic, metal, or other suitable materials or combinations thereof. A push-pull cable (520) is shown wound around the pulley (542). The distal portion of the rack (524) may be connected to the line (546) at the attachment point (548) to allow the end effector (504) to deflect in one direction; this line is generally not omitted for the unidirectional deflection of the end effector (504).

[0095] like Figures 15A to 15C As shown, the deflection drive assembly (300) may optionally include a locking assembly (534) similar to the locking assembly (316). The locking assembly (534) includes locking features (552, 554, 556) defining locking and unlocking configurations. Figure 15A As shown, the pinion (526) includes a locking feature (552). Although the pinion (526) is shown as including only a single locking feature (552), the pinion (526) may include two or more locking features. Similarly, the rack (524) includes locking features (554, 556) spaced apart from each other along the longitudinal axis (LL). As shown, the locking features (554, 556) of the rack (524) are located at either end of the working length of the rack (524). The frame (524) may include more or fewer locking features. The locking features (554, 556) of the rack (524) are complementary to the locking features (552) of the pinion (526). The locking feature (552) is configured in the locking configuration to engage one of the locking features (554, 556).

[0096] In the unlocking mechanism, the locking features (554, 556) and the locking feature (552) are spaced apart by a certain distance. In other words, in Figure 15AIn the unlocked position, the locking features (554, 556) of the rack (524) do not engage with the locking features (552) of the pinion (526). As shown, the locking features (552, 554, 556) are cylindrical in shape. Specifically, the locking feature (552) of the pinion (526) is a cylindrical pin (558), while the locking features (554, 556) of the rack (524) are cylindrical pawls (560, 562). The cylindrical pin (558) of the locking feature (552) of the pinion (526) is configured in the locking configuration to be removably engaged with (e.g., snapped into) the cylindrical pawls (560, 562) of the locking features (554, 556) of the rack (524). The cylindrical pin (558) can be positioned adjacent to the tip of a gear tooth. Alternatively, a cylindrical pin (558) may protrude integrally from a pulley (542), which is rotatably coupled to a pinion (526). Cylindrical pawls (560, 562) may be formed into the gear teeth of a rack (524). Using a linear slider (514) with the same or less resistance, the cylindrical pin (558) of the pinion (526) can be removed from one of the cylindrical pawls (560, 562) of the rack (524) to unlock the deflection of the end actuator (504). Thus, the locking assembly (534) can provide tactile indication when entering or exiting the locking and unlocking configurations. Although not shown, various non-cylindrical shapes are also envisioned for the locking features (552, 554, 556).

[0097] Figure 16A It shows Figure 13 A top plan view of the distal portion of the catheter, wherein a portion of the outer sheath (522) is omitted to show the internal components, wherein the distal portion of the catheter (502) is positioned relative to... Figure 15A The neutral, non-deflection position associated with the first longitudinal position of the linear slider (514). Therefore, Figure 16A The conduit assembly (500) is shown when the end effector (504) is in a neutral, non-deflected position. Similarly, the push-pull cable (520) is in a first position associated with the end effector (504) in the non-deflected position. A portion (536) of the push-pull cable (520) is connected to the distal end member (523) of the end effector (504) at attachment point (564). Similarly, a portion (538) of the push-pull cable (520) is connected to the distal end member (523) of the end effector (504) at attachment point (566). Since the end effector (504) is shown in a neutral, non-deflected position, the attachment point (564) is positioned along the longitudinal axis (LL) at approximately the same longitudinal location as the attachment point (566).

[0098] Figure 15BIt shows Figure 15A A top view of the deflection drive assembly (508). As shown, the linear slider (514) is in a second longitudinal position, the rack and pinion assembly (304) is in a second longitudinal position, and the locking assembly (534) is in a first locking configuration. Figure 15B As shown, the linear slider (514) is actuated distally (indicated by arrow (568)), which drives the rack (524) distally along the longitudinal axis (LL). Figure 15B As shown, the first locking configuration is the closest position of the rack (524). Since the teeth (530) of the rack (524) mesh with the teeth (532) of the pinion (526), ​​the longitudinal movement of the rack (524) causes the pinion (526) to rotate clockwise (as indicated by arrow (570)). This clockwise rotation of the pinion (526) drives the clockwise rotation of the pulley (542), since the pinion (526) and the pulley (542) are rotatably connected. For example, the pinion (526) and the pulley (542) may be integral or otherwise integrally fastened together. The clockwise rotation of the pulley (542) drives the clockwise rotation of the push-pull cable (520). Specifically, portion (536) of the push-pull cable (520) is pushed in the distal direction (as indicated by arrow (572)) and portion (538) of the push-pull cable (520) is pulled in the proximal direction (as indicated by arrow (574)). Figure 15B As shown, in the first locking configuration, the cylindrical pin (558) of the locking feature (552) is disposed in the cylindrical pawl (562) of the locking feature (556).

[0099] Alternatively, it is envisioned that the pulley (542) can be replaced by a sprocket, and at least a portion of the push-pull cable (520) (e.g., the portion that will directly engage the sprocket during operation) can be replaced by a chain, such that the chain can be wound around the sprocket, wherein the first and second push-pull cables engage at each end of the chain. In this alternative arrangement utilizing the chain and sprocket arrangement, the first and second push-pull cables move in opposite directions along the longitudinal axis (LL) in a manner similar to the bidirectional conduit shown and described in U.S. Provisional Patent Application No. 62 / 866,109, filed June 25, 2019, entitled “Catheter Deflection System with Deflection LoadLimiter,” the disclosure of which is incorporated herein by reference in its entirety.

[0100] Figure 16B It shows Figure 13A top plan view of the distal portion of the catheter (502), omitting a portion of the outer sheath (522) to show the internal components. As shown, the distal portion of the catheter (502) is positioned relative to... Figure 15B The first deflection position is associated with the second longitudinal position of the linear slider (514). When the physician (PH) desires to deflect the end effector (504) relative to the central longitudinal axis (LL) in the first direction to... Figure 16B At the first deflection position shown, the physician (PH) can translate the linear slider (514) relative to the handle (506) to Figure 15B The position shown. Since the end effector (504) is shown in the first deflection position, the attachment point (564) is located on the far side of the attachment point (566) along the longitudinal axis (LL).

[0101] Figure 15C Depicting Figure 15A A top view of the deflection drive assembly (508), but the linear slider (514) is in a third longitudinal position, the rack and pinion assembly (518) is in a third longitudinal position, and the locking assembly (534) is in a second locking configuration. Figure 15C As shown, a linear slider (514) is actuated proximally (indicated by arrow (576)) and drives a rack (524) proximally along the longitudinal axis (LL). Since the teeth (530) of the rack (524) mesh with the teeth (532) of the pinion (526), ​​the longitudinal movement of the rack (524) causes the pinion (526) to rotate counterclockwise (as indicated by arrow (578)). This rotation of the pinion (526) drives the pulley (542) to rotate counterclockwise, as the pinion (526) and pulley (542) are rotatably connected. The counterclockwise rotation of the pulley (542) drives the push-pull cable (160) to rotate counterclockwise. Specifically, portion (536) of the push-pull cable (520) is pulled in the proximal direction (as indicated by arrow (580)), and portion (538) of the push-pull cable (520) is pushed in the distal direction (as indicated by arrow (582)). Figure 15C As shown, in the second locking configuration, the cylindrical pin (558) of the locking feature (552) is disposed in the cylindrical pawl (560) of the locking feature (554). Figure 15C As shown, the second locking configuration is the nearest side position of the rack (524).

[0102] Figure 16C It shows Figure 13 A top plan view of the distal portion of the catheter (502), where a portion of the outer sheath is omitted to show the internal components, wherein the distal portion of the catheter (502) is positioned relative to... Figure 15CThe second deflection position is associated with the third longitudinal position of the linear slider (514). Since the end actuator (504) is shown in the second deflection position, the attachment point (564) is located near the attachment point (566) along the longitudinal axis (LL).

[0103] E. Fourth Exemplary Locking Component

[0104] Figure 17 A top view of a fourth exemplary deflection drive assembly (608) is shown, wherein a fourth exemplary locking assembly (634) is in a locked configuration. The deflection drive assembly (608) includes a linear slider (614) similar to a linear slider (514), a translation assembly (616) similar to a translation assembly (516), and a rack and pinion assembly (618) similar to a rack and pinion assembly (518). The rack and pinion assembly (618) includes a rack (624) with teeth (630) and a pinion (626) with teeth (632). The rack (624) is coupled to the linear slider (614). The locking assembly (634) includes a locking feature (652) located on the pinion (626) and locking features (654, ​​656) located on the rack (624). For example, the locking feature (652) is shown as a cylindrical pin (658), and the locking features (654, ​​656) are cylindrical pawls (660, 662) respectively formed in the gear tooth grooves. The cylindrical pin (658) may be formed together with the pulley (642).

[0105] A linear slider (614) is configured to translate relative to a handle (606) along a longitudinal axis (LL). The linear slider (614) is coupled to a pinion (626) via a shaft (628). The shaft (628) rotatably connects the pinion (626) and a pulley (642). The deflection drive assembly (608) includes a pulley (642) coaxial with the pinion (626) of the rack and pinion assembly (618). The pulley (642) is rotatably coupled to the pinion (626) via a shaft (628). The pulley (642) includes an interface surface (644) configured to contact a push-pull cable (620). The distal portion of the rack (524) can be coupled to a line (546) at an attachment point (548). The push-pull cable (620) has portions (636, 638) similar to those of the push-pull cable (520). The portion (636) of the push-pull cable (620) is connected to the distal end member (523) of the end effector (504) at an attachment point similar to an attachment point (564). The portion (638) of the push-pull cable (620) is connected to the distal end member (523) of the end effector (504) at an attachment point similar to an attachment point (566).

[0106] Instead of or as a supplement to the locking features (652, 654, 656), the locking assembly (634) may include a locking feature (shown as a locking pin (668)) that selectively engages with the teeth (670) of the linear slider (614) to maintain the deflection angle of the end effector (504) (see [link]). Figures 16A to 16C The locking pin (668) selectively holds the linear slider (614) in the locked position. Instead of the locking features (652, 654, 656) or the locking pin (668), or as a supplement to the locking features (652, 654, 656) or the locking pin (668), the locking assembly (634) may include a locking feature (shown as a locking pin (672)) that selectively engages with the teeth (674) of the rack (624) to maintain the deflection angle of the end effector (504) (see [link]). Figures 16A-16C ).

[0107] F. Exemplary Methods

[0108] Figure 18 A method (700) for operating a conduit assembly (100, 500) is shown. Step (702a) of method (700) includes manually actuating a rocker arm (230, 401) using a rotational motion. Step (702b) of method (700) includes manually actuating a linear slider (514, 614) using a linear motion. Step (704a) of method (700) includes transmitting the rotational motion of the rocker arm (230, 401) to a pinion (308, 408). Step (704b) of method (700) includes transmitting the linear motion of the linear slider (514, 614) to a rack (524, 624).

[0109] Step (706a) of method (700) includes converting the rotational motion of the pinions (308, 408) into subsequent rotational motion of the racks (306, 406) using rack and pinion assemblies (304, 404). Step (706b) of method (700) includes transmitting the linear motion of the racks (524, 624) to the subsequent rotational motion of the pinions (526, 626) using rack and pinion assemblies (518, 618). Step (708a) of method (700) includes transmitting the subsequent linear motion of the racks (306, 406) to translational assemblies (302, 402). Step (708b) of method (700) includes transmitting the subsequent rotational motion of the pinions (526, 626) to translational assemblies (516, 616).

[0110] Step (710) of method (700) includes using translation components (302, 402) to deflect the end effector (140) by an angle relative to the longitudinal axis (LL) or using translation components (516, 616) to deflect the end effector (504) by an angle relative to the longitudinal axis (LL). Step (712) of method (700) includes using locking components (316, 416, 534, 634) to lock the end effector (140, 504, 604) at a desired angle away from the longitudinal axis (LL) in a locked configuration.

[0111] IV. Exemplary Combinations

[0112] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0113] Example 1

[0114] An apparatus comprising: (a) a handle; (b) a conduit extending distally from the handle, the conduit having a proximal portion defining a longitudinal axis; (c) an end effector extending distally from the conduit, the end effector including at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly including: (i) an input member associated with the handle; and (ii) a translation assembly coupled to: (iii) a rack and pinion assembly connected to an input member and a translational assembly, the rack and pinion assembly being configured to: (1) transmit rotational motion of the pinion from the input member to linear motion of the rack to push the translational member distally or pull it proximally, or (2) transmit linear motion of the rack from the input member to rotational motion of the pinion to move a first end of the translational member proximally and a second end of the translational member distally.

[0115] Example 2

[0116] According to the device of embodiment 1, the input member includes a rocker arm configured to rotate about a drive axis relative to the handle, and the rack and pinion assembly is configured to transmit the rotational motion of the pinion from the rocker arm to the linear motion of the rack to push the translation member distally or pull it proximally.

[0117] Example 3

[0118] According to the device of embodiment 2, the translation component further includes a push-pull cable connected to the rack, and the deflection drive component is configured to transmit linear motion of the rack to push the push-pull cable in a distal direction or pull the push-pull cable in a proximal direction.

[0119] Example 4

[0120] According to any one or more of the devices described in Embodiments 2 to 3, the rocker arm and the pinion are coaxial about the drive axis.

[0121] Example 5

[0122] According to the device of embodiment 1, the input member includes a linear slider configured to move longitudinally along a longitudinal axis, and the rack and pinion assembly is configured to transmit the linear motion of the rack from the linear slider to the rotational motion of the pinion, so as to move a first end of the translation member proximally and a second end of the translation member distally.

[0123] Example 6

[0124] According to the device of Embodiment 1, the translation component further includes a push-pull cable having a first portion and a second portion, and the deflection drive component is configured to transmit the rotational motion of the pinion to push the first portion of the push-pull cable in a distal direction and pull the second portion of the push-pull cable in a proximal direction.

[0125] Example 7

[0126] According to the device of embodiment 6, the deflection drive assembly further includes a pulley coaxial with the pinion of the rack and pinion assembly, and the pulley includes an interface surface configured to contact the push-pull cable.

[0127] Example 8

[0128] According to any one or more of the devices described in Embodiments 5 to 7, the linear slider is fixedly connected to the rack, and the pulley is rotatably connected to the pinion.

[0129] Example 9

[0130] The device according to any of the foregoing embodiments further includes a locking component inserted between the input member and the translation component, the locking component being movable between a locking configuration and an unlocking configuration, the locking component being configured in the locking configuration to lock the end effector at the angle relative to the longitudinal axis.

[0131] Example 10

[0132] According to the device of embodiment 9, the locking component includes a first locking feature and a second locking feature, the first locking feature and the second locking feature being configured to switch between a locking configuration and an unlocking configuration, the locking component being configured in the locking configuration to prevent the translation component from translating along the longitudinal axis.

[0133] Example 11

[0134] According to the device of embodiment 10, the first locking feature is disposed on the pinion, the second locking feature is disposed on the rack, the second locking feature is complementary to the first locking feature, the first locking feature and the second locking feature are configured to mesh with each other in the locking structure, and the first locking feature and the second locking feature are configured to be spaced apart from each other by a certain distance in the unlocking structure.

[0135] Example 12

[0136] According to the device described in any one or more of Embodiments 10 to 11, the first locking feature and the second locking feature are cylindrical.

[0137] Example 13

[0138] According to the device of embodiment 12, the first locking feature includes a cylindrical pin, and the second locking feature includes a cylindrical pawl configured to receive the cylindrical pin in the locking configuration.

[0139] Example 14

[0140] According to the device of embodiment 13, the cylindrical pin protrudes integrally from the input member, and the cylindrical pawl is formed into the gear tooth groove of the rack.

[0141] Example 15

[0142] According to any one of Embodiments 9 to 14, the locking assembly further includes a biasing member configured to bias the rack away from the pinion to switch to the unlocking configuration.

[0143] Example 16

[0144] The device according to any one or more of Embodiments 1 to 8 further includes a locking component, the locking component including a first locking feature and a second locking feature, the first locking feature and the second locking feature being configured to switch between a locking configuration and an unlocking configuration, the first locking feature being disposed on a translation component and the second locking feature being selectively positioned on the handle.

[0145] Example 17

[0146] According to the device of embodiment 10, the input component includes a rocker arm configured to rotate relative to the handle about a drive axis, a first locking feature disposed on the rocker arm and a second locking feature movable on the handle.

[0147] Example 18

[0148] According to the device described in Embodiment 17, the drive axis is perpendicular to the longitudinal axis.

[0149] Example 19

[0150] According to the device of embodiment 10, the input member includes a linear slider configured to translate relative to the handle along the longitudinal axis, a first locking feature disposed on the linear slider and a second locking feature movable on the handle.

[0151] Example 20

[0152] According to the device described in Embodiment 1, the translation component consists of a single push-pull cable, and the rack and pinion assembly is configured to drive the single push-pull cable in opposite directions.

[0153] Example 21

[0154] According to the device described in Embodiment 20, the single push-pull cable includes a stainless steel rod.

[0155] Example 22

[0156] According to any one or more of the devices described in Embodiments 1 to 21, the at least one electrode is configured to emit RF energy.

[0157] Example 23

[0158] According to any one or more of the devices described in Examples 1 to 22, the at least one electrode is configured to perform electrophysiological mapping.

[0159] Example 24

[0160] According to any one or more of the devices described in Embodiments 1 to 23, the end effector includes a strain gauge assembly.

[0161] Example 25

[0162] According to any one or more of the devices described in Examples 1 to 24, the end effector is configured to emit flushing fluid.

[0163] Example 26

[0164] According to any one or more of the devices described in Embodiments 1 to 25, the end effector includes a position sensor.

[0165] Example 27

[0166] An apparatus comprising: (a) a handle; (b) a conduit extending distally from the handle, the conduit having a proximal portion defining a longitudinal axis; (c) an end effector extending distally from the conduit, the end effector including at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly including: (i) an input member associated with the handle; (ii) a translational assembly coupled to the end effector, the input member being configured to drive the translational assembly to deflect the end effector away from the longitudinal axis by an angle; and (iii) a rack and pinion assembly coupled to the input member and the translational assembly, the rack and pinion assembly comprising a rack and pinion, the rack and pinion assembly being configured to: 1) Transmitting the rotational motion of the pinion from the input member to the linear motion of the rack to push the translation member distally or pull it proximally, or (2) Transmitting the linear motion of the rack from the input member to the rotational motion of the pinion to move the first end of the translation member proximally and the second end of the translation member distally; and (e) a locking assembly configured to switch between a locking configuration and an unlocking configuration, the locking assembly including a first locking feature and a second locking feature configured in the locking configuration to lock the end actuator at the angle away from the longitudinal axis, and in the unlocking configuration to allow the end actuator to move along a range of angles.

[0167] Example 28

[0168] According to the device of embodiment 27, the locking component is inserted between the input member and the translation component, and the locking component is configured in the locking configuration to prevent the translation component from translating along the longitudinal axis.

[0169] Example 29

[0170] According to the device of embodiment 28, the first locking feature is disposed on the pinion, the second locking feature is disposed on the rack, the second locking feature is complementary to the first locking feature, the first locking feature and the second locking feature are configured to mesh with each other in the locking structure, and the first locking feature and the second locking feature are configured to be spaced apart from each other by a certain distance in the unlocking structure.

[0171] Example 30

[0172] According to the device described in any one or more of Embodiments 27 to 30, the first locking feature and the second locking feature are cylindrical.

[0173] Example 31

[0174] According to the device of embodiment 30, the first locking feature is a cylindrical pin, and the second locking feature is a cylindrical pawl configured to receive the cylindrical pin in the locking configuration.

[0175] Example 32

[0176] A method of operating a device, the device comprising: (a) a handle; (b) a conduit extending distally from the handle, the conduit having a proximal portion defining a longitudinal axis; (c) an end effector extending distally from the conduit, the end effector including at least one electrode; (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) an input member associated with the handle; (ii) a translation assembly coupled to the end effector; and (iii) a rack and pinion assembly connected to the input member and the translation assembly. The connection, wherein the rack and pinion assembly comprises a rack and a pinion, the method comprising: (a) manually actuating the input member using a rotational motion or a linear motion; (b) transmitting the rotational motion of the input member to the pinion or the linear motion of the input member to the rack; (c) using the rack and pinion assembly to transmit the rotational motion of the pinion to a subsequent linear motion of the rack or the linear motion of the rack to a subsequent rotational motion of the pinion; (d) transmitting the subsequent linear motion to the translational assembly or the subsequent rotational motion to the translational assembly; and (e) using the translational assembly to deviate the end effector from the longitudinal axis by a certain angle.

[0177] Example 33

[0178] According to the method of embodiment 32, the method further includes locking the end effector at an angle away from the longitudinal axis in the locking configuration.

[0179] Example 34

[0180] A method of manufacturing an apparatus, the apparatus comprising: (a) a handle; (b) a conduit extending distally from the handle, the conduit having a proximal portion defining a longitudinal axis; (c) an end effector extending distally from the conduit, the end effector including at least one electrode; and (d) a deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly including: (i) an input member associated with the handle, (ii) a translational assembly coupled to the end effector, and (iii) teeth coupled to the input member and the translational assembly. A rack and pinion assembly comprising a rack and a pinion, the method comprising: (a) inserting the pinion to engage with the rack at a first position configured for unidirectional end actuator deflection, the first position being longitudinally spaced from a second position along the rack for bidirectional end actuator deflection; or inserting the pinion to engage with the rack at a third position configured for bidirectional end actuator deflection, the third position being longitudinally spaced from a fourth position along the rack for unidirectional end actuator deflection; and (b) attaching a translational assembly to the rack and pinion assembly.

[0181] V. Miscellaneous

[0182] Any of the devices described herein may be cleaned and sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art may also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization (with or without gas plasma or vapor).

[0183] It should be understood that any embodiment described herein may also include various other features in addition to or in lieu of those described above. By way of example only, any embodiment described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0184] It should be understood that any one or more of the teachings, expressions, embodiments, and examples described herein can be combined with any one or more of the other teachings, expressions, embodiments, and examples described herein. Therefore, the teachings, expressions, embodiments, and examples described above should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0185] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0186] While various embodiments of the invention have been shown and described, further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, types, geometries, materials, dimensions, ratios, steps, etc., discussed above are exemplary and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus for providing cardiac ablation, the apparatus comprising: (a) Handle; (b) A catheter extending distally from the handle, the proximal portion of the catheter defining a longitudinal axis; (c) An end effector extending distally from the conduit, the end effector including at least one electrode; and (d) A deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) An input component associated with the handle. (ii) a translation assembly, said translation assembly being coupled to the end effector, and (iii) A rack and pinion assembly connected to the input member and the translational assembly, the rack and pinion assembly being configured to drive the translational assembly to deflect the end effector relative to the longitudinal axis by a certain angle, the rack and pinion assembly consisting of a rack and pinion, the rack and pinion assembly being configured as follows: (1) The rotational motion of the pinion from the input component is transmitted to the linear motion of the rack to push the translation component distally or pull it proximally, or (2) The linear motion of the rack from the input member is transmitted to the rotational motion of the pinion, so that the first end of the translation assembly moves proximally and the second end of the translation assembly moves distally. (e) A locking assembly, inserted between the input member and the translation assembly, the locking assembly comprising: a pin disposed on at least one tooth of a first plurality of teeth of the pinion, and at least one pawl formed in the rack between the nearest and farthest teeth of a second plurality of teeth of the rack, wherein the pin is configured to engage with the at least one pawl to releasably lock the end effector at a selected angle relative to the longitudinal axis.

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

3. The device of claim 2, wherein the translation component further comprises a push-pull cable connected to the rack, and the deflection drive component is configured to transmit linear motion of the rack to push the push-pull cable in a distal direction or pull the push-pull cable in a proximal direction.

4. The device according to claim 2, wherein the rocker arm and the pinion are coaxial around the drive axis.

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

6. The device according to claim 5, wherein the linear slider is fixedly connected to the rack, and the pulley is rotatably connected to the pinion.

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

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

9. The device of claim 1, further comprising a locking component disposed between the input member and the translation component, the locking component being movable between a locking configuration and an unlocking configuration, the locking component being configured in the locking configuration to lock the end effector at the angle relative to the longitudinal axis.

10. The device of claim 9, wherein the locking component includes a first locking feature and a second locking feature, the first locking feature and the second locking feature being configured to switch between a locking configuration and an unlocking configuration, the locking component being configured in the locking configuration to prevent the translation component from translating along the longitudinal axis.

11. The device according to claim 10, wherein the first locking feature is disposed on the pinion, the second locking feature is disposed on the rack, the second locking feature is complementary to the first locking feature, the first locking feature and the second locking feature are configured to mesh with each other in the locking configuration, and the first locking feature and the second locking feature are configured to be spaced apart from each other by a certain distance in the unlocking configuration.

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

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

14. The device of claim 9, wherein the locking assembly further includes a biasing member configured to bias the rack away from the pinion to switch to the unlocking configuration.

15. The device of claim 1, further comprising a locking assembly including a first locking feature and a second locking feature, the first locking feature and the second locking feature being configured to switch between a locking configuration and an unlocking configuration, the first locking feature being disposed on the translation assembly and the second locking feature being selectively positioned on the handle.

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

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

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

19. An apparatus for providing cardiac ablation, the apparatus comprising: (a) Handle; (b) A catheter extending distally from the handle, the proximal portion of the catheter defining a longitudinal axis; (c) An end effector extending distally from the conduit, the end effector including at least one electrode; (d) A deflection drive assembly configured to deflect the end effector away from the longitudinal axis, the deflection drive assembly comprising: (i) An input component associated with the handle. (ii) a translation assembly coupled to the end effector, the input member being configured to drive the translation assembly to deflect the end effector away from the longitudinal axis by an angle; and (iii) A rack and pinion assembly connected to the input member and the translation member, the rack and pinion assembly comprising a rack and a pinion, the rack and pinion assembly being configured such that: (1) The rotational motion of the pinion from the input component is transmitted to the linear motion of the rack to push the translation component distally or pull it proximally, or (2) The linear motion of the rack from the input member is transmitted to the rotational motion of the pinion, causing the first end of the translation assembly to move proximally and the second end of the translation assembly to move distally; and (e) A locking assembly, inserted between the input member and the translation member, the locking assembly being configured to switch between a locking configuration and an unlocking configuration, the locking assembly comprising: a pin disposed on at least one tooth of a first plurality of teeth of the pinion, and a first pawl and a second pawl formed within the rack between the nearest and farthest teeth of a second plurality of teeth of the rack, the first pawl and the second pawl being configured to lock the end effector at an angle away from the longitudinal axis in the locking configuration, the first pawl and the second pawl being configured to allow the end effector to move along a range of angles in the unlocking configuration, wherein the pin is configured to engage with the first pawl or the second pawl to releasably lock the end effector at a selected angle relative to the longitudinal axis.

Images