Apparatus for catheter insertion and locking detection and method for performing same

Abstract

Disclosed are an apparatus and method for medical applications and, more particularly, a hub attachment collar applicable for safe disconnect of guide tools and devices used in medical procedures, including in robotic medical procedures, with such guide tools and devices including catheters, cameras, and endoscopes.

Description

APPARATUS FOR CATHETER INSERTION AND LOCKING DETECTION AND METHOD FOR PERFORMING SAMECROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 603,338, which was filed with the U.S. Patent and Trademark Office on November 28, 2023, the entire disclosure of which is incorporated herein by reference.BACKGROUNDFIELD

[0002] The present disclosure relates generally to robotic catheter systems and, more particularly, sensors, systems, and methods for detection of insertion and locking of catheters.RELATED ART

[0003] Flexible medical instruments such as endoscopic surgical devices and catheters are broadly used in surgical and probative settings. Such flexible medical instruments continue to gain acceptance in the medical field. The medical devices generally include a flexible tube commonly referred to as a sleeve or sheath, with one or more tool channels extending along or inside the sheath to allow access to end effectors located at a distal end of the sheath.

[0004] Conventional systems include U.S. Pub. 2021 / 0259794 to Kato et al., entitled Medical apparatus having dual manipulation means and methods for use thereof; U.S. Pat. 11,559,190 to Okumura et al., entitled Steerable medical device and method; and U.S. Pub. 2021 / 0369085 to Kato et al., entitled Medical apparatus with reflow trapped anchors and method of use thereof, the content of each of which is incorporated herein by reference.

[0005] EP 2589407B1 discusses a catheter system with an attachable catheter hub via rotation around the hub for attachment. U.S. Pat. 11,553,917 to Sgroi discusses a loading unit locking collar with rotational actuated release. JP6857283B2 discusses a handheld surface cleaning unit in which components are mated together via tab flexes into a slot to lock components, with push tab release. JP2023103865A and U.S. Pub.2021 / 0121051 discuss a medical device and bendable unit. JP 2022-115015 discusses a medical apparatus having a main body that includes a plurality of drive sources, and an operation unit movable between a fixed position and a detached position when a bendable unit is attached to a base station.

[0006] In robotic catheter systems, a wire driven catheter may connect to a motor driven actuator by insertion of a proximal catheter hub into an actuator receptacle. Twisting the collar locks each of the catheter driving wires to respective actuator motor mechanisms.

[0007] U.S. Pat. 7,857,787 to Masters discusses systems and methods for locking and detecting the presence of a catheter. Conventional systems such as Masters utilize a hall sensor, i.e., a magnet in the proximal end of catheter, with a sensor in the receptacle, to detect the presence of a catheter. Conventional systems provide protection circuitry to disable the motor drive when catheter is not detected or use multiple magnets to determine different catheters.SUMMARY

[0008] Conventional systems lack a means for determining whether the user has connected the catheter and / or locked the catheter to the drive wires. To overcome shortcomings of conventional systems and methods, the present disclosure detects states of locking, performs locking sensing by proxy, and performs a catheter check method for initiating robotic navigation.

[0009] An aspect of the present disclosure provides a robotic apparatus that includes a catheter hub, a hub attachment collar, a collar locking sensor, and a catheter insertion sensor 152 that is configured to detect rotation of the catheter hub 170, with the catheter insertion sensor being configured to detect insertion of the catheter hub into an actuation handle.

[0010] Another aspect of the present disclosure provides a method of drive wire homing that includes inserting a catheter hub into an actuation handle; outputting a first signal by a catheter insertion sensor upon detecting insertion of the catheter hub into the actuation handle to a predetermined depth; rotating an attachment collar of the catheter hub relative to the catheter hub to engage at least two drive wires to respective clamps; outputting a second signal upon detecting, by a locked state sensor,rotation of the catheter hub to a predetermined location; summing the first signal and the second signal; and based on the sum of the first signal and the second signal, confirming locking of each clamp.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings, which are incorporated herein and form part of the specification, illustrate various embodiments, objects, features, and advantages of the present disclosure.

[0012] FIG. 1 illustrates a medical environment for use of a robotic catheter system, according to an embodiment.

[0013] FIG. 2 illustrates components of the robotic catheter system, according to an embodiment.

[0014] FIG. 3 illustrates a steerable catheter, according to an embodiment.

[0015] FIG. 4 is perspective view of an actuation handle of robotic catheter system of a medical apparatus, combined with a catheter hub, with a hub attachment collar therebetween, according to an embodiment.

[0016] FIG. 5 illustrates zones of movement of the hub attachment collar, according to an embodiment.

[0017] FIGS. 6A and 6B illustrate an external cylinder and an inner cylinder of the hub attachment collar, according to an embodiment.

[0018] FIGS. 7A to 7D illustrate detection states during a process of attaching / detaching the catheter hub to the actuation handle, according to an embodiment.

[0019] FIG. 8A illustrates a shelf mechanism for aligning the catheter hub with the attachment collar and a catheter insertion sensor, according to an embodiment.

[0020] FIG. 8B illustrates operation of the catheter insertion sensor with catheter hub inserted into the actuation handle recess, according to an embodiment.

[0021] FIGS. 9 A and 9B illustrate operation of the catheter insertion sensor, according to an another embodiment.

[0022] FIG. 10 is a flowchart illustrating an initialization routine utilizing a catheter insertion sensor and a collar locking sensor, according to an embodiment.

[0023] FIG. 11 is a flowchart illustrating an alternative initialization routine, according to an embodiment.DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0024] Aspects of the present disclosure can be understood by reading the following detailed description in light of the accompanying figures. It is noted that, in accordance with standard practice, the various features of the drawings are not drawn to scale and do not represent actual components. Several details such as dimensions of the various features may be arbitrarily increased or reduced for ease of illustration. In addition, reference numerals, labels and / or letters are repeated in the various examples to depict similar components and / or functionality. This repetition is for the purpose of simplicity and clarity and does not in itself limit the various embodiments and / or configurations the same components discussed.

[0025] Before the various embodiments are described in further detail, it shall be understood that the present disclosure is not limited to any particular embodiment. It is also to be understood that the terminology used herein is for the purpose of describing exemplary embodiments only, and is not intended to be limiting. Embodiments of the present disclosure may have many applications within the field of medical treatment or minimally invasive surgery (MIS).

[0026] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. In addition, while the subject disclosure is described in detail with reference to the enclosed figures, it is done so in connection with illustrative exemplary embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope of the subject disclosure as defined by the appended claims. Although the drawings represent some possible configurations and approaches, the drawings are not necessarily to scale and certain features may be exaggerated, removed, or partially sectioned to better illustrate and explain certain aspects of the present disclosure. The descriptions set forth herein are not intended to be exhaustive or otherwise limit or restrict the claims to the precise forms andconfigurations shown in the drawings and disclosed in the following detailed description.

[0027] Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an” limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.

[0028] In addition, even if a specific number of introduced claim recitation(s) is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those instances where a convention analogous to "at least one of A, B, or C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand theconvention (e.g., "a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will be further understood by those within the art that typically a disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms unless context dictates otherwise. For example, the phrase "A or B" will be typically understood to include the possibilities of "A" or "B" or "A and B."

[0029] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached", "coupled" or the like to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown in one embodiment can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0030] The terms first, second, third, etc. may be used herein to describe various elements, components, regions, parts and / or sections. It should be understood that these elements, components, regions, parts and / or sections are not limited by these terms of designation. These terms of designation have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed a second element, component, region, part, or section merely forpurposes of distinction but without limitation and without departing from structural or functional meaning.

[0031] As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "includes" and / or "including", “comprises” and / or “comprising”, “consists” and / or “consisting” when used in the present specification and claims, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof not explicitly stated. Further, in the present disclosure, the transitional phrase “consisting of’ excludes any element, step, or component not specified in the claim. It is further noted that some claims or some features of a claim may be drafted to exclude any optional element; such claims may use exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or it may use of a "negative" limitation.

[0032] The term “about” or “approximately” as used herein means, for example, within 10%, within 5%, or less. In some embodiments, the term “about” may mean within measurement error. In this regard, where described or claimed, all numbers may be read as if prefaced by the word "about" or "approximately," even if the term does not expressly appear. The phrase "about" or "approximately" may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / -0.1% of the stated value (or range of values), + / -1 % of the stated value (or range of values), +1-1% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical range, if recited herein, is intended to be inclusive of end values and includes all sub-ranges subsumed therein, unless specifically stated otherwise. As used herein, the term “substantially” is meant to allow for deviations from the descriptor that do not negatively affect the intended puipose. For example, deviations that are from limitations in measurements, differences within manufacture tolerance, or variations of less than 5% can beconsidered within the scope of substantially the same. The specified descriptor can be an absolute value (e.g. substantially spherical, substantially perpendicular, substantially concentric, etc.) or a relative term (e.g. substantially similar, substantially the same, etc.).

[0033] Unless specifically stated otherwise, as apparent from the following disclosure, it is understood that, throughout the disclosure, discussions using terms such as "processing," "computing," "calculating," "determining," "displaying," or the like, refer to the action and processes of a computer system, or similar electronic computing device, or data processing device that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices. Computer or electronic operations described in the specification or recited in the appended claims may generally be performed in any order unless context dictates otherwise. Also, although various operational flow diagrams are presented in a sequence(s), it should be understood that the various operations may be performed in other orders than those which are illustrated or claimed, or operations may be performed concurrently. Examples of such alternate orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatoiy, supplemental, simultaneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms like "responsive to," “in response to”, "related to," “based on”, or other like past- tense adjectives are generally not intended to exclude such variants, unless context dictates otherwise.

[0034] As used herein, the term “real-time” is meant to describe processes or events communicated, shown, presented, etc. substantially at the same time as those processes or events actually occur. Real time refers to a level of computer responsiveness that a user senses as sufficiently immediate or that enables the computer to keep up with some external process. For example, in computer technology, the term real-time refers to the actual time during which something takes place and the computer may at least partly process the data in real time (as it comes in). As another example, in signal processing, “real-time” processing relates to asystem in which input data is processed within milliseconds so that it is available virtually immediately as feedback, e.g., in a missile guidance, an airline booking system, or the stock market real-time quotes (RTQs).

[0035] The present disclosure generally relates to medical devices, and it exemplifies embodiments of an endoscope or catheter, and more particular to a steerable catheter controlled by a medical continuum robot (MCR). The embodiments of the endoscope or catheter and portions thereof are described in terms of their state in a three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian X, Y, Z coordinates); the term “orientation” refers to the rotational placement of an object or a portion of an object (three degrees of rotational freedom— e.g., roll, pitch, and yaw); the term “posture” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of object in at least one degree of rotational freedom (up to six total degrees of freedom); the term "shape" refers to a set of posture, positions, and / or orientations measured along the elongated body of the object.

[0036] As known in the field of medical devices, the terms “proximal” and “distal” are used with reference to the manipulation of an end of an instrument extending from the user to a surgical or diagnostic site. In this regal'd, the term “proximal” refers to the portion of the instrument that is closer to the user, and the term “distal” refers to the portion (tip) of the instrument further away from the user and closer to a surgical or diagnostic site. It will be further appreciated that, for convenience and clarity, spatial terms such as "vertical", "horizontal", "up", and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute. In that regard, all directional references (e.g., upper, lower, upward, downward, left, tight, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, anddo not create limitations, particularly as to the position, orientation, or use of the disclosure.

[0037] As used herein the term “catheter” generally refers to a flexible and thin tubular instrument made of medical grade material designed to be inserted through a narrow opening into an anatomical bodily lumen (e.g., an airway or a vessel) to perform a broad range of medical functions. The more specific term “steerable catheter” refers to a medical instrument comprising an elongated flexible shaft having at least one tool channel spanning through a plurality of bendable segments that are actuated by an actuator that applies an actuation force via drive wires arranged along a wall of the shaft.

[0038] As used herein the term “endoscope” refers to a rigid or flexible medical instrument which uses light guided by an optical probe to look inside a body cavity or organ. A medical procedure, in which an endoscope is inserted through a natural opening, is called an endoscopy. Specialized endoscopes are generally named for how or where the endoscope is intended to be used, such as the bronchoscope (mouth), sigmoidoscope (rectum), cystoscope (bladder), nephroscope (kidney), bronchoscope (bronchi), laryngoscope (larynx), otoscope (ear), arthroscope (joint), laparoscope (abdomen), and gastrointestinal endoscopes.

[0039] In the present disclosure, the terms “optical fiber”, “fiber optic”, or simply “fiber” refers to an elongated, flexible, light conducting waveguide capable of conducting light from one end to another end due to the effect known as total internal reflection. The terms “light guiding component” or “waveguide” may also refer to, or may have the functionality of, an optical fiber. The term “fiber” may refer to one or more light conducting fibers.<Robotic Catheter System>

[0040] An exemplary configuration of a robotic catheter system 1000 is described with reference to FIGS. 1 to 3.

[0041] FIG. 1 illustrates a medical environment for use of a robotic catheter system. As shown in FIG. 1, a robotic catheter system 1000 may be used in an operating room as, e.g., the medical environment. The system 1000 may include a robotic catheter 110 operable by a user 10 (e.g., a physician) to perform anintraluminal procedure on a patient 80. The system 1000 may include a computer 400 operatively connected to the robotic catheter 110 via a robotic platform 90. The robotic platform 90 includes one or more than one robotic arm 92 and a translation lineal’ stage 91. The computer 400 (e.g., a system console) includes at least a central processing unit (CPU) 410 comprised of one or more than one processor, and a display screen 420 (display device) such as a liquid crystal display (LCD), OLED or QLED display.

[0042] FIG. 2 illustrates components of the robotic catheter system. As shown in FIG. 2, the CPU 410 is operatively connected to a storage memory 411 (ROM and RAM memory), a system interface 412 (e.g., FPGA card), a user interface 413 (e.g. mouse and keyboard), and to the display screen 420.

[0043] The robotic catheter 110 includes an actuation handle 150 and a steerable catheter 100. The steerable catheter 100 is removably attached to the actuation handle 150 via a connector assembly 50 (connector hub). The steerable catheter 100 may also be referred to as a continuum robot catheter or a snake robot catheter configured to form continuous curves based on actuation principles known in the art. A well-known approach to form continuous curves with a continuum robot catheter is the folio w-the-leader (FTL) technique. The actuation handle 150 connects to an actuator system 300 which receives electronic commands from the computer 400 to mechanically actuate the steerable catheter 100. The actuation handle 150 is configured to be detachably mounted on the robotic platform 90 for robotically guiding the steerable catheter 100 through a bodily lumen 81 towards a target 181 within the subject or patient 80. When the actuation handle 150 is not mounted on the robotic platform 90, the actuation handle 150 can be operated manually by the user 10 one or more knobs to control the steerable catheter 100. For treating or examining a patient 80, the robotic catheter 110 may include one or more access ports 250 arranged in or around the actuation handle 150. Access ports 250 are used to introduce end effector tools, or to pass fluids to / from the patient 80. A tracking system (including, e.g., an electromagnetic (EM) field generator 60 and one or more EM sensors 190 arranged on the steerable catheter 100) is used for tracking the position, shape, pose, and / or orientation of the steerable catheter 100 while being insertedthrough the bodily lumen 81 towards the target 181. The target 181 is a region of interest (e.g., center of a tumor or a lesion) located in or around the lumen 81 of the patient 80. Alternatively or in addition to EM components, the tracking system may include magnetic and / or radiopaque markers.

[0044] During an intraluminal procedure, the system’s processor or CPU 410 is configured to perform operations based on the user’s input by executing (processing) computer-executable code pre-stored in the system’s memory 411 . The display screen 420 may include a graphical user interface (GUI) configured to display a graphical representation 421 of catheter navigation parameters and patient information, an endoscope image 422 (live view image), an intra-operative guiding image 423, and a pre-operative image 424 (e.g., a 3D or 2D slice image) of a region of interest of the patient 80. Intra-operative guiding image 423 may include conventional fluoroscopy images, or acoustic or ultrasound images. Pre-operative image 424 may include 2D or 3D computed tomography (CT) or magnetic resonance imaging (MRI) images.

[0045] As shown in FIG. 2, the steerable catheter 100 is comprised of a proximal section 140, a distal section 130, and a rigid catheter tip 120 arranged in this order from the proximal end to the distal end along a catheter axis (Ax). The distal section 130 is a steerable section comprised of a plurality of bendable segments. The proximal section 140 includes a flexible non- steerable tubular shaft which serves to connect the steerable section 130 to the actuation handle 150. At least the catheter tip 120 includes a tracking sensor 190 (e.g., one or more EM sensors), which is tracked by the system 1000 based on an EM field generator 60.

[0046] The steerable catheter 100 is controlled by an actuation system comprised of the actuation handle 150, the actuator system 300, the robotic platform 90 and / or a handheld controller 205 (e.g., a gamepad controller or joystick), which are in electronic communication with the computer 400 via a cable or network connection 425. The actuator system 300 includes a micro-controller 320 and an actuator 310 which are operatively connected to the computer 400 via the network connection 425. The micro-controller 320 may include a proportional-integral-derivative (PID) controller or other similar digital signal processor (DSP) circuit. The actuator 310 includes a plurality of actuating servo motors (or piezoelectric actuators) Ml throughMn, where “n” can be equal to a number of drive wires 210 necessary for steering the steerable catheter 100.

[0047] The robotic control system 300 also includes one or more sensors, including strain, position, and / or locked state sensors. The strain state sensor may include one or more of a strain sensor, a position sensor and / or a catheter insertion sensor 152. A strain sensor can be implemented by, for example, a strain gauge or a piezo resistor. A strain sensor serves to detect and / or measure compressive or tensile forces exerted on each drive wire 210. In this case, the strain sensor outputs a signal corresponding to the amount of compressive or tensile force (an amount of strain) being applied to each drive wire 210 during actuation of the steerable catheter 100. The sensors may output a signal corresponding to an amount of movement (distance of displacement) for each actuated drive wire 210. A sensor may measure the amount of displacement of the drive wire may also be implemented by a Hall-effect sensor. A sensors may be part of a tracking system implemented by an electromagnetic (EM) sensor configured to measure and / or detected the position and orientation (pose) of the catheter tip 120. Signals from the sensors (strain sensor, displacement sensor, and / or pose or position sensor) for one or more drive wires 210 are sent to the controller 320 and / or computer 400 to provide real-time feedback and create closed-loop control for each motor or actuator. In this manner, each drive wire 210 can be actively controlled to implement appropriate shaft guidance for safely navigating the steerable catheter 100 through the lumen 81.

[0048] The catheter insertion sensor 152 (Figs. 8 to 9B) may detect states during a process of attaching / detaching the catheter hub to the actuation handle (Figs 7 A to 7D).

[0049] The computer 400 includes suitable software, firmware, and peripheral hardware operated by one or more processor of CPU 410. The computer 400, the actuator system 300, and the actuation handle 150 are operably connected to each other by the network connection 425 (e.g., a cable bundle or wireless link). In addition, the computer 400, the actuator system 300 and the actuation handle 150 are operatively connected to each other by the robot platform 90. In some embodiments, the actuator system 300 may include or be connected to a handheld controller, such asa gamepad controller or a portable computing device like a smart phone or a tablet. Among other functions, the computer 400 and actuator system 300 can provide a surgeon or other operator with a GUI and navigation information through the display screen 420 to operate the steerable catheter 100.

[0050] FIG. 3 illustrates a steerable catheter 100. The proximal section 140 is configured to be attached to the actuation handle 150 via the connector assembly 50. The steerable distal section 130 includes a plurality of bendable segments configured to be actuated by drive wires 210 arranged along the wall of the catheter. The bendable segments of the steerable catheter 100 may include a distal bendable segment 130A, a middle bendable segment 130B, and a proximal bendable segment 130C. Each bendable segment is formed by a plurality of ring-shaped components (rings). The ring-shaped components are defined as wire-guiding members 108 or anchor members 109 depending on their function within the catheter. Anchor members 109 are ring-shaped components onto which the distal end of one or more drive wires 210 are attached. Wire-guiding members 108 are ring-shaped components through which some drive wires 210 slide through (without being attached thereto).

[0051] Detail A in FIG. 3 illustrates an exemplary embodiment of a ring-shaped component (a wire-guiding member 108 or an anchor member 109). Each ring-shaped component may include a central opening which forms the tool channel 105, and plural conduits 104 (sub-channels, or thru-holes) formed lengthwise and arranged equidistant from the central opening along the annular wall of each ring-shaped component. The non-steerable proximal section 140 is a tubular shaft made of extruded polymer material. The tubular shaft of the proximal section 140 may also have a central opening or tool channel 105 and plural conduits 104 along the wall of the shaft surrounding the tool channel. In this manner, at least one tool channel 105 formed inside the steerable catheter 100 provides passage for an imaging device 180 and / or end effector tools from the access ports 250 to the distal end of the catheter.

[0052] An imaging device 180 that can be inserted through the tool channel includes an endoscope camera (videoscope) along with illumination optics (e.g., optical fibers or LEDs). The illumination optics provides illumination light to irradiate a lesion target 181 which is a region of interest within the patient. End effector toolsrefer endoscopic surgical tools including clamps, graspers, scissors, staplers, ablation or biopsy needles, and other similar tools, which serve to manipulate body parts (organs or tumorous tissue) during examination or surgery.

[0053] Next, an example of robotic navigation of the steerable catheter 100 is explained. In general, either during insertion or retraction of the steerable catheter 100 through a bodily lumen 81, the center line of the lumen (e.g., the center line of a lung’s airway) is considered the desired trajectory to be followed during active control of the bendable segments of the steerable section 130 (refer to FIG. 3). To that end, various kinematic techniques are used to robotically operate the steerable catheter 100 with the goal of controlling the bendable segments to guide the catheter tip 120 along the desired trajectory to reach a target. In one such example, during robotic navigation, the steerable catheter 100 is advanced through a lumen 81 while sensors measure a depth of insertion of the catheter shaft into the lumen 81 , monitor the force applied to the catheter, and measure angulations of the catheter tip to obtain trajectory information. The trajectory information is stored in a memory of the system and continuously updated. After a short advance in insertion depth, the shape of the steerable catheter is updated by steering (rotating, twisting, or bending) one or more of the bendable segments of the catheter in such a way that the new shape closely matches the desired trajectory. This process is repeated until the target is reached. The same process (in reverse) is applied when the steerable catheter is withdrawn from the patient’s lumen. The segments of the distal steerable section 130 can be controlled individually to direct the catheter tip 120 with a combined actuation of all bendable segments, or the catheter tip can be operated in an FTL approach by controlling the most distal segment and the remaining segments following the path traced out by the most distal segment. To withdraw the catheter, a reverse FTL (rFTL) process can be implemented.

[0054] In a robotic catheter system as described herein, catheter collision with the patient’s anatomy may occur when the catheter trajectory is not maintained within the constraints of the lumen. In general, when navigating along a straight section of a lumen, it is desirable to maintain the catheter along the center line of the lumen. If making a turn, the trajectory should be offset away from the center line to navigate“around the corner” of a tight curve, in particular when the catheter has a rigid catheter tip. Therefore, when navigating through tortuous anatomies, the approach path that was followed by the catheter tip can deviate from the intended trajectory for various reasons (e.g., patient movement, user intervention, or the like). User-guided deviation from an ideal path (insertion trajectory) can propagate from the distal most section to the subsequent bendable segments based on the control algorithm used. In addition, the position of the robotically controlled bendable segments can deviate from the user-guided path for numerous reasons, including different section designs, different tolerances for different bendable segments, different positions of the base of that section, etc.

[0055] Challenges may arise during navigation due to a number of reasons, as described in the documents disclosed by the related art, including delays that may result from retracting the catheter 100 and re-start of a surgical procedure, which adds unwanted time to the surgical procedure.<Hub Attachment Collar>

[0056] FIG. 4 is perspective view of the actuation handle 150 of the robotic catheter system 1000 of the medical apparatus, combined with a catheter hub 170, with a hub attachment collar 160 (also referred to as attachment collar or collar herein) therebetween, according to an embodiment. As illustrated in FIG. 4, the collar 160 may be provided between the actuation handle 150 and the catheter hub 170. That is, the attachment collar 160 may be rotatably connected to the actuation handle 150, to control attachment / release of attachment pins 164a, 164b (FIG. 7A) to / from respective clamping mechanisms 165a, 165b (FIG. 6B), which are connected to respective tractors of the actuator system 300.

[0057] FIG. 5 illustrates zones of movement of the collar 160, according to an embodiment. FIG. 5 is a cut away view along line A- A’ of FIG. 4.

[0058] As illustrated in FIG. 5, the zones of movement include an inaction zone 510, a wire disengagement zone 540, and a hub release zone 560. The inaction zone 510 may occupy ranges of one or more of approximately ten degrees of rotation, approximately five to fifteen degrees of rotation, and approximately ten to forty-five degrees of rotation, with the relative degrees of rotation being variable depending onfactors that include a number of total drive wires and respective clamping mechanisms 165a, 165b. The collar 160 may be rotated relative to at least one of the actuation handle 150 and the catheter hub 170. In an embodiment, rotational movement of the actuation handle 150 controls attachment / release of the attachment pins 164a, 164b to / from the respective clamping mechanisms 165a, 165b.

[0059] A user may rotate the collar 160 in a release direction from the inaction zone 510, through the wire disengagement zone 540, and into the hub release zone 560 (FIGS. 10A-10D). The user may rotate the collar 160 in a securing direction from the hub release zone 560, through the wire disengagement zone 540, and into the inaction zone 510 (FIGS. 7A-7D). The hub release zone 560 may occupy approximately ten degrees of rotation, which may vary depending on factors that include a number of total drive wires and respective clamping mechanisms 165a, 165b. Rotation of the collar 160 through the wire disengagement zone 540 facilitates attachment / detachment of a medical apparatus actuator 310 to / from the catheter hub 170. The wire disengagement zone 540 may occupy ranges of one or more of approximately 90 degrees of rotation, approximately eighty to one hundred degrees of rotation, and approximately sixty to one hundred and twenty degrees of rotation, which may vary depending on factors that include a number of total drive wires and respective clamping mechanisms 165 a, 165b.

[0060] The inaction zone 510 includes a first end 512 and a second end 516 that is opposite the first end 512. The first end 512 of the inaction zone 510 may include a first hard stop to preclude rotation past the first end 512 of the inaction zone 510. Rotation of the attachment collar 160 between the first end 512 and the second end 516 of the inaction zone 510 does not result in a change of state or action being triggered by the attachment collar’ 160. Prior to rotation, the attachment collar 160 may be maintained in a stationary state by a detent that is located at the first end 512 of the inaction zone 510. When in the inaction zone 510, attachment pins 164a, 164b (FIG. 7A) of the catheter hub 170 are secured from the attachment collar 160, for example by respective clamping mechanisms 165a, 165b (FIG. 6B).

[0061] Rotation of the attachment collar' 160 in the release direction past the second end 516 of the inaction zone 510 may be arrested by a second detent or similarstructure that provides to the user of the attachment collar 160 at least one of tactile feedback and / or audio feedback. The detent may be a virtual detent or may be a mechanical detent, e.g., a notched wheel, a spring actuated lever, or the like. The detent may provide at least one of vibrotactile feedback and / or require increased rotational force to continue rotation of the attachment collar 160 past the second end 516 of the inaction zone 510 into the wire disengagement zone 540. The feedback may also include one or more of an audible sound, a visual indicator.

[0062] The wire disengagement zone 540 may include a first end 542 and a second end 546, with the first end 542 of the wire disengagement zone 540 being substantially adjacent to the second end 516 of the inaction zone 510 with the second detent therebetween. The second end 546 of the wire disengagement zone 540 may include a second hard stop that impedes rotation in the release direction of the attachment collar 160 past the second end 546 of the wire disengagement zone 540 until the user activates a release mechanism 550. The second hard stop that is provided at the second end 546 of the wire disengagement zone 540 may prevent accidental, continued rotation into the hub release zone 560. A first end 562 of the hub release zone 560 may be substantially adjacent to the second end 546 of the wire disengagement zone 540 with the second hard stop therebetween.

[0063] The release mechanism 550 may be a push button or engagement latch and an example of the release mechanism 550 is provided in FIG. 12. The release mechanism 550 avoids inadvertent release of the catheter hub 170, which may require restarting the surgical procedure from the beginning, thereby adding unwanted time to the surgical procedure.

[0064] Operation of, i.e., depressing, the release mechanism 550 may provide linear motion for controlled travel from / to the inaction zone 510 into / from the wire disengagement zone 540 and / or from / to wire disengagement zone into / from the hub release zone 560. For linear control, travel of approximately one quarter to a half inch may facilitate travel through the inaction zone 510, travel of approximately a half inch to two inches may facilitate travel through the wire disengagement zone 540, and travel of approximately one inch may facilitate travel through the hub release zone 560, with travel through the hub release zone 560 may only be accessible afterpressing an interlock button that allows final separation between the actuation handle 150 and the catheter hub 170.

[0065] A locked state sensor 305 (FIGS. 7B-7C) detects rotation between a locked state and an unlocked state of the hub medical apparatus actuator 310 with the catheter hub 170. The locked state sensor 305 may be provided in or on the hub attachment collar 160 or the catheter hub 170. The locked state sensor 305 may be configured to output a signal upon rotation of the hub attachment collar 160 relative to the catheter hub 170 into or through the hub release zone 560.

[0066] One or more position sensors 304a, 304b, 304c, 304d may be provided to detect rotational position. As shown in FIG. 5, a first position sensor 304a may be provided at the first end of the inaction zone 512, a second position sensor 304b may be provided at the first end of the wire disengagement zone 542, a third position sensor 304c may be provided at the second end of the wire disengagement zone 546, and a fourth position sensor 304d may be provided at the third hard stop 564, thereby providing output of rotational status of the hub attachment collar 160 relative to the catheter hub 170. Output of one or more of the locked state sensor 305 and / or the position sensors 304a, 304b, 304c, 304d may be displayed on the display screen 420. Detection of rotation into the hub release zone 560 may pause operation of the robotic catheter system 1000.

[0067] The attachment collar 160 may be maintained in the stationary state by a detent that is located at a second end 564 of the hub release zone 560.

[0068] FIGS. 6A and 6B illustrate an external cylinder and an inner cylinder of the hub attachment collar, according to an embodiment.

[0069] As shown in FIG. 6A, the hub collar 160 may include an external cylinder 161 that surrounds an inner cylinder 162. FIG. 6B is a cut away view of FIG. 6A. As shown in FIG. 6B, provided within the hub attachment collar 160 are clamping mechanisms that close based on operation of planetary gears that rotatably connect the external cylinder 161 and inner cylinder 162, so that rotation by a user of the external user cylinder 161 relative to the hub collar 160 rotates the inner cylinder 162.

[0070] Rotation of the external cylinder 161 rotates the inner cylinder 162 an amount proportional to a predetermined range of the planetary gears. The rotation ofthe inner cylinder 162 is configured to close the clamping mechanisms 165a, 165b. When the catheter hub 170 is joined with the actuation handle 150, as illustrated in FIG. 7A, the attachment pins 164a, 164b of the drive wires 210 extend into respective clamping mechanisms.< Attachment / Locking>

[0071] FIGS. 7 A to 7D illustrate states of detected attachment and locking of the catheter hub to the actuation handle, according to an embodiment.

[0072] FIG. 7A illustrates a first state (state 1), in which the catheter hub 170 is separated from the actuation handle 150. As illustrated in FIG. 7A, the catheter hub 170 is separated from the actuation handle 150, and the hub attachment collar 160 may be positioned in the hub release zone 560.

[0073] When the catheter hub 170 is moved axially toward the actuation handle 150, the plurality of drive wires 210 also move toward the actuation handle 150. Thus, attachment pins 164a, 164b of the drive wires 210 are inserted into respective clamping mechanisms (FIG. 6B). In a case where a guide rod or other guiding mechanism is provided, the guide rod / mechanism may similarly move / facilitate alignment of the catheter hub 170 with the actuation handle 150.

[0074] FIG. 7B illustrates a second state (state 2), in which the catheter hub 170 is inserted into the actuation handle 150, with the respective clamping mechanisms not being locked onto the respective attachment pins 164a, 164b of the drive wires 210. As illustrated in FIG. 7B, the catheter hub 170 is joined with the actuation handle 150.

[0075] In state 2, an initial rotation may be performed of the hub attachment collar 160 relative to the catheter hub 170. As shown in FIG. 7B, the hub attachment collar 160 may be rotated in the securing direction from the hub release zone 560 towards the wire disengagement zone 540.

[0076] FIGS. 7C and 7D illustrate a third state (state 3), in which the catheter hub 170 is inserted into the actuation handle 150 and with the respective clamping mechanisms being locked onto the respective attachment pins 164a, 164b of the drive wires 210.

[0077] FIG. 7C illustrates further rotation of the hub attachment collar 160 in the securing direction from the wire disengagement zone 540 into the inaction zone510. FIG. 7D illustrates the catheter hub 170 being joined with the actuation handle 150 after the hub attachment collar 160 is rotated in the securing direction into the inaction zone 510, rendering the actuation handle 150 ready to initiate a medical procedure. The locked state sensor 305 may detect rotation of the catheter hub 170 into or through at least of one or more of the inaction zone 510, the wire disengagement zone 540, and the hub release zone 560, with detection into the inaction zone 510 indicating joining the catheter hub 170 with the actuation handle 150, for output of a signal.

[0078] In a third state (state 4), the catheter insertion sensor 152 does not detect insertion of the catheter hub 170 within the actuation handle 150 (FIGs. 8A-9B) and the locked state sensor 305 outputs a signal that may be used to confirm that the actuation handle 150 is joined with the catheter hub 170, i.e., rotated into the inaction zone 510. In state 4, a locked state of each clamping mechanisms to each respective drive wires is not confirmed and the user is prompted to unlock the collar 160. The operational states are summarized in Table 1.

[0079] Table 1<Homing>

[0080] During system initialization, the robot performs a homing sequence that may confirm presence or absence of the catheter. Improper or incomplete homing may result in in improper navigation and / or damage of the catheter / actuator, in the event that the catheter begins operation from an incorrect position or state.

[0081] Before connecting the catheter hub 170, the motors of the actuator 310 are positioned to zero / home positions. For example, each tractor of the actuator 310moves to a zero position at a center of their stroke. When at the zero position, connecting the catheter clamp rods with respective clamping mechanisms 165a,b positions the catheter in a straight alignment. Commencing navigation after such homing results in bending of the distal catheter section that corresponds to predetermined drive wire movement. The present disclosure positively confirms catheter connection for initiation of robotic navigation.

[0082] FIG. 8A illustrates a shelf mechanism for aligning the catheter hub with the attachment collar’ and a catheter insertion sensor, according to an embodiment.

[0083] As illustrated in FIG. 8A, the shelf mechanism, which may be axially provided, expedites insertion of a catheter hub extension 170a onto an actuation handle recess 150a and avoids mis-alignment of the attachment pins 164a, 164b with respective clamping mechanisms 165a, 165b. FIG. 8A also provides a cutaway view of the catheter hub extension 170a and the actuation handle recess 150a, including the catheter insertion sensor 152 arranged with a trigger 154 that is configured to directly contact the catheter hub 170 when the catheter hub 170 is inserted into the actuation handle 150 by a predetermined amount.

[0084] FIG. 8B illustrates operation of the catheter insertion sensor with catheter hub into the actuation handle recess, according to an embodiment.

[0085] As shown in FIG. 8B, upon insertion of the catheter hub 170 into the actuation handle recess 150a by a predetermined amount, a distal end of the trigger 154 directly contacts the catheter hub extension 170a, resulting in pivot of the trigger 154. A cantilevered or similar pivot arrangement results in the trigger 154 engaging the catheter insertion sensor 152.

[0086] The transfer of movement by trigger 154 to the catheter insertion sensor 152 allows the catheter insertion sensor 152 to be located within the body of the actuation handle 150, thereby protecting the catheter insertion sensor 152 from external elements. As shown, the trigger 154 may utilize a biasing spring to default to an off position. The trigger 154 may have a shape matching a shape of the catheter hub, thereby reducing false triggering due to presence / insertion of a foreign object.

[0087] FIGS. 9A and 9B illustrate operation of the catheter insertion sensor, according to an another embodiment.

[0088] As shown in FIGS. 9A and 9B, the catheter insertion sensor 152 may be positioned along an internal wall of the actuation handle recess 150a, thereby eliminating the need for trigger 154. The catheter insertion sensor 152 may be an optical sensor where an emitter light is blocked or reflected from / to an emitter depending on the presence of the catheter body.

[0089] An extension of the actuation handle 150 may be provided to extend into the catheter hub 170, with an insertion sensor arranged with a trigger being provided within the catheter hub 170, rather than the actuation handle 150. Such alternative arrangement is a reversal of mechanical components, with the insertion sensor operating in similar manner as described above. Description of the operation is understood from the above discussion and is not repeated here, for conciseness.

[0090] The catheter insertion sensor 152 outputs a signal confirming insertion of the catheter hub 170 within the actuation handle 150 by a predetermined amount. In addition, the locked state sensor 305 outputs a signal confirming that the catheter hub 170 has been rotated onto the actuation handle 150 by a predetermined amount. Summing the signal output from the catheter insertion sensor 152 with the signal output from the locked state sensor 305 confirms a locked state of each clamping mechanisms to each respective drive wires, without the need for direct sensing of each drive wire clamps. Thus, the present disclosure detects locking of each of the multiple drive wires by analysis of output from two sensors, i.e., the catheter insertion sensor 152 and the locked state sensor 305.

[0091] FIG. 10 is a flowchart illustrating an initialization routine utilizing a catheter insertion sensor and a collar locking sensor, according to an embodiment.

[0092] As shown in FIG. 10, after start of initialization of the robot, at step 1003 a determination is made of continuity of system signals. For example, the continuity determination may include verification of receipt of signals from: (a) each motor of the nine motors of the actuator 310, including each of phases AB, BC and CA; (b) each encoder, including A, B, Z, A’, B’ and Z’ signals; (c) each force sensor for each motor; (d) each homing sensor, limit sensor and breakaway sensor for each motor; (e) the catheter insertion sensor 152; and (f) the locked state sensor 305.

[0093] As shown in FIG. 10, in response to failure to verify, the system enters an error state. When the verification is obtained, the initialization advances to step 1005, to detect whether breakaway has occurred between any tractor and respective drive wire. If breakaway is detected, the error state is entered. If breakaway is not detected, the initialization advances to step 1007, in which a signal from the catheter insertion sensor 152 is analyzed for presence of the catheter, i.e., connection of the catheter hub 170 and hub attachment collar 160 to the actuation handle 150.

[0094] If analysis of the signal from the catheter insertion sensor 152 in step 1007 indicates presence of the catheter, a prompt is issued at step 1008 for the user to remove the catheter. If the user enters a confirmation of removal the catheter but the signal from the catheter insertion sensor 152 continues to indicate presence of the catheter, the error state is entered.

[0095] If analysis of the signal from the catheter insertion sensor 152 in step 1007 does not indicate presence of the catheter, the initialization advances to step 1009, in which a signal from the locked state sensor 305 is analyzed to detect the actuation handle 150 being joined with the catheter hub 170.

[0096] If analysis of the signal from the locked state sensor 305 in step 1009 indicates that the actuation handle 150 is joined with the catheter hub 170, a prompt is issued at step 1010 for the user to remove the actuation handle 150 from the catheter hub 170. If the user enters a confirmation of removal but the signal from the locked state sensor 305 continues to indicate that the actuation handle 150 is joined with the catheter hub 170, the error state is entered.

[0097] If the analysis in step 1009 indicates that the actuation handle 150 is not joined with the catheter hub 170, the initialization advances to step 1011 , in which a prompt is output to the user to confirm acceptability to move the actuator motors. Upon receipt of user confirmation, in step 1013 the system moves the actuator motors.

[0098] In step 1015 a determination is made of whether a position error is detected that exceeds or is equal to a predetermined error. If the detected position error exceeds or is equal to the predetermined error, the error state is entered. If the detected position error does not exceed the predetermined error, the initializationadvances to step 1017, in which the homing sequence, as described above, is performed and the initialization advances to step 1019.

[0099] In step 1019 a determination is made of whether the homing sequence is successful. If not successful, the error state is entered. If the homing sequence is successful, the initialization advances to completion.[000100] FIG. 11 is a flowchart illustrating an alternative initialization routine, according to an embodiment.[000101] FIG. 11 includes similar’ steps as FIG. 10, other than output from steps 1108 and 1010. For conciseness, the description of steps 1103 to 1107 and steps 1111 to 1119 of FIG. 11 that are similar to steps 1003 to 1007 and steps 1011 to 1019 of FIG. 10 are not repeated here.[000102] After detecting the catheter in step 1107, a prompt is issued in step 1108 for the user to remove the catheter. If the user confirms removal of the catheter, but the signal from the catheter insertion sensor 152 continues to indicate presence of the catheter, the error state is entered. If the catheter insertion sensor 152 no longer indicates presence of the catheter, the initialization routine advances to step 1111, which corresponds to step 1011 regarding which the description provided for FIG. 10 is incorporated herein without repetition of same.[000103] In Step 1110 a determination is made of lock engagement. If lock engagement is true, the error state is entered. In contrast to step 1010, if lock engagement is false, the initialization advances to step 1011, in which a prompt is output to the user to confirm acceptability to move the actuator motors.[000104] Accordingly, the present disclosure provides a locking sensor with improved system feedback provided to the user that ensures proper locking of a connector. The present disclosure provides system input of a magnitude of collar unlocking for emergency removal. The collar locking sensor may be an analog sensor or encoder that detects the position of the rotation for a continuous or discretely incremental amounts between zero and one hundred percent.[000105] With the collar locking sensor, detection of the locked state of the collar is only detected directly, without directly sensing each of the drive wire clamps. The present disclosure indirectly senses locking of each of the drive wire clamps. Inresponse to rotating the collar, a gear mechanism translates the locking motion to each individual clamp that locks each respective drive wire. Due to the rigid nature of the gears, it is not possible to rotate the collar without simultaneously engaging each of the drive wire clamps. Thus, sensing the collar locked position allows for indirect detection that all drive wire clamps are locked.[000106] The present disclosure provides a system that may identify and understand four separate operational states, improves safety during the homing procedure, allows for confirmation of proper initial navigation, and detects sensing of multiple drive wires via feedback from a single sensor.[000107] The present disclosure provides a catheter detection sensor and associated system that safely initiates homing, and provides for a user prompt to remove or insert catheter depending on workflow step.[000108] In addition, the hub attachment collar and method of the present disclosure provide a method to safely initiate robotic navigation, provides a system that prompts as user to unlock the catheter, provides a system to engage emergency workflow, and senses locking of each of at least nine drive wires through a single sensor.[000109] An aspect of the present disclosure provides a robotic apparatus that includes a catheter hub 170, a hub attachment collar 160, a locked state sensor 305, and a catheter insertion sensor 152, with the locked state sensor 305 configured to detect rotation of the hub attachment collar 160 relative to the catheter hub 170, and the catheter insertion sensor 152 configured to detect insertion of the catheter hub 170 into an actuation handle 150.[000110] Upon rotation of the hub attachment collar 160 to a predetermined position relative to the catheter hub 170, attachment pins extending from the catheter hub 170 are secured to respective clamping mechanisms of a controller 205 operably connected to the actuation handle 150.[000111] Upon insertion of the catheter hub 170 into the actuation handle 150 to a predetermined depth, the catheter insertion sensor 152 is configured to output a first signal. The predetermined depth of insertion of the catheter hub 170 into the actuation handle 150 may be one or more of the insertion of the catheter hub 170 into theactuation handle 150, as illustrated in FIG. 8B or insertion to of the catheter hub 170 to a predetermined distance that is less than an entire depth that the catheter hub 170 may fit within the actuation handle 150, e.g., one quarter, one half or one third of the entire depth. Upon rotation of the catheter hub 170 to the predetermined location, the locked state sensor 305 is configured to output a second signal. The rotation of the hub attachment collar 160 relative to the catheter hub 170 may be determined by measuring one or more of full or partial, e.g., one quarter, one half or one third, through one or more of the inaction zone 510, the wire disengagement zone 540, and the hub release zone 560. Locking of each clamping mechanism to respective attachment pins is confirmed by summing the first signal and the second signal. The summing may be performed by the computer 400, the micro-controller 320, or similar component.[000112] A controller 205 may be operably connected to the actuation handle 150. The catheter hub 170 may be configured to detachably connect the robotic apparatus to the controller 205. The hub attachment collar 160 is configured to rotate through an inaction zone 510, a wire disengagement zone 540, and a hub release zone 560. Upon rotation of the hub attachment collar 160 from the wire disengagement zone 540 into the hub release zone 560, the catheter hub 170 is removable from the actuation handle 170.[000113] A trigger 154 may be provided that is configured to change orientation or state upon contact with the catheter hub 170. Upon the change of at least one of an orientation or state, the catheter insertion sensor 152 may output a signal.[000114] The locked state sensor 305 may be provided in one of the hub attachment collar 160 of the catheter hub 170, and may be configured to output a signal upon rotation of the hub attachment collar’ 160 relative to the catheter hub 170 into or through the hub release zone 560.[000115] The inaction zone 510 may be positioned on an opposite range of travel of the hub attachment collar 160 from a hub release zone 560.[000116] The catheter insertion sensor 152 may be provided on or within the actuation handle 150, and may be configured to output a signal upon insertion of the catheter hub 170 into the actuation handle 150 to a predetermined depth[000117] Another aspect of the present disclosure may provide a method of drive wire homing that includes inserting a catheter hub 170 into an actuation handle 150; outputting a first signal by a catheter insertion sensor 152 upon detecting insertion of the catheter hub 170 into the actuation handle 150 to a predetermined depth; rotating an attachment collar 160 relative to the catheter hub 170 to engage at least two drive wires to respective clamps; outputting a second signal upon detecting, by a locked state sensor 305, rotation of the catheter hub 170 to a predetermined location; summing the first signal and the second signal; and, based on the sum of the first signal and the second signal, confirming locking of each clamp.[000118] The catheter hub 170 is configured to detachably connect a robotic apparatus attached to the catheter hub 10 to a controller 205. The hub attachment collar 160 includes an inaction zone 510, a wire disengagement zone 540, and a hub release zone 560. Upon rotation of the hub attachment collar 160 into the hub release zone 560, the robotic apparatus is removable from the catheter hub 170. The actuation handle 150 may include a trigger 154 configured to change orientation upon the insertion of the catheter hub 170 into the catheter hub 170 to the predetermined depth, and the first signal is output based upon the change of orientation. The locked state sensor 305 may be one of positioned adjacent to the inaction zone 510 and / or integrated into the hub attachment collar 160. The locked state sensor 305 may be configured to output the second signal upon rotation of the hub attachment collar 160 relative to the catheter hub 170 into or through the hub release zone 560. The inaction zone 510 may be positioned on an opposite range of travel of the hub attachment collar 160 from the hub release zone 560. The catheter insertion sensor 152 may be provided on or within the actuation handle 150. The controller may be configured to determine a coupling state between the catheter hub 170 and actuation handle 150; and control an actuator of the controller according to the determined coupling state.[000119] The drive wire homing may commence in a first coupling state in which the catheter insertion sensor 152 does not detect the catheter hub 170 and the locked state sensor 305 does not detect the rotation of the catheter hub 170 to the predetermined location. In a second coupling state, a controller may detect, via the first signal output from the catheter insertion sensor 152, the insertion of the catheterhub 170 into the actuation handle 150 without detecting, via the second signal output by the locked state sensor 305, the rotation of the catheter hub 170 to the predetermined location. In the second coupling state, the controller may control output of a prompt to remove, connect and lock the catheter hub 170. In a third coupling state, the insertion of the catheter hub 170 into the actuation handle 150 to a predetermined depth and the rotation of the catheter hub 170 to the predetermined location may be detected. In the third coupling state, the controller may be configured to initiate robotic navigation.[000120] In a fourth coupling state, the insertion of the catheter hub 170 into the actuation handle 150 to a predetermined depth may be detected and the rotation of the catheter hub 170 to the predetermined location may not be detected. In the fourth coupling state, the controller may be configured to prompt a user to unlock the attachment collar 160.[000121] Reference numbers:[000122] In referring to the above description, specific details are set forth in order to provide a thorough understanding of the examples disclosed. In other instances, well-known methods, procedures, components and circuits have not been described in detail as not to unnecessarily lengthen the present disclosure.[000123] It should be understood that if an element or part is referred herein as being “on”, “against”, “connected to”, or “coupled to” another element or part, then it can be directly on, against, connected or coupled to the other element or pail, or intervening elements or parts may be present. In contrast, if an element is referred to as being “directly on”, “directly connected to”, or “directly coupled to” another element or part, then there are no intervening elements or parts present. When used, term “and / or”, includes any and all combinations of one or more of the associated listed items, if so provided.[000124] Spatially relative terms, such as “under” “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the various figures. It should be understood, however, that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, a relative spatial term such as “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein are to be interpreted accordingly. Similarly, the relative spatial terms “proximal” and “distal” may also be interchangeable, where applicable.[000125] The term “about,” as used herein means, for example, within 10%, within 5%, or less. In some embodiments, the term “about” may mean within measurement error.[000126] The terms first, second, third, etc. may be used herein to describe various elements, components, regions, parts and / or sections. It should be understood that these elements, components, regions, parts and / or sections should not be limited by these terms. These terms have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed asecond element, component, region, part, or section without departing from the teachings herein.[000127] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The use of the terms “a” and “an” and “the” and similar referents in the context of describing the disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “includes”, “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Specifically, these terms, when used in the present specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof not explicitly stated. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if the range 10-15 is disclosed, then 11, 12, 13, and 14 are also disclosed. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the disclosure and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosure.[000128] It will be appreciated that the methods and compositions of the instant disclosure can be incorporated in the form of a variety of embodiments, only a few of which are disclosed herein. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the disclosure to be practiced otherwise than as specifically describedherein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

What is claimed:

1. A robotic apparatus comprising: a catheter hub; a hub attachment collar; a locked state sensor; and a catheter insertion sensor, wherein: the locked state sensor is configured to detect rotation of the hub attachment collar relative to the catheter hub, and the catheter insertion sensor is configured to detect insertion of the catheter hub into an actuation handle.

2. The robotic apparatus of claim 1, wherein, upon rotation of the hub attachment collar to a predetermined position relative to the catheter hub, attachment pins extending from the catheter hub are secured to respective clamping mechanisms of a controller operably connected to the actuation handle.

3. The robotic apparatus of claim 2, wherein: upon insertion of the catheter hub into the actuation handle to a predetermined depth, the catheter insertion sensor is configured to output a first signal, upon rotation of the catheter hub to the predetermined position, the locked state sensor is configured to output a second signal, and locking of each clamping mechanism to respective attachment pins is confirmed by summing the first signal and the second signal.

4. The robotic apparatus of claim 1, further comprising a trigger configured to change orientation upon contact with the catheter hub, wherein: upon the change of at least one of an orientation or a state, the catheter insertion sensor outputs a signal.

5. The robotic apparatus of claim 1, wherein:the hub attachment collar is configured to rotate through an inaction zone, a wire disengagement zone, and a hub release zone, and upon rotation of the hub attachment collar from the wire disengagement zone into the hub release zone, the catheter hub is removable from the actuation handle.

6. The robotic apparatus of claim 5, wherein: the locked state sensor is provided in one of the hub attachment collar' or the catheter hub, and the locked state sensor is configured to output a signal upon rotation of the hub attachment collar relative to the catheter hub into or through at least of one or more of the inaction zone, the wire disengagement zone, and the hub release zone.

7. The robotic apparatus of claim 6, wherein the inaction zone is positioned on an opposite range of travel of the hub attachment collar' from a hub release zone.

8. The robotic apparatus of claim 1, wherein: the catheter insertion sensor is provided on or within the actuation handle, and the catheter insertion sensor is configured to output a signal upon insertion of the catheter hub into the actuation handle to a predetermined depth.

9. A method of drive wire homing, the method comprising: inserting a catheter hub into an actuation handle; outputting a first signal by a catheter insertion sensor upon detecting insertion of the catheter hub into the actuation handle to a predetermined depth; rotating an attachment collar relative to the catheter hub to engage at least two drive wires to respective clamps; outputting a second signal upon detecting, by a locked state sensor, rotation of the catheter hub to a predetermined position; summing the first signal and the second signal; andbased on the sum of the first signal and the second signal, confirming locking of each clamp.

10. The method of claim 9, wherein the catheter hub is configured to detachably connect a robotic apparatus attached to the catheter hub to a controller.1 1 . The method of claim 9, wherein: the actuation handle includes a trigger configured to change orientation upon the insertion of the catheter hub into the actuation handle to the predetermined depth, and the first signal is output based upon the change of orientation.

12. The method of claim 9, wherein the hub attachment collar includes an inaction zone, a wire disengagement zone, and a hub release zone.

13. The method of claim 12, wherein, upon rotation of the hub attachment collar from the wire disengagement zone into the hub release zone, the catheter hub is removable from the actuation handle.

14. The method of claim 12, wherein: the locked state sensor is one of positioned adjacent to the inaction zone and / or integrated in the hub attachment collar, and the locked state sensor is configured to output the second signal upon rotation of the hub attachment collar relative to the catheter hub into or through the inaction zone.

15. The method of claim 12, wherein the inaction zone is positioned on an opposite range of travel of the hub attachment collar from the hub release zone.

16. The method of claim 9, wherein the catheter insertion sensor is provided on or within the actuation handle.

17. The method of claim 9, further comprising: determining a coupling state between the catheter hub and actuation handle; and controlling an actuator according to the determined coupling state.

18. The method of claim 9, wherein: in a first coupling state, the catheter insertion sensor does not detect the catheter hub and the locked state sensor does not detect the rotation of the catheter hub; in a second coupling state, a controller detects, via the first signal output from the catheter insertion sensor, the insertion of the catheter hub into the actuation handle, without detecting, via the second signal output by the locked state sensor, the rotation of the catheter hub; and in the second coupling state, the controller controls output of a prompt to remove, connect and lock the catheter hub.

19. The method of claim 18, wherein: in a third coupling state, the insertion of the catheter hub into the actuation handle and the rotation of the catheter hub are detected; and in the third coupling state, the controller is configured to initiate robotic navigation.

20. The method of claim 19, wherein: in a fourth coupling state, the insertion of the catheter hub into the actuation handle is detected and the rotation of the catheter hub is not detected; and in the fourth coupling state, the controller is configured to prompt a user to unlock the attachment collar.

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