Surgical catheter system hub attachment collar and use method thereof

Abstract

To provide an attachment collar for detachably connecting a medical device actuator to a catheter hub.SOLUTION: Disclosed is a device and a method for medical applications, more specifically, a hub attachment collar 160 applicable to safe separation of a guide tool and a device used in a medical procedure including a robot medical procedure using a guide tool and a device such as a catheter, a camera, or an endoscope.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 603,365, filed with the United States Patent and Trademark Office on November 28, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to medical devices and methods, and more particularly to hub - attached collars applicable to the safe separation of guide tools and devices used in medical procedures, including robotic medical procedures using guide tools such as catheters, cameras, and endoscopes.

Background Art

[0003] In surgical and experimental environments, flexible medical instruments such as endoscope surgical instruments and catheters are widely used. Such flexible medical instruments are continuously accepted in the medical field. Medical devices generally include flexible tubes commonly referred to as sleeves or sheaths, along or within which one or more tool channels extend, allowing access to an end - effector located at the distal end of the sheath.

[0004] Examples of conventional systems include U.S. Patent Application Publication No. 2021 / 0259794 (Kato et al.) titled "Medical Device Having Dual Operating Means and Method of Using the Same"; U.S. Patent No. 11,559,190 (Okumura et al.) titled "Operable Medical Device and Method"; and U.S. Patent Application Publication No. 2021 / 0369085 (Kato et al.) titled "Medical Device Having a Reflow Trap Anchor and Method of Using the Same", the contents of each of which are incorporated herein by reference.

[0005] European Patent No. 2589407 discusses a catheter system with an attachable catheter hub, and rotation around the hub is used for attachment. U.S. Patent No. 11,553,917 to Sgroi discusses a loading unit locking collar that is rotationally actuated to be released. 。Special JP-A-2023-103865 and U.S. Patent Application Publication No. 2021 / 0121051 discuss a medical device and a bendable unit. JP-A-2022-115015 discusses a medical device having a main body including a plurality of drive sources and an operating portion movable between a fixed position and a removable position when the bendable unit is attached to the base. unit

Summary of the Invention

[0006] However, in conventional systems, a system with an attachment collar for connecting a catheter to a medical device actuator, including an inaction zone, a wire separation zone, and a hub release zone, has not been provided to ensure safety and avoid accidental rotation. To overcome various drawbacks of conventional systems, the present disclosure provides a hub attachment collar (also referred to herein as a collar) configured to connect a catheter to a medical device actuator (e.g., a robotic catheter system for peripheral lung biopsy).

[0007] Aspects of the present disclosure provide an attachment collar for removably connecting a medical device actuator to a catheter hub, the attachment collar including an inaction zone, a wire separation zone, and a hub release zone.

[0008] ​Another aspect of the present disclosure provides a method for fixing a catheter to an actuator of a medical device. The catheter includes a catheter hub, and the actuator includes a handle and a mounting collar operable to pass through an inactive zone, a wire separation zone, and a hub release zone. The method includes: attaching the handle to the catheter hub with the mounting collar in the hub release zone; rotating the mounting collar from the hub release zone to the wire separation zone; and rotating the mounting collar from the wire separation zone to the inactive zone. By rotating from the wire separation zone, the mounting pins extending from the catheter hub are fixed to the respective gripping mechanisms of the actuator.

[0009] A further aspect of the present disclosure provides a method for releasing a catheter from an actuator of a medical device. The catheter includes a catheter hub, and the actuator includes a handle and a mounting collar operable to pass through an inactive zone, a wire separation zone, and a hub release zone. The method includes: applying a rotational force to the mounting collar to rotate the mounting collar from the inactive zone to a detent provided at a transition between the inactive zone and the wire separation zone; receiving feedback from the detent; in response to the feedback, applying one of a pressing force and an increased rotational force to transition from the inactive zone to the wire separation zone; rotating the mounting collar from the wire separation zone to a hard stop provided at a transition between the wire separation zone and the hub release zone; rotating beyond the hard stop by actuating a release mechanism; rotating the mounting collar through the hub release zone, wherein rotating the mounting collar through the hub release zone releases the mounting pins extending from the catheter hub from the respective gripping mechanisms of the actuator; and removing the handle from the catheter hub.

Brief Description of the Drawings

[0010] The accompanying drawings are incorporated herein by reference and constitute a part of this specification, illustrating various embodiments, objects, features, and advantages of the present disclosure.

[0011]

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[0012] Aspects of the present disclosure can be understood by reading the following detailed description in light of the accompanying drawings. Note that, in accordance with standard practice, the various features of the drawings are not drawn to scale and do not represent actual components. Some details such as dimensions of various features may be arbitrarily increased or decreased for ease of explanation. Further, reference numerals, labels, and / or letters are repeated in various examples to depict similar components and / or functions. This repetition is for the purpose of brevity and clarity and does not in itself limit the various embodiments and / or configurations of the same components described.

[0013] Before various embodiments are described in more detail, it should be understood that the present disclosure is not limited to specific embodiments. Also, as a matter of course, the terms used herein are for the purpose of describing exemplary embodiments only and are not intended to be limiting. Embodiments of the present disclosure can have many applications within the field of medical procedures or minimally invasive surgery (MIS).

[0014] Throughout the figures, unless otherwise noted, the same reference numbers and characters are used to denote like features, elements, components, or parts of the illustrated embodiments. Further, the disclosure is described in detail with reference to the accompanying figures, which are made in connection with the exemplary embodiments. It is intended that changes and modifications may be made to the described exemplary embodiments without departing from the true scope of the disclosure as defined by the appended claims. The drawings represent several possible configurations and approaches, and while the drawings are not necessarily to scale, certain features may be exaggerated, removed, or partially cut away to more clearly illustrate and describe particular aspects of the disclosure. The description set forth herein is not intended to be exhaustive or to limit or restrict the claims to the exact forms and configurations shown in the drawings and disclosed in the following detailed description.

[0015] It is generally understood by those skilled in the art that terms used herein, particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "comprising" should be interpreted as "comprising, but not limited to", the term "having" should be interpreted as "having at least", "comprising" should be interpreted as "comprising, but not limited to", etc.). Further, it is understood by those skilled in the art that if a specific number introduced in a claim is intended, such intention is explicitly recited in the claims, and if there is no such recitation, such intention does not exist. For example, for purposes of illustration, the following appended claims may include the use of introductory phrases such as "at least one" or "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to mean that a particular claim including such an introduced claim recitation is limited to a claim that includes only one such recitation, even if the same claim includes both an introductory phrase such as "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should typically be interpreted as meaning "at least one" or "one or more"). The same holds true for the use of definite articles used to introduce claim recitations.

[0016] Furthermore, even when specific numbers recited in the introduced claims are explicitly recited, it should be understood by those skilled in the art that such recitations typically should be construed to mean at least the recited number (e.g., when only "two recitations" is recited without other modifiers, it typically means at least two recitations, or two or more recitations). Further, when a provision similar to "at least one of A, B, and C, etc." is used, generally, such syntax is intended in the sense that those skilled in the art can understand the provision (e.g., "a system having at least one of A, B, and C" may include a system having 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.). When a provision similar to "at least one of A, B, or C, etc." is used, generally, such syntax is intended in the sense that those skilled in the art can understand the provision (e.g., "a system having at least one of A, B, or C" may include a system having 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.). Further, it should be understood by those skilled in the art that typically, disjunctive words, and / or phrases representing two or more alternative terms (in any of the specification, claims, or drawings) should be construed to contemplate the possibility of including one of the terms, any of the terms, or both of the terms, unless otherwise indicated by the context. For example, the expression "A or B" is typically understood to include the possibility of "A" or "B" or "A and B".

[0017] As used herein, when a feature or element is referred to as being "above" another feature or element, it may be directly above 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 above" another feature or element, no intervening features or elements are present. Also, of course, when a feature or element is referred to as being "connected to", "attached to", "coupled to", etc. another feature or element, it may be directly connected to, attached to, or coupled to the other feature, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected to", "directly attached to", or "directly coupled to" another feature or element, no intervening features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated in one embodiment can be applied to other embodiments. Also, as will be understood by those skilled in the art, references to a structure or feature being "adjacent" to another feature may include portions that overlap or are beneath the adjacent feature.

[0018] In this specification, terms such as first, second, third, etc. may be used to describe various elements, components, regions, parts, and / or portions. Of course, these elements, components, regions, parts, and / or portions are not limited by these designated terms. These designated terms are used only to distinguish one element, component, region, part, or portion from another. Thus, a first element, component, region, part, or portion described hereinafter can be referred to as a second element, component, region, part, or portion for the purpose of distinction only, without limitation and without departing from its structural or functional meaning.

[0019] As used herein, the singular forms are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, of course, the terms "comprising," "including," and "having," when used in this specification and the claims, specify the presence of the described 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 expressly recited. Further, in the present disclosure, the transitional phrase "consisting of" excludes any element, step, or component not specified in the claim. Further, it should be noted that some claims or features of some claims may be drafted to exclude any element, and such claims may use exclusive terms such as "alone," "only," etc. in connection with the recitation of claim elements, or may use "negative" limitations.

[0020] As used herein, the terms "about" or "approximately" mean within, for example, 10%, within 5% or less. In some embodiments, the term "about" may mean within the measurement error. In this regard, when described or claimed, all numerical values may be read as if the term "about" or "approximately" preceded them, even if not explicitly stated. The phrases "about" or "approximately" may be used to indicate that the recited values and / or positions are within a reasonable expected range of values and / or positions when describing size and / or position. For example, a numerical value may include values that are ±0.1% of the recited value (or range of values), ±1% of the recited value (or range of values), ±2% of the recited value (or range of values), ±5% of the recited value (or range of values), ±10% of the recited value (or range of values), etc. As described herein, any numerical range is intended to include the end values and all sub-ranges subsumed therein, unless specifically stated otherwise. As used herein, the term "substantially" means allowing a deviation from the descriptor that does not adversely affect the intended purpose. For example, deviations resulting from limitations in measurements, differences within manufacturing tolerances, or variations of less than 5% can be considered to be within substantially the same range. The specified descriptor can be an absolute value (e.g., substantially spherical, substantially vertical, substantially concentric, etc.) or a relative term (e.g., substantially similar, substantially the same, etc.).

[0021] Unless otherwise specified, as will be apparent from the following disclosure, throughout this disclosure, discussions using terms such as "processing", "computing on a computer", "computing", "determining", "displaying", etc. refer to operations and processes of a data processing device that manipulates data represented as physical (electronic) quantities in a computer system, or a similar electronic computing device, or in the registers and memories of a computer system, and similarly converts it into other data represented as physical quantities in the memory or registers of the computer system or other such devices for storing, transmitting, or displaying information. Computer operations or electronic operations described herein or recited in the appended claims can generally be executed in any order, unless otherwise indicated by the context. Also, although various operation flowcharts are presented in sequence, of course, the various operations can be executed in an order other than the illustrated or claimed order, or the operations can be executed simultaneously. Examples of such alternative orderings include, unless otherwise indicated by the context, orderings of repetition, interleaving, interruption, reordering, incrementing, preparation, supplementation, simultaneity, reverse, or other variations. Further, terms such as "in response to", "in response to", "related to", "based on", etc., or other similar past participles, are not normally intended to exclude such variations, unless otherwise indicated by the context.

[0022] As used herein, the term "real-time" means, for example, describing a process or event that is communicated, shown, or presented substantially simultaneously with the actual occurrence of the process or event. Real-time refers to a level of responsiveness of a computer such that a user perceives it as being sufficiently immediate, or such that the computer can keep up with some external process. For example, in computer technology, the term "real-time" refers to the actual time at which something occurs, and the computer can process data at least partially in real-time (when the data is received). As another example, "real-time" processing in signal processing relates to systems such as missile guidance, airline reservation systems, and real-time quotes (RTQ) in the stock market, where input data is processed within a few milliseconds and is available for use almost immediately as feedback.

[0023] The present disclosure generally relates to medical devices, exemplifies embodiments of endoscopes or catheters, and more specifically relates to a steerable catheter controlled by a medical continuum robot (MCR). Embodiments of endoscopes or catheters and their parts are described with respect to their states in three-dimensional space. As used herein, the term "position" refers to the position of an object or a part of an object in three-dimensional space (e.g., three degrees of translational freedom along Cartesian X, Y, Z coordinates), the term "orientation" refers to the rotational arrangement of an object or a part of an object (three degrees of rotation - e.g., roll, pitch, yaw), the term "pose" refers to the position of an object or a part of an object having at least one degree of translational freedom and the orientation of an object or a part of an object having at least one degree of rotational freedom (a total of up to six degrees of freedom), and the term "shape" refers to a series of poses, positions, and / or orientations measured along the elongate body of an object.

[0024] As is known in the field of medical devices, the terms "proximal" and "distal" are used with respect to the manipulation of the ends of an instrument that extends from the user to the surgical or diagnostic site. In this regard, the term "proximal" refers to the part of the instrument that is closer to the user, and the term "distal" refers to the part of the instrument that is farther from the user and closer to the surgical or diagnostic site (the tip). Further, of course, for the sake of brevity, the present specification may use spatial terms such as "vertical", "parallel", "upper", "lower", etc. 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., superior, inferior, upward, downward, left, right, leftward, rightward, top, bottom, above ~, below ~, longitudinal, transverse, clockwise, counterclockwise) are used only for the purpose of identification to assist the reader's understanding of the present disclosure, and do not cause any limitation, particularly with respect to the position, orientation or method of use of the present disclosure.

[0025] As used herein, the term "catheter" generally refers to a flexible, thin, tubular instrument made of a medical-grade material that is designed to be inserted through a narrow opening into an anatomical body cavity (e.g., the airway or blood vessels) to perform a wide range of medical functions. The more specific term "operable catheter" refers to a medical instrument comprising an elongated flexible shaft having at least one tool channel extending through a plurality of bendable segments, the plurality of bendable segments being driven by an actuator that applies an actuating force via a drive wire disposed along the wall of the shaft.

[0026] As used herein, the term "endoscope" refers to a rigid or flexible medical instrument that observes the interior of a body cavity or organ using light guided by an optical probe. A medical procedure in which an endoscope is inserted through a natural opening is called an endoscopy. Dedicated endoscopes are generally named according to the method of use and the location of use of the endoscope, such as bronchoscope (mouth), sigmoidoscope (rectum), cystoscope (bladder), nephroscope (kidney), bronchoscope (bronchus), pharyngoscope (pharynx), otoscope (ear), arthroscope (joint), laparoscope (abdomen), gastrointestinal endoscope, etc.

[0027] In the present disclosure, terms such as "optical fiber" or simply "fiber" refer to an elongated flexible optical waveguide that can conduct light from one end to the other by an effect known as total internal reflection. The term "light guiding component" or "waveguide" may also refer to an optical fiber or may have the function of an optical fiber. The term "fiber" may refer to one or more optical conducting fibers.

[0028] <Robotic Catheter System>

[0029] Referring to FIGS. 1 to 3, an exemplary configuration of the robotic catheter system 1000 will be described.

[0030] FIG. 1 illustrates a medical environment for using the robotic catheter system. As shown in FIG. 1, the robotic catheter system 1000 may be used within an operating room (e.g., a medical environment). The system 1000 may include a robotic catheter 110 that is operable when a user 10 (e.g., a physician) performs an intracavitary procedure on a patient 80. The system 1000 may include a computer 400 that is operatively connected to the robotic catheter 110 via a robotic platform 90. The robotic platform 90 includes one or more robotic arms 92 and a linear translation stage 91. The computer 400 (e.g., a system console) includes at least a central processing unit (CPU) 410 composed of one or more processors and a display screen 420 (display device) such as a liquid crystal display (LCD), an OLED, or a QLED display.

[0031] FIG. 2 illustrates the 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 memories), a system interface 412 (e.g., an FPGA card), a user interface 413 (e.g., a mouse and keyboard), and a display screen 420.

[0032] The robotic catheter 110 includes an operating handle 150 and a steerable catheter 100. The steerable catheter 100 is removably attached to the operating handle 150 via a connector assembly 50 (connector hub). The steerable catheter 100 may be referred to as a continuum robotic catheter or a snake robotic catheter and is configured to form a continuous curve based on an operating principle known in the art. A well-known approach for forming a continuous curve using a continuum robotic catheter is the follow-the-leader (FTL) technique. The operating handle 150 is connected to an actuator system 300, which receives electronic commands from the computer 400 and mechanically actuates the steerable catheter 100. The operating handle 150 is configured to be removably attached to a robotic platform 90, which is configured to robotically guide the steerable catheter 100 through a body cavity 81 towards a target 181 within a subject or patient 80. When the operating handle 150 is not attached to the robotic platform 90, the operating handle 150 allows a user 10 to control the steerable catheter 100 is one or more knobs usedIt can be manually operated. For the treatment or examination of patient 80, the robotic catheter 110 may include one or more access ports 250 disposed on or around the operating handle 150. The access ports 250 are used to introduce end effector tools or allow fluid to pass between the patient 80. A tracking system (e.g., including an electromagnetic (EM) field generator 60 and one or more EM sensors 190 disposed on the steerable catheter 100) is used to track the position, shape, posture, and / or orientation of the steerable catheter 100 while it is being inserted through the body cavity 81 towards the target 181. The target 181 is an area of interest (e.g., the center of a tumor or lesion) located in or around the lumen 81 of the patient 80. As an alternative or addition to the EM components, the tracking system may include magnetic markers and / or radiopaque markers.

[0033] During the endoluminal procedure, the system's processor or CPU 410 is configured to perform operations based on user 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), which is configured to display a graphical representation 421 of catheter navigation parameters and patient information, an endoscopic image 422 (live view image), an intraoperative guidance image 423, and a preoperative image 424 (e.g., 3D or 2D slice image) of the area of interest of the patient 80. Examples of the intraoperative guidance image 423 include conventional fluoroscopic images, acoustic images, and ultrasonic images. Examples of the preoperative image 424 include 2D or 3D computed tomography (CT) and magnetic resonance imaging (MRI) images.

[0034] As shown in FIG. 2, the steerable catheter 100 comprises a proximal section 140, a distal section 130, and a rigid catheter tip 120, which are arranged in this order along the catheter axis (Ax) from the proximal end to the distal end. The distal section 130 is a steerable section comprising a plurality of bendable segments. The proximal section 140 includes a flexible non-steerable tubular shaft, which functions 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 the EM field generator 60.

[0035] The steerable catheter 100 is controlled by an actuation system, which comprises the actuation handle 150, the actuator system 300, the robotic platform 90 and / or the handheld controller 205 (e.g., a gamepad controller or a joystick), which are in electronic communication with the computer 400 via cables or network connections 425. The actuator system 300 includes a microcontroller 320 and actuators 310, which are operatively connected to the computer 400 via the network connection 425. Examples of the microcontroller 320 include a proportional-integral-derivative (PID) controller and other similar digital signal processor (DSP) circuits. The actuators 310 include a plurality of actuation servo motors (or piezoelectric actuators) M1 to Mn. Here, "n" can be equal to the number of drive wires 210 required to steer the steerable catheter 100.

[0036] In addition, the robot control system 300 includes one or more sensors including sensors for strain, position and / or locked state. The strain sensor can be implemented, for example, by a strain gauge or a piezoresistor. The strain sensor functions to detect and / or measure the compressive or tensile force applied to each drive wire 210. In this case, the strain sensor outputs a signal corresponding to the amount of compressive or tensile force (amount of strain) applied to each drive wire 210 during the operation of the steerable catheter 100. The sensor may output a signal corresponding to the amount of movement (displacement distance) of each activated drive wire 210. The sensor can measure the displacement amount of the drive wire and may be implemented by a Hall effect sensor. The sensor may be part of a tracking system implemented by an electromagnetic (EM) sensor configured to measure and / or detect the position and orientation (posture) of the catheter tip 120. Signals from the sensors (strain sensors, displacement sensors, and / or sensors for posture or position) of one or more drive wires 210 are sent to the control device 320 and / or the computer 400 to provide real-time feedback and form a closed-loop control for each of the motors or actuators. In this way, each drive wire 210 can be actively controlled to perform appropriate shaft guidance to safely navigate the steerable catheter 100 through the lumen 81.

[0037] Computer 400 includes suitable software, firmware, and peripheral hardware that are operated by one or more processors of CPU 410. Computer 400, actuator system 300, and actuation handle 150 are operatively connected to each other by network connection 425 (e.g., a cable bundle or a wireless link). Further, computer 400, actuator system 300, and actuation handle 150 are operatively connected to each other by robot platform 90. In some embodiments, actuator system 300 may include or be connected to a handheld controller (such as a gamepad controller) or a portable computing device (such as a smartphone or a tablet). Among other functions, computer 400 and actuator system 300 can provide a GUI and navigation information for operating the steerable catheter 100 to a surgeon or other operator through display screen 420.

[0038] FIG. 3 illustrates the 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 disposed along the wall of the catheter. The bendable segments of the steerable catheter 100 may include a distal bendable segment 130A, an intermediate bendable segment 130B, and a proximal bendable segment 130C. Each bendable segment is formed by a plurality of annular components (rings). The annular components are defined as wire guiding members 108 or anchor members 109 according to their functions within the catheter. The anchor member 109 is an annular component to which the distal ends of one or more drive wires 210 are attached. The wire guiding member 108 is an annular component through which some of the drive wires 210 slide (without being attached to the member).

[0039] Detail A of FIG. 3 illustrates an exemplary embodiment of an annular component (wire guiding member 108 or anchor member 109). Each annular component may include a central opening that forms a tool channel 105 and a plurality of conduits 104 (sub-channels or through-holes) that are disposed equidistant from the central opening along the annular wall of each annular component and formed in the longitudinal direction. The non-maneuverable proximal section 140 is a tubular shaft made of an extruded polymeric material. The tubular shaft of the proximal section 140 may also have a central opening or tool channel 105 and a plurality of conduits 104 along the wall of the shaft surrounding the tool channel. Thus, at least one tool channel 105 formed in the steerable catheter 100 allows an imaging device 180 and / or an end effector tool to pass from the access port 250 to the distal end of the catheter.

[0040] Examples of the imaging device 180 that can be inserted through the tool channel include an endoscope camera (video scope) equipped with an illumination optical system (such as an optical fiber or an LED). The illumination optical system emits illumination light and irradiates the lesion target 181, which is the region of interest within the patient. The end effector tool refers to an endoscopic surgical instrument such as a clamp, forceps, scissors, stapler, ablation or biopsy needle, and other similar tools that function to manipulate a part of the body (organ or tumor tissue) during an examination or surgery.

[0041] Next, an example of robotic control navigation of the steerable catheter 100 will be described. Generally, when inserting or retracting the steerable catheter 100 through the body cavity 81, the centerline of the lumen (e.g., the centerline of the airway of the lung) is regarded as the desired trajectory to be followed during the active control of the bendable segments of the steerable section 130 (see FIG. 3). For this purpose, various kinematic techniques are used to robotically operate the steerable catheter 100 with the goal of controlling the bendable segments and guiding the catheter tip 120 along the desired trajectory to reach the target. In such an example, during robotic control navigation, while the sensor measures the insertion depth of the catheter shaft, monitors the force applied to the catheter, and measures the angular position of the catheter tip to obtain trajectory information, the steerable catheter 100 advances through the lumen 81. The trajectory information is stored in the memory of the system and continuously updated. After advancing the insertion depth slightly, the shape of the steerable catheter is updated by manipulating (rotating, twisting, or bending) one or more of the bendable segments of the catheter so that the new shape closely matches the desired trajectory. This process is repeated until the target is reached. The same process is applied (in reverse) when the steerable catheter is withdrawn from the patient's lumen. The segments of the distal steerable section 130 can be individually controlled to direct the catheter tip 120 by combining the actuation of all the bendable segments. Alternatively, the catheter tip can be manipulated in a FTL approach by controlling the most distal segment and the remaining segments that follow the path traced by the most distal segment. When withdrawing the catheter, a reverse FTL (rFTL) process can be implemented.

[0042] In the robotic catheter system described in this specification, when the catheter trajectory is not maintained within the lumen constraints, a catheter collision with the patient's anatomical structure can occur. Generally, when advancing along the straight portion of the lumen, it is desirable to hold the catheter along the centerline of the lumen. In particular, when the tip of the catheter is stiff, when it bends, it is necessary to offset the trajectory from the centerline in order to navigate around the "corner" of a sharp curve. Thus, when passing through a convoluted anatomical structure, the approach path followed by the catheter tip may deviate from the intended trajectory for various reasons, such as patient movement or user intervention. Deviation from the ideal path (insertion trajectory) due to user guidance can, depending on the control algorithm used, propagate from the most distal section to subsequent bendable segments. Further, the position of the robotically controlled bendable segments may deviate from the path due to user guidance for various reasons, such as differences in the design of the segments, differences in the tolerance for each bendable segment, and differences in the position of the base of that segment.

[0043] As described in the documents disclosed by related technologies, problems may occur during navigation for various reasons, such as delays that may occur due to the withdrawal of the catheter 100 and the resumption of the surgical procedure, which adds unnecessary time to the surgical procedure.

[0044] <Hub Mounting Collar>

[0045] FIG. 4 is a perspective view of a configuration in which an operation handle 150 and a catheter hub 170 of a robotic catheter system 1000 for a medical device according to an embodiment are combined, and a hub attachment collar 160 (also referred to as an attachment collar or a collar in this specification) is disposed therebetween. As illustrated in FIG. 4, the collar 160 may be provided between the operation handle 150 and the catheter hub 170. That is, the attachment collar 160 may be rotatably connected to the operation handle 150 to control the attachment / detachment of attachment pins 164a, 164b (FIG. 7A) to respective gripping mechanisms 165a, 165b (FIG. 6B) connected to respective tractors of the actuator system 300.

[0046] FIG. 5 illustrates an operation zone of the collar 160 according to an embodiment. FIG. 5 is a cutaway view taken along line A-A' of FIG. 4.

[0047] As illustrated in FIG. 5, the operation zone includes an inactive zone 510, a wire separation zone 540, and a hub release zone 560. The inactive zone 510 may occupy one or more ranges of about 10 rotational degrees, about 5 to 15 rotational degrees, and about 10 to 45 rotational degrees, and the relative rotational degrees can be changed according to factors such as the total number of drive wires and each gripping mechanism 165a, 165b, etc.

[0048] The collar 160 can rotate with respect to at least one of the operation handle 150 and the catheter hub 170. In an embodiment, the rotation operation of the operation handle 150 controls the attachment / detachment of the attachment pins 164a, 164b to the respective gripping mechanisms 165a, 165b.

[0049] The user can rotate the collar 160 in the release direction from the inactive zone 510, through the wire separation zone 540, to the hub release zone 560 (Figs. 10A - 10D). The user can rotate the collar 160 in the fixing direction from the hub release zone 560, through the wire separation zone 540, to the inactive zone 510 (Figs. 7A - 7D). The hub release zone 560 may occupy about 10 degrees of rotation, but this can be changed according to factors such as the total number of drive wires and each gripping mechanism 165a, 165b, etc.

[0050] By rotating the collar 160 so as to pass through the wire separation zone 540, the attachment and detachment of the medical device actuator 310 to and from the catheter hub 170 becomes easy. The wire separation zone 540 may occupy one or more ranges of about 90 degrees of rotation, about 80 - 100 degrees of rotation, and about 60 - 120 degrees of rotation, but this can be changed according to factors such as the total number of drive wires and each gripping mechanism 165a, 165b, etc.

[0051] The inactive zone 510 includes a first limit 512 and a second limit 516 on the opposite side of the first limit 512. The first limit 512 of the inactive zone 510 may include a first hard stop for preventing rotation beyond the first limit 512 of the inactive zone 510. Even if the attachment collar 160 rotates between the first limit 512 and the second limit 516 of the inactive zone 510, no change in state or action is caused by the attachment collar 160. Before rotation, the attachment collar 160 is maintained in a stationary state by a detent arranged at the first limit 512 of the inactive zone 510.

[0052] When in the inactive zone 510, the mounting pins 164a, 164b (FIG. 7A) of the catheter hub 170 are fixed from the mounting collar 160, for example, by respective gripping mechanisms 165a, 165b (FIG. 6B). When the mounting collar 160 rotates in the release direction beyond the second limit 516 of the inactive zone 510, the rotation can be stopped by a second detent or by a similar structure that provides at least one of tactile feedback and / or audible feedback to the user of the mounting collar 160. The detent may be a virtual detent or a mechanical detent (such as a notched wheel or a spring-actuated lever, etc.). The detent can provide at least one vibration tactile feedback and / or can require an increase in the rotational force to continue rotating the mounting collar 160 from beyond the second limit 516 of the inactive zone 510 to the wire separation zone 540. The feedback may include one or more of an audible sound and a visual indicator.

[0053] The wire separation zone 540 may include a first limit 542 and a second limit 546. The first limit 542 of the wire separation zone 540 is substantially adjacent to the second limit 516 of the inactive zone 510 with the second detent therebetween.

[0054] The second limit 546 of the wire separation zone 540 may include a second hard stop that prevents the mounting collar 160 from rotating in the release direction beyond the second limit 546 of the wire separation zone 540 until the user actuates the release mechanism 550. The second hard stop provided at the second limit 546 of the wire separation zone 540 can prevent accidental continuous rotation into the hub release zone 560. The first limit 562 of the hub release zone 560 may be substantially adjacent to the second limit 546 of the wire separation zone 540 with the second hard stop therebetween.

[0055] The release mechanism 550 may be a push button or an engagement latch, and an example of the release mechanism 550 is shown in FIG. 12. The release mechanism 550 prevents the catheter hub 170 from being inadvertently released (if an inadvertent release occurs, the surgical procedure may need to be restarted from the beginning, adding unnecessary time to the surgical procedure).

[0056] At the end of the rotation, the mounting collar 160 is held stationary by a detent located at the second limit 564 of the hub release zone 560.

[0057] FIG. 6A illustrates an external lock collar and an internal lock collar provided within a catheter hub according to an embodiment. FIG. 6B is a cutaway view of FIG. 6A illustrating a gripping mechanism within the mounting collar according to an embodiment.

[0058] As shown in FIGS. 6A and 6B, the mounting collar 160 includes an external user cylinder 161 and an internal cylinder 162 configured to secure mounting pins 164a, 164b (FIG. 7A) extending from the distal end of the catheter hub 170 by respective gripping mechanisms 165a, 165b.

[0059] FIGS. 7A-7D illustrate the process of attaching a catheter hub 170 to an actuation handle 150 according to an embodiment.

[0060] In FIG. 7A, the catheter hub 170 is separated from the actuation handle 150, and the mounting collar 160 is positioned within the hub release zone 560. Next, the catheter hub 170 moves axially toward the actuation handle 150, and the plurality of drive wires 210 also move toward the actuation handle 150 such that respective mounting pins 164a, 164b of the drive wires 210 are inserted into respective gripping mechanisms (FIG. 6B). To facilitate alignment of the catheter hub 170 and the actuation handle 150, a guide rod may be provided at the center of the mounting pin to This can also be done.

[0061] FIG. 7B illustrates the state where the catheter hub 170 is coupled to the operating handle 150 and the initial rotation of the mounting collar 160 is being performed. In FIG. 7B, the mounting collar 160 rotates in a fixed direction from the hub release zone 560 to the wire separation zone 540.

[0062] In FIG. 7C, the mounting collar 160 further rotates in a fixed direction from the wire separation zone 540 to the inactive zone 510. FIG. 7D illustrates the state where, after the mounting collar 160 has completely rotated in a fixed direction and entered the inactive zone 510, the catheter hub 170 is completely coupled to the operating handle 150 and the operating handle 150 is ready for a medical procedure.

[0063] FIG. 8 illustrates a shelf-like mechanism for assisting in aligning the catheter hub and the mounting collar. As shown in FIG. 8, the shelf-like mechanism is provided axially to position the catheter hub 170 and align it with the mounting collar 160.

[0064] FIG. 9 illustrates a rail mechanism for aligning the catheter hub with the mounting collar. As shown in FIG. 9, the rail mechanism is provided axially to position the catheter hub 170 and align it with the mounting collar 160.

[0065] FIG. 8 form a shelf-like mechanism and the mechanism of FIG. 9 rail facilitate the alignment and rapid insertion of the catheter hub 170 with respect to the operating handle 150, and also avoid misalignment of the mounting pins 164a, 164b and the respective gripping mechanisms 165a, 165b.

[0066] FIGS. 10A - 10D illustrate the process of removing the catheter hub 170 from the operating handle 150 according to the embodiment.

[0067] In FIG. 10A, the catheter hub 170 is attached to the actuating handle 150, and the attachment collar 160 begins to rotate in the release direction from the inactive zone 510 to the detent disposed at the second limit 516 of the inactive zone 510. The attachment collar 160 is rotatable freely within the inactive zone 510. That is, even if the collar moves within the inactive zone 510, no state change (e.g., the attachment pins 164a, 164b coming out of their respective gripping mechanisms 165a, 165b) is caused. Thus, the user can freely rotate in the release direction or the fixing direction without any effect within the inactive zone 510, that is, between the first limit 512 and the second limit 516 of the inactive zone 510. to install the mounting collar 160 rotate freely in the release direction or the fixing direction to make can do.

[0068] In FIG. 10B, after passing the detent at the second limit 516 of the inactive zone 510, the attachment collar 160 rotates in the release direction and enters the wire separation zone 540. While within the wire separation zone 540, the distal ends of the plurality of drive wires 210 are in the detachment mode. The wire separation zone 540 is configured to simultaneously detach at least three drive wires of the medical device actuator 310. Thus, in the detachment mode, the catheter is in a flexible emergency mode. In the emergency mode, the attachment collar 160 rotates easily (i.e., rotates easily), detaches the drive wires 210, and enhances the safety during surgery such as robotic surgery.

[0069] FIG. 10C illustrates the user pressing the release mechanism 550 to cross the second hard stop provided at the second limit 546 of the wire separation zone 540.

[0070] FIG. 10D illustrates rotation in the release direction into the hub release zone 560 beyond the second limit 546 of the wire separation zone 540. By rotating the mounting collar 160 to the hub release zone 560, disconnection of the drive wire 210 from the drive mechanism provided in the operating handle 150 is initiated. As the mounting collar 160 rotates through the hub release zone 560 to the third (final) hard stop 564, the mounting pins 164a, 164b are released from the respective gripping mechanisms 165a, 165b provided in the operating handle 150. Thus, the user can axially slide the catheter hub 170 from the operating handle 150 to separate the operating handle 150 from the catheter hub 170.

[0071] FIGS. 11A and 11B illustrate a sleeve guard 585 according to an embodiment. The sleeve guard 585 can slide axially to a closed position so as to cover part or all of the mounting collar 160. As shown in FIG. 11A, when in the open state, the sleeve guard 585 enables rotation of the mounting collar 160 by enabling access to the mounting collar 160. As shown in FIG. 11B, when in the closed state, the sleeve guard 585 prevents rotation of the mounting collar 160 by preventing access to the mounting collar 160.

[0072] FIG. 12 illustrates the operation of the release mechanism according to an embodiment. By pressing the release mechanism 550, the drive wire 210 of the steerable catheter 100 can be released from the catheter hub 170. As shown in FIG. 12, the release mechanism 550 may be a double-sided button that requires pressing from both sides for its operation. Thus, for the release of the drive wire 210 from the catheter hub 170, linear control rather than rotational control is provided.

[0073] By operating (i.e., depressing) the release mechanism 550, linear motion can be provided to control movement between the inactive zone 510 and the wire separation zone 540 and / or movement between the wire separation zone and the hub release zone 560. In linear control, movement through the inactive zone 510 can be facilitated by a movement of about 1 / 4 inch to 1 / 2 inch, movement through the wire separation zone 540 can be facilitated by a movement of about 1 / 2 inch to 2 inches, and movement through the hub release zone 560 can be facilitated by a movement of about 1 inch. Movement through the hub release zone 560 can be made accessible only after the interlock button that enables final separation of the actuating handle 150 and the catheter hub 170 has been pressed.

[0074] The lock state sensor 305 (Figs. 7B - 7C) detects movement between the locked state and the unlocked state of the medical device actuator 310 and the catheter hub 170. One or more rotational sensors may be provided (e.g., position sensors 304a, 304b, 304c, 304d). As shown in Fig. 5, the first position sensor 304a may be provided at the first limit 510 of the inactive zone 512 , the second position sensor 304b may be provided at the first limit 540 of the wire separation zone 542 , the third position sensor 304c may be provided at the second limit 540 of the wire separation zone 546 , and the fourth position sensor 304d may be provided at the third hard stop 564, thereby providing an output of the rotational status of the mounting collar 160. An output of one or more of the lock state sensor 305 and / or the position sensors 304a, 304b, 304c, 304d may be displayed on the display screen 420. When rotation into the hub release zone 560 is detected, the operation of the robotic catheter system 1000 may be temporarily stopped.

[0075] Figure 13 illustrates a method of fixing a catheter to an actuator of a medical device according to an embodiment. In Figure 13, the catheter includes a catheter hub, and the actuator includes a handle and a mounting collar operable to pass through an inactive zone, a wire separation zone, and a hub release zone.

[0076] In step S1301 of Figure 13, with the mounting collar 160 in the hub release zone, the handle 150 is attached to the catheter hub 170. In step S1303, the mounting collar 160 is rotated from the hub release zone 560 to the wire separation zone 540. In step S1305, the mounting collar 160 is rotated from the wire separation zone 540 to the inactive zone 510. By rotating through the wire separation zone 540, the mounting pins 164a, 164b extending from the catheter hub 170 are respectively fixed to the gripping mechanisms 165a, 165b of the actuator.

[0077] Figure 14 illustrates a method of releasing a catheter from an actuator of a medical device according to an embodiment. In Figure 14, the catheter includes a catheter hub, and the actuator includes a handle and a mounting collar operable to pass through an inactive zone, a wire separation zone, and a hub release zone.

[0078] In step S1401 of Figure 14, a rotational force is applied to the mounting collar 160 such that the mounting collar 160 rotates from the inactive zone 510 to a detent provided at a transition between the inactive zone 510 and the wire separation zone 540. In step S1403, feedback from the detent is received. In step S1405, in response to the feedback, either a pressing force or an increased rotational force is applied to transition from the inactive zone 510 to the wire separation zone 540.

[0079] In step S1407, the mounting collar 160 rotates from the wire separation zone 540 to a hard stop provided at the transition between the wire separation zone 540 and the hub release zone 560. In step S1409, by activating the release mechanism, the rotation continues beyond the hard stop. In step S1411, the mounting collar 160 rotates through the hub release zone 560, and the mounting pins 164a, 164b extending from the catheter hub 170 are released from the respective gripping mechanisms 165a, 165b of the actuator. In step S1413, the handle 150 is removed from the catheter hub 170.

[0080] The mounting collar and method of use provide advantages including: providing a rotation zone that prevents the start of any action while absorbing accidental rotation; controlling wire detachment and attachment of the catheter hub to the operating handle while providing various feedback indicating the start / completion of a given action; allowing removal of the catheter by means of a final safety control, enhancing the safety of detachment and avoiding delays in the procedure; and receiving an input from the rotation detection sensor to pause the robotic system to avoid the possibility of the ongoing procedure being restarted.

[0081] Specific details are set forth in order to provide a thorough understanding of the disclosed examples when referring to the foregoing description. In other instances, well-known methods, procedures, components, and circuits are not described in detail so as not to unnecessarily lengthen the present disclosure.

[0082] Of course, when an element or component is referred to as "on", "against", "connected to", or "coupled to" another element or component, it may be directly on, against, connected to, or coupled to the other element or component, or intervening elements or components may be present. In contrast, when an element is referred to as "directly above", "directly connected", or "directly coupled" to another element or component, no intervening elements or components are present. When used, the phrase "and / or" includes any and all combinations of one or more of the associated listed items, as so provided.

[0083] To simplify the description for explaining the relationship between an element or feature and another element or feature as shown in various figures, in this specification, spatial relative terms such as "below", "directly below", "downward", "lower", "above", "up", "proximal", "distal", etc. may be used. However, of course, the spatial relative terms are intended to include various orientations of the device during use or operation in addition to the orientation shown in the figure. For example, an element described as "below" or "directly below" another element or feature will be oriented "above" the other element or feature when the device in the figure is turned over. Thus, relative spatial terms such as "below" can encompass both upward and downward orientations. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatial relative descriptors used in this specification should be interpreted accordingly. Similarly, the relative spatial terms "proximal" and "distal" may also be interchangeable where applicable.

[0084] The term "about" as used herein means within, for example, 10%, 5% or less. In some embodiments, the term "about" may mean within the measurement error.

[0085] In this specification, terms such as first, second, third, etc. may be used to describe various elements, components, regions, parts, and / or sections. Of course, such elements, components, regions, parts, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section described hereinafter may be referred to as a second element, component, region, part, or section without departing from the teachings of this specification.

[0086] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to be limiting. The use of the terms "a," "an," and "the" and similar referents in the context of describing the present disclosure (in particular, the context of the following claims) is to be construed to include both the singular and the plural unless otherwise stated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise noted. Specifically, when used in this specification, these terms specify the presence of the described 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 that are not expressly recited. The recitation of a range of values herein is intended to be merely a shorthand way of referring individually to each separate value falling within the range unless otherwise indicated herein, and each separate value is incorporated herein as if it were individually recited herein. For example, if a range of 10-15 is disclosed, then 11, 12, 13, and 14 are also disclosed. All of the methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any examples or exemplary language provided herein (e.g., "such as") is intended merely to make the present disclosure more understandable and is not to be construed as limiting the present disclosure unless otherwise claimed. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the present disclosure.

[0087] Of course, the methods and compositions of the present disclosure can be incorporated in various forms of embodiments, only some of which are disclosed herein. Variations of such embodiments will be apparent to those skilled in the art upon reading the foregoing description. The inventors expect that such variations will be appropriately adopted by those skilled in the art, and the inventors also intend that the present disclosure be implemented in ways other than those specifically described herein. Accordingly, the present disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Further, unless otherwise indicated herein or clearly inconsistent from the context, the present disclosure includes any combination of the above elements in all possible variations.

Explanation of Signs

[0088] 10 User 50 Connector Assembly 60 EM Field Generator 80 Patient 81 Body Cavity 90 Robot Platform 91 Linear Movement Stage 92 Robot Arm 100 Maneuverable Catheter 104 Conduit 105 Tool Channel 108 Wire Guidance Member 109 Anchor Member 110 Robot Catheter 120 Catheter Tip 130 Distal Section 140 Proximal Section 150 Actuating Handle 160 Mounting Collar 161 External User Cylinder 162 Internal Cylinder 164a,b Mounting Pin 165a,b Gripping Mechanism 170 Catheter Hub 180 Imaging Device 181 Target 190 EM Sensor 205 Handheld Controller 210 Drive Wire 250 Access Port 300 Actuator System 304a…d Position Sensor 305 Lock State Sensor 310 Actuator 320 Microcontroller 400 Computer 410 CPU 411 Memory 412 System Interface 413 User Interface 420 Display Screen 421 Graphic Representation 422 Endoscope (Live View) Image 423 Intraoperative Guidance Image 424 Preoperative Image 425 Network Connection 510 Inactive Zone 512 First Limit of Inactive Zone 516 Second Limit of Inactive Zone 540 Wire Separation Zone 542 First Limit of Wire Separation Zone 546 Second Limit of Wire Separation Zone 550 Release Mechanism 560 Hub Release Zone 562 First Limit of Hub Release Zone 564 Final Hard Stop 1000 Robot Catheter System

Claims

1. 1. A mounting collar configured to removably connect a medical device actuator to a catheter hub, comprising: Inactive zones and A wire separation zone; Hub release zone, A mounting collar comprising:

2. the inactive zone includes a first limit and a second limit opposite the first limit; The mounting collar of claim 1 .

3. the mounting collar is configured to rotate between the first and second limits of the inactive zone without causing a change of state. The mounting collar of claim 2.

4. the first limit of the inactive zone having a hard stop. The mounting collar of claim 2.

5. a detent at the second limit of the inactive zone; Further comprising: the detent is configured to provide feedback to a user of the mounting collar when the mounting collar is rotated to the second limit of the inactivity zone. The mounting collar of claim 2.

6. the feedback being at least one of an audible sound, a visual indicator, and an increasing rotational force to continue rotating the attachment collar.

6. The mounting collar of claim 5.

7. a first limit of the wire separation zone adjacent to the second limit of the inactive zone; a first limit of the hub release zone adjacent a second limit of the wire separation zone; The mounting collar of claim 2.

8. the second limit of the wire separation zone having a hard stop.

8. The mounting collar of claim 7.

9. The mounting collar of claim 8 , wherein the hard stop includes a release mechanism.

10. Actuation of the release mechanism allows the mounting collar to rotate past the hard stop.

10. The mounting collar of claim 9.

11. The mounting collar of claim 9 , wherein the release mechanism comprises a push button.

12. rotating the mounting collar from the second limit of the wire separation zone to the hub release zone releases a mounting pin of a catheter operatively connected to the catheter hub.

8. The mounting collar of claim 7.

13. rotating the attachment collar from the second limit of the wire separation zone to the hub release zone releases at least one drive wire of the medical device actuation.

8. The mounting collar of claim 7.

14. the medical device actuator is configured to be removable from the catheter hub when the attachment collar is rotated beyond the second limit of the wire separation zone.

8. The mounting collar of claim 7.

15. A release mechanism is further provided, Operation of the release mechanism allows release of at least one drive wire of a catheter operably connected to the catheter hub. The mounting collar of claim 1 .

16. a sensor configured to detect one of a locked and an unlocked state of the medical device actuator and the catheter hub; The mounting collar of claim 1 further comprising:

17. a sleeve guard configured to slide axially between an open position and a closed position; Further comprising: When in the open position, the sleeve guard allows access to the mounting collar; When in the closed position, the sleeve guard prevents access to the mounting collar. The mounting collar of claim 1 .

18. movably secured to an actuation handle of the robotic catheter system; The mounting collar of claim 1 .

19. 1. A method of securing a catheter to an actuator of a medical device, comprising: the catheter includes a catheter hub, and the actuator includes a handle and an attachment collar operable to pass through a dead zone, a wire separation zone, and a hub release zone; The method comprises: attaching the handle to the catheter hub with the attachment collar in the hub release zone; rotating the mounting collar from the hub release zone to the wire separation zone; rotating the mounting collar from the wire isolation zone to the inactive zone; Including, the step of rotating away from the wire separation zone causes mounting pins extending from the catheter hub to be secured to respective gripping mechanisms of the actuator. method.

20. 1. A method of releasing a catheter from an actuator of a medical device, comprising: the catheter includes a catheter hub, and the actuator includes a handle and an attachment collar operable to pass through a dead zone, a wire separation zone, and a hub release zone; The method comprises: applying a rotational force to the mounting collar to rotate the mounting collar from the inactive zone to a detent located at a transition between the inactive zone and the wire isolation zone; receiving feedback from the detent; applying one of a clamping force and an increased rotational force in response to the feedback to transition from the inactive zone to the wire separation zone; rotating the mounting collar from the wire separation zone to a hard stop at the transition between the wire separation zone and the hub release zone; rotating past the hard stop by actuating a release mechanism; rotating the mounting collar through the hub release zone, whereby mounting pins extending from the catheter hub are released from respective gripping mechanisms of the actuator; removing the handle from the catheter hub; The method includes:

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