Brake Mechanism for Operable Medical Devices and Related Methods - Patent application

Abstract

A manipulation system (60) for a medical device (20) may include a first drive member (303) having a central longitudinal axis, a central shaft (304) extending through the first drive member, a control knob (62) coupled to the first drive member, a brake knob (90) coupled to the central shaft and including a first protrusion (325), and a brake shoe member (308) coupled to the central shaft between the control knob and the brake knob. The first protrusion may be disposed within a first channel of the brake shoe member, the first protrusion configured to engage the brake shoe member to move a first arm (363) of the brake shoe member radially outward toward a wall (359) of the control knob when the brake knob is rotated in a first direction, and the first arm may be configured to move away from the wall when the brake knob is rotated in a second direction.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical systems, devices, and associated methods that may be used to treat a subject. Aspects of the present disclosure relate, inter alia, to medical devices and associated methods for endoscopic or other medical procedures incorporating steerable medical devices. [Background technology]

[0002] Current medical devices such as catheters and endoscopes are used for the examination and / or treatment of the mammalian body. In particular, various surgical procedures use catheters, endoscopes, or other devices to examine peripheral sites of the body and / or introduce surgical tools, fluids, or other materials into the body for the treatment. For example, in some procedures, catheters and endoscopes can be used to introduce, including but not limited to, radiographic contrast agents, drugs, angioplasty balloons, stents, fiberoptic scopes, laser light, and cutting instruments (e.g., biopsy forceps, RF cutters, atherectomy devices, etc.) into blood vessels, cavities, ducts, or tissues of the body.

[0003] It is known in the art to provide a steerable catheter or endoscope with a braking mechanism to prevent relative deflection of the elongate shaft during use. In a conventional manner, a control knob is manually manipulated to articulate the elongate shaft for guidance through a patient's vessel, body cavity, or duct. Manual release of the control knob returns the elongate shaft to its straightened state. At some point during any particular surgical procedure, it may be desirable to stop the relative orientation of the elongate shaft. At such time, a conventional braking mechanism is activated to simultaneously prevent movement of both control knobs relative to the remainder of the catheter.

[0004] Although known braking mechanisms for steerable catheters and endoscopes have proven acceptable for their intended uses, they do have limitations. For example, user fatigue can be increased due to the amount of force required to activate the braking mechanism using one or more control knobs. Additionally, braking mechanisms for steerable catheters and endoscopes often include an excessive amount of internal components, which increases production costs and increases manufacturing time required to assemble the system.

[0005] These concerns may increase the duration, cost, and risk of medical procedures requiring steerable catheters and / or endoscopes. The systems, devices, and methods of the present disclosure may remedy some of the deficiencies described above or address other aspects of the art. Summary of the Invention

[0006] Examples of the present disclosure relate, inter alia, to systems, devices, and methods for performing one or more medical procedures using medical systems and devices. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0007] In some aspects, a manipulation system for a medical device may include a first drive member having a central longitudinal axis, a central shaft extending through the first drive member, a control knob coupled to the first drive member, a brake knob coupled to the central shaft and including a first protrusion, and a brake shoe member coupled to the central shaft between the control knob and the brake knob. The first protrusion may be disposed within a first channel of the brake shoe member, the first protrusion may be configured to engage the brake shoe member to move a first arm of the brake shoe member radially outward relative to the central longitudinal axis toward a wall of the control knob when the brake knob is rotated in a first direction, and the first arm may be configured to move away from the wall of the control knob when the brake knob is rotated in a second direction opposite the first direction.

[0008] In other embodiments, the operating system may include one or more of the following features: A dual stop member is coupled to the central shaft and disposed between the brake shoe member and the control knob. The dual stop member may be configured to limit rotation of the control knob and the brake knob. The dual stop member may be coupled to the brake shoe member via at least one pin. The brake knob may further include a second protrusion, and the brake shoe member may include a second arm and a second channel, and the second protrusion may be disposed within the second channel and configured to engage the brake shoe member to move the second arm radially outward relative to the central longitudinal axis toward the wall of the control knob when the brake knob is rotated in a first direction. The control knob may include a recess, and the recess may receive the brake shoe member and the first protrusion. The brake shoe may include a central portion including a lumen configured to receive a central shaft, a first protrusion extending radially outward from the central portion relative to the central longitudinal axis, a second protrusion extending radially outward from the central portion relative to the central longitudinal axis, a first arm extending outward from the first protrusion, the first arm curved toward the central shaft and including a first enlarged end and a first recess, and a second arm extending outward from the second protrusion, the second arm curved toward the central shaft and including a second enlarged end and a second recess.

[0009] In other aspects, the operating system may include one or more of the following features: the brake knob may include a second protrusion, the first recess may be configured to receive the first protrusion, and the second recess may be configured to receive the second protrusion; the first enlarged end may include a roughened surface, grooves, and / or teeth configured to engage a wall, and the second enlarged end may include a roughened surface, grooves, and / or teeth configured to engage a wall; the brake shoe may further include a first spring beam extending from the first arm and at least partially extending into the first recess, and a second spring beam extending from the second arm and at least partially extending into the second recess; the brake shoe may further include a first lumen extending through the first enlarged end, and a second lumen extending through the second enlarged end; the first recess may extend from the first enlarged end to a portion of the first arm spaced from the enlarged end. The brake shoe member may include a central portion including a lumen configured to receive the central shaft, a first protrusion extending radially outward from the central portion relative to the central longitudinal axis, a second protrusion extending radially outward from the central portion relative to the central longitudinal axis, a first arm extending outward from the first protrusion, the first arm curved toward the central shaft and including a first end, a first enlarged portion located between the first end and the first protrusion, and a first recess proximate the first end, and a second arm extending outward from the second protrusion, the second arm curved toward the central shaft and including a second end, a second enlarged portion located between the second end and the second protrusion, and a second recess proximate the second end. The first protrusion may be spaced from the central shaft. A first arm may extend circumferentially about the central longitudinal axis.

[0010] In another aspect, a manipulation system for a medical device may include a handle housing configured to be connected to a deflectable insertion shaft, a first drive member, a control knob coupled to the first drive member, and a brake mechanism configured to lock the first drive member. The brake mechanism may include a central shaft extending through the first drive member and coupled to the handle housing and having a central longitudinal axis, a brake knob coupled to the central shaft and including a first protrusion, and a brake shoe member, the first protrusion disposed within a first channel of the brake shoe member, a first arm of the brake shoe member configured to move radially outward relative to the central longitudinal axis toward a wall of the control knob when the brake knob is rotated in a first direction. In some examples, the first protrusion may be configured to engage the brake shoe member to move a first arm of the brake shoe member radially outward relative to the central longitudinal axis toward the wall of the control knob when the brake knob is rotated in a first direction, and the first protrusion may be configured to be positioned within a first recess of the first arm when the brake mechanism is in a fully locked position. The wall may face radially inward opposite the central longitudinal axis. The brake mechanism may further include a dual stop member configured to limit rotation of the control knob and the brake knob.

[0011] In other aspects, a manipulation system for a medical device may include a first drive member coupled to a first manipulation wire and having a central longitudinal axis, a control knob coupled to the first drive member, a brake knob coupled to a central shaft and including a first protrusion, and a brake shoe member coupled to the central shaft between the control knob and the brake knob, the first protrusion being disposed within a first channel of the brake shoe member, and the brake shoe member configured to apply a frictional force against a wall of the control knob facing radially inward relative to the central longitudinal axis.

[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed. [Brief description of the drawings]

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] FIG. 1 is a perspective view of a steerable medical device according to an aspect of the present disclosure. [Diagram 2] 2 is a cross-sectional view of an insertion shaft of the steerable medical device of FIG. 1 according to an embodiment of the present disclosure. [Diagram 3] FIG. 2 is a side cross-sectional view of an exemplary brake mechanism according to aspects of the present disclosure. [Figure 4] FIG. 4 is a perspective, partial cross-sectional view of the exemplary brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Diagram 5] FIG. 4 is a perspective view of exemplary components of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 6] FIG. 4 is a perspective view of exemplary components of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 7] FIG. 4 is a perspective view of an exemplary lock knob of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 8] FIG. 4 is a top view of an exemplary brake shoe of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 9] FIG. 4 is a perspective view of an exemplary articulation knob of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 10] FIG. 4 is a perspective view of exemplary components of the brake mechanism of FIG. 3 according to an embodiment of the present disclosure. [Figure 11] 4A-4C are top and cross-sectional views of the brake mechanism of FIG. 3 in an unlocked position, according to an embodiment of the present disclosure. [Figure 12] 4A-4C are top and cross-sectional views of the brake mechanism of FIG. 3 in an unlocked position, according to an embodiment of the present disclosure. [Figure 13] 4A-4C are top and cross-sectional views of the brake mechanism of FIG. 3 in a locked position, according to an embodiment of the present disclosure. [Figure 14]4A-4C are top and cross-sectional views of the brake mechanism of FIG. 3 in a locked position, according to an embodiment of the present disclosure. [Figure 15] FIG. 1 illustrates a perspective view of an exemplary dual stop component according to aspects of the present disclosure. [Figure 16] FIG. 1 is a perspective view of an exemplary brake shoe according to aspects of the present disclosure. [Figure 17] FIG. 13 is a perspective view of an alternative embodiment of a brake shoe according to aspects of the present disclosure. [Figure 18] FIG. 13 is a perspective view of an alternative embodiment of a brake shoe according to aspects of the present disclosure. [Figure 19] FIG. 13 is a perspective view of an alternative embodiment of a brake shoe according to aspects of the present disclosure. [Figure 20] FIG. 13 is a perspective view of an alternative embodiment of a brake shoe according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The terms "proximal" and "distal" are used herein to refer to the relative locations of components of the exemplary medical system and exemplary medical device. As used herein, "proximal" refers to a location relatively closer to the outside of a subject's body or closer to a medical practitioner using the medical system or medical device. In contrast, "distal" refers to a location relatively farther away from a medical practitioner using the medical system or medical device or closer to the inside of a subject's body. The proximal and distal directions are labeled with arrows marked "P" and "D", respectively, throughout the drawings. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof are intended to cover a non-exclusive inclusion, such that a system, device, or method that includes a list of elements may include other elements not expressly listed or inherent thereto, rather than including only those elements. Unless otherwise specified, the term "exemplary" is used in the sense of "example" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values ​​within + / - 10% of the stated value.

[0015] Embodiments of the present disclosure are generally directed to steerable devices of the type having a control handle and a deflectable insertion shaft for insertion into a conduit, duct, body lumen, etc. Some embodiments of the present disclosure are generally directed to a manipulation system employed by the steerable device to control deflection of the insertion shaft, and in particular to a manipulation system that includes a brake mechanism for locking the distal end of the insertion shaft at a desired deflection angle. Embodiments of the present disclosure may also be directed to a control handle, a medical device, or a method of using a medical device employing such a manipulation system.

[0016] Guiding a catheter, endoscope, or other device through a vessel, cavity, or duct in the body to an area of ​​interest is important for successful examination and / or treatment. To this end, modern catheters and endoscopes include devices that allow an operator to deflect the distal end of an associated insertion shaft in order to guide the insertion shaft through a duct, blood vessel, or the like to an area of ​​interest. For example, conventional steerable catheters and endoscopes typically include a control handle from which an elongated insertion shaft extends. The elongated insertion shaft is formed from one or more materials having a stiffness that maintains the elongated shaft in a generally straight state in the absence of an external force. An outer end portion of the elongated shaft is relatively flexible to allow for deflection. Pairs of control wires are connected to the control handle, extend outwardly through the elongated shaft, and terminate at the flexible outer end of the elongated shaft. The control wire control mechanism is mounted to the control handle and includes a pair of rotatable control knobs which cooperate with respective pairs of control wires to manually control bending of the flexible outer end of the elongated tube, thereby effectively "steer" the catheter or endoscope up and down and left and right.

[0017] Although exemplary embodiments of the present disclosure are described with reference to steerable catheters, it will be understood that aspects of the present disclosure have broad application and thus may be suitable for use with many types of medical devices, such as endoscopes (e.g., bronchoscopes, colonoscopes, gastroscopes, duodenoscopes, etc.), steerable fiberscopes, steerable guidewires, and non-medical devices, such as borescopes, etc. Accordingly, the following description and illustrations should be considered exemplary in nature and, thus, not limiting the scope of the present disclosure.

[0018] FIG. 1 illustrates an exemplary steerable device 20 including a control handle 22 and an insertion shaft 24 extending outwardly from the control handle 22. In use, the insertion shaft 24 can be guided through a vessel, cavity, duct, or tissue of a mammalian body to an area of ​​interest for examination and / or treatment. In some examples, the insertion shaft 24 can enter the body through an orifice, such as the nose, mouth, or anus, and the insertion shaft 24 can be positioned in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. The steerable device 20 can be capable of introducing into the area of ​​interest, including, but not limited to, radiographic contrast agents, medications, angioplasty balloons, stents, fiberoptic scopes, laser lights, cutting instruments (e.g., biopsy forceps, radiofrequency cutters, atherectomy devices, etc.), and other endoscopic and medical devices (e.g., suction and infusion catheters, stone baskets, needles, cytology brushes, snares, ablation devices, etc.).

[0019] As described in more detail below, the steerable device 20 includes a manipulation system that controls the deflection angle of the distal end of the insertion shaft 24 in two or more non-planar directions to guide the insertion shaft 24 through a body lumen, duct, etc. to a region of interest. As described in more detail below, embodiments of the manipulation system may also include an exemplary braking or locking mechanism for preventing movement of the distal end of the insertion shaft 24 in a first direction independently of preventing movement of the distal end in a second non-planar direction.

[0020] The insertion shaft 24 may be formed as an elongate body having a proximal end 30 and a distal end 32. The insertion shaft 24 may be formed as a hollow tube, a multi-lumen extruded shaft as shown in cross section in FIG. 2, or other structure that allows for the passage of multiple control wires and optional instruments (e.g., biopsy forceps, vision probes, cutters, snares, etc.) to the distal end 32. In one example, the insertion shaft 24 is cylindrical in shape and may be constructed from any suitable material, such as PEBA® (polyether block amide), nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane, fluorinated ethylene propylene (FEP), thermoplastic polyurethane, thermoplastic elastomers, or combinations and mixtures thereof, using various techniques known in the art.

[0021] The insertion shaft 24 may be configured to be capable of being deflected or "steered" through or within a body cavity, vessel, duct, etc., to a region of interest. To that end, the insertion shaft 24 may be configured to vary in stiffness between the proximal end 30 and the distal end 32. In particular, the distal region of the insertion shaft 24 may be configured to be more flexible than the proximal region. This may allow the insertion shaft 24 to be easily advanced without compression and with minimal twisting, while still providing deflection capability to deflect the distal end 32. In some examples, the flexibility may vary gradually (e.g., incrementally) throughout the length of the insertion shaft from the proximal end 30 to the distal end 32. In other examples, the distal region of the insertion shaft (e.g., the distal most 1-4 inches (2.54-10.16 centimeters) of the insertion shaft) may be made more flexible (i.e., less stiff) than the remainder of the insertion shaft.

[0022] As shown in FIG. 1, the insertion shaft 24 may be comprised of a proximal portion 36, a more flexible deflection portion 38 disposed distally of the proximal portion 36, and a distal tip 40 disposed at the distal end 32. The deflectable portion 38 may be comprised of a less stiff material than the proximal portion 36. In other examples, the deflection portion 38 may be an articulating joint or a series of articulating joints. For example, the deflection portion 38 may include multiple segments that allow the distal end to deflect in two or more non-planar directions.

[0023] The steerable device 20 may further include a plurality of steering wires 44 that may deflect the distal end 32 (including the deflection portion 38 and the tip 40) of the insertion shaft 24 in two or more directions. As shown in FIG. 2, the steerable catheter may include two pairs of steering wires 44, each wire spaced approximately 90 degrees apart from the adjacent wire to provide four-way steering (i.e., up / down / left / right) of the insertion shaft 24. In another example (not shown), the steerable catheter may include two steering wires 44 that may allow the user to steer the distal end in at least two directions. The steering wires 44 may be routed, for example, through a corresponding number of steering wire lumens in the insertion shaft 24. The lumens may be disposed within the wall of the tubular shaft, may be formed by a tube extending through a central bore of the tubular shaft, or may be formed by a bore 46 of an extruded shaft as shown in FIG. 2. The steering wires 44 may have sufficient tensile strength and elastic modulus so as not to deform (stretch) during the curved deflection. In some examples, the manipulation wire 44 may be made of stainless steel, may be lubricated, and / or may be housed in a thin-walled PTFE extrusion to help prevent the insertion shaft from binding during deflection. The manipulation wire 44 may have any cross-sectional shape, and is shown as circular in FIG. 2 as an exemplary embodiment.

[0024] The distal end of the control wire 44 may be secured to the distal end 32 of the insertion shaft 24 in any conventional manner such that tension applied to the control wire 44 deflects the distal end 32 in a controllable manner. In some examples, the control wire 44 may be secured to the distal tip of the insertion shaft 24 using conventional techniques such as adhesive bonding, heat bonding, crimping, laser welding, resistance welding, soldering, etc. The control wire 44 extends from the distal end 32 of the insertion shaft 24 to the opposite proximal end 30 of the insertion shaft 24 and may be terminated in any suitable manner in a control system mounted on the control handle 22, as described in more detail below.

[0025] Referring again to FIG. 1, the insertion shaft 24 is operatively connected at its proximal end 30 to the control handle 22. In the embodiment shown in FIG. 1, the control handle 22 includes a handle housing 50 formed by two housing halves 50a and 50b joined by suitable removable fasteners, such as screws, or non-removable fasteners, such as rivets, snaps, thermal bonds, adhesive bonds, or interference fits (e.g., crash pins, etc.). The proximal end 30 of the insertion shaft 24 may be routed through a strain relief fitting 52 secured to the distal end of the handle housing 50. The handle housing 50 may include other features, such as one or more ports for providing access to any channel of the insertion shaft 24, as desired. As shown in FIG. 1, the handle housing 50 may include an imaging device port 54 (e.g., for connection to an umbilicus having imaging wiring and / or illumination wiring), a working channel port 56, and an irrigation / aspiration port 58.

[0026] The handle housing 50 carries a manipulation system 60 configured according to an embodiment of the present disclosure. In practice, an operator (e.g., a physician, technician, etc.) manually operates the manipulation system 60 to control the deflection of the distal end 32 of the insertion shaft 24 as the insertion shaft advances through a duct, body cavity, organ, etc. to a region of interest. In some examples, the manipulation system 60 may include two movable members operably connected to the distal end of the insertion shaft via a manipulation wire 44. As shown in FIG. 1, the movable members are control knobs 62, 64, which are connected to two pairs of manipulation wires 44 for manipulating the distal end 32 of the insertion shaft 24 in four directions, up and down and left and right. For example, the first control knob 62 may be connected to a pair of manipulation wires 44 for controlling up / down manipulation, and the second control knob 64 may be connected to a pair of manipulation wires 44 for controlling right / left manipulation. In other examples, other movable members, such as a manipulation dial, a linear slider, etc., may be used to manipulate the distal end of the insertion shaft 24. In some examples, a single control wire 44 may be coupled to each of the movable members, such as the first and second control knobs 62 and 64. In these examples, the termination position of the wire may determine the direction in which the insertion shaft may be deflected.

[0027] The manipulation system 60 may further include a brake mechanism that functions to lock or partially lock (e.g., inhibit further deflection) the distal end of the insertion shaft 24 in a desired deflected or angular position during use. For example, embodiments of the brake mechanism may be configured to lock the position of the distal end of the insertion shaft 24 in a first direction independent of movement of the distal end in a second direction. Stated differently, the brake mechanisms described herein may be configured to block movement of the distal end of the insertion shaft 24 in one direction while allowing the insertion shaft 24 to move in a second direction out of the plane of the first direction. This may be accomplished in some examples by blocking movement of the first and / or second control knobs 62, 64 and / or blocking movement of the first and / or second pair of manipulation wires 44 associated with the control knobs 62, 64. 1, actuation of the brake knob 90 can be configured to prevent movement of the control knob 62, and actuation of the lock lever 92 can be configured to prevent movement of the control knob 64. Although the braking mechanisms described herein below are described in connection with the outer control knob 62 and the brake knob 90, any of the braking mechanisms described in this disclosure may also be implemented using the control knob 64 and / or the lock lever 92.

[0028] FIG. 3 shows a side cross-sectional view of a brake mechanism 300 including a control knob 62 and a brake knob 90. For the purpose of explaining the structure of the brake mechanism 300 in FIG. 3, the outward direction is indicated by an arrow labeled "O" and the inward direction is indicated by an arrow labeled "I". The control knob 62 may be coupled to a drive member 303, which may be interconnected between the control knob 62 and the operating wire 44. The drive member (shaft) 303 is pressed into a pulley assembly 305. Both the shaft 303 and the pulley 305 rotate about a central shaft 304. The brake knob 90 is capable of rotating approximately 80-120 degrees relative to the central shaft 304 when the locking mechanism is engaged or disengaged by the user. The brake shoes 308 and the dual stop 310 are fixed relative to each other and to the central shaft 304. The drive member 303 may be an integrally formed piece of material, such as plastic or metal, that forms a tubular member that extends from the control knob 62 into the handle 22 (not shown in FIG. 3). A pulley assembly 305 may be fixed to the drive member 303 and coupled to the control wire 44 (not shown in FIG. 3). Rotation of the drive member 303 about a central longitudinal axis 399 may move the control wire 44 through the pulley assembly 305. Thus, when a user rotates the control knob 62 about the axis 399, the drive member 303 may move the control wire 44 to move the deflectable portion 38 of the insertion shaft 24. A first end of the drive member 303 may be coupled to the control knob 62, and a second end of the drive member 303 may be coupled to the pulley assembly 305 at an end opposite the first end. The central shaft 304 may extend through the drive member 303, and the drive member 303 may rotate about the central shaft 304. The central shaft 304 may be cylindrical in shape and may be rotatably coupled to the brake knob 90 such that the brake knob 90 may rotate about the central shaft 304 (about axis 399) without moving the central shaft 304. In some examples, the brake knob 90 may be coupled to the central shaft 304 by a screw 306. In some examples, an inner end 350 of the central shaft 304 may be fixedly coupled to a portion of the handle 22.The central shaft 304 may be fixedly coupled to the brake shoe member 308 and the dual stop member 310 and may be configured to maintain the position of the brake shoe member 308 and the dual stop member 310 relative to the control knob 62 and the brake knob 90.

[0029] The brake mechanism 300 may include a brake shoe member 308 and a dual stop member 310. As shown in FIG. 3, the brake shoe member 308 and the dual stop member 310 may be disposed between the control knob 62 and the brake knob 90 and may be fixedly coupled to the central shaft 304. A recess 321 of the control knob 62 may receive the brake shoe member 308 and the dual stop member 310, with the recess 321 facing outwardly toward the brake knob 90. A central lumen 356 may extend entirely through the control knob 62, may be disposed in a central portion of the recess 308, and may be configured to receive the drive member 303 and the central shaft 304. A circular outer protrusion 351 of the control knob 62 may extend from the top surface 315 of the control knob 62 and may extend around the circumference of the recess 321. The circular outer protrusion 351 may be received by a circular recess 352 of the brake knob 90. The brake knob 90 may be configured to rotate about an axis 399 relative to the control knob 62 and the drive member 303. The control knob 62 and the drive member 303 may be configured to rotate about an axis 399 relative to the central shaft 304, the brake knob 90, the brake shoe member 308, and the dual stop member 310. The central shaft 304 may extend through the brake shoe member 308, the dual stop member 310, the control knob 62, the drive member 303, and the pulley assembly 305, and may terminate at an innermost end of the brake mechanism 300.

[0030] FIG. 4 illustrates a perspective view of the brake mechanism 300 illustrated in FIG. 3, with a portion of the brake knob 90 shown in cross section to expose the brake shoe member 308 and a central portion 318 of the brake knob 90. As illustrated in FIG. 4, the central portion 318 of the brake knob 90 may include a first protrusion 325 and a second protrusion 326 (shown in FIG. 7) on an opposite side across the central portion 318 configured to engage the brake shoe member 308. The first protrusion 325 and the second protrusion 326 each project radially outward from the brake knob 90 toward the brake shoe member 308. The central portion 318 may be cylindrical in shape and may extend inward from an outermost portion of the brake knob 90. When disposed within the recess 321 of the control knob 62, each of the first protrusion 325 and the second protrusion 326 may abut the brake shoe member 308. A radially inwardly facing wall 359 forming part of the recess 321 of the control knob 62 may be configured to engage the brake shoe member 308. As described in further detail below, the first and second protrusions 325, 326 of the brake knob 90 may, upon rotation of the brake knob 90, urge a portion of the brake shoe member 300 radially outward from the axis 399 toward the wall 359 of the control knob 62, forcing the brake shoe member 308 against the wall 359, thereby applying a braking force to the control knob 62 and preventing rotation of the control knob 62 about the axis 399.

[0031] 5 illustrates a dual stop member 310 disposed about the central shaft 304 and received by the brake shoe member 308. The dual stop member 310 may be configured to abut a portion of the control knob 62 within the recess 321. Each of the dual stop member 310 and the brake shoe member 308 may be fixedly coupled to the central shaft 304.

[0032] FIG. 6 illustrates the dual stop member 310 disposed about the central shaft 304 with a portion of the central shaft 304 removed. The dual stop member 310 may include a circular central portion 601, a rectangular projection 620 extending radially outward from the central portion 601, and two tabs 603, 605 extending outward from and across the projection 620 and the central portion 601, respectively. Each of the tabs 603, 605 is configured to be received within a portion of the brake shoe member 308, as shown in FIG. 5. As described further herein below, the dual stop member 310 may be configured to maintain the rotational position of the brake shoe member 308 relative to the control knob 62 and the brake knob 90. The dual stop member 310 may also increase the structural integrity of the brake shoe member 308 and help prevent the brake shoe member 308 from breaking during operation of the brake mechanism 300.

[0033] FIG. 7 shows a perspective view of the brake knob 90. The brake knob 90 may be rectangular in shape and may include a gripping portion 335 configured to be gripped by a user with one or more fingers and / or thumb. The brake knob 90 may include a central lumen 341 configured to receive the central shaft 304 and may be configured to fixedly couple the brake knob 90 to the central shaft 304 (e.g., via a press fit or adhesive). The circular recess 352 may be disposed opposite the gripping portion 90, and the first protrusion 325 and the second protrusion 326 may extend radially inward from an inner-facing surface 701 of the brake knob 90. The first protrusion 325 may be disposed opposite the second protrusion 326 across the central lumen 341. The first and second projections 325, 326 may be spaced apart from one another such that each of the first and second projections 325, 326 may be received within channels 369, 370 (shown in FIG. 8 ) of the brake shoe member 308. Each of the first and second projections 325, 326 may have radially outwardly facing surfaces 705, 706, respectively, that are curved relative to the axis 399. Each of the surfaces 705, 706 may be configured to engage the brake shoe member 308.

[0034] FIG. 8 illustrates a top view of the brake shoe member 308. The brake shoe member 310 may include a central lumen 360 configured to receive the central shaft 304. The central lumen 360 may be configured to receive the central shaft 304 such that the brake shoe member 310 is fixedly coupled to the central shaft 304. A central portion 393 of the brake shoe member 308 may surround the central lumen 360 and may be generally circular in shape. A first protrusion 361 may extend radially outwardly from the central portion 393 relative to an axis 379. The central axis 379 may extend through the center of the central lumen 360. Note that the central axis 379 extends through the page of FIG. 8. A second protrusion 362 may extend radially outwardly from the central portion 393 relative to the axis 379 and may be disposed across the central portion 393 on the opposite side of the first protrusion 361. Each of the first protrusion 361 and the second protrusion 362 may 1) have a width that is smaller than the width of the central portion 393 when measured perpendicular to the axis 379, and 2) have a height that is equal to the height of the central portion 393 when measured parallel to the axis 379.

[0035] The first arm 363 may extend outwardly from the first projection 361 and may be curved toward the axis 379. The width of the first arm 363 may increase as the first arm 363 extends away from the first projection 361, as measured along a line extending perpendicular to and through the central axis 379. The first arm 363 forms a concave curve toward or facing the axis 379, and an outer surface of the first arm 363 is also concave toward the axis 379. The first arm 363 may extend from the first projection 361 to an enlarged end 365. The enlarged end 365 may have a curved surface 384 facing radially outwardly relative to the axis 379, and the surface 384 may be configured to engage the wall 359 of the control knob 62. The enlarged end 365 may also include a recess 367 configured to receive one of the surfaces 705, 706 of the brake knob 90. The recess 367 may face radially inward, opposite the axis 379. A channel 369 may be formed by the second projection 362, the central portion 393, the first projection 361, and the first arm 363, and the channel 369 may be configured to receive one of the first protrusion 325 and the second protrusion 326 of the brake knob 90. The channel 369 may extend from an opening 371 between the enlarged portion 365 and the second projection 362 of the first arm 363 to the first end 389 of the first projection 361.

[0036] The second arm 364 may extend outwardly from the second projection 362 and may be curved toward the axis 379. The width of the second arm 364, as measured along a line extending perpendicular to and through the central axis 379, may increase as the second arm 364 extends away from the second projection 362. The second arm 364 has an inner surface that forms a concave curve toward or facing the axis 379 and an outer surface that is also concave toward the axis 379. The second arm 364 may extend from the second projection 362 to an enlarged end 366. The enlarged end 366 may have a curved surface 385 that faces radially outwardly relative to the axis 379, and the surface 385 may be configured to engage the wall 359 of the control knob 62. In some examples, the surfaces 384, 385 may be coated with a material that increases friction between the surfaces 384, 385 and the wall 359 of the control knob 62. In other examples, the surfaces 384, 385 may have an irregular, roughened, and / or jagged surface, grooves, or teeth to increase friction between the surfaces 384, 385 and the wall 359 of the control knob 62. In some examples, the wall 359 may have an irregular, roughened, and / or jagged surface, grooves, or teeth to increase friction between the surfaces 384, 385 and the wall 359.

[0037] The enlarged end 366 may also include a recess 368 configured to receive one of the surfaces 705, 706 of the brake knob 90. The recess 368 may face radially inward, opposite the axis 379. A channel 370 may be formed by the first projection 361, the central portion 393, the second projection 362, and the second arm 364, and the channel 370 may be configured to receive one of the first protrusion 325 and the second protrusion 326 of the brake knob 90. The channel 370 may extend from an opening 372 between the enlarged portion 366 of the second arm 364 and the first projection 361 to the first end 388 of the second projection 362.

[0038] FIG. 9 shows a perspective view of the control knob 62 and illustrates the recess 321 configured to receive the brake shoe member 308 and the dual stop member 310. The recess 321 may be formed by a radially inwardly facing wall 359, an outwardly facing surface 907, and a stepped portion 909. A central lumen 356 extends through a central portion of the control knob 62. A circular outer projection 351 extends circumferentially around the recess 321 and extends outwardly from the top surface 315. The stepped portion 909 may be curved, may extend across the outwardly facing surface 907, and may be curved (concave) against the central lumen 356. The stepped portion 909 may be configured to engage the dual stop member 310 and may extend outwardly from the outwardly facing surface 907 a distance substantially equal to the width of the dual stop member 310.

[0039] FIG. 10 illustrates a perspective view of the top of the control knob 62, the dual stop member 1110 (shown in FIG. 15), and the central shaft 304. Although the dual stop member 1110 is shown in FIG. 10, any dual stop member described herein may be positioned in the same manner as the dual stop member 1110. The central shaft 304 is shown in cross section for clarity. The dual stop member 1110 is shown abutting the stepped portion 909 of the control knob 62. During operation of the brake mechanism 300, the dual stop member 1110 may control the knob 62 from rotating beyond a prescribed amount via the dual stop member 1110 engaging the stepped portion 909. The dual stop 310 may be altered to allow for different rotational throws of the control knob 62 or to alter the number of degrees required to rotate the dual stop 310 to apply a braking force to the control knob 62. A different amount of allowable throw motion may be required based on the connection to the drive wire system and / or tip articulation requirements at the distal end of the device. In some examples, the dual stop 310 allows for approximately 260-300 degrees of rotational throw motion in the control knob 62. Because the dual stop member 310 is fixed to the central shaft 304, when the dual stop member 1110 contacts the stepped portion 909 of the control knob 62, the dual stop member 1110 may prevent further rotation of the control knob 62.

[0040] 11 and 12 show a top view and a top partial cross-sectional view, respectively, of the brake mechanism 300 in an unlocked position. The brake knob 90 is shown in cross-section in FIG. 12. When in the unlocked position, the first and second protrusions 325, 326 may be disposed within the channels 369, 370 of the brake shoe member 308 and proximate the ends 388, 389 of the channels 369, 370. In the unlocked position, the enlarged ends 365, 366 may be spaced apart from the control knob 62 and / or may not apply pressure against the control knob 62 (via engagement with the wall 359). In some examples, rotation of the brake knob 90 in a clockwise direction may move the first and second protrusions 325, 326 through the channels 369, 370 toward the enlarged ends 365, 366. As the first and second protrusions 325, 326 move in a clockwise direction through the channels 369, 370, each of the arms 363, 364 may move radially outward from the axis 379 toward the wall 359 due to engagement of the first and second protrusions 325, 326 with the arms 363, 364. In some examples, this gradual increase in pressure applied to the control knob 62 from the brake shoe member 308 may provide different degrees of braking to the control knob 62, which may enable control of an operable device.

[0041] 13 and 14 show a top view and a top partial cross-sectional view, respectively, of the brake mechanism 300 in a locked position. When a user rotates the brake knob 90 to the fully locked position shown, the first protrusion 325 and the second protrusion 326 may be positioned within the recesses 367, 368 of the brake shoe member 308. In some examples, the recesses 367, 368 may enable the brake knob 90 to be held in the fully locked position, and an audible "click" may be generated when the user initially positions the first protrusion 325 and the second protrusion 326 within the recesses 367, 368. In some examples, positioning the first protrusion 325 and the second protrusion 326 within the recesses 367, 368 may provide tactile feedback to the user indicating that the brake mechanism 300 is in the fully locked position. The dual stop member 310, through engagement with the brake knob 90, may prevent the user from over-rotating the brake knob 90. When the first protrusion 325 and the second protrusion 326 are positioned within the recesses 367, 368, the user may release the brake knob 62 without releasing the braking applied to the control knob 62, which may facilitate operation of the operable device and reduce user fatigue from maintaining pressure on the brake knob 90 to control braking.

[0042] 15 shows a perspective view of an alternative embodiment of a dual stop member 1110. The dual stop member 1110 may include any of the features described herein in connection with the dual stop member 310. The dual stop member 1110 includes a central portion 1104, a first protrusion 1111, a central lumen 1105, and a second protrusion 1112. The second lumen 1106 and the third lumen 1107 may be disposed on either side of the central portion 1104 and across the central lumen 1105. The second lumen 1106 and the third lumen 1107 may be configured to receive pins 1290, 1291 of the brake shoe member 1208 shown in FIG. 16. The dual stop member 1110 may be incorporated into the brake mechanism 300.

[0043] 16 shows a perspective view of another embodiment of the brake shoe member 1208. The brake shoe member 1208 may include a central lumen 1260, a central portion 1250, protrusions 1261, 1262, channels 1269, 1270, and arms 1263, 1264 having enlarged ends 1265, 1266. Any of the features of the brake shoe member 308 may be included in the brake shoe member 1208. The pins 1290, 1291 may extend outwardly from the central portion 1250 and may be configured to be received by the second lumen 1106 and the third lumen 1107 of the dual stop member 1110. The pins 1290, 1291 may increase the structural integrity of the brake shoe member 1208 when used in the brake mechanism 300.

[0044] 17 shows a top view of another alternative embodiment of the brake shoe member 1308. The brake shoe member 1308 may include a central lumen 1360, a central portion 1350, protrusions 1361, 1362, channels 1369, 1370, and arms 1363, 1364 having enlarged ends 1365, 1366. Any of the features of the brake shoe members 308, 1208 may be included in the brake shoe member 1308. The enlarged ends 1365, 1366 may each include a lumen 1385, 1386 that extends through a central portion of the enlarged ends 1365, 1366, respectively. The lumens 1385, 1386 may be disposed below the recesses 1367, 1368 and may increase the compliance of the brake shoe member 1308. In some examples, the brake shoe member 1308 may not include the recesses 1367, 1368. When the brake shoe member 1308 is used in the brake mechanism 300, the lumens 1385, 1386 may reduce the amount of force required to position the brake mechanism in a fully locked position. In some examples, box-shaped cutouts or lumens 1377, 1378, 1477, 1478, 1577, 1578 may be included in the brake shoes 1308, 1408, 1508, and each lumen 1377, 1378, 1477, 1478, 1577, 1578 may be square, circular, oval, polygonal, or any other shape. In some examples, each lumen 1377, 1378, 1477, 1478, 1577, 1578 may be recessed and may not extend completely through the brake shoe 1308, 1408, 1508, instead of a lumen that extends completely through the brake shoe 1308, 1408, 1508. Each lumen 1377, 1378, 1477, 1478, 1577, 1578 may be configured to receive a bent tab or other protrusion of the dual stop, such as tabs 603, 605 of the dual stop 310. The tabs 603, 605 may be pressed into each lumen 1377, 1378, 1477, 1478, 1577, 1578 to provide additional reinforcement to the brake assembly.The intent of having the lumens 1377, 1378, 1477, 1478, 1577, 1578 is to allow for reinforcement of the brake shoes as the brake shoes 1308, 1408, 1508, 1608 are rotatably coupled to the central shaft 304. This reinforcement may allow for prevention of failure of the brake shoes, dual stops, or other components, such as where a plastic molded brake shoe without the additional reinforcement of the dual stop 310 would deform and slip on the central shaft 304. One or more lumens 1377, 1378, 1477, 1478, 1577, 1578 may be incorporated into any of the brake shoe embodiments disclosed herein.

[0045] 18 shows a top view of another alternative embodiment of a brake shoe member 1408. The brake shoe member 1408 may include a central lumen 1460, a central portion 1450, protrusions 1461, 1462, channels 1469, 1470, and arms 1463, 1464 having enlarged ends 1465, 1466. Any of the features of the brake shoe members 308, 1208, 1308 may be included in the brake shoe member 1408. Spring beams 1487, 1488 may extend through each channel 1469, 1470, respectively, and may extend partially into the recesses 1467, 1468, respectively. Each spring beam 1487, 1488 may include an angled end 1481, 1482, respectively, which may extend into each recess 1467, 1468, respectively. The spring beams 1487, 1488 may increase tactile feedback to a user when locking and unlocking the brake mechanism 300, as well as reduce the force required to transition the brake mechanism 300 from a fully locked position to an unlocked position. Each spring beam 1487, 1488 may be spring biased toward a position away from each arm 1463, 1464, respectively. To transition from the unlocked position to the locked position, the projections 325, 326 travel along the spring beams 1487, 1488 until the projections 325, 326 abut the ends 1481, 1482, forcing the ends 1481, 1482 into the recesses 1467, 1468. The spring beams 1487, 1488 may be nylon, fiberglass / mineral reinforced nylon, acrylonitrile butadiene styrene (ABS), polybutylene terephthalate polymer material (PBT), other injection moldable plastics, or other materials known in the art.

[0046] 19 shows a top view of another alternative embodiment of a brake shoe member 1508. The brake shoe member 1508 may include a central lumen 1560, a central portion 1550, protrusions 1561, 1562, channels 1569, 1570, and arms 1563, 1564 having enlarged ends 1565, 1566. Any of the features of the brake shoe members 308, 1208, 1308, 1408 may be included in the brake shoe member 1508. Each recess 1567, 1568 of the arms 1563, 1564 may be enlarged and may extend from a portion of the respective enlarged ends 1565, 1566 to a portion of the respective arms 1563, 1564 spaced from the respective enlarged ends 1565, 1566, respectively. By enlarging the recesses 1567, 1568, a user may adjust the amount of pressure applied by the brake shoe member 1508 to the control knob 62 while each of the first and second protrusions 325, 326 are disposed within their respective recesses 1567, 1568. The brake shoe 1508 allows a user to release the brake knob 90 without the brake mechanism transitioning from a locked position to an unlocked position when the first and second protrusions 325, 326 are disposed within their respective recesses 1567, 1568, and also allows a user to adjust the amount of braking force applied by the brake mechanism 300 while the first and second protrusions 325, 326 are disposed within their respective recesses 1567, 1568.

[0047] 20 shows a top view of another alternative embodiment of a brake shoe member 1608. The brake shoe member 1608 may include a central lumen 1660, a central portion 1650, protrusions 1661, 1662, channels 1669, 1670, and arms 1663, 1664. Any of the features of the brake shoe members 308, 1208, 1308, 1408, 1508 may be included in the brake shoe member 1408. Each arm 1663, 1664 may include an enlarged central portion 1665, 1666, respectively. The enlarged central portion 1665 may be disposed between the protrusion 1662 and the end 1695 of the arm 1663, and the enlarged central portion 1666 may be disposed between the protrusion 1661 and the end 1696 of the arm 1664. Each recess 1667, 1668 of the arms 1663, 1664 may be located proximate each end 1695, 1696, respectively, and may be spaced apart from each enlarged central portion 1665, 1666, respectively. Each enlarged central portion 1665, 1666 may be configured to engage the wall 359 of the control knob 62 to brake the control knob 62. By locating the enlarged central portions 1665, 1666 spaced apart from the recesses 1667, 1668, each arm 1663, 1664 may bend or flex when the brake mechanism 300 is in the fully locked position with the first protrusion 325 and the second protrusion 326 positioned within the respective recesses 1667, 1668. In some examples, each arm 1663, 1664 can apply a spring force to the brake knob 90 when the first protrusion 325 and the second protrusion 326 are positioned within the respective recesses 1667, 1668. Although the enlarged central portions 1665, 1666 are shown in the central portions of each arm 1663, 1664, other embodiments can include enlarged portions in any area of ​​each arm 1663, 1664.

[0048] It should also be understood that any of the medical devices described herein may be used in medical procedures such as for Endoscopic Submucosal Dissection (ESD), cancer treatment, kidney biopsy or resection or bladder biopsy or resection, other procedures requiring tissue removal, resection, incision, radiofrequency therapy, and / or ablation, or any other therapeutic or diagnostic procedure.

[0049] Various aspects described herein may help reduce procedure times, improve the effectiveness of tissue treatment, reduce risks to subjects, etc. Various systems and devices described herein may facilitate operation of steerable catheter devices such as endoscopes and may reduce user fatigue during operation.

[0050] Although the exemplary embodiments described above are disclosed in the context of a steerable catheter medical device, those skilled in the art will appreciate that the principles described above can be applied to any medical device or medical method and can be implemented in different ways without departing from the scope of the present disclosure as defined by the claims. In particular, structural details, including manufacturing techniques and materials, are well within the understanding of those skilled in the art and are not described in detail herein. These and other modifications and variations are well within the scope of the present disclosure and can be envisioned and implemented by those skilled in the art.

[0051] Furthermore, although certain exemplary embodiments may be illustrated and described herein together, it should be understood that any subsequent configurations designed to achieve the same or similar purpose may be substituted for the specific embodiments described and illustrated herein. The present disclosure is intended to encompass any and all subsequent adaptations or modifications of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those of skill in the art upon review of the description.

[0052] Although the principles of the present disclosure have been described herein with reference to exemplary embodiments for specific applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, embodiments, and equivalent substitutions, all within the scope of the embodiments described herein. Thus, the present disclosure should not be considered as limited by the foregoing description.

[0053] Other exemplary embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the detailed description and practice of the exemplary embodiments disclosed herein. It is intended that the specification and examples are merely illustrative, and that changes in form and detail can be made without departing from the scope and spirit of the disclosure as defined by the following claims.

Claims

1. An operating system for a medical device, comprising: a first drive member having a central longitudinal axis; a central shaft extending through the first drive member; a control knob coupled to the first drive member; a brake knob coupled to the central shaft and including a first projection; a brake shoe member coupled to the central shaft between the control knob and the brake knob, the first projection being disposed within a first channel of the brake shoe member; wherein the first projection is configured to engage the brake shoe member when the brake knob is rotated in a first direction, moving a first arm of the brake shoe member radially outward with respect to the central longitudinal axis toward a wall of the control knob; and wherein the first arm is configured to move away from the wall of the control knob when the brake knob is rotated in a second direction opposite to the first direction.

2. The operating system according to claim 1, further comprising a dual stop member coupled to the central shaft and disposed between the brake shoe member and the control knob.

3. The operating system according to claim 2, wherein the dual stop member is configured to limit rotation of the control knob and the brake knob.

4. The operating system according to claim 2, wherein the dual stop member is coupled to the brake shoe member via at least one pin.

5. The brake knob further includes a second projection; the brake shoe member includes a second arm and a second channel; wherein the second projection is disposed within the second channel and is configured to engage the brake shoe member when the brake knob is rotated in the first direction, moving the second arm radially outward with respect to the central longitudinal axis toward the wall of the control knob.

6. The operating system according to claim 1, wherein the control knob includes a recess that receives the brake shoe member and the first projection.

7. The brake shoe member includes: a central portion including a lumen configured to receive the central shaft; a first protrusion extending radially outward from the central portion with respect to the central longitudinal axis; a second protrusion extending radially outward from the central portion with respect to the central longitudinal axis; the first arm extending outward from the first protrusion, the first arm being curved toward the central shaft and including a first enlarged end portion and a first recess, the first arm; a second arm extending outward from the second protrusion, the second arm being curved toward the central shaft and including a second enlarged end portion and a second recess, the second arm, the operating system according to claim 1.

8. The brake knob includes a second protrusion, the first recess is configured to receive the first protrusion, and the second recess is configured to receive the second protrusion, the operating system according to claim 7.

9. The first enlarged end portion includes a rough surface, a groove, and / or teeth configured to engage the wall, and the second enlarged end portion includes a rough surface, a groove, and / or teeth configured to engage the wall, the operating system according to claim 7 or 8.

10. The brake shoe member, a first spring beam extending from the first arm and at least partially extending into the first recess; a second spring beam extending from the second arm and at least partially extending into the second recess, the operating system according to claim 7.

11. The brake shoe member, a first lumen extending through the first enlarged end portion; a second lumen extending through the second enlarged end portion, the operating system according to claim 7.

12. The first recess extends from the first enlarged end portion to a part of the first arm spaced from the first enlarged end portion, the operating system according to claim 7.

13. The brake shoe member, a central portion including a lumen configured to receive the central shaft; a first protrusion extending radially outward from the central portion with respect to the central longitudinal axis; a second protrusion extending radially outward from the central portion with respect to the central longitudinal axis; The first arm extending outward from the first protrusion, the first arm being curved toward the central shaft and including a first end, a first enlarged portion disposed between the first end and the first protrusion, and a first recess proximate to the first end, the first arm; The second arm extending outward from the second protrusion, the second arm being curved toward the central shaft and including a second end, a second enlarged portion disposed between the second end and the second protrusion, and a second recess proximate to the second end, the second arm; The operating system according to claim 1, comprising:

14. The operating system according to claim 1, wherein the first protrusion is spaced apart from the central shaft.

15. The operating system according to claim 1, wherein the first arm extends circumferentially around the central longitudinal axis.

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