CONTROL SYSTEM FOR TWO-WAY CONTROL OF AN ORIENTABLE CATHETER

专利摘要:
steerable catheter control system and device, steerable catheter device and method of using said control system. A control system and method (40,42) is provided for controlling a steerable catheter (90), the catheter (90) including at least two control wires, a distal end of each of the control wires (40,42) being coupled to the catheter (90) at a distal region thereof, the control system (100) comprising: a housing (20) coupled to the catheter; a sliding assembly (30) positioned within the housing (20) and operable to move linearly therein; a proximal portion of each of the at least two control wires (40,42) being positioned across the slide assembly (30); and a control knob (10) rotatably coupled to the housing (20) for linearly displacing the slide assembly, thus enabling the slide assembly (30) to separately manipulate each of said at least two control wires (40, 42) to effect a change in a deflection of said catheter. rotation of the control knob (10) in a first direction of rotation causes distal displacement of the slider assembly (30) in a first linear direction causing the slider (30) to apply tension to one of said at least two wires (40, 42) thereby effecting a change in the deflection of said catheter (90) in a first deflection direction and wherein rotation of the knob (10) in a second rotation direction causes proximal displacement of the slide assembly (30) in a second linear direction causing the slide assembly (30) to apply tension to the other of said at least two control wires (40, 42) thereby effecting a change in the deflection of said catheter (90) in a second deflection direction .
公开号:BR112014031843B1
申请号:R112014031843-3
申请日:2013-06-18
公开日:2022-01-18
发明作者:Davies Gareth
申请人:Baylis Medical Company Inc；
IPC主号:

专利说明:

TECHNICAL FIELD
[0001] The report concerns a cable for a medical device. More specifically, the report refers to a cable for a medical device that makes it possible to orient the medical device on the body. BACKGROUND OF THE TECHNIQUE
[0002] US patent 5,944,690 granted to Falwell et al. describes a steerable catheter control mechanism for manipulating a pair of control wires that utilizes a sliding mechanism coupled to the proximal ends of the control wires. However, the sliding mechanism described by Falwell is not user-friendly as it is difficult to understand and use. In addition, the sliding mechanism described provides limited control over catheter orientation. The device provides a thumb control that is not needed. It is incapable of providing accurate catheter guidance as it does not have a resolution that allows for immediate manipulations necessary to provide slight changes in catheter deflection.
[0003] US patent 7,691,095 granted to Bednarek et al. describes a bidirectional catheter steerable control cable that includes an adjustment knob rotatably connected to the cable. Cable rotation results in the deflection of two sliding members (each connected to a traction wire) in opposite directions, resulting in the respective deflection of the distal end of the catheter. However, the steerable control cable provided by Bednarek is complex and difficult to manufacture. SUMMARY
[0004] In a generic aspect, embodiments of the present invention provide a control system for bidirectional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter in a distal region thereof, the control system comprising: a housing coupled to the catheter; a sliding assembly positioned within the housing and operable to move linearly within; a proximal portion of each of the at least two control wires being mounted or positioned via the slide mount; and a control knob rotatably coupled to the housing to linearly displace the slide assembly, thereby enabling the slide assembly to separately manipulate each of said at least two control wires so as to effect a change in the deflection of said catheter; wherein rotation of the control knob in a first direction of rotation causes the slide assembly to create a tension in one of said at least two control wires by distal movement of the slide assembly in a first linear direction so as to effect a change in the deflection of said catheter in a first deflection direction and wherein rotation of the knob in a second direction of rotation causes the slide assembly to create tension in the other of said at least two control wires by proximal movement of the slide assembly in a second linear direction so as to effect a change in the deflection of said catheter in a second deflection direction.
[0005] In another generic aspect, embodiments of the present invention provide a slack limiting device for use with a steerable catheter control system having at least one control wire, the control system comprising a mechanism for creating tension in the hair. at least one control wire to create a deflection of the steerable catheter and to release tension thereon, where the slack limiting device is attachable with a portion of the at least one control wire to limit the slack present when tension is released from the hair least one control wire.
[0006] In a further generic aspect, embodiments of the present invention provide, a sliding limiting mechanism for use with a steerable control system for a steerable catheter having at least one control wire, the steerable control system comprising a handle containing a housing with a single slide assembly disposed within the housing having the at least one control wire coupled thereto, and a rotary knob for moving the single slide assembly so as to cause the catheter to deflect by creating a tension in the at least one control wire, the sliding limiting mechanism comprising: - a sliding limiting element positioned inside the handle to limit a linear movement of the single slide assembly in a first linear direction within the handle by rotating the knob in a first direction of rotation, so as to way to limit the voltage applied to the at least one control wire, to limit the deflection of the cable teter in a first deflection direction.
[0007] In a further generic aspect, embodiments of the present invention provide a method for using a control system to deflect a steerable catheter, the control system comprising a handle having a housing and a unique sliding assembly disposed within the housing. which is operable by means of a button, the steerable catheter comprising at least two control wires which are passed through the single slide assembly to be coupled thereto, to guide the catheter in opposite deflection directions, the method comprising: displacing the assembly single slider in a first linear direction to place one of the at least two control wires under tension by rotating the knob in a first direction of rotation so as to deflect the catheter in a first direction of deflection; and displacing the single slide assembly in a second linear direction opposite the first linear direction so as to place the other of the at least two control wires under tension by rotating the knob in a second direction of rotation so as to deflect the catheter in a second deflection direction.
[0008] In yet a further generic aspect, embodiments of the present invention provide a control system for providing unidirectional control of a bidirectional steerable catheter having at least two directions of deflection, the control system comprising an actuator for allowing deflection of the steerable catheter bidirectional in a first deflection direction by actuation in a first direction, and comprising a deflection limiting mechanism for substantially limiting deflection of the bidirectional steerable catheter in a second deflection direction by limiting actuation in a second direction.
[0009] In another generic aspect, embodiments of the present invention provide a slack limiting or restrictor device for use with a control system for a steerable catheter having at least one control wire, the control system comprising a mechanism for manipulating of at least one control wire to alter a deflection of the steerable catheter, wherein the slack limiting device is attachable to a portion of the at least one control wire to limit the slack therebetween during reverse manipulation of the at least one control wire. control. BRIEF DESCRIPTION OF THE DRAWINGS
[0010] In order that the invention may be easily understood, the embodiments of the invention are illustrated by means of examples in the accompanying drawings, in which:
[0011] Fig. 1 - is a top perspective view of a cable assembly according to an embodiment of the present invention;
[0012] Figs. 2A and 2B are perspective views showing the outer cable assembly and the inner cable assembly, in accordance with an embodiment of the present invention;
[0013] Fig. 2C - is an exploded view of a cable assembly, according to an embodiment of the present invention;
[0014] Fig. 2D - is a cross-sectional view of a swivel cable taken along the line line 2D-2D of Fig. 2A, according to an embodiment of the present invention;
[0015] Fig. 3A-3B - are perspective views of a slide assembly according to an embodiment of the present invention;
[0016] Fig. 3C - is a top perspective view of a two-part slider, according to an embodiment of the present invention;
[0017] Fig. 3D - is a cross-sectional view of a swivel cable taken along the 3D-3D line of Fig. 2A, according to an embodiment of the present invention;
[0018] Fig. 3E - is a cross-sectional view of a swivel cable taken along the line 3E-3E of Fig. 2B, according to an embodiment of the present invention;
[0019] Fig. 3F - illustrates a top cross-sectional view, a top view and a side view of a slide assembly, according to an embodiment of the present invention;
[0020] Fig. 3G is a perspective view of an internal cable assembly with a slide assembly according to an alternative embodiment of the present invention;
[0021] Fig. 3H - is a cross-sectional view of a slide assembly taken along line 3H-3H of Fig. 3G, in accordance with an alternative embodiment of the present invention;
[0022] Fig. 4A - is an end view of a cable assembly according to an embodiment of the present invention;
[0023] Fig. 4B - is a side cross-sectional view of a cable assembly taken along line 4B-4B of Fig. 4A, in accordance with one embodiment of the present invention;
[0024] Fig. 4C - is a side cross-sectional view of a cable assembly taken along line 4C-4C of Fig. 4A in accordance with an embodiment of the present invention;
[0025] Figs, 4D, 4E and 4F - illustrate the operation of a cable assembly according to an embodiment of the present invention;
[0026] Fig. 5A - shows a top perspective view of a pulley assembly within a cable according to an embodiment of the present invention;
[0027] Fig. 5B - illustrates a top view of a pulley assembly within a cable according to an embodiment of the present invention;
[0028] Fig. 5C - illustrates a side view of a pulley assembly within a cable according to an embodiment of the present invention;
[0029] Fig. 5D - is an exploded view of a cable showing a pulley assembly, in accordance with an embodiment of the present invention;
[0030] Fig. 5E - illustrates an enlarged top view of a pulley assembly, according to an embodiment of the present invention;
[0031] Fig. 5F - is a cross-sectional view of a cable taken along the line 5F-5F of Fig. 5A;
[0032] Fig. 5G. - is a cross-sectional view of a cable taken along the line 5G-5G of Fig. 5B, according to an embodiment of the present invention;
[0033] Fig. 6A - illustrates a side view of a limiting or restricting element, according to an embodiment of the present invention;
[0034] Fig. 6B - illustrates a bottom view of a limiting or restraining element, according to an embodiment of the present invention;
[0035] Fig. 7A-7B - are perspective side views of a limiting or restraining element, according to an embodiment of the present invention;
[0036] Fig. 7C - is a sectional view of a limiting or restraining element along the line 7C-7C of Fig. 7B, according to an embodiment of the present invention;
[0037] Fig. 8A - is a perspective view of an alternative embodiment of a limiting or restraining element, according to an alternative embodiment of the present invention;
[0038] Fig. 8B - is an exploded view of a cable assembly with an alternative embodiment of a limiting or restraining element according to an embodiment of the present invention;
[0039] Fig. 9A - is a perspective view of the cable assembly with an alternative embodiment of a limiting or restraining element, according to an alternative embodiment of the present invention;
[0040] Fig. 9B - is a perspective view of a limiting or restricting element, according to an embodiment of the present invention.
[0041] Figs 10A-10C - illustrate various embodiments of a slip limiting or slip blocking feature in accordance with various embodiments of the present invention;
[0042] Figs 10D-10F - illustrate alternative embodiments of a slip limiting or slip blocking feature in accordance with various embodiments of the present invention;
[0043] Figs 10G-10H - illustrate further alternative embodiments of a slip limiting or slip blocking feature in accordance with various embodiments of the present invention;
[0044] Figs 11A-11B - illustrate an alternative embodiment of a frieze, in side view and in cross sections, according to an embodiment of the present invention; and
[0045] Figs 12A-12C - illustrate a cable according to alternative embodiments of the present invention. DETAILED DESCRIPTION
[0046] With specific reference now to the drawings in detail, it is noted that the features shown are by way of example and for purposes of illustrative discussion only of certain embodiments of the present invention. Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not limited in its application to the construction details and arrangement of components shown in the description below or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or performed in various ways. Also, it should be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
[0047] As an overview, orientable medical devices have various uses and applications, such as for guiding and positioning devices such as catheters, guide wires and the like within a patient's body. Cables used with such steerable devices typically include a mechanism for driving one or more tension wires capable of deflecting the swiveling device and thereby guiding a working tip of a medical device positioned therein.
[0048] During the conception and practice of the present invention, the present inventors developed a unique design for a bidirectional control system that provides a rotary control mechanism to operate a sliding mechanism of reduced complexity to apply voltage to two or more wires. control to alter the deflection of a medical device, such as a steerable catheter. The rotary mechanism provides improved control of the slider mechanism to enable precise deflections of the medical device, while the slider mechanism itself comprises a relatively simplified design compared to existing products.
[0049] As further described below, the present invention provides a rotary control mechanism such as a knob where the rotation of the knob is converted into a tension force exerted separately on each of the two control wires by means of a slider mechanism. reduced complexity comprising a single movable slide assembly that is coupled, directly or indirectly, to the control wires. The tension force applied to each of the control wires results in a change in the deflection of the medical device, such as a steerable catheter, to which they are attached. Embodiments of the present invention thus obviate the need to have a plurality of sliding members, one for each of the tension wires.
[0050] In a generic aspect, embodiments of the present invention provide a rotating mechanism to control the deflection of two control wires (also called tension wires) using a movable member in order to allow a catheter or other medical device to be guided. in two different directions. Rotation of the knob in a first direction of rotation displaces the limb along a longitudinal direction to allow one of the two tension threads to be tensioned (to deflect the catheter to a first orientation) and rotation of the knob in an opposite direction of rotation (about a longitudinal axis of the cable) displaces the limb along the opposite longitudinal direction to allow the other of the two tension wires to be tensioned (to deflect the catheter to a different orientation).
[0051] In accordance with one embodiment, the present invention provides a control system for bidirectional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter in a distal region thereof, the control system comprising: a housing coupled to the catheter; a sliding assembly positioned within the housing and operable to move linearly; a proximal portion of each of the at least two control wires being positioned across the slide assembly; and a control knob rotatably coupled to the housing for linearly displacing the slide assembly, thereby enabling the slide assembly to separately manipulate each of said at least two control wires to effect a change in deflection of said catheter; where rotation of the control knob in a first direction of rotation causes the slide assembly to move distally in a first linear direction causing the slide assembly to apply tension to one of said at least two control wires thereby effecting a change in the deflection of the said catheter in a first direction of deflection and wherein rotation of the knob in a second direction of rotation causes proximal movement of the slide assembly in a second linear direction causing the slide assembly to apply tension to the other of said at least two control wires thereby effecting a change in the deflection of said catheter in a second deflection direction. Cable Assembly Overview
[0052] In one embodiment of the present invention, a steerable control system or cable (100) is provided for manipulating a medical device. The medical device may include, without limitation, a catheter, sheath, introducer or similar medical device. In a specific example, as shown in Figs. 1 and 2A, the cable (100) is coupled to a sheath (90) to enable a user to manipulate or orient the sheath (90) in a desired direction during use. The handle (100) comprises a button (10) which is rotatably coupled to a housing (20) on the handle. The knob (10) is rotatable about the longitudinal axis of the handle (100) and rotates with respect to the housing (20). In operation, rotating the knob (10) in a first direction of rotation allows the user to orient or create a deflection of the sheath (90) in a first direction, while rotation of the knob (10) in a second direction of rotation allows for the user to orient or deflect the hem (90) in a second direction. In some embodiments as described herein, the described bidirectional steerable catheter is operable to be deflected in two different deflection directions, a first and a second deflection direction. In other embodiments, the bidirectional steerable catheter is configured to (or has built-in functionality that makes it possible to a) deflect in two different deflection directions; however, the deflection of the catheter in one of its deflection directions is limited or constrained such that the observed deflection of the catheter is limited to a single deflection direction (relative to the starting or neutral position). Thus, in some embodiments, a unidirectional control system is provided for a bidirectional steerable catheter so as to provide a unidirectional steerable catheter including at least two control wires.
[0053] The rotation of the knob (10) is converted to a deflection of the sheath (90) by means of a slide assembly (30), shown in Fig. 2B. Generally, the button (10) is cooperatively coupled with the slide assembly (30) which is housed within a lumen defined by the housing (20) of the cable. In a specific example, the knob (10) is threaded into the slide assembly (30). Rotation of the knob (10) causes a corresponding linear displacement of the slide assembly (30) within the housing (20). This displacement of the slide assembly (30) is converted into a tension in the control wires coupled to the slide assembly (30) and thus results in a deflection of the sheath (90).
[0054] More specifically, the slide assembly (30) is coupled to the respective proximal ends of a pair of control wires that extend substantially along the length of the sheath (90), e.g., the control wires (40) and (42) as shown in Fig. 2B. A distal end (not shown) of each of the control wires (40, 42) is coupled to a distal portion of the sheath (90). Rotating the knob (10) in one direction causes the slide assembly (30) to move proximally within the housing (20) pulling one of the control wires (such as the control wire (40)) to deflect the sheath (90) in a first direction, while rotation of the knob (10) in an opposite direction causes the slide assembly (30) to move distally within the housing (20) pulling the other of the threads of control (such as control wire (42)) to deflect the sheath (90) in a second direction.
[0055] In an example as shown in Fig. 2B, in order to allow the slide assembly (30) to separately apply a tension force on each of the two control wires, one of the two control wires (such as the control wire (40)) is directly coupled to the slide assembly (30), while the other control wire (such as the control wire (42)) is indirectly coupled to the slide assembly (30) by means of a reversing element steering wheel (50') such as a pulley or pin. In other words, a means for coupling the distal ends of wires on opposite sides of the slider is included in the cable, whereby movement of the slider in one direction will apply tension to a wire while movement of the slider in the other direction will apply tension to a wire. voltage on the other wire. As used herein, "directly coupled" means that the proximal end of the wire is operatively coupled (but not necessarily physically bonded to or integral with) the slider without passing through an intermediate structure, while "indirectly coupled" means that the proximal end of the wire is operatively coupled to (but not necessarily physically bonded to or integral with) the slider after passing through an intermediate structure or element, such as a direction reversal element.
[0056] In a specific example, a proximal end of the control wire (40) exits the sheath (90) and is directed proximally through the slide assembly (30) to be mated to or a proximal face of the slide assembly ( 30), i.e. proximal to the slide assembly. Thus, in this example, the control wire (40) is "directly coupled" to the slide assembly (30). Similarly, a proximal end of the control wire (42) exits the sheath (90) and is directed proximally through the slide assembly (30) where it exits the slide assembly (30). The control wire (42) is then passed around or through the reversing element and directed back distally such that it can be passed distally through the slider to be coupled to or with a distal face of the sliding assembly (30), i.e. distally to the sliding assembly. Thus, in this example, the control wire (42) is "indirectly coupled" to the slide assembly (30). As used herein, the term "distal face of slide assembly (30)" may refer to a distal face of any part of slide assembly (30). Similarly, the proximal face of the slide assembly (30) may refer to a proximal face of any part of the slide assembly (30). As an example, the control wires exit the sheath (90) along a portion of the handle (100) defined by the knob (10) so as to minimize any excessive corners and/or stresses applied to the wire when coupled to the slide assembly ( 30). Button and Housing Overview
[0057] As shown in Fig. 2B, the housing (20) comprises an internal part (20a) (also called the internal housing (20a)) that defines a lumen that is surrounded by an external part of the housing (20b) (also called external housing (20b)). Similarly, the button (10) which is coupled to the housing (20), also comprises an internal part of the button (10a) (also called the internal button (10a)) defining a lumen through an external part of the button (10b) (also called external button (10b)) that surrounds the internal button (10a). A means is provided for fixing the inner button (10a) in the inner housing (20a). In one embodiment, a portion of the inner knob is received within the inner housing to allow one or more pins (12) to be inserted transversely through the inner knob (10a) and inner housing (20a) to secure them in place. The pins (12) may comprise a metal such as stainless steel. In a specific example, openings or holes (23) may be provided in the inner housing (20a) and a circumferential groove (11) (as shown in Fig. 2C) may be provided in a proximal part of the inner button (10a), each one to receive the pins (12). The pins (12) lock the inner button (10a) and the inner housing (20a) together to prevent longitudinal displacement, while allowing rotational movement relative to each other. In other words, the inner knob (10a) is free to rotate with respect to the inner housing (20a), while maintaining the engagement/locking of the inner knob (10a) with respect to the inner housing (20a). In a specific example, the cable (100) comprises two pins (12) that couple the inner button (10a) to the inner housing (20a). In one example, the knob (10) is positioned at the distal end of the handle defining the distal direction (D) and the opposite end of the housing (20) forms the proximal end of the handle defining the proximal direction (P), as shown in the drawings. . In an alternative example, a single opening or hole (23) may be provided to receive a pin (12).
[0058] In one embodiment, as shown in Fig. 2C, the internal housing (20a) defines a lumen (24) therethrough to house the slide assembly (30) and allow displacement of the slide assembly (30) therein. The inner housing (20a) further comprises a window (26) which can guide the slide assembly (30) during displacement and may also provide access to assist in coupling the control wires (40, 42) to the slide assembly (30). ). In some embodiments, the inner housing (20a) further comprises a groove or track (21a) for guiding and limiting displacement of the slide assembly (30) (shown in Fig. 4B). In one embodiment, both the inner housing (20a) and the outer housing (20b) may be made of a polymer. As a particular example, the inner housing (20a) is made of acrylonitrile butadiene styrene (ABS) and the outer housing (20b) is made of polypropylene. In other embodiments, housing (20) may be made of a metal.
[0059] In one example, the outer knob (10b) comprises inwardly extending projections that are cooperatively coupled with or fit into grooves within the inner knob (10a). This allows the inner knob (10a) to be rotated together with the outer knob (10b). In this way, the rotational movement of the outer knob (10b) is communicated to the inner knob (10a) and these can be operated as a single unit. In one embodiment, as shown in Figs. 2B and 2C, the inner button (10a) can be tapered towards the distal end. The inner button (10a) and the outer button (10b) can also be made of a polymer. As a particular example, the inner button (10a) is made of DUPONT™ DELRIN® 100P and the outer button (10b) is made of polypropylene.
[0060] In some embodiments, the external button (10b) may have an external grip for convenience (15) disposed thereon, as shown in Fig. 1-2B. An example of a gripper (15) is additionally shown in a cross-sectional view illustrated in Fig. 2D. The convenience grip (15) may be made of an elastomer layer that is molded over a portion of the outer button (10b). In one particular example, the outer comfort grip (15) is made of Santoprene® SSA 55 which is molded over a portion of the outer button (10b) which is made of polypropylene. Slide mount overview
[0061] In a specific example shown in Fig. 3A, the slide assembly (30) comprises a screw (32) and an intermediate housing (38) comprising a carriage (34). The carriage (34) comprises a proximal face (34a) and a distal face (34b). Each of the control wires (40, 42) exiting the sheath (90) passes through the carriage (34) with the control wire (40) being operatively coupled to the proximal face (34a) of the carriage (34) using a frieze (41) is added. The flange (41) substantially rests against the proximal face (34a) and ensures that as the slide assembly (30) moves proximally it pulls the thread (40) with it. Similarly, the control wire (42) is operatively coupled to the carriage (34) using a crimp (43). The rib (43) substantially rests against the distal face (34b) of the carriage (34) and ensures that as the carriage (34) moves distally, it pulls the control wire (42) with it. As shown in Fig. 3B, the control wire (42) is initially routed proximally through the carriage (34) and is then looped in such a way that it passes distally through the carriage (34) to be coupled to the carriage (34). distal face (34b). In some embodiments, the control wires (40, 42) may be pre-crimped. In other embodiments, the control wires (40, 42) may be crimped after assembly after being routed through the slide assembly (30). Example 1: A two-part slide assembly
[0062] In one embodiment of the slide assembly (30), the carriage (34) of the intermediate housing (38) may comprise multiple components that are cooperatively coupled or may be assembled to form the carriage (34). As an example of this, as shown in Fig 3C and seen in 3D cross-section, the carriage (34) may have a base part (34') having grooves (35x), (35y) and (35z) through which the wires (40) and (42) can be positioned, and a cover part or a wire retainer (34") which is coupled to the base part (34') after the wires have been placed to form openings or passages (35x') , (35y') and (35z') through which the control wires (40, 42) can slide. The cover part (34") can be detachably fixed to the base part (34'), e.g. using a snap-in arrangement. The cover portion (34") may comprise downwardly extending projections or legs (36), as shown in Fig. 3E, which are received within a slot (37) within the base portion (34'). The legs (36) may have tabs, such as snap-in tabs, which can be locked with the surface of the groove (37) in order to secure the cover part (34") to the base part (34').
[0063] Additionally, as shown in Fig. 3E, the base part may comprise a groove (5w) through which the control wires (40) and (42) may be routed after exiting the sheath (90) so as to assist in placing the wires through each of the slots (35x), (35y) and (35z). The cover part (34") may additionally comprise one or more teeth or ribs (35a) which interact with the grooves (35x), (35y) and (35z) so as to partially form the passages or openings (35x'), (35y') and (35z') to retain the threads therein. In one example, the covering part (34") comprises two ribs or teeth (35a). In other embodiments, the slots can be positioned inside the cover part (34"), or in still other embodiments, the slots can be positioned inside both the base part (34') and the cover part (34"). , as shown in Fig. 3E. In other words, either the base part (34') and/or the cover part (34") can receive wires (40, 42) and form openings (35x'), (35y') and (35z') inside of which the wires may be displaced longitudinally. In one example, as shown, the control wire (42) may be routed through openings or passages (35x') and (35z') which are located towards the outside or opposite side edges of the slide assembly (30) in order to prevent excessive stress or strain on the control wire (42) and can help prevent the slide assembly (30) from rotating within the inner housing (20a) (while the wire (40) is routed through the opening or passage (35y')) More specifically, the control wire (42) is routed proximally through the slide assembly (30) through the passage (35x'), wrapped around the pulley and directed from distal form through the sliding assembly (30) through the passage (35z) to be coupled to the distal face of the carriage (34). In other embodiments, wires (42) and (40) may be routed through any of the openings or passages within the slider.
[0064] In some embodiments, for example in the embodiments illustrated in Figs. 3A-3F, the slide assembly (30) comprises a channel (39) [shown in Fig. 3F] that extends through the screw (32) as well as through the carriage (34) to allow a portion of the sheath (90) ) is directed through it. In a specific example, the sheath (90) extends substantially through the entire length of the handle (100) including the button (10) as well as the housing (20). Example 2: Integrally formed slide assembly
[0065] Alternatively, as shown in Fig. 3G, the base part (34') and the cover part (34") may be integrally formed with each other. In other words, the carriage (34) may be a unitary construction and is formed of a single component. Similar to the embodiment described previously, the carriage (34) may comprise three channels or openings (35x'), (35y') and (35z') through which the wires (40) and (42) can be placed respectively as shown in the cross-sectional view of Fig. 3H. In one example, the control wire (42) is routed through the openings (35x') and (35y') and the control wire (40) is directed through the opening (35z'), in a similar manner as described above. Alternative slide mount embodiments
[0066] As discussed above, the slide assembly (30) of the handle (100) (as shown in Fig. 4A) comprises a screw (32) having an external thread arrangement that is received within the knob (10) having a internal thread arrangement. As shown in Figs. 4B and 4C, this allows the knob (10) to move the carriage (34) of the slide assembly (30) as it is rotated. In one example, the external thread of the screw (32) may be in the form of a helical thread (33a) which cooperatively couples with an internal helical thread (13) of the internal knob (10a). In some examples, the helical thread (33a) may be a continuous external thread as shown in Fig. 3F and Figs. 4B-4C. This can provide more contact surface between the thread (33a) of the screw (32) and the internal thread (13) of the inner knob (10a). This may increase friction between the screw (32) and the inner cable and may allow for improved control. After the knob (10) has been rotated, the increased friction can assist in maintaining the position of the knob (10) with respect to the housing so as to retain the sheath (90) in its desired deflection. Alternatively, the screw (32) may have a discontinuous thread along its length. In some embodiments, the slide assembly (30) including the screw (32) is formed from a polymer. More particularly, in one example, the slide assembly (30) is made of Dupont™ Delrin® 100P. Alternatively, the slide assembly (30) may be of a thermoplastic. In still other embodiments, the slide assembly may be made of a metal. In some embodiments, the bolt (32) of the slide assembly (30) may have a roughened outer surface to maintain frictional engagement with the inner knob (10a). In some embodiments, the screw (32) with external threads (33a) is coated with a lubricant such as 807 fluorocarbon gel. In one embodiment, the external thread of the screw (32) may have tapered edges that form a ridge or the thread can be chamfered, which can facilitate the manufacture of the slide assembly (30), for example by means of molding.Overview of reversing direction element
[0067] As mentioned above, the wire (42) is passed through a direction reversal element before being coupled to the slide assembly (30). In a specific example, as shown in Fig. 5A, the wire (42) as it exits the sheath (90) is passed in a proximal direction through the carriage (34) and then around a reversing element (50'). ) such that it can be passed distally through the carriage (34) to be coupled to the distal face (34b) of the carriage (34). In a specific embodiment, the direction reversal element is a pin. In another specific embodiment, as shown, the reversing element is a pulley assembly (50) comprising a pulley (52), also shown in the cross-sectional view of Fig. 5G. The pulley assembly (50) can be coupled to the inner housing (20a) using a fitting. More specifically, with reference to Fig. 5A, the wire (42) as it exits proximally from the carriage (34), is directed over the pulley assembly (50) around the pulley (52) and passed distally through the carriage (34) to be coupled to its distal face (34b). This is also illustrated in Figs. 5B and 5C.Example 1: Assembly of , pulley
[0068] In a specific embodiment, as shown in Figs. 5A-5B and 5D, the pulley assembly (50) comprises a height guide (54) that assists in maintaining or securing the control wire (42) around the pulley (52). The height guide (54) can prevent the control wire from protruding or slipping off the pulley (52) by maintaining its position along the plane of the pulley (52). In one example, the pulley (52) may comprise a groove or slot along its circumference to allow the control wire (42) to remain in place. The groove or slot (52') functions to guide and hold the control wire (42) around the pulley (52). Additionally, a pulley guide (56) may be provided which is substantially adjacent to and circumferentially surrounds at least a portion of the pulley (52). The control wire (42) is guided around the pulley such that it is positioned between the pulley (52) and the pulley guide (56). The pulley guide (56) functions to guide and secure the control wire (42) around the pulley (52) so as to maintain its position. In this way, the height guide (54) and the pulley guide (56) assist in retaining the control wire (42) around the pulley. As illustrated in Fig. 5E, the pulley guide (56) may additionally comprise teeth or projections (56a) that further restrict the movement of the control wire (42) to further reduce the chances of misalignment of the control wire (42) and prevent the control wire (42) from coming off the pulley (52). The teeth or projections (56a) extend from the pulley guide (56) inwardly towards the pulley (52) in order to control the movement of the control wire (42), as shown in Fig. 5E. By providing one or more projections (56a) between the pulley guide (56) and the pulley (52), the amount of friction between the control wire (42) and the pulley guide (56) is increased. In some examples, this may allow the pulley (52) to function as a pin. In some embodiments, each of the pulley (52), height guide (54) and pulley guide (56) may be a separate component or may be integrally formed with the pulley assembly (50), as shown. In a specific example, as shown in Figs 5A-5E, and in the cross-sectional view shown in Fig. 5F, the pulley (52) is mounted on a pin (53) of the pulley assembly (50). A washer (55a) and a bolt (55b) may be used to secure the pulley (52) to the pulley assembly (50). The pulley assembly (50) can be cooperatively coupled with the inner housing (20a). In one example, the washer (55a) may be made of stainless steel and the screw (55b) may be a tapped screw that is made of steel.
[0069] In one embodiment, the pulley assembly (50) is detachably coupled to the inner housing (20a) of the cable (100). In one example, the pulley assembly (50) is coupled to the inner housing (20a) using a friction fit. More specifically, the pulley assembly (50) is coupled to the housing (20) using a snap-in arrangement. In one example, the pulley assembly (50) may comprise four legs (57) (two on each side of the pulley assembly (50)), with each of the four legs (57) having laterally extending projections (57a) which are coupled with corresponding openings (25) inside the inner housing (20a), as shown in Fig. 5D. In one example, the pulley assembly (50) may be coupled to the inner housing (20a) after the sheath (90) has been inserted along the inner housing (20a). The sheath (90) may be coupled to a hub (80) which may also be partially positioned within the inner housing (20a). In one example, the hub (80) comprises a socket (85) to be coupled with a hub cap (85b). In one example, the hub (80) comprises ribs (83) and one or more keys that cooperatively engage or lock with corresponding grooves (27) within the inner housing (20a). This provides a rotary locking mechanism that prevents rotational displacement of the sheath (90) with respect to the handle (100). Once the sheath (90) with the hub (80) is positioned within the inner housing (20a), the projections of the pulley assembly (50) can then be cooperatively coupled with the openings (25) within the inner housing. (20a). This may allow the hub (80) to be longitudinally locked in such a way that the longitudinal displacement of the sheath (90) with respect to the inner housing (20a) is limited. Thus, in some embodiments, the control cable (100) provides both a rotary locking mechanism and a longitudinal locking mechanism for the sheath (90). In some embodiments, the hub (80) includes a door (84) that extends from the hub (80) and is enclosed by the interior of the outer housing (20b). In some embodiments, the pulley assembly (50) including the pulley (52) may comprise a biocompatible material such as a polymer. In one example, the polymer is Dupont™ Delrin®. In a specific example, the pulley assembly (50) is made of Dupont™ Delrin® 100P.Example 2: Pin
[0070] In an alternative example, the direction reversal element may comprise a pin or other structure for directing or redirecting an elongated element such as a tension wire. In such an example, the wire (42), as it exits proximally from the carriage (34), may be directed over and/or around the pin and passed distally through the carriage (34) to be coupled to its distal face. (34b) of the car (34). In a specific example, the pin extends perpendicular to the plane in which the control wire (42) travels. In some embodiments, the pin is positioned proximally to the slide assembly (30). For example, the pin may be coupled to a proximal portion of the cable assembly (100). Alternatively, the pin may be positioned in the slide assembly (30) or be coupled to the slide assembly (30). In embodiments where the pin is used, the control wire (42) which is directed proximally from the carriage (34) may be looped around the pin such that it can be directed distally to be attached to the distal face (34b) of the carriage (34). Clearance Limiting/Restricting Element
[0071] In one embodiment of the present invention, one or more limiting or restraining elements (60) may be provided within the cable (100) which may be coupled to one or both of the control wires (40, 42). In a specific example, a slack limiting element (60) is provided which allows frictional coupling of the control wire (42) to limit or restrict slack in a part of the control wire (42). In one example, the limiting or restraining element (60) is coupled to the pulley assembly (50) as shown in Fig. 5A. Serpentine Friction Device
[0072] In a specific embodiment, the limiting or restraining element (60) may comprise a serpentine friction device (60A), as shown by Figs. 4D-4F and Figs. 5A-5E. The serpentine friction device (60A) comprises pins (61) (as shown in Figs 5D) that extend perpendicular to the control wire path (42) as shown in Figs 5E-5F and Fig 6A. As further shown in Figs 6A-6B, the control wire (42) is routed or braided through spaces, voids or openings (61s) defined by pins (61) and held in place by pins (61). The serpentine friction device (60) may comprise pins (61) that are off-center with each other (e.g., offset laterally) and may partially overlap with each other with respect to the longitudinal axis of the control wire (42). In a specific example, the serpentine friction device (60A) comprises three pins (61). The two outermost pins 61(a) and 61(c) can be positioned such that they are off-axis from a central pin (61b), as illustrated in Fig. 6B. As further illustrated in Figs. 6A-6B, in a specific example, the serpentine friction device comprises pins that are secured together along an upper portion (66). In other embodiments, the serpentine friction device (60A) may comprise ribs or raised surfaces with which the wire frictionally engages. The control wire (42) can be braided across the ribs in such a way that it frictionally couples the ribs.
[0073] In another example, as shown in Figs. 7A, 7B and 7C, the serpentine friction device (60A) may comprise two parts, a base part (62) and an upper part (66) with the pins (61) extending between the base part (62) and the top (66). The control wire (42) can be passed through the openings (61s) between each of the pins (61) and the top (66) can be used to secure the control wire (42) in place. Alternatively, each of the pins (61) is formed integrally with the base part (62) and the top part (66), respectively, and the control wire (42) can be passed through the openings (65) before being coupled to the slide mount (30). Still additionally, the pins (61) can be fixed only to the base part (62).Inclined Friction Device
[0074] In an alternative embodiment of the present invention, the limiting or restricting element (60) comprises a friction device that is inclined (60B) as shown in Figs. 8A and 8B. The inclined friction device (60B) may be coupled to the pulley assembly (50) which is cooperatively operable to couple with the inner housing (20a). In one example, the inclined friction device (60B) may be coupled to the pulley assembly (50) by means of a snap-in arrangement. The friction device (60B) comprises a friction block (63) and clamp (64) coupled to the friction block (63). The friction block (63) may define an opening (63a) to receive the clamp (64). The clamp (64) can be tilted towards the friction block (63). As mentioned before, one or both of the control wires (40, 42) can be coupled to an inclined friction device (60B). In one example, the control wire (42) passes through the inclined friction device (60B) such that it is held between the clamp (64) and the friction block (63). In one example, the clamp (64) comprises a spring mechanism. In some embodiments, the friction block (63) may be made of a polymer. In other embodiments, the friction block (63) can be made of an elastomer and the clamp (64) can be made of metal. In one example, the friction block (63) can be made of rubber and the clamp comprises a wire and friction can be created between the wire and the rubber. In some embodiments, the tilting mechanism of the clamp (64), for example a spring, may be adjustable. Resilient Friction Device
[0075] In yet another embodiment, the friction device may comprise a resilient friction device (60C) for frictionally coupling the control wire (42). In one example, the resilient friction device (60C) may comprise an elastomer block (67a) as shown in Figs. 9A and 9B. In one embodiment, the elastomer block (67a) may comprise a rubber block. The elastomer block (67a) may define a slot (67b) extending longitudinally along its length. A control wire, for example the control wire (42), can be guided inside the slot opening (67b). The slot (67b) may define two downwardly extending legs (68) of the elastomer block (67a). The control wire (42) may be frictionally coupled by the downwardly extending legs (68) and held between the legs (68). Slip Restraining or Limiting ElementExample 1: track inside cable housing
[0076] In some embodiments, the inner housing (20a) is configured to guide the slide assembly (30) along a linear path within the inner housing (20a). In an example shown earlier in Figs. 3E and 4B, the inner housing (20a) comprises a groove or track (21a) running substantially along the length of the inner housing (20a). The slide assembly (30) may comprise a raised projection (31a) (see, for example, Figure 3E) along the base of the slide assembly (30) which is cooperatively coupled within the track (21a) so as to assist in maintaining the linear displacement of the slide assembly (30) along the track (21a).
[0077] The track (21a) may additionally function as a slide lock to restrict movement of the slide assembly (30) to allow a desired deflection of the sheath (90). In other words, the length of the track (21a) restricts the distance that the slide assembly (30) can travel in a given direction (or in the proximal direction and/or in the distal direction) which can be used to restrict the amount of deflection. of the sheath (90). The groove or track (21a) defines an end wall (21a') at each of its opposite ends as shown in Figs. 4B and 10A. Once the raised projection (31a) of the slide assembly (30) has reached the end of the track, it rests against the wall (21a') at the end of the groove or track (21a) interrupting the slide assembly (30) (as shown). in Fig. 10a, the groove or track (21a) functions as a slide lock in the absence of a tubular slide lock (21b) discussed further below). Figs 10a and 10b illustrate slots (21a) of different lengths and, as such, the distance the slide assembly (30) has moved is different for each of the embodiments shown in Figs. 10a and 10b.
[0078] In a further alternative embodiment, an adjustable length lock may be provided coupled to the track (21a) (it may be coupled to the track (21a) using a snap-in arrangement or may be coupled to it using any other means such as friction or glue attachment). The length-adjustable lock may comprise an arm that extends outward and can be coupled with the slide assembly (30) thus preventing displacement of the slide assembly (30). In another example, as shown in Fig. 10c, the length-adjustable lock may be a pin (21z) that can be inserted into the end of the groove or track (21a) [e.g., inside the groove of Fig. 10b] close to the wall (21a') in order to shorten the length of the track. In other words, the pin (21z) is provided to interact with the track (21a) in order to change the length of the track (21a). In some embodiments, the pin (21z) can be inserted into the track (21a) near the slide assembly (30). In other embodiments, the pin (21z) can be inserted into the track (21a) distal to the slide assembly (30). Still additionally, the adjustable length lock can be in the form of a block or an arm that can be fixed inside the track and work effectively to shorten the length of the track (21a).Example 2: Tubular Slip Lock
[0079] In some embodiments, the slip restraining element comprises a tubular slip lock (21b) as shown in Figs. 2A-2C, 4B-4C, 5A, 5D and 10D. As an example, the tubular slide lock (21b) is mounted to the sheath (90) on a proximal side of the slide assembly (30). In some embodiments, the tubular slide lock (21b) may comprise a piece of hard or rigid tubing that rests against a hub of the sheath and may comprise notches to permit coupling therebetween and with the inner housing (20a). In one example, a glue joint may be provided between the tubular slide lock (21b) and the hub on which it is mounted. In some embodiments, the contact surface between the tubular slide block (21b) and the hub (80) can be increased by adhering the tubular slide block (21b) to the hub. In some embodiments, the tubular slide lock (21b) may have additional notches to interact with the pulley assembly (50) and inner housing (20a). In some embodiments, as shown in Fig. 4B and Fig. 10d, the tubular slide lock (21b) may lean against and/or interact with the pulley assembly (50). In other embodiments, the tubular slide lock (21b) may be mounted on the sheath and may not be secured. The tubular slide lock (21b) may comprise a relatively flexible or soft/resilient material such as low density polyethylene (LDPE). In some embodiments, the tubular slide lock (21b) may comprise a relatively stiffer or stiffer material. In a specific example, the tubular slide lock (21b) comprises a high density polyethylene (HDPE). Alternatively, the tubular slide lock can be made of stainless steel. In one example, the tubular slide lock (21b) is a cylinder. Alternatively, the tubular slide lock (21b) is formed from a segment of a cylinder. In some embodiments, the inner diameter of the tubular slide lock (21b) may be greater than the outer diameter of the sheath (90) on which it is mounted. The tubular slide lock defines a distal wall (21b') that interacts with the slide assembly (30) to stop it.
[0080] In still other embodiments, as shown in Fig. 10e, the tubular slide lock (21b) may be in the form of a collar (21y) (defining a proximal wall (21y')) that is fitted over the screw ( 32) of the slide assembly (30) on a distal side of the slide assembly (30). Alternatively, the range of travel of the slide mount (30) can be changed by reducing or increasing the length of the screw (32) of the slide mount (30). In a further alternative, the tubular slide lock (21b) may be formed as a part of the pulley assembly (50) and may extend therefrom into the inner housing (20a). Example 3: A bar extending through from the internal accommodation
[0081] In alternative embodiments, as shown in Fig. 10f, the slip blocking or slip limiting or restricting feature may comprise a bar (21c) extending laterally through the inner housing (20a). In other words, the bar (21c) extends across the width of the inner housing (20a). The bar (21c) can be positioned between the slide assembly (30) and the pulley assembly (50) with the bar defining a distal wall (21c'). Example 4: The slide lock comprises a rivet
[0082] In some embodiments, as shown in Fig. 10g, the slide lock may comprise a rivet (21d). Alternatively, the slide lock may be in the form of a pin or a screw. The rivet (21d) is positioned through an opening in the groove or track (21a) within the inner housing (20a) and extends into the lumen of the inner housing (20a) in the form of a vertically upward projection. . The rivet (21d) can be fixed in the internal housing by means of a friction fit. The rivet (21d) is positioned in the path of the slide assembly (30) and functions to restrict its movement. Alternatively, the rivet (21d) may be coupled to a secondary component such as a block which is positioned within the inner housing (20a) and functions to lock the slide assembly (30).
[0083] Alternatively, a trigger may be provided on the handle which allows adjustment of the slip limiting characteristic by the user before or during use such that the maximum bend radius of the sheath (90) and one or both directions can be adjusted. In some embodiments, the trigger may be in the form of a button.Example 5: Slip lock is an extension of the pulley assembly
[0084] In yet a further alternative, the slip restraining or slip blocking component may comprise an extension (21e) of the pulley assembly (50), as shown in Fig. 10h, which extends distally into the pulley assembly (50) as shown in Fig. 10h. internal housing lumen (20a). control wires
[0085] In some embodiments, the control wires (40, 42) are made of a metal. More specifically, in one example, the wires (40, 42) are stainless steel. In some embodiments, the wires (40, 42) are a stainless steel wire obtained from the 300 series. In some embodiments, at least one of the control wires (40, 42) is a round wire. In other embodiments, at least one of the control wires (40, 42) is a flat wire which may be a rectangular wire. In a specific embodiment, the wires (40, 42) are made of 304V stainless steel. In one example, the wires (40, 42) have a cross section of about 0.004" x 0.015". In another example, the wires (40, 42) have a cross section of about 0.004" x 0.012". friezes
[0086] As shown in Figs. 11A and 11B, in some embodiments, the ribs (41, 43) may be an adjustable rib. In one example, the adjustable rib may be a nut and bolt assembly. In one embodiment, the adjustable crimp may be an externally threaded bolt (48) that cooperatively couples with the internal threads within the nut (46). A cylindrical crimped portion (41', 43') is held partially within the screw (48). The initial length of the wires (40) and (42) can be adjusted by adjusting the position of the screw (48) in relation to the nut (46). In some embodiments, one or more of the openings (35x'), (35y') and (35z') within the carriage (34) may have a diameter sufficient to accommodate the screw (48). In other embodiments, the ribs (41, 43) may not be adjustable ribs. Scabbard and Hub
[0087] In some embodiments, the sheath (90) may extend through the handle (100) from the proximal end to the distal end of the handle (100) as shown in Figs. 2A-2C. This is further illustrated in the cross-sectional view of Figs. 4B-4C. In one embodiment, the sheath (90) is coupled to a hub (80) at its proximal end as further shown in Figs 2C and 5D. The hub has a side door (84) defining an opening therethrough. In one example, the side door (84) may be angled. In one embodiment, the side port (84) may be at an angle of about 60° to the longitudinal axis of the hub (80). In other embodiments, any other suitable angle may be used. As shown in Fig. 2C, the side port is connected to a faucet (92), for example a 3-way faucet through tubing (94) which, in one example, may be polyurethane tubing. The angled side port (84) can increase the use of the cable (100) by ensuring that the side port (84) and the faucet (92) attached thereto remain out of the user's reach while using the cable (100). In some examples, the side port (84) can be used as a reference point to orient the distal tip of the sheath (90). In one example, the opening defined by the side port may allow clinicians to inject fluid, for example saline or contrast, through the sheath during the procedure. In one example, administration of contrast from the side port may allow imaging during use, where the steerable cable assembly (100) is used to access a region of tissue in the patient's body.
[0088] In some embodiments, the hub (80) can be wrapped around the inside of the outer housing (20b) as shown in Figs. 1, 2A-2C, 5D and cross-sectional views 4B-4C. A cap (20c) can be used to secure the hub (80) inside the inner housing (20a). In one embodiment, the cover (20c) may be made of a polymer. In a specific example, the cover (20c) is made of polypropylene. The hub (80) of the sheath is operable to receive a dilator for insertion into the sheath. locking mechanism
[0089] In one embodiment, a locking mechanism may be provided to lock the position of the knob (10) of the cable with respect to the housing (20) so as to maintain a specific deflection angle of the tip of the sheath. In one embodiment, a slide lock may be provided. In other embodiments, a friction fit or friction coupling between the threads (13) of the inner knob (10a) and the threads of the screw (32) of the slide assembly (30) (as shown in Figs. 4B and 4C) can provide a friction force sufficient to maintain the position of the button (10) to assist in maintaining the desired deflection of the sheath (90). In one example, the slide assembly (30) including the screw (32) and carriage (34) may have a surface finish that provides sufficient friction to maintain the desired deflection and thus the position of the distal end of the sheath. In one example, the slide assembly (30) and/or the internally threaded knob lumen (10) may have a rough surface finish to increase the friction between the two. In one example, both the inner knob (10a) and the slide assembly (30) are made from Dupont™ Delrin® 100P as indicated above.
[0090] Additionally, in some embodiments, as shown in Fig. 2C, a chamfer or groove (16) may be provided inside the inner knob (10a), at the interface between the inner knob (10a) and the inner housing (20a). ) to allow a resistor or friction element, such as an O-ring (16'), to be placed therein. This can increase the friction between the inner knob (10a) and the inner housing (20a) to maintain the position of the inner knob (10a) with respect to the inner housing (20a) after it has been rotated. In other words, the O-ring (16') allows maintenance of the curve of the sheath (90) after it has been driven or deflected. In one embodiment, the O-ring may be made of a polymer. In other embodiments, the O-ring may be made from a nitrile. In a specific embodiment, the O-ring may be made of BUNA-N. In another example, the O-ring may be made from a fluoroelastomer such as Viton®. In some such embodiments, a dampening lubricant or grease may be applied to the O-ring to dampen noise or, in other words, prevent creaking as the inner knob (10a) is rotated relative to the inner housing (20a). In a particular example, the lubricant is a synthetic hydrocarbon grease, such as Nyogel 767 A. Alternatively, a washer, for example a Teflon® washer, may be inserted over the inner knob (10a) at the interface between the outer knob. (10b) and the inner housing (20a) in order to reduce friction. In some further embodiments, one or more O-rings (28') may be provided as shown in Fig. 2C, which are received within one or more grooves (28) within the inner housing, which provide an interface. or seal between the inner housing (20a) and the outer housing (20b). In some embodiments, one of the grooves (28) may be formed partially within the inner housing (20a) and partially within a component within the inner housing (20a), such as within a segment of the pulley assembly (50). . Cable assembly operation overview
[0091] In use, the sheath (90) can be inserted into the vasculature of a patient's body and advanced to a target location. The handle (100) can then be manipulated to allow the user to deflect a distal portion of the sheath (90) in the desired direction. In a generic embodiment, a rotation mechanism is provided which allows rotational movement of the knob (10) in one direction to allow longitudinal displacement of the slide assembly (30) in one direction within the inner housing (20a) (in away from a neutral or home position) so as to place one of the control wires (40, 42) under tension. This allows the distal end of the to be deflected in a first direction. Whilst rotating knob (10) in a second direction releases tension on this control wire and allows sheath (90) to return to its neutral position. Further rotation of the knob in the second direction allows the slide assembly (30) to move linearly or longitudinally in the other (opposite) direction within the inner housing (20a) allowing the other of the two control wires (40, 42) to be put under tension. This allows the distal end of the sheath to be deflected in a second direction.
[0092] More specifically, with reference to Fig. 4D, the cable assembly (100) is shown with the slide assembly (30) positioned in the neutral position. As the handle knob (10) is rotated in a first direction (e.g. clockwise) as shown in Fig. 4E, the internal threads (13) of the inner knob (10a) [reviously illustrated in Figs. 4B and 4C] are mated with the external threads (33a) of the screw (32) of the slide assembly (30). As shown in Fig. 4E, rotation of the knob (10) displaces the slide assembly (30) including the carriage (34) linearly in a proximal direction (P) within the inner housing (20a). In other words, the slide assembly (30) moves longitudinally towards the proximal end (shown in the (d2) direction) of the handle (100). As the carriage (34) moves proximally within the inner housing, the proximal face (34a) of the carriage (34) rests against the rib (41). As the knob (10) is further turned clockwise, the displacement of the carriage (34) causes the rib (41) to move proximally, pulling the control wire (40) and putting it under tension. As the control wire (40) is placed under tension it causes a deflection at a distal end of the sheath (90) to which it is coupled, thus leading the sheath (90) in a first direction in a desired plane. In other words, as the control wire (40) is pulled and tensioned, as shown in Fig. 4E, it allows the curvature of the sheath tip to be altered. A deflection of the distal end of the sheath (90) in a first direction can be observed. Furthermore, as the wire (40) is placed under tension, the control wire (42) remains in a neutral or relaxed state. Additionally, as the carriage (34) moves towards the proximal end of the cable (100) by rotation of the knob (10), slack can be created in the control wire (42).
[0093] Similarly, as the knob (10) is turned in a second direction (e.g., in a counterclockwise direction) as shown in Fig. 4F, the internal threads (13) of the inner knob (10a) [reviously illustrated in Figs. 4B and 4C] are mated with the external threads (33a) of the screw (32) of the slide assembly (30). As shown in Fig. 4F, rotation of the knob (10) causes the slide assembly (30) and thus the carriage (34) to move linearly within the inner housing (20a) in a distal direction (D). As the carriage (34) moves distally, tension in the wire (40) is released and a gradual reduction in deflection of the distal end of the sheath (90) is observed. The sheath (90) can reach its neutral position where no stresses are observed in any of the threads (40) or (42).
[0094] As the carriage (34) moves further distally within the inner housing (20a), the distal face (34b) of the carriage (34) rests against the rib (43). As the knob (10) is additionally turned counterclockwise, the translational movement of the carriage (34) results in the rib (43) being displaced, pulling the control wire (42) and putting it under tension as shown in Fig. 4F. As the control wire (42) is placed under tension, it causes a deflection at the distal end of the sheath or catheter (90) to which it is attached, thus leading the sheath (90) in a second direction. In one embodiment, the sheath (90) can be manipulated in a second direction that is within the same plane as the first direction. In other embodiments, the sheath (90) may be deflected in a separate plane. Limiting or clearance restricting element operation
[0095] As mentioned above, in some embodiments, a means may be provided to prevent or limit any slack created in the control wire (42) by its displacement to the segment of the control wire (42) that is in contact with the pulley (52). As shown above in Fig. 4E, as the knob (10) is turned in a clockwise direction, the carriage (34) moves proximally putting tension on the control wire (40) while releasing tension on the control wire (42). ). In some embodiments, a limiting or restraining element (60) may be provided to limit or retain any slack in the control wire (42) as tension is removed from the wire (42) (or, in other words, during reverse handling). of the control wire (42)). In some embodiments, the limiting or restraining element (60) is coupled to the proximal portion of the control wire (42). Similarly, as the knob (10) is turned in a counterclockwise direction as shown previously in Fig. 4F, the carriage (34) moves distally, applying tension to the control wire (42) and releasing tension from the wire. control (40). In one embodiment, a limiting or restraining element (60) may be provided to limit or restrict slack in the control wire (40). In some embodiments, the limiting or restraining element (60) may limit or restrict any play in the threads (40, 42) due to compression of the axis of the orientable sheath (90) during use. In some embodiments of the present invention, the limiting or restraining element may be frictionally coupled to any of the control wires (40, 42). In some embodiments, each of the tension or control wires (40, 42) may be guided through a limiting or restraining element (60) in order to reduce slack in a segment of the wires (40, 42) or to direct the clearance for a specific direction.
[0096] In some embodiments, as described above, the limiting or restraining element (60) is coupled to the pulley assembly (50) and affects the control wire (42) that passes through it. The limiting or restraining element (60) functions to prevent any slack generated in the wire (42) by displacement to or effect on the wire segment (42) which is positioned around the pulley (52). In this way, the segment of control wire (42) positioned around the pulley remains substantially tense preventing the control wire (42) from leaving the pulley (52). In one example, the limiting or restraining element comprises a serpentine friction device (60a) as illustrated in Figs. 4D-4F. The serpentine friction device is further illustrated in Figs 5A-5E, 6A-6B and 7A-7C as described previously. Serpentine friction device operation
[0097] In one embodiment, as shown in Fig. 4F, a limiting or constraining element (60) is used that can force any slack created in the wire (42) to move distally (shown by direction (dl)) through its opening or passage inside the sliding assembly (30). In other words, any slack in the control wire (42) or, in other words, control wire (42) with slack, moves distally with respect to the carriage (34) through its respective opening. This can help prevent slack from affecting the control wire segment (42) around the pulley (52). In this way, the limiting or restraining element (60) can prevent excess slack in the wire around the pulley (52) and can help reduce the risk of the control wire (42) coming off the pulley (52). In some embodiments, where the pulley (52) has a groove to guide the control wire (42) around the pulley (52), the limiting or restraining element (60) may function to hold the control wire (42) ) in position.
[0098] In one example, the cable or device (100) includes a serpentine friction device (60A) as shown above and illustrated in Figs. 5A-5E, 6A-6B and 7A-7C. The serpentine friction device (60A) as further illustrated in Fig. 4E, allows for unidirectional displacement of the wire. The wire can travel in one direction (eg, distal (dl) direction) more easily than in the second direction (proximal (d2) direction). When the knob (10) is turned clockwise, the wire (40) is placed under tension, and slack is created in the control wire (42). The serpentine friction device (60A) prevents the control wire (42) from slipping or moving proximally, thus the control wire segment (42) around the pulley (52) remains taut. In other words, tension is maintained in the control wire segment (42) around the pulley (52) which minimizes the risk of the control wire (42) coming off the pulley (52). In other words, the friction provided by the serpentine friction device (60A) restricts the displacement of the control wire (42) in the proximal direction and ensures that any slack in the control wire (42) is guided distally. The friction between the control wire (42) and the pins (61) is sufficient such that in the absence of an active tension force on the control wire (42), the control wire (42) cannot overcome the friction force. In this way, the control wire (42) cannot travel in the proximal direction as shown in Fig. 4E and any slack created in the wire (42) is displaced in the distal direction (dl) through its respective opening. However, when tension is applied to the control wire (42), as shown in Fig. 4F, by a counterclockwise rotation of the knob (10) (after the slide assembly (30) has reached its neutral position), it is applied a force sufficient for it to overcome the friction force present between the wire (42) and the pins (61), thus allowing the wire to move around the pulley (52) in a way that allows the control wire (42) be put under tension. The control wire (42) is actively pulled in the distal direction (dl). Inclined friction device operation
[0099] In one embodiment, the limiting or restraining element comprises an inclined friction device (60B) comprising a friction block (63) and a clamp (64), as described above with respect to Figs. 8A and 8B. During operation, when the knob (10) is turned clockwise, tension is applied to the control wire (40) through proximal movement of the slide assembly (30) from its neutral position and a slack is generated in the wire. control (42). In the absence of tension applied to the control wire (42), the force exerted by the friction block (63) and clamp (64) is sufficient to prevent proximal displacement of the control wire (42), such that the slack created on the control wire (42) cannot be transmitted to the segment of the control wire (42) around the pulley (52). In other words, the thread segment (42) around the pulley (52) remains under tension. However, by counterclockwise rotation of the knob, the slide assembly (30) is displaced distally back to its neutral position, and by further counterclockwise rotation of the knob, the slide assembly (30) is displaced from distal shape from its neutral position and force is applied to the wire (42). When sufficient force is applied to (42) distally such that the force applied is greater than the force exerted by the friction device (60B) on the control wire (42), the control wire (42) may be displaced longitudinally under tension. In one example, the control wire (42) can be moved longitudinally in a distal direction by counterclockwise rotation of the knob (10). In sum, longitudinal displacement of the control wire (42) in a proximal direction can be prevented by clockwise rotation of the dial as the control wire (42) is released from tension and the control wire (40) is placed under voltage. In this way, the slack generated in the control wire (42) can be oriented away from the pulley by using the inclined friction device (60B), minimizing the risk of the control wire (42) coming off the pulley (52). Resilient friction device operation
[0100] Similar to the operation of the inclined friction device (60B) described above, as shown in Figs. 9A and 9B, the resilient friction device (60C) comprising the elastomer block (67a) frictionally couples the control wire (42) within the slot (67b) between the legs (68) of the elastomer block (67a) . The friction device (60C) allows distal displacement of the control wire (42) under tension as the slide assembly moves distally, but provides sufficient frictional force that the control wire (42) is unable to move longitudinally in a proximal direction when in a relaxed state during proximal displacement of the slide assembly (30). In this way, when the control wire (42) is idle (not under tension), the segment of the control wire (42) around the pulley (52) still remains tensioned as slack is not transmitted to this segment. . This is a result of frictional forces applied to the control wire (42) by the resilient friction device (60C). Cable assembly operation overview
[0101] In one embodiment, as shown in Figs 4A-4C, the control cable (100) can allow bidirectional deflection of the sheath (90). In one example, in the neutral position the carriage (34) may be positioned distal to the center of the inner housing (20a). In such an example, a curvature of the sheath tip in the range of about 0-180° can be obtained when the knob (10) is turned in a clockwise direction and about 0-90° of curvature of the sheath tip can be obtained. when the knob (10) is turned in a counterclockwise direction. In one embodiment, a left tip response can be observed with a clockwise or right rotation of the knob. In other embodiments, a right tip response can be observed with a clockwise or right rotation of the knob. The degree of curvature that is achieved in each direction can be adjusted by changing the neutral or starting position of the slide assembly (30) in combination with a slide limiting element to limit the range of displacement of the slide assembly (30). In some embodiments, the sheath can be deflected by about 270 degrees in at least one of the two deflection directions. In other embodiments, a curvature of over 270 degrees can be obtained. Mechanism for applying the adjustable cable using a slip limiting element Example 1: the slip limiting element is the track
[0102] As outlined above, the track (21a) within the inner housing (20a) may additionally function as a slide lock to restrict displacement of the slide assembly (30) so as to allow for a desired deflection of the sheath (90) . As shown in Fig. 10a, once the slide mount (30) (e.g. a protruding projection (31a) of the slide mount (30) shown in Fig. 3E) has reached the end of the track, it rests against a wall. (21a') at the end of the groove or track (21a), thus stopping or limiting the linear displacement of the slide assembly.
[0103] In some embodiments, the length of the track (21a) can be adjusted in order to change the degree of deflection that can be provided in the sheath (90) using the cable (100). Thus, in some embodiments, a shorter track (21a) may be provided in the inner housing (20a), as shown in Fig. 10a, providing a shorter travel distance for the slide assembly (30) resulting in a longer range. limited displacement for the hem (90). In other words, the sheath (90) is provided with a reduced maximum deflection angle or application length. The track (21a) can be shortened by inserting a pin (21z), as shown in Fig. 10c. Once a part of the slide assembly (30) has been supported against the pin (21z), the pin (21z) prevents further displacement of the slide assembly. In other embodiments, a longer track (21a) may be provided on the inner housing (20a), as shown in Fig. 10b, providing a longer travel distance for the slide assembly (30), resulting in a wider range of performance. displacement to the hem (90). In other words, the sheath (90) can be provided with a greater maximum deflection angle or application length. In general, the length of the track (21a) can restrict the distance that the slide assembly (30) can travel in a given direction (in the proximal direction and/or in the distal direction) which can be used to restrict the amount of deflection of the sheath (90).
[0104] In a specific example, the slide lock may be positioned proximal to the slide mount (30) and may restrict displacement of the slide mount (30). However, this restriction on the displacement of the slide assembly (30) can be used to limit the deflection of the sheath (90) in the proximal direction and/or in the distal direction. This can be achieved by changing the neutral position of the slide assembly (30). A neutral position [N] of the slide mount is illustrated in Fig. 4B. In a specific example, the neutral or home position of the slide mount (30) is adjustable, which can determine the allocation of the range of displacement of the slide mount (30) in each of the distal and proximal directions. In other words, adjusting the neutral or home position of the slide mount (30) determines the distance the slide mount (30) can travel in each of the distal and proximal directions, determining the amount of deflection of the sheath (90) in each of the deflection directions. In some embodiments, the neutral position may be adjusted in combination with the use of a slide lock to provide a sheath (90) capable of 90° degrees of rotation in each of its deflection directions (or, in other words, , the sheath (90) has an application length of 90° in each direction). Alternatively, the sheath (90) may be capable of being subjected to 180 degrees of deflection in each direction. In other embodiments, the sheath (90) may have a deflection angle of 90° in one direction and a deflection angle of 180° in the other direction. In this way, the sheath (90) can have an equal radius of curvature/deflection or application length in both directions or a variable radius of curvature/deflection in each direction. In yet another alternative, the sheath has a deflection angle of at most about 270 degrees in at least one of its deflection directions. In other embodiments, the sheath may have a deflection angle that is greater than 270 degrees. In embodiments of the present invention as described herein, the slide limiting element is a component that is separate from the slide assembly (30). Example 2: The slide limiting element is a tubular slide lock
[0105] In some embodiments, as described above, the slip limiting element is a tubular slip lock (21b), as shown in Figs. 2A-2C, 4B-4C, 5A and 10D. The use of a longer tubular slide lock (21b) results in more restricted movement of the slide assembly (30). In one example, the tubular slide lock (21b) is positioned proximal to the slide assembly (30). In some embodiments, the tubular stop (21b) is made of a relatively hard material and is substantially rigid such that it does not substantially deform under application of force. In one example, by clockwise rotation of the knob (10), as the slide assembly (30) is displaced proximally within the inner housing (20a), the slide assembly (30) rests against the wall (21b'). ) of a rigid tubular slide lock (21b) preventing further displacement of the slide assembly (30). This provides tactile feedback that can be experienced as a harsh interruption on the part of the user. This can assist in indicating to the user that maximum sheath deflection (90) has been reached. Alternatively, in some embodiments, as described above, the tubular slide lock (21b) may be made of a soft or resilient material that gently deforms when the slide assembly (30) rests against the wall (21b') preventing further displacement. of the slide mount (30). This provides tactile feedback that can be experienced as a gentle or gentle interruption on the part of the user. This may indicate to the user that the sheath (90) is close to reaching its maximum deflection. In one example, the tubular slide lock (21b) may have a diameter that is substantially larger than the outside diameter of the sheath (90) on which it is mounted. In one embodiment, as shown in Fig. 10e, the tubular slide lock (21b) is positioned distal to the slide assembly (30) and is in the form of a collar (21y) defining a proximal wall (21y'). In one example, the collar (21y) is made in a rigid method. For example, under counterclockwise rotation of the knob (10), the slide assembly (30) moves distally and is interrupted by the wall (21y') of the collar (21y).
[0106] In some embodiments, where the tubular slide lock (21b) has an inner diameter that is greater than the outer diameter of the sheath (90). The tubular slide lock (21b) can assist in retaining a curve of a rigid medical device, such as a rigid needle, that can be advanced through the sheath (90). The tubular slide lock (21b) can prevent the curve from being straightened by reducing the constraint against the sheath (90).Example 3: The slide limiting element is a bar
[0107] As previously described, in some embodiments, the slip-limiting or slip-blocking element is a bar (21c) that extends with the inner housing (20a) along a transverse plane. In one example, the bar (21c) is positioned between the slide assembly (30) and the pulley assembly (50). The bar (21c) prevents or restricts the movement of the slide assembly (30) as it rests against the wall (21c') of the bar, thus restricting the total travel distance available for the slide assembly (30). This consequently restricts the amount of tension that can be applied to one or more of the threads (40, 42) and thus limits the deflection of the sheath (90). Example 4: The slip limiting element is a rivet
[0108] As described above, in some embodiments, the slip limiting element may be a rivet that extends into the lumen of the inner housing (20a) at a point along the track (21a). The rivet (21d) can be positioned through an opening in the track (21a) and held there in frictional engagement. The rivet blocks the travel path of the slide assembly (30) and effectively shortens the length of the track (21a). In an example of this, there may be multiple openings or holes within the track (21a) and the position of the rivet (21d) may be adjusted. In other words, the rivet (21d) can be positioned in any of the openings. This may allow the user to vary the length of the track (21a) and the desired travel distance of the slide assembly (30) and, consequently, the deflection of the distal end of the sheath (90). In some embodiments, the rivet (21d) works in conjunction with a secondary component to block displacement of the slide assembly (30). The rivet secures the secondary component within the lumen of the inner housing (20a). In some examples of this, the longitudinal length of the secondary component can be adjusted to vary the range of displacement of the slide assembly (30) and, consequently, the deflection of the sheath (90). Alternatively, an actuator may be provided, for example, to activate a mechanical means to alter the length of the secondary component so as to adjust the maximum allowable displacement of the slide assembly (30).Example 5: A slide lock formed as an extension of the pulley assembly
[0109] As discussed above, and as shown in Fig. 10h, in yet a further alternative, the slip restraining or slip blocking component may comprise an extension (21e) of the pulley assembly (50) that extends distal into the lumen of the internal housing (20a). The extension (21e) functions to prevent displacement of the slide mount as described above in order to limit deflection of the sheath (90). Mechanism for providing unidirectional control of a bidirectional steerable catheter having two deflection directions Bidirectional steerable catheter overview
[0110] Referring now to Fig. 12A, in accordance with one embodiment of the present invention, a catheter or cable control system (200) is illustrated for use with a bidirectional steerable sheath or catheter (90). As shown in Fig. 12A, the steerable catheter handle (200) is similar in structure and operation to the handle (100) discussed previously. The handle (200) comprises an actuator comprising a button (10) (comprising internal and external buttons (10a), (10b) respectively) which is coupled to a housing (20) (comprising internal and external housings (20a, 20b)) . The internal knob (10a) has internal threads that cooperate with external threads (33) of the screw (32) of the slide assembly (30), shown in Fig. 12B. By driving in a first direction, for example by rotating the knob (10) in a first direction of rotation, the handle (200) is operable to move the slide assembly (30) in a first linear direction within the inner housing ( 20a) to apply tension to one of the two control wires (40, 42) which are coupled to the carriage (34) of the slide assembly (30) by means of crimps. By driving in a second direction, e.g. rotating the knob (10) in a second direction of rotation, the handle (200) is operable to move the slide assembly (30) in a second linear direction within the inner housing (20a). ) to apply voltage to the other of the two control wires (40, 42).
[0111] In some embodiments, the sheath or catheter (90) may have an overall length that equals between about 90.5 cm and about 91.5 cm, and more specifically equals about 91 cm. In such an example, the usable length of the catheter or sheath (90) (which is the length of the catheter that is distal to the handle (200)) can be from about 70.5 cm to about 71.5 cm. More specifically, the usable length is equal to about 71 cm. In another example, the usable length of the catheter (90) may be from about 44.5 cm to about 45.5 cm, and more specifically, the usable length is equal to about 45 cm. In such an example, the total length of the sheath can be between about 64.5 cm and about 65.5 cm, and more specifically the total length can be equal to about 65 cm. In alternative embodiments, catheter 90 may have a length ranging from about 70 cm to about 92 cm, with a usable length ranging from about 44 cm to about 72 cm. In still other embodiments, the catheter 90 may have a length that is less than about 70 cm with a usable length that is less than about 44 cm. In still other embodiments, the catheter may have a length that is greater than about 92 cm with a usable length that is greater than about 72 cm. In further embodiments, the catheter 90 may have other lengths and usable lengths as is known to one skilled in the art. A unidirectional control system utilizing a slide-limiting member positioned proximal to the slide assembly
[0112] Some embodiments of the present invention comprise a unidirectional control system for providing unidirectional control of a bidirectional steerable catheter having at least two deflection directions, the control system comprising an actuator coupled to at least two control wires, where the actuator actively drives the first control wire to apply tension to the first control wire to deflect a bidirectional steerable catheter from a neutral position into a first deflection direction, and where the driver actively drives the second control wire to apply tension to the second control wire to reverse deflection of the steerable catheter towards its neutral position to allow the bidirectional steerable catheter to return to its original position.
[0113] In the embodiment shown in Figs. 12A and 12B, the handle (200) further comprises a deflection limiting mechanism to limit deflection of the steerable catheter (90) in one of its two deflection directions. In some embodiments, the deflection limiting mechanism comprises a sliding limiting mechanism such as a sliding limiting element that functions to limit displacement of the slide assembly (30) in one of its two linear directions within the inner housing (20a) of so as to limit or restrict the deflection of the sheath (90) in one of its deflection directions. As shown in Figs 12A, 12B, in some embodiments, the slide-limiting member that is used to limit deflection of the catheter (90) may comprise a slide lock (221b) that is positioned within the lumen (24) of the housing. internal (20a). In a specific example, the slide lock (221b) comprises a tubular slide lock similar to the tubular slide lock (21b) (shown in Figs. 2B-2C, 4B-4C, 5A-5D) discussed above with reference to Fig. 10D. In some embodiments, as illustrated in Figs. 12A-12C, the tubular slide lock (221b) is hollow to accommodate the sheath (90) allowing the sheath (90) to extend into the proximal end of the handle (200). In one embodiment, the tubular slide lock (221b) is made of a relatively rigid HDPE material. In one example, the tubular slide lock (221b) has a length [L] of between about 2.15" and about 2.23". In one particular example, the inner diameter (ID) of the slide lock (221b) ranges from about 0.25" to about 0.26" and the outer diameter (OD) ranges from about 0.31" and about 0.32". In a particular example, the slide lock (221b) has a length that is equal to about 2.19" with the inner and outer diameters equal to about 0.255" and 0.315", respectively.
[0114] More specifically, with reference again to Figs 12A, 12B, in the illustrated embodiment, the slide lock (221b) is positioned proximal to the slide assembly (30) of the handle (200) and functions to restrict proximal displacement of the slide assembly (30) by activating the button (10) of the cable (100). In some embodiments, the position of the slide lock (221b) within the inner housing (20a) can be adjusted. As a result, deflection of the steerable bidirectional sheath or catheter (90) in one of its displacement or deflection directions (also called the second deflection direction) is substantially eliminated. However, the distal displacement of the slide assembly (30) remains unrestricted. In this way, when the knob (10) is turned counterclockwise, the slide assembly (30) moves distally within the lumen (24) of the internal housing (20a) to allow the slide assembly (30) ) pull the control wire (42) to cause the sheath or steerable catheter (90) to deflect in the other of its displacement or deflection directions (or the first deflection direction). Once the knob (10) is turned clockwise, tension on the wire (42) is released until the slide assembly (30) returns to its neutral position and the catheter (90) returns to its nominal position. In addition, clockwise rotation of the knob results in limited or restricted proximal displacement of the slide assembly (30) as it rests against the tubular slide lock (221b) which results in a limited amount of force to be applied. exerted on the control wire (40) and deflection of the catheter in the second deflection direction is substantially eliminated. In this way, the use of a slip-limiting element (e.g., slip lock (221b)) within the handle (200) allows for unidirectional use of a bi-directional driving catheter by limiting the proximal displacement of the slip assembly so as to substantially eliminate catheter deflection in its second deflection direction, while allowing distal displacement of the slide assembly in a manner that allows for catheter deflection in its first deflection direction. Unidirectional control system utilizing a slide limiting element in combination with a slide mount featuring an optimized neutral position
[0115] As discussed previously, and presently shown in Figs. 12A-12C, the curvature of the sheath (90) that can be achieved in each of the deflection directions can also be adjusted by changing the neutral position of the slide assembly (30) in combination with the use of a slide limiting element. The neutral position of the slide mount is the position where both control wires (40, 42) are in their unstressed or relaxed state. As illustrated in Fig. 12B, the slide limiting element (e.g., tubular slide lock (221b)) limits the total available travel range [R] of the slide assembly (30) within the lumen (24) along of the window (26) of the inner housing (20a). The neutral position of the slide mount (30) can then be adjusted so as to allocate the range of displacement of the slide mount (30) in each between the proximal and distal direction. Overview of a unidirectional control system with a slide mount presenting a neutral, proximal position
[0116] In order to provide unidirectional functionality to a bidirectional steerable catheter of the present invention, the neutral position is established such that the allocated range of displacement of the slide assembly in one of the two displacement directions is substantially restricted. In the embodiment shown in Fig. 12B, the neutral position [N] is set to be adjacent to the proximal boundary of the displacement range [R] at a distance [S] from the sliding block (221b), thus substantially restricting the displacement of the mount. sliding in the proximal direction. In other words, there is limited space for movement of the slide mount (30) in the proximal direction (as indicated by the limited amount of space or distance [S] between the slide mount (30) and the distal wall (221b') of the slip (221b)). As a result, deflection of the sheath or catheter (90) in the second deflection direction is substantially eliminated, allowing the cable (200) to impart unidirectional functionality to the catheter (90) in its first deflection direction allowing it to reach a first state or position. deflected.Details of the operation of the unidirectional control system featuring proximal neutral position
[0117] As mentioned previously, when using the control system or cable (200), when the knob (10) is turned counterclockwise, the slide assembly (30) moves distally from its position neutral, to apply tension to the wire (42) to deflect the catheter (90) in its first deflection direction. As the knob (10) is then turned clockwise, the slide assembly (30) returns to its neutral position and tension is removed from the control wire (42) to allow the catheter (90) to return to close to its original shape. or non-deflected or nominal state/position. However, the resistance observed due to friction between the control wire (42) and the catheter body (or sheath) (90) along the length of the catheter (90) prevents the catheter (90) from returning substantially to its non-returnable shape. deflected or nominal. A slight bend or bend is still observed in the catheter body (90). Thus, there is a need to overcome friction between the control wire (42) and the catheter (90) along the length of the catheter (90) in order to allow the catheter (90) to return to its shape. In order to overcome this friction between the catheter (90) and the control wire (42), the opposing control wire (40) is activated by rotating the knob (10) additionally in the clockwise direction. This allows the slide assembly (30) to move proximally from its neutral position by distance [S] until it rests against the slide lock (221b), which allows the catheter (90) to be straightened or in In other words, it allows the catheter to return to its undeflected or nominal state or position by overcoming the frictional force between the control wire (42) and the catheter (90). In some embodiments, the distance [S] traveled by the slide assembly (30) to straighten the catheter (90) (which is equivalent to the neutral position of the slide assembly (30) measured from the slide lock (221b) to the wall proximal to the slide assembly (30)) is about 2 mm. In some such examples, the distance [S] may be in the range of between about 1.5 mm and about 2.5 mm. Thus, in a particular embodiment, the neutral position of the slide assembly (30) is set such that it is sufficient to allow the catheter to return to its nominal shape or position as the catheter is straightened by clockwise rotation of the knob ( 10). However, further clockwise rotation of knob (10) is unable to deflect the catheter in its second deflection direction to achieve a second deflected state or position, as displacement of the slide assembly is restricted by the slide lock ( 221b). In this way, the deflection of the catheter (90) in the second deflection direction is substantially restricted or limited. As such, no deflection of the catheter (90) is observed in the second deflection direction. In this way, the control system or cable (200) of the present invention allows for the unidirectional use of a bidirectional steerable catheter. Overview of a unidirectional control system with a slide assembly showing a distal neutral position and details of its operation.
[0118] In some embodiments, as illustrated in Fig. 12C, the slide lock (221b) may be used, as above, in a position that is proximal to the slide assembly (30). However, unlike the embodiment of Fig. 12B, the slide lock (221b) is used to limit displacement of the slide assembly in the opposite direction, i.e., in the distal direction to substantially restrict deflection of the sheath or catheter (90) in its direction. first deflection direction. This can be achieved by changing the neutral position [N] of the slide assembly (30) as illustrated in Fig. 12C. As shown, the neutral position is set to be substantially adjacent to the distal boundary of the displacement band [R] at a distance [S] from the distal wall (20a') of the window (26) of the inner housing (20a). The distance [S] is measured from the distal wall (20a') of the window (26) to the distal wall of the housing (38) of the slide assembly (30). In one example, the distance [S] is about 2 mm. In some such examples, the distance [S] may vary from about 1.5 mm to about 2.5 mm. This neutral position [N] substantially restricts displacement of the slide assembly in the distal direction by counterclockwise rotation of the knob (10). As a result, minimal force is exerted on the control wire (42) such that deflection of the catheter (90) in the first deflection direction is substantially eliminated.
[0119] As an overview of the operation of the embodiment illustrated in Fig. 12C, starting from its neutral position [N], the sliding assembly (30) is free to move proximally within the handle (200) by rotation in the clockwise of the knob, until the slide assembly (30) rests against the distal wall (221b') of the slide lock (221b). This allows force to be exerted on the control wire (40) deflecting the catheter (90) in its second deflection direction, thus providing unidirectional functionality to the bidirectional steerable catheter (90). The inner knob (10a) can then be turned counterclockwise until tension is removed from the control wire (40) and the slide assembly (30) returns to its nominal position [N]. Similar to the embodiment discussed previously, the catheter (90) can be deflected close to its nominal shape, but friction between the control wire (40) and the catheter (90) along the length of the catheter (90) can prevent the catheter (90) fully returns to its nominal shape and a slight bend or bend may remain in the catheter (90). As the knob (10) is then further rotated counterclockwise, the slide assembly (30) is displaced distally until it rests against the proximal wall (20a') of the window (26) of the inner housing (20a) ( which prevents it from being displaced further distally) which allows the catheter to return substantially to its nominal position or shape, but prevents the catheter (90) from being deflected substantially in its first deflection direction. Unidirectional control system using a sliding limiting element positioned distal to the sliding assembly
[0120] Alternatively, the Sliding Limiting Element may be positioned distal to the Sliding Assembly (30) in such a way as to permit unidirectional use of the Bidirectional Conduction Catheter by substantially restricting the distal displacement of the Sliding Assembly. In such an example, the slide limiting element may be positioned distal to the carriage (34) of the slide assembly (30) (similar to the collar (21y) illustrated in Fig. 10e). The collar substantially restricts distal displacement of the slide assembly (30) by counterclockwise rotation of the knob, so as to substantially eliminate deflection of the sheath or catheter (90) in its first deflection direction. However, the slide assembly (30) is free to move proximally within the handle by clockwise rotation of the knob, so as to pull the control wire (40) to cause the catheter to deflect in its second direction of travel. deflection. In this way, the slide-limiting element may alternatively be used to permit unidirectional use of a bi-directional driving catheter by limiting displacement of the slide assembly in a manner that substantially eliminates deflection of the catheter in its first deflection direction, while allowing for deflection in its second deflection direction. In some embodiments, the collar (21y) may be positioned to allow limited distal displacement of the slide assembly (30) to allow straightening of the catheter after it has been deflected in its second deflection direction. Unidirectional control system using embodiments alternatives of a slip limiting element
[0121] As an alternative, any of the slip limiting elements discussed above in Figs. 10a-10h can be used to substantially restrict displacement of the slide assembly in one of its linear displacement directions to allow for unidirectional use of the bidirectional steerable catheter.
[0122] In this way, as described above, embodiments of the present invention provide a rotating mechanism to control the deflection of two control wires or tension wires using a movable member to allow the catheter or other medical device to be driven in two directions. many different. Rotation of the knob in a first direction of rotation displaces the limb along a longitudinal direction to allow one of the two control wires to be placed under tension (to deflect the catheter to a first orientation) and rotation of the knob in a direction opposite rotation (about a longitudinal axis of the cable) displaces the limb along the opposite longitudinal direction to allow the other of the two control wires to be placed under tension (to deflect the catheter to a different orientation).
[0123] In a generic aspect, embodiments of the present invention provide a control system for the bidirectional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof, the control system comprising: a housing coupled to the catheter; a sliding assembly positioned within the housing and operable to move linearly therein; a proximal portion of each of the at least two control wires being mounted or positioned via the slide mount; and a control knob rotatably coupled to the housing for linearly displacing the slide assembly, thereby enabling the slide assembly to separately manipulate each of said at least two control wires to effect a change in a deflection of said catheter; where rotation of the control knob in a first direction of rotation causes the slide mount to move distally in a first linear direction, causing the slide mount to apply voltage to one of said at least two control wires, thereby effecting a change in deflecting said catheter in a first deflection direction, and wherein rotation of the knob in a second direction of rotation causes proximal displacement of the slide assembly in a second linear direction, causing the slide assembly to apply tension to the other of said at least two control wires, thereby effecting a change in the deflection of said catheter in a second deflection direction.
[0124] In another generic aspect, embodiments of the present invention provide a clearance limiting or restricting device for use with a steerable catheter control system featuring at least one control wire, the control system comprising a mechanism for applying tension on at least one control wire to deflect the steerable catheter and release tension therefrom, wherein the slack limiting device is attachable to a portion of the at least one control wire to limit slack when tension is released from the at least one control wire.
[0125] In yet another generic aspect, embodiments of the present invention provide a slack limiting device for use with a steerable catheter control system having at least one control wire, the control system comprising a mechanism for applying tension to at least one control wire for deflecting the steerable catheter and releasing tension therefrom, wherein the slack limiting device is attachable to a portion of the at least one control wire to limit slack when tension is released from the at least one wire of control.
[0126] In a further generic aspect, embodiments of the present invention provide a slip limiting or restricting mechanism for use with a steerable control system for a steerable catheter having at least one control wire, the steerable control system comprising a cable having a housing with a single sliding assembly disposed within the housing having the at least one control wire attached, and a rotary knob for moving the single sliding assembly to cause deflection of the catheter by applying tension to the at least one wire control, the slide limiting mechanism comprising: a slide limiting or restraining element positioned within the handle to limit linear movement of the single slide assembly in a first linear direction within the handle by rotating the knob in a first direction of rotation, to limit the voltage applied to the at least one control wire, to to limit catheter deflection in a first deflection direction.
[0127] In a further generic aspect, embodiments of the present invention provide a method for using a control system to deflect a steerable catheter, the control system comprising a handle having a housing and a unique sliding assembly disposed within the housing which is operable by means of a button, the steerable catheter comprising at least two control wires which are passed through the single slide assembly to be coupled thereto to drive the catheter in opposite deflection directions, the method comprising: displacing single slide assembly in a first linear direction to place one of the at least two control wires under tension by rotating the knob in a first direction of rotation so as to deflect the catheter in a first direction of deflection; and displacing the single slide assembly in a second linear direction opposite the first linear direction to place the other of the at least two control wires under tension by rotating the knob in a second direction of rotation so as to deflect the catheter in a second direction of deflection.
[0128] In yet a further generic aspect, embodiments of the present invention provide a control system for providing unidirectional control of a bidirectional steerable catheter having at least two directions of deflection, the control system comprising a trigger to allow deflection of the catheter bidirectionally orientable in a first deflection direction by actuation in a first direction and comprising a deflection limiting mechanism for substantially limiting deflection of the bidirectional orientable catheter in a second deflection direction by limiting actuation in a second direction.
[0129] As a feature of these general aspects, embodiments of the present invention provide a cable that includes a rotating mechanism for controlling the tension of two tension wires. Rotation of the mechanism in one direction applies tension and thus applies a force to a first tension wire, while rotation in the opposite direction applies tension and thus applies a force to the second tension wire. As is further described herein, such application of tension to the wires can be used to torque or deflect a working end of a medical device connected to the cable.
[0130] Some of such embodiments comprise a cable for bidirectional control of a catheter, the cable comprising: a housing; a control knob rotatably coupled to the housing for cooperatively coupling with a slider positioned within said housing; a first control wire and a second control wire, a proximal end of each of said control wires being coupled to the slider and a distal end of each of said control wires being coupled to the catheter; wherein rotation of the knob causes the slider to move linearly within said housing so as to change the tension in one of said first and second control wires to effect a change in deflection of said catheter.
[0131] As a further feature of these embodiments, the slider comprises at least three openings/passages that extend longitudinally at least partially through the slider so as to allow said first and second control wires to be passed therethrough to be coupled. in this.
[0132] In a further example of this feature, the at least three openings/passages comprise: a first opening and a second opening, allowing the first and second control wires to pass proximally through them, the first control wire being coupled to a proximal face of said slider, a third opening allowing the second control wire to additionally pass distally therethrough a pulley to be coupled to the distal face of the slider.
[0133] In another example of this feature, the slider defines a hollow interior between a distal end of the slider defining said distal face and a proximal end of the slider defining said proximal face, so as to allow free passage to prevent strain on the first and second control wires.
[0134] In yet a further example of this feature, said first and third openings/passages housing said second control wire are positioned towards the outer side of the slider to avoid stress on the second control wire and to prevent the slide turn inside the housing.
[0135] As an additional feature of this generic appearance, the slider comprises a cover and a base. In an example of this feature, the cover comprises teeth which are cooperatively coupled with grooves within the slider to form said at least three openings. In a further example of this feature, the slider further comprises a central opening to allow the first and second control wires to pass therethrough to allow the wires to be guided through slots within the slider. In a particular example this central opening is in the form of a groove inside the base.
[0136] Yet as an additional feature of this generic aspect, the cable comprises a slack limiting/restricting element to limit/restrict slack in at least one between the first and second control wires.
[0137] As an additional feature of this generic aspect, the cable additionally comprises a means for coupling tension wires to opposite sides of the slider, such that displacement of the slider in one direction will apply tension to a wire, while the shifting the slider in the other direction will apply tension to the other wire. In a particular example, one of said first and second control wires is coupled to the slider through/by means of a pulley. In an example of this feature, the cable comprises a pulley guide to maintain the coupling of the second control wire with said pulley. In a further example of this feature, the cable comprises a height guide to maintain the coupling of the second control wire with said pulley.
[0138] Yet as a further feature of this general aspect, the handle additionally comprises a slot extending longitudinally within the housing to receive a projection within the slider to guide the slider within the housing.
[0139] Yet as a further feature of this generic aspect, the handle comprises a resistance/friction element within the inner button and the outer button to maintain a position of the slider to maintain a curvature/deflection of the catheter. In a further example of this feature, the resistance/friction element comprises an O-ring.
[0140] As a further feature of this generic aspect, the inner housing comprises a slide limiting element to limit the displacement of the slider within the housing to limit the voltage applied to at least one of said first and second control wires.
[0141] As a feature of this generic aspect, the slip limiting element is adjustable. In an example of this feature, where a slider start position is variable.
[0142] In a further generic aspect, embodiments of the present invention comprise a steerable catheter having one or more control wires comprising a slack limiting/restricting element for limiting/restricting slack in at least one of the one or more control wires .
[0143] As a feature of this aspect, the clearance limiting/restricting element comprises a friction element.
[0144] The embodiments of the invention described above are intended to be exemplary only. It is intended that the scope of the invention thus be limited only by the scope of the appended claims.
[0145] It should be noted that certain features of the invention, which are, for the sake of clarity, described in the context of the separate embodiments, may also be provided in combination in a single embodiment. On the other hand, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any sub-combination.
[0146] Although the invention has been described in conjunction with its specific embodiments, it is evident that many alternatives, modifications and variations will be obvious to those skilled in the art. Likewise, it is intended to encompass all such alternatives, modifications and variations that fall within the generic scope of the appended claims. All publications, patents and patent applications mentioned in this report are hereby incorporated in their entirety by reference, to the same extent as if each individual publication, patent or patent application were specifically and individually incorporated herein by reference. In addition, the citation or indication of any reference in this application should not be taken as an admission that such reference is available as prior art in connection with the present invention.

权利要求:
Claims (18)
[0001]
1. Control system (100) for bidirectional control of a steerable catheter, the catheter including at least two control wires (40, 42), a distal end of each of the control wires (40, 42) being coupled to the catheter in a distal region thereof, comprising: - a housing (20) coupled to the catheter, the housing (20) defining a lumen; - a sliding assembly (30) positioned within the lumen of the housing (20) and operable to be moved linearly inside, the housing (20) defining an internal wall configured to guide the sliding assembly (30) to allow linear displacement of the sliding assembly (30) inside the lumen of the housing (20); - a proximal part of each of the at least two control wires (40, 42) being positioned across the slide assembly (30); and - a control knob (10) rotatably coupled to the housing (20) for linearly displacing the slide assembly (30), thus enabling the slide assembly (30) to separately manipulate each of said at least two control wires ( 40, 42) for effecting a change in a deflection of said catheter characterized in that the control knob (10) is coupled to the housing (20) in a rotational but not translational relationship and in which rotation of the control knob (10) is control in a first direction of rotation causes distal displacement of the slide assembly (30) in a first linear direction causing the slide assembly (30) to apply tension to one of said at least two control wires (40, 42), thereby effecting a change in the deflection of said catheter in a first direction of deflection and wherein rotation of the knob (10) in a second direction of rotation causes proximal displacement of the slide assembly (30) in a second linear direction causing m that the slide assembly (30) applies tension to the other of said at least two control wires (40, RPI2637-BR112014031843-3 COMPLIANCE REQUIREMENT 6.1 42), thereby effecting a change in the deflection of said catheter in a second deflection direction in which one of said at least two control wires (40, 42) is indirectly coupled to the slide assembly (30) by means of a reversing member (50') and in which the reversing member (50') is in the plane with the at least two control wires (40, 42); in which the slide assembly (30) is positioned centrally within the lumen defined by the housing (20); in which the slide assembly (30) comprises a first component, the first component comprises a sliding component for slidingly coupling a portion of the housing (20), and the sliding assembly (30) comprising a second component, the second component comprising a threaded element for coupling with the knob (10) d and control; and wherein the threaded component is receivable within the control knob (10) to be threadedly coupled thereto along a longitudinal axis thereof.
[0002]
2. Control system (100) according to claim 1, characterized in that the direction reversal element (50') comprises a pulley.
[0003]
3. Control system (100) according to claim 1, characterized in that the direction reversal element (50') is positioned in a proximal region of the control system (100).
[0004]
4. Control system (100) according to claim 2, characterized in that it additionally comprises a pulley guide adjacent and that surrounds at least a part of the pulley to position the one of the at least two control wires (40, 42 ) among them.
[0005]
5. Control system (100) according to claim 2, characterized in that it additionally comprises a vertical guide to maintain a position of one of the at least two control wires (40, 42) along a vertical plane of the pulley to assist in retaining one of the at least two control wires (40, 42) on the pulley.
[0006]
6. Control system (100) according to claim 1, characterized in that the button (10) is rotatable around a longitudinal axis of the control system (100).
[0007]
7. Control system (100) according to claim 6, characterized in that the button (10) is threaded with the sliding assembly (30).
[0008]
8. Control system (100) according to claim 6, characterized in that it additionally comprises a position holding element to maintain a position of the button (10) in relation to the housing (20) by rotating the button (10) to maintain catheter deflection in one of the first or second deflection directions.
[0009]
9. Control system (100) according to claim 8, characterized in that the position holding element comprises a resistance element located at an interface between the button (10) and the housing (20) to create friction between the same.
[0010]
10. Control system (100) according to claim 1, characterized in that the sliding assembly (30) comprises a carriage comprising: - a base defining at least three slots for receiving said at least two control wires (40, 42); and - a cover for retaining said at least two control wires (40, 42) within said at least three grooves; wherein said cover is cooperatively coupled with said grooves to define said passages.
[0011]
11. Control system (100) according to claim 1, characterized in that the inner wall of the housing (20) defines a track to receive a portion of the slide assembly (30) to prevent rotation of the slide assembly (30) .
[0012]
12. Control system (100) according to claim 1, characterized in that the internal wall of the housing (20) defines at least one flat internal surface to interact with the sliding assembly (30) to prevent rotation of this RPI2637- BR112014031843-3 COMPLIANCE REQUIREMENT 6.1 under rotation of the control knob (10) to facilitate linear movement of the slide assembly (30) of the housing (20).
[0013]
13. Control system (100) according to claim 12, characterized in that the slide assembly comprises at least one flat outer surface to interact with said at least one flat inner surface of the housing (20) to prevent rotation of the slide mount (30).
[0014]
14. Control system (100) according to claim 12, characterized in that at least the flat inner surface comprises two laterally opposite flat inner surfaces.
[0015]
15. Control system (100) according to claim 13, characterized in that an internal width of the housing (20) is equal to a width of the sliding assembly (30) to allow linear movement of the sliding assembly (30) in the slip coupling with it.
[0016]
16. Control system (100) according to claim 1, characterized in that the sliding component comprises an intermediate housing (20) comprising a carriage.
[0017]
17. Control system (100) according to claim 1, characterized in that the threaded component is integral with the sliding component.
[0018]
18. Control system (100) according to claim 1, characterized in that the threaded component is distal to the sliding component.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-12-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-07-20| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-11-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2022-01-18| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/06/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201261661664P| true| 2012-06-19|2012-06-19|

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US61/661,664|2012-06-19|

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PCT/IB2013/055013|WO2013190475A2|2012-06-19|2013-06-18|Steerable medical device handle|

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