Device, System, and Method for Operating a Cartel

Abstract

A steering system for a steerable elongate flexible member, such as for delivering a medical device and / or system, is disclosed. The steering system can be configured for two-way steering or four-way steering. A control knob is rotatable to control the steering of the steerable elongate flexible member in a first direction or a second direction within a steering plane. In a four-way steering system, a first control knob steers the steerable elongate flexible member in a first steering plane and a second control knob steers the steerable elongate flexible member in a second steering plane that intersects the first steering plane. The steering system can be supported on a stand configured to enable rotational support of the steering system. The stand can support two steering systems in a manner that enables relative axial translation therebetween.

Description

Technical Field

[0001] The present disclosure generally relates to the field of medical devices and systems. More particularly, the present disclosure relates to devices, systems, and methods for manipulating elongate members such as catheters.

Background Art

[0002] To avoid more complex and invasive open surgeries, devices, systems, and methods for delivering and / or implanting medical devices using, for example, percutaneous and / or trans-tracheal minimally invasive techniques are desirable. Various techniques that do not require open surgery utilize systems and devices with various elongate flexible members that can be guided through the body (such as through the vasculature) from a small insertion opening in the patient's body to an anatomical site. A variety of endo-medical devices have been developed for trans-tracheal medical applications, such as for intravascular use. Some of these systems and devices include guidewires, catheters, medical device delivery systems (e.g., implantable devices such as tissue anchors, stents, grafts, replacement valves, etc.). Such systems can be multi-catheter / layered catheter assemblies that include a plurality of elongate tubular members stacked one within the other (coaxially and / or coextensively within another elongate tubular flexible member). To reach anatomical sites within the body, the various elongate members must be maneuverable to be guided through the tortuous internal pathways that lead to the anatomical site. Improvements to the handles for manipulating elongate members would be welcome in the art.

Summary of the Invention

[0003] This summary of the disclosure is provided to facilitate understanding and it will be appreciated by those skilled in the art that each of the various aspects and features of the disclosure can advantageously be used, in some instances separately, or in other instances in combination with other aspects and features of the disclosure. It is not intended that the scope of the claimed subject matter be limited by whether elements, components, etc. are included or not included in this summary.

[0004] According to various principles of the disclosure, a medical device delivery system includes a steerable elongate flexible member and a two - way steering system operably associated with the steerable elongate flexible member. According to various further principles of the disclosure, the two - way steering system includes a first elongate flexible steering element, a second elongate flexible steering element, and a control handle operably associated with the first elongate flexible steering element and the second elongate flexible steering element to control the steering of the steerable elongate flexible member via the first elongate flexible steering element and the second elongate flexible steering element.

[0005] In some embodiments, the control handle includes a control knob operably associated with a first elongate flexible steering element and a second elongate flexible steering element to control the movement of an operable elongate flexible member. In some embodiments, the control knob is rotatable to control a steering gear system operably coupled to the first elongate flexible steering element and the second elongate flexible steering element to control the movement of the operable elongate flexible member. In some embodiments, the steering gear system includes a control knob pinion assembly operably coupled to a steering gear pulley assembly. The control knob is operably coupled to the control knob pinion assembly to control the rotational movement of the control knob pinion assembly, and the steering gear pulley assembly is operably coupled to the first elongate flexible steering element and the second elongate flexible steering element to control the movement of the first elongate flexible steering element and the second elongate flexible steering element to steer the operable elongate flexible member. In some embodiments, the control knob has a direction control knob element that controls the movement of the first elongate flexible steering element and the second elongate flexible steering element, and a friction control knob element that controls the movement of the direction control knob element.

[0006] In some embodiments, the two - direction steering system is a first two - direction steering system operably associated with an operable elongate flexible member for steering the operable elongate flexible member in a first steering plane, and the medical device delivery system further includes a second two - direction steering system operably associated with the operable elongate flexible member for steering the operable elongate flexible member in a second steering plane that intersects the first steering plane. In some embodiments, the medical device delivery system further includes an operable elongate tubular flexible member and a two - direction steering system operably associated with the operable elongate tubular flexible member for steering the operable elongate tubular flexible member in a steering plane, and the operable elongate flexible member extends through the operable elongate tubular flexible member. In some embodiments, the operable elongate flexible member is longitudinally translatable within the operable elongate tubular flexible member. In some embodiments, the two - direction steering system operably associated with the operable elongate tubular flexible member is rotatable relative to a steering system operably associated with the operable elongate flexible member to adjust the orientation of the steering plane in which the operable elongate tubular flexible member is steered. In some embodiments, the medical device delivery system further includes a first control knob operably associated with the first two - direction steering system via a first steering gear system and a second control knob operably associated with the second two - direction steering system via a second steering gear system, wherein the gears of the first steering gear system rotate about respective first gear system axes that are parallel to each other, and the gears of the second steering gear system rotate around respective second gear system axes that are parallel to each other and intersect the first gear system axes.

[0007] According to various principles of the present disclosure, a control handle for controlling the manipulation of a manipulable elongated flexible member, the manipulable elongated flexible member having a first elongated flexible manipulation element and a second elongated flexible manipulation element operably associated therewith, is provided. According to various principles of the present disclosure, the control handle includes a control handle housing and a control knob mounted on the control handle housing, the control knob being operably associated with the first elongated flexible manipulation element for manipulating the manipulable elongated flexible member in a first direction and operably associated with the second elongated flexible manipulation element for manipulating the manipulable elongated flexible member in a second direction different from the first direction.

[0008] In some embodiments, the control knob includes a direction control knob element for controlling the movement of the first elongated flexible manipulation element and the second elongated flexible manipulation element, and a friction control knob element for controlling the movement of the direction control knob element.

[0009] In some embodiments, a gear system is further included having a control knob pinion assembly operably associated with the control knob and a steering gear pulley assembly operably associated with the control knob pinion assembly and the first elongated flexible manipulation element and the second elongated flexible manipulation element, the gear system operating to control the manipulation of the manipulable elongated flexible member in response to rotation of the control knob. In some embodiments, the steering gear pulley assembly includes a first steering gear pulley assembly operably associated with the first elongated flexible manipulation element and a second steering gear pulley assembly operably associated with the second elongated flexible manipulation element, at least one of the steering gear pulley assemblies including a gear having a gear barrel extending from the gear and configured to couple the elongated flexible manipulation element to the gear, the steering gear pulley assembly being configured to maintain the position of the elongated flexible manipulation element on the gear barrel without entanglement with the gear.

[0010] In some embodiments, the control knob steers an operable elongate flexible member in a first steering plane, the control handle further includes a control knob mounted to the control handle housing, and the control knob is operably associated with a third elongate flexible steering element and a fourth elongate flexible steering element for steering the operable elongate flexible member in a second steering plane that intersects the first steering plane.

[0011] According to various principles of the present disclosure, a method of steering an operable elongate flexible member of a medical device delivery system includes rotating a first control knob in a first direction to wind a first elongate flexible steering element around a first steering gear pulley assembly to steer the operable elongate flexible member in the first direction; and rotating the first control knob in a second direction to wind a second elongate flexible steering element around a second steering gear pulley assembly to steer the operable elongate flexible member in a second direction different from the first direction.

[0012] In some embodiments, rotating the first control knob steers an operable elongate flexible member in a first steering plane. In some embodiments, rotating a second control knob in a first direction winds a third elongate flexible steering element around a third steering gear pulley assembly to steer the operable elongate flexible member in a third direction; and rotating the second control knob in a second direction winds a fourth elongate flexible steering element around a fourth steering gear pulley assembly to steer the operable elongate flexible member in a fourth direction different from the third direction. In some embodiments, rotating the first control knob steers an operable elongate flexible member in a first steering plane, and rotating the second control knob steers an operable elongate flexible member in a second steering plane that intersects the first steering plane.

[0013] In some embodiments, the method further includes adjusting the friction applied to the control knob with respect to the control handle to maintain the operable elongate flexible member in a desired position. These features and advantages of the present disclosure, as well as other features and advantages, will become readily apparent from the following modes for carrying out the invention, and the scope of the claimed invention is set forth in the appended claims. The following disclosure is presented from the perspective of aspects or embodiments, but it should be understood that each aspect can be claimed separately or in combination with the aspects and features of its embodiments or any other embodiments.

[0014] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be shown to scale. The accompanying drawings are presented for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures in the drawings may be changed. For example, a device may be enlarged so that details are distinguishable, but is intended to be reduced, for example, in relation to fitting within a delivery catheter or the working channel of an endoscope. For purposes of clarification and simplification, not all elements in all figures are labeled, and not all elements of each embodiment are shown, where illustration is not necessary to enable those skilled in the art to understand the present disclosure.

[0015] The modes for carrying out the invention will be better understood in conjunction with the following accompanying drawings in which like reference characters represent like elements.

Brief Description of the Drawings

[0016]

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DETAILED DESCRIPTION OF THE INVENTION

[0017] The following embodiments for carrying out the invention should be read with reference to the drawings showing exemplary embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described, and may therefore be subject to change. All devices, systems, and methods discussed herein are examples of devices, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is presented for purposes of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. In fact, it will become apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Therefore, the subject matter is intended to embrace such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0018] In this application, it will be understood that the present disclosure is described in detail at various levels. In certain instances, details that are not necessary for those skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing only specific embodiments and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by those skilled in the art to which the present disclosure pertains. All devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0019] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, surgeon, physician, etc., which terms are used interchangeably herein without intent to limit and include an automated controller system or other means) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is closest to the delivery device. "Distal" refers to the direction or location that is farthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery), and / or the direction or location that is farthest from the delivery device. "Longitudinal" means extending along the longer dimension or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element but is not necessarily straight and does not necessarily maintain a constant shape if the element flexes or bends. "Center" means at least generally intersecting a center point and / or being generally equidistant from a perimeter or boundary, and a "central axis" with respect to an opening is a line that at least generally intersects the center point of the opening and, if the opening includes, for example, a tubular element, channel, cavity, or hole, extends longitudinally along the length of the opening. As used herein, "channel" or "hole" is not limited to a circular cross-section. As used herein, a "free end" of an element is the end beyond which such element does not extend.

[0020] Accessing regions within the body without making an incision (i.e., accessing such regions transductally) often requires maneuvering an elongate member into complex positions. For example, a procedure may involve guiding an elongate member in a first plane, then in a second plane intersecting the first plane, and further in additional third, fourth, fifth, etc. planes in multiple directions. Without limitation, various procedures such as mitral valve treatment utilize a system having two or more manipulable elongate members that are nested and / or stacked one within the other (coaxially and / or parallelly, optionally within another elongate tubular member). The elongate members of such a system may need to be independently maneuvered in different planes that intersect each other. For example, an outer manipulable elongate tubular member (such as a delivery catheter) may be maneuvered in one or more planes to position the distal end of the manipulable system at an anatomical site where a procedure is to be performed using a system and / or device delivered by such a manipulable system. The distal portion of the outer manipulable elongate tubular member may be maneuvered and / or bent in a delivery plane for the system to position another system or device at a desired location relative to the anatomical site (e.g., to place the distal end of the system at the center of the mitral valve to repair the mitral valve with another system or device). The outer manipulable elongate tubular member may remain generally bent at such a delivery position (within the delivery plane) to maintain its distal end at a predetermined position for the initial delivery of another system or device. Another system or device may be delivered and / or deployed by an inner manipulable elongate member that extends within the outer manipulable elongate tubular member. The inner manipulable elongate member may be withdrawn coaxially from the outer manipulable elongate tubular member and then maneuvered to another position. For example, the inner manipulable elongate member may be bent in a plane intersecting the delivery plane of the outer manipulable elongate tubular member. The inner manipulable elongate member may rotate and translate axially relative to the outer manipulable elongate tubular member.

[0021] According to various principles of the present disclosure, a system for delivering a medical device (hereinafter referred to as a delivery system for convenience without intention of limitation) includes one or more manipulable elongated flexible members and at least one steering system configured to manipulate the associated manipulable elongated flexible members in at least one plane. As used herein, terms such as "maneuver" (and other grammatical forms of such terms) may be used interchangeably, without intention of limitation, with terms such as "actuate," "advance," "articulate," "bend," "control," "drive," "flex," "operate," "move," "steer," "transition," "translate," "turn," etc. (and other grammatical forms of those terms). The steering system includes one or more elongated flexible steering elements extending along a steering plane, and the one or more elongated flexible steering elements are operably associated with the associated manipulable elongated flexible members such that movement of the elongated flexible steering elements causes movement of the manipulable elongated flexible members at least within the steering plane. The steering system further includes a control handle operably associated with the one or more elongated flexible steering elements. The control handle includes at least one control knob operably coupled to the one or more elongated flexible steering elements to cause movement of the one or more elongated flexible steering elements. Such movement of the one or more elongated flexible steering elements can be within a steering plane and optionally within a common steering plane. For example, the one or more elongated flexible steering elements can cause movement of the manipulable elongated flexible members in one or more directions within a common steering plane (e.g., left and right in a horizontally oriented plane or up and down in a vertically oriented plane). Accordingly, the steering system can be considered a two-direction steering system, and the manipulable elongated flexible members can be considered two-direction manipulable elongated flexible members. The steering plane can be considered to exist in a direction with respect to the anatomical site where the delivery system is guided. In some embodiments, the direction in which a common steering plane exists can be adjusted by rotating the manipulable elongated flexible members, such as by rotating the delivery system.

[0022] According to various principles of the present disclosure, a single control knob can control the movement of one or more elongate flexible control elements in a control plane such as a common control plane. For example, in some embodiments, rotation of the control knob in a first direction causes at least one elongate flexible control element to move such that an associated controllable elongate flexible member is steered in a first steering direction. The first steering direction can generally be the same direction as the first direction in which the control knob is moved, but the system need not be so limited. In some embodiments, rotation of the control knob in a first direction causes a first elongate flexible control element to be pulled and a second elongate flexible control element to be fed out such that an associated controllable elongate flexible member is steered in a first steering direction. In some embodiments, rotation of the control knob in a second direction causes at least one elongate flexible control element to move such that an associated controllable elongate flexible member is steered in a second steering direction. The second steering direction can be in a direction opposite to the first steering direction and can be in the same plane or a non - same plane as the first steering direction. The second steering direction can generally be the same direction as the second direction in which the control knob is moved, but the system need not be so limited. In some embodiments, rotation of the control knob in a second direction causes a second elongate flexible control element to be pulled and a first elongate flexible control element to be fed out such that an associated controllable elongate flexible member is steered in a second steering direction. The first steering direction and the second steering direction are optionally in a common control plane.

[0023] In some embodiments, the control handle includes a gear system configured to transmit rotation of the control knob to rotation of an element operably coupled to one or more elongate flexible steering elements. Thus, operation of the control knob controls movement of the elongate flexible steering elements, and thus controls movement of the steerable elongate flexible member to which the control handle and the one or more elongate flexible steering elements are operably associated. For example, the control knob can be operably coupled to a pinion, and the one or more elongate flexible steering elements can be operably coupled to corresponding steering gear pulleys that engage the control knob pinion. For example, the elongate flexible steering element can be wound around a gear barrel operably coupled to the corresponding steering gear pulley. The gear barrel can be a barrel, shaft, shank, etc. (such terms are used interchangeably herein without intent to limit) extending from the gear of the steering gear pulley along the axis of rotation of the steering gear pulley. Rotation of the pinion gear can rotate the steering gear pulley around which the one or more elongate flexible steering elements are wound. Thus, rotation of the control knob causes the elongate flexible steering element to be wound up / wound around or payed out from the gear barrel, depending on, for example, the direction in which the associated steering gear pulley is rotated, which is determined by the direction in which the control knob pinion is rotated. The gear system optionally includes one or more features configured to maintain a desired alignment of the elongate flexible steering element relative to the associated steerable elongate flexible member and / or steering plane and / or steering gear pulley, etc.

[0024] In some embodiments, the control knob includes a direction control element and a friction control element. Movement of the direction control element controls movement of the associated one or more elongate flexible steering elements. Movement of the friction control element adjusts the mobility of the direction control element, such as by increasing the friction applied to the direction control element to maintain a selected steering position of the elongate flexible steering element associated with the control knob, thereby reducing the mobility of the direction control element.

[0025] Optionally, the delivery system includes a stand that supports one or more control handles of the delivery system. The delivery system stand can be configured to facilitate rotation and / or translational movement of one or more components of the delivery system. More specifically, the delivery system stand can be configured to support the delivery system when the delivery system is adjusted axially along its longitudinal axis, such as adjusting components of the delivery system relative to each other. Additionally or alternatively, the delivery system stand can be configured to support the delivery system when the delivery system is rotated about its longitudinal axis.

[0026] In some embodiments, the two-directionally steerable elongate flexible member is tubular, and the delivery system further includes a four-directionally steerable elongate flexible member that extends within the two-directionally steerable elongate tubular flexible member. Viewed another way, the two-directionally steerable elongate flexible member can have an additional set of steering elements (i.e., a second two-directional steering system) such that it becomes a four-directionally steerable elongate flexible member. In some embodiments, such a four-directionally steerable elongate flexible member can be disposed within the two-directionally steerable elongate tubular flexible member.

[0027] According to various principles of the present disclosure, an elongate flexible member that is steerable in four directions has a steering system similar to that of a steering system for an elongate flexible member that is steerable in two directions. More specifically, an elongate flexible member that is steerable in four directions can have a first steering system for steering an elongate flexible member that is steerable in a first steering plane and a second steering system for steering an elongate flexible member that is steerable in a second steering plane. In some embodiments, the first steering system includes a first control knob operably coupled to cause movement of a first one of one or more elongate flexible steering elements. Such movement of the one or more elongate flexible steering elements can be within a steering plane and, optionally, within a common first steering plane. Similarly, the second steering system includes a second control knob operably coupled to cause movement of a second one of one or more elongate flexible steering elements. Such movement of the one or more elongate flexible steering elements can be within a steering plane and, optionally, within a common second steering plane. The first steering plane and the second steering plane can intersect each other, such as being orthogonal to each other. The first steering system and the second steering system can be housed within a common four-direction steering system housing and can thus be considered components of an integrated four-direction steering system. The components of each steering system can be substantially similar to those of the two-direction steering system described above and are referred to for the sake of brevity and simplicity.

[0028] A delivery system stand as described above can be configured to accommodate an elongate tubular flexible member that is steerable in two directions and an elongate flexible member that is steerable in four directions and slidable within the elongate tubular flexible member that is steerable in two directions. The delivery system stand can be configured to support the delivery system during and after adjustment of the rotational position of one or more components of the delivery system and / or adjustment of the axial relative position of the components of the delivery system.

[0029] Here, various embodiments of a steering system, related components, and methods of using them are described with reference to the examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, concept, and / or characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments can include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments presented herein. That is, any of the features, structures, concepts, and / or characteristics described herein can be used and integrated together to create a composite embodiment, and such a composite embodiment is within the scope of the present disclosure. Further, references herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., in various places do not necessarily all refer to the same embodiment, and distinct or alternative embodiments are not necessarily mutually exclusive of other embodiments. It should be further understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent of each other, distinct, and may be used or presented individually or in various combinations with each other to create alternative embodiments that are considered part of the present disclosure. Therefore, since it would be too cumbersome to describe all possible combinations and sub-combinations of features, structures, concepts, and / or characteristics, the present disclosure is not limited to only the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure. The following description is only an exemplary example of embodiments and does not limit the broader aspects of the present disclosure.

[0030] Common features in the drawings are identified by common reference elements, and it will be understood that, for the sake of brevity and convenience and without the intention of limiting, the description of common features will not normally be repeated. For clarity, not all components having the same reference numeral are labeled. Further, a particular feature in one embodiment may be used across different embodiments and not necessarily individually labeled when it appears in different embodiments.

[0031] Referring now to the drawings, an example of an embodiment of a delivery system 100 for delivering medical devices and / or systems 110, 120 is shown in FIG. 1. The delivery system 100 includes at least one (first) steering system, such as a two-direction steering system 200, for a first steerable elongate flexible member 300. The delivery system 100 optionally includes an additional (second) steering system, such as a four-direction steering system 400, for an additional (second) steerable elongate flexible member 500. As can be appreciated, in the illustrated example of an embodiment of the delivery system 100, the first steerable elongate flexible member 300 is tubular and has a lumen defined therethrough through which the second steerable elongate flexible member 500 extends. Accordingly, the first steerable elongate flexible member 300 is referred to herein as the steerable elongate tubular flexible member 300. In some embodiments, the second steerable elongate flexible member 500 is axially translatable through, extends from, or retracts into the steerable elongate tubular flexible member 300, as will be discussed in more detail below.

[0032] An example of an embodiment of a two - way steering system 200 formed in accordance with various principles of the present disclosure is shown in more detail in FIGS. 2, 3, 4, and 8. The two - way steering system 200 includes one or more elongated flexible steering elements 210 operably associated with an operable elongated tubular flexible member 300 and a control handle 220. The elongated flexible steering elements 210 are connected to the operable elongated tubular flexible member 300 (by any desired technique known to those skilled in the art) to control the movement of the operable elongated tubular flexible member 300. Optionally, the elongated flexible steering elements 210 extend along the operable elongated tubular flexible member 300. In an example of an embodiment shown in FIG. 8, the distal end 211 of the elongated flexible steering element 210 is connected to the distal end 301 of the operable elongated tubular flexible member 300, and by pulling the proximal end 213 of the elongated flexible steering element 210 (see, for example, the detailed view of FIG. 4), the movement of the operable elongated tubular flexible member 300 is controlled (e.g., steered). The one or more elongated flexible steering elements 210 can be, for example, pull wires, ribbon cables, Bowden cables, etc., as known to those skilled in the art for controlling or steering the movement of the elongated flexible member. For example, the one or more elongated flexible steering elements 210 can have a pull wire (such as a Bowden cable) that is axially movable within an outer sheath connected (e.g., joined) to the operable elongated tubular flexible member 210 by any desired technique known to those skilled in the art.

[0033] Examples of embodiments of the control handle 220 shown in FIGS. 2, 3, and 4 include a control knob 230 mounted on a housing block 240. The housing block 240 can be formed from an upper housing cover 240a and a lower housing cover 240b, which are connected to each other (e.g., by fasteners such as screws) and form an interior in which additional operating components of the two-way steering system 200 can be housed and supported. The housing covers 240a, 240b may alternatively be referred to herein as a carriage or carrier housing, without intending to limit. In some embodiments, an additional carrier bearing 242 is provided within the housing block 240. In some embodiments, the carrier bearing 242 is formed from an upper base component 242a and a lower base component 242b (connected to each other by fasteners such as screws) as shown in FIGS. 3 and 4. An example of an embodiment of the carrier bearing 242 shown in FIGS. 3 and 4 is configured to support an operable elongated tubular flexible member 300. In some embodiments, the carrier bearing 242 holds the operable elongated tubular flexible member 300 in place with one or more setscrews (any set screw known to those skilled in the art and thus not shown to simplify the illustration of other components of the two-way steering system 200). In some embodiments, a hypotenuse 310 is provided on and optionally joined to the operable elongated tubular flexible member 300 to provide a shaft mount that can protect the operable elongated tubular flexible member 300. Additionally or alternatively, the carrier bearing 242 is configured to support and / or manage one or more elongated flexible steering elements 210 (e.g., to prevent the excess length of one or more elongated flexible steering elements 210 from wrapping around / extending too far to the control handle 220). If the carrier bearing 242 is not provided, the housing block 240 can be configured to have various features of the carrier bearing 242.

[0034] In an example of an embodiment of the control handle 220 shown in FIGS. 3 and 4, the housing block 240 is also configured to accommodate a gear system 250 operably associated with (e.g., controlled thereby) the control knob 230. The gear system 250 is also operably associated with one or more elongated flexible control elements 210. The control knob 230 is operably associated with one or more elongated flexible control elements 210 such that, thereby, the movement (e.g., rotation, etc.) of the control knob 230 causes one or more elongated flexible control elements 210 to actuate (e.g., operate, move, be controlled, etc.) to control the steerable elongated tubular flexible member 300. An example of an embodiment of the gear system 250 shown in FIGS. 3 and 4 includes one or more steering gear pulley assemblies 260a, 260b and a control knob pinion assembly 270. Each steering gear pulley assembly 260 is operably associated with an associated elongated flexible control element 310. In the example of the embodiment shown, the steering gear pulley assembly 260 includes a steering gear 262 from which a pulley shaft, herein referred to as the gear barrel 264, extends. The elongated flexible control element 210 can be coupled to the gear barrel 264 by any of a variety of techniques known to those skilled in the art. For example, in an example of an embodiment shown in the detailed view of FIG. 4, the elongated flexible control element 210 can be insertable through a slot 265 formed in the gear barrel 264. The elongated flexible control element 210 can have an enlarged proximal end 213, such as by being provided or formed with a crimp or ferrule 212, as also shown in the detailed view of FIG. 4. Such an enlarged proximal end 213 (e.g., crimp or ferrule 212) can be fitted or seated within a pocket 266 of the gear barrel 264. The enlarged proximal end 213 can be further secured within the pocket 266 by adhesion, welding, brazing, soldering, etc., or any other technique known to those skilled in the art. In some embodiments, the gear barrel 264 includes a bulge or bump 268 arranged to maintain the position of the elongated flexible control element 210 relative to the gear barrel 264.In some embodiments, the shim 280 is provided between the elongated flexible steering element 210 and at least the gear 262 of the steering gear pulley assembly 260 to which the elongated flexible steering element 210 is associated. The shim 280 is arranged to prevent the shift or creeping of the elongated flexible steering element 210 onto the gear 262 and the meshing with the gear.

[0035] According to various principles of the present disclosure, the steering gear pulley assembly 260 is configured such that its rotation causes the movement of the associated elongated flexible steering element 210, and the associated steerable elongated tubular flexible member 300 is steered. More specifically, in the illustrated example of an embodiment, the rotation of the steering gear 262 of the steering gear pulley assembly 260 causes the rotation of the gear barrel 264, and the elongated flexible steering element 210 is connected to the gear barrel 264 of the steering gear pulley assembly 260 such that the elongated flexible steering element 210 is wound up / pulled relative to the gear barrel 264 or fed out from the gear barrel 264 according to the rotation direction of the steering gear pulley assembly 260. For example, by pulling the elongated flexible steering element 210 extending along the first side of the steerable elongated tubular flexible member 300, (e.g., by bending or deflecting the steerable elongated tubular flexible member 300 towards the first side), the steerable elongated tubular flexible member 300 is steered in a first direction towards the first side. Similarly, by pulling the elongated flexible steering element 210 extending along the second side of the steerable elongated tubular flexible member 300, (e.g., by bending or deflecting the steerable elongated tubular flexible member 300 towards the second side), the steerable elongated tubular flexible member 300 is steered in a second direction towards the second side.

[0036] According to various principles of the present disclosure, the control knob 230 is operably associated with a gear system 250 to operate or control the gear system 250 to steer an elongate tubular flexible member 300 that can be steered via one or more elongate flexible steering elements 210. In an example of an embodiment shown in FIG. 3, the control knob 230 is operably associated with a control knob pinion assembly 270 to control the rotational movement of the control knob pinion assembly 270. As can be understood with reference to FIG. 4, the control knob pinion assembly 270 includes a pinion 272 engaged with a steering gear 262 of a steering gear pulley assembly 260. In an example of an embodiment of the two-way steering system 200 shown in FIG. 4, the pinion 272 is operably engaged (e.g., meshed) with a steering gear 262a of a first steering gear pulley assembly 260a and a steering gear 262b of a second steering gear pulley assembly 260b. Thus, rotation of the pinion 272 causes rotation of both steering gear pulley assemblies 260a, 260b of the gear system 250. Also, as can be understood with reference to FIGS. 3 and 4, the control knob 230 is coupled to the control knob pinion assembly 270 to rotate the pinion 272. More specifically, the control knob 230 includes a direction control knob element 232 having a spline 234 that engages a corresponding spline 274 on the control knob pinion assembly 270, and transmits the rotational movement of the control knob 230 to the control knob pinion assembly 270. The direction control knob element 232 may be serrated or otherwise configured to facilitate its manual rotation. The direction control knob element 232 is coupled to the control knob pinion assembly 270 via a bolt 236 that extends through a bolt hole 235 through the direction control knob element 232 and a bolt hole 275 through the control knob pinion assembly 270. The head 237 of the bolt 236 may rest above the direction control knob element 232 to couple the direction control knob element 232 to the control knob pinion assembly 270 and may be larger than the bolt hole 235.

[0037] According to various principles of the present disclosure, it may be desirable to hold the steerable elongate tubular flexible member 300 in a desired orientation or configuration. For example, the steerable elongate tubular flexible member 300 can be an introducer or delivery sheath that delivers additional components or systems of the delivery system 100 to an anatomical site. When the steerable elongate tubular flexible member 300 reaches near an anatomical site, it may be desirable to fix or hold the steerable elongate tubular flexible member 300 in a particular configuration so that additional devices or systems (e.g., the four-direction steerable elongate flexible member 500 controlled by the four-direction steering system 400 described above, and / or other devices or systems such as medical devices and / or systems 110, 120 to be described in more detail below) can be obtained. According to various principles of the present disclosure, the control knob 230 can include a friction control knob element 238 in addition to the direction control knob element 232. The friction control knob element 238 is configured to limit, restrict, lock, prevent, etc., the movement of the direction control knob element 232 in the same manner as it limits, restricts, locks, prevents, etc., the movement of the steering gear pulley assembly 260 and one or more elongate flexible steering elements 210 (in this specification, such terms and other grammatical forms are used interchangeably without intention of limitation). In an example of an embodiment shown in FIGS. 3 and 4, the friction control knob element 238 is provided (e.g., mounted) on the direction control knob element 232 and is movable relative to the direction control knob element 232 to move the direction control knob element 232 closer to or away from the upper base component 242a of the carrier bearing 242. In some embodiments, the bolt 236 is a threaded bolt threaded into the direction control knob element 232, and the hexagonal head 237 of the bolt 236 fits into a non-circular (e.g., complementary hexagonal shape) hole 239 in the friction control knob element 238. Thus, rotation of the friction control knob element 238 causes the bolt 236 to rotate, moving the direction control knob element 232 closer to or away from the carrier bearing 242. In some embodiments, a friction element 233 (e.g., an O-ring) is provided between the direction control knob element 232 and the upper base component 242a.When the friction control knob element 238 is rotated, the engagement between the direction control knob element 232 and the friction element 233 increases the friction applied to the direction control knob element 232, and the direction control knob element 232 is held at a desired angular (rotational) position. In some embodiments, the friction element 233 rests on a shoulder 276 that extends radially from the control knob pinion assembly 270. In some embodiments, the shoulder 276 of the control knob pinion assembly 270 is seated within a seat 246a formed in the upper base component 242a of the carrier bearing 242 (towards which the direction control knob element 232 is advanced). The seating of the shoulder 276 within the upper base component 242a serves to stabilize the control knob pinion assembly 270 relative to the carrier bearing 242 and / or the housing block 240 of the control handle 220. When the friction control knob element 238 moves the direction control knob element 232 towards the upper base component 242a, the friction element 233 is compressed and the friction against the direction control knob element 232 increases, thereby preventing movement of the direction control knob element 232 and, thus, the movement of the gear system 250 and the steering gear pulley assembly 260 as well as the one or more elongated flexible steering elements 210 and the steerable elongated tubular flexible member 300.

[0038] It is understood that the upper base component 242a and the lower base component 242b of the carrier bearing 242 can include various additional features for supporting the other components of the two - way steering system 200. For example, the lower base component 242b can include one or more seats 246b on which the steering gear 262 of the steering gear pulley assembly 260 can be supported (e.g., to stabilize the steering gear pulley assembly 260).

[0039] An example of an embodiment of a two - direction steering system 200 as shown in use in FIGS. 1, 2, 3, 4, and 8 has a first elongated flexible steering element 210a extending along a first side of a steerable elongated tubular flexible member 300 and a second elongated flexible steering element 210b extending along a second side of the steerable elongated tubular flexible member 300 (see, for example, FIGS. 1 and 8). The elongated flexible steering elements 210a, 210b are operatively coupled to corresponding first and second steering gear pulley assemblies 260a, 260b. The steering gear pulley assemblies 260a, 260b are operatively coupled to a control knob 230 (such as via a control knob pinion assembly 270) such that rotation of the control knob 230 controls the steering of the steerable elongated tubular flexible member 300 as desired. In some embodiments, rotation of the control knob 230 in a first direction (e.g., clockwise rotation) pulls the first elongated flexible steering element 210a and steers the steerable elongated tubular flexible member 300 in a first direction (e.g., to the right), and rotation of the control knob 230 in a second direction (e.g., counterclockwise rotation) pulls the second elongated flexible steering element 210b and steers the second elongated flexible steering element 210b in a second direction (e.g., to the left). However, the present disclosure need not be so limited, and other configurations are within the scope and spirit of the present disclosure. One or more elongated flexible steering elements 210 are present within a steering plane and can be considered to control the movement of the steerable elongated tubular flexible member 300 within such a steering plane.

[0040] According to various principles of the present disclosure, a four-way steering system 400 generally as shown in FIG. 1 can be formed in a manner similar to the two-way steering system 200 described above. More specifically, the four-way steering system 400 shown in more detail in FIGS. 5, 6, and 7 is formed from two sets of steering systems that are each similar to the two-way steering system 200 of FIGS. 2-4 and are arranged to intersect each other, such that their respective steering planes are orthogonal to each other. The first section 400a of the four-way steering system 400 has substantially the same components as the components of the two-way steering system 200 described above. Accordingly, similar components are indicated by similar reference numerals incremented by 200. The second section 400b of the four-way steering system 400 has substantially the same components as the components of the two-way steering system 200 described above and the first section 400a of the four-way steering system 400. Accordingly, the components of the second section 400b of the four-way steering system 400 are indicated with a prime symbol (') to the same reference numerals used with reference to the first section 400a of the four-way steering system 400. For the sake of brevity and without intending to limit, the above description of such elements is referred to. As can be understood, the four-way steering system 400 has a first steering plane in which the first section 400a of the four-way steering system 400 can steer an elongate flexible member 500 with the aid of one or more elongate flexible steering elements 410a and 410b, and a second steering plane in which the second section 400b of the four-way steering system 400 can steer the elongate flexible member 500 with the aid of one or more elongate flexible steering elements 410a' and 410b' in a manner similar to that described above with reference to the two-way steering system 200. The first steering plane and the second steering plane intersect each other, such as being orthogonal to each other. The control knob pinion assembly 470 and the steering gear pulley assembly 460 of the gear system 450 of the first section 400a of the four-way steering system 400 rotate about a first axis of rotation parallel to each other.The control knob pinion assembly 470' and the steering gear pulley assembly 460' of the gear system 450' of the second section 400b of the four-way steering system 400 rotate about a second axis of rotation that is parallel to each other and intersects (e.g., is orthogonal to) the first axis of rotation.

[0041] To facilitate the placement and / or movement of the delivery system 100, as shown in FIG. 1, a stand can be provided to support at least the two-direction steering system 200 of the delivery system 100. The illustrated example of an embodiment with a stand 600 includes a base 610 that supports a first steering system support 620 configured to support the two-direction steering system 200. Optionally, the stand 600 facilitates moving the two-direction steering system 200, such as during operation of the two-direction steering system 200. For example, the two-direction steering system 200 can be rotated during its operation to adjust the orientation of the steering plane of the two-direction steering system 200, for example, the orientation of the steering plane in which the steerable elongated tubular flexible member 300 is guided relative to the anatomical site. In an example of an embodiment with a first steering system support 320 shown in FIG. 1 and shown in more detail in FIG. 8, a first yoke 622 and a second yoke 624 are configured and arranged to support the two-direction steering system 200. The two-direction steering system 200 can be rotated within the first steering system support 620 to adjust the steering plane in which the steerable elongated tubular flexible member 300 is steered. Thus, the yokes 622, 624 can be configured to allow rotation of the two-direction steering system 200 while being supported by the yokes 322, 324. Once the two-direction steering system 200 is positioned in the desired orientation, at least one locking element 626 can be provided to be fixed to at least one of the yokes 622, 624. The locking element 626 can include a thumb nut 628 that facilitates tightening or loosening of the locking element 626 to fix or release the angular position of the two-direction steering system 200 relative to the stand 600 manually (without the need for additional tools). Thus, the angular position of the two-direction steering system 200 can be easily adjusted during the procedure without interruption caused by the need for a separate additional adjustment tool.

[0042] Even in the delivery system 100 including the four-way steering system 400, the first steering system support 620 is connected to the second steering system support 640 via the coupler 630. An example of an embodiment with the stand 600 shown in FIG. 1 includes a second steering system support 640 configured to support the four-way steering system 400. In an example of an embodiment of the second steering system support 640 shown in FIG. 1 and shown in more detail in FIG. 9, the first yoke 642 and the second yoke 644 are configured and arranged to support the four-way steering system 400. When the four-way steering system 400 is disposed in a desired orientation or position within the second steering system support 640, at least one locking element 646 can be provided to be fixed to at least one of the yokes 642, 644.

[0043] As discussed above, the four - direction steering system 400 can be translated linearly or longitudinally relative to the two - direction steering system 200 so as to extend or retract an elongate flexible member 500 that is steerable relative to the steerable elongate flexible tubular member 300. In some embodiments, the stand 600 is configured not only to support both the two - direction steering system 200 and the four - direction steering system 400, but also to facilitate relative movement therebetween (e.g., along the longitudinal axis LA of the delivery system 100). For example, the first steering - system support 620 and the second steering - system support 640 can be connected to each other via a coupler 630 configured to allow a longitudinally slidable connection between the first steering - system support 620 and the second steering - system support 640. For example, the first steering - system support 620 can be slidably mounted to the coupler 630 using a slidable locking element 632 that is slidable through a slot 631, as shown in more detail in FIG. 8. Similarly, the second steering - system support 640 can be slidably mounted to the coupler 630 using a slidable locking element 634 that is slidable through a slot 633, as shown in more detail in FIG. 9. The slidable locking elements 632, 634 can include respective thumb nuts 636, 638 that facilitate loosening and tightening the slidable locking elements 632, 634 relative to their respective slots 631, 633, for example, manually (without the need for additional tools). Thus, the stand 600 facilitates rapid adjustment of the delivery system 100 during a procedure without the interruption caused by the need for a separate additional adjustment tool.

[0044] The principles of the present disclosure, as described above, are applicable in a wide range of delivery systems, such as devices delivered transvascularly / transcatheterically. An example of a delivery system 100 to which the principles of the present disclosure may be applied, which is configured to deliver and implant devices for cardiac surgery such as mitral valve and / or cardiac valve leaflet repair, is shown in FIG. 10. In the illustrated example of one embodiment, an operable elongate tubular flexible member 300 as described above can be used as an introducer sheath or guide sheath for delivering a treatment device and system to the heart (such as ventricle V). Further, in the illustrated example of one embodiment, an operable elongate flexible member 500 as described above can be used as a four-directionally operable delivery catheter for delivering medical devices and / or systems 110, 120 to the ventricle V, for example, for repairing a valve (such as mitral valve MV). One or more device delivery catheters 700, 800 can extend through the operable elongate tubular flexible member 300 and the operable elongate flexible member 500. The device delivery catheters 700, 800 are generally not operable by themselves such that their position and configuration are determined by the operable elongate tubular flexible member 300 and the operable elongate flexible member 500. The illustrated example of one embodiment of the device delivery catheter 700 is configured to deliver a valve leaflet clip delivery and implantation system 110. The valve leaflet clip delivery and implantation system 110 includes a valve leaflet clip spreader 112 configured to deliver a valve leaflet clip 112 to the cardiac valve leaflet L. The illustrated example of one embodiment of the delivery device catheter 800 is configured to deliver an anchor delivery and implantation device 120 configured to deliver and implant a cardiac anchor 122 (optionally using an anchor garage 124) to cardiac tissue such as ventricle V. An artificial chord 115 can be connected to the valve leaflet clip 114 and thus to the valve leaflet L and tethered to the ventricle V by the anchor 122.

[0045] It will be understood that the principles of the present disclosure may be applied to a steerable elongate flexible member used in a multi-catheter stacking assembly 100 as shown in FIG. 1, or separately or together with other devices, systems, instruments, etc. Although a steering system formed in accordance with various principles of the present disclosure is shown in an exemplary environment of the heart, it will be understood that other environments are within the scope and spirit of the present disclosure. The principles of the present disclosure are particularly useful, but not necessarily limited to, devices and systems for accessing anatomical sites within a patient's body without incising the body via transvascular access within the body. In addition to what has been discussed above, various further advantages of the various aspects, features, components, and structures of the steerable devices, systems, and methods as described above may be understood by those skilled in the art.

[0046] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation and is not intended to limit the disclosure to one or more of the forms disclosed herein. It will be understood that various additional, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from its concepts, spirit, or scope, or its characteristics. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the disclosure can be combined in alternative aspects, embodiments, or configurations. The disclosure is presented from the perspective of embodiments, but it should be understood that not all of the various distinct features of the subject matter need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. It will be understood by those skilled in the art that the disclosure can be used with many modifications, or structures, arrangements, ratios, materials, components, and other modifications specifically adapted to particular environments and operating requirements without departing from the principles, spirit, or scope of the disclosure. For example, an element shown as being integrally formed can be composed of a plurality of parts, or an element shown as a plurality of parts can be integrally formed, the operation of an element can be reversed or otherwise changed, and the size or dimensions of an element can be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be understood to mean that such a particular order is required to achieve a desired result, or that all operations, actions, or procedures should be performed. Furthermore, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve a desired result.Therefore, embodiments of the present disclosure should be regarded as illustrative in all respects and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the above description or to the specific embodiments or configurations described or shown herein. In view of the foregoing, the individual features of any embodiment can be used separately or in combination with the features of that embodiment or any other embodiment and can be claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the above description.

[0047] In the foregoing description and the following claims, the following points will be understood. The phrases "at least one", "one or more", and "and / or" are open-ended expressions that are used as both conjunctive and disjunctive when used herein. The terms "a", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the term "a" or "an" entity, when used herein, refers to one or more of that entity. Therefore, the terms "a" (or "an"), "one or more", and "at least one" can be used interchangeably herein. When used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context clearly indicates otherwise. When used herein, the conjunction "and" includes each of the structures, components, features, etc. so combined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so combined, alone and in any combination and number, unless the context clearly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used only for identification purposes to assist the reader's understanding of the present disclosure and / or to help distinguish the regions of related elements from each other, and do not particularly limit the related elements with respect to the position, orientation, or use of the present disclosure. References to connection (e.g., attached, coupled, connected, engaged, and joined) should be construed broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise indicated. Therefore, references to connection do not necessarily imply that two elements are directly connected and in a fixed relationship with each other.References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0048] The following claims are hereby incorporated by reference into this "Detailed Description of the Invention", and each claim, as independently of itself, is a separate embodiment of the present disclosure. In the claims, the terms "comprises", "comprising", "includes", and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Additionally, individual features may be included in different claims, and these may, in some cases, be advantageously combined, and being included in different claims does not mean that the combination of features is not feasible and / or not advantageous. Furthermore, references to the singular do not exclude the plural. The reference signs in the claims are presented merely as examples for clarification and should in no way be construed as limiting the claims.

Claims

1. An operable elongated flexible member, A two-way steering system operably associated with the operable elongated flexible member, A medical device delivery system comprising: wherein the two-way steering system A first elongated flexible steering element, A second elongated flexible steering element, A control handle operably associated with the first elongated flexible steering element and the second elongated flexible steering element for controlling the steering of the operable elongated flexible member via the first elongated flexible steering element and the second elongated flexible steering element, Comprising, Medical device delivery system.

2. The medical device delivery system according to claim 1, wherein the control handle includes a control knob operably associated with the first elongated flexible steering element and the second elongated flexible steering element for controlling the movement of the operable elongated flexible member.

3. The medical device delivery system according to claim 2, wherein the control knob is rotatable to control a steering gear system operably connected to the first elongated flexible steering element and the second elongated flexible steering element for controlling the movement of the operable elongated flexible member.

4. The steering gear system comprises a control knob pinion assembly operably connected to a steering gear pulley assembly, The control knob is operably connected to the control knob pinion assembly for controlling the rotational movement of the control knob pinion assembly, The steering gear pulley assembly is operably connected to the first elongated flexible steering element and the second elongated flexible steering element so as to control the movement of the first elongated flexible steering element and the second elongated flexible steering element for steering the operable elongated flexible member. The medical device delivery system according to claim 3.

5. The medical device delivery system according to any one of claims 2 to 4, wherein the control knob comprises a direction control knob element for controlling the movement of the first elongated flexible steering element and the second elongated flexible steering element, and a friction control knob element for controlling the movement of the direction control knob element.

6. The two-direction steering system is a first two-direction steering system operably associated with the steerable elongated flexible member for steering the steerable elongated flexible member in a first steering plane. The medical device delivery system further comprises a second two-direction steering system operably associated with the steerable elongated flexible member for steering the steerable elongated flexible member in a second steering plane that intersects the first steering plane. The medical device delivery system according to any one of claims 1 to 5.

7. A steerable elongated tubular flexible member, A two-direction steering system operably associated with the steerable elongated tubular flexible member for steering the steerable elongated tubular flexible member in a steering plane, A medical device delivery system further comprising: The steerable elongated flexible member extends through the steerable elongated tubular flexible member. The medical device delivery system according to claim 6.

8. The medical device delivery system according to claim 7, wherein the steerable elongated flexible member is longitudinally translatable within the steerable elongated tubular flexible member.

9. The two-direction steering system operably associated with the steerable elongated tubular flexible member is rotatable relative to the steering system operably associated with the steerable elongated flexible member for adjusting the orientation of the steering plane in which the steerable elongated tubular flexible member is steered. The medical device delivery system according to claim 7.

10. The medical device delivery system according to claim 6, further comprising a first control knob operably associated with the first two-direction steering system via a first steering gear system and a second control knob operably associated with the second two-direction steering system via a second steering gear system, wherein the gears of the first steering gear system rotate about respective first gear system axes that are parallel to each other, and the gears of the second steering gear system rotate about respective second gear system axes that are parallel to each other and intersect the first gear system axes.

11. A control handle for controlling the manipulation of an operable elongate flexible member, the operable elongate flexible member comprising a first elongate flexible control element and a second elongate flexible control element operably associated with the operable elongate flexible member, the control handle comprising a control handle housing, and a control knob attached to the control handle housing, wherein the control knob is operably associated with the first elongate flexible control element for manipulating the operable elongate flexible member in a first direction and is operably associated with the second elongate flexible control element for manipulating the operable elongate flexible member in a second direction different from the first direction. Control handle. **Claim 12** The control handle according to claim 11, wherein the control knob comprises a direction control knob element for controlling the movement of the first elongate flexible control element and the second elongate flexible control element, and a friction control knob element for controlling the movement of the direction control knob element. **Claim 13** The control handle according to claim 11 or 12, further comprising a gear system comprising a control knob pinion assembly operably associated with the control knob, and a steering gear pulley assembly operably associated with the control knob pinion assembly and the first elongate flexible control element and the second elongate flexible control element, wherein the gear system operates to control the manipulation of the operable elongate flexible member by rotation of the control knob. **Claim 14** The steering gear pulley assembly comprises a first steering gear pulley assembly operably associated with the first elongate flexible control element and a second steering gear pulley assembly operably associated with the second elongate flexible control element, at least one of the steering gear pulley assemblies comprising a gear having a gear barrel extending from the gear, the gear barrel being configured to connect an elongate flexible control element to the gear, the steering gear pulley assembly being configured to maintain the position of the elongate flexible control element on the gear barrel without entanglement with the gear. The control handle according to claim 13. **Claim 15** The control knob steers the steerable elongate flexible member in a first steering plane, the control handle further comprising a control knob attached to the control handle housing, the control knob being operably associated with a third elongate flexible steering element and a fourth elongate flexible steering element for steering the steerable elongate flexible member in a second steering plane intersecting the first steering plane, the control handle according to any one of claims 11 to 15.

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