Bidirectionally steerable catheter

Abstract

The bidirectionally steerable catheter may include a handle and an elongate sheath extending distally from the handle. The handle includes an axial translation mechanism. A first steering wire extends through the elongate sheath from the handle to a distal pull ring. A second steering wire extends through the elongate sheath from the handle to the distal pull ring, the second steering wire disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis. The first steering wire is configured to engage the axial translation mechanism to bend a distal portion of the elongate sheath in a first direction. The second steering wire is configured to engage the axial translation mechanism to bend the distal portion in a second direction opposite the first direction. A tension member couples a proximal end of the first steering wire to the handle.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices, and more particularly to mechanisms for steering catheters, sheaths, and / or elongate tubular shafts. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical, e.g., surgical and / or intravascular, applications. Some of these devices include guidewires, catheters, and medical device delivery systems (e.g., stents, grafts, replacement valves, etc.). These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of different methods. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and / or using medical devices. Summary of the Invention

[0003] In a first embodiment, a bidirectionally steerable catheter may include a handle and an elongate sheath extending distally from the handle. The handle may include an axial translation mechanism. A first steering wire may extend through the elongate sheath from the handle to a distal pull ring. A second steering wire may extend through the elongate sheath from the handle to the distal pull ring, the second steering wire being disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis of the elongate sheath. The first steering wire may be configured to engage with the axial translation mechanism to bend a distal portion of the elongate sheath in a first direction. The second steering wire may be configured to engage with the axial translation mechanism to bend the distal portion of the elongate sheath in a second direction opposite the first direction. A tension member may couple a proximal end of the first steering wire to the handle.

[0004] In addition to or instead of any of the examples described herein, the axial translation mechanism includes a screw member slidably disposed within the handle.

[0005] In addition to or instead of any of the examples described herein, the axial translation mechanism includes a rotatable knob configured to rotate about at least a portion of the handle.

[0006] In addition to or instead of any of the examples described herein, the rotatable knob is configured to engage a threaded member such that rotation of the rotatable knob relative to the handle causes axial translation of the threaded member within the handle.

[0007] In addition to or instead of any of the examples described herein, the first control wire includes a first stop element configured to engage the axial translation mechanism when the threaded member slides distally within the handle to apply tension to the first control wire.

[0008] In addition to or instead of any of the examples described herein, the first stop element is disengaged from the axial translation mechanism and releases the tension on the first control wire when the threaded member slides proximally within the handle.

[0009] In addition to or instead of any of the examples described herein, the first stop element is configured to float relative to the axial translation mechanism when the threaded member slides proximally within the handle.

[0010] In addition to or instead of any of the examples described herein, the second control wire includes a second stop element configured to engage the axial translation mechanism when the threaded member slides proximally within the handle.

[0011] In addition to or instead of any of the examples described herein, the second stop element is disengaged from the axial translation mechanism when the threaded member slides distally within the handle.

[0012] In addition to or instead of any of the examples described herein, the second stop element is configured to float relative to the axial translation mechanism when the threaded member slides distally within the handle.

[0013] In addition or alternatively to any of the examples described herein, the tension member is coupled to the handle at a location distal to the proximal end of the first steering wire.

[0014] In addition to or instead of any of the examples described herein, the bidirectionally steerable catheter may include a handle and an elongate sheath extending distally from the handle. The handle includes an axial translation mechanism. A first steering wire extends through the elongate sheath from the handle to a distal pull ring. A second steering wire extends through the elongate sheath from the handle to the distal pull ring, the second steering wire being disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis of the elongate sheath. The first steering wire is configured to engage with the axial translation mechanism to bend a distal portion of the elongate sheath in a first direction. The second steering wire is configured to engage with the axial translation mechanism to bend a distal portion of the elongate sheath in a second direction opposite the first direction. A tension member couples a proximal end of the first steering wire to the handle. A pulley is disposed within the handle, the pulley engaged with the first steering wire.

[0015] In addition or alternatively to any of the examples described herein, the pulley engages the first steering wire at a location proximal to the tension member.

[0016] In addition or alternatively to any of the examples described herein, the tension member is an elastic polymer.

[0017] In addition or alternatively to any of the examples described herein, the tension member is a coil spring.

[0018] In addition to or instead of any of the examples described herein, a bidirectionally steerable catheter may comprise a handle and a elongate sheath extending distally from the handle. The handle includes an axial translation mechanism. A first steering wire extends through the elongate sheath from the handle to a distal pulling ring. A second steering wire extends through the elongate sheath from the handle to the distal pulling ring, and the second steering wire is disposed on an opposite side of the elongate sheath from the first steering wire relative to a central longitudinal axis of the elongate sheath. The axial translation mechanism includes a first screw member and a first carriage member operably engaged with the first screw member, and the first carriage member is configured to engage the first steering wire to curve a distal portion of the elongate sheath in a first direction. The axial translation mechanism includes a second screw member and a second carriage member operably engaged with the second screw member, and the second carriage member is configured to engage the second steering wire to curve a distal portion of the elongate sheath in a second direction opposite the first direction. The axial translation mechanism includes a rotatable knob configured to rotate about at least a portion of the handle, and rotation of the rotatable knob causes rotation of the first screw member and the second screw member.

[0019] In addition to or instead of any of the examples described herein, the first screw member is laterally offset from the second screw member relative to a central longitudinal axis of the elongate sheath.

[0020] In addition to or instead of any of the examples described herein, the first screw member is coaxially aligned with the second screw member.

[0021] In addition to or instead of any of the examples described herein, the first carriage member and the second carriage member are configured to axially translate simultaneously in opposite directions within the handle.

[0022] In addition to or instead of any of the examples described herein, the first control wire includes a first stop element engaged with the first carriage member so as to apply tension to the first control wire by moving the first carriage member in the proximal direction, and the second control wire includes a second stop element engaged with the second carriage member so as to apply tension to the second control wire by moving the second carriage member in the proximal direction.

[0023] The foregoing summary of some exemplary embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present disclosure may be more fully understood in view of the following detailed description of various embodiments in connection with the accompanying drawings.

[0025]

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[0026] While aspects of the present disclosure are susceptible to various modifications and alternative forms, specifics of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, but not limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in every drawing, but the features and / or elements can be understood to be present regardless unless otherwise specified.

[0028] The following defined terms shall have these definitions applied, unless a different definition is given in the claims or elsewhere in this specification.

[0029] Whether or not explicitly indicated, all numerical values are assumed to be modified in this specification by the term "about." In the context of numerical values, the term "about" generally indicates a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) to the recited value. In many cases, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) may be understood from the context of this specification and may be assumed to have their ordinary customary definition(s) consistent with the context of this specification, unless otherwise indicated.

[0030] The recitation of a numerical range by endpoints includes all numbers within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0031] Although some preferred dimensions, ranges, and / or values are disclosed for various components, features, and / or specifications, those skilled in the art, being stimulated by the present disclosure, will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0032] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular, even though those features may be plural or repeated within the disclosed embodiment(s). Each instance of a feature includes, and / or may be encompassed by, a single disclosure, unless the contrary is explicitly stated. For brevity and clarity, not all elements of the present disclosure are necessarily shown in each drawing or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any and / or all of two or more components, unless the contrary is explicitly stated. Further, for clarity, not all instances of some elements or features are shown in each drawing.

[0033] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to the user / operator / manipulator of the device, where "proximal" and "retreating" indicate or refer to being closer to or towards the user, and "distal" and "advancing" indicate or refer to being farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the present disclosure, and in such cases, it will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" indicate the direction of fluid flow within a lumen such as a body lumen, blood vessel, etc., or within the device. Still other relative terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", and / or variations thereof generally indicate the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or device.

[0034] The terms "range" and / or "maximum range" may be understood to mean the maximum measured value of the stated or identified dimension, while the term "minimum range" may be understood to mean the minimum measured value of the stated or identified dimension. For example, an "outer range" may be understood to mean the maximum outer dimension, a "radial range" may be understood to mean the maximum radial dimension, a "longitudinal range" may be understood to mean the maximum longitudinal dimension, and so on. Each example of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to those skilled in the art from the context of the individual usage. In general, "range" or "maximum range" may be considered the maximum possible dimension measured in accordance with the intended usage. Alternatively, "minimum range" may be considered the minimum possible dimension measured in accordance with the intended usage. In some cases, "range" may generally be measured orthogonally in a plane and / or cross-section, but is not limited to this, and may be measured differently, such as angularly, radially, circumferentially (e.g., along an arc), etc., as is apparent from the particular context.

[0035] It should be noted that references to "certain embodiments", "some embodiments", "other embodiments", etc. in this specification indicate that the described embodiment(s) may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Further, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in relation to an embodiment, unless expressly stated otherwise or clearly stated to the contrary, it will be within the knowledge of those skilled in the art to bring about the particular feature, structure, or characteristic in relation to other embodiments. That is, the various individual elements described below may be combined or arranged with each other to form other additional embodiments or to complement and / or reinforce the described embodiment(s), as would be understood by those skilled in the art, even if not explicitly shown in a particular combination.

[0036] For clarity, a particular identification numbering convention (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish the various described and / or claimed features. It is to be understood that the numbering convention is not intended to be limiting and is merely illustrative. In some embodiments, for the sake of brevity and clarity, changes to and departures from previously used numbering conventions may be made. That is, a feature identified as a "first" element may later be shown as a "second" element, a "third" element, etc., or may be omitted altogether, and / or a different feature may be shown as the "first" element. The meaning and / or designation in each instance will be apparent to those skilled in the art.

[0037] In some medical procedures, a delivery and / or access sheath may be delivered percutaneously into a body cavity, lumen, and / or treatment site. Navigation through a patient's vasculature and / or organs may involve maneuvering through tortuous anatomical structures and / or directing the distal end of the delivery and / or access sheath into a body cavity, lumen, and / or treatment site. Examples of suitable medical devices for medical procedures include, but are not limited to, left atrial appendage closure, aortic valve replacement, mitral valve replacement, septal defect repair, etc., as described herein. Existing medical devices may have certain advantages and / or disadvantages. There is a continuing need for alternative steerable medical devices for delivering medical implants and / or performing other medical procedures.

[0038] FIG. 1 shows a selected embodiment of a bidirectionally steerable catheter 100. In some embodiments, the bidirectionally steerable catheter 100 may be any one of a variety of catheters, such as an intravascular catheter. Examples of intravascular catheters may include, but are not limited to, balloon catheters, atherectomy catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guide catheters. In some embodiments, the bidirectionally steerable catheter 100 may take the form of other suitable guiding, diagnostic, or therapeutic devices (including, for example, endoscopic and laparoscopic instruments) and may be suitable for use in various locations and / or body cavities within a patient.

[0039] The bidirectionally steerable catheter 100 may include a handle 110 and a long sheath 140 extending distally from the handle 110. In some embodiments, the bidirectionally steerable catheter 100 and / or the handle 110 may include a guide wire port, a side port, a fluid flush port, an imaging access port, or other suitable ports, access points or functional features. The handle 110 may include a handle housing 112. The long sheath 140 may extend into a distal opening within the handle housing 112 and / or extend through the distal opening. In at least some embodiments, the proximal end of the long sheath 140 may be fixedly attached to the handle housing 112 and / or fixedly attached therein. In some embodiments, the proximal portion of the long sheath 140 may include a key element configured to non-rotatably engage one or more locking elements fixedly attached to the inner surface of the handle housing 112 proximal to the distal end of the handle housing 112. In some embodiments, the key element may be adhered to the outer surface of the long sheath 140. In some embodiments, the key element may be integrally formed with the long sheath 140. In some embodiments, the key element may be welded (e.g., thermally welded, sonic welded, vibration welded, etc.) to the long sheath 140. In some embodiments, the key element may be melted with the long sheath 140 such that the material of the key element is mixed with the material of the long sheath 140 at the molecular level. In some embodiments, the handle housing 112 may include one or more locking elements fixedly attached to and / or integrally formed with the inner surface of the handle housing 112. In some embodiments, the one or more locking elements may be formed as ribs or other structural support members configured to increase the rigidity of the handle housing and enable torque transmission between the distal end of the handle housing 112 and the long sheath 140. In some embodiments, the long sheath 140 may have a normal configuration or a relaxed configuration. The long sheath 140 may be self-biased towards the normal configuration or the relaxed configuration and / or may return to the normal configuration or the relaxed configuration in the absence of any external force.Some suitable but non-limiting materials for the handle 110 and / or the handle housing 112 are described below.

[0040] In some embodiments, the elongate sheath 140 may include a soft and / or non-invasive distal tip 142. In some embodiments, the elongate sheath 140 may include a distal portion 144 having a first curvature 146 and a second curvature 148, whereby the elongate sheath 140 has a pre-set double curvature in its normal or relaxed configuration. In some embodiments, the first curvature 146 may be pre-set to curve upward when viewed from the side. Other configurations are envisioned. In some embodiments, the second curvature 148 may be pre-set to curve to the left when viewed proximally to distally along the elongate sheath 140. Other configurations are envisioned. In some embodiments, the distal portion 144 and / or the first curvature 146 may be configured to curve or deflect in a first direction, and the distal tip 142 may be curved and / or moved toward the handle 110 and / or curved and / or moved closer to the handle 110 and / or curved and / or moved toward and / or into a deflected configuration as shown in FIG. 1. In some embodiments, the distal portion 144 and / or the first curvature 146 may be configured to curve or deflect in a second direction opposite the first direction, and the distal tip 142 may be curved and / or moved away from the handle 110 and / or curved and / or moved farther from the handle 110 and / or curved and / or moved toward and / or into a linear configuration as shown in FIG. 1. In some embodiments, the elongate sheath 140 may have only a single curvature in its normal or relaxed configuration. In some embodiments, the elongate sheath 140 may be substantially linear in its normal or relaxed configuration. Other configurations including combinations of those described herein are envisioned.

[0041] Figures 2 and 3 show selected features of the bidirectionally steerable catheter 100. In the figures shown, a portion of the handle housing 112 has been removed to show internal components of the handle 110. In some embodiments, the handle 110 may include an axial translation mechanism 120. In some embodiments, the axial translation mechanism 120 can include a threaded member 122 slidably disposed within the handle 110 and / or the handle housing 112. In some embodiments, the axial translation mechanism 120 may include a rotatable knob 124. In some embodiments, the rotatable knob 124 may be disposed around at least a portion of the handle 110 and / or the handle housing 112 and / or may be configured to rotate around and / or relative to at least a portion thereof. In some embodiments, the rotatable knob 124 is configured to engage the threaded member 122 such that rotation of the rotatable knob 124 relative to the handle 110 and / or the handle housing 112 causes axial translation of the threaded member 122 proximally and / or distally within the handle 110 and / or the handle housing 112. In some embodiments, when viewed proximally to distally along the bidirectionally steerable catheter 100, clockwise rotation of the rotatable knob 124 can cause distal axial translation of the threaded member 122 within the handle 110 and / or the handle housing 112. In some embodiments, when viewed proximally to distally along the bidirectionally steerable catheter 100, counterclockwise rotation of the rotatable knob 124 can cause proximal axial translation of the threaded member 122 within the handle 110 and / or the handle housing 112. In some embodiments, reverse and / or opposite configurations may be used, and clockwise rotation of the rotatable knob 124 may move the threaded member 122 proximally and counterclockwise rotation of the rotatable knob 124 may move the threaded member 122 distally. The orientation of the female and male threads on the rotatable knob 124 and the threaded member 122, respectively, determines which rotational direction is associated with which direction of axial translation.Some suitable but non-limiting materials for the axial translation mechanism 120, the screw member 122, and / or the rotatable knob 124 are described below.

[0042] The first control wire 130 can extend from the handle 110 and / or the handle housing 112 through the elongate sheath 140 to the distal pull ring 150 (e.g., FIG. 4). The second control wire 132 can extend from the handle 110 and / or the handle housing 112 through the elongate sheath 140 to the distal pull ring 150 (e.g., FIG. 4). The second control wire 132 may be disposed on the opposite side of the elongate sheath 140 from the first control wire 130 with respect to the central longitudinal axis of the elongate sheath 140. Tension may be applied to the first control wire 130 and / or the second control wire 132 to bend and / or deflect the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 as described herein. The first control wire 130 engages the axial translation mechanism 120 and / or the screw member 122 to bend and / or deflect the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 in a first direction toward the handle 110 and / or the handle housing 112, toward and / or into a deflected configuration (e.g., FIG. 1). The second control wire 132 engages the axial translation mechanism 120 and / or the screw member 122 to bend and / or deflect the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 in a second direction opposite the first direction, away from the handle 110 and / or the handle housing 112, toward and / or into a straight configuration (e.g., FIG. 1).

[0043] In some embodiments, the bidirectionally steerable catheter 100 may include a pulley 160 disposed within the handle 110 and / or handle housing 112. The pulley 160 may engage with the first steering wire 130 via a circumferential channel extending around the pulley 160. In some embodiments, the pulley 160 may engage with the first steering wire 130 at a location proximal to the distal end of the threaded member 122. In some embodiments, the pulley 160 may engage with the first steering wire 130 at a location proximal to the distal end of the threaded member 122. In some embodiments, the bidirectionally steerable catheter 100 may include a tensioning member 170. The tensioning member 170 may couple a first end (e.g., a proximal end) of the first steering wire 130 to the handle 110 and / or handle housing 112. In at least some embodiments, the proximal end of first steering wire 130 may be fixedly coupled to handle 110 and / or handle housing 112 by tensioning member 170. In some embodiments, pulley 160 may engage first steering wire 130 at a location proximal to tensioning member 170. In some embodiments, tensioning member 170 may be coupled to handle 110 and / or handle housing 112 at a location distal to the proximal end of first steering wire 130. In some embodiments, tensioning member 170 may be an elastic polymer, as shown in FIG. 2. In another example, tensioning member 170 may be a coil spring, as shown in FIG. 3. Other configurations are also envisioned. As will be apparent, the tensioning member 170 may be configured to apply a small, non-biased amount of tension to the first steering wire 130 when the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 are disposed in a normal or relaxed configuration and / or when the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 are curved and / or deflected in a second direction toward and / or towards a straight configuration.The purpose of the tension member 170 is to prevent the first control wire 130 from coming off the pulley wheel 160 by holding the first control wire 130 stretched around the pulley wheel 160 when no tension is applied to the first control wire 130 by the axial translation mechanism 120 and / or the screw member 122 (e.g., in the normal configuration or the relaxed configuration, or when moving towards the linear configuration and / or in the linear configuration). Some suitable but non-limiting materials for the pulley wheel 160 and / or the tension member 170 are described below.

[0044] In addition or alternatively, in some embodiments, the bidirectionally steerable catheter 100 may include one or more ribs, protrusions, bosses, or pillars that extend laterally within the handle housing 112 between opposing walls and / or opposing surfaces of the handle housing 112. In some embodiments, the one or more ribs, protrusions, bosses, or pillars may be disposed at a location within the handle housing 112 configured to be proximate to the diameter and / or outer periphery of the pulley wheel 160. In some embodiments, the one or more ribs, protrusions, bosses, or pillars may be replaced by the pulley wheel 160. In some embodiments, in addition to the pulley wheel 160, one or more ribs, protrusions, bosses, or pillars may be provided. In some embodiments, the one or more ribs, protrusions, bosses, or pillars may extend completely across the interior of the handle housing 112 from one side of the handle housing 112 to the opposite side of the interior of the handle housing 112. In some embodiments, the first control wire 130 may be routed around and / or slide over the one or more ribs, protrusions, bosses, or pillars, similar to the first control wire 130 extending around the pulley wheel 160, such that the one or more ribs, protrusions, bosses, or pillars function as a guide for the first control wire 130 and can prevent loss of motion.

[0045] The screw member 122 can include a first catch 126 that extends laterally from the screw member 122 along a first lateral direction. The first control wire 130 may extend through and / or pass through the first catch 126. As seen in FIG. 2, the first control wire 130 can include a first stop element 134 configured to engage the axial translation mechanism 120 and / or the first catch 126 of the screw member 122 when the screw member 122 slides distally within the handle 110 and / or the handle housing 112 to apply tension to the first control wire 130. The tension applied by the axial translation mechanism 120 and / or the screw member 122 may be sufficient to overcome the self - biasing of the elongate sheath 140 towards its normal or relaxed configuration and curve and / or deflect the distal portion 144 and / or the first bend 146 of the elongate sheath 140 in a first direction.

[0046] The screw member 122 may include a second catch 128 that extends laterally from the screw member 122 along a second lateral direction opposite the first lateral direction. The second control wire 132 may extend through and / or pass through the second catch 128. As seen in FIG. 3, the second control wire 132 can include a second stop element 136 configured to engage the axial translation mechanism 120 and / or the second catch 128 of the screw member 122 when the screw member 122 slides proximally within the handle 110 and / or the handle housing 112 to apply tension to the second control wire 132. The tension applied by the axial translation mechanism 120 and / or the screw member 122 may be sufficient to overcome the self - biasing of the elongate sheath 140 towards its normal or relaxed configuration and curve and / or deflect the distal portion 144 and / or the first bend 146 of the elongate sheath 140 in a second direction.

[0047] The pulley 160 allows the threaded member 122 to apply tension to both the first steering wire 130 and the second steering wire 132, depending on which direction the threaded member 122 is moving. Tension applied to the first steering wire 130 and the second steering wire 132 bends and / or deflects the distal portion 144 and / or the first curved section 146 of the elongate sheath 140 away from the normal or relaxed configuration. Because both steering wires extend proximally from the distal pull ring 150, the pulley 160 is necessary so that the direction of the first steering wire 130 can be reversed relative to the second steering wire 132 within the handle 110 and / or handle housing 112, thereby selectively applying tension to both the first steering wire 130 and the second steering wire 132 by moving the threaded member 122 in opposite directions. In one or more alternative configurations, the handle 110 and / or the handle housing 112 may include, instead of the pulley 160, an internal rib, internal protrusion, or other feature disposed within the handle 110 and / or the handle housing 112 around which the first steering wire 130 extends and reverses direction, thereby functioning as described herein.

[0048] When the screw member 122 is disposed at the central position, the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 can be disposed in the normal configuration or the relaxed configuration. When the screw member 122 is disposed at the central position, substantially no tension is applied to the first control wire 130 and / or the second control wire 132. When the screw member 122 is axially translated proximally and / or distally within the handle 110 and / or the handle housing 112, the screw member 122 of the axial translation mechanism 120 engages the first control wire 130 and / or the second control wire 132 to apply tension and can curve and / or deflect the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 as described herein. Additionally, when the screw member 122 is disposed at the central position, the first catch 126 may engage the first stop element 134, but no tension is applied to the first control wire 130, and the second catch 128 may engage the second stop element 136, but no tension is applied to the second control wire 132. Thus, the central position of the screw member 122 may be tension neutral with respect to the first control wire 130 and the second control wire 132.

[0049] When the screw member 122 is moved from the central position toward the proximal position and / or until it is disposed at the proximal position, tension may be applied to the second control wire 132, and the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 may be curved and / or deflected in a second direction away from the handle 110 and / or the handle housing 112, and / or toward and / or into a straight configuration. When moving the screw member 122 proximally from the central position within the handle 110 and / or the handle housing 112, the second catch 128 engages the second stop element 136 and then translates the second stop element 136 proximally, thereby applying tension to the second control wire 132 as seen in FIG. 3. The first stop element 134 is disengaged from the axial translation mechanism 120, the screw member 122, and / or the first catch 126 when the screw member 122 slides proximally within the handle 110 and / or the handle housing 112, so that the tension on the first control wire 130 can be released. Thus, when the screw member 122 is moved proximally from the central position, the first catch 126 may be disengaged from the first stop element 134, and the first catch 126 may slide proximally along and / or on the first control wire 130. The first stop element 134 may be configured to float relative to the axial translation mechanism 120, the screw member 122, and / or the first catch 126 when the screw member 122 slides proximally within the handle 110 and / or the handle housing 112 (e.g., the first stop element 134 may not be directly fixed thereto). Thus, if slack is formed in the first control wire 130 and tension is not applied by the tension member 170, the first control wire 130 is disengaged from the pulley wheel 160. The tension member 170 holds the first control wire 130 stretched around the pulley wheel 160 while tension is not applied to the first control wire 130 by the screw member 122 and / or the first catch 126. The tension member 170 simply relieves any slack that would otherwise be formed in the first control wire 130 due to the first catch 126 being disengaged from the first stop element 134 and prevents the first control wire 130 from being disengaged from the pulley wheel 160.This feature can be seen, for example, in the configuration shown in FIG. 3.

[0050] As threaded member 122 is moved from the central position toward and / or until disposed in the distal position, tension may be applied to first steering wire 130, and distal portion 144 and / or first curved portion 146 of elongate sheath 140 may be curved and / or deflected in a first direction toward handle 110 and / or handle housing 112, or toward and / or toward the deflected configuration. Upon moving threaded member 122 distally from the central position within handle 110 and / or handle housing 112, first catch 126 engages first stop element 134, which then translates first stop element 134 distally, thereby applying tension to first steering wire 130, as seen in FIG. 2 . The second stop element 136 can be disengaged from the axial translation mechanism 120, the threaded member 122, and / or the second catch 128 to release tension on the second steering wire 132 as the threaded member 122 slides distally within the handle 110 and / or handle housing 112. Thus, when the threaded member 122 is moved distally from the central position, the second catch 128 can be disengaged from the second stop element 136, and the second catch 128 can slide distally along and / or over the second steering wire 132. The second stop element 136 can be configured to float relative to the axial translation mechanism 120, the threaded member 122, and / or the second catch 128 (e.g., the second stop element 136 need not be directly fixed thereto) as the threaded member 122 slides distally within the handle 110 and / or handle housing 112. 2 , slack is created in second steering wire 132 due to second catch 128 disengaging from second stop element 136. As threaded member 122 is translated distally from the proximal and / or central position, first catch 126 engages first stop element 134, which then pulls first steering wire 130 around pulley 160, releasing the tension applied by tensioning member 170 as tension is instead applied to first steering wire 130 by first catch 126 and / or threaded member 122.

[0051] FIG. 4 shows an exemplary configuration aspect of the elongate sheath 140. In some embodiments, the elongate sheath 140 may include a soft and / or non-invasive distal tip 142. In some embodiments, the elongate sheath 140 can include a distal portion 144 having a first curvature 146 and a second curvature 148 such that the elongate sheath 140 has a pre-set double curvature in a normal or relaxed configuration. In some embodiments, the first curvature 146 may be pre-set to curve upward when viewed from the side. Other configurations are envisioned. In some embodiments, the second curvature 148 may be pre-set to curve to the left when viewed proximally to distally along the elongate sheath 140. Other configurations are envisioned.

[0052] In some embodiments, elongate sheath 140 may include wall 141 defining a central lumen 143 extending from the proximal end to the distal tip 142 along a central longitudinal axis of elongate sheath 140. In at least some embodiments, central lumen 143 may be coaxial with the central longitudinal axis of elongate sheath 140. In some embodiments, central lumen 143 may be a guidewire lumen. In some embodiments, central lumen 143 may be a device lumen used to deliver a medical device or implant. In some embodiments, central lumen 143 may have multiple uses. Elongate sheath 140 may include multiple steering wire lumens 145 extending and / or disposed within wall 141. In some embodiments, multiple steering wire lumens 145 may include a first steering wire lumen and a second steering wire lumen. In some embodiments, multiple steering wire lumens 145 may include three or more steering wire lumens. In some embodiments, multiple steering wire lumens 145 may be oriented substantially parallel to the central longitudinal axis of central lumen 143 and / or elongate sheath 140. In some embodiments, multiple steering wire lumens 145 may be positioned opposite each other and / or on opposite sides of elongate sheath 140 relative to the central longitudinal axis of central lumen 143 and / or elongate sheath 140. Other configurations are also envisioned.

[0053] As discussed herein, the distal pulling ring 150 may be disposed within the distal portion 144 of the elongate sheath 140. In some embodiments, the distal pulling ring 150 may be disposed proximal to the second curvature 148 and / or the distal tip 142. In at least some embodiments, the distal pulling ring 150 may be disposed proximate to the distal end of the first curvature 146. In some embodiments, the distal pulling ring 150 may be embedded within the wall 141 of the elongate sheath 140. In some embodiments, the distal pulling ring 150 may be fixed, adhered, and / or fixedly attached to the inner surface of the wall 141 of the elongate sheath 140. Other configurations are envisioned. Some suitable but non-limiting materials for the distal pulling ring 150 are described below.

[0054] The first control wire 130 and the second control wire 132 may each be slidably disposed within a plurality of control wire lumens 145. In one example, the first control wire 130 may be slidably disposed within the first control wire lumen, and the second control wire 132 may be disposed within the second control wire lumen. The first control wire 130 and the second control wire 132 may be fixedly attached to the distal pulling ring 150 (e.g., by adhesion, welding, etc.). For example, the distal end of the first control wire 130 may be fixedly attached to the distal pulling ring 150, and the distal end of the second control wire 132 may be fixedly attached to the distal pulling ring 150 at a position opposite the distal end of the first control wire 130 with respect to the central longitudinal axis of the elongate sheath 140. Some suitable but non-limiting materials for the first control wire 130 and the second control wire 132 are described below.

[0055] In some embodiments, the elongate sheath 140 may be sized according to its intended use. For example, the elongate sheath 140 may have a length in the range of from about 50 to about 200 centimeters, from about 75 to about 175 centimeters, or from about 100 to about 150 centimeters. Other lengths are contemplated. It is further contemplated that the outer diameter of the elongate sheath 140 may vary based on the use or application. In some examples, the outer diameter of the elongate sheath 140 may be about 2 millimeters (mm), about 3 mm (i.e., 9 French), about 3.5 mm, about 4 mm (i.e., 12 French), about 4.5 mm, about 5 mm (i.e., 15 French), about 5.33 mm, about 5.5 mm, about 5.66 mm (i.e., 17 French), about 6 mm, about 6.5 mm, about 7 mm (i.e., 21 French), about 8 mm, or other suitable sizes. In some embodiments, the outer diameter of the elongate sheath 140 may be up to 5.66 mm (17 French), preferably less than 5.66 mm (17 French). Other configurations are contemplated. Some suitable but non-limiting materials for the elongate sheath 140 are described below.

[0056] Figures 5 and 6 show the relationship between certain features of the bidirectionally steerable catheter 100 in the deflection configuration and the straight configuration. As seen in FIG. 5, looking proximally to distally, a clockwise rotation of the rotatable knob 124 moves the screw member 122 distally within the handle 110 and / or the handle housing 112, thereby applying tension to the first steering wire 130 and causing the distal portion 144 and / or the first bend 146 of the elongate sheath 140 to curve or deflect toward the handle 110 and / or the handle housing 112, or toward, and / or into, the deflection configuration. As seen in FIG. 6, looking proximally to distally, a counterclockwise rotation of the rotatable knob 124 moves the screw member 122 proximally within the handle 110 and / or the handle housing 112, thereby applying tension to the second steering wire 132 and causing the distal portion 144 and / or the first bend 146 of the elongate sheath 140 to curve or deflect away from the handle 110 and / or the handle housing 112, or toward, and / or into, the straight configuration. As discussed herein, other configurations are envisioned.

[0057] Figures 7 through 9 show selected features of an alternative configuration of the handle 210 of the bidirectionally steerable catheter 200. As above, the bidirectionally steerable catheter 200 may include a handle 210 and a elongate sheath 140 extending distally from the handle 210. In some embodiments, the bidirectionally steerable catheter 200 and / or the handle 210 may include a guidewire port, a side port, a fluid flush port, an imaging access port, or other suitable ports, access points or functional features. The handle 210 may include a handle housing 212. The elongate sheath 140 may extend into and / or through a distal opening within the handle housing 212. In at least some embodiments, the proximal end of the elongate sheath 140 may be fixedly attached to the handle housing 212 and / or within it. In some embodiments, the elongate sheath 140 may have a normal configuration or a relaxed configuration. The elongate sheath 140 may be self-biased toward the normal configuration or the relaxed configuration and / or may return to the normal configuration or the relaxed configuration in the absence of any external force. Some suitable but non-limiting materials for the handle 210 and / or the handle housing 212 are described below.

[0058] In the depicted views, a portion of the handle housing 212 has been removed to show the internal components of the handle 210. In some embodiments, the handle 210 may include an axial translation mechanism 220. In some embodiments, the axial translation mechanism 220 may include a first threaded member 222 and a first carriage member 225 disposed within the handle 210 and / or handle housing 212. The first carriage member 225 may be operably engaged with the first threaded member 222. In at least some embodiments, the first threaded member 222 may include external threads configured to engage with internal threads formed in and / or on the first carriage member 225. In some embodiments, the axial translation mechanism 220 may include a second threaded member 223 and a second carriage member 227 disposed within the handle 210 and / or handle housing 212. The second carriage member 227 may be operably engaged with the second threaded member 223. In at least some embodiments, the second threaded member 223 may include external threads configured to engage with internal threads formed in and / or on the second carriage member 227. The first threaded member 222 and first carriage member 225 may be laterally offset from the second threaded member 223 and second carriage member 227 within the handle 210 and / or handle housing 212 relative to a central longitudinal axis of the elongate sheath 140.

[0059] In some embodiments, the axial translation mechanism 220 may include a rotatable knob 224. In some embodiments, the rotatable knob 224 may be disposed around at least a portion of the handle 210 and / or the handle housing 212, and / or may be configured to rotate around and / or relative to at least a portion thereof. In some embodiments, the rotatable knob 224 may be configured to engage the first screw member 222 and the second screw member 223 such that rotation of the rotatable knob 224 relative to the handle 210 and / or the handle housing 212 causes rotation of the first screw member 222 and the second screw member 223 within the handle 210 and / or the handle housing 212.

[0060] In some embodiments, rotation of the rotatable knob 224 can cause axial translation of the first carriage member 225 along a first threaded member 222 within the handle 210 and / or handle housing 212. In some embodiments, rotation of the rotatable knob 224 can cause axial translation of the second carriage member 227 along a second threaded member 223 within the handle 210 and / or handle housing 212. The first carriage member 225 and the second carriage member 227 can be configured to simultaneously translate in opposite axial directions within the handle 210 and / or handle housing 212. For example, rotation of the rotatable knob 224 that causes distal translation of the first carriage member 225 simultaneously causes proximal translation of the second carriage member 227. Similarly, rotation of the rotatable knob 224 that causes distal translation of the second carriage member 227 simultaneously causes proximal translation of the first carriage member 225. The orientation of the female and male threads on first threaded member 222 and first carriage member 225, and second threaded member 223 and second carriage member 227, determines which direction of rotation results in which direction of axial translation. In at least some embodiments, the male threads on first threaded member 222 and second threaded member 223 may be oriented in opposite directions to move first carriage member 225 and second carriage member 227, respectively, in opposite directions. Some suitable, but non-limiting, materials for axial translation mechanism 220, first threaded member 222, second threaded member 223, rotatable knob 224, first carriage member 225, and second carriage member 227 are described below.

[0061] The first control wire 130 may extend from the handle 210 and / or the handle housing 212 through the elongate sheath 140 to the distal pull ring 150 (e.g., FIG. 4). The second control wire 132 may extend from the handle 210 and / or the handle housing 212 through the elongate sheath 140 to the distal pull ring 150 (e.g., FIG. 4). The second control wire 132 may be disposed on the opposite side of the elongate sheath 140 from the first control wire 130 relative to the central longitudinal axis of the elongate sheath 140. Tension may be applied to the first control wire 130 and / or the second control wire 132 to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongate sheath 140 as described herein. The first control wire 130 may include a first stop element 134 that engages the axial translation mechanism 220 and / or the first carriage member 225 such that, as shown in FIG. 8, moving the first carriage member 225 in the proximal direction bends and / or deflects the distal portion 144 and / or the first bend 146 of the elongate sheath 140 in a first direction toward the handle 210 and / or the handle housing 212, toward a deflected configuration (e.g., FIGS. 1, 5), and / or toward the deflected configuration. The second control wire 132 may include a second stop element 136 that engages the axial translation mechanism 220 and / or the second carriage member 227 such that, as shown in FIG. 9, moving the second carriage member 227 in the proximal direction bends and / or deflects the distal portion 144 and / or the first bend 146 of the elongate sheath 140 in a second direction opposite the first direction, away from the handle 210 and / or the handle housing 212, toward a straight configuration (e.g., FIGS. 1, 6), and / or toward the straight configuration.

[0062] When first carriage member 225 and second carriage member 227 are disposed in a central position (e.g., FIG. 7 ) along first threaded member 222 and second threaded member 223, respectively, distal portion 144 and / or first curved portion 146 of elongate sheath 140 can be disposed in a normal configuration or a relaxed configuration. When first carriage member 225 and second carriage member 227 are disposed in a central position along first threaded member 222 and second threaded member 223, respectively, there is substantially no tension applied to first steering wire 130 and / or second steering wire 132. As first carriage member 225 and second carriage member 227 are axially translated proximally and / or distally within handle 210 and / or handle housing 212, first carriage member 225 and second carriage member 227 of axial translation mechanism 220 may engage and apply tension to first steering wire 130 and / or second steering wire 132 to curve and / or deflect distal portion 144 and / or first curved portion 146 of elongate sheath 140 as described herein. Additionally, when first carriage member 225 and second carriage member 227 are disposed in a centered position, first carriage member 225 may be engaged with first stop element 134 but no tension is applied to first steering wire 130, and second carriage member 227 may be engaged with second stop element 136 but no tension is applied to second steering wire 132. Thus, the center position of first carriage member 225 and second carriage member 227 may be in neutral tension with respect to first steering wire 130 and second steering wire 132 .

[0063] When the first carriage member 225 is moved from the central position toward the proximal position (e.g., FIG. 8) and / or until it is disposed at the proximal position, tension may be applied to the first control wire 130, and the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 may be curved and / or deflected in a first direction toward the handle 210 and / or the handle housing 212, or toward the deflected configuration (e.g., FIGS. 1, 5), and / or toward the deflected configuration. As seen in FIG. 8, when moving the first carriage member 225 proximally within the handle 210 and / or the handle housing 212 from the central position, the first carriage member 225 engages the first stop element 134 and then translates the first stop element 134 proximally, thereby applying tension to the first control wire 130. When the first carriage member 225 slides proximally within the handle 210 and / or the handle housing 212, the second carriage member 227 and the second stop element 136 may translate distally to release the tension on the second control wire 132.

[0064] When the second carriage member 227 is moved from the central position toward the proximal position (e.g., FIG. 9) and / or until it is disposed at the proximal position, tension may be applied to the second control wire 132, and the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 may be curved and / or deflected in a second direction away from the handle 210 and / or the handle housing 212, or toward the straight configuration (e.g., FIGS. 1, 6), and / or toward the straight configuration. As seen in FIG. 9, when moving the second carriage member 227 proximally within the handle 210 and / or the handle housing 212 from the central position, the second carriage member 227 engages the second stop element 136 and then translates the second stop element 136 proximally, thereby applying tension to the second control wire 132. When the second carriage member 227 slides proximally within the handle 210 and / or the handle housing 212, the first carriage member 225 and the first stop element 134 may translate distally to release the tension on the first control wire 130.

[0065] 10-12 illustrate selected features of alternative configurations of the handle 310 of the bidirectionally steerable catheter 300. Similar to the above, the bidirectionally steerable catheter 300 may include a handle 310 and an elongate sheath 140 extending distally from the handle 310. In some embodiments, the bidirectionally steerable catheter 300 and / or the handle 310 may include a guidewire port, a side port, a fluid flush port, an imaging access port, or other suitable ports, access points, or functional features. The handle 310 may include a handle housing 312. The elongate sheath 140 may extend into and / or through a distal opening in the handle housing 312. In at least some embodiments, the proximal end of the elongate sheath 140 may be fixedly attached to and / or within the handle housing 312. In some embodiments, the elongate sheath 140 may have a normal configuration or a relaxed configuration. The elongate sheath 140 may be self-biased toward the normal or relaxed configuration and / or may return to the normal or relaxed configuration in the absence of any external force. Some suitable, but non-limiting, materials for the handle 310 and / or handle housing 312 are described below.

[0066] In the depicted views, a portion of the handle housing 312 has been removed to show the internal components of the handle 310. In some embodiments, the handle 310 may include an axial translation mechanism 320. In some embodiments, the axial translation mechanism 320 may include a first threaded member 322 and a first carriage member 325 disposed within the handle 310 and / or handle housing 312. The first carriage member 325 may be operably engaged with the first threaded member 322. In at least some embodiments, the first threaded member 322 may include external threads configured to engage with internal threads formed in and / or on the first carriage member 325. In some embodiments, the axial translation mechanism 320 may include a second threaded member 323 and a second carriage member 327 disposed within the handle 310 and / or handle housing 312. The second carriage member 327 may be operably engaged with the second threaded member 323. In at least some embodiments, the second threaded member 323 may include external threads configured to engage with internal threads formed in and / or on the second carriage member 327. In some embodiments, the first threaded member 322 and the first carriage member 325 may be coaxially aligned with the second threaded member 323 and the second carriage member 327 within the handle 310 and / or handle housing 312. In some embodiments, the first threaded member 322 and the second threaded member 323 may be formed as bevel gears, planetary gears, or the like.

[0067] In some embodiments, the axial translation mechanism 320 may include a rotatable knob 324. In some embodiments, the rotatable knob 324 may be disposed around at least a portion of the handle 310 and / or the handle housing 312 and / or may be configured to rotate around and / or with respect to at least a portion thereof. In some embodiments, the rotatable knob 324 may be configured to engage with a first screw member 322 and a second screw member 323 such that rotation of the rotatable knob 324 with respect to the handle 310 and / or the handle housing 312 causes rotation of the first screw member 322 and the second screw member 323 within the handle 310 and / or the handle housing 312. In some embodiments, the first screw member 322 and the second screw member 323 may be fixedly secured together and / or to each other such that both the first screw member 322 and the second screw member 323 rotate in the same direction and / or as a single monolithic structure.

[0068] In some embodiments, rotation of the rotatable knob 324 can cause axial translation of the first carriage member 325 along a first threaded member 322 within the handle 310 and / or handle housing 312. In some embodiments, rotation of the rotatable knob 324 can cause axial translation of the second carriage member 327 along a second threaded member 323 within the handle 310 and / or handle housing 312. The first carriage member 325 and the second carriage member 327 can be configured to simultaneously translate in opposite axial directions within the handle 310 and / or handle housing 312. For example, rotation of the rotatable knob 324 that causes distal translation of the first carriage member 325 simultaneously causes proximal translation of the second carriage member 327. Similarly, rotation of the rotatable knob 324 that causes distal translation of the second carriage member 327 simultaneously causes proximal translation of the first carriage member 325. The orientation of the female and male threads on the first threaded member 322 and first carriage member 325, and the second threaded member 323 and second carriage member 327, determines which direction of rotation results in which direction of axial translation. In at least some embodiments, the male threads on the first threaded member 322 and the male threads on the second threaded member 323 may be oriented in opposite directions to move the first carriage member 325 and the second carriage member 327 in opposite directions, respectively. Some suitable, but non-limiting, materials for the axial translation mechanism 320, first threaded member 322, second threaded member 323, rotatable knob 324, first carriage member 325, and second carriage member 327 are described below.

[0069] First steering wire 130 can extend from handle 310 and / or handle housing 312 through elongate sheath 140 to distal pull ring 150 (e.g., FIG. 4). Second steering wire 132 can extend from handle 310 and / or handle housing 312 through elongate sheath 140 to distal pull ring 150 (e.g., FIG. 4). Second steering wire 132 can be positioned on the opposite side of elongate sheath 140 from first steering wire 130 relative to a central longitudinal axis of elongate sheath 140. Tension can be applied to first steering wire 130 and / or second steering wire 132 as described herein to bend and / or deflect distal portion 144 and / or first curved portion 146 of elongate sheath 140 (e.g., FIG. 1). The first steering wire 130 may include a first stop element 134 engaged with the axial translation mechanism 320 and / or the first carriage member 325, such that moving the first carriage member 325 proximally bends and / or deflects the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 in a first direction toward the handle 310 and / or handle housing 312, toward and / or towards the deflected configuration (e.g., FIGS. 1 and 5). The second steering wire 132 may include a second stop element 136 engaged with the axial translation mechanism 320 and / or the second carriage member 327, such that, as shown in FIG. 12 , moving the second carriage member 327 in a proximal direction causes the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 to curve and / or deflect in a second direction opposite the first direction, away from the handle 310 and / or handle housing 312, toward and / or towards a straight configuration (e.g., FIGS. 1 and 6 ).

[0070] When the first carriage member 325 and the second carriage member 327 are respectively disposed at the central position (e.g., FIG. 10) along the first screw member 322 and the second screw member 323, the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 can be disposed in the normal configuration or the relaxed configuration. When the first carriage member 325 and the second carriage member 327 are respectively disposed at the central position along the first screw member 322 and the second screw member 323, substantially no tension is applied to the first control wire 130 and / or the second control wire 132. When the first carriage member 325 and the second carriage member 327 are axially translated proximally and / or distally within the handle 310 and / or the handle housing 312, the first carriage member 325 and the second carriage member 327 of the axial translation mechanism 320 engage the first control wire 130 and / or the second control wire 132 to apply tension thereto to bend and / or deflect the distal portion 144 and / or the first curved portion 146 of the elongate sheath 140 as described herein. Additionally, when the first carriage member 325 and the second carriage member 327 are disposed at the central position, the first carriage member 325 can engage the first stop element 134, but no tension is applied to the first control wire 130, and the second carriage member 327 can engage the second stop element 136, but no tension is applied to the second control wire 132. Thus, the central position of the first carriage member 325 and the second carriage member 327 may be tension-neutral with respect to the first control wire 130 and the second control wire 132.

[0071] When the first carriage member 325 is moved from the central position toward the proximal position (e.g., FIG. 11) and / or until it is disposed at the proximal position, tension may be applied to the first control wire 130, and the distal portion 144 and / or the first bend 146 of the elongate sheath 140 may be curved and / or deflected in a first direction toward the handle 310 and / or the handle housing 312, or toward and / or into a deflected configuration (e.g., FIGS. 1, 5). As seen in FIG. 11, when the first carriage member 325 is moved proximally within the handle 310 and / or the handle housing 312 from the central position, the first carriage member 325 engages the first stop element 134 and then translates the first stop element 134 proximally, thereby applying tension to the first control wire 130. When the first carriage member 325 slides proximally within the handle 310 and / or the handle housing 312, the second carriage member 327 and the second stop element 136 translate distally to release the tension on the second control wire 132.

[0072] When the second carriage member 327 is moved from the central position toward the proximal position (e.g., FIG. 12) and / or until it is disposed at the proximal position, tension may be applied to the second control wire 132, and the distal portion 144 and / or the first bend 146 of the elongate sheath 140 may be curved and / or deflected in a second direction away from the handle 310 and / or the handle housing 312, or toward and / or into a straight configuration (e.g., FIGS. 1, 6). As seen in FIG. 12, when the second carriage member 327 is moved proximally within the handle 310 and / or the handle housing 312 from the central position, the second carriage member 327 engages the second stop element 136 and then translates the second stop element 136 proximally, thereby applying tension to the second control wire 132. When the second carriage member 327 slides proximally within the handle 310 and / or the handle housing 312, the first carriage member 325 and the first stop element 134 translate distally to release the tension on the first control wire 130.

[0073] The various components of a bidirectionally steerable catheter (and / or other systems or components disclosed herein) and the various materials that may be used for the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity, in the following discussion reference is made to a sheath and the like. However, this is not intended to limit the devices and methods described herein, and the discussion applies to, but is not limited to, elongate sheaths, handles, handle housings, screw member(s), carriage member(s), steering wire(s), etc., and / or other elements, members, components, or devices disclosed herein, such as elements or components thereof.

[0074] In some embodiments, the bidirectionally steerable catheter and / or its components may be made of metal, alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, and combinations thereof, or other suitable materials. Some examples of suitable metals and alloys include stainless steels such as 444V, 444L, and 314LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276®, and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY® and PHYNOX®), platinum-reinforced stainless steel, titanium, platinum, palladium, gold, and combinations thereof, or any other suitable material.

[0075] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as "linear elastic" or "non-superelastic" which may be chemically similar to conventional shape memory and superelastic types but exhibit distinct useful mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that the linear elastic and / or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "flag region" as shown by superelastic nitinol in its stress / strain curve. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress increases in a relationship that is substantially linear or in some cases linear but not necessarily entirely linear until plastic deformation begins, or at least in a relationship that is more linear than the superelastic plateau and / or flag region that may be seen in superelastic nitinol. Thus, for the purposes of the present disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0076] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol in that the linear elastic and / or non-superelastic nitinol can accept up to about 2 to 5% strain while remaining substantially elastic (e.g., prior to plastic deformation), while superelastic nitinol can accept up to about 8% strain prior to plastic deformation. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (which can also be distinguished based on its composition) that can only tolerate up to about 0.2 to 0.44 percent strain prior to plastic deformation.

[0077] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys that do not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys may not exhibit a martensite / austenite phase change detectable by DSC and DMTA analysis over a range of about -60 degrees Celsius (°C) to about 120°C. Thus, the mechanical bending properties of such materials may generally be inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient or room temperature are substantially the same as those at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic characteristics and / or properties.

[0078] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa Techno Material Co., Ltd., Kanagawa Prefecture, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve desired properties.

[0079] In at least some embodiments, some or all of the bidirectionally steerable catheter and / or its components may also be doped, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can generate a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image helps the user determine the position of the bidirectionally steerable catheter. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the bidirectionally steerable catheter to achieve the same result.

[0080] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the bidirectionally steerable catheter. For example, the bidirectionally steerable catheter and / or its components or a portion thereof may be made of a material that does not substantially distort the image and does not generate substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable as they can potentially generate artifacts in the MRI image. The bidirectionally steerable catheter or a portion thereof may also be made of a material that can be imaged by an MRI machine. Some materials exhibiting these properties can include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nitinol, and others.

[0081] In some embodiments, the bidirectionally steerable catheter and / or portions thereof may be made of or may include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate and / or HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanGRILAMID® available from Grilon, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, polyurethane silicone copolymer (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof, etc. may be included. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0082] In some embodiments, the bidirectionally steerable catheter may include and / or be formed from a textile material. Some examples of suitable textile materials include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyl, polymethyl acetate, polyamide, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylene. Additionally, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr-based alloys. The yarn may further include carbon, glass, or ceramic fibers. Desirably, the yarn is made from a thermoplastic material, including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarn may be multifilament, monofilament, or spun type. The type and denier of the yarn selected may be selected to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure, with desirable properties.

[0083] In some embodiments, the bidirectionally steerable catheter may include a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorphenylalanine proline arginine chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that can block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), antineoplastic / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetics (such as lidocaine, bupivacaine, and ropivacaine), anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides), vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters), vascular cell growth inhibitors (such as growth factor inhibitors, cell growth receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins), cholesterol-lowering agents, vasodilators, and agents that inhibit endogenous vasoactive mechanisms.

[0084] It should be understood that the present disclosure is merely exemplary in many aspects. Without departing from the scope of the present disclosure, details, particularly with respect to the shape, size, and arrangement of the steps, may be changed. This may include the use of any of the features of one exemplary embodiment used in other embodiments within an appropriate range. The scope of the present disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

1. A handle and a long sheath extending distally from the handle, wherein the handle includes an axial translation mechanism, a first control wire extends through the long sheath from the handle to a distal pulling ring, a second control wire extends through the long sheath from the handle to the distal pulling ring, and the second control wire is disposed on the opposite side of the long sheath from the first control wire with respect to a central longitudinal axis of the long sheath, the first control wire is configured to engage the axial translation mechanism to curve a distal portion of the long sheath in a first direction, the second control wire is configured to engage the axial translation mechanism to curve the distal portion of the long sheath in a second direction opposite the first direction, a tension member connects a proximal end of the first control wire to the handle, the axial translation mechanism includes a threaded member slidably disposed within the handle, the first control wire includes a first stop element configured to engage the axial translation mechanism when the threaded member slides distally within the handle to apply tension to the first control wire, the tension member is connected to the proximal end of the first control wire distal to the first stop element, a bidirectionally controllable catheter.

2. The bidirectionally controllable catheter according to claim 1, wherein the axial translation mechanism includes a rotatable knob configured to rotate about at least a portion of the handle.

3. The bidirectionally controllable catheter according to claim 2, wherein the rotatable knob is configured to engage the threaded member such that rotation of the rotatable knob relative to the handle causes axial translation of the threaded member within the handle.

4. The bidirectionally controllable catheter according to claim 1, wherein the first stop element is disengaged from the axial translation mechanism to release tension on the first control wire when the threaded member slides proximally within the handle.

5. The bidirectionally controllable catheter according to any one of claims 1 to 4, wherein the first stop element is configured to float relative to the axial translation mechanism when the threaded member slides proximally within the handle.

6. The second control wire includes a second stop element configured to engage the axial translation mechanism when the screw member slides proximally within the handle, the bidirectionally controllable catheter according to any one of claims 1 to 5.

7. The second stop element is disengaged from the axial translation mechanism when the screw member slides distally within the handle, the bidirectionally controllable catheter according to claim 6.

8. The second stop element is configured to float with respect to the axial translation mechanism when the screw member slides distally within the handle, the bidirectionally controllable catheter according to any one of claims 1 to 7.

9. The tension member is connected to the handle at a position distal to the proximal end of the first control wire, the bidirectionally controllable catheter according to any one of claims 1 to 8.

10. A pulley wheel is disposed within the handle and the pulley wheel is engaged with the first control wire, the bidirectionally controllable catheter according to any one of claims 1 to 9.

11. The pulley wheel is engaged with the first control wire at a proximal position of the tension member, the bidirectionally controllable catheter according to claim 10.

12. The tension member is an elastic polymer or a coil spring, the bidirectionally controllable catheter according to any one of claims 1 to 11.

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