A bi-directional 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. 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 the distal portion in a second direction opposite the first direction. A tensioning member couples a proximal end of the first steering wire to the handle.

TECHNICAL FIELD

The disclosure relates generally to medical devices and more particularly to mechanisms for steering catheters, sheaths, and/or elongate tubular shafts.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices.

SUMMARY

In a first example, a bi-directional steerable catheter may comprise 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 tensioning member may couple a proximal end of the first steering wire to the handle.

Additionally or alternatively to any example described herein, the axial translation mechanism includes a threaded member slidably disposed within the handle.

Additionally or alternatively to any example described herein, the axial translation mechanism includes a rotatable knob configured to rotate about at least a portion of the handle.

Additionally or alternatively to any example described herein, 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.

Additionally or alternatively to any example described herein, the first steering wire includes a first stop element configured to engage with the axial translation mechanism when the threaded member slides in a distal direction within the handle to apply tension to the first steering wire.

Additionally or alternatively to any example described herein, the first stop element disengages from the axial translation mechanism to release tension on the first steering wire when the threaded member slides in a proximal direction within the handle.

Additionally or alternatively to any example described herein, the first stop element is configured to float relative to the axial translation mechanism when the threaded member slides in a proximal direction within the handle.

Additionally or alternatively to any example described herein, the second steering wire includes a second stop element configured to engage with the axial translation mechanism when the threaded member slides in a proximal direction within the handle.

Additionally or alternatively to any example described herein, the second stop element disengages from the axial translation mechanism when the threaded member slides in a distal direction within the handle.

Additionally or alternatively to any example described herein, the second stop element is configured to float relative to the axial translation mechanism when the threaded member slides in a distal direction within the handle

Additionally or alternatively to any example described herein, the tensioning member is coupled to the handle at a position distal of the proximal end of the first steering wire.

Additionally or alternatively to any example described herein, a bi-directional steerable catheter may comprise 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 the distal portion of the elongate sheath in a second direction opposite the first direction. A tensioning member couples a proximal end of the first steering wire to the handle. A pulley wheel is disposed within the handle, the pulley wheel being engaged with the first steering wire.

Additionally or alternatively to any example described herein, the pulley wheel engages the first steering wire at a position proximal of the tensioning member.

Additionally or alternatively to any example described herein, the tensioning member is an elastic polymer.

Additionally or alternatively to any example described herein, the tensioning member is a coil spring.

Additionally or alternatively to any example described herein, a bi-directional steerable catheter may comprise 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 axial translation mechanism includes a first threaded member and a first carriage member operatively engaged with the first threaded member, the first carriage member being configured to engage the first steering wire to bend a distal portion of the elongate sheath in a first direction. The axial translation mechanism includes a second threaded member and a second carriage member operatively engaged with the second threaded member, the second carriage member being configured to engage the second steering wire to bend the 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, wherein rotation of the rotatable knob causes rotation of the first threaded member and the second threaded member.

Additionally or alternatively to any example described herein, the first threaded member is laterally offset from the second threaded member relative to the central longitudinal axis of the elongate sheath.

Additionally or alternatively to any example described herein, the first threaded member is coaxially aligned with the second threaded member.

Additionally or alternatively to any example described herein, the first carriage member and the second carriage member are configured to concurrently translate axially within the handle in opposite directions.

Additionally or alternatively to any example described herein, the first steering wire includes a first stop element engaged with the first carriage member such that moving the first carriage member in a proximal direction applies tension to the first steering wire, and the second steering wire includes a second stop element engaged with the second carriage member such that moving the second carriage member in the proximal direction applies tension to the second steering wire.

The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate 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 may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the disclosure. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.

The recitation of numerical ranges 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).

Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as “upstream”, “downstream”, “inflow”, and “outflow” refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Still other relative terms, such as “axial”, “circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.

The terms “extent” and/or “maximum extent” may be understood to mean a greatest measurement of a stated or identified dimension, while the term “minimum extent” may be understood to mean a smallest measurement of a stated or identified dimension. For example, “outer extent” may be understood to mean a maximum outer dimension, “radial extent” may be understood to mean a maximum radial dimension, “longitudinal extent” may be understood to mean a maximum longitudinal dimension, etc. Each instance of an “extent” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an “extent” or “maximum extent” may be considered a greatest possible dimension measured according to the intended usage. Alternatively, a “minimum extent” may be considered a smallest possible dimension measured according to the intended usage. In some instances, an “extent” may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently—such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

In some medical procedures, delivery and/or access sheaths may be routed percutaneously into a body cavity, lumen, and/or treatment site. Navigation through patient vasculature and/or organs may include steering through tortuous anatomy and/or directing a distal end of the delivery and/or access sheath into a body cavity, lumen, and/or treatment site. Examples of medical devices suitable for use in medical procedures, such as but not limited to left atrial appendage closure, aortic valve replacement, mitral valve replacement, septal defect repair, etc., are described herein. Existing medical devices may have certain advantages and/or disadvantages. There is an ongoing need for alternative steerable medical devices for delivering medical implants and/or conducting other treatment procedures.

FIG. 1illustrates selected aspects of a bi-directional steerable catheter100. In some embodiments, the bi-directional steerable catheter100may 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 bi-directional steerable catheter100may take the form of other suitable guiding, diagnosing, or treating devices (including endoscopic instruments, laparoscopic instruments, etc., and the like) and it may be suitable for use at various locations and/or body lumens within a patient.

The bi-directional steerable catheter100may include a handle110and an elongate sheath140extending distally from the handle110. In some embodiments, the bi-directional steerable catheter100and/or the handle110may 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 handle110may include a handle housing112. The elongate sheath140may extend into and/or through a distal opening in the handle housing112. In at least some embodiments, a proximal end of the elongate sheath140may be fixedly attached to and/or inside of the handle housing112. In some embodiments, a proximal portion of the elongate sheath140may include a key element configured to non-rotatably engage one or more lock elements fixedly attached to an inner surface of the handle housing112proximal a distal end of the handle housing112. In some embodiments, the key element may be bonded to an outer surface of the elongate sheath140. In some embodiments, the key element may be integrally formed with the elongate sheath140. In some embodiments, the key element may be welded (e.g., heat weld, sonic weld, vibration weld, etc.) to elongate sheath140. In some embodiments, the key element may be melted together with the elongate sheath140such that material of the key element is co-mingled with material of the elongate sheath140at a molecular level. In some embodiments, the handle housing112may include one or more lock elements fixedly attached to and/or integrally formed with the inner surface of the handle housing112. In some embodiments, the one or more lock elements may be formed as ribs or other structural support members configured to increase the rigidity of the handle housing and permit torque transfer between the distal end of the handle housing112and the elongate sheath140. In some embodiments, the elongate sheath140may have a normal or relaxed configuration. The elongate sheath140may be self-biased toward, and/or in the absence of any outside forces may return to, the normal or relaxed configuration. Some suitable but non-limiting materials for the handle110and/or the handle housing112are described below.

In some embodiments, the elongate sheath140may include a soft and/or atraumatic distal tip142. In some embodiments, the elongate sheath140may include a distal portion144having a first curve146and a second curve148, such that the elongate sheath140has a preset double curve, in the normal or relaxed configuration. In some embodiments, the first curve146may be preset to curve upwards, as viewed from the side. Other configurations are also contemplated. In some embodiments, the second curve148may be preset to curve to the left, as viewed proximally to distally along the elongate sheath140. Other configurations are also contemplated. In some embodiments, the distal portion144and/or the first curve146may be configured to bend or deflect in a first direction, wherein the distal tip142is bent and/or moved towards and/or closer to the handle110, toward and/or to a deflected configuration, as shown inFIG. 1. In some embodiments, the distal portion144and/or the first curve146may be configured to bend or deflect in a second direction opposite the first direction, wherein the distal tip142is bent and/or moved away from and/or farther from the handle110, toward and/or to a straightened configuration, as shown inFIG. 1. In some embodiments, the elongate sheath140may have only a single curve in the normal or relaxed configuration. In some embodiments, the elongate sheath140may be substantially straight in the normal or relaxed configuration. Other configurations, including combinations of those described herein, are also contemplated.

FIGS. 2 and 3illustrate selected features of the bi-directional steerable catheter100. In the view shown, a portion of the handle housing112has been removed to show internal components of the handle110. In some embodiments, the handle110may include an axial translation mechanism120. In some embodiments, the axial translation mechanism120may include a threaded member122slidably disposed within the handle110and/or the handle housing112. In some embodiments, axial translation mechanism120may include a rotatable knob124. In some embodiments, the rotatable knob124may be disposed about and/or may be configured to rotate about, and/or relative to, at least a portion of the handle110and/or the handle housing112. In some embodiments, the rotatable knob124may be configured to engage the threaded member122such that rotation of the rotatable knob124relative to the handle110and/or the handle housing112causes axial translation of the threaded member122proximally and/or distally within the handle110and/or the handle housing112. In some embodiments, rotation of the rotatable knob124in a clockwise direction, as viewed along the bi-directional steerable catheter100proximally to distally, may cause axial translation of the threaded member122distally within the handle110and/or the handle housing112. In some embodiments, rotation of the rotatable knob124in a counterclockwise direction, as viewed along the bi-directional steerable catheter100proximally to distally, may cause axial translation of the threaded member122proximally within the handle110and/or the handle housing112. In some embodiments, the reverse and/or opposite configuration may be used, wherein clockwise rotation of the rotatable knob124moves the threaded member122proximally and counterclockwise rotation of the rotatable knob124moves the threaded member122distally. The orientation of the internal and external threads on the rotatable knob124and the threaded member122, respectively, determine which direction of rotation is tied to which direction of axial translation. Some suitable but non-limiting materials for the axial translation mechanism120, the threaded member122, and/or the rotatable knob124are described below.

A first steering wire130may extend through the elongate sheath140from the handle110and/or the handle housing112to a distal pull ring150(e.g.,FIG. 4). A second steering wire132may extend through the elongate sheath140from the handle110and/or the handle housing112to the distal pull ring150(e.g.,FIG. 4). The second steering wire132may be disposed on an opposite side of the elongate sheath140from the first steering wire130relative to a central longitudinal axis of the elongate sheath140. Tension may be applied to the first steering wire130and/or the second steering wire132as described herein to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140(e.g.,FIG. 1). The first steering wire130may be configured to engage the axial translation mechanism120and/or the threaded member122to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140in the first direction toward the handle110and/or the handle housing112, toward and/or to the deflected configuration (e.g.,FIG. 1). The second steering wire132may be configured to engage the axial translation mechanism120and/or the threaded member122to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140in the second direction opposite the first direction and away from the handle110and/or the handle housing112, toward and/or to the straightened configuration (e.g.,FIG. 1).

In some embodiments, the bi-directional steerable catheter100may include a pulley wheel160disposed within the handle110and/or the handle housing112. The pulley wheel160may be engaged with the first steering wire130via a circumferential channel extending around the pulley wheel160. In some embodiments, the pulley wheel160may engage the first steering wire130at a position proximate a distal end of the threaded member122. In some embodiments, the pulley wheel160may engage the first steering wire130at a position proximal of a distal end of the threaded member122. In some embodiments, the bi-directional steerable catheter100may include a tensioning member170. The tensioning member170may couple a first end (e.g., a proximal end) of the first steering wire130to the handle110and/or to the handle housing112. In at least some embodiments, the proximal end of the first steering wire130may be fixedly coupled to the handle110and/or the handle housing112by the tensioning member170. In some embodiments, the pulley wheel160may engage the first steering wire130at a position proximal of the tensioning member170. In some embodiments, the tensioning member170may be coupled to the handle110and/or the handle housing112at a position distal of the proximal end of the first steering wire130. In some embodiments, the tensioning member170may be an elastic polymer, as shown inFIG. 2. In another example, the tensioning member170may be a coil spring, as shown inFIG. 3. Other configurations are also contemplated. As will be apparent, the tensioning member170may be configured to apply a small, non-biasing amount of tension to the first steering wire130when the distal portion144and/or the first curve146of the elongate sheath140is disposed in the normal or relaxed configuration and/or when the distal portion144and/or the first curve146of the elongate sheath140is bent and/or deflected in the second direction, toward and/or to the straightened configuration. The purpose of the tensioning member170is to prevent the first steering wire130from disengaging from the pulley wheel160when there is no tension being applied to the first steering wire130by the axial translation mechanism120and/or the threaded member122(e.g., in the normal or relaxed configuration, or toward and/or in the straightened configuration) by holding the first steering wire130taught around the pulley wheel160. Some suitable but non-limiting materials for the pulley wheel160and/or the tensioning member170are described below.

In addition or alternatively, in some embodiments, the bi-directional steerable catheter100may include one or more ribs, projections, bosses, or posts extending transversely within the handle housing112between opposing walls and/or opposite sides of the handle housing112. In some embodiments, the one or more ribs, projections, bosses, or posts may be disposed within the handle housing112at positions configured to approximate the diameter and/or the perimeter of the pulley wheel160. In some embodiments, the one or more ribs, projections, bosses, or posts may replace the pulley wheel160. In some embodiments, the one or more ribs, projections, bosses, or posts may be provided in addition to the pulley wheel160. In some embodiments, the one or more ribs, projections, bosses, or posts may extend completely across an interior of the handle housing112from one side of the handle housing112to an opposing side of the handle interior112. In some embodiments, the first steering wire130may be routed around and/or may slide past the one or more ribs, projections, bosses, or posts in a manner similar to the first steering wire130extending around the pulley wheel160, such that the one or more ribs, projections, bosses, or posts may serve as guides for the first steering wire130and prevent loss of motion.

The threaded member122may include a first catch126extending transversely from the threaded member122in a first lateral direction. The first steering wire130may extend and/or pass through the first catch126. The first steering wire130may include a first stop element134configured to engage with the axial translation mechanism120and/or the first catch126of the threaded member122when the threaded member122slides in a distal direction within the handle110and/or the handle housing112to apply tension to the first steering wire130, as seen inFIG. 2. The tension applied by the axial translation mechanism120and/or the threaded member122may be sufficient to overcome the self-bias of the elongate sheath140toward the normal or relaxed configuration and bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140in the first direction.

The threaded member122may include a second catch128extending transversely from the threaded member122in a second lateral direction opposite the first lateral direction. The second steering wire132may extend and/or pass through the second catch128. The second steering wire132may include a second stop element136configured to engage with the axial translation mechanism120and/or the second catch128of the threaded member122when the threaded member122slides in a proximal direction within the handle110and/or the handle housing112to apply tension to the second steering wire132, as seen inFIG. 3. The tension applied by the axial translation mechanism120and/or the threaded member122may be sufficient to overcome the self-bias of the elongate sheath140toward the normal or relaxed configuration and bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140in the second direction.

The pulley wheel160permits the threaded member122to apply tension to both the first steering wire130and the second steering wire132, depending upon which direction the threaded member122is moving. Tension applied to the first steering wire130and the second steering wire132causes bending and/or deflection of the distal portion144and/or the first curve146of the elongate sheath140away from the normal or relaxed configuration. Since both steering wires extend proximally from the distal pull ring150, the pulley wheel160is needed to reverse the direction of the first steering wire130relative to the second steering wire132within the handle110and/or the handle housing112such that the threaded member122is able to selectively apply tension to both the first steering wire130and the second steering wire132by moving in opposite directions. In one or more alternative configurations, the handle110and/or the handle housing112may include an internal rib, an internal protrusion, or other features disposed therein, in place of the pulley wheel160, around which the first steering wire130may extend and reverse direction to function as described herein.

When the threaded member122is disposed in a central position, the distal portion144and/or the first curve146of the elongate sheath140may be disposed in the normal or relaxed configuration. When the threaded member122is disposed in the central position, substantially no tension is being applied to the first steering wire130and/or the second steering wire132. As the threaded member122is axially translated proximally and/or distally within the handle110and/or the handle housing112, the threaded member122of the axial translation mechanism120may engage with the first steering wire130and/or the second steering wire132to apply tension thereto to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140as described herein. Additionally, when the threaded member122is disposed in the central position, the first catch126may be engaged with the first stop element134but tension is not being applied to the first steering wire130, and the second catch128may be engaged with the second stop element136but tension is not being applied to the second steering wire132. As such, the central position of the threaded member122may be tension-neutral with respect to the first steering wire130and the second steering wire132.

When the threaded member122is moved from the central position toward and/or until disposed in a proximal position, tension may be applied to the second steering wire132and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the second direction away from the handle110and/or the handle housing112, or toward and/or to the straightened configuration. In moving the threaded member122proximally within the handle110and/or the handle housing112from the central position, the second catch128engages the second stop element136and thereafter translates the second stop element136proximally, thereby applying tension to the second steering wire132, as seen inFIG. 3. The first stop element134may disengage from the axial translation mechanism120, the threaded member122, and/or the first catch126to release tension on the first steering wire130when the threaded member122slides in the proximal direction within the handle110and/or the handle housing112. Accordingly, when the threaded member122is moved proximally from the central position, the first catch126may be disengaged from the first stop element134and the first catch126may slide proximally along and/or over the first steering wire130. The first stop element134may be configured to float relative to (e.g., the first stop element134may not be directly fixed to) the axial translation mechanism120, the threaded member122, and/or the first catch126when the threaded member122slides in the proximal direction within the handle110and/or the handle housing112. As such, slack would form in the first steering wire130, which would allow the first steering wire130to disengage from the pulley wheel160, except for the tension applied by the tensioning member170. The tensioning member170holds the first steering wire130taught around the pulley wheel160while no tension is being applied to the first steering wire130by the threaded member122and/or the first catch126. The tensioning member170merely absorbs any slack that would be formed in the first steering wire130due to the first catch126being disengaged from the first stop element134and prevents the first steering wire130from disengaging from the pulley wheel160. This feature may be seen in the configuration shown inFIG. 3, for example.

When the threaded member122is moved from the central position toward and/or until disposed in a distal position, tension may be applied to the first steering wire130and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the first direction toward the handle110and/or the handle housing112, or toward and/or to the deflected configuration. In moving the threaded member122distally within the handle110and/or the handle housing112from the central position, the first catch126engages the first stop element134and thereafter translates the first stop element134distally, thereby applying tension to the first steering wire130, as seen inFIG. 2. The second stop element136may disengage from the axial translation mechanism120, the threaded member122, and/or the second catch128to release tension on the second steering wire132when the threaded member122slides in the distal direction within the handle110and/or the handle housing112. Accordingly, when the threaded member122is moved distally from the central position, the second catch128may be disengaged from the second stop element136and the second catch128may slide distally along and/or over the second steering wire132. The second stop element136may be configured to float relative to (e.g., the second stop element136may not be directly fixed to) the axial translation mechanism120, the threaded member122, and/or the second catch128when the threaded member122slides in the distal direction within the handle110and/or the handle housing112. As such, slack forms in the second steering wire132, as may be seen in the configuration shown inFIG. 2, due to the second catch128being disengaged from the second stop element136. As the threaded member122is translated distally from the proximal position and/or the central position, the first catch126engages the first stop element134and the first steering wire130is thereafter pulled around the pulley wheel160and tension applied by the tensioning member170is relieved as tension is instead applied to the first steering wire130by the first catch126and/or the threaded member122.FIG. 4illustrates aspects of an example configuration for the elongate sheath140. In some embodiments, the elongate sheath140may include the soft and/or atraumatic distal tip142. In some embodiments, the elongate sheath140may include the distal portion144having the first curve146and the second curve148, such that the elongate sheath140has a preset double curve, in the normal or relaxed configuration. In some embodiments, the first curve146may be preset to curve upwards, as viewed from the side. Other configurations are also contemplated. In some embodiments, the second curve148may be preset to curve to the left, as viewed proximally to distally along the elongate sheath140. Other configurations are also contemplated.

In some embodiments, the elongate sheath140may include a wall141defining a central lumen143extending from a proximal end to the distal tip142along the central longitudinal axis of the elongate sheath140. In at least some embodiments, the central lumen143may be coaxial with the central longitudinal axis of the elongate sheath140. In some embodiments, the central lumen143may be a guidewire lumen. In some embodiments, the central lumen143may be a device lumen used to delivery a medical device or implant. In some embodiments, the central lumen143may have multiple uses. The elongate sheath140may include a plurality of steering wire lumens145extending and/or disposed within the wall141. In some embodiments, the plurality of steering wire lumens145may include a first steering wire lumen and a second steering wire lumen. In some embodiments, the plurality of steering wire lumens145may include more than two steering wire lumens. In some embodiments, the plurality of steering wire lumens145may be oriented substantially parallel to the central lumen143and/or the central longitudinal axis of the elongate sheath140. In some embodiments, the plurality of steering wire lumens145may be disposed opposite each other and/or on opposite sides of the elongate sheath140relative to the central lumen143and/or the central longitudinal axis of the elongate sheath140. Other configurations are also contemplated.

As discussed herein, a distal pull ring150may be disposed within the distal portion144of the elongate sheath140. In some embodiments, the distal pull ring150may be disposed proximal to the second curve148and/or the distal tip142. In at least some embodiments, the distal pull ring150may be disposed proximate a distal end of the first curve146. In some embodiments, the distal pull ring150may be embedded within the wall141of the elongate sheath140. In some embodiments, the distal pull ring150may be secured, bonded, and/or fixedly attached to an inner surface of the wall141of the elongate sheath140. Other configurations are also contemplated. Some suitable but non-limiting materials for the distal pull ring150are described below.

The first steering wire130and the second steering wire132may each be slidably disposed within the plurality of steering wire lumens145. In one example, the first steering wire130may be slidably disposed within the first steering wire lumen and the second steering wire132may be disposed within the second steering wire lumen. The first steering wire130and the second steering wire132may be fixedly attached (e.g., bonded, welded, etc.) to the distal pull ring150. For example, a distal end of the first steering wire130may be fixedly attached to the distal pull ring150and a distal end of the second steering wire132may be fixedly attached to the distal pull ring150at a position opposite the distal end of the first steering wire130relative to the central longitudinal axis of the elongate sheath140. Some suitable but non-limiting materials for the first steering wire130and the second steering wire132are described below.

In some embodiments, the elongate sheath140may be sized in accordance with its intended use. For example, the elongate sheath140can have a length that is in the range of about 50 to about 200 centimeters, about 75 to about 175 centimeters, or about 100 to about 150 centimeters. Other lengths are also contemplated. It is further contemplated that the outer diameter of the elongate sheath140may vary based on the use or application. In some examples, the outer diameter of the elongate sheath140may be about 2 millimeters (mm), about 3 mm (or 9 French), about 3.5 mm, about 4 mm (or 12 French), about 4.5 mm, about 5 mm (or 15 French), about 5.33 mm, about 5.5 mm, about 5.66 mm (or 17 French), about 6 mm, about 6.5 mm, about 7 mm (or 21 French), about 8 mm, or other suitable sizes. In some embodiments, the outer diameter of the elongate sheath140may be a maximum of 5.66 mm (17 French), and is preferably smaller than 5.66 mm (17 French). Other configurations are also contemplated. Some suitable but non-limiting materials for the elongate sheath140are described below.

FIGS. 5 and 6illustrate the relationship between certain features of the bi-directional steerable catheter100in the deflected and straightened configurations. As seen inFIG. 5, clockwise rotation of the rotatable knob124, as viewed proximally to distally, has moved the threaded member122distally within the handle110and/or the handle housing112, thereby applying tension to the first steering wire130and bending or deflecting the distal portion144and/or the first curve146of the elongate sheath140toward the handle110and/or the handle housing112, or toward and/or to the deflected configuration. As seen inFIG. 6, counterclockwise rotation of the rotatable knob124, as viewed proximally to distally, has moved the threaded member122proximally within the handle110and/or the handle housing112, thereby applying tension to the second steering wire132and bending or deflecting the distal portion144and/or the first curve146of the elongate sheath140away from the handle110and/or the handle housing112, or toward and/or to the straightened configuration. As discussed herein, other configurations are also contemplated.

FIGS. 7-9illustrate selected features of an alternative configuration for a handle210of the bi-directional steerable catheter200. Similar to above, the bi-directional steerable catheter200may include the handle210and an elongate sheath140extending distally from the handle210. In some embodiments, the bi-directional steerable catheter200and/or the handle210may 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 handle210may include a handle housing212. The elongate sheath140may extend into and/or through a distal opening in the handle housing212. In at least some embodiments, a proximal end of the elongate sheath140may be fixedly attached to and/or inside of the handle housing212. In some embodiments, the elongate sheath140may have a normal or relaxed configuration. The elongate sheath140may be self-biased toward, and/or in the absence of any outside forces may return to, the normal or relaxed configuration. Some suitable but non-limiting materials for the handle210and/or the handle housing212are described below.

In the view shown, a portion of the handle housing212has been removed to show internal components of the handle210. In some embodiments, the handle210may include an axial translation mechanism220. In some embodiments, the axial translation mechanism220may include a first threaded member222and a first carriage member225disposed within the handle210and/or the handle housing212. The first carriage member225may be operatively engaged with the first threaded member222. In at least some embodiments, the first threaded member222may include external threads configured to engage internal threads formed in and/or on the first carriage member225. In some embodiments, the axial translation mechanism220may include a second threaded member223and a second carriage member227disposed within the handle210and/or the handle housing212. The second carriage member227may be operatively engaged with the second threaded member223. In at least some embodiments, the second threaded member223may include external threads configured to engage internal threads formed in and/or on the second carriage member227. The first threaded member222and the first carriage member225may be laterally offset from the second threaded member223and the second carriage member227within the handle210and/or the handle housing212relative to the central longitudinal axis of the elongate sheath140.

In some embodiments, axial translation mechanism220may include a rotatable knob224. In some embodiments, the rotatable knob224may be disposed about and/or may be configured to rotate about, and/or relative to, at least a portion of the handle210and/or the handle housing212. In some embodiments, the rotatable knob224may be configured to engage the first threaded member222and the second threaded member223such that rotation of the rotatable knob224relative to the handle210and/or the handle housing212causes rotation of the first threaded member222and the second threaded member223within the handle210and/or the handle housing212.

In some embodiments, rotation of the rotatable knob224may cause axial translation of the first carriage member225along the first threaded member222within the handle210and/or the handle housing212. In some embodiments, rotation of the rotatable knob224may cause axial translation of the second carriage member227along the second threaded member223within the handle210and/or the handle housing212. The first carriage member225and the second carriage member227may be configured to concurrently translate axially within the handle210and/or the handle housing212in opposite directions. For example, rotation of the rotatable knob224that causes distal translation of the first carriage member225concurrently causes proximal translation of the second carriage member227. Similarly, rotation of the rotatable knob224that causes distal translation of the second carriage member227concurrently causes proximal translation of the first carriage member225. The orientation of the internal and external threads on the first threaded member222and the first carriage member225, as well as the second threaded member223and the second carriage member227, determine which direction of rotation is tied to which direction of axial translation. In at least some embodiments, the external threads on the first threaded member222and the external threads on the second threaded member223may be oriented in opposite directions so as to drive the first carriage member225and the second carriage member227, respectively, in opposite directions from each other. Some suitable but non-limiting materials for the axial translation mechanism220, the first threaded member222, the second threaded member223, the rotatable knob224, the first carriage member225, and the second carriage member227are described below.

A first steering wire130may extend through the elongate sheath140from the handle210and/or the handle housing212to the distal pull ring150(e.g.,FIG. 4). A second steering wire132may extend through the elongate sheath140from the handle210and/or the handle housing212to the distal pull ring150(e.g.,FIG. 4). The second steering wire132may be disposed on an opposite side of the elongate sheath140from the first steering wire130relative to a central longitudinal axis of the elongate sheath140. Tension may be applied to the first steering wire130and/or the second steering wire132as described herein to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140(e.g.,FIG. 1). The first steering wire130may include a first stop element134engaged with the axial translation mechanism220and/or the first carriage member225such that moving the first carriage member225in a proximal direction, as shown inFIG. 8, bends and/or deflects the distal portion144and/or the first curve146of the elongate sheath140in the first direction toward the handle210and/or the handle housing212, toward and/or to the deflected configuration (e.g.,FIGS. 1, 5). The second steering wire132may include a second stop element136engaged with the axial translation mechanism220and/or the second carriage member227such that moving the second carriage member227in the proximal direction, as shown inFIG. 9, bends and/or deflects the distal portion144and/or the first curve146of the elongate sheath140in the second direction opposite the first direction and away from the handle210and/or the handle housing212, toward and/or to the straightened configuration (e.g.,FIGS. 1, 6).

When the first carriage member225and the second carriage member227are disposed in a central position (e.g.,FIG. 7) along the first threaded member222and the second threaded member223, respectively, the distal portion144and/or the first curve146of the elongate sheath140may be disposed in the normal or relaxed configuration. When the first carriage member225and the second carriage member227are disposed in the central position along the first threaded member222and the second threaded member223, respectively, substantially no tension is being applied to the first steering wire130and/or the second steering wire132. As the first carriage member225and the second carriage member227are axially translated proximally and/or distally within the handle210and/or the handle housing212, the first carriage member225and the second carriage member227of the axial translation mechanism220may engage with the first steering wire130and/or the second steering wire132to apply tension thereto to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140as described herein. Additionally, when the first carriage member225and the second carriage member227are disposed in the central position, the first carriage member225may be engaged with the first stop element134but tension is not being applied to the first steering wire130, and the second carriage member227may be engaged with the second stop element136but tension is not being applied to the second steering wire132. As such, the central position of the first carriage member225and the second carriage member227may be tension-neutral with respect to the first steering wire130and the second steering wire132.

When the first carriage member225is moved from the central position toward and/or until disposed in a proximal position (e.g.,FIG. 8), tension may be applied to the first steering wire130and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the first direction toward the handle210and/or the handle housing212, or toward and/or to the deflected configuration (e.g.,FIGS. 1, 5). In moving the first carriage member225proximally within the handle210and/or the handle housing212from the central position, the first carriage member225engages the first stop element134and thereafter translates the first stop element134proximally, thereby applying tension to the first steering wire130, as seen inFIG. 8. The second carriage member227and the second stop element136may translate distally to release tension on the second steering wire132when the first carriage member225slides in the proximal direction within the handle210and/or the handle housing212.

When the second carriage member227is moved from the central position toward and/or until disposed in a proximal position (e.g.,FIG. 9), tension may be applied to the second steering wire132and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the second direction away from the handle210and/or the handle housing212, or toward and/or to the straightened configuration (e.g.,FIGS. 1, 6). In moving the second carriage member227proximally within the handle210and/or the handle housing212from the central position, the second carriage member227engages the second stop element136and thereafter translates the second stop element136proximally, thereby applying tension to the second steering wire132, as seen inFIG. 9. The first carriage member225and the first stop element134may translate distally to release tension on the first steering wire130when the second carriage member227slides in the proximal direction within the handle210and/or the handle housing212.

FIGS. 10-12illustrate selected features of an alternative configuration for a handle310of the bi-directional steerable catheter300. Similar to above, the bi-directional steerable catheter300may include the handle310and an elongate sheath140extending distally from the handle310. In some embodiments, the bi-directional steerable catheter300and/or the handle310may 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 handle310may include a handle housing312. The elongate sheath140may extend into and/or through a distal opening in the handle housing312. In at least some embodiments, a proximal end of the elongate sheath140may be fixedly attached to and/or inside of the handle housing312. In some embodiments, the elongate sheath140may have a normal or relaxed configuration. The elongate sheath140may be self-biased toward, and/or in the absence of any outside forces may return to, the normal or relaxed configuration. Some suitable but non-limiting materials for the handle310and/or the handle housing312are described below.

In the view shown, a portion of the handle housing312has been removed to show internal components of the handle310. In some embodiments, the handle310may include an axial translation mechanism320. In some embodiments, the axial translation mechanism320may include a first threaded member322and a first carriage member325disposed within the handle310and/or the handle housing312. The first carriage member325may be operatively engaged with the first threaded member322. In at least some embodiments, the first threaded member322may include external threads configured to engage internal threads formed in and/or on the first carriage member325. In some embodiments, the axial translation mechanism320may include a second threaded member323and a second carriage member327disposed within the handle310and/or the handle housing312. The second carriage member327may be operatively engaged with the second threaded member323. In at least some embodiments, the second threaded member323may include external threads configured to engage internal threads formed in and/or on the second carriage member327. In some embodiments, the first threaded member322and the first carriage member325may be coaxially aligned with the second threaded member323and the second carriage member327within the handle310and/or the handle housing312. In some embodiments, the first threaded member322and the second threaded member323may be formed as beveled gears, planetary gears, and the like.

In some embodiments, axial translation mechanism320may include a rotatable knob324. In some embodiments, the rotatable knob324may be disposed about and/or may be configured to rotate about, and/or relative to, at least a portion of the handle310and/or the handle housing312. In some embodiments, the rotatable knob324may be configured to engage the first threaded member322and the second threaded member323such that rotation of the rotatable knob324relative to the handle310and/or the handle housing312causes rotation of the first threaded member322and the second threaded member323within the handle310and/or the handle housing312. In some embodiments, the first threaded member322and the second threaded member323may be fixedly secured together and/or relative to each other such that the first threaded member322and the second threaded member323both rotate in the same direction and/or as a single monolithic structure.

In some embodiments, rotation of the rotatable knob324may cause axial translation of the first carriage member325along the first threaded member322within the handle310and/or the handle housing312. In some embodiments, rotation of the rotatable knob324may cause axial translation of the second carriage member327along the second threaded member323within the handle310and/or the handle housing312. The first carriage member325and the second carriage member327may be configured to concurrently translate axially within the handle310and/or the handle housing312in opposite directions. For example, rotation of the rotatable knob324that causes distal translation of the first carriage member325concurrently causes proximal translation of the second carriage member327. Similarly, rotation of the rotatable knob324that causes distal translation of the second carriage member327concurrently causes proximal translation of the first carriage member325. The orientation of the internal and external threads on the first threaded member322and the first carriage member325, as well as the second threaded member323and the second carriage member327, determine which direction of rotation is tied to which direction of axial translation. In at least some embodiments, the external threads on the first threaded member322and the external threads on the second threaded member323may be oriented in opposite directions so as to drive the first carriage member325and the second carriage member327, respectively, in opposite directions from each other. Some suitable but non-limiting materials for the axial translation mechanism320, the first threaded member322, the second threaded member323, the rotatable knob324, the first carriage member325, and the second carriage member327are described below.

A first steering wire130may extend through the elongate sheath140from the handle310and/or the handle housing312to the distal pull ring150(e.g.,FIG. 4). A second steering wire132may extend through the elongate sheath140from the handle310and/or the handle housing312to the distal pull ring150(e.g.,FIG. 4). The second steering wire132may be disposed on an opposite side of the elongate sheath140from the first steering wire130relative to a central longitudinal axis of the elongate sheath140. Tension may be applied to the first steering wire130and/or the second steering wire132as described herein to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140(e.g.,FIG. 1). The first steering wire130may include a first stop element134engaged with the axial translation mechanism320and/or the first carriage member325such that moving the first carriage member325in a proximal direction, as shown inFIG. 11, bends and/or deflects the distal portion144and/or the first curve146of the elongate sheath140in the first direction toward the handle310and/or the handle housing312, toward and/or to the deflected configuration (e.g.,FIGS. 1, 5). The second steering wire132may include a second stop element136engaged with the axial translation mechanism320and/or the second carriage member327such that moving the second carriage member327in the proximal direction, as shown inFIG. 12, bends and/or deflects the distal portion144and/or the first curve146of the elongate sheath140in the second direction opposite the first direction and away from the handle310and/or the handle housing312, toward and/or to the straightened configuration (e.g.,FIGS. 1, 6).

When the first carriage member325and the second carriage member327are disposed in a central position (e.g.,FIG. 10) along the first threaded member322and the second threaded member323, respectively, the distal portion144and/or the first curve146of the elongate sheath140may be disposed in the normal or relaxed configuration. When the first carriage member325and the second carriage member327are disposed in the central position along the first threaded member322and the second threaded member323, respectively, substantially no tension is being applied to the first steering wire130and/or the second steering wire132. As the first carriage member325and the second carriage member327are axially translated proximally and/or distally within the handle310and/or the handle housing312, the first carriage member325and the second carriage member327of the axial translation mechanism320may engage with the first steering wire130and/or the second steering wire132to apply tension thereto to bend and/or deflect the distal portion144and/or the first curve146of the elongate sheath140as described herein. Additionally, when the first carriage member325and the second carriage member327are disposed in the central position, the first carriage member325may be engaged with the first stop element134but tension is not being applied to the first steering wire130, and the second carriage member327may be engaged with the second stop element136but tension is not being applied to the second steering wire132. As such, the central position of the first carriage member325and the second carriage member327may be tension-neutral with respect to the first steering wire130and the second steering wire132.

When the first carriage member325is moved from the central position toward and/or until disposed in a proximal position (e.g.,FIG. 11), tension may be applied to the first steering wire130and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the first direction toward the handle310and/or the handle housing312, or toward and/or to the deflected configuration (e.g.,FIGS. 1, 5). In moving the first carriage member325proximally within the handle310and/or the handle housing312from the central position, the first carriage member325engages the first stop element134and thereafter translates the first stop element134proximally, thereby applying tension to the first steering wire130, as seen inFIG. 11. The second carriage member327and the second stop element136may translate distally to release tension on the second steering wire132when the first carriage member325slides in the proximal direction within the handle310and/or the handle housing312.

When the second carriage member327is moved from the central position toward and/or until disposed in a proximal position (e.g.,FIG. 12), tension may be applied to the second steering wire132and the distal portion144and/or the first curve146of the elongate sheath140may be bent and/or deflected in the second direction away from the handle310and/or the handle housing312, or toward and/or to the straightened configuration (e.g.,FIGS. 1, 6). In moving the second carriage member327proximally within the handle310and/or the handle housing312from the central position, the second carriage member327engages the second stop element136and thereafter translates the second stop element136proximally, thereby applying tension to the second steering wire132, as seen inFIG. 12. The first carriage member325and the first stop element134may translate distally to release tension on the first steering wire130when the second carriage member327slides in the proximal direction within the handle310and/or the handle housing312.

The materials that can be used for the various components of the bi-directional steerable catheter (and/or other systems or components disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the sheath, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the elongate sheath, the handle, the handle housing, the threaded member(s), the carriage member(s), the steering wire(s), etc. and/or elements or components thereof.

In some embodiments, the bi-directional steerable catheter may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.