Abstract: An aspiration catheter includes an elastically deformable distal tip transformable between an orthogonal configuration and an oblique configuration to selectively and controllably appose the tip with thrombus or other matter to be aspirated. A core wire is slidably disposed in a core wire lumen within the catheter and is operably connected to the catheter distal tip. The core wire is controlled from the catheter proximal end to transform the distal tip between orthogonal and oblique configurations.

Abstract: A deflectable medical device incorporates a strut that is configured to reduce or eliminate axial shortening of the deflectable portion of the medical device, for example, the deflectable distal end portion of a catheter or access sheath. The strut may is coaxially disposed in the medical device in the section that is contemplated to undergo the repeated deflection. The strut provides improved column strength and axial restoration. The strut may be stent-like device, an elongate device having opposing ends coupled by a connecting lattice involving a plurality of helical connecting elements or a tube having a plurality of circumferentially-extending slots arranged in longitudinally-extending rows.

Abstract: A system for remotely controlling the positioning within the body of a patient of an elongated medical device optionally having a control handle, comprises a robotic system and a remote controller configured to control the robotic device. The robotic system comprises a handle controller; a sled member coupled to the handle controller, the sled member being configured to position the medical device within the body of the patient; and a sled base configured to advance the sled member towards the body of a patient, the sled bed being coupled to a sterile barrier effective to maintain sterility inside the sled base. A medical device introducer is effective to guide the elongated medical device into a patient's body.

Abstract: The present invention provides a deflectable catheter whose puller member connections are accomplished with minimal, if any, surface deformation which could otherwise accelerate breakage under tension. The catheter includes a molded member that encases an end of a puller member to enable connection of the end to a fixed or movable structure in the control handle without significant surface deformation in the puller member. The molded member is of a thermoplastic material that encases a preformed end of the puller member, which may be a puller wire or a high modulus fiber material. The molded member may be configured as desired, for example, as a screw that is fastened to a structure in the control handle. Alternatively, the preformed end of the puller member, for example, a puller wire, can be directly connected to and jointly encased in the molded member with another preformed end of a second puller member, for example, a high modulus fiber material.

Abstract: An improved steerable catheter with biased, in-plane bi-directional deflection has an elongated catheter body, a deflectable intermediate section having a tubing with at least a first and a second off-axis opposing lumens for puller wires that define a plane of deflection, and a control handle at a proximal end of the catheter body. The deflectable intermediate section includes at least two elongated bias members that extend along the length and lie on a plane perpendicular to the plane of deflection so as to resist flexure outside of the plane of deflection. In a more detailed embodiment, the deflectable intermediate section has an integrated tubular construction that includes an inner layer, a braided mesh surrounding the inner layer and an outer layer, where the bias members can be situated between the inner layer and the braided mesh, or between the braided mesh and the outer layer.

Abstract: A torque-transmitting, variably-flexible, corrugated insertion device includes a hollow body having a proximal end with an entrance for receiving an instrument and a distal end with a tip for protrusion of the instrument. A vacuum-activated device transitions the hollow body between a relatively flexible condition and a relatively stiff condition. A corrugated tube transmits torque from the proximal end toward the distal end. A method for transmitting torque and variably flexing an insertion device for receiving an instrument includes providing a hollow body, transmitting torque along the hollow body with a corrugated tube, applying suction to create a vacuum in the hollow body for placing the hollow body in a relatively stiff condition, and relieving the vacuum for placing the hollow body in a relatively flexible condition.

Abstract: A deflectable interstitial ablation device includes an elongated housing, an electrode mounted within the elongated housing, a driver coupled to the electrode, an imaging device integrally mounted within the elongated housing and a deflection system disposed within the elongated housing. The elongated housing has a proximal end, a distal end, and a deflectable segment. The electrode is deployable from a first position within the elongated housing to a second position a predetermined distance beyond the distal end of the elongated housing. The electrode further has a flexible portion capable of deflecting with the deflectable segment of the elongated housing, and can be deployed by the driver with a sufficient force such that penetration of the urethral wall occurs in a single motion. The imaging device further has a flexible portion capable of deflecting with the deflectable segment of the elongated housing.

Abstract: An airway implant device for maintaining and/or creating an opening in air passageways is disclosed. Methods of using the device are also disclosed.

Abstract: A steerable kink resistant access device is provided having an elongated body and a steerable portion; methods for manufacturing the kink resistant device are also provided. The access sheath has an outside diameter sufficiently small so that it may be inserted into a body cavity or conduit. The access sheath typically has two internal lumen, a first lumen sized and configured as an access to a surgical site and a second lumen sized and configured to contain a tensioning device that, when acted upon, will deflect the steerable portion. The tensioning device may be directly or remotely attached to an actuation device that operates to control the tensioning and loosening of the tensioning device.

Abstract: A medical instrument assembly and robotic medical system are provided. The medical instrument assembly comprises an intravascular catheter having an elongated flexible shaft, and a drivable mechanism to which the flexible catheter shaft is mounted. The drivable mechanism has an actuating element configured for effecting movement of the catheter within at least one degree-of-freedom. The medical instrument assembly further comprises a receiver to which the drivable mechanism is configured for being removably mated. The receiver is configured for operably coupling a drive unit to the actuating element. The robotic medical system comprises the medical instrument assembly, a user interface configured for generating at least one command, a drive unit coupled to the receiver, and an electric controller configured, in response to the command(s), for directing the drive unit to drive the actuating element via the receiver to effect movement of catheter to the degree(s)-of-freedom.

Abstract: A catheter for use in a patient's heart, especially for mapping a tubular region of the heart, has a catheter body, a deflectable intermediate section and a distal mapping assembly that has a generally circular portion adapted to sit on or in a tubular region of the heart. A control handle of the catheter allows for single-handed manipulation of various control mechanisms that can deflect the intermediate section and contract the mapping assembly by means of a deflection control assembly and a rotational control assembly. The deflection control assembly has a deflection arm and a rocker member. The rotational control assembly has an outer rotational member, an inner rotational member and a cam. A pair of puller members are responsive to the deflection control assembly to bi-directionally deflect the intermediate section. A third puller member is responsive to the rotational control assembly to contract the generally circular portion of the mapping assembly.

Abstract: The invention includes an assembly having a handle for articulating an articulator in an ergonomically improved manner. The handle can be adapted to articulate a distal portion of the articulator when squeezed. The handle can have at least one accessible attachment mechanism useful for reattachably attaching the articulator and the handle during a medical procedure. The invention also includes methods of making and using such a handle.

Abstract: A magnetically navigable catheter includes a sheath having a proximal end and a distal end, and an extension member having a proximal end and a distal end, slidably mounted in the sheath so that the distal end portion of the extension member telescopes from the distal end of the sheath. The distal end portion of the extension member being relatively more flexible than the distal end of the sheath. There may be one or more electrodes on the distal end of the extension member. There is also at least one magnet on the distal end portion of the extension member to allow the distal end of extension member to be oriented by the application of an externally applied magnetic field.

Abstract: A deflectable catheter comprises a catheter body, a tip section, and a control handle for affecting deflection of the tip section. The tip section comprises a flexible tubing having proximal and distal ends and at least two lumens extending therethrough. The proximal end of the tip section is fixedly attached to the distal end of the catheter body. The flexible tubing comprises a plastic core, a metal braid over the core, a plastic skin over the braid, and at least two pieces of plastic tubing in longitudinal arrangement extruded over the plastic skin, wherein the at least two pieces of plastic tubing have different stiffnesses and are arranged with the stiffer plastic being proximal the less stiff plastic. The tip section is made by extruding a plastic core over at least one mandrel and braiding a metal over the plastic core.

Abstract: Steerable medical delivery devices and their methods of use.

Abstract: A medical device shaft for connection with a handle and for insertion within a body includes an elongated, deflectable shaft having a proximal shaft portion, an intermediate shaft portion, and a distal shaft portion. The elongated, deflectable shaft includes a transition in stiffness from the proximal shaft portion to the distal shaft portion. In a preferred implementation, the shaft includes a plurality of slits that extend perpendicular to a longitudinal axis of the shaft. Varying at least one of the number of slits, the location of slits, the frequency of slits, the orientation of the slits, the size of the slits, and the depth of the slits varies the transition of stiffness.

Abstract: A methods using a robotic catheter system to perform a procedure on a patient includes generating a control signal corresponding to movement of a master input device, and moving a plurality of drive elements of an instrument driver in response to the control signal, the drive elements operatively coupled to a corresponding plurality of control elements of an elongate guide instrument, the control elements secured to a distal end of the guide instrument and moveable axially relative to the guide instrument such that movement of the drive elements causes a corresponding movement of the guide instrument distal end.

Abstract: This invention relates to devices for navigating passageways in a body, and in particular, to a steerable catheter that can be used to navigate the tortuous anatomy of a body's vasculature. In one embodiment of the invention the deflectable catheter comprises an inner catheter body having a first strut spine member and a cantilevered second strut tang member. An outer catheter body is cooperatively associated with the second strut tang member and an actuator is cooperatively associated with the first strut spine member. The actuator is slideably engaged within the outer catheter body.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Abstract: A combination aspiration/irrigation and illumination device using optical fibers circumferentially disposed around the aspiration conduit for transmitting illuminating light to a cavity to be aspirated. The ends of the optical fibers being formed at an angle relative to the aspiration conduit so as to direct the illuminating light inward to provide intensified illumination ahead of the aspiration conduit.

Abstract: An instrument having a flexible and elongated body includes at least a lumen and a flex member disposed within the lumen. The flex member may be capable of providing steering control to a first portion of the elongate body while providing load bearing support to a second portion of the elongate body. A pull wire may be disposed within the flex member, and at least a distal portion of the pull wire may be coupled to the elongate body and a proximal portion of the pull wire may be operatively coupled to a control unit. The control unit may be coupled to a proximal portion of the elongate body. In addition, a control member may be operatively coupled to the control unit such that a distal portion of the control member may be positioned near a proximal portion of the flex member. The control member may be configured to support the flex member and control the movement or displacement of the flex member.

Abstract: A drainage catheter hub for use in connection with a drainage catheter to receive and secure a suture therein, wherein the hub includes: (i) a housing having a channel to accommodate the suture therein; (ii) a bistable locking mechanism positioned in the housing and being adapted to provide selective securement of the suture; and (iii) a resilient outer layer utilized in connection with the bistable locking mechanism and coupled to the housing. The bistable locking mechanism is configured to: (i) allow movement of the suture when the bistable locking mechanism is in a first position; and (ii) minimize axial movement of the suture when the bistable locking mechanism is in a second position. The resilient outer layer is adapted to allow a user to actuate the bistable locking mechanism between the first and second positions to selectively secure and release the suture.

Abstract: A RF catheter system includes a catheter with a proximal portion, a distal portion having a distal end and a lumen extending from the proximal portion to the distal portion. Inner and outer coaxially aligned conductors extend within the catheter and are coaxial with the lumen. A deflectable catheter guide is disposed within the catheter lumen and extends proximally within the catheter lumen and terminates distally of the distal end of the catheter to define a biological ablation pathway. A radio-frequency antenna is disposed at the distal portion of the catheter and is in electrical communication with the inner and outer coaxially aligned conductors. The radio-frequency antenna is adaptable to receive and transmit radio-frequency energy for ablating biological tissue along the ablation pathway.

Abstract: The invention provides an articulating mechanism useful, for example, for remote manipulation of various surgical instruments and diagnostic tools within, or to, regions of the body. Movement of segments at the proximal end of the mechanism results in a corresponding, relative movement of segments at the distal end of the mechanism. The proximal and distal segments are connected by a set of cables in such a fashion that each proximal segment forms a discrete pair with a distal segment. This configuration allows each segment pair to move independently of one another and also permits the articulating mechanism to undergo complex movements and adopt complex configurations. The articulating mechanisms may also be combined in such a way to remotely mimic finger movements for manipulation of an object or body tissue.

Abstract: In a device for the intermittent occlusion of the coronary sinus, including a catheter with several lumens and an occlusion device fixed to the catheter and operable through at least one lumen of the catheter, the operating elements of the catheter cooperate with a first axial portion of the catheter for bending the same in said first portion, and with at least one further axial portion of the catheter for bending the same in said at least one further axial portion, and/or for stiffening said axial portions.

Abstract: An injection catheter is provided. The catheter comprises a catheter body comprising a flexible tubing having proximal and distal ends and at least one needle passage extending therethrough. The needle passage has a proximal region having a proximal diameter and a distal region having a distal diameter less than the proximal diameter. A needle control handle is provided at the proximal end of the catheter body. An injection needle extends through the catheter body and needle control handle and has a proximal end within the needle control handle and a distal end within the needle passage. The injection needle is longitudinally slidable within the catheter body so that its distal end can extend beyond the distal end of the catheter body. A needle stop is mounted on a portion of the injection needle that is positioned within the proximal region of the needle passage.

Abstract: A disposable access sheath having a deflectable tip is provided. The access sheath is very flexible and allows a physician or other medical professional to provide diagnostic or therapeutic services to a remote body cavity. The access sheath has a deflectable tip that is able to bend at least 90° or 180° or more. This flexibility allows the physician or medical professional to make a very tight turn to visualize or treat the body cavity being treated. The access sheath may include a visualization system, a working channel, an irrigation channel, or other desirable features. The access sheath may include an interface at the proximal end of the working channel for insertion of an instrument for diagnosis or treatment of a human or mammalian patient.

Abstract: A transformable catheter includes a sheath having a length which is a substantial fraction of the entire length of the transformable catheter and a bore therethrough. A preformed inner catheter having a complex curve formed into the distal end thereof is disposed in the sheath bore. By axially moving the inner catheter with respect to the sheath, various tip shapes may be achieved. At least one wire runs from the proximal end of the sheath to the vicinity of the distal end of the sheath to selectively deflect the distal tip of the sheath as desired by the user to assist in reformation and transformation of the tip of the catheter. By suitable manipulation of the wire and of the inner catheter with respect to the sheath, the shape of the exposed portion of the distal end of the inner catheter may be transformed to any of a variety of shapes.

Abstract: An ablation catheter employing a continuous or nearly continuous flexible electrode arrangement. In one implementation, the flexible electrode include at least one electrode defining a saw tooth pattern. In another implementation, the flexible electrode is arranged in an interlaced pattern. Generally, the flexible electrodes are configured to adapt to the change in shape of the portion of the catheter that the electrode is connected with. Moreover, the flexible electrodes are arranged to provide a continuous or nearly continuous lesion of the target tissue. In some implementations, the flexible electrode may be connected with the catheter in a biased configuration, and as such may assist in changing the shape of a curve in the catheter.

Abstract: A sheath useful for remote steering, guidance and/or manipulation of a flexible instrument, including e.g. an endoscope, received through the sheath.

Abstract: A steerable catheter sheath for use in directing a catheter into a desired position is provided. The sheath includes an elongated member configured to receive the catheter therein. The distal end of the elongated member is steerable in two directions, each direction having a different bent configuration, e.g., a sharp curve in one direction and an open arching curve in the other direction. A resilient structure having different bending properties in each of its lateral sides is carried in the distal portion of the elongated member and causes the asymmetric bending. In one embodiment, the resilient structure includes a hypotube with a plurality of notches and slits in the sides. In another embodiment, the resilient structure is covered in an outer coating having different durometer portions. The sheath is particularly useful for accessing left and right pulmonary veins when a transeptal entry approach is used into the left atrium.

Abstract: A medical device allows movement control of a distal end portion of the medical device and is adapted for one-handed operation. The medical device is capable of omni-directional control of the distal end portion of the device. The device has an elongated member including a deflectable portion at a distal end portion of the elongated member. The device also has a control portion disposed on the elongated member. This control portion can be a handle for one-handed use by an operator of the medical device. The control portion comprises an elastic element and a flexible element. Angular movement of a first portion of the control portion with respect to a second portion of the control portion results in amplification of that angular movement in the deflectable portion of the device.

Abstract: A delivery system for delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly and handle. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes openings in a slotted tube of the delivery sleeve assembly to close, thus causing the delivery sleeve assembly to bend. A stretchable cover is placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the native valve site, the prosthetic valve is deployed by inflating the balloon.

Abstract: In one embodiment, an elongate body with a proximal end and a distal end is disclosed and which is controllable by an operator at the proximal end; in one embodiment, the elongate body is a catheter and the catheter tip is located at the distal end. The body contains numerous magnets along its length, at least one of which is an electromagnet, controllable by means of a current delivered by the operator of the body at the proximal end of the body. The magnets are placed such that a force is created at the distal end of the elongate body. The magnetic forces which control the distal end of the body originate from the controllable magnets placed on the body.

Abstract: This invention relates to devices for navigating passageways in a body, and in particular, to a steerable catheter that can be used to navigate the tortuous anatomy of a body's vasculature. In one embodiment of the invention the deflectable catheter comprises an inner catheter body having a first strut spine member and a cantilevered second strut tang member. An outer catheter body is cooperatively associated with the second strut tang member and an actuator is cooperatively associated with the first strut spine member. The actuator is slideably engaged within the outer catheter body.

Abstract: A medical therapy delivery device that includes a shaft formed by an outer layer and a deflectable tip that includes a tapered portion. A manipulator wire extends through the shaft to adjust deflection of a second portion of the shaft relative to a first portion. The outer layer forms a single shaft lumen having a first lumen portion positioned about a thru lumen tubing and a second lumen portion, offset from and in fluid communication with the first lumen portion, the second lumen portion having a first side wall, a second side wall and a bottom wall extending between the first side wall and the second side wall. The thru lumen tubing, first side wall, the second side wall and the bottom wall position the manipulator wire within the second lumen portion.

Abstract: A catheter shaft includes a wall defining a lumen, a distal segment, and a proximal segment. At least one distal segment deflection wire extends through the proximal segment and terminates in the wall in the distal segment, while at least one proximal segment deflection wire extends through the proximal segment and terminates in the wall in the proximal segment. The proximal and distal segment deflection wires respectively permit the proximal and distal segments of the catheter shaft to deflect independently of each other. The catheter shaft may also include one or more wire reinforcing layers embedded in the wall.

Abstract: A deflectable catheter includes a catheter shaft having a deflectable distal tip. A support member is coupled around a proximal portion of the catheter shaft, and the support member includes a first brake portion extending along at least a portion of the support member. A handle is coupled around the support member. The deflectable catheter includes a carriage moveably coupled along the handle, and the carriage includes a second brake portion sized and shaped to engage with at least a portion of the first brake portion. A flexible element is coupled between the deflectable distal tip and the carriage. A biasing device is adapted to bias the second brake portion into engagement with the first brake portion.

Abstract: A catheter kit including a drainage catheter hub having a rotatable lever handle adapted to secure a suture thread to maintain the anchor configuration of the distal end of the catheter to secure the position of the catheter within the patient's body. The rotatable lever handle has a released position for allowing movement of the suture and a secured position for preventing movement of the suture. A rotatable lever handle adapted to secure the proximal portion of the suture that may otherwise remain loose during the procedure. The rotatable lever handle and associated rotatable barrel can be depressed relative to hub body in a locked configuration to prevent inadvertent rotational movement of the rotatable lever handle and a release slot or release button that can be actuated by the practitioner with a release tool to allow for rotational movement of the rotatable lever handle.

Abstract: A drainage catheter having a weld to secure the distal end of the catheter in an anchor configuration. The suture is welded into a loop at the distal end of the suture to secure the anchor configuration of the distal end of the catheter either directly or by securing the suture to a stylet positioned in the catheter wall. A plurality of drainage bores are positioned on the inside diameter of the anchor loop to provide advantageous draining of fluid into the lumen of the catheter. The drainage catheter includes a stylet and stylet lumen positioned in the sidewall of the catheter approximately 90 degrees from the inside diameter of the catheter tube and drainage allowing the drainage bores on the inside diameter of the drainage catheter to operate without obstruction from the stylet and suture.

Abstract: The present invention relates to a system adapted to position a medical device, such as an ablation catheter, at a location where a pulmonary vein extends from an atrium. The system optimally includes a deflectable catheter and a sheath. An ablation member is disclosed for use with the positioning system, wherein the deflectable catheter and the sheath cooperate so as to facilitate positioning of the ablation member at the location.

Abstract: An apparatus including an elongate body having a lumen extending therethrough and a steering wire, having a distal portion defining a non-circular cross-section, associated with the distal portion of the elongate body.

Abstract: The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Abstract: A delivery apparatus for a stimulating catheter has a conductive wire wound within a reel dispenser. The reel dispenser has a base portion and a rotating portion that are coupled at the axle with the rotating portion rotatable relative to the base portion. The proximal region of the conductive wire is in electrical connection with the axle of the dispenser. A method for delivering a stimulating catheter includes introducing the distal regions of the conductive wire and catheter into a subject, rotating the rotating portion of the reel dispenser relative to the base portion whereby the catheter and conductive wire are advanced into the subject, providing an electrical current to the conductive wire through the axle, and rewinding the rotating portion of the reel dispenser relative to the base portion whereby the conductive wire is retracted in a proximal direction through the catheter.

Abstract: A hydraulically assisted actuator in a handle connects with a catheter having a deflectable distal ablation tip. The hydraulic actuator translates small mechanical movement by a clinician into large travel movements of connected steering cables and increased tension in the ablation tip for greater deflection. The hydraulic system further dampens the return of the ablation tip from a deflected position to an equilibrium position. The hydraulic actuation system is also incorporated into a set of foot pedals.

Abstract: The invention is directed to a multifunctional catheter handle. The handle comprises a handle body and a core mounted within the handle body. A piston is provided having a distal end mounted in the handle body and a proximal end extending outside the handle body, to which a catheter body can be attached. The piston is longitudinally moveable relative to the core and handle body. A first puller wire anchor is fixedly mounted to the core. A cam receiver is mounted in the handle body so that the cam receiver is longitudinally slidable relative to the piston and core. A second puller wire anchor is fixedly mounted to the cam receiver. A generally cylindrical cam is mounted distal to the cam receiver in surrounding relation to the piston and core. Rotation of the cam relative to the piston and core causes longitudinal movement of the cam receiver and second puller wire anchor.

Abstract: A catheter assembly employs an outer catheter with a pre-formed distal end and an open lumen. An inner catheter having an open lumen and a pre-formed distal end is movably disposed within the outer catheter. Relative rotation and extension of the inner and outer catheters provides the distal end of the catheter assembly with an adjustable range of two- and three-dimensional shapes. The inner catheter can include sections of varying stiffness, such that extension of the inner catheter within the outer catheter modifies the shape of the outer catheter's pre-formed distal end. The adjustable shaping of the catheter assembly's distal tip provides an improved system for locating and cannulating cardiac venous structures, particularly the coronary sinus via the right atrium.

Abstract: A shaft of a steerable medical device includes a torque tube that allows the tip of the shaft to be torqued from the proximal end. In one embodiment, the torque tube includes a metal tube having a series of opposing cuts therein to form a number of axially aligned rings that are joined by spacing beams. The cuts are oriented in different directions along the length of the torque tube to allow bending in any direction and effective transfer of rotational torque.

Abstract: A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Abstract: An apparatus including an elongate body having a lumen extending therethrough and a steering wire, having a distal portion defining a non-circular cross-section, associated with the distal portion of the elongate body.