Abstract: A catheter that provides bi-directional steering and allows for deflection sensitivity adjustment includes a catheter body, a deflectable tip section and a control handle, wherein the control handle has a deflection member adapted for user manipulation, a deflection assembly responsive to the deflection member to draw on a tensile puller member for deflecting the tip section, and an adjustment mechanism adapted to adjust sensitivity of the deflection member. The adjustment mechanism also correspondingly adjusts a maximum degree of deflection of the tip section. The deflection assembly includes a rotatable pulley arm and two pulleys, and a deflection sensitivity adjustment mechanism with a cam device that varies a separation distance between the pulleys.

Abstract: A steerable medical device is used to controllably introduce a guidewire or other medical instrument into a body of a patient and direct placement of the guidewire or other medical instrument in the body of the patient. The steerable medical device can include an elongated member, a steering mechanism, and an attachment member. The elongated member extends along a longitudinal axis and comprises a deflectable distal portion that is deflectable off of the longitudinal axis. The steering mechanism is adapted to control longitudinal and rotational movement of the elongated member and to control off-axis deflection of its deflectable portion. The attachment member is removably couplable to another medical device. The attachment member is moveably coupled to the steering mechanism and the elongated member.

Abstract: A flexible highly-articulable dual-catheter device includes an outer catheter and an inner catheter. The outer catheter contains at least one lumen to support advancement and in-situ replacement of the inner catheter. An optional second lumen in the outer catheter enables carriage of a fiber-optic line for vision to aid a clinician to advance the dual-catheter device to the desired location in a body. The inner catheter is a multi-lumen catheter that enables a hypotube and a navigation wire to be passed through two of the lumens. The provision of a multi-segment region placed at the distal end of the hypotube, with each segment of a differing durometer, enables a wide range of articulability of the device. An optional second navigation wire can also be coupled to the distal end of the hypotube to provide additional articulation. Both diagnostic and therapeutic tools can be coupled to the elongated device. Various tips such as RF energy and aspiration tips can be coupled to the dual-catheter device.

Abstract: A method of manufacturing a deflectable electrophysiological catheter includes constructing a shaft having a distal end and at least one lumen. The method further includes inserting a component into the lumen, and processing at least a portion of the distal end to reduce the cross-sectional profile of the lumen to capture/confine the component. A catheter manufactured using this method includes a shaft having at least one lumen. The lumen comprises a longitudinally-extending trough defined by a longitudinally-extending recess, within which a component is disposed, and a longitudinally extending open edge. The lumen further comprises a longitudinally-extending channel defined by a longitudinally-extending cavity and by the open edge of the trough. A planarity wire is disposed within the cavity and is configured to close the open edge of the trough to within a pre-defined tolerance that is less than the size of the component to retain the component in the recess.

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: Disclosed herein are elongate flexible medical devices which are capable of axial elongation through the mechanism of eversion or toposcopic expansion. In general, this may be accomplished by providing a flexible tubular device having a proximal end and a distal end. Retraction of the distal end in a proximal direction through the tubular body inverts the tube upon itself, causing an axial shortening of the overall length of the device. The original length of the device can be restored by coupling a pressurized media to the proximal end of the sleeve. If the distal end of the sleeve is temporarily restricted or closed, the pressurized media causes the distal end of the sleeve to travel distally until the full length of the sleeve has been restored.

Abstract: A catheter for diagnosing or treating the vessels found within a body or body space includes a center strut that is bonded, preferably thermally, along its longitudinal axis with the thermoplastic tubular member within which it is housed. The tubular member preferably has three layers: an inner layer, a braided layer and an outer layer. The composite catheter is made using a process in which two half-cylinder shaped mandrels are placed on each side of the center strut while the strut is heated in order to cause the thermal bonding. The bonded center strut provides in-plane deflection and improved transfer of torque to the tip of the catheter.

Abstract: A catheter with a mechanism for omni-directional deflection of a catheter shaft includes a shaft assembly and a controller. The shaft assembly includes a first tubular component that has a preformed curvilinear distal section, a second, substantially straight tubular component with a main axis and an outer shaft. The first and second components are configured for slidable movement therebetween while preserving common rotation so that when the second component is axially moved in a distal direction, the second component deflects the preformed curvilinear section towards the main axis while orientation of the outer shaft is preserved. The controller is configured to effect relative axial movement between the first and second components as well as to effect rotation of the first and second components (and thus also of the preformed curvilinear distal section) without any rotation of the shaft relative to the handle.

Abstract: A device and method is provided for localized agent delivery through a coronary vessel. In one configuration, the device includes an elongated member having a first and second end with a tip and an aperture positioned near the second end. An injection lumen places the first end of the elongated member in fluid communication with the aperture, permitting fluids such as contrast agent or therapeutic agents to be delivered therebetween. In an exemplary method, the device is tracked through a bend in the coronary anatomy, forcing the tip of the device toward the greater curve and through the vessel wall. The aperture may advanced to the desired location and agents may be delivered through the device into target tissue or space. Other configurations and embodiments of the device and method are presented.

Abstract: Embodiments of the invention provide methods for inserting a non-metallic multi-strand braid through a coil tube. Techniques for bonding one end of a lead line to one end of a multi-strand non-metallic braid are provided. There are also embodiments of steerable instruments described having a plurality of hinged segments; a multi-strand non-metallic braid connected distally to one segment of the plurality of segments and proximally to an actuator; and a steering controller adapted to control the actuator to move the hinged segment using the multi-strand non-metallic braid.

Abstract: A method and device for treating a Chronic Total Occlusion provides a controllable stiffness catheter with a shaft having a stiffness sheath and an access lumen. The device has a stiffness device in a stiff state below a given temperature and in a soft state above the temperature, a temperature-changing device in thermal contact with the stiffness device, the temperature-changing device changing a temperature of the stiffness device below and above the temperature, and a power controller electrically connected to the stiffness device and selectively supplying power to the temperature-changing device to change a stiffness of the stiffness device between the stiff and soft states. A guidewire is moved to a treatment site and the catheter moves along the guidewire up to CTO in its soft state. The catheter stiffens without straightening and, in the stiff state, the catheter or the guidewire is projecting through the CTO.

Abstract: A steerable catheter device which can be steered to locations within the epidural space, as well as methods of use and manufacture are disclosed. The steerable catheter provides a site-specific drug delivery system for accessing the epidural space. The catheter devices includes a steerable wire or a liner extending from a proximal end of the catheter to the catheter's distal end. Forces applied to the wire or the liner cause the distal end to deflect and/or rotate to reach a targeted epidural site.

Abstract: Apparatus is provided for use with a steerable catheter that includes a thumb control adapted to control a deflection of a distal tip of the catheter. The apparatus includes a robot, including an end-effector, adapted to be coupled to the thumb control, and a controller, adapted to drive the end-effector to deflect the distal tip by manipulating the thumb control.

Abstract: A tendon deflection system including a shaft, a plurality of tendons movably disposed within the shaft, and a force-balancing element coupled to the tendons. In a first section, the plurality of tendons are arranged around the shaft at equal angles to each other and at an equal distance from the center of the shaft. The tendons operating in concert with the force-balancing element minimize the moment expressed in the first section. The second section is deflectable and includes at least one tendon, extending from the plurality of tendons in the first section, which is arranged along one side of the shaft such that the bending moment expressed in the second section is greater than the first section.

Abstract: A connectorized ultrasound probe includes a distal section that is configured for insertion into a patient's body and a proximal section configured to interface the distal section with an ultrasound system. The distal section is easily attachable and detachable from the proximal section using at least one set of connectors. When connected, a user-operated actuator located on the proximal section controls the bending of the distal section, and the ultrasound system sends driving signals to and receives return signals from the ultrasound transducer via the proximal section. This arrangement is particularly advantageous for long term monitoring, because the disconnectability of the proximal section makes it possible to leave the distal section in place in the patient for longer periods of time without undue discomfort.

Abstract: A catheter capable of articulating in two and three directions is provided. Articulation at the distal tip of the catheter is facilitated by applying selective tension on a steering wire disposed in a lumen that resides peripheral to a central working lumen. Tension on the steering wire through the peripheral lumen causes the catheter tip to bend while the central working lumen resists compression.

Abstract: A system for manipulating a guide catheter within a patient's nasal passages or sinus cavities includes a guide catheter formed from an elongate flexible member having a lumen passing there through. A wire guide is slidably disposed within the lumen of the guide catheter. The system further includes a steering member fixedly secured to a proximal end of the wire guide and a proximal hub secured to a proximal end of the guide catheter. The system further includes a recessed handle having a first recess for fixedly receiving the proximal hub of the guide catheter and a second recess for receiving the steering member, the second recess being dimensioned to permit axial and rotational movement of the steering member while disposed in the second recess.

Abstract: An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

Abstract: The apparatus of one embodiment of the present invention is comprised of a flexible sheath instrument, a flexible guide instrument, and a tool. The flexible sheath instrument comprises a first instrument base removably coupleable to an instrument driver and defines a sheath instrument working lumen. The flexible guide instrument comprises a second instrument base removably coupleable to the instrument driver and is threaded through the sheath instrument working lumen. The guide instrument also defines a guide instrument working lumen. The tool is threaded through the guide instrument working lumen. For this embodiment of the apparatus, the sheath instrument and guide instrument are independently controllable relative to each other.

Abstract: Methods and apparatuses for manipulating an elongated flexible shaft of a catheter provide ease and reliability of positioning electrodes against or near tissue. Dual-bend flexible distal tips may be used in combination with flat wires. In some embodiments, flat wires which are free to rotate upon initial bending of shaft segments are employed. In some embodiments, one or more transition segments are used to relocate the satellite lumen-to-main lumen transition of pull wires away from a change in shaft stiffness.

Abstract: A steerable elongated medical device that is capable of forming as “s” shaped bend. The devices include an outer tube extending between an outer tube proximal segment and an outer tube distal segment, having an outer tube wall forming an outer tube lumen and first and second elongated outer tube slots through the outer tube wall to the outer tube lumen. The first elongated outer tube slot has a first portion and a second portion and formed between a first outer tube slot proximal end and a first outer tube slot distal end and extending axially along the outer tube distal segment through a first outer tube slot length to define a first cutaway portion of the outer tube.

Abstract: According to an embodiment of the present invention, a steerable elongated medical device includes an outer tube extending between an outer tube proximal segment and an outer tube distal segment, and having an outer tube wall forming an outer tube lumen and an elongated outer tube slot through the outer tube wall to the outer tube lumen. The elongated outer tube slot has a first portion and a second portion and is formed between an outer tube slot proximal end and an outer tube slot distal end and extends axially along the outer tube distal segment through an outer tube slot length to define a cutaway portion of the outer tube. A reinforcing sleeve is positioned within the outer tube lumen and extends between a reinforcing sleeve proximal end and a reinforcing sleeve distal end.

Abstract: A steerable elongated medical device that is capable of forming as “s” shaped bend and having a guidewire tip at its distal end. The devices include an outer tube extending between an outer tube proximal segment and an outer tube distal segment, having an outer tube wall forming an outer tube lumen and first and second elongated outer tube slots through the outer tube wall to the outer tube lumen. The first elongated outer tube slot has a first portion and a second portion and formed between a first outer tube slot proximal end and a first outer tube slot distal end and extending axially along the outer tube distal segment through a first outer tube slot length to define a first cutaway portion of the outer tube.

Abstract: A bi-directional catheter with nearly double the throw in its catheter tip deflection defines a puller wire travel path having a U-turn a pulley which minimizes the offset angle between the puller wire and the longitudinal axis of the control handle while maximizing the travel distance of that puller wire for any given distance traveled by the pulley drawing the puller wire. In particular, the control handle of the catheter which includes a steering assembly having a lever arm carrying a pair of pulleys for drawing corresponding puller wires to deflect the tip section of the catheter. The pulleys are rotatably mounted on opposing portions of the lever arm such that one pulley is moved distally as the other pulley is moved proximally when the lever arm is rotated.

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 hand-holdable steering mechanism is used as part of a medical device such as a catheter or an endoscope to allow movement of a steerable distal portion of the catheter or endoscope. The mechanism can include a housing and an actuation system. The actuation system is adapted for one-handed operation by a user, and it allows the user to achieve 360 degree articulation of the steerable distal portion. The actuation system can include a first actuator and a second actuator where the first and second actuators are movable with respect to each other. The first actuator can be at least partially disposed within the second actuator.

Abstract: A hand-holdable steering mechanism is used as part of a medical device such as a catheter or an endoscope to allow movement of a steerable distal portion of the catheter or endoscope. The mechanism can include a housing, a first actuator, and a second actuator. The first actuator is configured to move the steerable portion along a first plane when the first actuator is moved between first and second positions. The second actuator is configured to move the steerable portion along a second plane different than the first plane when the second actuator is moved between first and second positions.

Abstract: A control handle for a steerable catheter body for navigation of the catheter body through a biological lumen and manipulation at a treatment site. The control handle includes a housing assembly that houses a piston assembly and a resistance adjusting assembly. The resistance adjusting assembly can be adjusted to provide the desired frictional characteristics of the user for control of the resistance between the piston assembly and the housing assembly. In one embodiment, the piston assembly is configured to provide a frictional resistance that varies dynamically to substantially match the restorative force across the range of catheter tip deflection. Other embodiments include a vibrating member that provides tactile feedback to the operator to indicate conditions at the distal end of the catheter, such as contact force.

Abstract: The Access guide catheter provides passage for therapeutic and diagnostic devices through vessels or conduits that return substantially in a direction from which they originated. One application is for delivery of therapeutic catheters to the carotid or cerebral arteries via access from the radial or brachial artery. The guide catheter enters the aorta from one of the great vessels, forms a closed loop in the aorta, and is directed back into a great vessel in an opposed direction. The distal portion of the guide catheter is advanced into the great vessel for support. Further support is attained by providing tension to the proximal shaft of the guide catheter. Flexibility of the guide catheter allows diagnostic angiograms to be performed prior to delivery of a therapeutic catheter or device.

Abstract: An apparatus includes a catheter for an intrathecal drug delivery system and a stylet having a curved forward end. Preferably, the curved forward end has a shape in the form of a “J” or a “C.” Also preferably, the catheter has a distal end that conforms to the curved forward end of the stylet. Thus, the present invention provides a catheter having a blunt forward end that minimizes the risk of penetrating the substance of the spinal cord. Additionally, the curved forward end of the stylet can be formed of a springy material so that it straightens out during the processes of insertion through a guide needle and retraction from the needle.

Abstract: An input device (101) for a robotic medical system (10) includes a handle (102) configured to be rotatable about a center axis, and to be longitudinally displaceable along the center axis. The input device (101) also includes a deflection control element disposed on the handle (102), and configured to selectively control deflection of the distal end of a flexible medical instrument electrically coupled to the input device. Longitudinal displacement of the handle (102) may cause or result in a corresponding longitudinal motion of the flexible medical instrument. Rotation of the handle (102) may cause or result in a corresponding rotation of the deflection plane. Longitudinal displacement and rotation of the handle (102) may be detected or sensed electronically. The handle (102) can be easily replaced with a device that mimicks the performance of one or more novel, known or traditional handles.

Abstract: A robotic medical system comprises an operator control station having a master input device, a catheter instrument, and an instrument driver in communication with the operator control station. The catheter instrument includes an elongate flexible catheter member, a flexible control element extending within the catheter member, and a proximal drivable assembly configured to axially move the control element relative to the catheter member to perform a kinematic function at a distal end of the catheter member. The instrument driver is configured to operate the drivable assembly to axially move the control element in response to control signals generated, at least in part, by the master input device. The drivable assembly is mounted to the instrument driver, thereby providing mechanically close relationship between the drivable assembly and the instrument driver.

Abstract: A bi-directional catheter with nearly double the throw in its catheter tip deflection defines a puller wire travel path having a U-turn a pulley which minimizes the offset angle between the puller wire and the longitudinal axis of the control handle while maximizing the travel distance of that puller wire for any given distance traveled by the pulley drawing the puller wire. In particular, the control handle of the catheter which includes a steering assembly having a lever arm carrying a pair of pulleys for drawing corresponding puller wires to deflect the tip section of the catheter. The pulleys are rotatably mounted on opposing portions of the lever arm such that one pulley is moved distally as the other pulley is moved proximally when the lever arm is rotated.

Abstract: An improved steerable catheter with in-plane deflection comprises a catheter body having proximal and distal ends and a lumen extending therethrough and a tip section at the distal end of the catheter body. The tip section comprises a flexible plastic tubing having a pair of diametrically-opposed lumens extending therethrough. The catheter also provides two puller wires manipulated through a control handle at the proximal end of the catheter body. Each puller wire extends through one of the pair of lumens in the tip section and through the lumen of the catheter body and is anchored to the control handle at its proximal end and anchored to the tip section at its distal end. The deflection mechanism is configured to generally define a plane along which deflection most readily occurs and an edge along which deflection is most readily avoided.

Abstract: An apparatus for determining a length of a portion of a steering wire disposed within a bendable medical device includes an electrical contact slidably coupled with a steering wire, an electrical source configured to transmit an electrical signal through a portion of the steering wire, and a processor configured to monitor a parameter of the electrical signal at or about the electrical contact and configured to determine a length of a portion of the steering wire using the monitored parameter.

Abstract: Several embodiments of the present invention are generally directed to medical visualization systems that comprise combinations of disposable and reusable components, such as catheters, functional handles, hubs, optical devices, etc. Other embodiments of the present invention are generally directed to features and aspects of an in-vivo visualization system that comprises an endoscope having a working channel through which a catheter having viewing capabilities is routed. The catheter may obtain viewing capabilities by being constructed as a vision catheter or by having a fiberscope or other viewing device selectively routed through one of its channels. The catheter is preferably of the steerable type so that the distal end of the catheter may be steered from its proximal end as it is advanced with the body. A suitable use for the in-vivo visualization system includes but is not limited to diagnosis and/or treatment of the duodenum, and particularly the biliary tree.

Abstract: A catheter assembly includes a catheter body extending from a deflectable distal end to a proximal end, and the catheter body includes an actuator lumen. A housing is engaged to the proximal end of the catheter body. A flexible element extends from the housing through the actuator lumen to the deflectable distal end. The deflectable distal end is deflected by pushing and pulling of the flexible element. An actuator is movably coupled with the housing and connected to the flexible element. A tubular support is engaged around the flexible element and connected to the actuator, the tubular support moves with the actuator, and the tubular support substantially constrains lateral movement of the flexible element. The tubular support is telescopically received and engaged with an inner surface of the actuator lumen. The inner surface of the actuator lumen substantially constrains lateral movement of the tubular support and the flexible element.

Abstract: Methods and apparatuses for manipulating an elongated flexible shaft of a catheter provide case and reliability of positioning electrodes against or near tissue. Dual-bend flexible distal tips (30) may be used in combination with flat wires. In some embodiments, flat wires which are free to rotate upon initial bending of shaft segments are employed. In some embodiments, one or more transition segments (48) are used to relocate the satellite lumen-to-main lumen transition of pull wires (42, 40) away from a change in shaft stiffness.

Abstract: The present invention provides a deflectable catheter-based system for assisting in the delivery of therapeutic agents, cellular materials and the like to one or more sites in a target body tissue. The system provides for one or more injections to a predetermined needle insertion depth with a single core needle that can be advanced and retracted from the tip of the catheter. The catheter assembly includes a handle subassembly having a mechanism for setting and limiting the depth of insertion of the needle, a slide for moving the injection needle between retracted and extended positions, a return spring for biasing the needle to the retracted position, and a modified pulley mechanism for compensating for catheter shaft compression when the catheter is deflected.

Abstract: A deflectable catheter assembly is disclosed. The assembly comprises a catheter shaft having a catheter proximal section and a catheter distal section, and at least one lumen extending therethrough. The catheter distal section is more flexible than the catheter proximal section. A tendon is disposed within a first lumen of said catheter shaft. The first lumen is approximately centrally located within the catheter shaft at the catheter proximal section. The first lumen is located off-center of the catheter shaft at the catheter distal section. The tendon is able to deflect the catheter distal section when being pulled on. A catheter handle is coupled to the catheter shaft at the catheter proximal section, the catheter handle includes a control mechanism to control the tendon.

Abstract: A support catheter that can puncture a heart septum with a guidewire without buckling and that can access difficult to reach arteries such as carotid or renal arteries from the aorta under difficult circumstances is provided. The support catheter comprises a catheter body having a proximal end, a distal end, and an interior wall surface defining a first lumen extending from the proximal end toward the distal end. A second lumen is disposed between the interior wall surface and an outer surface of the catheter body. A plurality of stiffening members is disposed around the second lumen, the plurality of stiffening members being engageable to selectively stiffen the catheter body. In another configuration, the catheter further comprises a second plurality of stiffening members disposed between the first lumen and the second lumen.

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 feeding tube and method for introducing a feeding tube within the gastrointestinal tract of a patient, whereby the feeding tube is introduced by using a variation of the Ponsky “pull” method of feeding tube placement. The feeding tube comprises an elongate shaft having a distal end and proximal end. The feeding tube also comprises a coupling structure for coupling the feeding tube to a pull wire, the coupling structure be proximal of the distal end of the feeding tube shaft. The feeding tube further comprises a guiding structure for aligning the pull wire with the distal end of the shaft. The feeding tube is introduced within the patient by attaching the previously placed pull wire to the coupling and guiding structures of the feeding tube, and then pulling the pull wire so as to pull the feeding tube into and through the gastrointestinal tract of the patient.

Abstract: An apparatus including an elongate body having a lumen extending therethrough and a steering wire associated with the distal portion of the elongate body.

Abstract: A robotic catheter system includes a controller with a master input device, and an instrument driver in communication with the controller, the instrument driver configured for independently controlling each of number of desired motions of a flexible, elongate guide instrument in a body of a patient in response to control signals generated by the controller, the desired motions selected from the group comprising axial advancement, axial retraction, axial rotation, and radial bending. Integrated haptics capability may be provided, in which one or more motors provide tactile feedback to an operator through the master input device.

Abstract: A robotic catheter system includes a controller with a master input device. An instrument driver is in communication with the controller and has a guide instrument interface including a plurality of guide instrument drive elements responsive to control signals generated, at least in part, by the master input device. An elongate guide instrument has a base, distal end, and a working lumen, wherein the guide instrument base is operatively coupled to the guide instrument interface. The guide instrument includes a plurality of guide instrument control elements operatively coupled to respective guide drive elements and secured to the distal end of the guide instrument. The guide instrument control elements are axially moveable relative to the guide instrument such that movement of the guide instrument distal end may be controlled by the master input device.

Abstract: Steering engagement catheter devices, systems, and methods of using the same for accessing tissue, including the internal and external tissues of the heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

Abstract: Catheter orientation control system mechanisms which facilitate the operation of multiple degrees of freedom of a steerable catheter system can be used for any procedure where catheter orientation relative to the body is desirable. Such systems may comprise a handle having a distal portion which is rotatable independently of the remainder of the handle to enable the handle to maintain a stationary configuration relative to the operator while the catheter distal end is torqued in any configuration by utilizing a single hand and/or single finger to effect complex configurations. Orientation indicators may be incorporated to track the deflectable distal end by visualizing the indicators through an imaging hood on the distal end corresponding to orientation markers on the control handle. Articulation of a steering mechanism in a direction relative to the orientation markers deflects the catheter distal end in a corresponding direction relative to the visualized orientation markers.

Abstract: An improved steerable catheter with in-plane deflection comprises a catheter body having proximal and distal ends and a lumen extending therethrough and a tip section at the distal end of the catheter body. The tip section comprises a flexible plastic tubing having a pair of diametrically-opposed lumens extending therethrough. The catheter also provides two puller wires manipulated through a control handle at the proximal end of the catheter body. Each puller wire extends through one of the pair of lumens in the tip section and through the lumen of the catheter body and is anchored to the control handle at its proximal end and anchored to the tip section at its distal end. The deflection mechanism is configured to generally define a plane along which deflection most readily occurs and an edge along which deflection is most readily avoided.

Abstract: Deflection mechanisms are disclosed that are positionable to deflecting portions of a flexible body, such as a catheter, in more than one direction in a single plane, as well as in more than one plane. The invention allows a distal portion of a catheter to be deflected more than 360 degrees to provide a loop.