Abstract: A robotic catheter rotatable device cartridge may include a housing member attachable to a drive mechanism for rotating the cartridge and a catheter attached to the cartridge along an axial direction of the catheter. A slider block may be generally slidable relative to the housing and engaged with one or more steering wires for controlling movement of the catheter in a transverse direction relative to the axial direction. The catheter may include the steering wire(s) engaged therewith and movable in the transverse direction when the slider block is linearly driven in a predetermined direction.

Abstract: A robotic catheter manipulator assembly may include a support member including a catheter manipulation base and a sheath manipulation base movable relative to each other and to the support member. Each respective manipulation base may be releasably connectable to a catheter cartridge and a sheath cartridge. A drive mechanism may be provided for moving the catheter and sheath manipulation bases relative to each other and to the support member. The manipulation base or the cartridge may include a first element engageable with a complementary second element slidably engaged with the other one of the manipulation base or the cartridge for controlling movement of a component connected to the cartridge. The cartridge, for example, may be a transseptal cartridge, a catheter cartridge or a sheath cartridge, and the component may respectively be a surgically insertable device such as a transseptal needle, a catheter or a sheath.

Abstract: Systems and method are disclosed whereby elongate medical instruments may be registered to adjacent tissue structures and other structures, and may be navigated and operated in a coordinated fashion to maximize ranges of motion, ease of use, and other factors. A method for registering an instrument relative to nearby structures may comprise moving a portion of the instrument between two in situ positions, tracking movement during this movement with both a kinematic model and also a localization sensor based configuration, determining the orientation of the tracked portion relative to both the instrument coordinate system used in the kinematic modeling and also a localization coordinate reference frame, and adjusting the orientation of the instrument coordinate reference frame to minimize the difference between determined orientations using the kinematic model and localization sensors. Methods and configurations for navigating coupled and registered instrument sets are also disclosed.

Abstract: A deflectable sheath for use in medical procedures in the vasculature is described. The sheath includes a handle supporting the sheath. Two pull wires run along opposite sides of the sheath to anchors at the deflectable distal end. The handle includes a rotatable member that moves a threaded member including wire guide in a back and forth translation. As the movement occurs, force is applied to either one or the other of the pull wires to cause deflection of distal end of the sheath in either and upwardly or a downwardly direction with respect to the longitudinal axis of the sheath.

Abstract: Disclosed is an access catheter, having a distal segment which is moveable from a reduced outside diameter for positioning at a target site, and an enlarged outside diameter to create an enlarged internal working lumen. In one application, the catheter is configured for use as an intracranial aspiration catheter. Methods are also disclosed.

Abstract: A dual braided catheter shaft includes an inner helical braid and outer helical braid than encapsulate an axially extending steering wire there between. In one embodiment, the shaft includes an inner polymer jacket, an inner braid formed on the inner jacket, a steering wire disposed along an outside surface of the inner braid, an outer braid formed over the inner braid and steering wire assembly and an outer jacket formed on the outer braid. The braiding parameters of the inner and outer braids can be varied along the length of the catheter to provide varying mechanical properties.

Abstract: The bendable catheter includes a flexible tubular main tube; a bendable part having a longitudinal axis and an internal space formed along the longitudinal axis, and being capable of being bent; a first coil provided in the internal space along the longitudinal axis; a second coil having a central axis extending parallel to a central axis of the first coil and provided adjacent to the first coil in a space formed between the bendable part and the first coil; and a bending manipulation wire arranged within the second coil, being capable of bending the bendable part, and having one end fixed to the bendable part.

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 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 flexible segment system including: a first link; a first flexible hinge integral to the first link; and a second link integral to and continuing from the first flexible hinge.

Abstract: An esophagus isolation catheter for deflecting an esophagus of a patient away from an ablation site in the left atrium of the patient's heart is provided. The catheter comprises an elongated catheter body and a deflectable section. In one embodiment, the catheter comprises a deflectable intermediate section mounted at the distal end of the catheter body and a generally straight tip section mounted at the distal end of the intermediate section. In this embodiment, the catheter comprises two puller wires, one anchored proximal the other. The intermediate section deflects to form a generally C-shaped curve. In an alternative embodiment, the catheter comprises a deflectable tip section mounted at the distal end of the catheter body. In this embodiment, the catheter comprises only one puller wire. The tip section carries a tip electrode having an atraumatic design to prevent damage to the esophagus upon deflection.

Abstract: A system for arterial access for delivery of treatment devices is provided. In one embodiment, the system comprises a guidewire and a catheter. The catheter comprises a handle and a shaft. The shaft may be a steerable/deflectable tip shaft with a lumen adapted to allow passage of the guidewire at least partially there through. A passive sheath may also be provided to be delivered over the shaft. The handle controls the steerable/deflectable tip shaft and may be used to deflect the distal tip of the shaft.

Abstract: An endoluminal surgical instrument has first and second steering controls on a handle. A flexible shaft attached to the handle has a distal steerable end including a first link and a second link separated by a plurality of intermediate links. First and second steering elements, such as pairs of steering wires, are linked to first and second steering controls and to the first and, second links. One or more of the links is pivotable through an angle of at least 30 degrees relative to an adjoining link. The set back position of the second steering elements from the first steering elements, and the pivoting capability of the links allows the steerable end to be steered into a small bend radius. This makes the instrument highly maneuverable for use in endoluminal surgery, such as incision-less surgery of the stomach.

Abstract: The present invention relates to a device developed for surgical interventions comprising (i) an inner end (1) guidable/steerable to the operation field, (ii) an outer end (3) operated by the user and (iii) a middle part (2) which connects both ends (1, 3) together. According to the main concept of the present invention, it further comprises force transmission units extending between the outer (3) and the inner (1) ends, and said force transmission units, the outer and the inner ends and the middle part (2) are designed to transfer the movements of the outer end (3) to the inner end (1) in an identical measure, as if the inner end (1) were the straight continuation of the outer end (3).

Abstract: A steerable catheter or sheath includes a catheter or sheath body defining a longitudinal axis; first and second actuation wires extending from a proximal end of the body; and a control handle coupled to the body for steering a distal end of the body. The control handle includes a grip portion including a pivot; a wire diverting assembly located on the grip portion at a location separate from the pivot; and an actuator assembly coupled to the pivot and configured for pivotal movement in a single plane. The wire diverting assembly can include first and second actuation wire connection locations that are disposed on opposite sides of the longitudinal axis. The first and second actuation wires can extend toward the wire diverting assembly in a first orientation, and the wire diverting assembly can change the first orientation to a second orientation that is at an angle to the first orientation.

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: 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: An apparatus is disclosed for introducing surgical instruments into a body cavity. The apparatus includes a series of interconnected segments configured to pivot relative to one another allowing an end effector to be steered into position. The apparatus is also capable of achieving a rigidized state wherein the interconnected segments are in high frictional contact with one another providing a stable platform for the manipulation of tissue. Tensile elements are attached to the end effector and a control member such that an operator may use the same control member to both rigidize the instrument and also to thereafter control the end effector.

Abstract: Shape-controllable catheters are provided that are versatile in application and that, in human-imaging applications, minimize or reduce patient discomfort. One such catheter is provided with at least one control wire that extends inside the catheter and a control mechanism for tensioning the control wire to produce in the catheter a humped shape or a cantilevered configuration. Hardness of the catheter may be varied along the length thereof to facilitate desired bending. For example, hardness may be reduced in bend areas. Hardness may be maintained or increased in other areas for performance reasons, for example to maintain planarity of an imaging array.

Abstract: A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Abstract: A steerable catheter includes a body portion, a flexible catheter body with a proximal end and a distal tip and a continuous steering wire passing through the flexible body from the proximal end to the distal tip and turning back through the flexible body from the distal tip to the proximal end.

Abstract: A catheter assembly comprises a deflectable catheter shaft comprising a distal end and a lumen extending therethrough. The catheter assembly further comprises least one pull wire comprising a distal portion comprising a side and a distal end, wherein the side comprises a first side portion and a second side portion. The catheter assembly further comprises a distal pull assembly operatively coupled to the at least one pull wire. The distal pull assembly comprises a longitudinal axis, a first surface, and a second surface. The first side portion of the at least one pull wire is adjacent to the first surface of the distal pull assembly, and the second side portion of the at least one pull wire is adjacent to the second surface of the distal pull assembly.

Abstract: An elongate medical device with independently-deflectable segments and a handle for manually deflecting those segments can include a shaft having a distal segment and proximal segment, at least one proximal segment deflection wire adapted to deflect the proximal segment, at least one distal segment deflection wire adapted to deflect the distal segment independent of the proximal segment, and a handle portion. The handle portion may comprise a first manual actuation mechanism coupled to the at least one distal segment deflection wire and a second manual actuation mechanism coupled to the at least one proximal segment deflection wire. Actuation of the first manual actuation mechanism may impart a tensile force on the distal segment deflection wire to cause the distal segment to deflect, and actuation of the second manual actuation mechanism may impart a tensile force on the proximal segment to cause the proximal segment to deflect.

Abstract: This invention is directed to a medical device with a handle and a catheter. The handle can include a body having a proximal end and a distal end, an actuator moveably coupled to the body, and a handle control member coupled to the actuator, wherein the actuator can be configured to move relative to the body to move the handle control member. The catheter can include a shaft having a proximal end and a distal end, wherein the proximal end of the shaft and the distal end of the body can be configured for releasable coupling. The catheter can also include a steering section located along the shaft and a catheter control member coupled to the steering section. A securing member may move relative to at least one of the handle and the catheter to releasably couple the handle control member to the catheter control member.

Abstract: A catheter includes a handle that advantageously limits the amount of torque that can be imparted to the body of the catheter. This advantageously reduces the likelihood of catheter failure, damage to tissue, or damage to medical devices introduced into the vasculature via the catheter. The catheter handle includes a grip portion that the practitioner manipulates in order to impart a torque and a torque transmitting portion operably coupled thereto that transmits the torque to the catheter body. A torque limiting mechanism decouples the torque transmitting portion from the grip portion, the body, and/or any pull wires when the torque imparted to the grip portion exceeds a torque threshold, thereby preventing excessive torques from being transmitted to the catheter body and/or pull wires. A practitioner may be able to adjust the torque threshold and may be able to disable the torque limiting mechanism.

Abstract: A medical catheter instrument has a shaft portion, a distal portion bendable in a controlled manner in at least one direction relative to the shaft portion, and a control element extending in an axially movable manner through the shaft portion to the distal portion. The axial movement of the control element controls a corresponding bending movement of the distal portion. The catheter instrument includes a bending assembly having at least one elongated, elastically bendable stiffening element and at least one elongated, bendable and axially length-adjustable bending element, the elements being provided in an axial sub-region of the distal portion and extending therein with an axial main component, wherein the stiffening element forms an element restoring bending movement and has a higher flexural stiffness than the bending element, and the bending element is coupled to the control element or forms part of the same.

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: The invention provides a deflectable catheter capable of forming many variable radius spiral forms from a single, flexible, distal end section. In one aspect, the catheter employs a variable radius control wire to extend or deform a pre-formed loop structure into a three dimensional spiral-like form or geometry. The ability of a single catheter to create a multitude of shapes and sizes allows users to access to a number of anatomical areas without changing the catheter during a procedure or treatment. In another aspect, the invention encompasses methods of producing deflectable variable radius catheters, where two or more regions of the catheter having common control wires are fused or formed onto one another.

Abstract: A catheter procedure system including a user interface for receiving at least a first user input and a second user input and a guide catheter is provided. The catheter procedure system also includes a guide catheter actuating mechanism coupled to the guide catheter and a Y-connector. The guide catheter actuating mechanism is configured to advance and retract the guide catheter in response to the first user input and to rotate the guide catheter in response to the second user input. The catheter procedure system includes a first connector coupling the Y-connector to the guide catheter actuating mechanism, and the first connector is configured to allow the Y-connector to advance and retract with the guide catheter and to allow the guide catheter to rotate without also causing the Y-connector to rotate.

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 catheter is provided with improved position and/or location sensing with the use of single axis sensors that are mounted directly along a length or portion of the catheter whose position/location is of interest. The magnetic based, single axis sensors are provided on a single axis sensor (SAS) assembly, which can be linear or nonlinear as needed. A catheter of the present invention thus includes a catheter body and a distal member of a particular 2D or 3D configuration that is provided by a support member on which at least one, if not at least three single axis sensors, are mounted serially along a length of the support member. In one embodiment, the magnetic-based sensor assembly including at least one coil member that is wrapped on the support member, wherein the coil member is connected via a joint region to a respective cable member adapted to transmit a signal providing location information from the coil member to a mapping and localization system.

Abstract: Certain embodiments provide systems and methods for catheter positioning. Certain embodiments provide a catheter for use in at least intravenous and intracardiac spaces. The catheter includes a catheter body having a length and a tip portion at a distal end of the catheter body. The catheter also includes a plurality of wires for moving the catheter body in a plurality of directions. The catheter further includes a first control for manipulating the plurality of wires in two primary planes of movement for the catheter body. The catheter includes a second control for manipulating the plurality of wires in two secondary planes of movement for the catheter body. The second control is distinct in appearance and operation from the first control.

Abstract: The present invention encompasses apparatus and methods for mapping electrical activity within the heart. The present invention also encompasses methods and apparatus for creating lesions in the heart tissue (ablating) to create a region of necrotic tissue which serves to disable the propagation of errant electrical impulses caused by an arrhythmia.

Abstract: A reinforced medical catheter (10) includes an elongated tubular outer wall reinforced by an internal helical coil spring (36). Successive loops of the coil spring adjoining the distal end are longitudinally separated, and a working lumen extends longitudinally through the catheter. A longitudinally extending reinforcing cable is captured in the tubular outer wall against the exterior of the coil spring. A steering cable operably interconnected with the distal end of the coil spring extends proximally from the distal end of the coil spring freely through the working lumen to the proximal end of the catheter. The reinforcing cable and the steering cable may constitute a continuous elongated filament. Withdrawing the steering cable proximally through the working lumen causes the distal tip of the catheter to be deflected laterally.

Abstract: A catheter assembly includes a catheter body that extends from a distal end to a proximal end. The catheter body includes a delivery lumen, and an actuator lumen, where the actuator lumen extends from a position near or at the distal end to an intermediate portion that does not extend through the proximal end of the catheter body. The catheter body optionally includes an accessory lumen that extends from at or near the distal end and terminates at an intermediate portion that does not extend through the proximal end surface of the catheter body, for example, on a side wall.

Abstract: A catheter 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 includes a handle that advantageously limits the amount of torque that can be imparted to the body of the catheter. This advantageously reduces the likelihood of catheter failure, damage to tissue, or damage to medical devices introduced into the vasculature via the catheter. The catheter handle includes a grip portion that the practitioner manipulates in order to impart a torque and a torque transmitting portion operably coupled thereto that transmits the torque to the catheter body. A torque limiting mechanism decouples the torque transmitting portion from the grip portion, the body, and/or any pull wires when the torque imparted to the grip portion exceeds a torque threshold, thereby preventing excessive torques from being transmitted to the catheter body and/or pull wires. A practitioner may be able to adjust the torque threshold and may be able to disable the torque limiting mechanism.

Abstract: A deflecting guide catheter for use in minimally invasive medical procedures such as the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The catheter includes an elongated tubular portion having various durometers along its length and at least one puller wire attached to an anchor band near the distal end. The deflecting guide catheter is used to provide a means for guiding a plication device or other medical instrument into a desired position within the vasculature or heart chambers of a patient.

Abstract: A medical device has a distal member with a configuration that can be changed by means of a control handle with a control assembly employing a rotational cam, a shaft, and a pulley, where the rotational cam is rotationally mounted on a portion of the control handle for rotation by a user. The rotational cam operates on the shaft to move it proximally or distally depending on the direction of rotation which in turn rotates the pulley to draw or release a puller wire to change the configuration of the distal member of the medical device. The shaft is oriented along a diameter of the control handle. The shaft has two ends which extends through two axial guide slots in the portion of the control handle to sit two opposing helical tracks formed on inner surface of the rotational cam. The guide slots are parallel with the longitudinal axis of the control handle and therefore maintain the shaft's diametrical orientation as the rotational cam is rotated to move the shaft proximally or distally.

Abstract: The invention provides a deflectable catheter capable of forming many variable radius spiral forms from a single, flexible, distal end section. In one aspect, the catheter employs a variable radius control wire to extend or deform a pre-formed loop structure into a three dimensional spiral-like form or geometry. The ability of a single catheter to create a multitude of shapes and sizes allows users to access to a number of anatomical areas without changing the catheter during a procedure or treatment. In another aspect, the invention encompasses methods of producing deflectable variable radius catheters, where two or more regions of the catheter having common control wires are fused or formed onto one another.

Abstract: A steerable endoluminal device adapted for delivery into a patient's vasculature. The device includes a tubular member having a distal deflection portion that extends to the distal end and a main body portion that extends from the deflectable portion to the proximal end, the tubular member further including a stiff portion extending along the distal deflection portion, and being formed of polymeric material, which is disposed circumferentially adjacent to the stiff portion. The stiff portion is made of a material that has an elastic modulus greater than the elastic modulus of the polymeric material. A pull wire extends between the proximal end and the distal end of the tubular member and is attached to the distal deflection portion to control deflection of the distal deflection portion of the tubular member.

Abstract: A steerable catheter or sheath control handle for steering a distal end of a tubular catheter body or sheath body having first and second actuation wires extending from a proximal end of the body comprises a grip portion, a bearing assembly, and an actuator. The first grip potion includes a pivot and an actuation wire pathway. The bearing assembly is located on the grip portion proximal to the pivot. The actuator is pivotally coupled to the pivot and includes first and second ends that are on opposite sides of the centerline from each other. When the distal end of the handle is coupled to the proximal end of the body, the first and second actuation wires extend along the pathway to the bearing assembly. The bearing assembly diverts the first actuation wire to a first connection point on the actuator and the second actuation wire to a second connection point on the actuator.

Abstract: A medical catheter assembly includes a deflectable catheter shaft, a distal tip with tip element and a mounting shaft, and a pull ring assembly, the distal tip defining guide channels through which pull wires of the pull ring assembly pass such that the pull wires will initially extend from the pull ring toward the tip element and then loop back toward and through the catheter shaft and to a handle actuator. Pulling of the pull wires by the handle actuator to tilt the pull ring and deflect the catheter shaft will cause the pull ring to move toward tip element. The pull ring and tip element are thus interlocked. Stress forces on the connection joints between the pull wires and the pull ring will be dissipated, reducing the incidence of failure of the pull ring assembly. The medical catheter can be a non-irrigated ablation catheter wherein the tip element is a tip electrode, or an irrigated ablation catheter wherein the tip element is a tip electrode and a fluid manifold.

Abstract: A guide catheter and a needle catheter are disclosed. The guide catheter construction provides for maximum articulation of the deflectable tip and maximum torque response during rotation. The needle catheter may include a release mechanism that imparts a sudden force to the needle in order to facilitate tissue penetration.

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: Medical devices having an elongated steerable member are described herein. In one embodiment, a device includes an elongated body having a proximal section, a distal section, and a working lumen extending through the proximal and distal sections, a first coil having a distal portion, and a proximal portion, the proximal portion of the first coil being slidable relative to the proximal section of the elongated body, and being closer to a wall of the elongated body than to an axis of the elongated body, wherein a lengthwise portion of the distal portion of the first coil is anchored to the distal section of the elongated body, and a first steering wire located within a lumen of the first coil.

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.