Abstract: The present invention provides various embodiments of electrodes and/or electrode tips for use in connection with ablation catheters and ablation catheter systems. In an embodiment, an electrode tip for an ablation catheter is provided, comprising an electrode carrier, a first electrode, and second electrode, each adapted to direct energy is various directions and configured to be selectively activated. In another embodiment, an electrode is provided that comprises an electrode body having an insulated portion to protect adjacent tissue from ablation while further adapted to direct energy in a downward direction towards the target tissue. Other embodiments of electrodes and/or electrode tips providing ablative elements that are directed laterally are also disclosed. Moreover, embodiments of several types of electrodes and/or electrode tips, which may include positioning, orientation, irrigating, cooling, and deflecting features, whether provided individually or in various combinations, are also disclosed.

Abstract: Coupler assemblies and methods are disclosed as the coupler assemblies may be used with a catheter. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.

Abstract: Catheter systems and methods are disclosed. An exemplary catheter includes an outer tubing housing and an inner fluid delivery tubing, the inner fluid delivery tubing having at least one fluid delivery port. The catheter also includes a deployment member movable axially within the inner fluid delivery tubing. A plurality of splines are each connected at a proximal end to the outer tubing and at a distal end to deployment member. A seal is provided between the outer tubing and the inner fluid delivery tubing. A gasket is provided between the deployment member and the inner fluid delivery tubing. Both the seal and the gasket are configured to prevent blood or other fluid from ingressing into the outer tubing.

Abstract: A wire harness for a medical device includes a wiring bundle, a distal flex circuit, and a proximal flex circuit. The wiring bundle includes a plurality of twisted pair wiring and a shield, and operatively or conductively connects the distal flex circuit to the proximal flex circuit. The distal flex circuit may be configured to operatively or conductively connect to an electrically controlled object located in a distal portion of the medical device. The proximal flex circuit may be configured to operatively or conductively connect to an electrical connector.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: A catheter tip is disclosed comprising a proximal stem that comprises a lumen. An electrode wall that comprises a center cavity can be coupled to the distal end of the proximal stem. An electrode cap can be coupled to a distal end of the electrode wall. An elongate thermocouple element can extend through the lumen of the proximal stem and the center cavity and can be coupled to the electrode cap. The elongate thermocouple element can be turned around a portion of a longitudinal axis defined by the catheter tip assembly.

Abstract: A medical device for the diagnosis or treatment of tissue in a body and method for fabricating the same are provided. The device includes comprises a first shaft and a second shaft. The first shaft includes a longitudinal axis, and the second shaft includes a second shaft axial end disposed within the first shaft. The second shaft is connected to the first shaft by a first nested lap joint formed between the first shaft and the second shaft.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis with a distal end and a proximal end. First and second pull wires can extend along the elongated body and can have a proximal end and a distal end. First and second pull wire liners can be disposed over a portion of one of the first and second pull wires, respectively. Each of the first and second pull wires can have a proximal end and a distal end. A first gap can exist between the proximal end of the first pull wire liner and the proximal end of the elongated body and a second gap can exist between the proximal end of the second pull wire liner and the proximal end of the elongated body.

Abstract: Coupler assemblies and methods are disclosed as the coupler assemblies may be used with a catheter. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.

Abstract: A family of catheter electrode assemblies includes a flexible circuit having a plurality of electrical traces and a substrate; a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the electrode. A non-contact electrode mapping catheter includes an outer tubing having a longitudinal axis, a deployment member, and a plurality of splines, at least one of the plurality of splines comprising a flexible circuit including a plurality of electrical traces and a substrate, a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the ring electrode. A method of constructing the family of catheter electrode assemblies is also provided.

Abstract: A magnetically-guided catheter includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter includes an electrically-conductive capsule in the form of a casing that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion.

Abstract: A handle assembly is provided for use in navigating a deformable shaft within a body. The assembly includes a first guide member defining first and second linear channels and a second guide member configured for rotation relative to the first guide member. First and second connectors are disposed within, and movable within, the first and second linear channels along first and second parallel axes, respectively, and are configured for coupling to first and second steering wires, respectively. The assembly includes means, such as a flexible coupling connected to the second guide member and the connectors, for translating rotation of the second guide member into linear movement of the first connector in a first axial direction and linear movement of the second connector in a second axial direction, opposite the first axial direction such that the first and second steering wires move in opposite directions.

Abstract: A circuit configured for connecting an electrode to a catheter or sheath is disclosed. The circuit includes a member having a longitudinal axis and configured to extend along at least a portion of the length of the catheter or sheath. The circuit further includes a trace printed on the member, where the trace includes at least a longitudinal segment extending generally along at least a portion of the longitudinal axis and a transverse segment extending generally transverse to the longitudinal axis. In an embodiment, the circuit further includes a pad integral with and extending from the circuit proximal the transverse segment of the trace. A catheter or sheath assembly comprising the circuit and an electrode connected to the circuit is also disclosed. A method of forming a catheter or sheath assembly is also provided.

Abstract: Deflection actuators configured to provide variable mechanical advantage and to optionally maintain a desired state of deflection are disclosed. Each deflection actuator may comprise a plurality of planar components, at least one of which is adapted to move relative to at least one other component. The planar components may comprise a channeled platform and a pivotable base mounted adjacent to the channeled platform. The platform may comprise a slider trough to slidably retain a slider. The base may have a cam arm pivotally connected to it and adapted to push a slider in its trough, whereby pivoting of the pivotable base relative to the channeled platform produces linear motion by the slider in its slider trough. The deflection actuator may also comprise a friction-lock knob, a knob receiver, and a pivot hub to selectably produce friction between various components to hold a catheter shaft in a desired state of deflection.

Abstract: A family of catheter electrode assemblies includes a flexible circuit having a plurality of electrical traces and a substrate; a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the electrode. A non-contact electrode mapping catheter includes an outer tubing having a longitudinal axis, a deployment member, and a plurality of splines, at least one of the plurality of splines comprising a flexible circuit including a plurality of electrical traces and a substrate, a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the ring electrode. A method of constructing the family of catheter electrode assemblies is also provided.

Abstract: A magnetically-guided catheter includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter includes an electrically-conductive capsule in the form of a casing that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion.

Abstract: A handle assembly is provided for use in navigating a deformable shaft within a body. The assembly includes a first guide member defining first and second linear channels and a second guide member configured for rotation relative to the first guide member. First and second connectors are disposed within, and movable within, the first and second linear channels along first and second parallel axes, respectively, and are configured for coupling to first and second steering wires, respectively. The assembly includes means, such as a flexible coupling connected to the second guide member and the connectors, for translating rotation of the second guide member into linear movement of the first connector in a first axial direction and linear movement of the second connector in a second axial direction, opposite the first axial direction such that the first and second steering wires move in opposite directions.

Abstract: A medical device is provided comprising a shaft comprising a first segment and a second segment. The first segment is configured to buckle upon application of a first critical force. The second segment includes an outer surface and an inner surface and is configured to buckle upon application of a second critical force. The second critical force is lower than the first critical force. The medical device further comprises a coil disposed radially inwardly of the inner surface of the second segment.