Abstract: The present invention is a catheter actuation handle for deflecting a distal end of a tubular catheter body, the handle including an auto-locking mechanism. The handle comprises upper and lower grip portions, an actuator, and an auto-locking mechanism. The auto-locking mechanism is adapted to hold a deflected distal end of the catheter in place without input from the operator. When the distal end of the catheter is deflected from its zero position, it typically will seek a return to its zero position, and as a result exerts a force on the actuator. The auto-locking mechanism acts by providing a second force that resists this force from the distal end and holds the distal end in place. As a result, the operator does not need to maintain contact with the buttons to maintain the distal end 18 in a set position once placed there by actuating the actuator.

Abstract: An irrigated ablation catheter includes a shaft having a proximal end, a distal end, and an irrigation lumen therein. The catheter further includes an electrode assembly coupled to the distal end of the shaft. The electrode assembly includes an ablation electrode and a manifold. The manifold is coupled to each of the distal end of the shaft and the proximal end of the electrode. At least a portion of the manifold is constructed of a flexible material to allow the electrode assembly to deflect. The manifold includes a body, an inner cavity within the body configured for fluid communication with the irrigation lumen, and an irrigation port also within the body and configured for fluid communication with the inner cavity. The irrigation port extends from the inner cavity to the outer surface of the body, and is configured to allow for an irrigating fluid to be distributed from the manifold.

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: A method of tracking a position of a catheter within a patient includes securing a navigational reference at a reference location within the patient, defining the reference location as the origin of a coordinate system, determining a location of an electrode moving within the patient relative to that coordinate system, monitoring for a dislodgement of the navigational reference from the initial reference location, for example by measuring the navigational reference relative to a far field reference outside the patient's body, and generating a signal indicating that the navigational reference has dislodged from the reference location. Upon dislodgement, a user may be provided with guidance to help reposition and secure the navigational reference to the initial reference location, or the navigational reference may be automatically repositioned and secured to the initial reference location. Alternatively, a reference adjustment may be calculated to compensate for the changed reference point/origin.

Abstract: A catheter includes a braid assembly having a dual-laminate coating. The braid assembly includes a plurality of braid members interwoven to provide for interstices between the braid members, each braid member having an electrically conductive element, a flexible non-electrically-conductive polymer coating that insulates the electrically conductive element and a thermoplastic bonding adhesive coating. The braid assembly is formed between an inner polymer layer and an outer polymer layer. One or more of the braid members may be coupled to an energy delivery element.

Abstract: A method and system for presenting information representative of lesion formation is provided. The system comprises an electronic control unit (ECU). The ECU is configured to acquire a value for an ablation description parameter and/or a position signal metric, wherein the value corresponds to a location in the tissue. The ECU is further configured to evaluate the value, assign it a visual indicator of a visualization scheme associated with the parameter/metric corresponding to the value, and generate a marker comprising the visual indicator such that the marker is indicative of the acquired value. The method comprises acquiring a value for the parameter/metric, and evaluating the value. The method further includes assigning a visual indicator of a visualization scheme associated with the parameter/metric corresponding to the value, and generating a marker comprising the visual indicator.

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: 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: An embodiment of a handle assembly for an elongate medical device that may reduce the weight and/or expense of traditional handle may include an exterior adjusting knob extending along a longitudinal axis and configured to rotate about the axis, an insert, and a dowel pin. The insert may be configured to engage the adjusting knob and to rotate about the axis responsive to rotation of the adjusting knob. The insert may comprise an annular groove configured to engage a dowel pin, the annular groove comprising a sidewall comprising a chamfer. The dowel pin may be configured to engage the annular groove to resist rotation of the insert. In an embodiment, the insert may comprise plastic or polymer.

Abstract: A catheter and patch electrode system is provided for use with an apparatus, such as an ablation generator, having a 4-wire interface for improved impedance measurement. The 4-wire interface includes a pair of source connectors across which an excitation signal is produced and a pair of sense connector wires across which the impedance is measured. The RF ablation generator may also produce an ablation signal across a source wire and an indifferent return patch electrode. The system further includes a cable that connects the generator to a catheter. The catheter includes a shaft having a proximal end and a distal end, with an ablation tip electrode disposed at the distal end. A source lead is electrically coupled to the tip electrode and extends through the shaft to the proximal end where it is terminated. An optional sense lead is also electrically coupled to the tip electrode and extends through the shaft to the proximal end. The system further includes a source return (e.g.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis and comprising a distal end and a proximal end; and a plurality of lumens extending along the longitudinal axis of the elongated body, wherein at least one of the lumens is abutting at least another one of the lumens. A catheter comprising the deflectable catheter shaft section and a method of manufacturing the deflectable catheter shaft section are also disclosed. A catheter incorporating a deflectable catheter shaft section can further comprise first and second compression coils disposed over pull wires located within the catheter, wherein the compression coils are unattached to the catheter or components thereof, but can be constrained by a shaft coupler at a distal end of each of the compression coils and by at least a portion of a handle assembly at a proximal end of each of the compression coils.

Abstract: An imaging system is provided with an ultrasound catheter and a controller coupled to the ultrasound catheter. The catheter includes a localizer sensor configured to generate positional information for the ultrasound catheter, and an imaging ultrasound sensor having a restricted field of view. The controller co-registers images from the imaging ultrasound sensor with positional information from the localizer sensor.

Abstract: Disclosed herein are ablation systems and methods for providing feedback on lesion formation in real-time. The methods and systems assess absorptivity of tissue based on a degree of electric coupling or contact between an ablation electrode and the tissue. The absorptivity can then be used, along with other information, including, power levels and activation times, to provide real-time feedback on the lesions being created. Feedback may be provided, for example, in the form of estimated lesion volumes and other lesion characteristics. The methods and systems can provide estimated treatment times to achieve a desired lesion characteristic for a given degree of contact, as well as depth of a lesion being created. The degree of contact may be measured using different techniques, including the phase angle techniques and a coupling index.

Abstract: A system for diagnosis or treatment of tissue in a body is provided. The system includes an ablation catheter having a deformable, elongate shaft having proximal and distal ends. The catheter further includes an ablation delivery member disposed proximate the distal end of the shaft and configured to deliver ablation energy to ablate the tissue. In one embodiment, the ablation delivery member comprises an ablation electrode and may also be configured to generate a signal indicative of electrical activity in the tissue. The catheter further includes one or more sensing electrodes disposed proximate the ablation delivery member. The sensing electrodes are configured to generate signals indicative of electrical activity in the tissue. The system further includes an electronic control unit configured to control delivery of ablation energy from the ablation delivery member responsive to one or more of the generated signals indicative of electrical activity in the tissue.

Abstract: Catheter shaft handles and deflection actuators are disclosed. The actuators include at least one pull wire guide wall and a means for anchoring the proximal portion of a pull wire or of a fiber attached to a pull wire. Each actuator is pivotable relative to the catheter handle housing, and may comprise at least one boss for pivoting the actuator relative to the catheter handle housing. The actuators transfer rotational motion based upon user input on a boss into longitudinal motion of a pull wire. The actuators may include a tensioning mechanism comprising a tension adjustment pin and a pin block, wherein the tension adjustment pin is rotatably attached to the pin block to enable adjustment of tension in a pull wire (e.g., during assembly of the catheter handle).

Abstract: A lumen extension member is provided for a catheter having a catheter body and an elongate electrode coupled to the catheter body. The elongate electrode defines an electrode lumen extending therethrough. The lumen extension member is positioned within the electrode lumen and is coupled to the catheter body. The lumen extension member includes a tubular member including a sidewall and at least one opening that extends through the sidewall.

Abstract: A system for determining a location of an electrode of a medical device (e.g., a catheter) in a body of a patient includes a localization block for producing an uncompensated electrode location, a motion compensation block for producing a compensation signal (i.e., for respiration, cardiac, etc.), and a mechanism for subtracting the compensation signal from the uncompensated electrode location. The result is a corrected electrode location substantially free of respiration and cardiac artifacts. The motion compensation block includes a dynamic adaptation feature which accounts for changes in a patient's respiration patterns as well as intentional movements of the medical device to different locations within the patient's body. The system further includes an automatic compensation gain control which suppresses compensation when certain conditions, such as noise or sudden patch impedance changes, are detected.

Abstract: A compensation circuit has a predetermined, known complex impedance and is located in a handle of a catheter or in a distal end of a cable that connects to the catheter. The compensation circuit is probed with a pilot signal produced by a compensation control. The compensation control measures the complex impedance, which is the combination of the circuit's known impedance as well as that of the cable and then determines the difference between the measured and the known complex impedances which represents that which is attributable to the cable, and is used to cancel out such cable-related contributions to complex impedance in other electrical connections in the same cable. In another aspect, an unknown tissue is identified as one of a plurality of possible tissue types such as regular myocardium, scar and fat based on the measured phase angle of the complex impedance of the unknown tissue.

Abstract: A sensing assembly for sensing contact with an object is disclosed. The contact sensing assembly may comprise an elongate tubular body. An electrode may be connected to the elongate tubular body. A vibration element is operatively connected with the electrode and configured to deliver a vibration-inducing signal to induce vibration of the electrode. A sensor is configured to monitor the electrode for a perturbation in the induced vibration. The perturbation results from contact between the electrode and the object.

Abstract: A method of refining an anatomical model includes acquiring a two-dimensional echocardiogram that has a variable intensity, relating the two-dimensional echocardiogram to a plurality of mapping points that exist in three-dimensional space, and determining a confidence value for each of two or more mapping points that corresponds to an intensity at a point on the two-dimensional echocardiogram.