Abstract: A medical device positioner for use with a remote catheter guidance system (RCGS) is provided, which can address angular, lateral and/or translational misalignment of an elongate medical device between the RCGS and an access point on a patient's body. Such a medical device positioner can comprise a base configured to attach to a remote catheter guidance system and a first support member extending from the base and having a receiving portion for receiving at least a portion of the elongate medical device. The medical device positioner can further include a second support member movably coupled to the first support member and including a second receiving area sized and configured to receive at least a portion of the elongate medical device. The medical device positioner can also include first and second tube sections with at least a portion of the first tube section being adapted to be inserted into a vascular system of a patient at an access point.

Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines. Each of the plurality of splines can have a proximal end portion and a distal end portion. The assembly further comprises a first element defining an axis and comprising an outer surface. The outer surface comprises a plurality of slots configured to receive the distal end portion of each of the plurality of splines. The first element is configured such that the distal end portion of each of the plurality of splines may move with respect to each slot. In accordance with some embodiments, the distal end portion of each of the plurality of splines comprises a section configured for engagement with the first element, wherein the section comprises a shoulder.

Abstract: Medical navigation and mapping system and methods are disclosed for modeling both unobstructed and obstructed portions of a catheter. An exemplary system includes a rendering component operatively associated with an output device. The rendering component overlays a plurality of data images on one another to generate a three-dimensional image representing both the internal tissue and a visible portion of a catheter body. An enhancement component is configured to overlay a silhouette on the three-dimensional image. The silhouette represents an obstructed portion of the catheter body.

Abstract: A method of manufacturing a catheter assembly generally includes providing a catheter shaft having an outer layer and an inner reinforcing layer; removing at least a portion of the outer layer from a length of the distal end of the catheter shaft in order to expose a distal segment thereof; providing an inner jacket segment; axially engaging the inner jacket segment with an interior surface of the distal segment of the catheter shaft; providing an outer jacket segment around at least the exposed exterior region of the distal segment of the catheter shaft; and bonding the distal segment of the catheter shaft to the inner jacket segment and the outer jacket segment.

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: The present invention relates to steerable access sheath assembly (12). Moreover, the present invention relates to a steerable short sheath access device (10) for use in epicardial procedures. Embodiments of the present invention including shorter steerable access sheaths or introducers (10, 12) may provide epicardial access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources. The steerable access device (10) provides an elongated member (20) having a proximal section (26) and a distal section (28), wherein the deflection of the distal section (28) provides a primary curve including an inner radius (r1) that result in a secondary curve of proximal section (26) having an inner radius (r2, r3), wherein the inner radius of curvature (r1) of the primary curve is less than the inside radius of curvature (r2, r3) of the secondary curve.

Abstract: A medical device comprising a cell including an ablation element and a carrier configured to receive at least a portion of said ablation element is disclosed. The medical device further comprises a tube enclosing the cell. At least a portion of the tube includes a membrane and the tube includes at least one hole proximate the ablation element for facilitating fluid flow. The medical device further comprises a fluid inlet for providing fluid to the interior of the tube. A method of using the medical device is also disclosed.

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: Systems and methods are disclosed for assessing tissue contact, e.g., for mapping, tissue ablation, or other procedures. An exemplary tissue contact sensing system comprises a flexible tip device. At least one piezoelectric sensor is housed within the flexible tip device. The at least one piezoelectric sensor is responsive to contact stress of the flexible tip device by generating electrical signals corresponding to the amount of contact stress. An output device is electrically connected to the at least one piezoelectric sensor. The output device receives the electrical signals for assessing tissue contact by the flexible tip device. Methods for assembling and using the flexible tip device are also disclosed.

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 method for scaling the impedance measured during the course of an electrophysiology study accounts for impedance drifts. By scaling the impedance there is greater assurance that previously recorded positional information can be used to accurately relocate an electrode at a prior visited position. The scale factor may be based upon a mean value across several sensing electrodes. Alternatively, the scale factor may be calculated specifically with respect to an orientation of a dipole pair of driven electrodes.

Abstract: An apparatus for transmitting electrical signals is disclosed. The apparatus includes a substrate and a twisted pair of conductors located on the substrate. The twisted pair of conductors has a first layer comprising conductive material, a second layer comprising nonconductive material, and a third player comprising conductive material. The first layer has a plurality of segments separated by a plurality of gaps. The second layer is positioned in said gaps and electrically insulates a portion of the segments positioned within the gaps. The third layer is positioned over the second layer. The third layer is configured to electrically connects an end of one segment to an end of another segment. The twisted pair of conductors formed by the three dimensional structure comprises two electrically isolated conductors twisted about each other.

Abstract: An apparatus for detecting deformation of an elongate body may comprise a light source configured to sequentially provide light of multiple frequencies, an optical receiver configured to receive light from the light source, and a filter disposed between the light source and the optical detector. The filter may comprise multiple segments, each of the segments configured to filter light at one of the frequencies so as to alter the amount of light incident on said optical receiver. A total amount of light detected by the optical receiver may change during the sequence so as to be indicative of deformation of the elongate body.

Abstract: A flexible tip electrode for an ablation catheter is disclosed. The catheter includes a catheter body and a hollow elongate tip electrode disposed at a distal end of the catheter body. The electrode includes a sidewall provided with one or more elongate gaps extending therethrough. The one or more elongate gaps providing flexibility in the sidewall for bending movement of the tip electrode relative to a longitudinal axis of the catheter body.

Abstract: A catheter configured for use with a magnetic field-based localization system includes a distributed location sensor that includes a plurality of individual location sensing coils electrically connected in series. The distributed location sensor has an effective magnetic center based on the individual characteristics of each location sensing coil. The effective magnetic center can be located in a space occupied by another structure such as an irrigation fluid delivery tube. The plurality of individual location sensing coils are generally smaller, thereby easing placement, and collectively, when connected in series, output a relatively strong and noise-free signal.

Abstract: A hemostasis valve has a housing having proximal and distal ends defining proximal and distal openings configured for passage of a medical device therethrough. The housing further defines a cavity between the proximal and distal ends. One or more rollers are received within the cavity and define end sections and a central section having a smaller diameter than the end sections. Sleeves are disposed about the rollers and are elastically deformable to form a fluid seal around the device. The sleeves each assume a first form when the device is absent from the cavity wherein a radially inner surface of the sleeve is located at a first distance from the central section of a roller and a second form when the device is present in the cavity wherein the surface is located at a second distance, less than the first distance, from the central section of the roller.

Abstract: An ultrasonic endovascular clearing device for use in a bodily lumen includes a powering handle configured to enclose one or more acoustic drivers, an acoustic amplifier and/or acoustic matching section including one or more amplifiers and/or matching elements and a driven wire. The acoustic drivers are configured to produce acoustic vibration in the ultrasonic frequency range. The amplifier/matching section matches and amplifies the acoustic vibration and drives the wire accordingly. The wire cleans due to one or both of a) its asymmetric shape being driven, b) its feature-enhanced surface being driven, whether on an asymmetric wire or not. The driving is pulsed or continuous, cavitating or noncavitating, and torsional or radial/lateral in its possible operational embodiments. A drug may be used by or delivered by the device and wire/tissue parameter sensing is optionally provided.

Abstract: A cardiac navigation system including a mapping catheter, a control system coupled to the mapping catheter, an electrode array, and means for driving an electrical current across the electrode array. The mapping catheter includes means for sensing an electrical field. The control system includes means for receiving sensed signals from the mapping catheter. The cardiac navigation system includes at least one electrode array including means for providing an electrical field across three axes. The three axes are approximately orthogonal with respect to one another. The means for driving an electrical current across the three axes includes means for providing a plurality of individual current sources to the electrode array.

Abstract: A deflection mechanism for an elongate medical device may comprise an actuator. The actuator may comprise a rotatable body comprising a channel, the channel comprising a plurality of recesses. The deflection mechanism may further comprises an activation wire having a proximal end and a distal end, and a wire lock attached to the proximal end of the activation wire. The wire lock may be disposed within the channel and configured to ride therein when the actuator body is rotated. An adjustable stop may be placed in one or more of the recesses of the channel so as to apply a force to the wire lock as the actuator is rotated so as to increase tension on the activation wire.

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 in a set position once placed there by actuating the actuator.