Abstract: A catheter or lead having a flexible printed circuit for conveying signals and/or energy. Each trace may be in electrical connection with one or more external electrical contacts. More specifically, each trace is typically electrically connected to a single contact. The traces and contacts may assist in diagnosis and/or detection of bio-electrical signals emitted by organs, and may transmit such signals to a connector or diagnostic device affixed to the catheter. The external electrical contacts may detect bioelectric energy or may deliver electrical or thermal energy to a target site.

Abstract: A system and method are provided for assessing the compliance of internal patient tissue for purposes of catheter guidance and/or ablation procedures. Specifically, the system/method provides for probing internal patient tissue in order to obtain force and/or tissue displacement measurements. These measurements are utilized to generate an indication of tissue elasticity. In one exemplary embodiment, the indication of elasticity is correlated with an image of the internal tissue area and an output of this image including elasticity indications is displayed for a user.

Abstract: Embodiments of the present invention provide an irrigated catheter having irrigation fluid directed at target areas where coagulation is more likely to occur so as to minimize blood coagulation and the associated problems. In one embodiment, an irrigated ablation electrode assembly for use with an irrigated catheter device comprises a proximal member having at least one passageway for a fluid with an outlet disposed at an external surface of the proximal member; and a distal member connected with the proximal member and having an external surface. The distal member includes an electrode. The external surface of the proximal member and the external surface of the distal member meet at an intersection. The at least one passageway of the proximal member is configured to direct a fluid flow through the outlet toward a region adjacent the intersection.

Abstract: A method of identifying the fossa ovalis in a patient by positioning one or more electrodes against the tissue of the interatrial septum of the patient and acquiring unipolar and/or bipolar electrograms of the tissue of the interatrial septum while moving the electrodes to a plurality of positions against the tissue of the interatrial septum. The fossa ovalis is identified on the basis of unipolar voltage reduction, signal fractionation, broadened signal, reduced signal slew rate, reduced local myocardial impedance, increased phase angle and/or increased pacing threshold. An apparatus for identifying the fossa ovalis is also provided.

Abstract: The present invention relates to improved ablation electrodes and catheter assemblies, as well as methods useful in conjunction with irrigated ablation catheters. Embodiments of the present invention further relate to an irrigated catheter having irrigation fluid directed at target areas where coagulation is more likely to occur to help minimize blood coagulation and the associated problems. The present invention further relates to an ablation electrode having an outer body with a proximal portion and a distal portion an inner cavity and at least one passageway that extends to an opening on the outer surface of the electrode, wherein the passageway is directed towards the proximal portion and/or proximal end of the electrode forming an acute angle with a longitudinal axis of the electrode.

Abstract: A method of repairing a three dimensional surface mesh model to be watertight and manifold generally includes identifying a plurality of hole edges in the surface mesh model, selecting one of the hole edges, creating a cycle of hole edges that defines a hole in the surface mesh model, converting the cycle of hole edges into two or more cycles of exactly three edges each, and adding a triangular facet to the surface mesh model for each of the cycles of exactly three edges. The process may be repeated until the model is substantially watertight. Non-manifold vertices may be repaired by selecting a vertex of the model, identifying a number of independent cycles of triangular facets sharing the selected vertex, and redefining the selected vertex for at least all but one of the number of independent cycles. This process may be repeated until the model is manifold.

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: 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: An electrode for ablation therapy includes a flexible conductive element for conducting electrical energy and a flexible conductive polymer member in electrically conductive contact with the conductive element. A catheter shaft may be coupled to the conductive element and/or the flexible conductive polymer member. The flexible conductive element may be formed as a helical coil, a mesh coating or wrap, or any other suitable form, and may surround (wholly or partially) a flexible electrically insulative, and optionally thermally conductive, member. A heat sink may be thermally coupled to at least one of the flexible conductive polymer member and the flexible electrically insulative member. The flexible electrically insulative member may include a passageway for coolant fluid to cool the electrode during ablation. The passageway may include at least one efflux hole to permit coolant fluid to flow from the passageway, or may define a closed loop.

Abstract: An ablating device has a cover which holds an interface material such as a gel. The cover contains the interface material during initial placement of the device. The ablating device may also have a removable tip or a membrane filled with fluid. In still another aspect, the ablating device may be submerged in liquid during operation.

Abstract: A transseptal needle includes an elongate needle body having a distal end and a proximal end and a cannular needle tip located proximate the distal end of the needle body. The needle tip has a distal segment, a proximal segment, and a longitudinal axis. An inner surface of the needle tip defines a passageway spanning at least a portion of the needle tip, and an outer surface of the needle tip defines a wall with the inner surface. The distal segment of the needle tip also includes a wedge surface and a dome-shaped region. The wedge surface forms a wedge angle of other than 90 degrees relative to the longitudinal axis. The dome-shaped region, which intersects the wedge surface, includes at least two bevels that intersect the wedge surface and that intersect each other at one or more points on the needle tip.

Abstract: A high intensity focused ultrasound transducer includes an ultrasonic emitter having a surface that emits ultrasonic energy along a beam path, at least one low attenuation polymeric ultrasonic lens acoustically coupled to the surface in the beam path of the ultrasonic energy, such that the lens can direct the ultrasonic energy in at least one direction, and at least one stress mitigation feature, such as a kerf, a heat sink, or an acoustic matching layer, to mitigate thermal expansion mismatch stresses within the transducer. For manufacturing simplicity, the first surface is typically either flat or monotonically curvilinear. The lens may take a variety of shapes, including Fresnel features, and may focus, collimate, or defocus the ultrasonic energy. Any orientation and positioning of the at least one ultrasonic lens relative to the first ultrasonic emitter is contemplated. Manufacture is further simplified by molding, casting, or thermoforming the lens.

Abstract: A method and apparatus for enhancing evaluation of valvular function in terms of regurgitation is described. The techniques include a method and apparatus for monitoring flow across a valve and evaluating regurgitation through the valve. An ultrasound scanner with Doppler capabilities processes and represents Doppler signal data in a color scale. The Doppler signal data is processed such that different colors are assigned to signals that have different power levels. An ECG signal may be correlated to the Doppler signals to determine systole and diastole periods, then the regurgitation is determined by estimating a peak reverse blood flow based on Doppler signals from blood at systole. The Doppler signals may also be processed so as to determine a cardiac cycle, then regurgitation is determined as the ratio of a reverse blood flow as a percentage of a forward blood flow.

Abstract: Methods for processing two-dimensional ultrasound images from an intracardiac ultrasound imaging catheter provide improved image quality and enable generating three-dimensional composite images of the heart. Two-dimensional ultrasound images are obtained and stored in conjunction with correlating information, such as time or an electrocardiogram. Images related to particular conditions or configurations of the heart can be processed in combination to reduce image noise and increase resolution. Images may be processed to recognize structure edges, and the location of structure edges used to generate cartoon rendered images of the structure. Structure locations may be averaged over several images to remove noise, distortions and blurring from movement.

Abstract: An ablating device has a cover which holds an interface material such as a gel. The cover contains the interface material during initial placement of the device. The ablating device may also have a removable tip or a membrane filled with fluid. In still another aspect, the ablating device may be submerged in liquid during operation.

Abstract: An ablation and visualization device includes a shaft, at least one ablation element coupled to the distal end of the shaft, and a scope coupled to the shaft proximate the distal end. The scope may be a fiber optic endoscope, an infrared sensor, or an ultrasound sensor, and may be coupled to an output device to display imagery collected by the scope. The scope includes at least one aperture, which may be movable. An optical element, such as a lens or filter, may be positioned over the aperture. The scope may be positioned laterally relative to the ablation elements or in a plane substantially parallel to and spaced apart from the ablation elements. The scope may be positioned with the aperture positioned distally or proximally relative to the ablation elements. The scope may be slidably or rotatably coupled to the shaft.

Abstract: An ultrasound imaging catheter system includes a pivot head assembly coupled between a ultrasound transducer array and the distal end of the catheter. The pivot head assembly includes a pivot joint enabling the transducer array to pivot through a large angle about the catheter centerline in response pivot cables controlled by a wheel within a handle assembly. Pivoting the ultrasound transducer array approximately 90° once the catheter is positioned by rotating the catheter shaft and bending the distal section of the catheter, clinicians may obtain orthogonal 2-D ultrasound images of anatomical structures of interest in 3-D space. Combining bending of the catheter by steering controls with pivoting of the transducer head enables a greater range of viewing perspectives. The pivot head assembly enables the transducer array to pan through a large angle to image of a larger volume than possible with conventional ultrasound imaging catheter systems.

Abstract: Embodiments of the present invention provide an irrigated catheter having irrigation fluid directed at a taper angle generally in parallel with a proximally tapered portion of the tip electrode to provide improved electrode surface cooling. In one embodiment, an irrigated ablation electrode assembly for use with an irrigated catheter device comprises a proximal member having at least one passageway for a fluid with an outlet disposed at an external surface of the proximal member; and a distal member connected with the proximal member and having an external surface, the distal member including an electrode. The external surface of the distal member has a tapered proximal portion narrowing toward the proximal member at a taper angle with respect to a longitudinal axis of the distal member.

Abstract: A process for preventing atrial premature contractions originating within a pulmonary vein from being conducted into the left atrium of a human heart. More specifically, an ablation lesion is formed which electrically isolates the located source of the atrial premature contraction in the pulmonary vein from connection with the left atrium and blocks passage of the atrial premature contraction originating from the located source.

Abstract: Atrial arrhythmias, a major contributor to cardiovascular morbidity, are believed to be influenced by autonomic nervous system tone. The main purpose of this invention was to highlight new findings that have emerged in the study of effects of autonomic nervous system tone on atrial arrhythmias, and its interaction with class III antiarrhythmic drug effects. This invention evaluates the significance of sympathetic and parasympathetic activation by determining the effects of autonomic nervous system using a vagal and stellar ganglions stimulation, and by using autonomic nervous system neurotransmitters infusion (norepinephrine, acetylcholine).