Abstract: An apparatus for maintaining a robotic catheter system in a responsive state includes a catheter, a plurality of linear translatable control elements, and a controller. In an embodiment, the catheter includes a proximal portion, a distal portion, and at least two steering wires. The steering wires may be configured at one end to control the movement of at least a portion of the distal portion of the catheter and at the other end for connection to a control member. In an embodiment, each control element may be configured to engage or interface with a respective control member, and the controller may be configured to measure a force exerted on at least one control member by a respective control element and further configured to linearly translate the control element to substantially maintain a force within a predetermined range.

Abstract: A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU) configured to acquire magnitudes for a component of a complex impedance between an electrode and tissue, and the power applied to the tissue during lesion formation. The ECU is configured to calculate a value responsive to the complex impedance component and the power. The value is indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, or a predicted tissue temperature. The method includes acquiring magnitudes for a component of a complex impedance between an electrode and tissue and the power applied during lesion formation. The method includes calculating a value responsive to the complex impedance component and the power, the value being indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, and/or a predicted tissue temperature.

Abstract: An input device for a robotic medical system includes a handle configured to be rotatable about a center axis, and to be longitudinally displaceable along the center axis. The input device also includes a deflection control element disposed on the handle and configured to selectively control deflection of the distal end of a flexible medical instrument electrically coupled to the input device. Longitudinal displacement of the handle may cause or result in a corresponding longitudinal motion or deflection of the flexible medical instrument. Rotation of the handle may cause or result in a corresponding rotation of the deflection plane. Longitudinal displacement and rotation of the handle may be detected or sensed electronically.

Abstract: A system and method for determining a position of a medical device within a body are provided. The system includes an electronic control unit that receives position signals from position sensors of a first type and a second type disposed on the device and applies a filter to each of the position signals to obtain filtered estimated positions for each sensor. The unit computes a spline connecting the position sensors of the first type responsive to the filtered estimated positions for the sensors and estimates a spline position for the sensor of the second type along the spline. The unit generates maps between the spline position and filtered and unfiltered estimated positions for the sensor of the second type and determines actual positions for the sensors of the first type responsive to the filtered estimated position for the sensors and a composite map of the two maps.

Abstract: A fluid delivery catheter configured to allow optimal fluid distribution through each electrode by varying the diameter of a catheter lumen is disclosed. Uniform or different fluid flow rates through longitudinally spaced apart elution holes may be achieved. Exemplary fluids for use with the catheter include a cooling fluid, a therapeutic fluid, and a medication.

Abstract: The invention relates to a flexible assembly for use in a region of a medical or surgical device. In preferred embodiments, the flexible region comprises a set of pull wires for controllably moving a treatment end of the device, and elements to separate the pull wires and maintain the integrity of the shaft of the flexible region in order to improve the operating aspects of the device. The devices and methods can be especially useful in ablation treatments, such as ablation at cardiac or epicardial tissues.

Abstract: A remotely deflectable electrophysiology/ablation catheter of the type intended for placing into an interior passage of the heart is disclosed. The distal end of this elongated tubular catheter has a pair of tension/compression members each with a flattened end portion connected to the distal electrode and extending through the catheter casing and attached to a user moveable actuator for effecting the tension/compression thereon for remotely curling the distal end of the catheter. Spaced ring electrodes are provided adjacent the distal electrode. A permanent bend is pre-formed in the casing and tension/compression members adjacent the ring electrodes about an axis perpendicular to the elongated tension/compression members.

Abstract: An electrode coupling output system associated with an electrode catheter that provides indication to the physician via the navigation system, concerning the electrical coupling of an electrode, such as an ablative or mapping electrode, with a patient. The indication may be provided by changing the color or other display characteristics of the electrode on the navigation system display or by way of providing a waveform indicating the electrode coupling. In this manner, electrode coupling information is provided to a physician in a manner that minimizes physician distraction.

Abstract: A method of generating a diagnosis map of at least a portion of the heart includes inserting an electrode within the portion of a heart, robotically moving the electrode therein, measuring electrophysiology information at a point on the surface of the heart, associating the measured electrophysiology information with position information for the point on the surface of the heart, repeating the measuring and associating steps for a plurality of points on the surface of the heart, thereby generating a plurality of surface diagnostic data points, and generating the diagnosis map therefrom. The electrode may be moved within the heart randomly, pseudo-randomly, or according to one or more predetermined patterns. A three-dimensional model of the portion of the heart may be provided and presented as a graphical representation, either with or without information indicative of the measured electrophysiology information superimposed thereon.

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: The present invention is directed to a high density mapping catheter including a number of shape memory electrode fibers and associated methods of construction and operation. The invention ensures good electrical contact between a large number of mapping electrodes and cardiac tissue in relation to a number of cardiac tissue approach angles, including head-on approaches. In addition, the invention allows for a reduced range of deflection angles in relation to deployment and retraction of the electrode fibers, thereby reducing resistance to retraction and reducing stress on the fibers and associated concerns regarding patient safety. The catheter of the present invention allows for rapid acquisition of a large amount of mapping data and allows for a variety of different geometries in relation to sweeping of the catheter across the cardiac tissue.

Abstract: A robotic catheter control system includes a plurality of electric motors. Diagnostic logic automatically detects motor runaway fault conditions based on the current motor position, the target motor position and a predetermined tolerance parameter. Fault conditions include overshoot, movement in the a non-prescribed direction, exceeding a prescribed maximum motor speed and exceeding a prescribed maximum motor acceleration. The diagnostic logic terminates operating power to the electric motor when a fault condition is detected for any one of the motor. An error message is generated to notify the operator of the fault.

Abstract: A catheter assembly includes an inner liner made of flexible material and an outer layer having a steering mechanism. The steering mechanism includes at least one flat wire and a corresponding lumen through which the flat wire may travel. The steering mechanism may also include at least one pull ring to which the flat wires are attached. A layer of heat shrink material may encompass the outer layer. A braided wire assembly may also be provided in the outer layer, and may be formed by braiding a plurality of flat wires into a wire mesh. The overall cross-section of the catheter assembly is preferably substantially circular. A catheter shaft may include a plurality of segments of differing hardness characteristics. The outer layer typically comprises a melt processing polymer such that the catheter assembly may be laminated using heat.

Abstract: A catheter comprising a flexible tubing having a proximal end and a distal end. An electrode assembly is attached to the distal end of the flexible tubing. The electrode assembly includes an electrically conductive tip electrode and a coupler which is connected between the tip electrode and the distal end of the flexible tubing. The coupler and the tip electrode are coupled by an interlocking connection. A first magnet is at least partially housed in the coupler. A fluid lumen extends through the flexible tubing to the coupler. The fluid lumen extends completely through the first magnet and connects to at least one port formed in the electrode assembly. A second magnet is spaced from the electrode assembly along a longitudinal axis of the tubing. The first magnet and the second magnet are responsive to an external magnetic field to selectively position and guide the electrode assembly within a body of a patient.

Abstract: The present invention is a splitable/peelable reinforced flexible tubular body (10) for a catheter or sheath (12). The body (10) comprises a proximal end (14), a distal end (16), a wall structure (18), and a lumen (20) defined by the wall structure (18). The wall structure (18) extends between the ends and includes a reinforcement layer (22) within the wall structure (18) and a separation line (26) extending longitudinally along the wall structure (18). The separation line (26) is adapted to facilitate the splitting/peeling of the wall structure (18) to allow a medical device such as a pacemaker lead to be removed from within the tubular body (10).

Abstract: An electrode coupling output system provides indication to the physician, via electrode guidance instrumentation, concerning the electrical coupling of an electrode, such as an ablative or mapping electrode, with a patient. The output can be provided to the physician via an output device incorporated into the handle set of the electrode catheter. For example, a visual, audio or mechanical output can be provided via the handle set. Additionally or alternatively, the output can be provided to the physician via a navigation system. The indication may be provided by changing the color or other display characteristics of the electrode on the navigation system display or by way of providing a waveform indicating the electrode coupling. In this manner, electrode coupling information is provided to a physician in a manner that minimizes physician distraction.

Abstract: An electrophysiology catheter includes an elongate catheter body having an elastically-deformable distal region predisposed to assume a spiral shape and a first plurality of electrodes disposed thereon. Each of the first plurality of electrodes includes an electrically active region limited to the inner surface of the spiral shape for use in non-contact electrophysiology studies. A second plurality of electrodes may also be disposed on the distal region interspersed (e.g., alternating) with the first plurality of electrodes, with each of the second plurality of electrodes having an electrically active region extending into the outer surface of the spiral shape for use in contact electrophysiology studies. The distal region may be deformed into a straight configuration for insertion into and navigation through the patient's vasculature, for example via use of a tubular introducer. As the distal region deploys beyond the distal end of the introducer, it resumes the spiral shape.

Abstract: The invention provides apparatus and methods for mapping conduction pathways and creating lesions in the heart wall for the treatment of atrial fibrillation. The apparatus may include at least one epicardial ablation probe having a plurality of electrodes for creating a lesion. The apparatus and method facilitate the formation of a lesion which electrically isolates the pulmonary veins from the surrounding myocardium.

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 catheter includes a flexible tubing having a proximal end and a distal end. The catheter also includes an electrode assembly attached to the distal end of the flexible tubing and having a first magnet therein. The electrode assembly further includes an electrically conductive tip electrode and an electrically nonconductive coupler which is connected between the tip electrode and the distal end of the flexible tubing. The coupler and the tip electrode are coupled by an interlocking connection. The catheter also includes a second magnet spaced from the electrode assembly along a longitudinal axis of the tubing. The first magnet and the second magnet are responsive to an external magnetic field to selectively position and guide the electrode assembly within a body of a patient.