Abstract: A diagnostic device and method for assessing lesion formation by measuring temperature changes during endocardial ablation. Intracardiac echo catheter data is accurately mapped into a model maintained by a visualization, navigation, or mapping system using the position and orientation of the intracardiac echo catheter transducer within the model. For each point in the model, either a frequency shift or echo time shift is calculated from the intracardiac echo data to determine local temperature changes, and the local temperature changes are displayed within a rendering of the model for the user.

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.

Abstract: A system and method for identifying a location of a physical structure in a body is provided. The system includes an electronic control unit configured to register a first image of a portion of the body in a three-dimensional coordinate system. The electronic control unit is further configured to identify the location of the physical structure in the three-dimensional coordinate system responsive to flow of a fluid shown in the image. The fluid may comprise blood. In one embodiment, the electronic control unit is further configured to generate a second image, such as a three dimensional model, incorporating a representation of the physical structure within a larger physical environment in the three-dimensional coordinate system.

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: 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. A device and method to manufacture a magnetically driven electrode-catheter with flexible tethering includes one or more KEVLAR® fibers, distributed centrally or peripherally within a catheter shaft and oriented longitudinally, transversely, angularly or spirally.

Abstract: A flexible guidewire comprising a hollow tube, having a proximal section and a distal section, the distal section having a distal tip, the outer diameter of the distal section gradually decreasing toward the distal tip, the outer diameter of the distal tip being larger than the smallest outer diameter of the distal section, the flexible guidewire further comprising a plug coupled with the distal tip of the hollow tube for creating a non-traumatic tip, and the flexible guidewire further comprising a tubular spring, being place around the distal section of the hollow tube for maintaining the outer diameter of the hollow tube over the length thereof and for supporting compressive loads.

Abstract: A medical device, such as an introducer, includes a shaft having a lumen therethrough. A distal region of the shaft includes both a fixed curve region and a steerable region. According to certain aspects of the disclosure, the fixed curve region is more proximal than the steerable region. The fixed curvature of the distal region is selected to facilitate positioning of the distal end of the medical device in the general vicinity of a target, such as the left atrial appendage, while the steerable region allows for “fine tuning.” The lumen of the shaft is a large bore, typically on the order of about 12F to about 14F, to facilitate passage of larger medical devices, including left atrial appendage occlusion devices.

Abstract: A control system for a medical remote catheter guidance system includes an ECU, a computer-readable memory coupled to the ECU, and user interface (UI) logic stored in the memory configured to be executed by the ECU. The user interface logic receives input from a touch screen display with respect to a view of an anatomical model, associates a user type with the input, and interprets the input according to the associated user type and input. The user interface logic may be further configured to receive simultaneous inputs from at least two different users and to associate different user types with each of said simultaneous inputs. The user interface logic may associate each input with a user type according to a location of the input on the touch screen display.

Abstract: An apparatus for determining a length of a portion of a steering wire disposed within a bendable medical device includes an electrical contact slidably coupled with a steering wire, an electrical source configured to transmit an electrical signal through a portion of the steering wire, and a processor configured to monitor a parameter of the electrical signal at or about the electrical contact and configured to determine a length of a portion of the steering wire using the monitored parameter.

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: A method of constructing an EP map is provided. The method comprises obtaining a first surface model of an anatomic structure, the first model comprising an alpha shell of a cloud of location data points. The method further comprises obtaining a second surface model of the structure, the second surface model comprising an alpha shell of a cloud of measurement points. The method further comprises processing the first and second models to identify, for at least one of the location data points, a point on the second surface model that is closest in distance to the location data point, wherein said identified point has a value of said EP parameter associated therewith. The method still further comprises assigning a visual indicator to the location data point based on the EP parameter value associated with the identified point and in accordance with a visualization scheme corresponding to the EP parameter.

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: A transseptal medical device (10, 110) is provided including a dilator (12, 112), a needle (14, 114), and a needle control mechanism (22, 122). The needle (14, 114) may be disposed within the dilator (12, 112), and the needle control mechanism (22, 122) may be operably connected to a proximal end (24, 124, 16, 116) of the needle (14, 114) or the dilator (12, 112) for selective adjustment of the distal end (26, 126) of the needle (14, 114) from a first position within the dilator (12, 112) to a second position external to the dilator (12, 112). The needle control mechanism (22) may include an actuator (32) configured for rotation within the dilator in one embodiment.

Abstract: A three dimensional physiological mapping system utilizing an intracardiac echo catheter capable of being located in six degrees of freedom by a visualization, navigation, or mapping system. An echocardiography image of the intracardiac echo catheter may be projected within a geometric model of the visualization, navigation, or mapping system where the location of the projected image is adjusted in response to user input identifying a structure present in the echocardiography image and the geometric model.

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.

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: 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 catheter assembly includes an inner liner made of flexible material and an outer layer having a steering mechanism. A catheter assembly is provided that includes an inner liner made of flexible material, and an outer layer having a steering mechanism that includes at least one wire and a corresponding lumen for each of the at least one wire through which the respective wire may travel. The outer layer includes a braided wire assembly that includes at least two wires braided into a wire mesh, and further includes a see-through portion positioned proximate a pull wire extraction location to facilitate extraction.

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 distal tip assembly for an elongate medical device having an axis comprises a shaft having a proximal end portion, a distal end portion, a wall, and a central lumen extending axially between said proximal end portion and said distal end portion. The distal tip assembly further comprises a position sensor disposed in an outer sleeve such that the sensor can shift relative to the sleeve. The sleeve is disposed at least in part in the wall and is substantially fixed thereto.