Abstract: An intracardiac imaging system configured to display electrode visualization elements within an intracardiac echocardiography image where the electrode visualization elements represent intracardiac electrodes in close proximity to the plane of the image. The system further allows cross sections of tissue structures embodied in intracardiac echocardiography images to be modeled within a visualization, navigation, or mapping system when automatically segmented to generate shell elements for modifying the modeled tissue structures.

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.

Abstract: A catheter includes a handle that advantageously limits the amount of torque that can be imparted to the body of the catheter. This advantageously reduces the likelihood of catheter failure, damage to tissue, or damage to medical devices introduced into the vasculature via the catheter. The catheter handle includes a grip portion that the practitioner manipulates in order to impart a torque and a torque transmitting portion operably coupled thereto that transmits the torque to the catheter body. A torque limiting mechanism decouples the torque transmitting portion from the grip portion, the body, and/or any pull wires when the torque imparted to the grip portion exceeds a torque threshold, thereby preventing excessive torques from being transmitted to the catheter body and/or pull wires. A practitioner may be able to adjust the torque threshold and may be able to disable the torque limiting mechanism.

Abstract: Medical devices and systems comprising medical devices are provided. The device comprises a shaft having a major lumen sized to receive a second medical device and an electroanatomical system imaging element mounted thereon. The shaft includes an inner liner and outer layer. The system comprises a medical device having a shaft and an electroanatomical system imaging element mounted thereon. The shaft has a major lumen sized to receive another device. The system further comprises an electroanatomical navigation system configured to receive signals from the electroanatomical system imaging element and to determine a position of the electroanatomical system imaging element and/or monitor electrophysiological data.

Abstract: Medical devices, methods of manufacturing medical devices, and systems comprising medical devices are provided. The device comprises a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon. The shaft includes an inner liner and outer layer. The method of manufacture includes forming a shaft by forming an inner liner and an outer layer by covering the inner liner with a polymeric material. The method further includes mounting an electrode onto the shaft of the device, and then heating and cooling the shaft. The system comprises a medical device having a shaft and an electrode mounted thereon. The shaft has a major lumen sized to receive another device. The system further comprises an electronic control unit configured to receive signals from the electrode and to determine a position of the electrode and/or monitor electrophysiological data.

Abstract: Ablation catheter comprising an elongate member with proximal and distal ends, wherein the distal end is arranged to apply a high energy electrical shock from a plurality of locations along the length of said distal end and wherein said distal end is curved. Preferably the distal end of the elongate member extends in a circle segment.

Abstract: Medical devices and systems comprising medical devices are provided. The kit includes a catheter-introducer comprising a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon and a catheter comprising an elongate body and at least two flexible electrode segments on the distal end. The shaft includes an inner liner and outer layer. The system comprises a first medical device having a shaft and an electroanatomical system imaging element mounted thereon and a second medical device having an elongate body and at least two flexible electrodes mounted on the distal end. The shaft has a major lumen sized to receive the second medical device. The system further comprises an electroanatomical navigation system configured to receive signals from the electroanatomical system imaging element and to determine a position of the electroanatomical system imaging element and/or monitor electrophysiological data.

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 kit for the diagnosis or treatment of tissue in a body cavity includes an introducer and a catheter insertable through the lumen of the introducer having a proximal segment, a working segment and a flexible distal tip segment. The flexible distal tip segment is located adjacent the distal end of the working segment and includes a proximal end, a distal end and a pre-formed bend or curve that permits the catheter to exit the introducer in a lateral direction relative to the introducer body to prevent inadvertent damage to the tissue during a medical procedure. All or part of the working segment and the flexible distal tip segment may be adhesive-filled. The catheter may also include a plurality of sensing and/or energy delivery elements on the working segment and a shape-memory wire terminating at the distal end of the working segment. Methods of use and methods of manufacturing are also described.

Abstract: A method of manufacturing a catheter shaft includes extruding an inner polymeric layer having a main lumen and two or more side lumens spaced about the main lumen; forming an outer polymeric layer about the inner polymeric layer; and inserting at least one elongate member, such as a wire, through each side lumen of the inner polymeric layer. The side lumens are less than about ? the size of the main lumen. The method may further include the step of forming a braided layer between the inner polymeric layer and the outer polymeric layer. In an alternate embodiment, the method includes co-extruding an inner polymeric layer and a multi-lumen layer, the multi-lumen layer having two or more side lumens; forming an outer polymeric layer about the multi-lumen layer; and inserting at least one elongate member through each side lumen. Catheter assemblies made according to the described methods are also disclosed.

Abstract: Disclosed herein are various deflectable catheter systems that utilize materials having negative coefficients of thermal expansion to cause the catheter to deflect. A representative embodiment of the present invention includes a catheter having a heat-sensitive control member located outside the distal end of the catheter, but which is in mechanical communication with the distal end of the catheter such that heat may be applied to the control member to cause the distal portion to deflect. The applied heat, however, does not introduce any significant heat into the distal end of the catheter. The system may also include a processor to estimate an amount by which the catheter has been deflected based in part on temperature information of the control member, or even resistance measurements for the control member. The system may also include calibration systems and methods.