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: A system for implementing a procedure for the diagnosis or treatment of tissue in a body is provided. The system includes an electronic control unit configured to generate a graphical user interface on a display. The interface depicts an image of the tissue. The unit is further configured to receive one or more inputs regarding target locations on the tissue for diagnosis or treatment. The electronic control unit identifies a catheter for use in the procedure and determines configurations for a distal end of the catheter at each target location. The unit superimposes representations of the distal end of the catheter having the determined configurations on the image of the tissue at the target locations. The unit may also generate control signals to guide the distal end of the catheter to the target locations and to assume the determined configurations at each location.

Abstract: An ablation device for ablating epicardial tissue on a heart is disclosed. The device includes an elongated probe having at least one tissue contacting surface for contacting the epicardial tissue. The device also includes a plurality of suction ports and a plurality of ablating elements aligned along at least part of the axis of the elongated probe and coupled with a tissue contacting member. The assembly may optionally include a visualization device to determine the location and depth of transmural lesions. Also disclosed are methods of locating and placing the ablation device and forming transmural lesions on a heart for treatment of cardiac arrythmias.

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: A system and method for assessing a degree of coupling between an electrode and tissue in a body is provided. Values for first and second components of a complex impedance (e.g., resistance and reactance or impedance magnitude and phase angle) between the electrode and the tissue are obtained. These values are used together with a standardization value indicative of a deviation from a reference standard by a parameter associated with at least one of the body, the electrode and another component of the system to calculate a coupling index that is indicative of a degree of coupling between the electrode and the tissue. The coupling index may be displayed to a clinician in a variety of ways to indicate the degree of coupling to the clinician. The system and method find particular application in ablation of tissue by permitting a clinician to create lesions in the tissue more effectively and safely.

Abstract: A medical device can be localized by providing at least three non-colinear localization elements (e.g., electrodes) thereon. Once placed in a non-ionizing localization field, three adjacent localization elements, at least one of which will typically be a spot electrode, may be selected, and the non-ionizing localization field may be used to measure their locations. A cylinder is defined to fit the measured locations of the selected localization elements. The cylinder is rotationally oriented using the measured location of a spot electrode. Location and rotational attitude information may be used to construct a three-dimensional representation of the medical device within the localization field. The electrodes may be provided on the medical device or on a sheath into which the medical device is inserted. The invention also provides systems and methods for identifying and calibrating deflection planes where the medical device and/or sheath are deflectable.

Abstract: A catheter with a mechanism for omni-directional deflection of a catheter shaft includes a shaft assembly and a controller. The shaft assembly includes a first tubular component that has a preformed curvilinear distal section, a second, substantially straight tubular component with a main axis and an outer shaft. The first and second components are configured for slidable movement therebetween while preserving common rotation so that when the second component is axially moved in a distal direction, the second component deflects the preformed curvilinear section towards the main axis while orientation of the outer shaft is preserved. The controller is configured to effect relative axial movement between the first and second components as well as to effect rotation of the first and second components (and thus also of the preformed curvilinear distal section) without any rotation of the shaft relative to the handle.

Abstract: A catheter assembly comprises a deflectable catheter shaft comprising a distal end and a lumen extending therethrough. The catheter assembly further comprises least one pull wire comprising a distal portion comprising a side and a distal end, wherein the side comprises a first side portion and a second side portion. The catheter assembly further comprises a distal pull assembly operatively coupled to the at least one pull wire. The distal pull assembly comprises a longitudinal axis, a first surface, and a second surface. The first side portion of the at least one pull wire is adjacent to the first surface of the distal pull assembly, and the second side portion of the at least one pull wire is adjacent to the second surface of the distal pull assembly.

Abstract: A robotic catheter rotatable device cartridge may include a housing member attachable to a drive mechanism for rotating the cartridge and a catheter attached to the cartridge along an axial direction of the catheter. A slider block may be generally slidable relative to the housing and engaged with one or more steering wires for controlling movement of the catheter in a transverse direction relative to the axial direction. The catheter may include the steering wire(s) engaged therewith and movable in the transverse direction when the slider block is linearly driven in a predetermined direction.

Abstract: The invention relates to an ablation catheter which controls the temperature and reduces the coagulation of biological fluids on an electrode of a catheter, prevents the impedance rise of tissue in contact with the electrode, and maximizes the potential energy transfer to the tissue, thereby allowing an increase in the lesion size produced by the ablation. The electrode includes passages positioned to allow saline flow out of an inner cavity of the electrode. This fluid flow is pulsatile to increase turbulence, reducing areas of stagnant flow, and produces a desired cooling effect.

Abstract: A catheter is disclosed having a flexible tubing with a proximal end and a distal end. The catheter comprising at least one movable magnet provided within the distal end of the flexible tubing. A control mechanism is operable to selectively activate the at least one movable magnet from the proximal end of the flexible tubing. The at least one movable magnet is responsive to an external magnetic field to position and guide the distal end of the flexible tubing within a body of a patient.

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: A robotic catheter device cartridge may include a finger or a slider block generally disposed in a channel and engaged with a steering wire. The steering wire may control movement of a component having the steering wire engaged thereto when the finger or the slider block is linearly driven in a predetermined direction. The cartridge may be a transseptal cartridge having a transseptal needle connected thereto, a catheter cartridge having a catheter connected thereto, or a sheath cartridge having a sheath connected thereto.

Abstract: A medical device for diagnosis or treatment of tissue is disclosed. The device includes an electronically-controlled tool configured for diagnosis or treatment, an electrical connector, and a computer readable memory. The electrical connector is configured for connection with an electronic control unit and configured to receive control signals, including signals concerning the operation of the tool, from the electronic control unit. The computer readable memory is accessible through the connector. The memory can include a set of programming instructions for control of the tool, and the programming instructions can be configured to be downloadable from the memory upon connection of the electrical connector with the electronic control unit. A system is also disclosed in which the electronic control unit is configured to transmit a data log from memory in the electronic control unit to the memory in the medical device upon the occurrence or detection of a predetermined event.

Abstract: A family of catheter electrode assemblies includes a flexible circuit having a plurality of electrical traces and a substrate; a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the electrode. A non-contact electrode mapping catheter includes an outer tubing having a longitudinal axis, a deployment member, and a plurality of splines, at least one of the plurality of splines comprising a flexible circuit including a plurality of electrical traces and a substrate, a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the ring electrode. A method of constructing the family of catheter electrode assemblies is also provided.

Abstract: An elongate medical device with independently-deflectable segments and a handle for manually deflecting those segments can include a shaft having a distal segment and proximal segment, at least one proximal segment deflection wire adapted to deflect the proximal segment, at least one distal segment deflection wire adapted to deflect the distal segment independent of the proximal segment, and a handle portion. The handle portion may comprise a first manual actuation mechanism coupled to the at least one distal segment deflection wire and a second manual actuation mechanism coupled to the at least one proximal segment deflection wire. Actuation of the first manual actuation mechanism may impart a tensile force on the distal segment deflection wire to cause the distal segment to deflect, and actuation of the second manual actuation mechanism may impart a tensile force on the proximal segment to cause the proximal segment to deflect.

Abstract: An electrode catheter and a method for assessing catheter-tissue contact for tissue ablation are disclosed. An exemplary electrode catheter comprises a flexible catheter shaft. At least one piezoelectric sensor is oriented coaxial to the flexible catheter shaft. The at least one piezoelectric sensor is responsive to movement of the flexible catheter shaft by generating electrical signals corresponding to the amount of movement. The system may also include an output device electrically connected to the at least one piezoelectric sensor. The output device receives the electrical signals for dynamically assessing a level of contact between the flexible catheter shaft and a moving tissue. In another exemplary embodiment, the system may be implemented in a hydrodynamic environment.

Abstract: A method of calibrating a robotic device, such as a cardiac catheter, includes oscillating the device on an actuation axis by applying an oscillation vector at an oscillation frequency. While oscillating, a location of the device is periodically measured to generate a plurality of location data points, which may express the location of the device relative to a plurality of measurement axes. The location data points are then processed using a signal processing algorithm, such as a Fourier transform algorithm, to derive a transfer function relating a position of the device to a movement vector for the actuation axis. The transfer function may be resolved into and expressed as a calibration vector for the actuation axis, which may include one or more components, including zero components, directed along each of the measurement axes. The process may be repeated for any actuation axes on which calibration is desired.

Abstract: Template systems and methods for various procedures (e.g., tissue ablation procedures) are disclosed. An exemplary template system comprises a track having at least one suction port. The at least one suction port anchors the track to a tissue after the track is positioned adjacent a target area. The template system may further comprise a transducer operatively associated with the track. Exemplary transducers include imaging transducers and ablating transducers. The transducer is guided by the track adjacent the target area while the transducer is moved along the track for a procedure. One or more umbilical may provide a conduit to the track and/or transducer so that the template system may be positioned in a patient's body (e.g., for a procedure on the patient's heart) and operated remotely by a physician or other user from outside of the patient's body.

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.