Abstract: The disclosure relates generally to applications of Orientation Independent Sensing (OIS) and Omnipolar mapping Technology (OT) to various system, device and method embodiments as recited herein. Similarly, systems and methods suitable for supporting OIS and OT systems and methods are disclosed. Further, OIS and OT implementations that provide end user interfaces, diagnostic indicia and visual displays generated, in part, based on measured data or derived from measured data are also disclosed. Embodiments also describe applying optimization techniques to determine the greatest voltage difference of a local electric field associated with an electrode-based diagnostic procedure and a vector representation thereof. Various graphic user interface related features are also described to facilitate orientation and electrode clique signal display.

Abstract: A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an index responsive to the first and second values. The ECU is further configured to process the ECI to assess lesion formation in the tissue.

Abstract: Flexible high-density mapping catheter tips and flexible ablation catheter tips with onboard high-density mapping electrodes are disclosed. These tips can be used for diagnosing and treating cardiac arrhythmias. The flexible, distal tips are adapted to conform to tissue and comprise a plurality of microelectrodes mounted to permit relative movement among at least some of the microelectrodes. The flexible tip portions may comprise a flexible framework forming a flexible array of microelectrodes (for example, a planar or cylindrical array) adapted to conform to tissue and constructed at least in part from nonconductive material in some embodiments. The flexible array of microelectrodes may be formed from a plurality of rows of longitudinally-aligned microelectrodes. The flexible array may further comprise, for example, a plurality of electrode-carrying arms or electrode-carrier bands. Multiple flexible frameworks may be present on a single device.

Abstract: A method of displaying a virtual electrogram for a virtual bipole includes receiving a plurality of electrophysiological signals from a respective plurality of electrodes carried by a multi-dimensional catheter; using the received electrophysiological signals to compute a plurality of virtual electrograms associated with a respective plurality of virtual bipoles, each having a corresponding virtual bipole orientation; selecting a virtual bipole orientation; and displaying the virtual electrogram associated with the virtual bipole having the selected virtual bipole orientation. Aspects of the disclosure can be executed through a graphical user interface of an electroanatomical mapping system that also incorporates a visualization processor.

Abstract: Flexible high-density mapping catheter tips (10A) and flexible ablation catheter tips with onboard high-density mapping electrodes (18) are disclosed. These tips can be used for diagnosing and treating cardiac arrhythmias. The flexible, distal tips are adapted to conform to tissue and comprise a plurality of microelectrodes mounted to permit relative movement among at least some of the microelectrodes. The flexible tip portions may comprise a flexible framework forming a flexible array of microelectrodes (for example, a planar or cylindrical array) adapted to conform to tissue and constructed at least in part from nonconductive material in some embodiments. The flexible array of microelectrodes may be formed from a plurality of rows of longitudinally-aligned microelectrodes (18). The flexible array may further comprise, for example, a plurality of electrode-carrying arms or electrode-carrier bands. Multiple flexible frameworks may be present on a single device.

Abstract: Arrhythmic foci and other driver sites can be mapped using a multi-dimensional catheter. For instance, using a clique of three or more electrodes on the multi-dimensional catheter, an electroanatomical mapping system can identify a maximum bipolar voltage and an average unipolar voltage. The ratio of the average unipolar voltage to the maximum bipolar voltage can be interpreted as an indication of whether a cardiac location is an arrhythmic focus. Alternatively, an evaluation region can be defined about location in the patient's heart. The evaluation includes a plurality of rods, each associated with a respective E-field loop having a respective maximum and minimum amplitude bipole axes, with the rods being defined by the maximum amplitude bipole axes. For a sufficient number of rods within the evaluation region, a focus score for the evaluation region can be computed to reflect rod orientation consistency within the evaluation region.

Abstract: Electrophysiological signals from a graphical representation of an electrophysiology map including a plurality of electrophysiology data points can be sorted by receiving user inputs specifying a number of virtual electrodes for a virtual catheter and defining a pathway of the virtual catheter. A corresponding number of virtual electrodes can be defined on the pathway of the virtual catheter, and one or more electrophysiology data points relevant to electrical activity at the virtual electrodes can be identified, allowing output of a graphical representation of electrophysiological signals corresponding to the identified electrophysiology data points. Relevant electrophysiology data points can be identified by applying one or more relevance criterion, such as a distance criterion, a bipole orientation criterion, a time criterion, and/or a morphology criterion.

Abstract: The disclosure relates generally to applications of Orientation Independent Sensing (OIS) and Omnipolar mapping Technology (OT) to various system, device and method embodiments as recited herein. Similarly, systems and methods suitable for supporting OIS and OT systems and methods are disclosed. Further, OIS and OT implementations that provide end user interfaces, diagnostic indicia and visual displays generated, in part, based on measured data or derived from measured data are also disclosed. Embodiments also describe applying optimization techniques to determine the greatest voltage difference of a local electric field associated with an electrode-based diagnostic procedure and a vector representation thereof. Various graphic user interface related features are also described to facilitate orientation and electrode clique signal display.

Abstract: Aspects of the present disclosure are directed to flexible high-density mapping catheters with a planar array of high-density mapping electrodes near a distal tip portion. These mapping catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and may be used to diagnose cardiac conditions, such as cardiac arrhythmias for example.

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 method of generating a cardiac electrophysiology map includes receiving a reference biological signal and an electrical signal indicative of electrical activity at a location on a patient's heart. Using a graphical user interface, a practitioner designates at least two trigger point icons, one upward-pointing and one downward-pointing, on a graphical representation of the reference biological signal (e.g., a waveform). By pairing one upward-pointing icon with one downward-pointing icon, a plurality of triggering criteria are defined. Electrophysiology data points are captured and/or added to the electrophysiology map when the triggering criteria are satisfied.

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 method of generating a cardiac electrophysiology map includes receiving a reference biological signal and an electrical signal indicative of electrical activity at a location on a patient's heart. Using a graphical user interface, a practitioner designates at least two trigger point icons, one upward-pointing and one downward-pointing, on a graphical representation of the reference biological signal (e.g., a waveform). By pairing one upward-pointing icon with one downward-pointing icon, a plurality of triggering criteria are defined. Electrophysiology data points are captured and/or added to the electrophysiology map when the triggering criteria are satisfied.

Abstract: A method of generating a cardiac electrophysiology map includes receiving a reference biological signal and an electrical signal indicative of electrical activity at a location on a patient's heart. Using a graphical user interface, a practitioner designates at least two trigger point icons, one upward-pointing and one downward-pointing, on a graphical representation of the reference biological signal (e.g., a waveform). By pairing one upward-pointing icon with one downward-pointing icon, a plurality of triggering criteria are defined. Electrophysiology data points are captured and/or added to the electrophysiology map when the triggering criteria are satisfied.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter. Tip electrodes can be constructed from an electrically insulative substrate comprising an inner lumen, an external tip surface, and a plurality of channels extending from the inner lumen to the external tip surface, a plurality of segmented electrodes, and a plurality of spot electrodes. Each of the plurality of segmented electrodes and each of the plurality of spot electrodes can be laterally separated from each other by an electrically non-conductive substrate portion and each of the spot electrodes and each of the segmented electrodes can be electrically coupled to at least one wire or conductor trace.

Abstract: An electrophysiology catheter is provided. In one embodiment, the catheter includes an elongate, deformable shaft having a proximal end and a distal end and a basket electrode assembly coupled to the distal end of the shaft. The basket electrode assembly has a proximal end and a distal end and is configured to assume a compressed state and an expanded state. The electrode assembly further includes one or more tubular splines having a plurality of electrodes disposed thereon and a plurality of conductors. Each of the plurality of conductors extends through the tubular spline from a corresponding one of the plurality of electrodes to the proximal end of the basket electrode assembly. The tubular splines are configured to assume a non-planar (e.g., a twisted or helical) shape in the expanded state.

Abstract: A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an index responsive to the first and second values. The ECU is further configured to process the ECI to assess lesion formation in the tissue.

Abstract: A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an index responsive to the first and second values. The ECU is further configured to process the ECI to assess lesion formation in the tissue.

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 method of mapping cardiac electrical activity includes the acquisition of electrophysiological signals and using signal processing hardware to process such signals to identify lateness attributes thereof. If the lateness attribute exceeds a lateness threshold, then the corresponding point on the patient's heart can be designated as a therapy (e.g., ablation) target. It is also contemplated to use an upper bound on the lateness threshold, such that the corresponding point on the patient's heart is only designated as a therapy target if the lateness attribute both exceeds the lateness threshold and does not exceed the lateness bound. Both late activation (“Late-A”) and late potential (“Late-P”) attributes are contemplated.