Abstract: A system and method for obtaining an OIS coordinate frame comprising an electronic control unit configured to determine a local 3D electric field loop, create a zero mean version of E(t) over a depolarization interval, compute an ? value at each of a plurality of time intervals, compute an initial estimate of ? from a cross product of E and the ? value for each of the plurality of time intervals, average the initial estimate of ? from each of the plurality of time for a best estimate of ?, determine a plurality of â(?) values and using the corresponding {circumflex over (n)}(?) values, compute a composite match score, and choose at least one best value for â and a best value for {circumflex over (n)}.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter or more proximally located. Tip electrodes can be constructed from an electrically-insulative substrate covered with a conductive material. The conductive material can be deposited on the electrically-insulative substrate to form a single tip electrode or multiple segmented electrodes. In some embodiments the tip electrode can include irrigation flow holes for irrigation. A method of manufacturing a tip electrode comprising a thin layer of conductive material deposited on an electrically-insulative substrate is disclosed. Segmented ring electrodes can be constructed from segmented ring electrodes that can be equally separated around a circumference of a catheter. The segmented ring electrodes can be formed into segmented electrode subassemblies that can then be joined to a catheter shaft.

Abstract: An efficient system for diagnosing arrhythmias and directing catheter therapies may allow for measuring, classifying, analyzing, and mapping spatial electrophysiological (EP) patterns within a body. The efficient system may further guide arrhythmia therapy and update maps as treatment is delivered. The efficient system may use a medical device having a high density of sensors with a known spatial configuration for collecting EP data and positioning data. Further, the efficient system may also use an electronic control system (ECU) for computing and providing the user with a variety of metrics, derivative metrics, high definition (HD) maps, HD composite maps, and general visual aids for association with a geometrical anatomical model shown on a display device.

Abstract: A system and method for assessing effective delivery of ablation therapy to a tissue in a body is provided. A three-dimensional anatomical map of the tissue is generated and displayed with the map defining a corresponding volume. An index is generated corresponding to a location within the volume with the index indicative of a state of ablation therapy at the location. The index may be derived from one or more factors such as the duration an ablation electrode is present at the location, the amount of energy provided, the degree of electrical coupling between an ablation electrode and the tissue at the location and temperature. A visual characteristic (e.g., color intensity) of a portion of the anatomical map corresponding to the location is then altered responsive to the index.

Abstract: A system and method are provided for determining electrophysiological data. The system comprises an electronic control unit that is configured to receive electrical signals from a set of electrodes, receive position and orientation data for the set of electrodes from a mapping system, compensate for position and orientation artifacts of the set of electrodes, compose cliques of a subset of neighboring electrodes in the set of electrodes, determine catheter orientation independent information of a target tissue, and output the orientation independent information to a display.

Abstract: An efficient system for diagnosing arrhythmias and directing catheter therapies may allow for measuring, classifying, analyzing, and mapping spatial electrophysiological (EP) patterns within a body. The efficient system may further guide arrhythmia therapy and update maps as treatment is delivered. The efficient system may use a medical device having a high density of sensors with a known spatial configuration for collecting EP data and positioning data. Further, the efficient system may also use an electronic control system (ECU) for computing and providing the user with a variety of metrics, derivative metrics, high definition (HD) maps, HD composite maps, and general visual aids for association with a geometrical anatomical model shown on a display device.

Abstract: A system and method for assessing effective delivery of ablation therapy to a tissue in a body is provided. A three-dimensional anatomical map of the tissue is generated and displayed with the map defining a corresponding volume. An index is generated corresponding to a location within the volume with the index indicative of a state of ablation therapy at the location. The index may be derived from one or more factors such as the duration an ablation electrode is present at the location, the amount of energy provided, the degree of electrical coupling between an ablation electrode and the tissue at the location and temperature. A visual characteristic (e.g., color intensity) of a portion of the anatomical map corresponding to the location is then altered responsive to the index.

Abstract: An introducer sheath for a medical device is provided. The sheath includes a deformable, elongate body disposed about a longitudinal axis. The body has proximal and distal ends and defines a lumen extending between the proximal and distal ends and configured to allow passage of the medical device therethrough. The body is configured to allow an electric current to pass radially between a space outside of the body and the lumen such that the position of the medical device within a patient can be monitored and electrogram readings from body tissues can be measured while the device is in the sheath. In some embodiments of the invention, the body may include a one or more apertures extending from the radially outer surface of the body to the lumen or a portion of the body may be made from a conductive and/or fluid permeable material.

Abstract: A method of stimulation therapy and an apparatus for providing the therapy which addresses cardiac dysfunction including heart failure. The therapy employs atrial pacing pulses delivered to a heart after the atrial refractory period and timed so that they will not cause a ventricular contraction. These atrial pacing are timed to achieve beneficial effects on myocardial mechanics (efficacy) while maintaining an extremely low level of risk of arrhythmia induction. These methods may be employed individually or in combinations in an external or implantable ESS therapy delivery device.

Abstract: An electrophysiological laboratory system comprises a subsystem configured to perform diagnostic and/or therapeutic functions, a medical device, and an interface module disposed therebetween. The medical device comprises a shaft having proximal and distal portions, high- and low-impedance electrical pathways disposed within the shaft, and an electrode disposed at the distal portion of the shaft and electrically coupled to one or both of the high- and low-impedance electrical pathways. The electrode is configured to perform diagnostic and/or therapy delivery functions. The interface module comprises a high-impedance channel configured to couple the high-impedance pathway of the medical device to the subsystem, and to attenuate magnetic resonance RF and gradient field pulses generated by the MRI system. The interface module further comprises a low-impedance channel configured to couple the low- impedance pathway of the medical device to the subsystem.

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 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: 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: An embodiment of a method for solving the inverse problem of electrophysiology and determining a voltage distribution on a surface of a tissue may comprise receiving a plurality of voltages collected by a plurality of electrodes adjacent to the surface, discretizing the problem using a Finite Element Method (FEM) or a Boundary Element Method (BEM), introducing one or more regularization terms to an error minimization formulation, and solving, by a processor, the voltage distribution according to the plurality of voltages and according to the regularization terms. The regularization terms may comprise one or more of a Laplacian smoothness operator, a Tikhonov regularization matrix, a confidence matrix, and a linear operator that interpolates the plurality of electrode voltages to the tissue voltage distribution.

Abstract: The invention relates to medical devices such as pacemakers, pulse generators, cardioverter-defibrillators and the like and more particularly relates to modular and reconfigurable medical system platforms and methods of designing, testing, controlling and implementing diverse therapies, diagnostics, physiologic sensors and related instrumentation using said medical system platforms. Methods, systems and devices provide a new design platform for implantable and external medical devices such as pacemakers, defibrillators, neurostimulators, heart monitors, etc. A real-time, highly flexible system of software and hardware modules enables both prototypes and products to respond to patient and customer needs with greater design and manufacturing efficiency. Certain embodiments integrate a general-purpose processor with interface circuitry to provide a standard platform for implementing new and conventional therapies with software models rather than custom circuitry.

Abstract: A system and method for tracking catheter electrode locations with the body of a patient during an MRI scan sequence includes mitigation logic configured to identify one or more impedance measurements that were taken during potentially noise-inducing conditions (i.e., magnet gradients, RF pulses), and were thus subject to corruption by noise. The mitigation logic is configured to replace the potentially corrupt impedance measurements with previously-obtained impedance measurements taken from an immediately preceding acquisition cycle (e.g., from a previous time-slice).

Abstract: A medical device having a sensor sensing an n-dimensional signal during a first known variable condition and during a second known variable condition different from the first known variable condition, a processor performing principal component analysis (PCA) on the sensed n-dimensional signal to generate a first template corresponding to a principal component of variation associated with the first known variable condition and a second template corresponding to a principal component of variation associated with the second known variable condition, a storage device storing the first template and the second template, and a controller detecting a patient condition in response to the stored templates.

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: An electrode catheter device with indifferent electrode for direct current tissue therapies is disclosed. An example of the catheter device has a flexible tubing with at least one ablation electrode. The catheter device also may also be used with a sheath for introducing the flexible tubing inside a patient's body. An indifferent electrode on the sheath can provide a ground for a direct current (DC) pulse to deliver electrical energy and create an electrical field adjacent a tissue. Various other embodiments are also disclosed.

Abstract: A system and method for assessing effective delivery of ablation therapy to a tissue in a body is provided. A three-dimensional anatomical map of the tissue is generated and displayed with the map defining a corresponding volume. An index is generated corresponding to a location within the volume with the index indicative of a state of ablation therapy at the location. The index may be derived from one or more factors such as the duration an ablation electrode is present at the location, the amount of energy provided, the degree of electrical coupling between an ablation electrode and the tissue at the location and temperature. A visual characteristic (e.g., color intensity) of a portion of the anatomical map corresponding to the location is then altered responsive to the index.