Abstract: A medical device is disclosed, including a handle assembly; an elongate body coupled to the handle assembly, the elongate body defining a guide wire lumen therethrough; and a substantially semi-circular electrode array coupled to the elongate body. The device may include a substantially rigid shaft extending distally from the elongate body and defining a lumen therethrough, the shaft including a substantially rigid segment, and a flexible coil coaxial with and extending distally from the shaft.

Abstract: The present invention includes systems, devices and methods for treating and/or diagnosing a heart arrhythmia, such as atrial fibrillation. Specifically, the present invention provides a system including a diagnostic catheter and an ablation catheter. The diagnostic catheter includes a shaft, multiple dipole mapping electrodes and multiple ultrasound transducers. The ablation catheter is slidingly received by the diagnostic catheter shaft.

Abstract: A system comprises a catheter configured for delivery to a body cavity defined by surrounding tissue; a plurality of ultrasound transducers coupled to a distal end of the catheter; and an electronics module configured to selectively turn on/off each ultrasound transducer according to a predetermined activation sequence and to process signals received from each ultrasound transducer to produce at least a 2D display of the surrounding tissue. A user can selectively calculate and display various aspects of cardiac activity. The user can display Dipole Density (DDM), Charge Density (CDM), or Voltage (V-V). The shape and location of the chamber (surface), and the potentials recorded at electrodes can be displayed. The system can also change back and forth between the different display modes, and with post processing tools, can change how various types of information is displayed. Methods are also provided.

Abstract: Methods of generating a graphical representation of cardiac information on a display screen are provided. The method comprises: electronically creating or acquiring an anatomical model of the heart including multiple cardiac locations; electronically determining a data set of source information corresponding to cardiac activity at the multiple cardiac locations; electronically rendering the data set of source information in relation to the multiple cardiac locations on the display screen. Systems and devices for providing a graphical representation of cardiac information are also provided.

Abstract: A medical method, device, and system are provided, including advancing an ablation element of a medical device into contact with tissue to be treated, selecting a power level of energy to ablate the tissue, delivering energy at the selected power level to the ablation element, determining whether the ablation element is in continuous contact with the tissue, and reducing the selected power level when the ablation element ceases to be in continuous contact with the tissue.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having hi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate. Optional features include a series of thermocouples for monitoring local temperatures.

Abstract: A medical method, device, and system are provided, including advancing an ablation element of a medical device into contact with tissue to be treated, selecting a power level of energy to ablate the tissue, delivering energy at the selected power level to the ablation element, determining whether the ablation element is in continuous contact with the tissue, and reducing the selected power level when the ablation element ceases to be in continuous contact with the tissue.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate. Optional features include a series of thermocouples for monitoring local temperatures.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate.

Abstract: Provided is a flex-PCB catheter device that is configured to be inserted into a body lumen. The flex-PCB catheter comprises an elongate shaft, an expandable assembly, a flexible printed circuit board (flex-PCB) substrate, a plurality of electronic components and a plurality of communication paths. The elongate shaft comprises a proximal end and a distal end. The expandable assembly is configured to transition from a radially compact state to a radially expanded state. The plurality of electronic elements are coupled to the flex-PCB substrate and are configured to receive and/or transmit an electric signal. The plurality of communication paths are positioned on and/or within the flex-PCB substrate. The communication paths selectively couple the plurality of electronic elements to a plurality of electrical contacts configured to electrically connect to an electronic module configured to process the electrical signal. The flex-PCB substrate can have multiple layers, including one or more metallic layers.

Abstract: A medical device is disclosed, including a catheter body; an electrode array coupled to the catheter body, the electrode array being transitionable from a substantially linear configuration to a substantially helical configuration; and a fluid conduit coupled to the catheter body spaced apart from the electrode array, wherein the fluid conduit is transitionable from a substantially linear configuration to a substantially helical configuration. The device may include a fluid source in communication with the fluid conduit and a radiofrequency signal generator coupled to the electrode array.

Abstract: A medical device including a catheter having a shaft with a distal portion; a first plurality of substantially hemispherical electrodes coupled to the distal portion; a second plurality of substantially hemispherical electrodes coupled to the shaft proximal of the first plurality, where the second plurality of electrodes are oriented substantially orthogonal to the first plurality of electrodes; and an additional electrode coupled to the shaft. A console may have a processor in electrical communication with the first and second plurality of electrodes and the reference electrode, the processor programmed to obtaining a monophasic action potential recording from at least one of the first and second plurality of electrodes.

Abstract: The present invention includes systems, devices and methods for treating and/or diagnosing a heart arrhythmia, such as atrial fibrillation. Specifically, the present invention provides a system including a diagnostic catheter and an ablation catheter. The diagnostic catheter includes a shaft, multiple dipole mapping electrodes and multiple ultrasound transducers. The ablation catheter is slidingly received by the diagnostic catheter shaft.

Abstract: A medical device including a catheter having a shaft with a distal portion; a first plurality of substantially hemispherical electrodes coupled to the distal portion; a second plurality of substantially hemispherical electrodes coupled to the shaft proximal of the first plurality, where the second plurality of electrodes are oriented substantially orthogonal to the first plurality of electrodes; and an additional electrode coupled to the shaft. A console may have a processor in electrical communication with the first and second plurality of electrodes and the reference electrode, the processor programmed to obtaining a monophasic action potential recording from at least one of the first and second plurality of electrodes.

Abstract: A medical device including a catheter having a shaft with a distal portion; a first plurality of substantially hemispherical electrodes coupled to the distal portion; a second plurality of substantially hemispherical electrodes coupled to the shaft proximal of the first plurality, where the second plurality of electrodes are oriented substantially orthogonal to the first plurality of electrodes; and an additional electrode coupled to the shaft. A console may have a processor in electrical communication with the first and second plurality of electrodes and the reference electrode, the processor programmed to obtaining a monophasic action potential recording from at least one of the first and second plurality of electrodes.

Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

Abstract: A medical device is disclosed, including a handle assembly; an elongate body coupled to the handle assembly, the elongate body defining a guide wire lumen therethrough; and a substantially semi-circular electrode array coupled to the elongate body. The device may include a substantially rigid shaft extending distally from the elongate body and defining a lumen therethrough, the shaft including a substantially rigid segment, and a flexible coil coaxial with and extending distally from the shaft.

Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.