Abstract: A polyacrylamide tissue phantom embedded with multi-formulated thermochromic liquid crystals for use in the evaluation of RF ablation therapies is provided. The tissue phantom approximates the properties of biological tissue, and therefore provides a suitable substitute for use in testing the effects of RF and other energy-emitting devices on biological tissue. Also provided is a system for using the tissue phantom in the evaluation of RF therapies.

Abstract: A method and system capable of identifying ectopic foci, rotors, or conduction pathways involved in reentrant arrhythmias within cardiac tissue, and then treating identified ectopic foci, rotors, and/or pathways with either lethal or sub-lethal temperatures. The system includes a medical device having one or more mapping elements and one or more treatment elements, and a computer programmable to identify ectopic foci and rotors based at least in part on signals received from the one or more mapping elements at one or more locations.

Abstract: A medical method is provided, including a medical device having a distal assembly including at least one electrode and at least one treatment element, the medical device generating information regarding at least one of a physiological measurement and an operational parameter of the medical device; a plurality of surface electrodes affixable to a skin of the patient, wherein the surface electrodes are in electrical communication with the distal assembly to obtain position information of the medical device; and a processor pairing the position information and the at least one of a physiological measurement and an operational parameter of the medical device.

Abstract: A method and system for manufacturing a multi-lumen device that includes extruding a first layer of material to form an elongate body with a first lumen and a second lumen, the elongate body having a length of at least 100 feet, depositing a mesh layer over the first layer of material along the entire length of the elongate body, and extruding a second layer of material over the mesh layer along at least a portion of the length of the elongate body. The length of at least 100 feet may be considered a first length, the method further comprising cutting the elongate body into a plurality of shortened elongate bodies having a usable length, such as between approximately two feet and approximately six feet.

Abstract: A method of ablating an epicardial tissue region, including positioning a medical device adjacent the epicardial tissue region, the medical device having a first electrode, a second electrode, and a third electrode located in between the first and second electrodes; delivering an irrigation fluid to the tissue region; and ablating at least a portion of the tissue region by sequentially activating the third electrode in a monopolar radiofrequency delivery mode and activating the first and second electrodes in a bipolar radiofrequency delivery mode.

Abstract: A method and system capable of identifying ectopic foci, rotors, or conduction pathways involved in reentrant arrhythmias within cardiac tissue, and then treating identified ectopic foci, rotors, and/or pathways with either lethal or sub-lethal temperatures. The system includes a medical device having one or more mapping elements and one or more treatment elements, and a computer programmable to identify ectopic foci and rotors based at least in part on signals received from the one or more mapping elements at one or more locations.

Abstract: A method for manufacturing a distal portion of a mapping and/or ablation device with fewer components and manufacturing steps than are required for presently known devices. The method generally includes aligning one or more electrodes and electrode wires within a housing mold, overmolding a biocompatible material over the one or more wires and a portion of each of the one or more electrodes, creating a housing component that integrates a dome component and an insulation component. Alternatively, the method generally includes aligning one or more wires within a housing mold so that at least a portion of each wire protrudes from the mold, overmolding a biocompatible material over the one or more wires, thus creating a housing component that integrates a dome component and insulation component. The protruding wire portions are cleaved off and at least a portion of the housing component is coated with a layer of conductive material.

Abstract: Devices, systems and methods are disclosed for the ablation of tissue. A steerable ablation catheter can include one or more ablation elements at its distal end and one or more ablation elements fixedly attached to its shaft. The distal end of the ablation catheter can be deflected to assume a number of different deflection geometries in at least one direction along the shaft. One feature of the ablation catheter is that its shaft can comprise materials of differing durometers or stiffnesses attached together at a joint. Methods associated with use of the ablation catheter are also covered.

Abstract: Systems and methods for assessing tissue contact, including positioning a plurality of electrodes adjacent a tissue region; delivering radiofrequency energy to the plurality of electrodes, wherein the delivered radiofrequency energy is sufficient to ablate at least a portion of the tissue region; obtaining a plurality of impedance measurements from the plurality of electrodes during the delivery of the radiofrequency energy; calculating a change in the impedance measurements for each of the plurality of electrodes over a pre-determined time period; comparing the calculated change for at least one of the plurality of electrodes to the calculated change in at least one other of the plurality of electrode to determine if there is significant variation in the calculated changes; and terminating the delivery of radiofrequency energy to at least one of the plurality if there is significant variation in the calculated changes.

Abstract: A transseptal sheath defining a sheath lumen, a proximal end, and a distal end. A valve disposed within the sheath lumen proximate the distal end. The transseptal sheath defining at least one port along a portion of its periphery proximate the valve.

Abstract: Devices, systems and methods are disclosed for the ablation of tissue. Embodiments include an ablation catheter which has an array of ablation elements attached to a deployable carrier assembly. The carrier assembly can be constrained within the lumen of a catheter, and deployed to take on an expanded condition.

Abstract: Devices, systems and methods are disclosed for the ablation of tissue. Embodiments include an ablation catheter that has an array of ablation elements attached to a deployable carrier assembly. The carrier assembly can be constrained within the lumen of a catheter, and deployed to take on an expanded condition. The carrier assembly includes multiple electrodes that are configured to ablate tissue at low power. Additional embodiments include a system that includes an interface unit for delivering one or more forms of energy to the ablation catheter.

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: 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: A method of dimensionally stabilizing a lumen of a multi-lumen device during manufacture wherein one or more minor lumens may contain a fluid that maintains patency of the one or more minor lumens without the need for a solid core within. The at least one second lumen tube may be in fluid communication with a fluid source during the manufacturing process, such as during extrusion and/or mesh overlay steps. Preventing collapse of the one or more minor lumens during manufacture using a fluid instead of a solid core allows the lumens to have any of a variety of shapes and configurations that would be difficult, cost prohibitive, or impossible for a solid core to be used. Also, obviating the need for a solid core within one or more lumens reduces cost and production complexity. The fluid may be a non-compressible liquid or a pressurized gas.

Abstract: Devices, systems and methods are disclosed for the mapping of electrical signals and the ablation of tissue. Embodiments include an ablation catheter that has an array of ablation elements attached to a deployable carrier assembly. The carrier assembly can be transformed from a compact, linear configuration to a helical configuration, such as to map and ablate pulmonary vein ostia.

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: A method of detecting a thermocouple short circuit in a medical device, including obtaining a first temperature measurement from a thermocouple of the medical device; obtaining a second temperature measurement from the thermocouple; calculating a rate of change over time between the first and second temperature measurements; comparing the calculated rate of change over time to a predefined rate of change over time threshold; and generating an indication of a thermocouple short circuit based at least in part on the comparison.

Abstract: A medical system, including a catheter body, an elongate body disposed in the catheter body; an expandable element having a proximal portion coupled to the catheter body and a distal portion coupled to the elongate body, the distal portion of the expandable element defining the distal-most portion of the medical device; a mesh or array of longitudinal splines substantially surrounding the expandable element, at least a portion of the mesh or splines being electrically conductive; and a coolant source in fluid communication with the expandable element.