Abstract: Delivery devices configured to deliver therapeutic and visualization devices to a surgical site are disclosed. An example delivery device may include a proximally disposed handle; a shaft extending distally from the handle, the shaft including a therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; and a space-making element disposed proximate a distal end portion of the shaft and configured to separate biological tissues to create or expand a working space. At least a portion of the space-making element may be reconfigurable between a retracted configuration and an expanded configuration.

Abstract: The present invention pertains to multiple piece irrigated ablation electrode assemblies wherein the irrigation channels are insulated or separated from at least one temperature sensing mechanism within the distal portion of the electrode assembly. The present invention further pertains to methods for improved assembly and accurate measurement and control of the electrode temperatures while effectively irrigating the device and target areas.

Abstract: Delivery devices configured to deliver therapeutic and visualization devices to a surgical site are disclosed. An example delivery device may include a proximally disposed handle; a shaft extending distally from the handle, the shaft including a therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; and a space-making element disposed proximate a distal end portion of the shaft and configured to separate biological tissues to create or expand a working space. At least a portion of the space-making element may be reconfigurable between a retracted configuration and an expanded configuration.

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: The present invention pertains to multiple piece irrigated ablation electrode assemblies wherein the irrigation channels are insulated or separated from at least one temperature sensing mechanism within the distal portion of the electrode assembly. The present invention further pertains to methods for improved assembly and accurate measurement and control of the electrode temperatures while effectively irrigating the device and target areas.

Abstract: The present invention pertains to multiple piece irrigated ablation electrode assemblies wherein the irrigation channels are insulated or separated from at least one temperature sensing mechanism within the distal portion of the electrode assembly. The present invention further pertains to methods for improved assembly and accurate measurement and control of the electrode temperatures while effectively irrigating the device and target areas.

Abstract: The invention relates to electrodes used in ablation catheter devices, where the electrodes contain two or more thermal sensors at different positions within the electrode that are capable of detecting temperature differences along the external surface of the electrode. In preferred embodiments, the thermal sensors are separated by one or more thermal insulating members and the thermal sensors are positioned near the external surface of the electrode at about the same distance from the end of the electrode, so that temperature measurements can indicate the position of the electrode with respect to the tissue desired to be ablated.

Abstract: A system for displaying characteristics of target tissue during an ablation procedure is provided that includes an electronic control unit (ECU) configured to receive data regarding electrical properties of the target tissue for a time period. The ECU is also configured to determine a value responsive to the data and indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period. The system further includes a display device operatively connected to the ECU. The display device is configured to receive the value and display a visual representation indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period.

Abstract: A system for displaying characteristics of target tissue during an ablation procedure is provided that includes an electronic control unit (ECU) configured to receive data regarding electrical properties of the target tissue for a time period. The ECU is also configured to determine a value responsive to the data and indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period. The system further includes a display device operatively connected to the ECU. The display device is configured to receive the value and display a visual representation indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period.

Abstract: A method of producing a multi-lumen elongate body for a medical device. Unlike known methods requiring a solid core of material inserted into each lumen to maintain patency of the lumens during manufacture, the present method obviates the need for a solid core within one or more minor lumens, which saves cost and production complexity. One or more material overlay and mesh overlay steps may be used to produce the multi-lumen elongate body, but only the main lumen may include a solid core therein during all manufacturing steps. The one or more minor lumens may each be defined by a lumen tube having a sufficient stiffness to withstand external pressure during all manufacturing steps without the need for a solid core within.

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: 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: The present invention pertains to multiple piece irrigated ablation electrode assemblies wherein the irrigation channels are insulated or separated from at least one temperature sensing mechanism within the distal portion of the electrode assembly. The present invention further pertains to methods for improved assembly and accurate measurement and control of the electrode temperatures while effectively irrigating the device and target areas.

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 method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU) configured to acquire magnitudes for a component of a complex impedance between an electrode and tissue, and the power applied to the tissue during lesion formation. The ECU is configured to calculate a value responsive to the complex impedance component and the power. The value is indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, or a predicted tissue temperature. The method includes acquiring magnitudes for a component of a complex impedance between an electrode and tissue and the power applied during lesion formation. The method includes calculating a value responsive to the complex impedance component and the power, the value being indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, and/or a predicted tissue temperature.

Abstract: The invention relates to electrodes used in ablation catheter devices, where the electrodes contain two or more thermal sensors at different positions within the electrode that are capable of detecting temperature differences along the external surface of the electrode. In preferred embodiments, the thermal sensors are separated by one or more thermal insulating members and the thermal sensors are positioned near the external surface of the electrode at about the same distance from the end of the electrode, so that temperature measurements can indicate the position of the electrode with respect to the tissue desired to be ablated.

Abstract: A system for displaying characteristics of target tissue during an ablation procedure is provided that includes an electronic control unit (ECU) configured to receive data regarding electrical properties of the target tissue for a time period. The ECU is also configured to determine a value responsive to the data and indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period. The system further includes a display device operatively connected to the ECU. The display device is configured to receive the value and display a visual representation indicative of at least one of a predicted depth of a lesion in the target tissue, a predicted temperature of the target tissue, and a likelihood of steam pop of the target tissue for the time period.

Abstract: Embodiments of the present invention provide an irrigated catheter having irrigation fluid directed at target areas where coagulation is more likely to occur so as to minimize blood coagulation and the associated problems. In one embodiment, an irrigated ablation electrode assembly for use with an irrigated catheter device comprises a proximal member having at least one passageway for a fluid with an outlet disposed at an external surface of the proximal member; and a distal member connected with the proximal member and having an external surface. The distal member includes an electrode. The external surface of the proximal member and the external surface of the distal member meet at an intersection. The at least one passageway of the proximal member is configured to direct a fluid flow through the outlet toward a region adjacent the intersection.

Abstract: The invention relates to electrodes used in ablation catheter devices, where the electrodes contain two or more thermal sensors at different positions within the electrode that are capable of detecting temperature differences along the external surface of the electrode. In preferred embodiments, the thermal sensors are separated by one or more thermal insulating members and the thermal sensors are positioned near the external surface of the electrode at about the same distance from the end of the electrode, so that temperature measurements can indicate the position of the electrode with respect to the tissue desired to be ablated.

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.