Abstract: A system, device, and method for the treatment of cardiac arrhythmia by, specifically, cryolipolysis of non-myocardial tissue and cryoablation of myocardial tissue. A system for treating cardiac arrhythmia may include a first thermal treatment device configured for placement within a heart in contact with myocardial tissue, a second thermal treatment device configured for placement in contact with pericardial tissue, an ablation energy source in communication with the first thermal treatment device, and a cooling energy source in communication with the second thermal treatment device, the cooling energy source causing the second thermal treatment device to reach a temperature insufficient for myocardial ablation when the second thermal treatment device is activated.

Abstract: A system and method for the delivery of a medical device to a treatment location. The device may include an elongate body, the elongate body including a plurality of annular segments and a jacket disposed about the plurality of annular segments and defining an interior space, and a vacuum source in fluid communication with the interior space of the jacket. When a vacuum is applied to the interior space of the jacket, the jacket may constrict about the plurality of annular elements, thereby increasing the frictional forces between the plurality of segments and between the plurality of segments and an inner surface of the jacket.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: A medical device and method are provided for mapping and therapeutic treatment, which may include a source of cryogenic fluid, a balloon or other expandable member in fluid communication with the source of cryogenic fluid, and a plurality of electrodes on the expandable member. The medical device may include a catheter or elongate body, and the electrodes may take the form of longitudinal strips. The expandable member may take the form of an inner and outer balloon, and the electrodes may be on the outer balloon. The electrodes may be on a proximal or distal conical portion of the expandable member, or both. An electrical insulator may be provided covering a portion of the electrodes.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: A medical device, including an elongate body having a proximal portion and a distal portion; a shaft at least partially disposed within the elongate body; an expandable element at the distal portion of the elongate body; and a fluid delivery conduit defining a deflectable segment movably coupled to the shaft, the deflectable segment being transitionable from a substantially linear configuration to a substantially curvilinear configuration.

Abstract: A method of treating tissue is provided, including positioning a stimulation device proximate a phrenic nerve; stimulating the phrenic nerve with the stimulation device; measuring a physiological response to the stimulation; defining a threshold physiological response value based at least in part on the measured physiological response; positioning a thermal treatment element proximate to an arrhythmogenic cardiac tissue region; applying a thermal treatment regimen to the cardiac tissue region with the medical device; measuring a physiological parameter during the thermal treatment regimen application; and conveying the measured physiological parameter to a controller, the controller comparing the measured physiological parameter to the defined physiological response value threshold, the controller adjusting the thermal treatment regimen in response to the comparison of the measured physiological parameter to the defined physiological response value threshold.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: A medical device, including an elongate body having a proximal portion and a distal portion; a shaft at least partially disposed within the elongate body; an expandable element at the distal portion of the elongate body; and a fluid delivery conduit defining a deflectable segment movably coupled to the shaft, the deflectable segment being transitionable from a substantially linear configuration to a substantially curvilinear configuration.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: A device, system, and method for enhancing cooling uniformity and efficiency of cryogenic fluids and providing a treatment element the shape of which can be adjusted for multiple purposes. The device may include a balloon catheter and fluid dispersion element, the fluid dispersion element directing the flow of coolant from a fluid injection element the interior wall of the balloon. The method of changing the shape of the treatment element may include retracting and extending a shaft to which the distal neck of a balloon is coupled, so that the balloon goes from a first shape to a second shape.

Abstract: A system, device, and method for the treatment of cardiac arrhythmia by, specifically, cryolipolysis of non-myocardial tissue and cryoablation of myocardial tissue. A system for treating cardiac arrhythmia may include a first thermal treatment device configured for placement within a heart in contact with myocardial tissue, a second thermal treatment device configured for placement in contact with pericardial tissue, an ablation energy source in communication with the first thermal treatment device, and a cooling energy source in communication with the second thermal treatment device, the cooling energy source causing the second thermal treatment device to reach a temperature insufficient for myocardial ablation when the second thermal treatment device is activated.

Abstract: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: A device, system, and method for enhancing cooling uniformity and efficiency of cryogenic fluids and providing a treatment element the shape of which can be adjusted for multiple purposes. The device may include a balloon catheter and fluid dispersion element, the fluid dispersion element directing the flow of coolant from a fluid injection element the interior wall of the balloon. The method of changing the shape of the treatment element may include retracting and extending a shaft to which the distal neck of a balloon is coupled, so that the balloon goes from a first shape to a second shape.

Abstract: The present invention may include a medical device having a handle, a catheter coupled to the handle, and an expandable element coupled to the catheter. The medical device may also include first and second elongate bodies that traverse a length of the handle and the catheter. A housing may be disposed within the handle, with the housing defining a first opening able to receive a portion of the first elongate body, a second opening able to receive a portion of the second elongate body, and a third opening opposite the first and second openings able to receive a portion of both the first and second elongate bodies. A separation element may be disposed within the housing, with the separation element defining a path able to receive a portion of the second elongate body, and whereby a portion of the first elongate body forms a loop around the separation element.

Abstract: A medical device including a catheter body defining a proximal portion and a distal portion. An expandable element is included defining a proximal end and a distal end, the proximal end being coupled to the distal portion of the catheter body. A tip element coupled to the distal end of the expandable element is included, the tip element including a shaft slideably receivable within a portion of the catheter body. A tensioning element coupled to the shaft and disposed within the expandable element is included, the tensioning element being engageable with the distal end of the catheter body and biasing the expandable element toward a pre-determined longitudinal position. An electrode array defining a substantially closed loop affixed to and extending from the tip element is also included.

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 method and system for delivering coolant to a medical device having an expandable element, a guidewire lumen movable within the medical device, and an actuator element coupled to the guidewire lumen for manipulation of longitudinal movement thereof is provided, including transferring a fluid from a console to the medical device to inflate the expandable element; manipulating the actuator element, and initiating a predetermined fluid control sequence of the console in response to the manipulation of the actuator element.