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: A method and system for performing pulmonary vein isolation, mapping, and assessing pulmonary vein occlusion using a single device. The device may generally include an ablation element, such as a cryoballoon, and a sensing component slidably disposed within a lumen of the device and bearing one or more mapping electrodes and one or more pressure sensors. The method may generally include mapping cardiac electrical signals within a heart and/or pulmonary vein, positioning a distal portion of the sensing component within a pulmonary vein, advancing the ablation element until it is in contact with the pulmonary vein ostium, recording blood pressure measurements within the pulmonary vein with the one or more pressure sensors to assess pulmonary vein occlusion, and activating the treatment element when the pulmonary vein is completely occluded. The sensing component may have a straight or hooped configuration, or a configuration therebetween.

Abstract: A medical device including an ablation element. A thermally insulative sheath is included disposed within the ablation element. A fluid injection tube is disposed within a portion of the thermally insulative sheath. The ablation element passively transitions from a substantially linear geometric configuration to a substantially circular geometric configuration as the sheath is retracted proximally from a first position in which the sheath substantially encloses the fluid injection tube to a second position in which a portion of the fluid injection tube extends a distance away from the sheath.

Abstract: A method and system for cryotreatment of target tissue using a cryotreatment catheter through which a mapping catheter may be freely movable, even during activation of the cryotreatment element. The cryotreatment system may include a cryotreatment catheter, a mapping catheter slidably disposed within a lumen of the cryotreatment catheter, and one or more heating elements. The one or more heating elements may be disposed on the mapping catheter or within the lumen of the cryotreatment catheter. Activation of the one or more heating elements prevents the freezing of, or thaws, fluid within the lumen of the cryotreatment device when one or more cryotreatment elements are activated. The lack of frozen fluid within the lumen allows the mapping catheter to freely move within the cryotreatment catheter during a cryotreatment procedure, so that the mapping catheter may be positioned proximate the treatment site after initiation of cryotreatment.

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: 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: An intravascular ablation device, including a flexible elongate body; an expandable element positioned on the elongate body; a radiofrequency or electroporation treatment segment located distally of the expandable element; a cryogenic coolant source in fluid communication with an interior of the expandable element; and a radiofrequency or electroporation energy source in communication with the radiofrequency or electroporation treatment segment.

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 comprising a shaft having a kink radius; a tube disposed within the shaft; a fluid source in fluid communication with the tube; an elongate member disposed within the tube, and the elongate member imparting a kink radius on the tube, the imparted kink radius of the tube being larger than the kink radius of the shaft.

Abstract: The present invention advantageously provides a method and system for the improved isolation and corresponding treatment of tissue targeted for cryogenic or other thermal therapy to increase the thermal efficacy and thermal efficiency of the treatment. In particular, the present invention provides methods and systems for improved thermal treatment of target tissue, such as a pulmonary vein and/or regions of the left atrium by reducing the resistive forces and/or increased thermal energy experienced from blood flow exiting the pulmonary vein into the left atrium during treatment.

Abstract: A device, method, and system for thermally affecting tissue. The device may generally include an elongate body, an actuation element slidably disposed within the elongate body, a balloon defining an interior chamber, a proximal neck, and a distal neck, the first neck being coupled to the distal portion of the elongate body and the second neck being coupled to the distal portion of the actuation element, retraction of the actuation element within the elongate body causing the treatment element to transition from a first configuration to a second configuration. The distal neck may be located external to the interior chamber in the first configuration and within the interior chamber in the second configuration. The device may also include a fluid injection element that is transitionable to an expanded configuration when the balloon is inflated, thereby enhancing the cooling capacity of the balloon.

Abstract: A device and system for thermally affecting tissue that includes a balloon catheter with a reduced distal length for ease of navigation and that also includes a balloon that is more resistant to bursting and delamination. The balloon may include a proximal neck generally attached to an elongate body and a distal neck generally attached to a shaft disposed within the elongate body. The distal neck is turned inward to extend within the balloon chamber and the proximal neck may either extend within the chamber or extend proximally away from the balloon chamber. Alternatively, the device may include an inner balloon and an outer balloon, the distal necks of both being turned inward and extending within the inner balloon chamber. The proximal necks may both also be turned inward to extend within the chamber or the proximal neck of the outer balloon may extend away from the balloon chamber.

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 device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A medical device is provided, having an elongate body defining a distal portion and a proximal portion; a first expandable member disposed on the distal portion of the elongate body and defining a cooling chamber therein, the first expandable member having a first rigidity; a second expandable member disposed around the first expandable member to define an interstitial region therebetween, where the second expandable member has a second rigidity less than the first rigidity; a gel disposed within the interstitial region; a coolant flow path in fluid communication with the cooling chamber; and a cryogenic coolant source in fluid communication with the coolant flow path.

Abstract: A method and system for improved lesion creation. The method generally includes positioning a treatment element of a medical device proximate an area of target tissue and operating a control unit in accordance with a duty cycle, that includes at least one freeze-warm cycle, each freeze-warm cycle including: supplying coolant to the treatment element at a first flow rate that causes the treatment element to reach a first temperature, the first temperature causing ablation of the target tissue and cryoadhesion between the treatment element and target tissue, and supplying coolant to the treatment element at a second flow rate that causes the treatment element to reach a second temperature, the second temperature being higher than the first temperature and the second flow rate being lower than the first flow rate, the second temperature being above a temperature at which ablation occurs and below a temperature at which cryoadhesion is broken.