Abstract: A system and method for creating radial-linear lesions in tissue. The system includes a cryoablation device having a first balloon, a second balloon disposed about the first balloon, and one or more splines disposed between the first balloon and second balloon, each spline defining a plurality of ports. The splines may be in communication with a coolant supply, and the first balloon may be in communication with a coolant supply or non-coolant inflation fluid supply. When the first balloon is in the uninflated configuration, the splines may have a substantially linear configuration. Each of the splines may be radially oriented about an elongate shaft and transitionable between the substantially linear configuration and an arcuate configuration when the first balloon is in the inflated configuration. Coolant expelled from the splines between the first and second balloons creates an ablation pattern on the outer surface of the second balloon.

Abstract: A method and device for treating tissue with temperature-sensitizing adjuvants to enhance the effects of ablation therapy. The method may comprise identifying tissue to receive ablation therapy, treating the tissue with a temperature-sensitizing agent, and activating an ablation therapy device proximate the treated tissue. The device may comprise a cryo-sensitizing adjuvant operable in association with a cryotherapy device, the cryo-sensitizing adjuvant enhancing the effectiveness of tissue destruction upon application of temperatures below 0° C.

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: The present invention provides a medical system, including a catheter defining an injection lumen, a chamber in fluid communication with the injection lumen, and an exhaust lumen in fluid communication with the chamber; a first temperature sensor positioned in the exhaust lumen proximal to the chamber; a second temperature sensor positioned in the chamber; and a console in electrical communication with the first and second temperature sensors, the controller modifying coolant flow through the medical device based at least in part upon a signal received from the first and second temperature sensor. The system may further include a thermally-conductive element circumscribing a substantial portion of the exhaust lumen proximal to the chamber, where the first temperature sensor is mounted to the thermally-conductive element, and the thermally-conductive element may include at least one of a braid, coil, and band.

Abstract: The present invention provides a medical device having an catheter body defining proximal and distal portions, and a guidewire lumen at least partially disposed within and movable within the catheter body. The medical device may include an expandable element defining a proximal end and a distal end, wherein the proximal end is coupled to the distal portion of the catheter body and the distal end is coupled to the guidewire lumen. In addition, an actuator element may be coupled to the guidewire lumen for longitudinal movement thereof, and a tensioning element may further be coupled to the guidewire lumen to bias the guidewire lumen and/or the expandable element towards a particular geometric configuration.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. A check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. Additionally, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: A method of operating a medical system, including coupling a medical system to an outlet of a fluid distribution network having a plurality of fluid outlets in a patient treatment center; delivering fluid from the outlet to the medical system; compressing the delivered fluid with the medical system; decreasing the moisture content of the delivered fluid with the medical system; cooling the fluid with the medical system; delivering the fluid from the medical system to a medical device; and removing the fluid from medical device with the medical system.

Abstract: A medical device includes a steering element defining a passage for a guide wire. A fluid injection tube defining a proximal and a distal end is also included, wherein a portion of the fluid injection tube is contoured about a portion of the steering element. A plurality of injection ports may be disposed in the portion of the fluid injection tube contoured about the steering element.

Abstract: A catheter based medical device including controlled refrigerant dispersion is disclosed. The device includes a fluid injection tube that carries refrigerant from a coolant supply to the distal portion of the device. An open distal end or one or more orifices may be provided on the injection tube for the refrigerant to be expelled into an expandable chamber such as a balloon disposed on the distal portion of the catheter. The dispersion of the refrigerant from the injection tube may be controlled or manipulable to direct the refrigerant to one or more target locations.

Abstract: A method and system for monitoring phrenic nerve function and preventing phrenic nerve injury during cardiac ablation. The system includes a pacing device operable to transmit stimulation energy to the phrenic nerve through target tissue proximate the phrenic nerve, a plurality of assessment electrodes operable to make comparisons between baseline, real-time, and predetermined threshold values for CMAP signal amplitude and amplitude over time. The processing device may be connected to an ablation console, and the processing device may interrupt or adjust an ablation procedure controlled by the ablation console and/or generate a system alert in response to one of these comparisons, if the comparison indicates phrenic nerve injury.

Abstract: A method and system for cryotreatment and mapping of target tissue. The cryotreatment system may include a cryotreatment catheter, a mapping catheter including one or more mapping electrodes, and one or more temperature sensors located on the mapping catheter and/or the cryotreatment catheter. The cryotreatment catheter distal tip may be short enough to allow at least one mapping electrode to be positioned proximate the cryoballoon, for example, within 6 mm or less from the cryoballoon. Energy, such as radiofrequency energy, may be delivered to one or more mapping electrodes when one or more temperature sensors indicate a temperature of approximately 0° C. or below at one or more mapping electrode in order to thaw or prevent the formation of ice on the mapping electrodes when positioned proximate a cryoballoon during a cryotreatment procedure in order to recapture cardiac signals.

Abstract: The present invention advantageously provides a method and system for cryogenically ablating large areas of tissue within the left atrium. In an exemplary embodiment a cryotherapy device includes a catheter body, a proximal end and a distal end; a first lumen; a second lumen; and an ablation element expandable from a first diameter to a second diameter, the ablation element having a surface portion that conforms to the uneven surface topography of the cardiac tissue. The ablation element can include one or more deformable balloon and/or flexible elements. The surface of the balloon can further be shaped by regulation of pressure within the one or more balloons. In an exemplary method, a tissue ablation device is provided and tissue in the left atrium is ablated with the device, whereby the ablation is created by freezing 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 and system for preventing phrenic nerve injury during a cardiac ablation procedure. The method generally includes stimulating a phrenic nerve with a pacing electrode at a location proximate a target treatment location, ablating tissue at the target treatment location with a treatment element, obtaining a heart audio signal with an audio sensor positioned proximate the target treatment location, and determining whether phrenic nerve stimulation (PNS) is present based as least in part on the obtained heart audio signal. A processor may be used to compare an amplitude of the obtained heart audio signal to a predetermined threshold amplitude. The processor may determine that PNS is present if the amplitude of the obtained audio signal is greater than the threshold amplitude. If PNS is present, ablation of the tissue may continue at the current or greater energy level and/or at the current treatment location without injuring the phrenic nerve.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

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.

Abstract: An accessory and system to provide a medical device with mapping and ablation functionality. The system may include an ablation device with a handle, a treatment element, and an elongate body. The ablation element may be located on the elongate body distal portion, and a mapping sleeve may be disposable about at least part of the distal portion of the ablation device and may include mapping electrodes disposed on the outer surface. The mapping sleeve proximal region may include a retraction element defining a proximal end and a distal end, the distal end being coupled to the proximal region of the mapping sleeve, such that retracting the retraction element toward the elongate body proximal portion pulls the mapping sleeve away from the treatment element of the ablation device.

Abstract: A method for purging a cryotreatment system, in particular, for clearing moisture and thus preventing ice blockages within a fluid flow path that may be formed when moisture pockets within the fluid flow path of the system are encountered by a first injection of refrigerant at the beginning of a cryotreatment procedure. The method may include injecting refrigerant from a refrigerant source into a fluid delivery conduit at a preselected pressure for a first period of time, the refrigerant flowing from the fluid delivery conduit through a fluid injection element and into a fluid recovery conduit, and evacuating refrigerant from the fluid recovery conduit by vacuum pressure generated by the vacuum pump for a second period of time. This method may be repeated for a plurality of cycles.