Abstract: A cryoballoon deflation assembly for an intravascular catheter system for use during a cryoablation procedure includes a first deflation initiator and a first deflation initiator inhibitor. The first deflation initiator is configured to automatically activate a vacuum pump to deflate a cryoballoon upon completion of a stage of the cryoablation procedure. The first deflation initiator inhibitor is manually changeable to between an activated and deactivated state. When in the activated state, the first deflation initiator inhibitor is configured to inactivate the first deflation initiator. The cryoballoon deflation assembly can further include a second deflation initiator. The second deflation initiator is manually changeable between an activated and deactivated state. When in the activated state, the second deflation initiator is triggered to activate the vacuum pump to deflate the cryoballoon.

Abstract: A cryogenic balloon catheter system for use in an ablation procedure, the cryogenic balloon catheter system comprising a balloon catheter including a shaft, an expandable balloon attached to a distal portion of the shaft, a plurality of sensors each configured to sense an ablation parameter during an ablation phase of the ablation procedure and to generate a sensor output based on the sensed ablation parameter a fluid source operatively coupled to the expandable balloon and configured to deliver a cryogenic fluid to the expandable balloon, a controller configured to receive the sensor output and calculate a plurality of ablation metrics and to generate a plurality of ablation quality indicator outputs, and a graphical display operatively coupled to the controller and configured to display a plurality of graphical ablation quality indicators each based on a respective one of the ablation quality indicator outputs.

Abstract: A cryogenic balloon catheter system for treating a condition in a patient includes a balloon catheter including a shaft, an expandable balloon attached to a distal portion of the shaft, and a pressure sensor coupled to the balloon catheter at a location distal to the expandable balloon. The system further includes a pump coupled to and configured to inflate the expandable balloon with a fluid, a graphical display configured to display a complication of data relating to the balloon catheter and a control system adapted to selectively inflate the expandable balloon and detect and display on the graphical display a pressure waveform sensed by the pressure sensor.

Abstract: A system including a controller to determine an in-body time of a medical device in a patient during a medical procedure. The controller to: receive signals from at least one temperature sensor; detect insertion of the medical device into the patient by one or more of determining the temperature of the medical device and determining the change of temperature of the medical device with respect to time; increment an in-body time counter to measure the in-body time of the medical device after detecting insertion of the medical device into the patient; detect that the medical device has been removed from the patient by determining that the change of temperature of the medical device with respect to time is negative; and stop incrementing the in-body time counter in response to detecting that the medical device has been removed.

Abstract: A balloon catheter system for use by an operator for treating a targeted vein, the balloon catheter system comprising a balloon catheter, a fluid source and a control system. The balloon catheter includes a balloon having a balloon interior, the balloon configured to undergo one or more inflation cycles. The fluid source contains a cryogenic fluid that is selectively delivered to the balloon interior. The control system is configured to selectively control the delivery of the fluid to the balloon interior and to that selectively adjusts an inflation pressure to of the balloon interior based on a number of inflation cycles undergone by the balloon so as to selectively adjust an inflated balloon diameter of the balloon.

Abstract: A container replacement system for replacing a fluid container with a replacement fluid container, wherein the fluid container contains a cryogenic fluid and is coupled to a pressure line, includes a control valve that vents the cryogenic fluid within the pressure line, a pressure sensor that senses a line pressure of the cryogenic fluid and generates sensor output and a controller that receives sensor output and determines whether to replace the fluid container. If the line pressure is below a threshold line pressure, the controller determines replacing the fluid container is permissible. Contrarily, if the line pressure is above the threshold line pressure, the controller determines replacing the fluid container is not permissible. The container replacement system further includes a GUI that instructs whether replacing the fluid container is permissible.

Abstract: A phrenic nerve pacing monitor assembly for a cryogenic balloon catheter system used during a cryoablation procedure, which monitors movement of a diaphragm of a patient, includes a pacing detector and a safety system. The pacing detector directly monitors movement of the diaphragm of the patient to detect when phrenic nerve pacing is occurring. Additionally, the pacing detector generates monitor output based on the movement of the diaphragm of the patient. The safety system receives the monitor output and based at least in part on the monitor output selectively provides an alert when movement of the diaphragm of the patient is atypical. The safety system is configured to provide the alert only while at least one of (i) phrenic nerve pacing is occurring, and (ii) cryoablation is occurring.

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 system including a controller to determine an in-body time of a medical device in a patient during a medical procedure. The controller to: receive signals from at least one temperature sensor; detect insertion of the medical device into the patient by one or more of determining the temperature of the medical device and determining the change of temperature of the medical device with respect to time; increment an in-body time counter to measure the in-body time of the medical device after detecting insertion of the medical device into the patient; detect that the medical device has been removed from the patient by determining that the change of temperature of the medical device with respect to time is negative; and stop incrementing the in-body time counter in response to detecting that the medical device has been removed.

Abstract: A method for controlling a balloon pressure of an inflatable balloon of an intravascular catheter system includes the steps of (i) sending sensor output to a controller, the sensor output being based at least partially on the balloon pressure, and (ii) maintaining the balloon pressure within a predetermined pressure range based at least partially upon the sensor output received by the controller. The step of maintaining includes one of (a) adjusting a flow rate of a cryogenic fluid through the inflatable balloon while moving the inflatable balloon from a first treatment site to a second treatment site, and (b) adjusting the flow rate of the cryogenic fluid that is selectively delivered from the fluid source to the inflatable balloon through an adjunct fluid injection line that is in fluid communication with a fluid exhaust line.

Abstract: A cryoballoon deflation assembly for an intravascular catheter system for use during a cryoablation procedure includes a first deflation initiator and a first deflation initiator inhibitor. The first deflation initiator is configured to automatically activate a vacuum pump to deflate a cryoballoon upon completion of a stage of the cryoablation procedure. The first deflation initiator inhibitor is manually changeable to between an activated and deactivated state. When in the activated state, the first deflation initiator inhibitor is configured to inactivate the first deflation initiator. The cryoballoon deflation assembly can further include a second deflation initiator. The second deflation initiator is manually changeable between an activated and deactivated state. When in the activated state, the second deflation initiator is triggered to activate the vacuum pump to deflate the cryoballoon.

Abstract: A phrenic nerve pacing monitor assembly for a cryogenic balloon catheter system used during a cryoablation procedure, which monitors movement of a diaphragm of a patient, includes a pacing detector and a safety system. The pacing detector directly monitors movement of the diaphragm of the patient to detect when phrenic nerve pacing is occurring. Additionally, the pacing detector generates monitor output based on the movement of the diaphragm of the patient. The safety system receives the monitor output and based at least in part on the monitor output selectively provides an alert when movement of the diaphragm of the patient is atypical. The safety system is configured to provide the alert only while at least one of (i) phrenic nerve pacing is occurring, and (ii) cryoablation is occurring.

Abstract: A system for inflating a cryogenic ablation catheter balloon, the system comprising a fluid source containing a fluid in a liquid state, a first supply line fluidly coupled to the fluid source and configured to be fluidly coupled to an internal space within the cryogenic ablation catheter balloon, the first supply line including an inline multi-stage pressure regulating system. The multi-stage pressure regulating system includes a first stage configured to cause the fluid to transition from the liquid state to a gas state, and a second stage downstream of the first stage configured to maintain the fluid downstream of the second stage at a pressure corresponding to an inflation pressure of cryogenic ablation catheter balloon.

Abstract: A cryogenic balloon catheter system for treating a condition in a patient includes a balloon catheter and an inter-balloon pressure control assembly. The balloon catheter includes a first balloon; and a second balloon that substantially encircles the first balloon to define an inter-balloon space between the first balloon and the second balloon, the inter-balloon space having an inter-balloon pressure. The inter-balloon pressure control assembly controls the inter-balloon pressure in the inter-balloon space. The inter-balloon pressure control assembly includes a vacuum pump that is configured to selectively evacuate fluid from the inter-balloon space to adjust the inter-balloon pressure; and a solenoid valve that is in fluid communication with the inter-balloon space, the solenoid valve selectively allowing the vacuum pump to evacuate the fluid from the inter-balloon space.

Abstract: A container replacement system for replacing a fluid container with a replacement fluid container, wherein the fluid container contains a cryogenic fluid and is coupled to a pressure line, includes a control valve that vents the cryogenic fluid within the pressure line, a pressure sensor that senses a line pressure of the cryogenic fluid and generates sensor output and a controller that receives sensor output and determines whether to replace the fluid container. If the line pressure is below a threshold line pressure, the controller determines replacing the fluid container is permissible. Contrarily, if the line pressure is above the threshold line pressure, the controller determines replacing the fluid container is not permissible. The container replacement system further includes a GUI that instructs whether replacing the fluid container is permissible.

Abstract: A cryogenic balloon catheter system includes an inflatable balloon, a handle assembly and a pressure sensor. The inflatable balloon has a balloon interior. The pressure sensor senses a balloon pressure within the balloon interior. In various embodiments, the pressure sensor can be positioned within the balloon interior, within the handle assembly and/or between the inflatable balloon and the handle assembly. The cryogenic balloon catheter system also includes a controller that receives a sensor output from the pressure sensor. The controller can control injection of a cooling fluid to the balloon interior and/or removal of the cooling fluid from the balloon interior based upon the sensor output. The cryogenic balloon catheter system can also include an injection proportional valve, an exhaust proportional valve, an injection flow sensor and/or an exhaust flow sensor.

Abstract: A method for filling a fluid container with a cryogenic fluid, the method including the step of reducing with a container temperature reducer a container temperature of the fluid container prior to adding the cryogenic fluid to the fluid container. The method can include additional steps, including: compressing with a compressor the cryogenic fluid based at least partially on the container temperature, controlling with a controller the extent that the compressor compresses the cryogenic fluid, cooling with a fin pack the cryogenic fluid, filtering with a filter the cryogenic fluid, analyzing with a fluid analyzer a fluid within the cryogenic fluid, monitoring with a water monitor a water content of the cryogenic fluid and/or monitoring with a fluid sensor a fluid property of the cryogenic fluid.

Abstract: A differential pressure limiter (226) for limiting a differential fluid pressure of cryogenic fluid (228) during a cryoablation procedure includes one or more of a fluid source (216), a pressure regulator (230), one or more proportional valves (232) and a backpressure regulator (234). The fluid source (216) selectively retains cryogenic fluid (228). The pressure regulator (230) receives cryogenic fluid (228) from the fluid source (216) and regulates a fluid pressure of the cryogenic fluid (228). The proportional valve(s) (232) receives cryogenic fluid (228) from the pressure regulator (230) and at least partially controls a flow rate of the cryogenic fluid (228).

Abstract: A balloon catheter system for use by an operator for treating a targeted vein, the balloon catheter system comprising a balloon catheter, a fluid source and a control system. The balloon catheter includes a balloon having a balloon interior, the balloon configured to undergo one or more inflation cycles. The fluid source contains a cryogenic fluid that is selectively delivered to the balloon interior. The control system is configured to selectively control the delivery of the fluid to the balloon interior and to that selectively adjusts an inflation pressure to of the balloon interior based on a number of inflation cycles undergone by the balloon so as to selectively adjust an inflated balloon diameter of the balloon.

Abstract: A method for conditioning an inflatable balloon of a balloon catheter prior to use inside a patient includes submerging the inflatable balloon in a liquid solution, inflating the inflatable balloon, removing any bubbles on an exterior surface of the inflated, inflatable balloon, deflating the inflatable balloon while maintaining the inflatable balloon submerged in the liquid solution, and retracting the deflated, inflatable balloon into a catheter sheath while maintaining the inflatable balloon submerged in the liquid solution.