Abstract: A catheter device includes a housing extending from a proximal end to a distal end, a fixed tubular segment extending from a proximal end immovably coupled to the housing to a distal end, an outer tubular member extending from a proximal end immovably coupled to the housing to a distal end, and an inner tubular member extending from a proximal end to a distal end. The inner tubular member is slidably received within an interior of the outer tubular member and is slidably received over an exterior of the fixed tubular segment. The inner tubular member is configured to slide relative to each of the fixed tubular segment and the outer tubular member to selectively extend or retract the distal end of the inner tubular member relative to the distal end of the outer tubular member.

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 fluid injection line compensation assembly for an intravascular catheter system including a balloon catheter having a guidewire lumen and a cryoballoon, includes a fluid injection line, a proximal fluid injection line stop, and a distal fluid injection line stop. The fluid injection line has a fluid discharge region positioned within the cryoballoon. The fluid discharge region includes a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon. The fluid discharge region is not affixed to the guidewire lumen. The proximal fluid injection line stop is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon. The distal fluid injection line stop is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

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: Catheter devices and uses thereof are provided that include inner and outer tubular members, each having proximal and distal ends, where the distal end of the outer tubular member is shaped, including at least one curve, such as a Judkins right curve or an Amplatzer left curve. At least a portion of the inner tubular member is coaxially positioned within the outer tubular member. The control mechanism has a housing with a means to seal an inner luminal space thereof, where the control mechanism is coupled to the proximal ends of the outer tubular member and the inner tubular member. The control mechanism is operable to extend and retract the distal end of the inner tubular member from the shaped distal end of the outer tubular member.

Abstract: A sensing guidewire device used to measure physiological parameters within a living body. In one embodiment, the device is used to measure the fractional flow reserve (FFR) across a stenotic lesion in a patient's vasculature. The device includes a sensor that is adapted to be affixed near the distal end of a guidewire. The guidewire contains a corewire, processed to enclose electrical conductors in a sealed, off-centered interstice or channel, with an outer diameter approximate to the outer diameter of the device, running substantially the full length of the device, and has a homogenous outer surface. The enclosed eccentric channel provides space for electrical conductors to move freely. The corewire can have a tapered segment to create desirable flexibility. A solid connector comprised of alternating conductive and insulating elements for connecting the conductors to an external device is disclosed.

Abstract: A cryoablation catheter system comprises a cryoablation catheter having a shaft, a guidewire lumen member and an expandable balloon attached to the shaft and the guidewire lumen member, and an auxiliary device configured for use in combination with the cryoablation catheter, the auxiliary device including a location sensor configured to provide a sensor output indicative of a location of the location sensor within a localization volume responsive to a localization field. A user-accessible relative position indicator is located on one or both of the cryoablation catheter and the auxiliary device and is configured to provide an indication of a relative position of the cryoballoon and the location sensor.

Abstract: A cryoablation catheter comprises a tubular shaft having a shaft distal end and a shaft lumen, a tubular guidewire lumen member extending within the shaft lumen and forming a guidewire lumen extending between the guidewire lumen member proximal end and the guidewire lumen member distal end, an expandable cryoballoon having a proximal portion attached to the shaft distal end and a distal portion attached to the guidewire lumen member distal end, and a cryoablation catheter location sensor configured to generate a cryoablation location signal when in the cryoablation catheter location sensor is within a magnetic localization field.

Abstract: A sensing guidewire device used to measure physiological parameters within a living body. In one embodiment, the device is used to measure the fractional flow reserve (FFR) across a stenotic lesion in a patient's vasculature. The device includes a sensor that is adapted to be affixed near the distal end of a guidewire. The guidewire contains a corewire, processed to enclose electrical conductors in a sealed, off-centered interstice or channel, with an outer diameter approximate to the outer diameter of the device, running substantially the full length of the device, and has a homogenous outer surface. The enclosed eccentric channel provides space for electrical conductors to move freely. The corewire can have a tapered segment to create desirable flexibility. A solid connector comprised of alternating conductive and insulating elements for connecting the conductors to an external device is disclosed.

Abstract: A mapping catheter comprises a flexible shaft having a proximal end and an opposite distal end, and an expandable mapping element attached to the distal end of the shaft. The expandable mapping element is configured to self-expand from a collapsed configuration to an expanded configuration. The expanded configuration is defined by a proximal portion extending from the distal end of the shaft and forming a proximally-facing concave recess, an intermediate portion extending distally from the proximal portion and defining a maximum diameter of the mapping element when in the expanded configuration, and a distal portion having a conical shape with a distal portion diameter that decreases in a direction distally of the intermediate portion. The mapping element further includes a plurality of electrodes located in one or both of the intermediate portion or the distal portion.

Abstract: A balloon catheter for an intravascular catheter system includes a cryogenic balloon that is formed from a blend of polyurethane and polyamide block copolymer. The percentages of polyurethane and polyamide block copolymer can vary. For example, the cryogenic balloon can be formed from greater than 50% polyurethane and less than 50% polyamide block copolymer; greater than 75% polyurethane and less than 25% polyamide block copolymer; or approximately 85% polyurethane and approximately 15% polyamide block copolymer. Additionally, a ratio of a change in inflation pressure (in psi) to a change in outer diameter (in mm) of the cryogenic balloon, and a ratio of outer diameter (in mm) of the cryogenic balloon to inflation pressure (in psig) can be varied to form the desired cryogenic balloon.

Abstract: A balloon catheter for an intravascular catheter system includes an outer inflatable balloon and an inner inflatable balloon that is positioned substantially within the outer inflatable balloon. At a nominal working balloon pressure, the outer inflatable balloon has an outer balloon diameter and the inner inflatable balloon has an inner balloon diameter that is greater than the outer balloon diameter at the nominal working balloon pressure. The inner balloon diameter can be at least approximately 5%, 10%, 15%, 20%, 25% or 30% greater than the outer balloon diameter. The inner balloon diameter can be between approximately 29-35 millimeters, and the outer balloon diameter can be between approximately 23-29 millimeters. The inner inflatable balloon can be less compliant than the outer inflatable balloon. The outer balloon compliance can be at least approximately 2%, 5%, 8%, 10%, 15% or 20% greater than the inner balloon compliance.

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 cryoablation catheter comprises a catheter shaft, a guidewire lumen disposed within the catheter shaft, a cryoballoon having a first end connected to the catheter shaft and an opposite second end connected to the guidewire lumen, the cryoballoon configured to transition between a deflated state and an inflated state, the cryoballoon having a maximum circumference in the inflated state, a proximal electrode array having a plurality of proximal electrodes arranged around the cryoballoon and located proximally of the maximum circumference of the cryoballoon, and a distal electrode array having a plurality of distal electrodes arranged around the cryoballoon and located distally of the maximum circumference of the cryoballoon. The cryoablation catheter has no electrodes located at the maximum circumference of the cryoballoon.

Abstract: An intravascular catheter system for treating a condition in a body includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The first inflatable balloon is positioned near a distal end of the catheter shaft. The first inflatable balloon moves between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon away from the maximum circumference of the first inflatable balloon. In some embodiments, the plurality of electrodes are attached to the inner surface of the first inflatable balloon. In various embodiments, the intravascular catheter system can also include two or more flex circuits that substantially face one another when the first inflatable balloon is in the substantially deflated state.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a compensation assembly for a balloon catheter system. The balloon catheter system may include a balloon catheter having a guidewire lumen and a balloon that is secured to the guidewire lumen with the balloon being movable between a deflated state and an inflated state.

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 cryogenic balloon catheter system includes a cryoballoon, a guidewire lumen that extends through and is secured to the cryoballoon, an injection line receiver and a fluid injection line. The injection line receiver is fixedly secured to the guidewire lumen so that movement of the guidewire lumen moves the injection line receiver. The injection line receiver includes an interior chamber. The fluid injection line delivers cryogenic fluid to the interior chamber. In certain embodiments, the fluid injection line extends into the injection line receiver and allows relative movement between the fluid injection line and the injection line receiver. The fluid injection line is not affixed to the injection line receiver. The fluid injection line is not affixed to the guidewire lumen. The injection line receiver can include one or more injection line sealers that are positioned around the fluid injection line.

Abstract: A fluid injection line compensation assembly for an intravascular catheter system including a balloon catheter having a guidewire lumen and a cryoballoon, includes a fluid injection line, a proximal fluid injection line stop, and a distal fluid injection line stop. The fluid injection line has a fluid discharge region positioned within the cryoballoon. The fluid discharge region includes a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon. The fluid discharge region is not affixed to the guidewire lumen. The proximal fluid injection line stop is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon. The distal fluid injection line stop is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

Abstract: A steering assembly for steering, navigating, articulating and/or positioning a catheter includes a steering ring having a first edge surface, a second edge surface and a side surface. The steering ring includes one or more notches formed within the side surface. The notches are spaced apart and extend to one of the first edge surface and the second edge surface. The steering ring can also include one or more apertures formed within the side surface. In one embodiment, the steering ring can include one or more lattice structures formed within the side surface. In certain embodiments, the lattice structures can form at least approximately 10%, 25% and/or 50% of the side surface.