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 and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device 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. In one embodiment, an intermediate console is placed between the console and the balloon catheter and coupled thereto.

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 catheter. A housing may be disposed within the handle, with the housing defines 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 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 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 device includes a catheter having a proximal end and a distal end, the catheter defining a lumen. A passage for a guide wire is disposed within the lumen so as to be coaxial with the lumen. The passage has an open proximal end that is substantially coterminous with the proximal end of the catheter and an open distal end that is substantially coterminous with the distal end of the catheter. A fluid injection tube is wound around the passage for the guide wire and is provided with radially spaced fluid injection ports.

Abstract: A catheter includes a first expandable membrane having a first pressurization limit and a second expandable membrane, having a second pressurization limit, wherein the second pressurization limit is greater than the first pressurization limit, the first expandable membrane defines a cooling chamber, the second expandable membrane being disposed around the first expandable membrane to define an junction therebetween. The catheter includes a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, and a primary coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber. The coolant injection tube, the cooling chamber, and the primary coolant return lumen define a first fluid pathway. The catheter further includes a secondary coolant return lumen in fluid communication with the at least one fluid outlet port and the junction. The junction and the secondary coolant return lumen define a second fluid pathway.

Abstract: A method and system for determining contact assessment includes the steps of positioning a catheter at a tissue treatment site, where the catheter has a proximal end portion and a distal end portion, the proximal end portion defining at least one fluid inlet port and at least one fluid outlet port, an expandable membrane defining a cooling chamber a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, a coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber, the coolant injection tube, the cooling chamber, and the primary coolant return lumen defining a fluid pathway and a temperature sensor located near the coolant return lumen; measuring an internal temperature of the chamber, and modifying the position of the catheter in response to the measured temperature. The method and system can also use a measured impedance to determine contact assessment.

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. Moreover, 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. In addition, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device 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. In one embodiment, an intermediate console is placed between the console and the balloon catheter and coupled thereto.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device 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. In one embodiment, an intermediate console is placed between the console and the balloon catheter and coupled thereto.

Abstract: A method and apparatus for detecting plaque proximate an area of a human body is described, the method comprising the steps of moving one or more electrically sensitive sensors substantially near an area where plaque may be present, obtaining electrical signal readings from the sensors, and determining the presence or absence of plaque. The presence or absence of the plaque corresponds to the electrical signal readings. Another aspect of the invention provides a method for inhibiting plaque formation and passivating plaque formed on a lumenal surface of a body lumen. A cooling device is positioned at the lumenal surface at a point proximate to a plaque formation. The lumenal surface is cooled at the point proximate to the plaque formation to inhibit the progression of plaque formation in which the lumenal surface is cooled to a temperature of less than about zero degrees Celsius. As another aspect, a method is provided for reducing the risk of plaque rupture in a vessel.

Abstract: A cryosurgical system including a housing having a front portion and a rear portion. The front portion and rear portion are connectable to support a fluid supply. A control unit attached to the front portion, and has a regulator assembly connecting the fluid supply to the control unit. A medical device is connected to the control unit, the medical device including a handle, a shaft, and a thermally-transmissive region. The handle, the shaft, and the thermally-transmissive region defining a fluid pathway through the handle, shaft, and thermally-transmissive region. The shaft is malleable to retain a first shape until manipulated to a second shape.

Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. One or more sensors may be disposed between the balloons or the vacuum return lumen, to detect leaks and control the flow of fluid through the device. Examples of sensors include pressure and temperature sensors, optical sensors, magnetic flow switches and flow meters.

Abstract: A cryosurgical system including a housing having a font portion and a rear portion. The front portion and rear portion are connectable to support a fluid supply. A control unit attached to the front portion, and has a regulator assembly connecting the fluid supply to the control unit. A medical device is connected to the control unit, the medical device including a handle, a shaft, and a thermally-transmissive region. The handle, the shaft, and the thermally-transmissive region defining a fluid pathway through the handle, shaft, and thermally-transmissive region. The shaft is malleable to retain a first shape until manipulated to a second shape.

Abstract: A method and apparatus for detecting plaque proximate an area of a human body is described, the method comprising the steps of moving one or more electrically sensitive sensors substantially near an area where plaque may be present, obtaining electrical signal readings from the sensors, and determining the presence or absence of plaque. The presence or absence of the plaque corresponds to the electrical signal readings. Another aspect of the invention provides a method for inhibiting plaque formation and passivating plaque formed on a lumenal surface of a body lumen. A cooling device is positioned at the lumenal surface at a point proximate to a plaque formation. The lumenal surface is cooled at the point proximate to the plaque formation to inhibit the progression of plaque formation in which the lumenal surface is cooled to a temperature of less than about zero degrees Celsius. As another aspect, a method is provided for reducing the risk of plaque rupture in a vessel.