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 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 having a substantially fixed diameter, a proximal end and a distal end; a first lumen for permitting passage of a cooling fluid from the proximal end to the distal end; a second lumen permitting return of the cooling fluid from the distal end to the proximal end; and an ablation element expandable from a first diameter that is substantially the same as the diameter of the catheter body to a second diameter that is at least twice the diameter of the catheter body, 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 balloon and/or a flexible element that is deformed by moving the distal end of the catheter toward the proximal end of the catheter.

Abstract: A cryocatheter system includes a first handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; a second handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; and a catheter having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path. The distal end of the first handle portion is matable with the proximal end of the second handle portion to place the respective first and second fluid flow paths of each handle portion in fluid communication; and the distal end of the second handle portion is matable with the proximal end of the catheter to place the respective first and second fluid flow paths of the second handle portion and the catheter in fluid communication.

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 catheter includes a cryoablation tip with an electrically-driven ablation assembly for heating tissue. The cryoablation tip may be implemented with a cooling chamber through which a controllably injected coolant circulates to lower the tip temperature, and having an RF electrode at its distal end. The RF electrode may be operated to warm cryogenically-cooled tissue, or the coolant may be controlled to conductively cool the tissue in coordination with an RF treatment regimen, allowing greater versatility of operation and enhancing the lesion size, speed or placement of multi-lesion treatment or single lesion re-treatment cycles. In one embodiment a microwave energy source operates at a frequency to extend beyond the thermal conduction depth, or to penetrate the cryogenic ice ball and be absorbed in tissue beyond an ice boundary, thus extending the depth and/or width of a single treatment locus.

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 catheter having an extended treatment zone for cooling tissue is provided. The catheter includes an elongate catheter body having a distal tip, and a fluid injection conduit disposed inside the catheter body defining a return lumen therein. The fluid injection conduit further defines two or more injection orifices including a first distal orifice near the distal tip, and a second orifice longitudinally offset along the fluid injection conduit to be less proximate the distal tip than the first orifice. Fluid cryogen flowing through the orifices creates an extended tissue cooling contour about the distal end portion of the catheter. At least one ECG ring electrode is provided about the catheter body near the second orifice. The catheter may thus provide for electrocardiographic mapping of tissue nodes lying transversely between the distal tip and the ECG ring electrode.

Abstract: A thermal treatment medical system including an umbilical having a first portion and a second portion, and a connector including a male coupling body connected to the first portion, the male coupling body having a central shank defining first and second lumens, a female coupling body connected to the second portion, the female coupling body, matable with the male coupling body and defining third and fourth lumens matable to be in fluid communication with the first and second lumens, respectively, to define first and second fluid flow pathways, respectively, through the connector when the male coupling body is mated with the female coupling body. The second fluid flow pathway is co-axially disposed about a central axis coincident with the first fluid flow pathway. The connector includes a mating mechanism for spatially locking the male and female coupling bodies with respect to each other.

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. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. 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. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.

Abstract: A catheter includes a cryoablation tip with an electrically-driven ablation assembly for heating tissue. The cryoablation tip may be implemented with a cooling chamber through which a controllably injected coolant circulates to lower the tip temperature, and having an RF electrode at its distal end. The RF electrode may be operated to warm cryogenically-cooled tissue, or the coolant may be controlled to conductively cool the tissue in coordination with an RF treatment regimen, allowing greater versatility of operation and enhancing the lesion size, speed or placement of multi-lesion treatment or single lesion re-treatment cycles. In one embodiment a microwave energy source operates at a frequency to extend beyond the thermal conduction depth, or to penetrate the cryogenic ice ball and be absorbed in tissue beyond an ice boundary, thus extending the depth and/or width of a single treatment locus.

Abstract: The present invention provides a medical device having an elongate body, which includes an injection lumen, an exhaust lumen, and a guidewire lumen. The medical device further includes a first pliable element defining a cooling chamber, and a second pliable element at least partially enclosing the first pliable element, defining a junction between the first and second pliable element. Moreover, a first leak detector is provided in fluid communication with the cooling chamber, while a second leak detector is in fluid communication with the junction. In addition, the medical device may be in communication with a control console, a fluid supply, or a vacuum source.

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: An integrated multiple energy ablation system that allows for a variety of ablation procedures to be performed without the interchanging of catheters. A console is provided that is connected to one or more energy treatment devices such as catheters or probes, via an energy-delivering umbilical system. A processor in the console allows a user to selectively control which type of energy is released into the umbilical system and delivered to the energy treatment devices. Cryogenic fluid, RF energy, microwave or direct current as well as laser energy can be supplied in order to cover a wide range of ablation techniques. The integrated ablation station is designed to be compatible with commercial catheters and allows for sequential or simultaneous ablation and mapping procedures to be performed when a deeper and wider lesion capability and/or a broader temperature ablation spectrum is desired.

Abstract: A cryogenic catheter system provides safe and effective treatment of tissue. The system includes a catheter that is coupled to a console via fluid and electrical umbilicals. The console controls the overall operation of the system based to provide and maintain a predetermined temperature at the catheter tip. The console also controls and monitors operating parameters for providing warning indications to the user and terminating operation of the system in the event of a failure that may compromise patient safety.

Abstract: A cryogenic medical system includes a medical device and a console connectable to the medical device at a connection point. The console controls the temperature of the medical device. The console includes a first cooling system directing coolant to the medical device at a first temperature along a coolant supply line and a second cooling system chilling the coolant within the coolant supply line to a temperature below the first temperature before the coolant reaches the connection point.

Abstract: A method is disclosed for treating heart and vascular tissue with cryotreatment. A medical instrument, such as a catheter is positioned to contact a target region of cardiac tissue such as the epicardial tissue. The instrument or catheter provided includes a cryotreatment element that has thermally-transmissive properties. The cryotreatment element may be a cryochamber for enclosing the flow of a fluid refrigerant therein. The cryotreatment element is disposed at the situs of heart or vascular tissue to be treated, usually by piercing the epicardium sac via an opening in the patient's body. A refrigerant flow within the cryochamber creates endothermic cooling with respect to the targeted heart or vascular tissue, inducing hypothermia and forming iceballs proximate the tissue. The cooling may be reversible and non-permanent, or may be permanent leading to cell death, necrosis, apoptosis and/or surgical excision or ablation of tissue.

Abstract: A surgical device includes a device body defining a sealed fluid path having a first end and a second end, a refrigerant supply in communication with the first end of the sealed fluid path, and a vacuum source in communication with the second end of the sealed fluid path. Leak detection apparatus can be provided in communication with the sealed fluid path.

Abstract: A medical device is provided having a means for actuating a pair of opposing jaw members. The jaw members are movable relative to one another from a first position, wherein the jaw members are disposed in a spaced apart relation relative to one another, to a second position, wherein the jaw members cooperate to grasp tissue therebetween. An ablation mechanism is connected to at least one of the jaws members, such that the jaw members are capable of conducting ablation energy through the tissue grasped therebetween.

Abstract: A medical device is provided having a means for actuating a pair of opposing jaw members. The jaw members are movable relative to one another from a first position, wherein the jaw members are disposed in a spaced apart relation relative to one another, to a second position, wherein the jaw members cooperate to grasp tissue therebetween. An ablation tool is connected to at least one of the jaws members, such that the jaw members are capable of conducting ablation energy through the tissue grasped therebetween.

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.