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 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.

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: Methods and systems for detecting fluid egress, assessing lesion quality, determining tissue composition or structure, determining ice coverage of catheter tip and providing tissue contact assessment, by providing a catheter having a shaft with a proximal end portion and a distal end portion, the proximal end portion and the distal end portion define at least one fluid pathway therebetween with the shaft having a plurality of electrodes, positioning the catheter at a tissue treatment site, applying an electrical current between at least two of the plurality of electrodes, measuring impedance voltage between the at least two of the plurality of electrodes and, processing the measured impedance voltage caused by the applied electrical current to determine if fluid egress is present, to assess lesion quality, to determine tissue composition, ice cover of catheter tip, and to provide contact assessment.

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 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: A catheter includes a cryoablation tip with an ablation assembly for heating tissue. The cryoablation tip may be implemented with a cooling chamber and have an RF electrode at its distal end. The electrode may be operated to warm cryogenically-cooled tissue, or the coolant may be controlled in combination with an RF treatment regimen to enhance the lesion size, speed or placement of multi-lesion or single lesion cycles. In one embodiment a microwave energy source operates to extend beyond the thermal conduction depth, or penetrate the ice ball and be absorbed in tissue beyond an ice boundary, thus extending a dimension of treatment. Also, the cooling and application of RF energy can be controlled to position the ablation region away from the surface contacted by the electrode thereby leaving surface tissue unharmed while ablating at depth or to provide an ablation band of greater uniformity with increasing depth.

Abstract: Methods and systems for detecting fluid egress, assessing lesion quality, determining tissue composition or structure, determining ice coverage of catheter tip and providing tissue contact assessment, by providing a catheter having a shaft with a proximal end portion and a distal end portion, the proximal end portion and the distal end portion define at least one fluid pathway therebetween with the shaft having a plurality of electrodes, positioning the catheter at a tissue treatment site, applying an electrical current between at least two of the plurality of electrodes, measuring impedance voltage between the at least two of the plurality of electrodes and, processing the measured impedance voltage caused by the applied electrical current to determine if fluid egress is present, to assess lesion quality, to determine tissue composition, ice cover of catheter tip, and to provide contact assessment.

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: 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 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 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: The present invention provides a surgical device including an elongate body defining a fluid flow path therethrough. An expandable element may be coupled to the elongate body and placed in fluid communication with the fluid flow path. Moreover, the surgical device may include a first leak detection element at least partially surrounding a portion of the expandable element, and a second leak detection element may be provided in fluid communication with the fluid flow path. In addition, a console may be provided, where the console may be in communication with the first and second leak detection elements. Further, a supply of cryogenic fluid as well as a vacuum source may be provided in fluid communication with the fluid flow path.

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 system and method for controlling the inflation, ablation, and deflation of a balloon catheter is provided. 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.

Abstract: The present invention provides a surgical device including an elongate body defining a fluid flow path therethrough. An expandable element may be coupled to the elongate body and placed in fluid communication with the fluid flow path. Moreover, the surgical device may include a first leak detection element at least partially surrounding a portion of the expandable element, and a second leak detection element may be provided in fluid communication with the fluid flow path. In addition, a console may be provided, where the console may be in communication with the first and second leak detection elements. Further, a supply of cryogenic fluid as well as a vacuum source may be provided in fluid communication with the fluid flow path.

Abstract: A medical device is provided that may include a catheter body having proximal and distal portions, a fluid injection lumen disposed within elongate body, and a guidewire lumen disposed within the elongate body. A tip portion defining a cavity in fluid communication with the fluid injection lumen may be coupled to the distal end of the guidewire lumen, and an expandable element may be coupled to the distal portion of the catheter body and to the tip portion, such that the expandable element is in fluid communication with the fluid injection lumen. A shaping element may at least partially surround the expandable element, where the shaping element is configurable in a first geometric configuration and a second geometric configuration.

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 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: 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.