Abstract: A medical device, including an elongate body having a proximal portion and a distal portion; a shaft at least partially disposed within the elongate body; an expandable element at the distal portion of the elongate body; and a fluid delivery conduit defining a deflectable segment movably coupled to the shaft, the deflectable segment being transitionable from a substantially linear configuration to a substantially curvilinear configuration.

Abstract: A cryoablation method, system, and device that allows for real-time and accurate assessment and monitoring of PV occlusion and lesion formation without the need for expensive imaging systems and without patient exposure to radiation. The system includes a cryoballoon catheter with a cryoballoon, a distal electrode, a proximal electrode, and a temperature sensor. Impedance measurements recorded by the electrodes may be used to predict ice formation, quality of pulmonary vein occlusion, and lesion formation.

Abstract: A cryotreatment catheter for treating tissue. The catheter may include an outer elongate body, a balloon treatment element coupled to the distal portion of the elongate body with a plurality of balloon lobes radially arranged around the outer elongate body, an inner elongate body rotatably movable within the lumen of the outer elongate body, and a fluid delivery lumen located within the lumen of the outer elongate body and at least partially within the lumen of the inner elongate body. The fluid delivery lumen may be branched at a distal portion into a plurality of linear segments, each linear segment being in fluid communication with one of the plurality of balloon lobes. Each of the balloon lobes may be inflated independently of each other by the linear segments of the fluid delivery lumen.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: A method, system, and device for predicting lesion quality. Specifically, lesion quality may be predicted based on an assessment of pulmonary vein occlusion using saline injection and evaluation of temperature measurements recorded by a thermocouple located distal to the cryoballoon of the treatment device. The quality of the occlusion may be rated based on the time it takes the temperature recorded by the thermocouple to increase from approximately 2° C. to approximately 38° C., the rate of temperature change over a predetermined time period, and/or the rate of dissipation within the pulmonary vein of the saline with a volume of contrast medium. For example, the quality of the occlusion may be rated as being good, fair, or poor. This assessment may be quickly and easily communicated to an operator.

Abstract: A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.

Abstract: A device, system, and method for identifying an area of ablated tissue and/or assessing contact between a treatment element and tissue and/or assessing occlusion of a body lumen by the treatment element. Specifically, the device, system, and method may include a device having one or more fiber sensors and a processing unit for receiving emitted and/or reflected light from tissue and making one or more determinations based on the received light regarding ablated tissue, tissue contact, and/or occlusion. Each of the fiber sensors may include at least one multimode waveguide segment and at least one singlemode waveguide segment, or each of the fiber sensors may be singlemode waveguide including fiber Bragg grating for assessing strain of a treatment element by tissue contact. The processing unit may include a beam processing apparatus and a hyperspectral imaging and analysis apparatus, and may optionally include a light source.

Abstract: A device, method, and system for adding mapping functionality to an ablation device without adding electrodes, wiring, or other components to the ablation device. The device includes a treatment catheter including a proximal portion and a distal portion, the distal portion including a longitudinal groove. The device also includes a mapping catheter including a proximal portion and a distal portion, the distal portion of the mapping catheter being coupled to the distal portion of the treatment catheter. For example, the distal portion of the mapping catheter is snapped into the groove of the treatment catheter. Together the treatment and mapping catheters are transitionable between a variety of configurations. In this way, the medical device may be used to both treat and map tissue without complicating the design and manufacture of the treatment catheter.

Abstract: A system and method for determining the optimum dose of cryotreatment to an area of target tissue to achieve isolation based on the time to effect (TTE). The system may generally include a treatment device, a sensing device, and a processor programmed to calculate the optimum dose of cryotreatment, in seconds, based on TTE. The TTE may be based on electrical signals received by the processor from the sensing device. The processor may be further programmed to automatically terminate a cryoablation procedure when the optimum dose of cryotreatment has elapsed. The optimum dose of cryotreatment may be the time, in seconds, it takes to achieve isolation, which may be the time it takes for an area of tissue to reach approximately ?20° C.

Abstract: A device, system, and method for providing support to a mapping catheter during mapping or pacing and for adjusting the diameter of a distal loop portion of currently available mapping catheters. A medical device support device includes an elongate body defining a wall and an at least substantially linear proximal portion and a distal portion being transitionable between an at least substantially linear configuration and an expanded configuration, the elongate body defining a lumen extending through the proximal portion and distal portion, the lumen being entirely surrounded by the wall in the proximal portion and being partially surrounded by the wall in the distal portion. For example, the lumen may be sized to receive a mapping catheter therein such that adjustment of the configuration or diameter of the distal portion of the elongate body will likewise modify the configuration or diameter of the distal portion of the mapping catheter.

Abstract: A method and system for performing pulmonary vein isolation, mapping, and assessing pulmonary vein occlusion using a single device. The device may generally include an ablation element, such as a cryoballoon, and a sensing component slidably disposed within a lumen of the device and bearing one or more mapping electrodes and one or more pressure sensors. The method may generally include mapping cardiac electrical signals within a heart and/or pulmonary vein, positioning a distal portion of the sensing component within a pulmonary vein, advancing the ablation element until it is in contact with the pulmonary vein ostium, recording blood pressure measurements within the pulmonary vein with the one or more pressure sensors to assess pulmonary vein occlusion, and activating the treatment element when the pulmonary vein is completely occluded. The sensing component may have a straight or hooped configuration, or a configuration therebetween.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: A method and system for automatic location of a target treatment structure, such as a pulmonary vein ostium, from an anatomical image. The method includes calculating a most likely path of blood flow through a pulmonary vein based on a cross-sectional area minimization technique and calculating pulmonary vein geometry as a function of length. For example, a pulmonary vein ostium may be located by analyzing a change in pulmonary vein dimensional size or other anatomical factors, such as absolute size. The method may also include determining tissue thickness at the pulmonary vein ostium or other treatment size for treatment dose optimization. The method may be an algorithm performed by a processing unit of a navigation system or other component of a medical system.

Abstract: A method and system for monitoring phrenic nerve function and preventing phrenic nerve injury during cardiac ablation. The system includes a pacing device operable to transmit stimulation energy to the phrenic nerve through target tissue proximate the phrenic nerve, a plurality of assessment electrodes operable to make comparisons between baseline, real-time, and predetermined threshold values for CMAP signal amplitude and amplitude over time. The processing device may be connected to an ablation console, and the processing device may interrupt or adjust an ablation procedure controlled by the ablation console and/or generate a system alert in response to one of these comparisons, if the comparison indicates phrenic nerve injury.

Abstract: A cryotreatment catheter for treating tissue. The catheter may include an outer elongate body, a balloon treatment element coupled to the distal portion of the elongate body with a plurality of balloon lobes radially arranged around the outer elongate body, an inner elongate body rotatably movable within the lumen of the outer elongate body, and a fluid delivery lumen located within the lumen of the outer elongate body and at least partially within the lumen of the inner elongate body. The fluid delivery lumen may be branched at a distal portion into a plurality of linear segments, each linear segment being in fluid communication with one of the plurality of balloon lobes. Each of the balloon lobes may be inflated independently of each other by the linear segments of the fluid delivery lumen.

Abstract: A cryogenic medical system and method of use thereof for transseptal puncturing is disclosed, including a medical device having an elongate body with a fluid flow path therein, a thermally-transmissive region coupled to the elongate body in thermal communication with the fluid flow path, and a puncturing element movably coupled to the elongate body; and a cryogenic coolant source in fluid communication with the fluid flow path. The medical device may alternatively include an elongate body, a thermally-transmissive region coupled to the elongate body, a thermo-electric cooler in thermal communication with the thermally-transmissive region, and a puncturing element movably coupled to the elongate body.

Abstract: The present invention includes a medical device providing for the measurement and/or monitoring of the thermal conditions and/or environment existing across a substantial portion of a thermal element disposed on the medical device and the corresponding tissue region being treated by the device. The medical device of the present invention may generally include an elongate body having a thermal element coupled thereto for providing thermal energy to a desired tissue region, as well as a thermocouple array providing a plurality of temperature measurement positions about the thermal element. The thermocouple array may include one or more thermocouple elements arranged as a mesh or wire structure disposed about a substantial portion of the surface area of the thermal element.

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

Abstract: A cryoablation method, system, and device that allows for real-time and accurate assessment and monitoring of PV occlusion and lesion formation without the need for expensive imaging systems and without patient exposure to radiation. The system includes a cryoballoon catheter with a cryoballoon, a distal electrode, a proximal electrode, and a temperature sensor. Impedance measurements recorded by the electrodes may be used to predict ice formation, quality of pulmonary vein occlusion, and lesion formation.

Abstract: A system and method of using a source of low-pressure refrigerant for a cryotherapy procedure. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, and an expansion valve located between the condenser and the thermal exchange device. The method may include transferring a low-pressure refrigerant to a first fluid reservoir, reducing the temperature of the refrigerant within the first fluid reservoir, increasing the temperature of the refrigerant within the first fluid reservoir, and transferring the pressurized refrigerant from the first fluid reservoir to a second fluid reservoir.