Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

Abstract: A device and system for providing a centered lumen within a catheter body. A coiled guide lumen (CGL) is composed of a length of wire forming a plurality of coils about the longitudinal axis of the CGL, the CGL including one or more first sections having a first diameter and one or more sections having a second diameter, the second diameter being greater than the first diameter, and a secondary guide lumen extending through the first sections. The CGL may include at least one pull wire extending through the secondary guide lumen and attached at the distal portion of the catheter body. A band may be coupled to an interior of the catheter body distal portion, each of the pull wires being coupled to the annular band. Alternatively, the system may further include a shim coupled to the band, each of the pulls wire being coupled to the shim.

Abstract: An intravascular ablation device, including a flexible elongate body; an expandable element positioned on the elongate body; a radiofrequency or electroporation treatment segment located distally of the expandable element; a cryogenic coolant source in fluid communication with an interior of the expandable element; and a radiofrequency or electroporation energy source in communication with the radiofrequency or electroporation treatment segment.

Abstract: A device and system for thermally affecting tissue that includes a balloon catheter with a reduced distal length for ease of navigation and that also includes a balloon that is more resistant to bursting and delamination. The balloon may include a proximal neck generally attached to an elongate body and a distal neck generally attached to a shaft disposed within the elongate body. The distal neck is turned inward to extend within the balloon chamber and the proximal neck may either extend within the chamber or extend proximally away from the balloon chamber. Alternatively, the device may include an inner balloon and an outer balloon, the distal necks of both being turned inward and extending within the inner balloon chamber. The proximal necks may both also be turned inward to extend within the chamber or the proximal neck of the outer balloon may extend away from the balloon chamber.

Abstract: Devices, systems, and methods for assessing contact between a treatment element and an area of target tissue using resistive-type and/or capacitive-type contact sensing elements. In one embodiment, a medical system for determining tissue contact includes an elongate body including a distal portion and a proximal portion and a treatment element coupled to the elongate body distal portion. The treatment element may have a first expandable element, a second expandable element, the first expandable element being within the second expandable element, and at least one contact sensing element between the first and second expandable elements. In one example, the device may include a plurality of contact sensing elements arranged in a matrix or in a plurality of linear configurations. In another example, the device may include a layer of conductive microparticles or a contact-sensing film.

Abstract: A device, system, and method for identifying an area of ablated tissue. 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. Further, each fiber sensor may have a core with long-period grating for optically coupling light from tissue to the fiber sensor. 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 thermally affecting tissue. The device may generally include an elongate body, an actuation element slidably disposed within the elongate body, a balloon defining an interior chamber, a proximal neck, and a distal neck, the first neck being coupled to the distal portion of the elongate body and the second neck being coupled to the distal portion of the actuation element, retraction of the actuation element within the elongate body causing the treatment element to transition from a first configuration to a second configuration. The distal neck may be located external to the interior chamber in the first configuration and within the interior chamber in the second configuration. The device may also include a fluid injection element that is transitionable to an expanded configuration when the balloon is inflated, thereby enhancing the cooling capacity of the balloon.

Abstract: A system for the recovery of expanded refrigerant from a cryotreatment system for storage and disposal may generally include first fluid flow path having a first compressor and a fluid recovery reservoir, and a closed-loop second fluid flow path having a thermal exchange device that is in thermal communication with the fluid recovery reservoir, a second compressor, and a condenser. The first fluid flow path may include a primary refrigerant from a cryotreatment system and the closed-loop second fluid flow path may contain a secondary refrigerant for cooling the primary refrigerant within the fluid recovery reservoir. The refrigerant recovery conduit may be in fluid communication with both the cryotreatment system and a medical facility scavenging system. The refrigerant recovery conduit and the cryotreatment system may be located within the same cryotreatment console.

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.

Abstract: An intravascular catheter is provided, including a flexible elongate body; an expandable element positioned on the elongate body; a substantially linear thermal segment located proximally of the expandable element, the thermal segment defining a first flexibility, where the thermal segment is positioned between two portions of the catheter body each including a flexibility less than that of the thermal segment; a first fluid flow path in fluid communication with the expandable element; and a second fluid flow path in fluid communication with the thermal segment.

Abstract: The present invention provides a medical device 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: A system and kit for using a source of low-pressure refrigerant for a cryotherapy procedure and for subcooling a cryotherapy refrigerant. 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 first thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the first thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, a second thermal exchange device located between the reversing valve and the compressor, and an expansion valve located between the condenser and the thermal exchange device. The third thermal exchange device may be configured to be in fluid communication with the cryotherapy console and configured to place a secondary refrigerant within the first fluid flow path in thermal communication with a secondary refrigerant of the cryotherapy system.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: An adapter for putting two incompatible medical systems in fluid communication with each other. The adapter may have a continuous outer diameter and may include two segments: a first segment composed of a rigid material and including a first portion and a second portion, the first portion having a continuous outer diameter and the second portion defining one or more flanges, the first segment defining a first passage therethrough; and a second segment composed of a flexible material and coupled to the first segment, including a first portion and a second portion. The first portion of the second segment may have an inner surface configured to surround the flanges of the second portion of the first segment, and the second portion of the second segment having a tapered inner surface, the second segment defining a second passage therethrough that is continuous with the first passage.

Abstract: A system and method for creating radial-linear lesions in tissue. The system includes a cryoablation device having a first balloon, a second balloon disposed about the first balloon, and one or more splines disposed between the first balloon and second balloon, each spline defining a plurality of ports. The splines may be in communication with a coolant supply, and the first balloon may be in communication with a coolant supply or non-coolant inflation fluid supply. When the first balloon is in the uninflated configuration, the splines may have a substantially linear configuration. Each of the splines may be radially oriented about an elongate shaft and transitionable between the substantially linear configuration and an arcuate configuration when the first balloon is in the inflated configuration. Coolant expelled from the splines between the first and second balloons creates an ablation pattern on the outer surface of the second balloon.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: A system and kit for using a source of low-pressure refrigerant for a cryotherapy procedure and for subcooling a cryotherapy refrigerant. 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 first thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the first thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, a second thermal exchange device located between the reversing valve and the compressor, and an expansion valve located between the condenser and the thermal exchange device. The third thermal exchange device may be configured to be in fluid communication with the cryotherapy console and configured to place a secondary refrigerant within the first fluid flow path in thermal communication with a secondary refrigerant of the cryotherapy system.

Abstract: An epicardial device, system, and method for stabilizing the left atrial appendage during a left atrial appendage ligation/occlusion procedure. A cryoadhesion device including a stabilization element is positioned within the pericardial space proximate the left atrial appendage through subxiphoid access. Once the stabilization element is in contact with the left atrial appendage, the stabilization element is cooled to a temperature that is sufficient to cryoadhere the stabilization element to the left atrial appendage. In this way, the cryoadhesion device stabilizes the left atrial appendage in order to perform left atrial appendage ligation/occlusion with a secondary medical device.

Abstract: An intravascular catheter is provided, including a flexible elongate body; an expandable element positioned on the elongate body; a substantially linear thermal segment located proximally of the expandable element, the thermal segment defining a first flexibility, where the thermal segment is positioned between two portions of the catheter body each including a flexibility less than that of the thermal segment; a first fluid flow path in fluid communication with the expandable element; and a second fluid flow path in fluid communication with the thermal segment.