Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon is configured to transmit the RF energy in a direction distally towards a leading end of the ablation device. Multiple ablation electrodes on the device can be used for providing lesions of different size or shape.

Abstract: The present invention relates to a device for the prevention of air embolisms during a catheterization procedure. The device includes a bulb element configured to secure to a sheath assembly. The bulb element includes a flexible wall, including a proximal section and a distal section, and an interior chamber in fluid communication with a pressurized fluid source. The proximal section of the bulb element includes a proximal hub, and the distal section of the bulb element includes a distal hub. The bulb element is collapsible, under the action of an external force, from a first, relaxed state in which the interior chamber has a first volume, to a second, collapsed state in which the interior chamber has a second volume less than the first volume, and wherein the bulb element is configured to assume its first, relaxed state in the absence of the external force.

Abstract: Ablation devices and methods for determining a degree of contact between an electrode and a target tissue are disclosed. An example ablation device for treating body tissue may include a catheter having a proximal end region and a distal end region. An electrode may be disposed adjacent to the distal end region of the catheter. The device may also include a processing unit having a memory. The processing unit may be in electrical communication with the electrode. The processing unit may be capable of determining a degree of contact between the electrode and a target tissue.

Abstract: Devices, systems, and methods for performing a mapping procedure on body tissue are disclosed. An example mapping device for mapping a tissue surface includes an elongate shaft and an electrode assembly. The electrode assembly includes a plurality of splines and a plurality of electrodes disposed on at least some of the splines. The electrode assembly is capable of moving between a collapsed configuration and an expanded configuration. In the expanded configuration, the electrode assembly may have a generally planar structure.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. The ablation device can have a steering mechanism configured to deflect the balloon.

Abstract: Methods and devices for biasing a balloon catheter are disclosed. In one example, a medical device may include a catheter shaft and a balloon assembly coupled to a distal region of the catheter shaft. The balloon assembly can define a chamber configured to be inflated and deflated using a fluid supplied from the catheter shaft. A biasing member may be positioned in the chamber of the balloon assembly and may be configured to bias the balloon assembly to a longitudinally extended state without obstructing an exhaust lumen of the catheter shaft. In some cases, the biasing member may be a spring. In other cases, the biasing member may be a coiled portion of a fluid supply line.

Abstract: An apparatus which includes a dual loop structure that carries a plurality of operative elements. A guide with a distal indentation that may be used to reorient a dual loop structure.

Abstract: Methods and devices for bonding a balloon assembly, such as a balloon assembly including an inner balloon and an outer balloon, to a catheter shaft are disclosed. In some cases, a proximal waist of the inner balloon may be bonded to an interior surface of an outer tubular member of the catheter shaft and a proximal waist of the outer balloon may be bonded to an exterior surface of the outer tubular member. In other cases, the proximal waist of the inner balloon may be bonded to a reduced diameter portion of the outer tubular member of the catheter shaft and the proximal waist of the outer balloon may be bonded to the outer tubular member, such as a non-reduced outer diameter portion of the outer tubular member.

Abstract: Methods and apparatus for supplying fluid during a tissue coagulation procedure.

Abstract: The present invention relates to a device for the prevention of air embolisms during a catheterization procedure. The device includes a bulb element configured to secure to a sheath assembly. The bulb element includes a flexible wall, including a proximal section and a distal section, and an interior chamber in fluid communication with a pressurized fluid source. The proximal section of the bulb element includes a proximal hub, and the distal section of the bulb element includes a distal hub. The bulb element is collapsible, under the action of an external force, from a first, relaxed state in which the interior chamber has a first volume, to a second, collapsed state in which the interior chamber has a second volume less than the first volume, and wherein the bulb element is configured to assume its first, relaxed state in the absence of the external force.

Abstract: Various embodiments concern sensing a first signal indicative of a plurality of different phases of a cardiac cycle with a sensor and sensing a second signal with an ultrasound sensor within the heart over different phases, the second signal indicative of the density of a section of cardiac tissue. Each phase can be associated with an indication of the density of the section of cardiac tissue during the phase based on the second signal. It can be determined whether the section of cardiac tissue compressed during the cardiac cycle based on a change in the indication of density of the cardiac tissue over the plurality of different phases. The efficacy of ablation therapy can be evaluated based on the compressibility of the section of cardiac tissue.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. A method for fabricating a semi-permeable ablation balloon using ionizing radiation and an etching process is also disclosed.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon is configured to transmit the RF energy in a direction distally towards a leading end of the ablation device. Multiple ablation electrodes on the device can be used for providing lesions of different size or shape.

Abstract: A tissue ablation device comprising an elongate member having a proximal end, a distal end and a side wall defining a lumen, and an elongate ablation member having an ablation element proximate a distal end thereof, the elongate ablation member rotatable about an longitudinal axis of the elongate member, and wherein one of the elongate ablation member and the elongate member is at least partially contained within the other and methods of use therefor.

Abstract: Balloon catheters and methods for manufacturing catheter shafts are disclosed. In one example, a balloon catheter may include an outer tubular member disposed about an inner tubular member. In some cases, a fluid (e.g. cryogenic fluid) can be provided between the inner tubular member and the outer tubular member and may cool the inner tubular member. To help provide a relatively uniform temperature distribution around a circumference of the inner tubular member, two or more spacers, protrusions, or gap-maintaining members can be positioned between the outer tubular member and the inner tubular member to maintain a gap therebetween. In some cases, the spacers, protrusions, or gap-maintaining members may be attached to an inner surface of the outer tubular member or, in other cases, to an outer surface of the inner tubular member. In other embodiments, a step-down in an outer diameter of the outer tubular member is disclosed.

Abstract: Methods and devices for bonding a balloon assembly, such as a balloon assembly including an inner balloon and an outer balloon, to a catheter shaft are disclosed. In some cases, a proximal waist of the inner balloon may be bonded to an interior surface of an outer tubular member of the catheter shaft and a proximal waist of the outer balloon may be bonded to an exterior surface of the outer tubular member. In other cases, the proximal waist of the inner balloon may be bonded to a reduced diameter portion of the outer tubular member of the catheter shaft and the proximal waist of the outer balloon may be bonded to the outer tubular member, such as a non-reduced outer diameter portion of the outer tubular member.

Abstract: Methods and devices for biasing a balloon catheter are disclosed. In one example, a medical device may include a catheter shaft and a balloon assembly coupled to a distal region of the catheter shaft. The balloon assembly can define a chamber configured to be inflated and deflated using a fluid supplied from the catheter shaft. A biasing member may be positioned in the chamber of the balloon assembly and may be configured to bias the balloon assembly to a longitudinally extended state without obstructing an exhaust lumen of the catheter shaft. In some cases, the biasing member may be a spring. In other cases, the biasing member may be a coiled portion of a fluid supply line.

Abstract: According to an embodiment of a method for cooling an open-irrigated ablation electrode, pressurized fluid is delivered from a fluid lumen of a catheter body into an ablation electrode. Fluid flow in the fluid lumen is generally laminar. The generally laminar fluid flow is transformed from the fluid lumen into a turbulent fluid flow within the ablation electrode. The pressurized fluid with turbulent fluid flow is delivered through irrigation ports of the ablation electrode.

Abstract: Methods and apparatus for supplying fluid during a tissue coagulation procedure.

Abstract: An apparatus which includes a dual loop structure that carries a plurality of operative elements. A guide with a distal indentation that may be used to reorient a dual loop structure.