Abstract: A deflection system for deflecting a body lumen that includes a deflection mechanism, wherein the deflection mechanism includes: a beam having a proximal end and a distal end, wherein the beam includes a neutral position and a deflected position, a pull wire coupled to the distal end of the beam, wherein the beam is configured to be placed in the deflected position when a tension force is applied to the pull wire, and wherein at least a portion of the pull wire is configured to move to a displacement distance away from the beam when the tension force is applied to the pull wire, and one or more constraint members operatively coupled to the beam, wherein each one of the one or more constraint members is configured to limit the displacement distance of the pull wire from the beam when the tension force is applied to the pull wire.

Abstract: A deflection system for deflecting a body lumen that includes a deflection mechanism, wherein the deflection mechanism includes: a beam having a proximal end and a distal end, wherein the beam includes a neutral position and a deflected position, a pull wire coupled to the distal end of the beam, wherein the beam is configured to be placed in the deflected position when a tension force is applied to the pull wire, and wherein at least a portion of the pull wire is configured to move to a displacement distance away from the beam when the tension force is applied to the pull wire, and one or more constraint members operatively coupled to the beam, wherein each one of the one or more constraint members is configured to limit the displacement distance of the pull wire from the beam when the tension force is applied to the pull wire.

Abstract: A positioning device configured for introduction within a body lumen. Some embodiments include a catheter shaft with a longitudinal axis; an expandable element coupled along a length of the shaft, the expandable element being substantially thin and flexible in an unexpanded state and exerting a gentle outward force in an expanded state; and a deflection mechanism located within the shaft, wherein the deflection mechanism is flexible when in a non-deflected state and wherein, in the deflected state, the deflection curves in a predetermined lateral direction such that the positioning device laterally deflects the body lumen. In some embodiments, the deflection is a lateral curve that moves the body lumen away from a surgical site, such as a cardiac ablation site.

Abstract: A positioning device configured for introduction within a body lumen. Some embodiments include a catheter shaft with a longitudinal axis; an expandable element coupled along a length of the shaft, the expandable element being substantially thin and flexible in an unexpanded state and exerting a gentle outward force in an expanded state; and a deflection mechanism located within the shaft, wherein the deflection mechanism is flexible when in a non-deflected state and wherein, in the deflected state, the deflection curves in a predetermined lateral direction such that the positioning device laterally deflects the body lumen. In some embodiments, the deflection is a lateral curve that moves the body lumen away from a surgical site, such as a cardiac ablation site.

Abstract: A positioning device configured for introduction within a body lumen. Some embodiments include a catheter shaft with a longitudinal axis; an expandable element coupled along a length of the shaft, the expandable element being substantially thin and flexible in an unexpanded state and exerting a gentle outward force in an expanded state; and a deflection mechanism located within the shaft, wherein the deflection mechanism is flexible when in a non-deflected state and wherein, in the deflected state, the deflection curves in a predetermined lateral direction such that the positioning device laterally deflects the body lumen. In some embodiments, the deflection is a lateral curve that moves the body lumen away from a surgical site, such as a cardiac ablation site.

Abstract: A positioning device configured for introduction within a body lumen. Some embodiments include a catheter shaft with a longitudinal axis; an expandable element coupled along a length of the shaft, the expandable element being substantially thin and flexible in an unexpanded state and exerting a gentle outward force in an expanded state; and a deflection mechanism located within the shaft, wherein the deflection mechanism is flexible when in a non-deflected state and wherein, in the deflected state, the deflection curves in a predetermined lateral direction such that the positioning device laterally deflects the body lumen. In some embodiments, the deflection is a lateral curve that moves the body lumen away from a surgical site, such as a cardiac ablation site.

Abstract: The present invention provides an irrigated ablation electrode that includes a plurality of high L/d interior fluid passageways and/or slit-shaped apertures to provide for a lower rate of fluid flow and a more uniform distribution of fluid over an exterior surface of the electrode and reduce propensity for aperture blockage. In some embodiments, the slit-shaped apertures have an aspect ratio of at least three, at least five, at least ten, or at least fifteen. Some embodiments include maintaining a pressure drop of at least 345 pascals between irrigation fluid inside the irrigated ablation electrode and fluid immediately outside the electrode when the irrigation fluid has a flow rate of no more than five milliliters per minute (5 ml/min). Some embodiments include a low-density insert with a plurality of fluid channels on its exterior surface to more efficiently cool the electrode and provide a faster thermal response.

Abstract: The present invention provides an irrigated ablation electrode that includes a plurality of high L/d interior fluid passageways and/or slit-shaped apertures to provide for a lower rate of fluid flow and a more uniform distribution of fluid over an exterior surface of the electrode and reduce propensity for aperture blockage. In some embodiments, the slit-shaped apertures have an aspect ratio of at least three, at least five, at least ten, or at least fifteen. Some embodiments include maintaining a pressure drop of at least 345 pascals between irrigation fluid inside the irrigated ablation electrode and fluid immediately outside the electrode when the irrigation fluid has a flow rate of no more than five milliliters per minute (5 ml/min). Some embodiments include a low-density insert with a plurality of fluid channels on its exterior surface to more efficiently cool the electrode and provide a faster thermal response.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: The present invention provides an irrigated ablation electrode that includes a plurality of high L/d interior fluid passageways and/or slit-shaped apertures to provide for a lower rate of fluid flow and a more uniform distribution of fluid over an exterior surface of the electrode and reduce propensity for aperture blockage. In some embodiments, the slit-shaped apertures have an aspect ratio of at least three, at least five, at least ten, or at least fifteen. Some embodiments include maintaining a pressure drop of at least 345 pascals between irrigation fluid inside the irrigated ablation electrode and fluid immediately outside the electrode when the irrigation fluid has a flow rate of no more than five milliliters per minute (5 ml/min). Some embodiments include a low-density insert with a plurality of fluid channels on its exterior surface to more efficiently cool the electrode and provide a faster thermal response.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: A tear-away sheath (8) having a tubular element (10) with a distal end and a proximal end, at least one axial fault line (12), and an integral stop (16) is disclosed. The tear-away sheath may also have a handle (14) or closing element at the proximal end. An angioplasty balloon catheter (22) having the disclosed tear-away sheath is also disclosed.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: A method and apparatus for treating a body tissue in situ (e.g., an atrial tissue of a heart to treat atrial fibrillation) include a lesion formation tool is positioned against the heart surface. The apparatus includes a guide member having a tissue-opposing surface for placement against a heart surface. The guide member also has interior surfaces and a longitudinal axis. A guide carriage is sized to be received with the guide member and moveable therein along the longitudinal axis. An optical fiber is positioned within the guide carriage with the carriage retaining the fiber. The carriage receives the fiber with an axis substantially parallel to the longitudinal axis and bends the fiber to a distal tip with an axis of said fiber at said distal tip at least 45 degrees to the longitudinal axis and aligned for discharge of laser energy through the tissue opposing surface.

Abstract: The ablation catheter is comprised of a guiding catheter and an inner catheter. The guiding catheter is comprised of a shaft section which is attached to an articulating section at its distal end and a first handle at its proximal end. The inner catheter is comprised of an elongated central shaft, an electrode assembly attached to the distal end of the central shaft, and a second handle attached to the proximal end of the central shaft. The electrode assembly is comprised of a flexible plastic catheter tube having an outer surface, a porous tip electrode, and at least one linear electrode carried on the outer surface of the catheter tube. The electrode assembly is articulated to better align the electrode assembly to the generally arcuate shape of the inner chambers of the heart.

Abstract: The ablation catheter is comprised of a guiding catheter and an inner catheter. The guiding catheter is comprised of a shaft section which is attached to an articulating section at its distal end and a first handle at its proximal end. The inner catheter is comprised of an elongated central shaft, an electrode assembly attached to the distal end of the central shaft, and a second handle attached to the proximal end of the central shaft. The electrode assembly is comprised of a flexible plastic catheter tube having an outer surface, a porous tip electrode, and at least one linear electrode carried on the outer surface of the catheter tube. The electrode assembly is articulated to better align the electrode assembly to the generally arcuate shape of the inner chambers of the heart.

Abstract: The ablation catheter is comprised of a guiding catheter and an inner catheter. The guiding catheter is comprised of a shaft section which is attached to an articulating section at its distal end and a first handle at its proximal end. The inner catheter is comprised of an elongated central shaft, an electrode assembly attached to the distal end of the central shaft, and a second handle attached to the proximal end of the central shaft. The electrode assembly is comprised of a flexible plastic catheter tube having an outer surface, a porous tip electrode, and at least one linear electrode carried on the outer surface of the catheter tube. The electrode assembly is articulated to better align the electrode assembly to the generally arcuate shape of the inner chambers of the heart.

Abstract: An irrigated tip catheter comprises a catheter body, a tip section, and a porous tip electrode. The catheter body has an outer wall, proximal and distal ends, and a lumen extending therethrough. The tip section comprises a segment of flexible tubing having proximal and distal ends and at least one lumen therethrough. The proximal end of the tip section is fixedly attached to the distal end of the catheter body. The porous tip electrode is fixedly attached to the distal end of the tubing of the tip section. The tip electrode has an outer surface and comprises a body and an insert. The body comprises a porous material through which fluid can pass and has a cavity therein. The insert, which comprises a non-porous material, is contained within the cavity of the shell. The insert has at least one passage extending therethrough in fluid communication with a lumen in the tip section. An infusion tube having proximal and distal ends extends through the central lumen in the catheter body.