Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

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: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

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: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

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: An intraluminal microneurography probe has a probe body that is configured to be introduced into an artery near an organ of a body without preventing the flow of blood through the artery. An expandable sense electrode and an expandable stimulation electrode are fixed to the probe body at one end of each electrode such that movement of the other end toward the fixed end causes the sense electrode to expand from the probe body toward a wall of the artery. A ground electrode is configured to couple to the body, and a plurality of electrical connections are operable to electrically couple the electrodes to electrical circuitry. The sense electrode is operable to measure sympathetic nerve activity in response to excitation of the stimulation electrode. An ablation element is located between the expandable sense electrode and expandable stimulation electrode, and is operable to ablate nerves proximate to the artery.

Abstract: Method and systems for ablating nerves including measurement of physiological parameters and/or electrical conduction. The method may include ablating nerves within an artery of a patient such as the renal artery and may include advancing a catheter into the artery, measuring a physiological parameter, emitting an electrical pulse into a wall of the artery, measuring the physiological parameter during or after the step of emitting the electrical pulse, ablating the artery wall, then repeating the steps of measuring the physiological parameter, emitting an electrical pulse, and measuring the physiological parameter during or after the step of emitting the electrical pulse. The change in the physiological parameter caused by the electrical pulse before ablation may be compared to the change in the physiological parameter caused by the electrical pulse after ablation to determine the degree of nerve ablation achieved and whether or not to perform further ablation.

Abstract: The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient's heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.

Abstract: Method and systems for ablating nerves including measurement of physiological parameters and/or electrical conduction. The method may include ablating nerves within an artery of a patient such as the renal artery and may include advancing a catheter into the artery, measuring a physiological parameter, emitting an electrical pulse into a wall of the artery, measuring the physiological parameter during or after the step of emitting the electrical pulse, ablating the artery wall, then repeating the steps of measuring the physiological parameter, emitting an electrical pulse, and measuring the physiological parameter during or after the step of emitting the electrical pulse. The change in the physiological parameter caused by the electrical pulse before ablation may be compared to the change in the physiological parameter caused by the electrical pulse after ablation to determine the degree of nerve ablation achieved and whether or not to perform further ablation.

Abstract: The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient's heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.

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.