A calcification treatment device includes an outer body (12) including an inner cavity and at least one outer calcification treatment member (16) facing towards the inner cavity. An inner body (18) is movable into the inner cavity and includes at least one inner calcification treatment member (20) facing towards an inner surface of the outer body. One of the outer and inner calcification treatment members includes an expandable treatment member and one of the outer and inner calcification treatment members includes one or more fracturing elements capable of fracturing a calcification of a valve tissue.

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

Methods of heart valve decalcification may include mechanically removing calcium deposits on a heart valve, and removing debris from the mechanical decalcification via suction. The mechanical removal of the calcium deposits may be accomplished with a burr and/or an ultrasonic device. In some embodiments, mechanical removal of the calcium deposits may be accomplished with a handheld mechanical decalcification device comprising a bur extending from a hand piece. A catheter system for removing plaque deposits from a heart valve may include at least one mechanical decalcification device configured for cleaning the edges of heart valve leaflets, and at least one active aspiration device. The at least one mechanical decalcification device may comprise a bur and/or an ultrasonic device. The system may additionally include a deployable net apparatus configured to encompass at least a portion of a heart valve.

An apparatus includes a balloon adapted to be placed adjacent a calcified region of a body. The balloon is inflatable with a liquid. The apparatus further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the calcified region adjacent the balloon. The shock wave generator includes a plurality of shock wave sources distributed within the balloon.

Articulation devices, systems, methods for articulation, and methods for fabricating articulation structures will often include simple balloon arrays, with inflation of the balloons interacting with elongate skeletal support structures so as to locally alter articulation of the skeleton. The skeleton may comprise a simple helical coil or interlocking helical channels, and the array can be used to locally deflect or elongate an axis of the coil under control of a processor. Liquid inflation fluid may be directed so as to pressurize the balloons from an inflation fluid canister, and may vaporize within a plenum or the channels or balloons of the articulation system, with the inflation system preferably including valves controlled by the processor. The articulation structures can be employed in minimally invasive medical catheter systems, and also for industrial robotics, for supporting imaging systems, for entertainment and consumer products, and the like.

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

A calcification treatment device includes an outer body (12) including an inner cavity and at least one outer calcification treatment member (16) facing towards the inner cavity. An inner body (18) is movable into the inner cavity and includes at least one inner calcification treatment member (20) facing towards an inner surface of the outer body. One of the outer and inner calcification treatment members includes an expandable treatment member and one of the outer and inner calcification treatment members includes one or more fracturing elements capable of fracturing a calcification of a valve tissue.

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

The invention provides a device for generating shock waves. The device may comprise an elongated tube and a conductive sheath circumferentially mounted around the elongated tube. The device may further comprise first and second insulated wires extending along the outer surface of the elongated tube. A portion of the first insulated wire is removed to form a first inner electrode, which is adjacent to a first side edge of the conductive sheath. A portion of the second insulated wire is removed to form a second inner electrode, which is adjacent to a second side edge of the conductive sheath. Responsive to a high voltage being applied across the first inner electrode and the second inner electrode, a first shock wave is created across the first side edge and the first inner electrode, and a second shock wave is created across the second side edge and the second inner electrode.

A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts. Each of the struts includes two or more pairs of notches formed on opposite sides of the strut. The struts have a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve.