A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

A device for fracturing calcifications in heart valves characterized by a stabilizer assembly and an impactor assembly assembled on and deployed by a delivery system, wherein said delivery system is operable to cause relative motion between said impactor assembly and said stabilizer assembly with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between said stabilizer assembly and said impactor assembly, wherein said impactor assembly and said stabilizer assembly have shaped impact delivery portions of which the footprint on the valve leaflets is shaped in accordance with a shape of desired fracture sites.

A device for fracturing calcifications in heart valves includes a stabilizer assembly (20) for use with an impactor assembly (10). Relative motion between the impactor assembly (10) and the stabilizer assembly (20) with sufficient energy fractures a calcification located in tissue which is sandwiched between the stabilizer assembly (20) and the impactor assembly (10). The stabilizer assembly (20) includes a plurality of distal stabilizer struts (28) connected by stabilizer loops (30) which extend proximally backwards.

A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts (4). Each of the struts includes two or more pairs of notches (3) 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.

Device for the treatment of tissue calcification, in particular aortic valve leaflets, characterized by the fact that it comprises a first ultrasound emission source that is adapted to provide ultrasound waves with MHz frequencies and a second ultrasound emission source that is adapted to provide ultrasound waves with KHZ frequencies, both MHz and KHz waves being used for the said treatment. The invention also includes a method for the treatment of tissue calcification that is characterized by the simultaneous use of ultrasound waves with MHz frequencies and ultrasound waves with KHz frequencies.

A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.

The present disclosure provides a balloon catheter for treating a stenosis in a body lumen that incorporates at least one shock wave generator located within at least one balloon and at least one channel that permits blood to flow through the body lumen past the balloon while the balloon is inflated. The at least one channel acts as a bypass around the inflated balloon(s) of the catheter such that blood flow through the lumen is generally not fully blocked during a shock wave treatment.

Balloon catheters, sleeves, cages, and endoluminal prostheses are provided with stress-applying and spacing features coupled to expandable surfaces thereof. The stress-applying features may have blunt and/or rounded contact regions which contact tissue or calcified regions in the vasculature. The contact regions dent or fracture occlusive material on the wall of a vascular lumen and/or patient valve leaflets when expanded. The spacing features permit blood, drug, and contrast perfusion past structures expanded in the vasculature, particularly balloon catheters.

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.

A device for fracturing calcifications in heart valves including an expandable stabilizer and expandable impactor arms assembled on and deployed by a delivery system, wherein the delivery system is operable to move the impactor arms, while in an expanded position, with respect to the stabilizer with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between the stabilizer and the impactor arms.