An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid. The apparatus comprises a shaft, an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, and a valve for controlling the fluid flow within the passage. The valve may be connected to the shaft, or may comprise an elongated tube partially connected to the balloon. The balloon may comprise a plurality of cells in a single cross-section, each cell including a neck, and the valve may be positioned in a space between the shaft and the necks for controlling the fluid flow within the passage. A connector may also be provided to control the position of the valve.

An invasive electrohydraulic lithotripter probe may comprise a lithotripter tip that comprises a first electrode and a second electrode. The lithotripter tip has a length in excess of 250 cm and is dimensioned to be inserted into a long channel having a length in excess of 250 cm. The lithotripter probe may include a material that reinforces a linear strength of at least a portion of the lithotripter probe.

A device for fracturing calcifications in heart valves includes a stabilizer and an impactor movable towards each other. The impactor includes one or more impactor arms, each of which extends distally from a proximal cap. The impactor further includes one or more lever arms each of which is distally coupled to a lever cap and proximally coupled to a corresponding one of the one or more impactor arms. The lever cap slides on a shaft which extends towards the proximal cap. Proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform.

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.

Methods, systems, and computer readable media for utilizing a therapeutic ultrasound device to perform mitral valve decalcification are disclosed. One method includes acquiring, via an ultrasound imaging component, imaging data of a mitral valve in real-time, defining a therapeutic region of interest corresponding to the mitral valve, and utilizing, by a system controller engine, imaging data from the ultrasound imaging component to determine an interval period of minimal mitral annular movement. The method further includes defining a sequence of therapeutic targets within the region of interest of the mitral valve, utilizing the imaging data acquired in real-time by the ultrasound imaging component to provide a therapeutic ultrasound transducer array with a location and depth of an intra-annular focal zone within the mitral valve, and emitting a high intensity focused ultrasound (HIFU) pulse wave from the therapeutic ultrasound transducer array to each of the therapeutic targets of the mitral valve during the determined interval period and in accordance with the defined sequence.

A method and device for perforating an aortic valve to remove excessive calcium deposits on aortic valve leaflets improves the implantation of TAVI replacement valves in patients. By removing excessive calcium deposits, the radial pressure exerted by implanted TAVI replacement valves is reduced, such that there is less blood leakage around the valve and less stress on the cardiac conductive system. A device with a collapsible punch is inserted into the aortic valve. The punch is separable such that the aortic valve leaflets are positioned between at least two elements of the punch. The two elements then compress together with the leaflets between them, causing the aortic valve to be perforated. A circumferential ring of the remaining aortic valve and calcium deposits are left to provide stability for the TAVI replacement valve.

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

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.