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 balloon catheter includes: an outer cylinder shaft having flexibility; an inner cylinder shaft having flexibility and inserted into the outer cylinder shaft; a balloon fixed to the outer cylinder shaft, that inflates or deflates in the transverse direction due to the pressure of an internal fluid supplied through the space within the outer cylinder shaft; and a securing member provided on the outer peripheral side of the balloon, whose diameter expands or contracts in the transverse direction independently of the balloon, due to the mutual movement of the outer cylinder shaft and the inner cylinder shaft in the longitudinal direction thereof; wherein the distal end portion of the inner cylinder shaft and the distal end portion of the securing member are fixed to each other, and the distal end portion of the outer cylinder shaft and the rear end portion of the securing member are fixed to each other.

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 method of delivering a prosthetic heart valve to the aortic valve annulus while a patient's heart is beating is disclosed. The method includes accessing the left ventricle through an intercostal incision and forming a puncture in the left ventricle. A guidewire is advanced into the left ventricle and through the native aortic valve. An introducer is passed over the guidewire and into the left ventricle. A valve delivery device is advanced over the guidewire and through the introducer until a prosthetic heart valve positioned thereon is located within the native aortic valve. The prosthetic heart valve is then radially expanded within the aortic valve annulus for replacing the function of the native aortic 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.

The invention provides a non-occlusive dilation and deployment catheter device which includes a catheter having a distal end configured for entering a patient and a proximal end for manipulating the device. A distender is provided at or near the distal end which is movable between a collapsed configuration which enables introduction and removal thereof to and from an operative site in a vessel or other hollow organ of a patient, and an expanded configuration in which the distender assumes a radially expanded condition and defines a flow path therethrough. The distender includes a substantially tubular, radially expandable frame having a plurality of spaced apertures and at least one inflatable tube threaded through the apertures and shaped to extend in a spiral when inflated. The distender is movable to the expanded configuration by inflating the tube, and movable to the collapsed configuration from the expanded configuration by deflating the tube.

A balloon dilation assembly for use in balloon valvuloplasty is disclosed, which includes at least three outer balloons arranged around a central balloon and fixed to the central balloon, wherein each balloon has a supply tube for inflation and flow channels are provided between each adjacent pair of outer balloons, whereby at least one of the outer balloons is shorter in length than the remaining outer balloons and the central balloon.

A method for determining whether a medical device is appropriate for implanting into a cardiovascular conduit of a patient is disclosed comprising imaging a first section of the conduit of the patient into which the medical device is to be implanted during a first expanded state occurring at a first portion of a heart rhythm; reimaging the first section of the conduit of the patient during a first contracted state occurring at a second portion of the heart rhythm; deriving, from the imaging and the reimaging, dimensional characteristics of the first section of the conduit; and determining whether the medical device is appropriate for implantation in the first section of conduit based on the derived dimensional characteristics. The first section of the conduit includes a sizing device providing a selected radial force on the patient.

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.

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.