Abstract: 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.

Abstract: A catheter for delivering shockwaves to a calcified lesion includes an elongated carrier, a pair of electrodes carried by the carrier, said electrodes being immersed in a conductive liquid, and a power source with a circuit coupled to the electrodes for supplying voltage pulses to the electrodes. The power source includes a capacitor and a switch. Each voltage pulse is between 1,000 volts and 10,000 volts. Each voltage pulse is generated by closing the switch that causes a charge stored on the capacitor to be delivered to the electrode pair. Each voltage pulse has sufficient energy to generate an arc in the liquid, allowing current to flow across the pair of electrodes to produce a shock wave associated with the expansion of a steam bubble. The catheter also includes a temperature sensor configured to sense the temperature of the conductive fluid proximate to the pair of electrodes.

Abstract: A system for implanting a flow modifying device in a heart comprises a flow modifying device comprising a tubular body comprising first and second openings located at first and second ends of the tubular body and a neck positioned between the first opening and the second opening, and a guide catheter comprising a flexible elongate shaft comprising a proximal portion comprising a fitting for receiving an insertion instrument and distal portion comprising an enlarged distal tip to prevent the flexible elongate shaft from passing through the flow modifying device. A guide catheter for cannulating a coronary sinus from a superior vena cava comprises a pre-formed distal portion comprising a proximal straight zone, a proximal curved zone extending along a first curved path, a distal straight zone extending along a straight path and a distal curved zone extending along a second curved path. The guide catheter can have different stiffnesses.

Abstract: Disclosed herein shock wave catheters comprising one or more shock wave electrodes for cracking calcifications located within blood vessels. In some variations, a shock wave catheter has first and second shock wave electrodes each circumferentially disposed over the outer surface of the catheter. In certain variations, the first electrode has a recess and the second electrode has a protrusion that is received by the recess and a spark gap is located along the separation between the recess and the protrusion. The second electrode can also have a recess that receives a protrusion from a third shock wave electrode, where the separation between the second and third electrodes along the separation between the recess and the protrusion forms a second spark gap. A shock wave can be initiated across these spark gaps when a voltage is applied over the electrodes.

Abstract: A catheter system for treating stenosis in a body lumen includes a first energy source, a second energy source, and a catheter. The catheter includes an elongate member that is navigable through the body lumen, a first acoustic energy emitter connected to the first energy source and configured to emit acoustic energy when energy is received from the first energy source, and a second acoustic energy emitter connected to the second energy source and configured to emit acoustic energy when energy is received from the second energy source.

Abstract: A catheter for treating a stenosis in a body lumen includes an elongate tube; a member sealed to a distal end of the elongate tube that is fillable with a conductive fluid; a metallization layer comprising at least one trace forming at least one inner electrode, the metallization layer being connected to at least one wire; and at least one outer electrode extending radially outwardly of the metallization layer and separated from the at least one inner electrode by at least one gap such that, when a voltage pulse is applied to the inner and outer electrodes, current flows across the at least one gap to generate at least one shock wave.

Abstract: A shock wave catheter for performing intravascular lithotripsy (IVL) is provided. The catheter includes an elongated tube having a central longitudinal axis, an enclosure sealed to the distal end of the elongated tube, and an adjustable emitter assembly disposed within the enclosure. The emitter assembly includes at least one laterally moveable or positionable shock wave generating emitter that, in a first configuration, is closer to the central longitudinal axis of the catheter, and, in a second configuration, is farther from the central longitudinal axis than in the first position. Various embodiments include support structures for the emitters, multiple balloons for positioning the emitters, helical ribbons, angled emitter ports, and other exemplary features for moving and/or positioning the emitters. Systems and methods for treating lesions in a body lumen are also provided herein.

Abstract: The present invention provides a catheter for treating occlusions in blood vessels. An exemplary catheter for treating occlusions in blood vessels comprises a tubular inner member including a base segment with a first lumen defining a fluid inlet port, and a second lumen defining a fluid outlet port. An extension segment is distal to the base segment. The extension segment has a reduced cross-section. An emitter assembly includes a first insulated wire extending through the second lumen and a second insulated wire, and a conductive sheath wrapped circumferentially around the first insulated wire, the second insulated wire, and the extension segment. A cap or balloon is sealably attached to the distal end of the catheter and surrounds the emitter assembly, said cap or balloon being fillable with conductive fluid.

Abstract: 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.

Abstract: Described herein is a shock wave device for the treatment of vascular occlusions. The shock wave device includes an outer covering and an inner member inner connected at a distal end of the device. First and second conductive wires extend along the length of the device within the volume between the outer covering and the inner member. A conductive emitter band circumscribes the ends of the first and second wires to form a first spark gap between the end of the first wire and the emitter band and a second spark gap between the end of the second wire and the emitter band. When the volume is filled with conductive fluid and a high voltage pulse is applied across the first and second wires, first and second shock waves can be initiated from the first and second spark gaps.

Abstract: A system that breaks calcium in a liquid includes a catheter including first and second electrodes arranged to receive there-across a high electrical voltage at an initial low current. The high electrical voltage causes an electrical arc to form across the electrodes creating a gas bubble within the liquid, a high current to flow through the electrodes, and a mechanical shock wave. A power source provides the electrodes with the high electrical voltage at the initial current and terminates the high electrical voltage in response to the high current flow through the electrodes.

Abstract: Described herein are low-profile electrodes for use with an angioplasty shockwave catheter. A low-profile electrode assembly may have an inner electrode, an insulating layer disposed over the inner electrode such that an opening in the insulating layer is aligned with the inner electrode, and an outer electrode sheath disposed over the insulating layer such that an opening in the outer electrode sheath is coaxially aligned with the opening in the insulating layer. This layered configuration allows for the generation of shockwaves that propagate outward from the side of the catheter. In some variations, the electrode assembly has a second inner electrode, and the insulating layer and outer electrode may each have a second opening that are coaxially aligned with the second inner electrode. An angioplasty shockwave catheter may have a plurality of such low-profile electrode assemblies along its length to break up calcified plaques along a length of a vessel.

Abstract: Described herein are systems and methods for implementing a power source for a shock wave catheter system, the power source including two separate voltage sources: a bubble generation voltage source and an arc generation voltage source. In one or more examples, the power source can be configured such that the bubble generation voltage source provides a lower voltage to a pair of electrodes of the shock wave catheter system. The lower voltage can be configured to induce electrolysis of a fluid that surrounds the pair of electrodes of the shock wave catheter system for generating and growing a bubble. Once a bubble has formed, the arc generation voltage source can then be engaged to provide a high-voltage electrical pulse to the electrodes of the shock wave catheter system, thereby generating an arc (i.e., spark) across the electrodes.

Abstract: A system includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon arranged to carry a voltage there-across including an initial high electrical voltage at an initial low current. The initial high electrical voltage causes an electrical arc to form across the first and second electrodes within the balloon. The electrical arc causes a gas bubble within the liquid, a high current to flow through the first and second electrodes, a decrease in the initial high electrical voltage, and a mechanical shock wave within the balloon. The system further includes a power source that provides the first and second electrodes with a drive voltage that creates the initial high electrical voltage at the initial current and that terminates the drive voltage in response to the decrease in the initial high electrical voltage.

Abstract: Described herein are systems and methods for implementing a power source for a shock wave catheter system, the power source including two separate voltage sources: a bubble generation voltage source and an arc generation voltage source. In one or more examples, the power source can be configured such that the bubble generation voltage source provides a lower voltage to a pair of electrodes of the shock wave catheter system. The lower voltage can be configured to induce electrolysis of a fluid that surrounds the pair of electrodes of the shock wave catheter system for generating and growing a bubble. Once a bubble has formed, the arc generation voltage source can then be engaged to provide a high-voltage electrical pulse to the electrodes of the shock wave catheter system, thereby generating an arc (i.e., spark) across the electrodes.

Abstract: 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.

Abstract: The invention provides a system for treating an occlusion within a body lumen. The system may comprise an insulated outer sheath; an elongated conductive tube, wherein the insulated outer sheath is circumferentially mounted around the elongated conductive tube; and an insulated wire having a helically coiled portion at a distal end of the insulated wire. The coiled portion includes an exposed distal tip, and a distal portion of the elongated conductive tube is circumferentially mounted around the distal coiled portion of the insulated wire. When a voltage is applied across the insulated wire and the elongated conductive tube, a current is configured to flow from the exposed distal tip of the insulated wire to the elongated conductive tube to generate a plurality of cavitation bubbles. In an alternate embodiment, an elongated central electrode is used in place of the conductive tube.

Abstract: Various shock wave catheters and methods of use thereof that do not utilize a guidewire are described herein. The shock wave catheters include at least one shock wave emitter disposed within a distal portion of the shock wave catheter and configured to generate shock waves. The ends of conductive wires extending within an elongate tube can form the shock wave emitter(s). The shock wave emitter(s) can be surrounded by an enclosure fillable with a conductive fluid delivered by the lumen of the elongate tube. The elongate tube can include a coil or slits therein that enable flexibility of the shock wave catheter, which, in combination with the narrow profile of the shock wave catheters described herein, enable their use in navigating and treating small, tortuous vessels.

Abstract: 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.

Abstract: 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.