Abstract: Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave. In some embodiments, the electrodes comprise a plurality of points that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.

Abstract: Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating flow and pressure waves. In some embodiments, the electrodes are spaced apart across relatively long distances to create a stronger shock. In some embodiments, the saline ionically conducting between the electrodes is confined to reduce parasitic heating. In some embodiments, the balloon is partially deflated during arc generation.

Abstract: Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave. In some embodiments, the electrodes comprise a plurality of points that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: Devices, methods and systems are described that enable achieving a working diameter that is greater than a resting diameter and to stimulate fluid circulation during high-speed rotation. The drag coefficient of the drive shaft is increased and, in some embodiments, the mass is increased. Among other advantages, the resulting drive shaft with an eccentric element integrated with and/or attached thereto will achieve orbital motion at a rotational speed that is less the rotational speed required to achieve orbital motion without the increased drag coefficient. The concomitant increase in fluid flow and/or fluid stirring at a comparatively lower rotational speed is a further advantage. These characteristics may allow, therefore, a smaller diameter abrasive element to be used which is advantageous in small and/or highly tortuous vessels.

Abstract: The present invention comprises at least sensing, monitoring, and display of motor current which is then used in various embodiments of a rotational atherectomy device to determine and/or predict, among other things, treatment progression, treatment completion, optimal rotational speed, optimal advancement or traversal speed during treatment, whether stall appears imminent, and/or reacting to stop motor rotation before a stall occurs. In some embodiments, the determination or prediction results in an automatic, or preprogrammed adjustment by the control unit of the rotational speed of the rotating drive shaft and associated tool.

Abstract: A medical device with an implantable blood pump and a control and sensing unit configured to determine the flow rate generated by the blood pump when driven by an electric motor, wherein the flow rate is determined using peak-to-peak current data generated by the electric motor and, in some cases, associated heart rate data. In some embodiments, the validity of pulsatility of the resulting blood flow is determined and, if out of predetermined limits, an alarm may be actuated.

Abstract: A thrombectomy system is provided that, in various embodiments, a rotating impeller that may be translated within limits along a guidewire and within a catheter. The rotating impeller is, during operation, either located entirely inside or outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen. In some cases, the impeller may be prevented from rotating if at least partially inside the catheter's lumen. The rotating impeller may achieve a working diameter that is greater than its resting diameter.

Abstract: The present invention provides an intravascular blood pump system with an external motor and comprising an impeller housing and/or impeller blade(s) that may be expandable and collapsible. The blade(s) and/or impeller housing may be biased to expand or may be expanded by centrifugal forces generated during rotation of the impeller and blades an operatively connected rotational external motor.

Abstract: A rotational atherectomy device includes a drive shaft, a cutter mechanism coupled to the drive shaft and configured to cut occlusive material from a lesion, and a multi-stage macerator coupled to the drive shaft and configured to macerate cut occlusive material into a fine slurry. Successive stages of the multi-stage macerator macerate the cut occlusive material into successively smaller particles, which are moved proximally through a lumen of a sheath of the device that surrounds the drive shaft proximal to the macerator. The device may include a movable cutter mechanism guard that is passively rotatable between a first position in which it covers the cutter mechanism and a second position in which it exposes the cutter mechanism. One or more features of the device may limit a depth to which the cutter mechanism is able to cut the occlusive material to reduce a likelihood of undesirable tissue dissection.

Abstract: A flexible drive shaft assembly is provided for an intravascular medical device, for example and without limitation, a blood pump, a rotational atherectomy device, or a rotational thrombectomy device. The blood pump embodiment provides an electric motor and a rotational impeller, with a rotational drive shaft disposed therebetween and configured to rotationally drive the impeller. The drive shaft is moved from an undeformed length to a deformed length when connected between the electric motor and the rotational impeller to provide a biasing force on the rotational impeller in the proximal direction to maintain the impeller in a desired axial or linear location. In other embodiments, drive shaft comprises a proximal section with a length and a spring constant and a distal section of relatively longer length and a relatively higher spring constant. In other embodiments, hypotube(s) and/or support mandrel(s) may be provided.

Abstract: Various embodiments of devices and systems comprising a polymer driveshaft for use in high-speed rotational medical procedures, e.g., atherectomy, are disclosed. Generally, the primary driveshaft for transferring torque and activating rotation of a tool attached thereto, e.g., an abrasive element, is constructed with at least a polymer outer and inner surface. In certain embodiments, the polymer driveshaft may comprise a metallic band for fixed attachment of a structure, e.g., an abrasive element, thereto. Various embodiments may comprise a coupler that connects a drive shaft connected with a prime mover, e.g., a turbine or electric motor, with the polymer drive shaft, the coupler comprising openings through the coupler wall to the inner diameter of the coupler to allow fluid flow to the inner diameter of the coupled polymer drive shaft.

Abstract: The present invention comprises at least sensing, monitoring, and display of motor current which is then used in various embodiments of a rotational atherectomy device to determine and/or predict, among other things, treatment progression, treatment completion, optimal rotational speed, optimal advancement or traversal speed during treatment, whether stall appears imminent, and/or reacting to stop motor rotation before a stall occurs. In some embodiments, the determination or prediction results in an automatic, or preprogrammed adjustment by the control unit of the rotational speed of the rotating drive shaft and associated tool.

Abstract: Devices, methods and systems are described that enable achieving a working diameter that is greater than a resting diameter and to stimulate fluid circulation during high-speed rotation. The drag coefficient of the drive shaft is increased and, in some embodiments, the mass is increased. Among other advantages, the resulting drive shaft with an eccentric element integrated with and/or attached thereto will achieve orbital motion at a rotational speed that is less the rotational speed required to achieve orbital motion without the increased drag coefficient. The concomitant increase in fluid flow and/or fluid stirring at a comparatively lower rotational speed is a further advantage. These characteristics may allow, therefore, a smaller diameter abrasive element to be used which is advantageous in small and/or highly tortuous vessels.

Abstract: The present invention provides an intravascular blood pump comprising an impeller housing and/or impeller blade(s) that may be expandable and collapsible. The blade(s) and/or impeller housing may be biased to expand or may be expanded by centrifugal forces generated during rotation of the impeller and blades with an operatively connected rotational motor.

Abstract: A thrombectomy system is provided that, in various embodiments, a rotating impeller that may be translated within limits along a guidewire and within a catheter. The rotating impeller is, during operation, either located entirely inside or outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen. In some cases, the impeller may be prevented from rotating if at least partially inside the catheter's lumen. The rotating impeller may achieve a working diameter that is greater than its resting diameter.

Abstract: A gearless rotational motor comprising a motor drive shaft adapted to be rotated by the gearless rotational motor, the motor drive shaft having a lumen, a proximal end extending proximally from the motor and a distal end extending distally away from the motor. The distal end adapted to connect with a torqueable flexible shaft whereby rotation of the motor drive shaft also rotates the torqueable flexible shaft.