Abstract: The present invention provides an intravascular blood pump comprising a housing region that may be expandable and collapsible, wherein the expandable housing region includes the inlet to the pump and wherein the distal diameter of the expandable housing region, including the inlet, is larger than a proximal diameter of the expandable housing region. A non-expandable region may be provided and disposed between the expandable housing region and the pump assembly of the intravascular blood pump.

Abstract: The present invention provides an intravascular blood pump comprising a handle in operational connection and communication with a rotational motor and impeller assembly that is configured for placement and positioning within a patient's vasculature. The handle comprises a display for displaying real-time physiological parameters associated with the blood pump procedure and controls for modifying operational parameters. In some embodiments, the display portion of the handle may be connected and/or disconnected from the non-display portion to allow re-use of the display portion in subsequent blood pump procedures.

Abstract: The present invention provides an intravascular blood pump comprising a housing region that may be expandable, wherein the housing region comprises a series of troughs extending along at least a portion of the length of the housing region, wherein the integrated lead trough(s) may be defined by or within the housing region and wherein each adjacent pair of troughs are separated by an insulated spacing gap and may be covered to form insulated conduits. The integrated lead trough(s) may be configured to receive one or more electrical leads therein.

Abstract: The present invention provides an intravascular blood pump comprising a housing region that may be expandable, wherein the housing region comprises at least one trough extending along and/or around at least a portion of the length of the housing region, wherein the integrated lead trough(s) may be defined by or within the housing region. The integrated lead trough(s) may be configured to receive one or more electrical leads therein that may be in operative connection with a sensor and/or working element.

Abstract: The present invention provides an intravascular blood pump comprising an expandable and collapsible region distal to a pump assembly. In some embodiments, the expandable and collapsible region may comprise expandable and collapsible proximal and/or distal transition sections adjacent a central expandable and collapsible region. Support structure, e.g., an expandable and collapsible stent may comprise at least a part of the expandable and collapsible region. In some embodiments, a distal portion of the housing comprises the expandable and collapsible region, wherein an inversion of the distal housing results in a collapsed configuration and eversion of the distal housing results in an expanded configuration.

Abstract: The present invention provides an intravascular blood pump comprising an expandable and collapsible region distal to a pump assembly and proximal in certain embodiments to inlet apertures in the pump housing. In some embodiments, the expandable and collapsible region may comprise expandable and collapsible proximal and/or distal transition sections adjacent a central expandable and collapsible region. Support structure, e.g., an expandable and collapsible stent may comprise at least a part of the expandable and collapsible region.

Abstract: The present invention provides an intravascular blood pump comprising a pump assembly without a flow inducer or diffuser, and proximal and distal flow rate or pressure sensors, wherein the distal flow rate or pressure sensor may be tracked distal to the impeller after placement of the blood pump within the patient's vasculature.

Abstract: Various embodiments of devices and systems comprising a driveshaft for use in high-speed rotational medical procedures; e.g., atherectomy, are disclosed. Generally, the driveshaft is configured for transferring torque and activating rotation of a tool attached thereto, e.g., an abrading head, and is covered by a polymer jacket. In certain embodiments, the polymer jacket is allowed to rotate in response to the rotation of the drive shaft such that the polymer jacket is not fixed at its proximal end. Various embodiments of the drive shaft may include proximal and/or distal stops that enable the polymer jacket to move longitudinally between the stops, in embodiments comprising proximal and distal stops, or to the distal stop in embodiments comprising only a distal stop. Various embodiments of the devices and systems described herein optionally may include a metallic inner liner within the drive shaft, in addition to or instead of a polymer jacket.

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 outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen, whereby rotation is prevented if the impeller is completely within the catheter's lumen.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: The present invention provides an intravascular blood pump comprising a housing that is at least partially expandable and collapsible and having an impeller with one or more blades attached thereto. The housing having spanning sections that are aligned with the blade(s) and adapted to collapse into recesses or spaces defined or provided between or along the blade(s) and along the central rotor to which the blade(s)s are attached.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: The present system is directed in various embodiments to methods, devices and systems for rotational atherectomy procedures. More specifically, embodiments comprise a rotational driver with rotational drive shaft and abrasive element attached thereto, the rotational driver being controlled by the rotational controller to rotate at unsustained low rotational speeds and/or rotational direction.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

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: Devices, methods and systems are described that enable achieving a working diameter during high-speed rotation that is greater than a resting diameter. The various embodiments comprise structural modifications to rotational drive shafts that result in a radial shift of the center of mass of an affected portion of the drive shaft away from the rotational axis of the drive shaft. As a result, high-speed rotation of the drive shaft induces orbital motion. Certain aspects include more dense plugs inserted into or integrated into one or more spaced apart locations in one or more wire turns or filars along the drive shaft. One or more filars may comprise a denser portion than other filars. A flexible strip of preferably semi-circular cross-sectional shape may be affixed to the interior of the drive shaft within the lumen to add mass and affect the location of the center of mass.

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: A rotational medical device comprising an airfoil on a rotational drive shaft to generate lift forces generally directed radially away from a rotational axis of the drive shaft, thereby enabling the drive shaft and/or a working element thereon to achieve a working diameter during rotation that is greater than the resting diameter of the drive shaft and/or a working element thereon.

Abstract: The present invention provides an intravascular blood pump comprising a handle in operational connection and communication with a rotational motor and impeller assembly that is configured for placement and positioning within a patient's vasculature. The handle comprises a display for displaying real-time physiological parameters associated with the blood pump procedure and controls for modifying operational parameters. In some embodiments, the display portion of the handle may be connected and/or disconnected from the non-display portion to allow re-use of the display portion in subsequent blood pump procedures.

Abstract: The present invention provides an intravascular blood pump comprising a pump assembly without a flow inducer or diffuser, and proximal and distal flow rate or pressure sensors, wherein the distal flow rate or pressure sensor may be tracked distal to the impeller after placement of the blood pump within the patient's vasculature.