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: 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: 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 collapsible and expandable prosthetic heart valve stent is provided and comprising an outer section, a valve support defining a flow channel therethrough, a transition section configured to smoothly transition the outer section to the valve support. The valve support is disposed within an interior defined by the outer section, with the inflow end of the valve support disposed inside the outer section's interior. In some cases, the outflow end of the valve support is at least partially defined by the transition section. The prosthetic leaflets are disposed on the inner surface of the valve support's flow channel and are located at or above the annulus of the heart chamber. A prolapse prevention system is attached to the stent to mitigate native valve leaflet prolapse.

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: 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: 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 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 a prosthetic heart valve device with improved fit and/or apposition between the device frame and left atrial tissue and/or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and/or mitigate paravalvular leakage. The improved fit and/or apposition arises in various embodiments by providing or allowing an asymmetrical frame and/or frame base and/or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and/or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

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: 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: 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 a prosthetic heart valve device with improved fit, apposition and/or paravalvular leakage mitigation. Thus, the prosthetic device comprises an anchoring structure for supporting prosthetic valve leaflets, wherein the anchoring structure comprises and/or is formed at least partially from a hydrophilic material designed to swell when contacted by the water solute in the patient's blood. Locating the hydrophilic material to provide swelling to improve the fit and/or apposition of the device to the patient's tissues results in, inter alia, improved paravalvular leakage mitigation. Some of the methods and mechanisms described herein may also be used to provide a seal against the septal hole created during transseptal delivery of the device.

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: 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: 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.