Cardiovascular Systems, Inc.

4c Medical Technologies, Inc.

Jeffrey R Stone

Joseph P Higgins

Matthew D Cambronne

Saravana B Kumar

Jeffrey W Chambers

Jason S Diedering

Robert J Thatcher

Gregory G Brucker

Matthew Wayne Tilstra

Scott M Hanson

Walter John Dobrovolny

Nicholas W Rydberg

James E Flaherty

Tristan A Van De Moortele

Kayla J Eichers

Karl A Kabarowski

Benjamin D Haselman

Preston L Grothe

Steven D Kruse

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.

Devices and methods for generating orbital motion in drive shafts for rotational medical devices

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.

Systems, methods and devices for removal of thrombus and/or soft plaque with asymmetric mass distribution within working region of impeller

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.

Intravascular blood pump with external motor and centrifugal force-driven expansion of impeller blades and/or expandable and collapsible impeller housing

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.

Prosthetic mitral valve with improved atrial and/or annular apposition and paravalvular leakage mitigation

Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.

Systems, methods and devices for prosthetic heart valve with single valve leaflet

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.

Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves

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.

Intravascular pump without inducer and centrifugal force-driven expansion of impeller blades and/or expandable and collapsible impeller housing

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.

Drive shaft with metallic inner layer and polymer jacket

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.

Intravascular pump with expandable distal region

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.

Intravascular pump with expandable region

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.

Rotational medical device with airfoil

The invention provides a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with an abrasive section within a pre-curved section of the drive shaft. The device may further comprise a concentric or eccentric enlarged diameter section that is at least partially covered with abrasive material to comprise the abrasive section. The abrasive section may further comprise an abrasive crown or burr mounted to the drive shaft. The pre-curved drive shaft allows smaller diameter and/or massive abrasive regions to be used while sweeping larger diameters during high-speed rotation. The pre-curved region is substantially straightened for insertion into vasculature and placement adjacent stenosis by insertion of the guide wire. Removal of guide wire proximally from the pre-curved region allows the drive shaft to return to its pre-curved form for ablation. Reinsertion of the guide wire beyond the pre-curved region straightens the drive shaft for ease of removal.

Growing community of inventors

Minnetonka, MN, United States of America

Jeffrey R Stone