Abstract: Disclosed herein is an inflow cannula for an implantable blood pump assembly. The inflow cannula includes a tubular body that extends from a proximal end to a distal end. The tubular body includes a proximal portion adapted for connection to a pump housing, and a distal portion adapted for positioning within an opening formed in a heart. The inflow cannula further includes an expandable sleeve coupled to an exterior surface of the distal portion. The sleeve has a first portion coupled to the distal portion of the tubular body, and a second portion extending from the distal end of the tubular body. The second portion is deployable from a first, stored configuration to a second, deployed configuration in which the second portion expands radially to engage and conform to an endocardial surface of the heart.

Abstract: Disclosed are synthetic tissue phantoms, which mimic the properties of real human or animal tissue, and methods of manufacturing the same.

Abstract: Disclosed herein is a delivery catheter for implanting a leadless biostimulator. The delivery catheter includes a shaft and a tubular body having a lumen and an atraumatic end. The atraumatic end includes at least one of a braided, woven or mesh construction configured to facilitate the atraumatic end changing diameter. When a distal portion of the shaft is coupled to a proximal region of the leadless biostimulator, at least one of distally displacing the tubular body relative to the shaft or proximally displacing the shaft relative to the tubular body causes the leadless biostimulator to be received in the volume of the atraumatic end and the atraumatic end to encompass the leadless biostimulator. Conversely, at least one of proximally displacing the tubular body relative to the shaft or distally displacing the shaft relative to the tubular body causes the leadless biostimulator to exit the volume of the atraumatic end.

Abstract: Disclosed herein is a delivery catheter for implanting a leadless biostimulator. The delivery catheter includes a shaft and a tubular body having a lumen and an atraumatic end. The atraumatic end includes at least one of a braided, woven or mesh construction configured to facilitate the atraumatic end changing diameter. When a distal portion of the shaft is coupled to a proximal region of the leadless biostimulator, at least one of distally displacing the tubular body relative to the shaft or proximally displacing the shaft relative to the tubular body causes the leadless biostimulator to be received in the volume of the atraumatic end and the atraumatic end to encompass the leadless biostimulator. Conversely, at least one of proximally displacing the tubular body relative to the shaft or distally displacing the shaft relative to the tubular body causes the leadless biostimulator to exit the volume of the atraumatic end.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a first plurality of elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration. A first sealing portion connected to the first plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Abstract: A device for transcatheter gathering of tissue of a heart valve leaflet may include an elongated tube extending in a longitudinal direction and having an open distal end, a tissue securing component disposed at the distal end of the elongated tube, and a capture tool movable in the elongated tube between a retracted position and an extended position. The elongated tube may have an inner surface and a lumen extending therethrough. The tissue securing component may include a clip having a roller and a support element. The roller may be rotatable relative to the support element. The capture tool may be operable to capture tissue of the heart valve leaflet and to draw the captured tissue into the tissue securing component. The tissue securing component may be adapted to be applied to the captured tissue to hold the captured tissue in a gathered configuration.

Abstract: A device (10) for repair of a heart valve leaflet includes an elongated body (12) having a lumen (16) extending therethrough in a longitudinal direction, a proximal end, an open distal end (19). A core (11) is disposed within the lumen, and is operable to spin about an axis extending in the longitudinal direction. The spinning of the core draws a portion of the heart valve leaflet into the lumen through the open distal end of the body and secures the portion of the heart valve leaflet to the core in a gathered configuration.

Abstract: A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.

Abstract: A device for gathering tissue of a heart valve leaflet may include an outer tube extending in an elongated direction, a capture tool moveable in the outer tube between a contained position and a use position, and a tissue securing component disposed at a distal end of the outer tube and adapted to be applied to tissue captured by the capture tool and to hold the captured tissue in a gathered configuration. The capture tool may include two grasping members that are moveable relative to one another in the elongated direction. Each grasping member may have a proximal portion and a plurality of fingers or barbs. The grasping members may be operable to capture tissue of the heart valve leaflet therebetween and to draw the captured tissue into the outer tube in the gathered configuration.

Abstract: A clip for leaflet tissue includes a substantially cylindrical hollow body having a proximal end and a distal end. In an initial configuration of the clip, the distal end has a diameter that is smaller than the diameter of the hollow body. The distal end is held in an expanded condition for delivery into a patient. When deployed, the distal end collapses to its initial configuration to grasp onto captured leaflet tissue.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a first plurality of elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration. A first sealing portion connected to the first plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: Disclosed herein is a catheter pump that includes an expandable cannula and an impeller system. The expandable cannula defines a blood flow channel and includes an impeller blade zone, an inlet zone, and an outlet zone. The catheter pump further includes an impeller system including an impeller body, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump. The catheter pump is selectively transitionable between a separated configuration in which the impeller body is axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: An assembly for guiding a medical apparatus within a patient includes an elongated shaft and a balloon affixed to the shaft and movable between a collapsed condition and an expanded condition. A mesh material may be affixed to the shaft and movable between a collapsed condition and an expanded condition. The balloon may project away from the shaft when the balloon is in the expanded condition. The mesh material may project away from the shaft when the mesh material is in the expanded condition.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.

Abstract: A method of implanting a stented device in a cardiovascular system of a mammalian subject includes guiding a delivery device that has an anchoring device connected to a distal end thereof within the cardiovascular system to a target location. The anchoring device has a body and a mooring feature extending from the body. The anchoring device is anchored at the target location by penetrating tissue at the target location with the mooring feature. The mooring feature is configured to anchor the body to the tissue when penetrated therein. The stented device is then guided through the cardiovascular system to the target location and deployed such that a stent of the stented device engages the anchoring device so as to restrict movement of the stented device within the cardiovascular system.

Abstract: A structure for sealing a gap between a medical device and adjacent body tissue includes a ring-shaped body formed at least in part of a material that expands from a compressed condition to an expanded condition when heated to a transition temperature and that is adapted to conform to the body tissue in the expanded condition.