Abstract: In some examples, an expandable introducer sheath includes an clastic outer layer, and a liner disposed within the clastic outer layer and defining a lumen, the liner being capable of transitioning between a folded collapsed condition, and a star-shaped expanded condition.

Abstract: A prosthetic valve delivery system may include a handle, an inner catheter extending through an outer catheter, a nosecone attached to the inner catheter, and a balloon. The balloon may have a proximal portion fixed to the outer catheter, a distal portion fixed to either the nosecone or the inner catheter, and a center portion. A prosthetic heart valve may be configured to be received over the center portion of the balloon. A steering wire may have a proximal end operably coupled to the handle and a distal end coupled to the steering ring to form a deflection point, the deflection point being positioned distal to a point at which the proximal portion of the balloon is fixed to the distal end portion of the outer catheter.

Abstract: A prosthetic heart valve delivery system may include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal end portion of the outer catheter. A prosthetic heart valve may be configured to be received over the balloon, and a balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon segment and a distal balloon segment positioned distal to the proximal balloon segment. An interior volume of the proximal balloon segment may be fluidly isolated from an interior volume of the distal balloon segment so that the proximal balloon segment and the distal balloon segment may be inflated independently of each other.

Abstract: A delivery system for delivering a medical device may include a handle, a delivery catheter extending distally from the handle, and a balloon mounted to a distal end portion of the delivery catheter. An actuator on the handle may be operably coupled to the delivery catheter such that actuation of the actuator applies a torque on a proximal end portion of the delivery catheter. The delivery catheter may have a proximal segment formed of a first material and the delivery catheter may have a distal segment formed of a second material, the first material being stiffer than the second material, and the proximal segment being stiffer than the distal segment.

Abstract: A delivery device for delivering a prosthetic heart valve may include a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, an atraumatic distal tip positioned at a distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip. In an uninflated condition of the balloon, the balloon may include a proximal bulge, a distal bulge, and an intermediate section having a diameter that is smaller than a diameter of the proximal bulge and smaller than a diameter of the distal bulge. The distal bulge may extend a first length in the proximal-to-distal direction, and the proximal bulge may extend a second length in the proximal-to-distal direction, the first length being different than the second length.

Abstract: A delivery device includes a catheter, and an inflatable balloon coupled to the catheter, the inflatable balloon forming a leading pillow and a trailing pillow spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat therebetween to retain a prosthetic heart valve during tracking of the delivery device.

Abstract: A prosthetic heart may include an expandable frame and prosthetic leaflets that each have a free edge, an attached edge having a contour, a first flat surface facing toward the frame, and a second flat surface facing away from the frame. A spacer fabric may be attached to each leaflet, the spacer fabric having a first surface, a second surface, and an inner matrix between the first and second surfaces.

Abstract: A method of manufacturing a prosthetic heart valve includes coupling a plurality of prosthetic leaflets to each other, and coupling the plurality of prosthetic leaflets to a cuff, to form a valve assembly. The valve assembly may be coupled to a stent to form the prosthetic heart valve. The valve assembly may be formed prior to the plurality of prosthetic leaflets being coupled to the stent and prior to the cuff being coupled to the stent.

Abstract: In some embodiments, a prosthetic heart valve system, includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and the stent having one or more retention tabs, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

Abstract: A method of implanting a prosthetic heart valve includes delivering the prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped over a deflated balloon of a delivery device. The method may include advancing fluid through the delivery device and into the balloon to inflate the balloon and to expand the prosthetic heart valve into the native valve annulus. The method may include monitoring a pressure within the delivery device while advancing fluid through the delivery device. The method may also include displaying the monitored pressure on a display device in real time during monitoring the pressure.

Abstract: A prosthetic heart valve system may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal end portion of the delivery catheter. In a delivery condition of the system and in an activated condition of the system, the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and so that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve. In the activated condition of the system, the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve.

Abstract: A grip for inhibiting travel of a prosthetic valve loading tube along an outer shaft of a delivery catheter system has a lumen extending therethrough. A portion of the lumen has a variable internal diameter for selective frictional engagement with the outer shaft. In some arrangements, the variable internal diameter is provided by variable compression of a gasket aligned on the lumen. In other arrangements, the variable internal diameter is provided by a portion of the grip that surrounds the lumen and that has at least one circumferential gap of variable width.

Abstract: A delivery device for an implantable medical device includes an inner shaft with a device-carrying region, an outer shaft surrounding the inner shaft, a sheath at a distal end of the outer shaft, and a sleeve. The outer shaft is movable relative to the inner shaft from an advanced position in which the sheath surrounds the device-carrying region to a retracted position in which the sheath exposes the device-carrying region. The sheath includes a proximal structure having a cylindrical portion between first and second transition zones. The sleeve surrounds the outer shaft and is movable relative to the outer shaft from an advanced position in which a distal end portion of the sleeve surrounds the cylindrical portion to a retracted position in which the distal end portion of the sleeve is spaced proximally from the cylindrical portion.

Abstract: A delivery device for an implantable medical device includes an inner shaft with a device-carrying region, an outer shaft surrounding the inner shaft, a sheath at a distal end of the outer shaft, and a sleeve. The outer shaft is movable relative to the inner shaft from an advanced position in which the sheath surrounds the device-carrying region to a retracted position in which the sheath exposes the device-carrying region. The sheath includes a proximal structure having a cylindrical portion between first and second transition zones. The sleeve surrounds the outer shaft and is movable relative to the outer shaft from an advanced position in which a distal end portion of the sleeve surrounds the cylindrical portion to a retracted position in which the distal end portion of the sleeve is spaced proximally from the cylindrical portion.