Abstract: Biodegradable magnesium alloy implantable medical devices are protected to delay onset of corrosion, and thus biodegradability, or to corrode more uniformly. The protection allows for extended effective use of the devices while maintaining biodegradability. Examples of protective coatings include conversion coatings that at least partially remove exposed second phases from a surface of the magnesium alloy and coatings that provide a barrier between water and the surface of the magnesium alloy.

Abstract: A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Abstract: Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a covering feature associated with the spindle for selectively covering at least a portion of a stented prosthetic heart valve tethered to the spindle in a delivery state. In some embodiments, the covering feature includes a tip mounted to the spindle. The tip can include an overhang region for selectively covering a portion of the stented prosthetic heart valve. In other embodiments, the tip can include a tip body and a compressible foam bumper. In yet other embodiments, the covering feature includes an outer sheath arranged to selectively cover the stented prosthetic heart valve. The outer sheath can be elastic and stretchable for recapturing a partially expanded prosthesis, for example by including one or more windows covered by a stretchable covering layer.

Abstract: A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Abstract: Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.

Abstract: The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.

Abstract: Biodegradable magnesium alloy implantable medical devices are protected to delay onset of corrosion, and thus biodegradability, or to corrode more uniformly. The protection allows for extended effective use of the devices while maintaining biodegradability. Examples of protective coatings include conversion coatings that at least partially remove exposed second phases from a surface of the magnesium alloy and coatings that provide a barrier between water and the surface of the magnesium alloy.