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: 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: 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: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

Abstract: A catheter based balloon enabled prosthetic heart valve delivery device is provided. The balloon enabled delivery device is configured to deploy a prosthetic heart valve through inflation. The balloon enabled delivery device is further configured to reduce or prevent migration of the prosthetic heart valve during deployment. Migration is prevented through a combination of balanced inflation of the balloon, inflation fluid flow balancing structures, retention rings, retention covers, and balloon surface treatments.

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 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: Distal tips for use with delivery catheters are disclosed that are configured to maintain complete engagement between the distal tip and a distal opening of a sheath component of the delivery catheter so as to prevent separation therebetween and/or to prevent fish-mouthing of a distal leading edge of the sheath component during in vivo use. Distal tips so configured realize one or more of the objectives of safer tracking of the delivery catheter through the vasculature, safe crossing of the delivery catheter through structural components of the vasculature and heart, such as through native valves, and safe removal of the delivery catheter post deployment.

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: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

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: A catheter based balloon enabled prosthetic heart valve delivery device is provided. The balloon enabled delivery device is configured to deploy a prosthetic heart valve through inflation. The balloon enabled delivery device is further configured to reduce or prevent migration of the prosthetic heart valve during deployment. Migration is prevented through a combination of balanced inflation of the balloon, inflation fluid flow balancing structures, retention rings, retention covers, and balloon surface treatments.

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: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

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: Systems for delivering prosthetic heart valve devices can include, for example, an elongated catheter body, a deliver capsule carried by the catheter body, and an expandable atraumatic member. The delivery capsule includes a platform and a housing having an outer wall and a proximal rim, and the platform is configured to be releasably coupled to a prosthetic heart valve device. The housing is configured to slide along the platform from a containment configuration to a deployment configuration. The expandable atraumatic member has an atraumatic surface and a peripheral portion. The atraumatic member has a compacted configuration and an expanded configuration in which the peripheral portion extends laterally outward over the proximal rim of the housing to protect tissue of the heart and the vasculature from potentially being damaged by the proximal rim of the housing as the delivery system is withdrawn in a proximal direction through the patient.

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 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: 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: Distal tips for use with delivery catheters are disclosed that are configured to maintain complete engagement between the distal tip and a distal opening of a sheath component of the delivery catheter so as to prevent separation therebetween and/or to prevent fish-mouthing of a distal leading edge of the sheath component during in vivo use. Distal tips so configured realize one or more of the objectives of safer tracking of the delivery catheter through the vasculature, safe crossing of the delivery catheter through structural components of the vasculature and heart, such as through native valves, and safe removal of the delivery catheter post deployment.