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: 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 system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

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 delivery devices for transcatheter stented prosthesis loading, delivery and implantation. The delivery devices provide a loaded delivery state in which the stented prosthesis is loaded and compressed over the delivery device. The compression of the stented prosthesis can be adjusted with one or more elongate tension members, which extend around the stented prosthesis and proximately to an actuation and release assembly that can be provided as part of a handle assembly. The delivery device can be manipulated to adjust tension in the tension members to permit the stented prosthesis to compress, self-expand, and ultimately release from the shaft assembly. In some embodiments, the tension in one or more tension members is adjusted with one or more actuation and release assemblies.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: The present disclosure relates to delivery devices for transcatheter stented prosthesis loading, delivery and implantation. The delivery devices provide a loaded delivery state in which the stented prosthesis is loaded and compressed over the delivery device. The compression of the stented prosthesis can be adjusted with one or more elongate tension members, which extend around the stented prosthesis and proximately to an actuation and release assembly that can be provided as part of a handle assembly. The delivery device can be manipulated to adjust tension in the tension members to permit the stented prosthesis to compress, self-expand, and ultimately release from the shaft assembly. In some embodiments, the tension in one or more tension members is adjusted with one or more actuation and release assemblies.

Abstract: An example medical system includes a medical device configured to join the edges of the leaflets together, an elongate body configured to be navigated through vasculature to a heart valve of patient, and a plurality of tissue engagement devices extending from a distal end of the elongate body, each tissue engagement device comprising at least one clamp configured to capture leaflets of the heart valve.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: An example medical system includes a medical device configured to join the edges of the leaflets together, an elongate body configured to be navigated through vasculature to a heart valve of patient, and a plurality of tissue engagement devices extending from a distal end of the elongate body, each tissue engagement device comprising at least one clamp configured to capture leaflets of the heart valve.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: Aspects of the disclosure include bodily lumen reshaping and reduction systems, devices and methods. Such implants can include a plurality of anchors serially interconnected with a cinching member. Delivery devices of the disclosure are configured to deploy a first anchor into tissue. The delivery device can then deploy a second anchor and wind the cinching member around the second anchor to reduce a distance between the first and second anchors, placating the tissue between the anchors. Additional anchors can be similarly deployed and the cinching member can be similarly adjusted to reshape the lumen. Methods of deploying and reshaping a bodily lumen are also disclosed. In various examples, the bodily lumen is a heart valve, atrial appendage, portion of a gastrointestinal tract or urethra. Various embodiments include one or more anchors having a ratchet assembly or the like to substantially prevent the cinching member from unwinding.

Abstract: Devices including a capsule having an interior and a clamp assembly including a plurality of clamps. Each clamp includes a first arm having a first free end and a second arm having a second free end. The device includes a clamp assembly including a compacted state in which the plurality of clamps are compressed within the capsule and a deployed state in which at least the free ends of the plurality of clamps are positioned outside of the interior of the capsule. The first free end is closer to the second free end in the compacted state as compared to the deployed state. The device can further include a push rod releasably secured to the clamp assembly and a delivery rod releasably secured to the capsule. Methods of using the devices are also disclosed.

Abstract: Delivery devices and device elements that provide steering capabilities and methods of steering such delivery devices during the delivery of a stented prosthesis to a target site. Various delivery devices include a shaft assembly having a plurality of lumens through which tension members that compressively retain the stented prosthesis to the shaft assembly are routed. By selectively tensioning one or more tension members, the shaft assembly can be pulled or steered in a desired direction. Various embodiments include one or more steering or stiffening rods that can reinforce the device or counteract any unintended bending or steering of the delivery device.

Abstract: Delivery devices and device elements that provide steering capabilities and methods of steering such delivery devices during the delivery of a stented prosthesis to a target site. Various delivery devices include a shaft assembly having a plurality of lumens through which tension members that compressively retain the stented prosthesis to the shaft assembly are routed. By selectively tensioning one or more tension members, the shaft assembly can be pulled or steered in a desired direction. Various embodiments include one or more steering or stiffening rods that can reinforce the device or counteract any unintended bending or steering of the delivery device.

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: The present disclosure relates to delivery devices for transcatheter stented prosthesis loading, delivery and implantation. The delivery devices provide a loaded delivery state in which the stented prosthesis is loaded and compressed over the delivery device. The compression of the stented prosthesis can be adjusted with one or more elongate tension members, which extend around the stented prosthesis and proximately to an actuation and release assembly that can be provided as part of a handle assembly. The delivery device can be manipulated to adjust tension in the tension members to permit the stented prosthesis to compress, self-expand, and ultimately release from the shaft assembly. In some embodiments, the tension in one or more tension members is adjusted with one or more actuation and release assemblies.

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: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.