Abstract: A delivery apparatus can include a handle, a first annular shaft having a proximal end portion coupled to the handle and a distal end portion, a second annular shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion, an extension portion having a proximal end and a distal end, the proximal end coupled to the distal end portion of the second shaft, a shoulder, the shoulder having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

Abstract: A delivery apparatus can include a handle, a first shaft extending from the handle and having a proximal end portion coupled to the handle and a distal end portion and a second shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion. The delivery apparatus can further include a shoulder coupled to the distal end portion of the second shaft and having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, an extension portion extending from the shoulder, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Abstract: A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Abstract: A catheter device includes a shaft having a steerable distal portion and a plurality of layers including a braided layer. A plurality of pull-wire lumens extend along a length of the shaft and are grouped together and incorporated into the braided layer in a proximal portion of the shaft. At least one pull-wire lumen of the plurality of pull-wire lumens leaves the braided layer, diverges around a circumference of the shaft to a selected angular offset, and is reincorporated into the braided layer.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a method can include advancing a distal end portion of an assembly toward a native heart valve, the assembly comprising a delivery apparatus and a prosthetic heart valve, and including one or more radiopaque markers, where one radiopaque marker is suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve. The method further includes receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus, determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation, and rotating the assembly until the prosthetic heart valve is in the desired rotational orientation.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Abstract: A catheter device includes a shaft having a steerable distal portion and a plurality of layers including a braided layer. A first pull-wire lumen is disposed at least partially within the braided layer, and a second pull-wire lumen is disposed at least partially within the braided layer. The first pull-wire lumen and the second pull-wire lumen are circumferentially spaced apart from each other in the steerable distal portion of the shaft.

Abstract: Embodiments of a balloon cover for a balloon catheter are disclosed. The balloon cover can include a first shell member and a second shell member. The first and second shell members are configured to matingly engage with each other to define a lumen that is configured to receive a distal portion of the balloon catheter. The first shell member includes a plurality of first wedges juxtaposed with a plurality of first cavities and the second shell member comprises a plurality of second wedges juxtaposed with a plurality of second cavities.

Abstract: A steerable delivery apparatus for an implantable medical device comprises a shaft extending distally from the handle, the shaft having a steering-member lumen extending through a length of the shaft, and a steering member extending through the steering-member lumen, the steering member having a proximal end portion and a distal end portion. A pull ring is disposed along a distal end portion of the shaft, the pull ring comprising a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter. The distal end portion of the steering member is fixed to the distal segment of the pull ring, and an adjustment mechanism is further provided in the handle, the mechanism operatively coupled to the proximal end portion of the steering member and configured to adjust tension in the steering member so as to adjust a curvature of the shaft.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a third shaft surrounding the first shaft. The first shaft is configured to rotate within the third shaft and translate axially relative to the third shaft, and the third shaft includes a distal tip portion including a plurality of internal helical expansion grooves and a plurality of external helical expansion grooves that are configured to allow the distal tip portion to flex radially outward.

Abstract: Catheter systems and methods including a hydraulic shock arrestor. A system may include an inflatable balloon for insertion within a patient's body. The inflatable balloon may be configured to be inflated with a fluid within the patient's body. The system may further include an elongate shaft. The elongate shaft may be configured to extend within the patient's body. The system may further include a fluid conduit. The system may further include a hydraulic shock arrestor configured to mitigate pressure surge within the fluid conduit.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: The present embodiments relate generally to devices, systems, and methods for dilating implants utilizing dilation devices. An example includes a dilation device for an implant. The dilation device includes an inflatable body having a proximal end and a distal end, and a central body positioned between the proximal end and the distal end and having a length. The central body is configured to press an inner surface of the implant to dilate the implant. The inflatable body includes at least one outer inflatable body fold radius of curvature greater than or equal to one half a thickness of the inflatable body.

Abstract: A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a third shaft surrounding the first shaft. The first shaft is configured to rotate within the third shaft and translate axially relative to the third shaft, and the third shaft includes a distal tip portion including a plurality of internal helical expansion grooves and a plurality of external helical expansion grooves that are configured to allow the distal tip portion to flex radially outward.

Abstract: A sizing tool for use in implanting a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end. The tool includes a proximal handle and a distal shaft, a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft, and a conduit graft replica having an axis mounted on the shaft proximal to the heart valve sizer. A method of securing a composite valved conduit includes introducing to an excised ascending aorta the sizing tool, measuring the aortic annulus with the prosthetic heart valve sizer, and determining whether the coronary arteries have sufficient length or whether an additional tubular coronary extension segment is required to add to one or both of the ends of the coronary arteries by extending the coronary arteries toward the conduit graft replica.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each including a first portion defining a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon. The balloon cover includes one or more depression members, each having a free end configured to move radially inward toward a central longitudinal axis of the balloon cover, and a tubular sleeve configured to be positioned around the depression members and the first portions of the first and second shell members such that the first and second shell members are held in mating engagement with each other and the free ends of the depression members are depressed radially inward and form a negative radial depression in the balloon.