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: 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: 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 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.

Abstract: An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

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 delivery apparatus comprises a handle, a first shaft, and a second shaft. The first shaft extends through and is movable axially relative to the second shaft. The delivery apparatus comprises an inflatable balloon having a proximal end portion coupled to the second shaft and a distal end portion of the balloon coupled to the first shaft. An inflation hub assembly comprises an inflation manifold and a piston, wherein the inflation manifold comprises a main body defining a main lumen and an inflation port defining an inflation port lumen. The piston extends into the main lumen and is slidable relative to the inflation manifold. A proximal end portion of the first shaft is coupled to the piston. The piston is moveable relative to the inflation manifold in proximal and distal directions to produce movement of the first shaft and adjust the length of the balloon.

Abstract: A valve holder for delivering a prosthetic heart valve to an implant site is in various embodiments configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. The valve holder can be configured to deploy or actuate automatically when performing preparatory steps that are already familiar to practitioners, such as attaching a delivery handle to the valve holder, so that the valve holders will not require additional steps or training to use. Therefore, operation of the valve holders is kept simple, and occurrences of mistakes caused by user error can be minimized or reduced. Valve holders according to different embodiments can be designed to accommodate implantation of prosthetic heart valves from either the inflow end or the outflow end of the native valve annulus.

Abstract: A valve holder for delivering a prosthetic heart valve to an implant site is in various embodiments configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. The valve holder can be configured to deploy or actuate automatically when performing preparatory steps that are already familiar to practitioners, such as attaching a delivery handle to the valve holder, so that the valve holders will not require additional steps or training to use. Therefore, operation of the valve holders is kept simple, and occurrences of mistakes caused by user error can be minimized or reduced. Valve holders according to different embodiments can be designed to accommodate implantation of prosthetic heart valves from either the inflow end or the outflow end of the native valve annulus.

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: 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: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. A dual-wireform support frame including an upper and a lower wireform permits expansion of the valve by one or two valve sizes, for example, with a 2-mm gap between each valve size. The lower wireform has a relatively shallow undulation so that it may stretch apart by a small amount and then prevent further expansion of the valve.

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.