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 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:
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 multiple-fire securing device includes a hollow outer shaft, a reloader, a reloader movement assembly, a rail, and securing structures each defining an inner securing orifice. The reloader longitudinally moves within the outer shaft and has a distal end shaped to temporarily contact one of the securing structures. The rail is disposed within the reloader and has an installing location. The securing structures are disposed on the rail. The reloader movement assembly moves the reloader longitudinally in a distal direction to deliver a first securing structure to the installing location from a first proximal position and moves the reloader proximally away from the installing location without the first securing structure to a position in which the distal end of the reloader temporarily contacts a second one of the securing structures. The second and successive securing structures are moved one at a time to the installing location.
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:
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:
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:
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.