Abstract: A prosthetic heart valve includes a radially expandable and collapsible frame having an inflow end and an outflow end, the inflow end including a plurality of inflow apices and the outflow end including a plurality of outflow apices. A plurality of valve leaflets is coupled to the frame and configured to control blood flow through the prosthetic heart valve, and a covering is disposed around the frame and includes an inflow end portion and an outflow end portion. The inflow end portion of the covering is disposed over the inflow apices of the frame and covers the inflow apices, and the outflow end portion of the covering is disposed over the outflow apices of the frame and covers the outflow apices. The covering defines narrower end openings than the inflow and outflow ends of the frame.

Abstract: An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

Abstract: A prosthetic heart valve includes a radially expandable and collapsible frame with an inflow end including a plurality of inflow apices and an outflow end including a plurality of outflow apices. A plurality of valve leaflets are positioned in the frame and configured to control blood flow through the prosthetic heart valve. A covering is disposed around the frame. The covering has an inflow end portion having an inflow edge and an outflow end portion having an outflow edge. The inflow end portion of the covering is disposed over the inflow apices of the frame such that the inflow edge of the covering is inside the frame. The outflow end portion of the covering is disposed over the outflow apices of the frame such that the outflow edge of the covering is inside the frame, and the covering covers an entire outer surface of the frame.

Abstract: A method of delivering an anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. The anchors can be delivered to be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame with a central portion defining a lumen, and first and second opposing end portions. The frame can expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can also have a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member permits a medical instrument to be inserted through the lumen and into the left atrium, for performing a subsequent medical procedure in the left side of the heart.

Abstract: A replacement valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native heart valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration such that a plurality of protrusions is disposed in an overlapping portion of the sheath. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during application of a radial outward force by passage of a medical device through the sheath.

Abstract: A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Abstract: Various systems, devices, and methods are described herein pertaining to expandable sheaths. Sheath aspects are described that include a flexible sheath tip that is expandable and bendable. In some aspects, the sheath includes a radially expandable proximal end and a radially expandable distal end. In some aspects, the sheath tip includes a plurality of layers that expand to accept a medical device traveling axially and bi-directionally therethrough with minimal deformation of the sheath tip.

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a helical scroll slidable configuration. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during the application of a radial outward force by passage of a medical device through the sheath.

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration at least a portion of the outer surface of the sheet comprises a plurality of bonding sites that are at least partially embedded within the sheet and disposed such that the outer surface of the sheet in the overlapping portion is substantially free of the plurality of bonding sites.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: A prosthetic heart valve includes a radially expandable and collapsible frame with an inflow end including a plurality of inflow apices and an outflow end including a plurality of outflow apices. A plurality of valve leaflets are positioned in the frame and configured to control blood flow through the prosthetic heart valve. A covering is disposed around the frame. The covering has an inflow end portion having an inflow edge and an outflow end portion having an outflow edge. The inflow end portion of the covering is disposed over the inflow apices of the frame such that the inflow edge of the covering is inside the frame. The outflow end portion of the covering is disposed over the outflow apices of the frame such that the outflow edge of the covering is inside the frame, and the covering covers an entire outer surface of the frame.

Abstract: A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Abstract: An expandable sheath including an elongated inner member defining a central lumen extending therethrough. The inner member includes a first circumferential portion including a first and second longitudinal edges, and a second circumferential portion extending between the first and second longitudinal edges. The wall thickness of the first circumferential portion is greater than the wall thickness of the second circumferential portion. The elongated inner member is configured to transition from an unexpanded configuration to an expanded configuration in response to a radially outward force on an inner surface of the central lumen. In the unexpanded configuration, the elongated inner member is creased proximate the first and second longitudinal edges into a folded configuration such that the second circumferential portion is positioned at least partially radially inward of the first circumferential portion.

Abstract: An introducer sheath system is disclosed herein that includes an introducer locking hub, an introducer coupled to the introducer locking hub, and a hypotube disposed within the central lumen of the introducer. The introducer locking hub prevents axial and rotational translation of the introducer with respect to the sheath. The introducer defines an elongated body having a proximal piece and a separate distal piece, the proximal piece coupled to the introducer locking hub and the distal piece coupled to the distal end of the hypotube. The body portion of the hypotube is slidably disposed within the central lumen of the proximal piece of the introducer such that movement of the hypotube within the central lumen of the proximal piece causes the distal piece of the introducer to move with respect to the proximal piece.

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath comprising an inner layer comprising a reinforcing layer rolled into a spiral slidable configuration and encapsulated within a polymer layer comprising a tether portion and an outer layer disposed over the inner layer. The disclosed sheath is configured to locally expand from a predetermined first diameter d1 to an expanded second diameter d2 during application of a radial outward force by passage of the medical device through the sheath.

Abstract: Disclosed herein is an expandable sheath that can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. The disclosed herein sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath comprising an inner layer comprising a reinforcing layer comprising a plurality of struts that can be encapsulated within a polymer layer comprising a tether portion and an outer layer disposed over the inner layer. The disclosed sheath is configured to locally expand from a predetermined first diameter d1 to an expanded second diameter d2 during application of a radial outward force by passage of a medical device through the sheath.

Abstract: A covering layer for a transcatheter heart valve is in various embodiments configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted. In some cases, prosthetic valves are manufactured with the covering layer attached. Other covering layers are stand-alone accessories that can be mounted onto pre-existing prosthetic valves by an end user. Covering layers that can be mounted by an end user are provided with various features that can facilitate easier attachment of the covering layer to the prosthetic valve, which further reduces the possibility of damage to the covering layer or to the valve. Another covering is provided with two layers in order to insulate and protect the native tissue surrounding the implant from damage due to friction or abrasion, and/or other movement driven wear.

Abstract: A sheath locking system comprising an introducer locking hub comprising a hub body defining a locking channel for engaging a corresponding guide on a sheath locking sleeve. The sheath locking sleeve removably coupled to the introducer locking hub via engagement between the guide and the locking channel. The sheath locking sleeve movable between an unlocked position where the sheath locking sleeve is rotationally and axially movable with respect to the introducer locking hub, and a locked position where the sheath locking sleeve is axially fixed with respect to the introducer locking hub.