Abstract: Skirts for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve can include a frame comprising a plurality of interconnected struts, a plurality of leaflets arranged on an interior of the frame, and a fabric skirt disposed around an inner surface of the frame. An inner surface of the skirt that faces away from the frame comprises a less thromboresistant portion and a more thromboresistant portion which is shaped to correspond to a shape of cusp edge portions of the leaflets of the plurality of leaflets. The cusp edge portions of the leaflets are attached to the more thromboresistant portion of the inner surface of the skirt with a plurality of stitches.

Abstract: A prosthetic valve includes a frame and a leaflet assembly having a plurality of leaflets coupled to the frame. The leaflet assembly is movable between an open state and a closed state to allow unidirectional blood flow through the prosthetic valve. Each leaflet includes an outflow edge, a cusp edge, and a pair of commissure tabs extending from opposite sides of the leaflet and between the outflow edge and the cusp edge. Each commissure tab is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure of the leaflet assembly. The outflow edge of each leaflet includes a coaptation edge region and cut-out regions between opposite ends of the coaptation edge region and the commissure tabs. When the leaflet assembly moves between the open and closed states, the coaptation edge regions pivot relative to the commissure tabs at respective pivot axes intersecting the cut-out regions.

Abstract: A prosthetic valve includes a frame with inflow and outflow ends and a longitudinal axis extending therebetween. The frame is in a radially expanded state defining a radially expanded diameter and is configured to define a partially radially compressed diameter when the frame is in a partially radially compressed state. A sealing skirt coupled to the frame includes inflow and outflow end portions, an inelastic skirt portion with weft and warp threads, and a tensioning element extending circumferentially along the outflow end portion. The sealing skirt includes a terminal outflow edge configured to define a skirt diameter greater or equal to the partially radially compressed diameter and less than the radially expanded diameter when the sealing skirt is in a relaxed state. The weft and warp threads are configured to be oriented at an approximately 45-degree angle to the longitudinal axis when the sealing skirt is in the relaxed state.

Abstract: A prosthetic heart valve includes a radially expandable frame and a valvular structure having a plurality of leaflets. The frame includes one or more commissure windows, with two window struts, to receive and support the leaflets. Each leaflet is attached to the frame by a commissure tab which extends through a commissure window. A reinforcing member is attached to the commissure tab of each leaflet by one or more suture lines. Adjacent commissure tabs and reinforcing members are attached to the window struts by being folded around them and secured with one or more securing loops. In some examples, the commissure tabs can be attached to the window struts without any load-bearing sutures extending through the leaflets.

Abstract: A flow restrictor for a blood vessel can include a frame positionable within a blood vessel, and a leaflet or flap comprising an inflow end and an outflow end. The inflow end of the leaflet or flap can be configured to move (optionally using a control element) in response to a first increase in a blood pressure within the blood vessel, and in response to the blood pressure being within a first blood pressure range. The flow restrictor can be further configured to be a bi-modal flow restrictor, wherein the leaflet or flap can be configured to collapse or prolapse in response to the blood pressure being within a second blood pressure range. In some cases, the bi-modal flow restrictor can include an inner valve configured to move with respect to the frame in response to the blood pressure being within the second blood pressure range.

Abstract: An implantable prosthetic device can include a radially expandable and compressible annular frame comprising an inflow end portion and an outflow end portion, the frame comprising one or more axially extending struts that defining one or more commissure windows. The device can further include a valvular structure comprising a plurality of leaflets arranged within the frame, each leaflet comprising a main body and one or more commissure tabs, and a commissure comprising a flexible connector and the commissure tabs of two adjacent leaflets coupled to the flexible connector via one or more primary sutures. The commissure can be secured to a respective commissure window via one or more secondary sutures, each secondary suture extending through a radially outer layer of the flexible connector, a respective commissure tab, a radially inner layer of the flexible connector, and a free edge portion of the flexible connector.

Abstract: Coverings and/or skirts for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame comprising three axially extending commissure support portions, a plurality of rows of angled struts including a first row defining an inflow end, a second row downstream of the first row, and a third row downstream of the second row and defining an outflow end, where downstream ends of the struts of the second row are connected to each other at junctions, and the commissure support portions extend from respective junctions to the third row of struts. The valve further comprises leaflets forming three commissures secured to respective commissure support portions, and an outer skirt comprising an outflow edge forming three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions, the outflow edge comprising straight sections extending between adjacent projections upstream of the junctions.

Abstract: The expandable sheaths disclosed herein have a plurality of radially arranged layers, including an inner liner, a first polymeric layer positioned radially outward of the inner liner, a braided layer positioned radially outward of the first polymeric layer, a second polymeric layer positioned radially outward of the braided layer, and an outer liner positioned radially outward of the second polymeric layer. The sheath comprises a plurality of longitudinally-extending pleats in a collapsed (unexpanded) configuration, and the longitudinally-extending pleats incorporate the plurality of radially arranged layers. When a medical device is passed through the sheath, a diameter of the sheath locally expands around the medical device while the first and second polymeric layers resist axial elongation of the sheath such that a length of the sheath remains substantially constant. The sheath resiliently collapses after the passage of the medical device.

Abstract: A compliance-enhancing implant device dimensioned for deployment within a blood vessel includes a first sealed chamber containing a compressible gas medium and one or more second sealed chambers separated from the first sealed chamber by one or more first membrane portions. The one or more second sealed chambers contain an at least partially liquid medium. The first sealed chamber is surrounded on all sides by the one or more second sealed chambers. A portion of the compressible gas medium in the first sealed chamber can pass through the first membrane portion into the at least partially liquid medium in the one or more second sealed chambers.

Abstract: Introducers that can be used in combination with sheaths for introducing a delivery apparatus into a patient's vasculature, and methods for utilizing such introducers, are disclosed herein. As one example, an introducer can include a nosecone, and inner shaft attached to the nosecone, and outer shaft disposed around the inner shaft, and a plug disposed around the inner shaft. The plug is configured to expand from a first diameter in a compacted configuration thereof, to a second diameter in an expanded configuration thereof.

Abstract: A medical implant for managing blood flow through a blood vessel comprises a stent body forming a proximal portion and a tapered distal end, the tapered distal end being angled relative to the proximal portion to face a direction of blood flow and limit blood flow into an inner lumen of the stent body, and the tapered distal end having a flexible structure to allow the tapered distal end to bend and straighten in response to blood flow, and a covering extending along the stent body.

Abstract: An introducer sheath can be used to safely introduce a delivery apparatus into a patient’s vasculature (e.g., via the femoral artery). It is advantageous to visualize the placement of an introducer sheath within the vasculature using an imaging system. The sheaths disclosed herein include radiopaque features that assist with imaging without sacrificing the low profile, expandability, and other advantageous aspects of the introducer sheath.

Abstract: The expandable sheaths disclosed herein include an expandable outer layer and a generally non-expandable inner layer. The outer layer is movable between a non-expanded configuration and an expanded configuration, where the outer layer/tubular layer is biased to the non-expanded configuration. Receipt of the inner layer within the central lumen of the outer layer causes the outer layer to transition from the non-expanded configuration to the expanded configuration.

Abstract: Expandable sheaths are disclosed herein. In some aspects, the sheath comprises at least one plurality of struts arranged to form an expandable cylindrical frame such that the formed frame is kink resistant. The disclosed frames are configured to expand from a first diameter d1 in an unexpanded position to a second diameter d2 an expanded position upon passage of a medical device, while maintaining the kink resistance. Also disclosed are methods of making the same.