Abstract: Embodiments herein relate to cardiac stent-valves for transcatheter delivery. A cardiac stent-valve for transcatheter delivery is compressible to a compressed state for delivery and expandable to an expanded state for implantation. The stent-valve can include a stent with an axial inflow end and an axial outflow end, a plurality of leaflets arranged within the stent, and a structured sealing skirt for reduction or prevention of paravalvular leakage. The structured sealing skirt comprises one or more sealing formations arranged on a radially outer surface of the structured sealing skirt. At least in the expanded state, at least one of the one or more sealing formations is shaped and arranged such that, at each axial level of the structured sealing skirt covered by the one or more sealing formations. Other embodiments are also included herein.

Abstract: Embodiments herein include a cardiac stent-valve for transcatheter delivery being compressible to a compressed state for delivery, and expandable to an expanded state for implantation. The stent-valve including a stent with an axial inflow end and an axial outflow end, a plurality of leaflets arranged within the stent, and a sealing skirt for reduction or prevention of paravalvular leakage. In the expanded state, the sealing skirt includes a tubular inner wall and at least one pocket which is positioned on the tubular inner wall and comprises an outer wall which extends radially outward from the tubular inner wall. The pocket is configured to be distended radially outward in response to inflow of blood in the expanded state. In the expanded state, the outer wall of the pocket includes one or more pre-shaped bulges which extend radially outward from the outer wall of the pocket. Other embodiments are also included herein.

Abstract: A delivery catheter (12) for a stent valve (10), the delivery catheter having a distal portion (14) insertable into an anatomy, the distal portion comprising an accommodation region (18) for accommodating a stent-valve for delivery into the anatomy, the delivery catheter further comprising at least one sheath (20; 22) that is translatable between a closed position for at least partly closing the accommodation region and an open position for at least partly opening the accommodation region.

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: Various embodiments of a seal for a stent-valve, and methods of production, are described. In some embodiments, the seal or a skirt comprises a fabric wall portion and a polymeric material fused to the fabric wall portion, the polymeric material having a melting temperature that is lower than that of the fabric wall portion. The fibres of the fabric may remain unmelted at the interface with the polymeric material, the polymeric material being attached to material to the fibres of the fabric wall portion by fusion. The polymeric material may provide a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric.

Abstract: Embodiments include implantable valves with attached polymeric components. In an embodiment, an implantable valve is included having a frame comprising a plurality of frame struts. The frame defines a central lumen and at least one of the frame struts defines a connection aperture. The implantable valve can include at least one valve leaflet including a coaptation edge and two connection portions, with one connection portion disposed on either end of the coaptation edge. The connection portion can be disposed within the connection aperture thereby coupling the valve leaflet to the frame. Other embodiments are also included herein.

Abstract: Embodiments include prosthetic valves and related methods. In an embodiment, an implantable valve is included having a frame that includes a plurality of frame struts. The frame can define a central lumen. An outer skirt can be disposed on an abluminal surface of the frame. The outer skirt can include a flap having a first end and a second end. The first end of the flap can be fixed to the abluminal surface of the frame and the second end can be free to move away from the abluminal surface of the frame. Other embodiments are also included herein.

Abstract: Various embodiments of a seal for a stent-valve, and methods of production, are described. In some embodiments, the seal or a skirt comprises a fabric wall portion and a polymeric material fused to the fabric wall portion, the polymeric material having a melting temperature that is lower than that of the fabric wall portion. The fibres of the fabric may remain unmelted at the interface with the polymeric material, the polymeric material being attached to material to the fibres of the fabric wall portion by fusion. The polymeric material may provide a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric.

Abstract: Embodiments include implantable valves with attached polymeric components. In an embodiment, an implantable valve is included having a frame comprising a plurality of frame struts. The frame defines a central lumen and at least one of the frame struts defines a connection aperture. The implantable valve can include at least one valve leaflet including a coaptation edge and two connection portions, with one connection portion disposed on either end of the coaptation edge. The connection portion can be disposed within the connection aperture thereby coupling the valve leaflet to the frame. Other embodiments are also included herein.

Abstract: Embodiments include prosthetic valves and related methods. In an embodiment, an implantable valve is included having a frame that includes a plurality of frame struts. The frame can define a central lumen. An outer skirt can be disposed on an abluminal surface of the frame. The outer skirt can include a flap having a first end and a second end. The first end of the flap can be fixed to the abluminal surface of the frame and the second end can be free to move away from the abluminal surface of the frame. Other embodiments are also included herein.

Abstract: A device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.

Abstract: A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprises material that swells in response to contact with blood. In some embodiments, the seal comprises a flap or pocket that is distensible in response to backpressure and/or paravalve back-flow of blood.

Abstract: A device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.

Abstract: A delivery catheter for a stent. The delivery catheter may comprise a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further comprises a handle at its proximal end and at least one sheath which may at least partially circumferentially cover said stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on said handle portion. The catheter further comprises at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or the stent when observed using medical imaging during implantation of the stent.

Abstract: Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Abstract: A stent-valve having a valve component and a stent component for housing the valve component, as well as associated methods and systems for delivery of the stent-valve via minimally-invasive surgery. The stent-valve can be configurable between two or more configurations to assist in delivery of the stent-valve to an implantation site of a patient.

Abstract: A delivery catheter for a stent. The delivery catheter may have a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further includes a handle at its proximal end and at least one sheath which may at least partially circumferentially cover the stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on the handle portion. The catheter further includes at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or the stent when observed using medical imaging during implantation of the stent.

Abstract: Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Abstract: Apparatus (40) for compressing a transcatheter cardiac stent-valve (10) comprises: a first compressor stage (100) including a hollow channel (42) with a tapered interior surface configured for compressing a stent-valve in response to longitudinal advancement of the stent-valve within the channel; and a second compressor stage (102) comprising a crimper for compressing a portion of the stent-valve without longitudinal advancement.