Abstract:
Heart valve prostheses are provided having a self-expanding frame that supports a valve body comprising a skirt and a plurality of coapting leaflets. The leaflets are constructed with four commissure points to reduce the stress and strain applied to the commissure points and to efficiently distribute and transmit forces along the leaflets and to the frame.
Abstract:
A method for treating paravalvular leakage at a location of a stented prosthetic valve includes the steps of delivering a clip to a location adjacent chordae tendinae of a native valve, and deploying the clip such that the clip captures at least some of the chordae tendinae of the native valve, thereby increasing tension in the captured chordae tendinae. The clip is delivered to the location in a collapsed stated and is released from a sheath convert to an undeflected or relaxed state. After the clip is released from the sheath, the clip is rotated to capture the chordae tendinae. The clip is then released from the delivery system and the delivery system is retracted.
Abstract:
A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.
Abstract:
A visualization device for use with a loading tray includes a frame comprising a floor, a first side wall extending generally perpendicular from the floor, and a second side wall extending generally perpendicular from the floor and spaced from the first side wall. The visualization device further includes a mirror abutting the floor of the frame. A magnifying glass may also be supported by top edges of the first and second side walls, or by runners coupled to the top edges of the first and second side walls. The visualization device may be slideably disposed in a reservoir of a loading tray.
Abstract:
A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes at least one release feature for releasing the stented prosthetic heart valve from the delivery device.
Abstract:
A catheter shaft includes an inner layer defining an innermost circumferential surface of the catheter shaft and defining a lumen of the catheter shaft, and an outer layer defining an outermost circumferential surface of the catheter shaft. The inner layer is formed by a first polymer having a first durometer and a first melting temperature. The outer layer is formed by alternating first and second segments of the first polymer and a second polymer, respectively, that alternate in a circumferential direction. The second polymer has a second durometer softer than the first durometer and a second melting temperature lower than the first melting temperature. Each segment of the alternating first and second segments extend in an axial direction for substantially an entire length of the catheter shaft. A method of forming the catheter shaft via extrusion is also disclosed.
Abstract:
A catheter shaft includes an inner layer defining an innermost circumferential surface of the catheter shaft and defining a lumen of the catheter shaft, and an outer layer defining an outermost circumferential surface of the catheter shaft. The inner layer is formed by a first polymer having a first durometer and a first melting temperature. The outer layer is formed by alternating first and second segments of the first polymer and a second polymer, respectively, that alternate in a circumferential direction. The second polymer has a second durometer softer than the first durometer and a second melting temperature lower than the first melting temperature. Each segment of the alternating first and second segments extend in an axial direction for substantially an entire length of the catheter shaft. A method of forming the catheter shaft via extrusion is also disclosed.
Abstract:
A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.
Abstract:
A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.
Abstract:
In some embodiments, a medical device delivery system includes a catheter and a retainer. The retainer can be engaged with the medical device to restrain relative movement of the medical device in one or more axial and/or radial directions. A variety of retainers and retainer systems are disclosed, many of which can reliably disengage the medical device from the retainer. Methods for using the medical device delivery system are also described.