Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Abstract: A prosthetic heart valve may include a collapsible and expandable frame that, in an expanded condition, includes a central portion, an atrial portion flaring radially outwardly from the central portion, and a ventricular portion flaring radially outwardly from the central portion. A tube positioned within the frame may have a lumen extending along a longitudinal axis of the frame, wherein the tube is formed of tissue or fabric. Prosthetic leaflets may be directly coupled to the tube to form a valve allowing blood to flow through the lumen of the tube in an antegrade direction but substantially blocking blood from flowing through the lumen of the tube in a retrograde direction. A plurality of cords may each have a first end coupled to the frame and a second end coupled to the tube. Each of the plurality of cords may extend in a radial direction toward the longitudinal axis.

Abstract: An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes an inner collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an interior surface of a heart wall, an outer collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an exterior of the heart wall, and a connector extending between the inner and outer collars. The inner collar is moveable relative to the outer collar to clamp the heart wall and to seal an incision extending through the heart wall.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A prosthetic heart valve system includes a prosthetic heart valve, an anchor, a tether, and a tensioning member. The prosthetic heart valve has an expandable stent and a prosthetic valve assembly disposed within the stent. The anchor is adapted to be disposed on or adjacent an epicardial surface of a heart of a patient. The tether has a first end coupled to the anchor and a second end coupled to the prosthetic heart valve. The tensioning member is disposed along an intermediate portion of the tether between the first end of the tether and the second end of the tether, the tether forming a loop around the tensioning member. The tensioning member is adjustable to increase or decrease a size of the loop to change an effective length of the tether between the prosthetic heart valve and the anchor.

Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A prosthetic valve packaging system includes a jar, a lid, a lid liner, and a humectant. The jar has a closed end, an open end, a side wall and an interior sized to receive the prosthetic heart valve. The lid is connected to the open end of the jar. The lid liner includes a rim sandwiched between the lid and the side wall of the jar to provide a fluid-tight seal. The humectant is supported within the interior of the jar. The humectant may be supported by the lid liner. The lid liner may include one or more windows so that the humectant may provide a desired humidity to the inside of jar to maintain a desired water content in the tissue of the valve. The system may obviate the need to store the valve in a dry state, or to otherwise store the valve submerged in an aldehyde solution.

Abstract: Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.

Abstract: Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.

Abstract: A prosthetic valve packaging system includes a jar, a lid, a lid liner, and a humectant. The jar has a closed end, an open end, a side wall and an interior sized to receive the prosthetic heart valve. The lid is connected to the open end of the jar. The lid liner includes a rim sandwiched between the lid and the side wall of the jar to provide a fluid-tight seal. The humectant is supported within the interior of the jar. The humectant may be supported by the lid liner. The lid liner may include one or more windows so that the humectant may provide a desired humidity to the inside of jar to maintain a desired water content in the tissue of the valve. The system may obviate the need to store the valve in a dry state, or to otherwise store the valve submerged in an aldehyde solution.