Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commissure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commissure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: A prosthetic mitral valve with a compressible and expandable base structure that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the base structure comprise a primary member and a secondary member surrounding the primary member and coupled thereto. Three flexible leaflets are attached to commissure sections of the primary member in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window for enhanced access to the commissure posts and leaflets. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation.

Abstract: Prosthetic annuloplasty ring(s) configured to attach to and remodel a valve annulus. Each ring can comprise a generally oval shaped inner body made of a semi-rigid material. The inner body can be surrounded by an outer suture-permeable sheath that permits the ring body to be attached to the valve annulus. The inner body can include a posterior section contiguous with an anterior section together forming a continuous periphery oriented about a flow axis. In plan view as seen along the flow axis, the ring can have a major axis perpendicular to a minor axis, wherein a maximum dimension lies along the major axis and a minimum dimension lies along the minor axis. The rings can be a set of rings of increasing ring sizes, where a ratio of the minimum dimension to the maximum dimension changes for at least some of the rings of different ring sizes.

Abstract: A prosthetic mitral valve with a compressible and expandable base structure that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the base structure comprise a primary member and a secondary member surrounding the primary member and coupled thereto. Three flexible leaflets are attached to commissure sections of the primary member in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: Methods of remodeling an abnormal mitral valve with an annuloplasty ring having a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P1, P2, and P3 segments. The anterior-to-posterior dimension of the ring body is reduced from conventional rings; such as by providing, in atrial plan view, a pulled-in P3 segment. The ring body may have a downwardly deflected portion in the posterior section. The downwardly deflected portion may have an apex which is the lowest elevation of the ring body and may be offset with respect to the center of the downwardly deflected portion toward the P3 segment.

Abstract: A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure regions disposed towards an outflow end and three curved cusp regions between adjacent commissure regions. Three flexible leaflets are attached to the commissure regions in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commis sure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence.

Abstract: A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure regions disposed towards an outflow end and three curved cusp regions between adjacent commissure regions. Three flexible leaflets are attached to the commissure regions in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure posts disposed towards an outflow end and three curved cusp regions between adjacent commissure posts. Three flexible leaflets are attached to the commissure posts in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases, such as fibroelastic deficiency (FED), Marfan's or Barlow's. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes.

Abstract: Methods of remodeling an abnormal mitral valve with an annuloplasty ring having a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P1, P2, and P3 segments. The anterior-to-posterior dimension of the ring body is reduced from conventional rings; such as by providing, in atrial plan view, a pulled-in P3 segment. The ring body may have a downwardly deflected portion in the posterior section. The downwardly deflected portion may have an apex which is the lowest elevation of the ring body and may be offset with respect to the center of the downwardly deflected portion toward the P3 segment.

Abstract: Bioprosthetic tissues and methods for making same, comprising fixing bioprosthetic implant tissue by treatment with 0.1 to 10 wt. % glutaraldehyde at elevated temperature, capping said fixed tissue by treatment with a diamine crosslinking agent, and treating said capped tissue with about 0.6 wt. % glutaraldehyde.

Abstract: A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure posts disposed towards an outflow end and three curved cusp regions between adjacent commissure posts. Three flexible leaflets are attached to the commissure posts in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.