Abstract: A heart valve sizer and sizer cover are provided for determining the size of a heart valve annulus. The valve sizer can include a handle, a shaft extending distally from the handle, a sizing element coupled to the distal end of the shaft, the sizing element being movable between a first retracted position and a second expanded position, and a sizer cover. The sizer cover can be formed from a continuous sheet of material configured to surround at least a portion of the sizing element of the heart valve sizer so as to guard against entanglement of the sizing element with structures of a human heart.

Abstract: A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. Interlocking members or flexible loops are included to limit expansion of the valve to one or two valve sizes, for example, with a 2-mm gap between each valve size. The valve may include an internal structural band with overlapped free ends having structure for limiting expansion, or external loops of suture may be added to the fabric covering which limits expansion.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. Interlocking members or flexible loops are included to limit expansion of the valve to one or two valve sizes, for example, with a 2-mm gap between each valve size. The valve may include an internal structural band with overlapped free ends having structure for limiting expansion, or external loops of suture may be added to the fabric covering which limits expansion.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A mitral repair annuloplasty ring that will accommodate implantation of a transcatheter valve therein for a valve-in-ring reoperation. The ring has a semi-rigid core with features that allow the ring to better conform to the cylindrical geometry of a transcatheter valve when implanted. The inner core defines a continuous peripheral D-shape with a substantially straight anterior side diametrically across from a more rounded posterior side with arcuate lateral sides therebetween. Segments of the ring core are subject to differing rates of bending due to variable radial thicknesses or radial slits opening to both inner and outer edges around the core periphery. One or more expansion joints may also be used to create the more circular final expanded shape. A plastically expandable sealing sleeve may surround the transcatheter valve for sealing gaps between the valve and annuloplasty ring.

Abstract: A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

Abstract: A minimally-invasive annuloplasty ring for implant at a mitral annulus. The annuloplasty ring has an inner core member with a C-shaped plan view that generally defines an oval with a major axis and a minor axis, and is symmetric about the minor axis. A posterior portion of the core member bisected by the minor axis has a thicker radial dimension than a pair of free end regions terminating on an anterior side of the core member. The radial thickness smoothly transitions between the posterior portion and the end regions. The inner core member may be covered with a fabric, and is a superelastic metal so that it can be straightened out and delivered through an access tube. The curvatures and thicknesses around the core member are selected so that the strain experienced when straightened does not exceed 7-8%.

Abstract: Compressible heart valve annulus sizing templates suitable for minimally-invasive or otherwise reduced accessibility surgeries. The sizing templates may be folded, rolled, or otherwise compressed into a reduced configuration for passage through an access tube or other such access channel. Once expelled from the access tube the sizing templates expand to their original shape for use in sizing the annulus. The templates may be formed of an elastomeric polymer material such as silicone, a highly elastic metal such as NITINOL, or both. Grasping tabs or connectors for handles permit manipulation from outside the body. A NITINOL wireform may be compressed for passage through an access tube and expelled from the distal end thereof into a cloth cover to assume a sizer shape.

Abstract: Sensor-integrated prosthetic valves that can comprise a variety of features, including a plurality of valve leaflets, a frame assembly configured to support the plurality of valve leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, a sensor signal indicating deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmission signal that is based at least in part on the sensor signal.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A minimally-invasive annuloplasty ring for implant at a mitral annulus. The annuloplasty ring has an inner core member with a C-shaped plan view that generally defines an oval with a major axis and a minor axis, and is symmetric about the minor axis. A posterior portion of the core member bisected by the minor axis has a thicker radial dimension than a pair of free end regions terminating on an anterior side of the core member. The radial thickness smoothly transitions between the posterior portion and the end regions. The inner core member may be covered with a fabric, and is a superelastic metal so that it can be straightened out and delivered through an access tube. The curvatures and thicknesses around the core member are selected so that the strain experienced when straightened does not exceed 7-8%.

Abstract: A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

Abstract: A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

Abstract: Sensor-integrated prosthetic valves that can comprise a variety of features, including a plurality of valve leaflets, a frame assembly configured to support the plurality of valve leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, a sensor signal indicating deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmission signal that is based at least in part on the sensor signal.

Abstract: A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

Abstract: A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

Abstract: Compressible heart valve annulus sizing templates suitable for minimally-invasive or otherwise reduced accessibility surgeries. The sizing templates may be folded, rolled, or otherwise compressed into a reduced configuration for passage through an access tube or other such access channel. Once expelled from the access tube the sizing templates expand to their original shape for use in sizing the annulus. The templates may be formed of an elastomeric polymer material such as silicone, a highly elastic metal such as NITINOL, or both. Grasping tabs or connectors for handles permit manipulation from outside the body. A NITINOL wireform may be compressed for passage through an access tube and expelled from the distal end thereof into a cloth cover to assume a sizer shape.