Abstract: Artificial heart valves, their manufacture, and methods of use are described. Generally, artificial heart valves can be deployed to replace or supplement defective heart valves in a patient. These artificial heart valves can comprise a frame with an inner skirt and leaflets. These inner skirt and leaflets can be generated from regenerative tissue to allow integration of the tissue with the body of a patient, while the frame can be generated from bioabsorbable material to allow dissolution of the frame over time. This combination of materials may allow for the artificial valve to grow with a patient and avoid costly and potentially dangerous replacement for patients receiving artificial valves.

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: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: Suture locking clamps for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots improve the ease of implantation. The clamps have opposed clamp halves separated by a slot opening to one side and surrounded by a biasing member such as one or more C-clip springs. Sutures pass laterally into the slot which is held open by a retention member positioned between the clamp halves. The locking clamp slides along the sutures into position, the tension of the sutures is adjusted, and the retention member removed to allow the biasing member to clamp the sutures between the clamp halves. A delivery tool used to deliver and deploy the locking clamps contains a number of clamps within a delivery tube in a stack and bonded together for safety and a common retention member. The tool has a longitudinal channel on one side for entry of sutures.

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: Artificial heart valves, their manufacture, and methods of use are described. Generally, artificial heart valves can be deployed to replace or supplement defective heart valves in a patient. These artificial heart valves can comprise a frame with an inner skirt and leaflets. These inner skirt and leaflets can be generated from regenerative tissue to allow integration of the tissue with the body of a patient, while the frame can be generated from bioabsorbable material to allow dissolution of the frame over time. This combination of materials may allow for the artificial valve to grow with a patient and avoid costly and potentially dangerous replacement for patients receiving artificial valves.

Abstract: An annuloplasty band having a differentiation in area moment of inertia, where the area moment of inertia in the out of plane direction is much less than the area moment of inertia in the plane of the annulus. This makes the band stiff enough to hold the annulus in the correct shape while being flexible enough out of plane to minimize the risk of suture dehiscence or breakage. One example is a C-shaped band with a core formed of nitinol and having a constant cross-section with a wider radial dimension than an axial dimension. The cross-section may be rectangular. The band is asymmetric across a minor axis with one end extending around the anterior side farther than the other. The free ends rise up from adjacent lateral sides, and a continuous posterior mid-section also rises upward.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: Systems, devices, kits, and methods are described for securing a bioprosthetic heart valve within an anatomical feature of a patient. Kits can comprise a bioprosthetic heart valve, a curable composition, and an applicator configured to deliver the curable composition to a target area. The bioprosthetic heart valve can comprise a support structure and one or more valve leaflets coupled thereto. The support structure can comprise a sewing portion peripheral of the bioprosthetic heart valve. The support structure and the valve leaflets can define a central flow orifice. The curable composition can comprise a pre-polymer composition and an initiator. Methods can comprise positioning the bioprosthetic heart valve within the anatomical feature of a patient, applying the curable composition to one or both of the bioprosthetic heart valve and the anatomical feature, and curing the curable composition for a cure time. The applying can be performed before or after the positioning.

Abstract: An orifice-expanding device for measuring an expanded heart valve. The device includes a proximal handle having a shaft and an orifice-expanding device with a hub mounted to a distal end of the shaft and a plurality of arms evenly spaced around the axis and connected to the hub and extending therefrom in a distal direction to distal ends of the arms. The distal end of each arm has an expanding portion with an outer surface, the expanding portions being configured to move radially outward with respect to each other, wherein expansion of the expanding portions causes the distal ends of the arms to flex outward. A pressure-measuring device measures a pressure applied to the aortic valve annulus, and a size-measuring device measures a dimension of the aortic valve annulus after the annulus has been expanded.

Abstract: A tissue anchor delivery includes comprises a needle including a hollow shaft portion, a tip portion, and an outlet opening. The tissue anchor delivery device further includes a plurality of tissue anchors disposed within the shaft portion of the needle and a suture coupled to each of the plurality of tissue anchors and disposed at least partially within the shaft portion of the needle.

Abstract: Systems, devices, kits, and methods are described for securing a bioprosthetic heart valve within an anatomical feature of a patient. Kits can comprise a bioprosthetic heart valve, a curable composition, and an applicator configured to deliver the curable composition to a target area. The bioprosthetic heart valve can comprise a support structure and one or more valve leaflets coupled thereto. The support structure can comprise a sewing portion peripheral of the bioprosthetic heart valve. The support structure and the valve leaflets can define a central flow orifice. The curable composition can comprise a pre-polymer composition and an initiator. Methods can comprise positioning the bioprosthetic heart valve within the anatomical feature of a patient, applying the curable composition to one or both of the bioprosthetic heart valve and the anatomical feature, and curing the curable composition for a cure time. The applying can be performed before or after the positioning.

Abstract: Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.

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: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smooths the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: A method for repairing a native valve of a patient during a non-open-heart procedure includes attaching two or more attachment members to the native valve. The method also includes applying a force to the two or more attachment members such that the two or more attachment members cause a cinching effect on at least a portion of the native valve. The method further includes securing the two or more attachment members with one or more anchor members such that the two or more attachment members maintain the cinching effect.

Abstract: A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.