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: 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: 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 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.

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 smoothes 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 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.

Abstract: A hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a substantially non-expandable, non-compressible prosthetic valve member having a peripheral sealing ring and an expandable stent frame projecting from an inflow end, thereby enabling attachment to the annulus without sutures. The stent frame may be plastically-expandable and may have a thin fabric layer covering its entirety as well as secondary sealing structures around its periphery to prevent paravalvular leaking. Other sealing solutions include interactive steps at the time of valve implant to establish seals around the stent and especially between the stent and the sealing ring of the valve member.

Abstract: An articulating implant holder system for heart valve repair or replacement has an implant configured to be secured to a heart valve annulus, an implant holder secured to the implant, an articulating handle assembly comprising a handle, a swivel pivotably secured to the handle at a first location and a connector pivotably secured to the swivel at a second location, an actuating cable secured between the handle and the connector to cause the swivel to move from a first position to a second position, and a latch removably secured to the implant holder. A plurality of sizer heads are configured to correspond to different sizes of heart valve annuluses and each of the plurality of sizer heads has a latching feature. A latching feature of the swivel is configured to removably snap on to the latching feature of each of the plurality of sizer heads and is configured to permanently snap on to the latch.

Abstract: An annuloplasty ring assembly with detachable handle includes an annuloplasty ring configured to be secured to an annulus of a heart valve and an annuloplasty ring. The annuloplasty ring is attached to the ring holder such that the annuloplasty ring is in conformal contact along a lower surface of a peripheral edge portion of the ring holder. The assembly includes a handle adapter extending proximally from an upper proximal face of the ring holder. The handle adapter is also attached or attachable to a distal attachment end of the handle on one side and removably attached to the annuloplasty ring holder on another side.

Abstract: A tissue anchor includes a memory metal wire configured to transition between an at least partially straightened delivery configuration and an expanded deployed configuration forming an anchor and a suture-attachment feature configured to have a suture coupled thereto. In the expanded deployed configuration, one or more portions of the memory metal wire extend radially outward from a center of the tissue anchor.

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 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: 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.