Abstract: A prosthetic heart valve, comprising (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b) one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) a water-absorbing polymer coupled to the cuff.

Abstract: A prosthetic heart valve includes (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) one or more biasing elements connected to the stent body and to the cuff, the biasing elements being adapted to bias at least a portion of the cuff outwardly with respect to the stent body.

Abstract: A stabilized fabric composed of a mesh or a woven fabric is disclosed as are methods of their manufacture, the manufacture of medical devices made using a stabilized fibers and stabilized medical devices are all disclosed. Fabrics can be stabilized by several techniques including: using mechanical, chemical and/or energetic fasteners at warp and weft intersections in the weave; by using various weaving techniques and fibers. Meshes can be stabilized when properly dimensioned and arranged junctions and struts of the necessary properties are used. All of these stabilized fabrics can be made of synthetic polymer materials such as ultrahigh molecular weight PE or PP and expanded PTFE.

Abstract: A prosthetic heart valve for replacement of a native heart valve having a native valve annulus includes a stent body having a proximal end adjacent an inflow end and a distal end adjacent an outflow end and including an annulus section, the stent body having a radially collapsed condition and a radially expanded condition, one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a cuff coupled to the stent body, the cuff having a mobile portion that is moveable relative to the stent body, and at least one engagement element remote from the stent body.

Abstract: A stabilized fabric composed of a mesh or a woven fabric is disclosed as are methods of their manufacture, the manufacture of medical devices made using a stabilized fibers and stabilized medical devices are all disclosed. Fabrics can be stabilized by several techniques including: using mechanical, chemical and/or energetic fasteners at warp and weft intersections in the weave; by using various weaving techniques and fibers. Meshes can be stabilized when properly dimensioned and arranged junctions and struts of the necessary properties are used. All of these stabilized fabrics can be made of synthetic polymer materials such as ultrahigh molecular weight PE or PP and expanded PTFE.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

Abstract: A surgical heart valve includes a non-collapsible frame having features that enable the frame to expand from an initial condition having a first diameter to an expanded condition having a second diameter larger than the first diameter after the valve has been implanted within a patient. The frame may include members that prevent the unintended expansion of the frame, such as during implantation, and members that prevent the over-expansion of the frame. The surgical heart valve further includes a valve assembly connected to the frame and including a plurality of leaflets.

Abstract: At least a portion of sheet materials for use in medical devices is formed from polymeric materials. The sheet materials may be partially coated or fully coated with one or more additional layers of a polymer. The sheet materials may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

Abstract: A stabilized fabric composed of a mesh or a woven fabric is disclosed as are methods of their manufacture, the manufacture of medical devices made using a stabilized fibers and stabilized medical devices are all disclosed. Fabrics can be stabilized by several techniques including: using mechanical, chemical and/or energetic fasteners at warp and weft intersections in the weave; by using various weaving techniques and fibers. Meshes can be stabilized when properly dimensioned and arranged junctions and struts of the necessary properties are used. All of these stabilized fabrics can be made of synthetic polymer materials such as ultrahigh molecular weight PE or PP and expanded PTFE.

Abstract: At least a portion of fabrics for use in medical devices is formed from polymeric materials. The fabrics may be uncoated, partially coated or fully coated with one or more layers of a polymer. The fabrics may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

Abstract: Methods of preparing a solid reference material so as to elicit a positive control response when tested for in-vitro complement activation include providing biological tissue; treating the tissue with an aqueous cellulose solution for a time sufficient to allow fluid in the tissue to be replaced by the aqueous cellulose solution; drying the cellulose-treated tissue by a vacuum-drying process or a lyophilization process to form dried tissue; and storing the dried tissue in a dry, ambient environment. The tissue prepared by these methods and its use in an in-vitro complement assay and diagnostic kit are also described.

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: At least a portion of fabrics for use in medical devices is formed from polymeric materials. The fabrics may be uncoated, partially coated or fully coated with one or more layers of a polymer. The fabrics may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

Abstract: A method of augmenting the length of a native leaflet to improve leaflet coaptation includes delivering a cutting tool to a surgical site adjacent the native leaflet, cutting a slit through the native leaflet, inserting a collapsible and expandable occlusion device into the slit, expanding the occlusion device, engaging a first surface of the first disk with a first surface of the native leaflet, and engaging a second surface of the second disk with a second surface of the native leaflet opposite the first surface. The occlusion device includes a first disk, a second disk, and an intermediate portion coupling the first disk to the second disk.

Abstract: An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

Abstract: Prosthetic heart devices may be implanted into the heart with a sensor coupled to the device, the sensor being configured to measure physiological data, such as blood pressure, in the heart. Devices that may employ such sensors include prosthetic heart valves and occlusion devices, although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body with different configurations for attaching to the implantable device, such as apertures for sutures or fingers for connecting to structures of the implantable device. The sensors may provide data that allow a determination of aortic regurgitation or other information indicative of function of the implantable device and patient health during and after implantation of the device.

Abstract: A surgical heart valve includes a non-collapsible frame having features that enable the frame to expand from an initial condition having a first diameter to an expanded condition having a second diameter larger than the first diameter after the valve has been implanted within a patient. The frame may include members that prevent the unintended expansion of the frame, such as during implantation, and members that prevent the over-expansion of the frame. The surgical heart valve further includes a valve assembly connected to the frame and including a plurality of leaflets.

Abstract: A prosthetic device for implanting in a patient's heart includes (i) a therapeutic device capable of restoring function to a native heart valve; and (ii) at least one sensor including a body, an inductor coil disposed within the body, and a capacitor in communication with the inductor coil, the at least one sensor being coupled to the therapeutic device, and being configured to monitor proper function of the therapeutic device within the patient's heart.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.