Abstract: Vascular grafts, and methods for making the same, are provided. The vascular grafts comprise a graft tissue derived from a biological source that is enclosed within an external synthetic sleeve. The synthetic sleeve has an extended length that is greater than the length of the graft tissue. However, the sleeve is longitudinally compressed such that it has a resting length substantially similar to the length of the graft tissue.

Abstract: A prosthetic cardiac valvular member of flexible material includes a flexible stent member which may be either attached to the cardiac valvular member or molded therein. The stent member is formed by a plurality of adjacent filaments which are bound together by suturing, braiding, jacketing or encapsulating. The prosthetic cardiac valvular member may be either a flexible heart valve or an annuloplasty ring. Post members are formed into the stent member when the stent member is used in the flexible heart valve.

Abstract: A method for treating biological tissue is provided in which a cross-linked biological tissue containing free aldehyde groups is reacted with a suitable neutralization agent in order to chemically block the aldehyde groups from reactivity toward cellular proteins. Also provided is the cross-linked biological tissue so produced which is substantially free of reactive aldehyde groups and, as a result, exhibits reduced toxicity and improved biocompatibility.

Abstract: A valve body assembly for being mounted adjacent an annulus within a heart. A first retainer is attached to the valve body assembly for engaging a first side of the annulus. A second retainer is attached to the valve body assembly and includes a resiliently-deformable retaining member for resiliently engaging a second side of the annulus. The resiliently deformable retaining member is collapsed to a size permitting it to be inserted into through the annulus and positioned adjacent the second side of the annulus. The retaining member is then allowed to expand such that it resiliently engages the second side of the annulus.

Abstract: An implantable prosthetic heart valve comprising: a valve body, a sewing ring assembly surrounding the valve body and comprising at least a fabric collar and preferably also a stiffening ring, and a tubular vascular graft having a proximal end and a distal end. The proximal end of the graft passes between the fabric collar and the valve body, but not between the stiffening ring and the valve body. The proximal end of the graft is preferably retained by a retaining ring that engages a retaining ring in the downstream end of the fabric sleeve.

Abstract: A heart valve prosthesis which incorporates a substantially permanently implantable abutment structure which is surgically attached to a native heart valve annulus through utilization of a resilient metal substructure having an attachment portion which moves into engagement with a native heart annulus upon being released from a retracted orientation. The system employs a positioning instrument which locates the abutment structure and associated heart valve prosthesis at the proper location for releasing the attachment components. Mechanical heart valve components including an occluder function are removably attached to the abutment structure using sutures, such that the valve function itself may be subsequently replaced.

Abstract: A heart valve is disclosed which includes a valve body and a plurality of flexible leaflets coupled to the valve body. The plurality of leaflets has an open position and a closed position. Each of the plurality of leaflets comprises a belly when the plurality of leaflets are in their respective closed positions. The belly of one or more of the plurality of leaflets has a continuous curvature except for a non-continuous portion.

Abstract: A valve includes an elastic valve body and a stent. A first portion of the stent is embedded in the elastic valve body and a second portion of the stent is outside the valve body. A method of manufacturing such a valve is also claimed.

Abstract: A method for the treatment of an infected area within a body. The method comprises applying a electrically conductive biocide composition to an infected area within a body that has been exposed during surgery. Then, an electric field is applied to the biocide composition. The electric field strength and duration of application may be sufficient to produce killing of microorganisms in the infected area.

Abstract: This invention relates, in general, to a process for cross-linking and stabilizing proteinaceous material, and in particular, to a process for oxidizing collagenous material, by oxidizing the tissue. The invention also relates to the resulting cross-linked product. The method comprises immersing the material to be cross-linked in a solution comprising compounds designed to generate the radical species singlet oxygen or other oxidizing intermediates without the addition of an external energy source. Immersing collagen containing tissue in a solution comprising an oxidizing agent and sufficient dissolved oxygen, under controlled conditions of pH and temperature, provides a cross-linked and stabilized collagen containing tissue that resists chemical and enzymatic degradation.

Abstract: A prosthetic heart valve is disclosed which has a rigid shoulder with staple receiving means. Using the staple receiving means of the shoulder, the heart valve may be secured within the heart by stapling the shoulder of the prosthesis to the patient's tissue. Such a prosthesis is advantageous in that it may be secured in a much shorter time period than conventional valves thereby reducing the risks and complications of surgery.

Abstract: A heart valve prosthesis including a valve body having a first retainer integrally formed with an outer surface thereof. A grafting assembly is formed to include a stiffening member having an axial bore extending therethrough and a second retainer integral with a surface of the stiffening member. The valve body is mounted within the bore of the stiffening member. A retaining member engages the first and second retainers to limit axial displacement of the stiffening member relative to the valve assembly.

Abstract: An angiogenic factor comprising a mixture of proteins derived from bone. The angiogenic protein mixture is produced by a series of steps that allow the proteins to be kept in solution. The angiogenic mixture of bone proteins is produced by a multi-step process that includes at least one ultrafiltration step, an anion exchange chromatography step, a cation exchange chromatography step and a high performance liquid chromatography (HPLC) purification step.

Abstract: A heart valve prosthesis having improved flow characteristics. A heart valve prosthesis includes a valve body and a pair of leaflet occluders. The valve body includes an interior surface that defines a central passage for blood flow. The pair of leaflet occluders are pivotably mounted in the passage via ears or tabs that are received in recesses formed in the interior surface that defines the central passage. The recesses are formed with sloped sidewalls to improve the blood flow therethrough. The recesses are also formed such that the leaflet occluder ears act against at least two surfaces that limit the motion of the leaflet occluder to provide a more stable movement that is less damaging to blood cells.

Abstract: A mechanical heart valve assembly includes an orifice coupled with a stiffening ring and sewing cuff by a lock wire. The lock wire is made from a super-elastic material, e.g., a nickel-titanium alloy, and pre-formed into a C-shape. The lock wire is inserted between the orifice and stiffening ring by piercing the sewing cuff that surrounds the ring, and passing the lock wire into a window in the stiffening ring and into the aligned lock wire grooves on the stiffening ring and orifice. Once seated in the lock wire grooves, the lock wire retains its C-shape, providing a secure coupling between the orifice and stiffening ring.

Abstract: A packaging container for a heart valve includes a container having a first inner barrier member and a second inner barrier member. A support shelf is mounted in the first inner barrier member of the container. A heart valve has a first side and a second side, first side being engaged with the support shelf. An insert member is engaged with the second side of the heart valve and is engaged with the second inner barrier member the packaging container is mounted within an outer barrier container.

Abstract: A method whereby one or more occluders are inserted in the housing of a prosthetic heart valve by compressing the housing of the prosthetic heart valve at four discrete locations, thereby causing the housing to deform sufficiently for insertion of occluders between diametrically opposed pivot supports on the inner surface of the housing. The appropriate locations for application of the compressive forces are identified. Compression force is then applied using either pin blocks or v-shaped blocks. One or more occluders are inserted in the pivot supports. The compressive forces are released, allowing the housing to return to its unstressed generally annular shape and securing the occluders in the housing.

Abstract: A pusher-rotator for installing a heart valve prosthesis including a handle and a flexible shaft extending from the handle. A valve holder is attached to a terminal end of the shaft. A bendable member is formed of a material which is bendable to hold a fixed shape. The bendable member includes multiple contact points for supporting the flexible shaft at spaced apart support points and maintaining the flexible shaft rotatable in a flexed orientation.

Abstract: A heart valve prosthesis includes a valve housing having an opening formed therein having an inmost arcuate surface and a leaflet pivotally mounted in the opening for movement between an open position and a closed position with the inmost arcuate surface. The leaflet has an outmost edge providing multiple points of contact with the housing. The leaflet also forms a leakage gap adjacent the leaflet major radius and between the inmost and outmost surfaces such that the multiple points of contact are displaced from the leaflet major radius and are adjacent to and on opposite sides of the leakage gap. One or several such leaflets may be provided in the housing. Each leaflet respectively includes the leakage gap and the adjacent multiple points of contact.

Abstract: An improved mechanical heart valve that reduces the time required to perform heart valve replacement surgery is provided. The mechanical heart valve is comprised of a valve body and a plurality of staples extending around the valve body that are coupled to the valve body through at least one intermediate member.