Abstract: A heart valve prosthesis includes a molded body and a plurality of leaflets. Each leaflet includes a free margin having opposite ends and a mid-point. The opposite ends are attached to a peripheral portion of the valve. Each free margin is adjacent each other free margin to form a natural-state non-uniform gap therebetween. The gap has a maximized width adjacent the mid-point of each leaflet. Each free margin is scalloped to form a peak at the opposite ends and a mid-point peak between the opposite ends. Each peak is substantially the same height above the base.

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: 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 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 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 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 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: 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: An apparatus and method of proof testing a planar, brittle materials such as those used for valve leaflets in the manufacture of mechanical heart valve prostheses, in which the material to be tested is placed between two interfitting, spherically-shaped shoes, one convex and one concave, and the shoes are compressed together, causing a biaxial stress force to be applied across the surface of the material. The use of a biaxial force created by the spherical shoe surfaces simplifies the testing procedure over the prior art, allowing a single application of force to test the material for flexure in any direction. The magnitude of the stress which is applied to the material is determined by the radii of the interfitting test shoes relative to the thickness of the material sample being tested. Sufficient force is applied to conform the material to the shoes such that any flaws of a predetermined minimum critical size will be revealed by acoustical monitoring during the test or visual inspection thereafter.

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.

Abstract: A composite graft for a fluid-carrying vessel in a living body, comprising: an inner vessel comprising a biologic collagenic material that has been stabilized, an outer member surrounding at least a segment of the inner vessel and defining an annulus between the inner vessel and the sleeve, the outer member comprising a polymeric fabric, and a bioactive compound in said annulus, said bioactive compound being carried on a time-release vehicle. The bioactive compound is preferably an occlusion-preventing agent. Alternatively, the sleeve includes the bioactive compound, either on its inner surface or integrally as part of its fibers.

Abstract: A method for cross-linking biological tissue is provided which uses as a cross-linking agent a low molecular weight, substantially monomeric polyfunctional aldehyde formed in situ or just prior to cross-linking. The polyfunctional aldehyde is essentially free of the undesirable heterogeneous polymeric species that result from polyfunctional aldehyde self-reactivity. Also provided is biological tissue that is cross-linked with a substantially monomeric glutaraldehyde.

Abstract: A flexible leaflet heart valve includes a base, a peripheral portion and a plurality of leaflets. Each leaflet includes a scalloped free margin having opposite ends and a mid-portion between the opposite ends. The opposite ends are attached to the peripheral portion of the valve at a first height above the base. The mid-portion of each free margin is positioned at a second height above the base, less than the first height. Each free margin is adjacent each other free margin to form a gap therebetween. Each leaflet is of a first thickness and at least a portion of each free margin is of a second thickness, greater than the first thickness. This may include extending the second thickness along the entire free margin between the opposite ends or extending the second thickness only along the mid-portion of the free margin.

Abstract: Collagen-containing tissue is cross-linked to provide tissue suitable for use in production of bioprosthetic devices. A cross-linking agent is used having an aliphatic component containing about 8 to 40 carbon atoms and two collagen-reactive groups such as isocyanate, epoxy or n-hydroxysuccinimide. The cross-linking agent may be produced by dimerizing fatty acids, and modifying carboxylic acid group of the fatty acids before or after dimerization to contain collagen-reactive groups. The cross-linked tissue has desirable mechanical and biocompatibility features and a reduced susceptibility to calcification.

Abstract: An annuloplasty ring is provided for implanting about a mitral valve. The annuloplasty ring includes a first, generally rigid section and a second, generally flexible section. The rigid section is positioned adjacent the posterior portion of a mitral valve annulus and the flexible section is positioned adjacent the anterior portion of the mitral valve annulus.