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 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 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: 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.

Abstract: An instrument for spreading the anterior leaflet of a mitral valve. The surgical instrument is designed to allow a surgeon to grip an instrument with one hand during sizing of the anterior leaflet prior to implantation of an annuloplasty ring in a heart valve. The instrument includes a pair of tines that each have an engagement tip for engaging the chordae tendinae proximate an anterior leaflet of a heart valve. The tines are coupled together by a gripping mechanism that may be easily held in one hand, while an annuloplasty ring sizer is held in the surgeon's other hand.

Abstract: The disclosed invention relates to the process of fixating tissue to obtain tissue for bioprosthetic applications. The fixating process comprises exposing the tissue to a fluid comprising activated difunctional or polyfunctional acids that can react with amino groups in tissue under mild conditions. Activating moieties include disuccinimidyl moieties, n-hydroxy disuccinimidyl moieties, sulfo-disuccinimidyl moieties, and mixtures thereof. The acid is preferably aliphatic difunctional or polyfunctional acids, more preferably a naturally occurring aliphatic difunctional or polyfunctional acids. Even more preferred is an acid consisting of glutaric, suberic acid, sebacic acid, tartaric acid, or mixtures thereof. The activated difunctional or polyfunctional acids are esters comprising the difunctional or polyfunctional acids and the activating moieties.

Abstract: A device and method are disclosed for reinforcing an anastomotic site (24). The device (14) includes a body (16) and a cuff (18). The body (16) is formed to receive a vascular graft (10). The cuff (18) is coupled to the body (16) and is formed to couple to a target vessel (22) proximate the anastomotic site (24) and to engage the anastomotic site (24). According to one aspect, the cuff (18) is impregnated with medication (30) to be delivered directly to the anastomotic site (24). According to another aspect, the cuff (18) has an adhesive surface (34) for affixation to the target vessel (22).

Abstract: A valve including a living hinge coupling a leaflet to a valve body. The leaflet can be coupled through the living hinge to the valve body's inner diameter, its outer diameter, or somewhere between the two diameters. Because the living hinge design of the valve is an integrated part, it can be manufactured in a single step.

Abstract: An implantable attaching device includes an annular ring having an axial passageway and a plurality of channels extending radially through the ring. Tissue attaching pins are positioned in the channels and extend radially inward into the axial passageway during implantation. The pins are driven into the native annulus tissue after the ring is positioned. Once the pins are driven into the annulus, the axial passageway of the ring is unobstructed and is adapted to receive a heart valve or other implantable device.

Abstract: A support ring for a natural human heart valve includes a first ring portion having opposite terminal ends and a second ring portion having opposite terminal ends. An interconnector extends through and interconnects the first and second ring portions, to maintain the opposite terminal ends of the first ring portion adjacent the opposite terminal ends of the second ring portion, to form a segmented ring having a first and a second interface between the first and second ring portions. The first ring portion is of a greater length than the second ring portion. The ring portions are separable by severing the interconnector at the first and second interfaces, thus producing two variable size ring segments.