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: 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.

Abstract: A heart valve prosthesis rotator having a flexible drive for flexibly turning a heart valve. One embodiment has a shaft constructed from elastically deformable metal alloy such as super elastic nickel-titanium alloy. Another embodiment has a shaft constructed of surgical tubing. Yet another embodiment also has an annealed stainless steel shaft which can be bent by the surgeon interoperatively. The shaft will retain its shape after bending. Surrounding the shaft is a drive coil which connects a rotator head at a proximal end of the shaft to a drive knob at a distal end of the shaft and adjacent a handle. By turning the drive knob, a surgeon can turn the rotator head, thus orienting the prosthetic heart valve. Torsional motion is carried along the path defined by the bendable shaft so that the rotator head can be turned without displacing the handle of the heart valve rotator.

Abstract: This invention relates to tanning biomaterial to obtain calcification resistant biomaterial with good mechanical properties for bioprosthetic applications. The biomaterial of the invention is obtained by tanning tissue by any method except by oxidation, and then at a later time tanning the tissue by any of the oxidative fixation methods. The process was shown to provide beneficial results with the most frequently used fixation process, which involves fixating tissue with glutaraldehyde. Tissue fixated with glutaraldehyde and then by oxidative fixation has a lower calcification potential than does glutaraldehyde-only tanned tissue and has mechanical properties more similar to glutaraldehyde tanned tissue than to oxidative stabilized tissue. In particular, a process is described where tissue is fixed with glutaraldehyde followed by photoxidation.

Abstract: A prosthetic heart valve holder includes a valve holder selectively attachable with a handle assembly. The handle assembly includes a handle end, a flexible, medial segment, and a coupling member. The valve holder includes a valve coupling member and a handle receiving member. The valve coupling member may include a leaflet bias member, leaflet guards, or both. The handle receiving member includes locking tabs and receiving windows for receiving the handle coupling member. The handle receiving member also includes anti-rotation stays which serve to transfer rotational forces from the handle assembly to the valve holder. Also, alignment stays serve to properly align the handle receiving member with the coupling member so that the handle assembly and valve holder are properly coupled. The handle assembly is made from resterilizable materials so that the handle assembly may be reused. The valve holder is disposable.

Abstract: An apparatus and method are disclosed for cutting a heart valve annulus. The apparatus includes an actuator and a backup plate coupled to the actuator. The apparatus also includes an annulus cutter movably coupled to the actuator. The annulus cutter can thereby oppose and engage the backup plate. The method includes positioning a backup plate proximate heart valve tissue to be removed. An annulus cutter is then positioned proximate the heart valve tissue opposing the backup plate. The annulus cutter is engaged in opposition with the backup plate to cut the heart valve tissue and form a heart valve annulus. The heart valve tissue is then removed.

Abstract: A method and apparatus for treating and preventing arteriosclerosis includes a magnet located inside the human body adjacent an artery. The magnet generates magnetic flux through the artery. At least a portion of the magnetic flux has a component perpendicular to the direction of blood flow through the artery.

Abstract: A system and method are disclosed for implanting a medical device (12) into a body. The medical device (12) has an expanded state and a collapsed state and is inserted into the body while in the collapsed state. The medical device (12) is positioned proximate a desired implant site (14) in the body, and the medical device (12) is expanded to the expanded state by filling the medical device (12) with a hardenable fluid (18). The hardenable fluid (18) is then hardened such that the medical device (12) is set in the expanded state at the desired implant site (14).