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).

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: A device for positioning during surgery, a heart valve prosthesis having a general annular configuration with an inside diameter that includes a handle and a introducer/rotator. The handle has a proximal end and a distal end. The introducer/rotator is attached to the distal end of the handle and has a length in operative relates to the inside diameter of the valve prosthesis. The introducer/rotator has a width that is less than the length, which facilitates intercostal insertion through a patient's ribs.

Abstract: A heart valve holder is provided for implanting a prosthetic heart valve in either an inflow (mitral or tricuspid) or an outflow (aortic or pulmonary) implantation. The valve holder may be repeatedly sterilized for multiple implantations. The valve holder includes holding members to securely hold the valve, a valve-sizing member to allow the holder to hold valves of various sizes, an over rotation stop to prevent the holder from impinging upon the valve leaflets, alignment members to align the holding members for receiving a valve, and means to rotate the valve without damaging the valve leaflets.

Abstract: A combined heart valve and vascular graft, or "valve/graft combination", wherein the heart valve has a sewing ring that is substantially impervious to blood flow. In our preferred embodiment, the sewing ring comprises a solid circular silicone insert which supports the sewing ring radially outwardly form the valve and forms a shield to prevent the flow of blood through the sewing ring.

Abstract: A fluidized bed apparatus which produces a pyrolitic carbon coating with improved wear and porosity characteristics of the coating by producing a more uniform flat temperature profile throughout a reaction chamber in the area where coating is taking place. The apparatus has heating coils surrounding a lower end of the reaction chamber placed immediately adjacent one another at tight spacing. This contrasts to previous apparatus wherein heating coils were spaced between 2 cm and 5 cm apart. The apparatus also has a multi-jet nozzle to control a flow of gases through the reaction chamber. The jets in the nozzle comprise passages which are oriented such that the length of the passages lie on a series of cones having common axes.

Abstract: Packaging (10) for a heart valve device (11) is disclosed that includes a container (42) having an inner compartment. The container (42) has an aortic orientation and a mitral orientation and is constructed to be opened in either orientation. The packaging (10) also includes an aortic support member (22, 24, 26), located in the compartment, that supports the heart valve device (28) when the container (42) is opened in the aortic orientation. The heart valve device (11) is supported such that it is prepared for receiving a holding instrument for implantation as an aortic valve. The packaging (10) further includes a mitral support member (20), located in the compartment, that supports the heart valve device (11) when the container (42) is opened in the mitral orientation. The heart valve device (11) is supported such that it is prepared for receiving a holding instrument for implantation as a mitral valve.