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 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: 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: 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.

Abstract: A heart valve prothesis rotator which 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: 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: A heart valve holder and packaging for supporting a bioprosthetic heart valve. The holder is attached to the heart valve, preferably with a single suture, and has a grip for either direct manual manipulation of the heart valve or for the attachment of a removable handle. A clip is provided which attaches to the heart valve holder and suspends the valve holder and the heart valve within a casing or jar. Ethanol or another suitable fluid within the jar protects the heart valve from biologic contamination, while the structure of the heart valve holder and clip protect the heart valve from physical damage. The valve holder, with attached heart valve, and the clip, can be removed from the jar as a single unit, and the clip can be detached from the heart valve holder.

Abstract: An orthopedic prosthetic implant having a pyrolytic carbon or ceramic articulating surface and a metallic sheath or shell interfacing with adjacent bone. The articulating surface and shell are attached to one another with a layer of resilient adhesive, such as polymethylmethacrylate (PMMA) which forms a shock absorbing layer between the pyrolytic carbon or ceramic parts and the metal parts. Also, a circumferential seal enclosing two adjacent articulating surfaces on adjacent implant parts. The invention further includes first and second implant parts having mating articulating surfaces, the first and second implant parts being joined by ligament structures. Ligament structures include bands or spring means connecting the first and second implant parts.

Abstract: An apparatus for proof testing mechanical heart valve prostheses. The apparatus also provides an in vitro test environment simulating in vivo loads, providing a function test. If the heart valve passes the pivot proof test, a function test is performed. The apparatus first directs a pressurized back flow against the tested valve, closing the valve and applying pressure against the leaflet occluders well beyond the maximum functional in vivo load. The heart valve is positioned so that the leaflets assume their "worst-case" position, that is, the heart valve is oriented so that all the necessary play or gap between the leaflet pivots and pivot recesses is subsumed at one location, thus representing the most severe condition that might be experienced with a heart valve in use. The heart valve is loaded by back pressure applied through a working fluid. Pressure transponders detect the pressure on each side of the heart valve, to determine if a valid test has been performed.

Abstract: An integrated heart valve rotator and holder comprising a central rotator which is used, first, to protect and stabilize the leaflets of the heart valve during implantation and, second, to rotate the heart valve into a desired position after the sewing ring has been attached. A heart valve holder mounts on the rotator and is secured to the heart valve suture ring by a thread or suture. After the heart valve is stitched into the proper location in the heart, the attending physician cuts the suture at a single location and withdraws the heart valve holder, rotator and suture as a single component. The heart valve holder, carrying both parts of the severed suture, is removed from the rotator. The rotator can then be returned to the heart valve to adjust the orientation of the annular valve body within the suture ring.

Abstract: A hinged heart valve holder and suturing method whereby the heart valve holder can be secured within a mechanical heart using a single suture. This suture operates both to secure the hinged heart valve holder within the annulus of the heart valve and to prevent the sewing ring from rotating on the annular valve body. Severing the suture at a single point both releases the heart valve holder and the sewing ring, permitting the annular valve body to be rotated within the sewing ring. Simultaneously, the suture remains secured to the heart valve holder and thus will be withdrawn in its entirety from the operation site.

Abstract: The present invention provides an iodine-based solution, and a method of using that solution, which sterilizes tissue implants without denaturing the proteins in the implant and without inducing calcification of the implant in vivo. Preferably, the tissue implants sterilized using the present invention are fixed without using glutaraldehyde. Most preferably, the tissue implants are fixed by photooxidation.