Abstract: A driver tool drives multiple fasteners simultaneously through the outer ring of a heart valve component into the surrounding tissue annulus of a heart. The driver tool includes two stacked satellite gear layers that drive flexible shafts that simultaneously drive the fasteners into tissue surrounding the heart valve component. The flexible shafts from the second drive gear layer can pass through gaps between satellite gears in the first drive gear layer. The number of fasteners is increased while maintaining the mechanical advantage of the tool and the size of the tool, and reducing the concentration of stress in the tissue annulus.

Abstract: Novel adhesive compositions are described that include an epoxyamine and, preferably, a curing agent. The adhesive composition can be used in surgical settings such as implanting bioprostheses and/or in manufacturing of bioprostheses. Biocompatible substrates can be adhered together by an adhesive bond formed by curing of the epoxyamine adhesive composition.

Abstract: Implantable vascular devices and implantable cardiovascular devices suitable for contacting a patient's blood or bodily fluids include a polymer substrate that is at least partly coated with a diamond-like carbon coating. The diamond-like carbon coated polymer substrate can be flexible or rigid. Preferred medical devices include heart valve prostheses with leaflets or orifice rings formed from diamond-like carbon coated polymer materials. Preferred approaches for the deposition of the diamond-like carbon coating are performed at low pressures and include ion beam assisted deposition.

Abstract: An improved device for performing medical procedures, preferably minimally invasive medical procedures, includes a shaft with a proximal and distal end and a bendable tip extending from the distal end of the shaft. In some preferred embodiments, a fastener applicator extends from the bendable tip. In other preferred embodiments, a malleable section is located between the bendable tip and the shaft. The bendable tip can include a plurality of articulating segments. The improved directional device can be used to repair native valves in a patient, especially heart valves.

Abstract: A prosthetic heart valve for replacing a native heart valve is provided and includes a generally circular heart valve body having an inner wall defining a lumen configured to allow blood flow therethrough. Occluders are configured to rotate about opposed occluder ends between an open position and a closed position. The minor radius arcs cooperate with the occluders to allow the occluders to block blood flow through lumen when in a closed position yet provide an increased lumen when the occluders are in an open position.

Abstract: A prosthesis is formed from a biocompatible material having one or more associated cell adhesion stimulating proteins. The biocompatible material can be a ceramic material or a carbon coated material. The cell adhesion stimulating protein can be a structural protein or a polypeptide growth factor, such as vascular endothelial growth factor. Viable cells can be adhered in vivo or in vitro to the biocompatible material with the cell adhesion stimulating protein.

Abstract: Improved tools for visualizing, sizing and/or marking include a prosthesis template with a diameter approximately equal to the diameter of an aortic heart valve prosthesis. In preferred embodiments, the prosthesis template has an annulus end and a sinotubular junction end wherein the diameter at the annulus end is less than the diameter at the sinotubular junction end. The prosthesis template can include a marking element configured to mark tissue at particular positions relative to the prosthesis template. Marking can be performed with a variety of techniques.

Abstract: A prosthetic heart valve having an orifice is configured to allow blood flow through an orifice. A suture cuff extends around an outer circumference of an outer ring. The suture cuff is adapted for attachment to a native tissue annulus of a patient. A weld between the suture cuff and the ring is configured to attach the suture cuff to the ring.

Abstract: A novel approach to mitral or tricuspid valve repair involves the performance of an edge-to-edge fastening/securing of opposing heart valve leaflets through a catheter entering the heart. Thus, a device is introduced including a leaflet fastener applicator through a cardiac catheter or other suitable catheter. The leaflet fastener applicator and cardiac catheter can be formed into a kit. A gripper can be used to hold the heart valve leaflets while they are fastened.

Abstract: An apparatus is disclosed for differentially treating a medical device. One portion of the device is treated with a first fluid and a separate portion is treated with a second fluid. The second fluid generally is substantially different from the first fluid. The first fluid can be contacted with an flow region of the medical device. The apparatus can include a conduit system, where fluid flowing through the conduit system flows through the flow region. Sheet material can be treated differentially on the opposite surfaces of the sheet. The medical device can include vascular tissue.

Abstract: Medical devices include biocomatible materials and a plurality of exogenous storage structures. The exogenous storage structures store a therapeutic agent which acts to inhibit restenosis. In some embodiments, the therapeutic agents are radioactive metal ions. In other embodiments, the medical device has an expandable structure with particles of therapeutic agent on its surface. The particles of therapeutic agent are delivered into a region susceptible to restenosis by direct application of the medical device against the adjacent wall.

Abstract: Crosslinked tissue is contacted with one or more toxicity reducing solutions to remove cytotoxicity associated with the crosslinking process. In particular, crosslinked tissue can be contacted with an inorganic sulfur-oxygen group to form chemical adducts of aldehydes and the inorganic sulfur-oxygen group. Preferably, the cytotoxicity reduced crosslinked tissue has no residual cytotoxicity. In preferred embodiments, a plurality of toxicity reducing agents are used to detoxify the tissue. Preferred toxicity reducing agents include, for example, inorganic sulfur-oxygen ions, such as bisulfate and thiosulfate, organic sulfates, amines, ammonia/ammonium, and surfactants.

Abstract: Novel adhesive compositions are described that include an epoxyamine and, preferably, a curing agent. The adhesive composition can be used in surgical settings such as implanting bioprostheses and/or in manufacturing of bioprostheses. Biocompatible substrates can be adhered together by an adhesive bond formed by curing of the epoxyamine adhesive composition.

Abstract: A heart valve prosthesis can be formed with a harvested tissue heart valve and a sewing rim that extends outwardly from the annulus of the harvested heart valve for easier attachment of the prosthesis. The heart valve prosthesis can further include a belt that extends along the annulus to provide further support to the valve annulus. A single piece of pericardial tissue can be used to form the sewing rim, belt and a collar that envelopes the edge of the annulus. The harvested heart valve prosthesis can have the diameter of its annulus adjusted using pledgeted suture prior to the application of additional support structures such as the belt, sewing rim and collar.

Abstract: Mechanical heart valve prostheses are disclosed that inherently reduce the probability of thrombus formation by minimizing blood flow disturbance, high shear stress, and stagnation. The pivot configuration includes a recess, preferably in the housing, that has a profile which promotes smooth blood flow.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: Approaches are described for sterilizing medical and biological articles using sterilizing compositions. The sterilizing compositions include epoxy amine compounds and, optionally, alcohol. The epoxy amine compounds act as antimicrobial agents in the sterilizing compositions. In particular, medical articles can be sterilized and/or stored in the compositions described.

Abstract: A prosthesis is formed from a substrate with an associated attraction compound. The attraction compound binds viable precursor cells to the substrate. Thus, the substrate forms a synthetic tissue supporting viable cells once the substrate is contacted with a solution containing viable precursor cells. Preferred precursor cells differentiate into fibroblasts or into endothelial cells.

Abstract: A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess.

Abstract: Medical devices are formed from metal/polymer composites that have improved characteristics. The metal/polymer composites have a relatively thick metal coating with an average metal thickness of greater than about 3 microns. The composite has mechanical properties, such as mechanical strength, durability and resiliency, contributed by the metal coating. The metal/polymer composites can be formed by solution based or vapor based approaches.