Abstract: A heart valve comprises a stent and a sewing cuff comprising a stiffening ring, wherein the stent and the stiffening ring are adapted to be snap-fitted. In one embodiment, the stent and the stiffening ring can together comprise one or more projections and one or more openings.

Abstract: Pannus-resisting implantable medical devices comprise one or more antimicrobial reservoirs, each such reservoir incorporating antimicrobial substances in predetermined distributions for timed release in vivo. Predetermined distributions of antimicrobial substances incorporated in antimicrobial reservoirs are achieved through use of fluid solvent carriers, which may comprise supercritical fluid solvents. Precipitation of antimicrobial substances from such solvent carriers in predetermined distributions is accomplished through evaporation and/or application of heating, cooling or decreased ambient pressure to the solvent carriers.

Abstract: A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Abstract: The present invention is generally directed to a method of controlling a pyrolytic carbon deposition coating process performed in a fluidized bed. In one illustrative embodiment, the method comprises positioning a product to be coated in the fluidized bed, determining a coating rate of carbon material formed on the product in the fluidized bed, and determining a desired duration of the coating process by dividing a desired coating thickness for the product by the determined coating rate.

Abstract: Biocompatible prostheses, specifically, biocompatible heart valves, are described having incorporated therein an effective amount of coating applied thereto to render the valve resistant to in vivo pathologic thrombus formation and in vivo pathologic mineralization. Preferably, the coating is derived from a precursor having the formula: X—Y—Z wherein X is a chemically reactive group capable, upon activation, of bonding to the surface of the heart valve; Y is either null or a relatively inert skeletal moiety resistant to cleavage in aqueous physiological fluids; and Z is a functionally active moiety or a biocompatible agent.

Abstract: A prosthetic heart valve having an elastomeric stent with an annular base and a plurality of apertures or holes circumferentially spaced around the base for receiving a suture. Flexible polymeric leaflets are molded over the stent. Polymeric material surrounds the apertures, leaving a central opening in each aperture. The base may be a frustro-conical ring. A sewing ring is mounted on the heart valve by suturing the ring through the apertures. Apertures or holes may also be provided by extending an area covered by woven material around all or part of the circumference of the base.

Abstract: The present invention provides a prosthetic valve and a sewing cuff assembly for attaching the prosthetic valve in a patient's heart. The suture cuff generally includes at least one lock ring and sewing cuff material disposed at least partially around the lock ring. The valve body includes a peripheral groove for receiving the lock ring therein and securing the lock ring thereto. A stiffening ring may be coupled to the peripheral groove or otherwise provided on the valve body.

Abstract: The invention, in a first aspect, is an apparatus for holding a flexible annuloplasty ring during implantation. The apparatus has a top piece including a bottom surface sized to engage substantially all of the inner diameter of the annuloplasty ring and finished to grip the annuloplasty ring; a bottom piece including a top surface sized to engage substantially all of the inner diameter of the annuloplasty ring and finished to grip the annuloplasty ring; and a haft capable of engaging the top and bottom pieces to clamp the annuloplasty ring therebetween. In a second aspect, the invention is a method of manipulating a flexible annuloplasty ring for implantation. The method involves disposing the annuloplasty ring between a top piece and a bottom piece; and engaging the top piece and the bottom piece with a haft to clamp the annuloplasty ring between the top and bottom pieces.

Abstract: A heart valve is disclosed which includes a valve body and a plurality of flexible leaflets coupled to the valve body. The plurality of leaflets can have an open position and a closed position. Each of the plurality of leaflets can comprise a belly when the plurality of leaflets are in their respective closed positions. The belly of one or more of the plurality of leaflets preferably has a continuous curvature except for two or more features.

Abstract: A heart valve prosthesis includes an annular body that has a fluid passageway and at least one rigid leaflet that is pivotally mounted in the passageway of the body. The leaflet is movable between a closed position wherein the fluid passageway is substantially closed and an open position wherein the fluid passageway is not substantially closed. The heart valve prosthesis has a biasing mechanism that is connected to the body and leaflet and is configured to exert a force on the leaflet to move the leaflet to the closed position before a second fluid pressure exerted on an outflow surface of the leaflet exceeds a first fluid pressure exerted on an inflow surface of the leaflet.

Abstract: A stent includes a stent member having a plurality of post members formed therein. Each post member is connected to an adjacent post member by an interconnecting portion. A plurality of leg members extend from the stent member. The stent may be molded within a flexible polymer valve. The legs stabilize and locate the stent in the mold. Upon completion of the molding process, the legs can be separated from the stent.

Abstract: A tri-leaflet prosthetic cardiac valve with leaflets having an analytic shape in a selected position. The leaflets are connected to a valve body at attachment curves. The shape of the leaflet is selected from a set of geometries that can be represented mathematically. The attachment curve is selected to improve the durability of the tri-leaflet valve by moving the point of maximum loaded stress along the attachment curve away from the commissures. An inner wall of the valve body is given a non-circular shape near the attachment curve, the shape of the inner wall corresponding to the attachment curve. Also, a method of making a valve by selecting an analytic leaflet shape, selecting an attachment curve to improve durability of the valve by moving the point of maximum loaded stress along the attachment curve away from the commissures, and forming a valve body to support one or more leaflets, the valve body having a non-circular inner wall conforming to the attachment curve.

Abstract: Biocompatible prostheses, specifically, biocompatible heart valves, are described which comprise a blend of a polyurethane (PU) and a polysiliconeurethane (PSU). Preferably, the polyurethane is a polyetherurethane (PEU). More preferably, it is a polyetherurethane urea (PEUU). Such prostheses typically exhibit reduced mineralization or thrombosis and/or reduced biological degradation.

Abstract: Herein is disclosed a method of cross-linking a tissue, comprising treating the tissue under effective cross-linking conditions with a diunsaturated organic compound comprising structure I: wherein R, R′, and R″ are each independently an organic moiety having from 1 to 20 carbon atoms. Also disclosed is a cross-linked biological tissue produced by treating the tissue according to the above method.

Abstract: A packaging for an implantable medical device such as a heart valve wherein the implantable medical device is immersed in a liquid medium. The packaging comprises a jar and a lid assembly having a seal and a ridge therebetween, the ridge being adapted to contact the seal. At least one circumferential leg is interposed between the lid assembly and the jar. The leg maintains a predetermined spacing between the lid and the jar and may be loaded in compression. The lid assembly may comprise a lid and an overcap. The overcap may turn independently of the lid and may apply compressive pressure to the lid over the ridge and seal. The lid and overcap may be coupled together by, for example, mating snap hooks. At least one of the lid or overcap may have a plurality of snap hooks. At least one of the plurality of snap hooks may be of different length than other of the snap hooks, whereby an asymmetric force may be applied to the lid when the overcap is loosened from the jar.

Abstract: A method is provided for producing antimicrobial, antithrombogenic medical devices. The method employs an antimicrobial treatment process wherein an antimicrobial agent is dissolved in an appropriate solvent and the resulting solution is contacted with a portion of a medical device of interest. The antimicrobial treatment process is advantageously performed without the need for additional compounds to facilitate antimicrobial agent uptake into the device. The method further comprises an antithrombogenic treatment process wherein antithrombogenic agents or materials are applied or otherwise associated with at least some portion of the medical device.

Abstract: A method for treating biomaterial is provided in which a biological tissue, typically after being cross-linked, is contacted with an anticalcification treatment solution under condition effective to render the biomaterial resistant to in vivo calcification upon implantation in a host animal. The anticalcification treatment solutions comprise higher alcohol solutions, a polyol solutions and/or a polar aprotic organic solvent solutions.

Abstract: A stent includes an elongated stent member having a plurality of post members. Each post member includes a pair of opposite sides. A first end of each post member includes an arcuate apex interconnecting the opposite sides. A second end of each post member has an open end. The opposite sides are angled to converge toward each other at the second end. The second end of each post member is connected to an adjacent post member by a stent portion. Each opposite side and each stent portion converge at an angle of less than 90°. The opposite sides are angled to converge toward each other at the second end.

Abstract: A method for manufacturing a prosthetic heart valve. An elastic valve body and at least one leaflet are formed on a mold. The leaflet has a free edge which is formed by the mold without cutting the leaflet at the free edge.

Abstract: A polymer heart valve has a leaflet with a base geometry of a cylinder for simplicity and effective opening. A helical swept surface is added to the top of the cylinder to enhance stable coaption. The heart valve includes a plurality of flexible leaflets. Each leaflet includes a top portion and a bottom portion. The bottom portion is an axial section of a cylinder having an axis and a radius. A first section of the top portion is a surface defined by a first arc having a first radius swept along a first helix. The first arc is tangent to the axial section of the cylinder. A second section of the top portion is a surface defined by a second arc having a second radius swept along a second helix. The second arc is tangent to the axial section of the cylinder. The second helix is a left-handed helix having the same radius and axis as the cylinder.