Abstract: A holder for a prosthetic heart valve is disclosed. The holder, comprising a holder assembly disposed at the distal end of an elongate handle, includes a plurality of distally-projecting fingers adapted to engage the commissure posts of a stented prosthetic valve. The commissure-engaging fingers are movable in a radially-inward direction toward the longitudinal axis of the holder. A mechanism is provided for retaining the fingers in an inwardly-moved position. When the commissure posts of the valve are coupled to the fingers, inward movement of the fingers causes the commissure posts to be deflected inward with respect to the valve, improving the implanting surgeon's access to the valve's suture ring and surrounding tissue.

Abstract: A stent for receiving and supporting a tissue heart valve for ultimate implantation into a human, the heart valve including tissue leaflets joined at circumferentially spaced commissures, wherein the stent includes at least one commissure support post and at least one sinus support structure each sinus support structure being disposed between but not functionally connected to an adjacent commissure support post.

Abstract: A fully flexible annuloplasty ring is temporarily stiffened during implantation by inserting a withdrawable stiffening wire into a lumen of the ring. The annuloplasty ring has a lumen which is able to hold the stiffener prior to and during insertion. The stiffener includes a portion extending out of the lumen which can be pulled to withdraw the stiffener once the implant has been implanted.

Abstract: A holder for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the holder to the heart valve prosthesis. The heart valve prosthesis includes a circular valve body having an annulus with a substantially annular aperture therein. At least one movable occluder is carried in the aperture and is movable between an open position and a closed position. The attachment mechanism attaches to the occluder thereby securing the holder to the heart valve prosthesis.

Abstract: This invention comprises a method of using tubular material to replace a heart valve during cardiac surgery. To create a replacement atrioventricular (mitral or tricuspid) valve, the tube inlet is sutured to a valve annulus from which the native leaflets have been removed, and the tube outlet is sutured to papillary muscles in the ventricle. To create a semilunar (aortic or pulmonary) valve, the tube inlet is sutured to an annulus from which the native cusps have been removed, and the tube is either "tacked" at three points distally inside the artery, or sutured longitudinally along three lines; this allows the flaps of tissue between the three fixation points at the valve outlet to function as movable cusps. These approaches generate flow patterns that closely duplicate the flow patterns of native valves.

Abstract: A surgical implement particularly useful for implanting a prosthetic valve in an excised annulus includes a manually grippable handle, and a suture retainer carried by the handle and having an outer face carrying a coiled spring whose coils define an annular array of slits each having opposed yielding surfaces for receiving and releasably retaining sutures between selected coils. Optimum spacing of the sutures according to the shape of the excised annulus is attained by providing reference ribs between selected coils of the spring, and also by making the outer annular face of the suture retainer of substantially the same shape as that of the excised annulus. Embodiments are also described including an illuminating device for artificially illuminating the working area. Also described is a method of implanting a prosthetic valve in a quick and efficient manner using such an implement.

Abstract: In annuloplastic surgery, the holder which supports the annuloplasty ring during the suturing of the ring to a heart valve annulus is released from its handle, and reattached for subsequent removal, without rotary or axially compressive stress on the holder. This is accomplished by inserting laterally movable locking tabs from the handle into the holder. The locking tabs are the ends of a Y-shaped clip which translates the axial movement of a locking button on the handle into a transverse holder-engaging movement.

Abstract: The valve consists of a ring (1) enclosing hinged curved wings (2), the ring having diametrically opposite fixtures (1b-1c) designed to offset the means of hinging the wings so that in their maximum opened position of at least 85.degree., the latter only project beyond the plane of the ring by a small amount thus delimiting, in conjunction with the shape of the wings, three equivalent areas allowing a laminar, axial central flow, the means of hinging the said wings being integrated in the thickness of the ring so that the ends of the wings, at the level of fixtures (1b-1c), are spread apart thus delimiting a space which is completely unobstructed in order not to limit or interfere with the central flow. The ring (1) has an internal peripheral fixture (1a) suitable to provide a support surface corresponding to the external shaped edge (2b) of wings (2) in the closed position of the latter, thus creating a damping effect.

Abstract: A method for constructing stents for autologous tissue heart valves is provided. The method includes creating a stent profile primitive which is rotated about a first axis to create a solid stent blank having inner and outer surfaces. First and second splines are created and intersected with the inner and outer surfaces, respectively, to form a plurality of planes. Posts are formed on the stent blank by removal of material above the planes, and filleting is performed to provide a smooth upper surface for each post. Additional features corresponding to whether the stent is an inner or an outer stent for the heart valve are added, and the final stent shape is input into machine tooling which cuts an electrode into the corresponding stent shape. The electrode is then used to dissolve a pattern into a block of metal, such as a nickel-steel alloy, to form the final mold of the stent.

Abstract: A prosthetic ring includes a core enclosed in a textile sheath, the sheath being sutured to the heart or the aorta of a patient. The core includes at least one relatively rigid portion and one portion that is relatively flexible compared to the rigid portion. The cross-sectional diameter of the core varies along the circumference of the ring, decreasing from a maximum at the rigid portion to a minimum at the flexible portion, giving the ring sufficient flexibility to accommodate heart wall movement.

Abstract: A device for engaging a heart valve prosthesis during implantation includes a handle and a low profile holder. The handle has a proximal end and a distal end. The distal end is attached to the low profile holder which includes a distal engaging surface adapted for engaging the heart valve prosthesis. The distal engaging surface of the low profile holder maintains a leaflet of the heart valve in a closed position during implantation. This provides a low profile to the heart valve and holder which facilitates insertion through a trocar in a patient.

Abstract: A multi-leaflet (usually trileaflet) heart valve composed of biocompatible polymer which, in all of its embodiments, simultaneously imitates the structure and dynamics of biological heart valves and avoids promotion of calcification. The valve includes a plurality of flexible leaflets dip cast on a mandrel, which leaflets are then bonded with a bonding agent to the interior surfaces of a plurality of struts on a metal-reinforced prosthetic stent. The leaflets open and close in response to the pumping action of the heart and, due to the design of the leaflets, fatigue resistance of the heart valve is high. The leaflets and the polymer components of the prosthetic stent are manufactured of biocompatible polymers exhibiting intrinsic calcification-resistant properties.

Abstract: An inflatable prosthetic cardiovascular valve which is constructed so as to be initially deployable in a deflated "collapsed" configuration wherein the valve may be passed through the lumen of a cardiovascular catheter and subsequently inflated to an "operative" configuration so as to perform its intended valving function at its intended site of implantation within the cardiovascular system. The inflated valve may be held in place by mechanical means (e.g., hooks, projections), by chemical adhesive or through biological assimilation by the heart tissue.

Abstract: A bioprosthetic valve comprising a support ring having three spaced apart end stops projecting upwardly therefrom, a stent post ring having three spaced apart stent posts pivotally connected thereto and adapted to engage respective ones of the end stops so as to permit outward pivoting of the stent posts and to prevent inward pivoting thereof, a leaflet valve having three generally triangular leaflets defining respective cusps, the leaflets being joined at respective commissures, and a sewing ring for attaching the leaflet valve to the stent post ring and support ring.

Abstract: A frame to be placed as an external support of a biological valved conduit containing three leaflets. This external frame, made of biocompatible metal or plastic is sutured to the outer surface of the valved conduit made of biological or biocompatible membrane or sigmoid valve root in order to maintain its natural geometry. The frame has a general cylindrical configuration, circular as viewed from above and below. From a side view however, both upper and lower ends of the cylinder present three convex curvatures joined at equidistant points of the circumference. These upper and lower curves are joined by three vertical struts, so that three large saddle shaped paraboloid gaps result. The frame is a wire-like structure that follows perfectly the anatomical shape of the three sinuses of Valsalva, i.e. it corresponds to the external aspect of the line of implantation of the three sigmoid cusps below and the curved line of the sino-tubular junction above.

Abstract: This invention provides a method of altering the water content of a hydrogel comprising treatment of said hydrogel with a liquid dehydrating composition. There is further provided a method of altering the water content of a hydrogel-containing medical device. The medical devices of the present invention comprise a hydrogel having a water level ex vivo lower than the thermodynamic equilibrium water level when in vivo. These medical devices comprise a hydrogel contacted with a liquid dehydrating agent, wherein said medical device has a lower water level ex vivo than the thermodynamic equilibrium water level when the medical device is in vivo.

Abstract: The present invention provides a prosthetic heart valve holder specifically configured to hold a prosthetic heart valve comprised of a stent. The heart valve holder assembly has three main components: a handle, a valve capture loop assembly and a valve retainer. The prosthetic heart valve is secured to the valve retainer by a loop of suture as the surgeon sutures or attaches the valve to the annulus of the heart. Thus, the valve holder assembly facilitates attachment of the prosthetic valve to the annulus so that the procedure may be performed in a time and labor efficient manner.

Abstract: A stentless heart valve assembled from autologous tissue is provided. The tissue is cut into a rectangular shape, folded, and stapled at several locations to form the cusps of the valve. The outer walls of the valve are pinched at the midpoint of each cusp to prevent the cusps from adhering to the valve walls. The ends of the rectangle are then stapled to form the annular valve itself.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. The valve comprises at least one piece of tissue clamped between an inner and an outer stent. The outer stent is configured with a plurality of spaced posts extending from a base, wherein the posts are configured with open windows so that at least a portion of the tissue in the assembled valve is exposed through the windows. Several embodiments of the outer stent are disclosed, including where the outer stent comprises a crimped metal wire frame covered with a Dacron tube.

Abstract: The present invention provides a heart valve measurement tool in the form of an obturator. The obturator is specifically configured to measure the size of the annulus of the heart to be fitted with a prosthetic heart valve. A plurality of obturators of varying sizes are utilized to determine the appropriate valve size.

Abstract: The invention relates to a bioprosthetic heart valve having leaflets affixed to a substantially absorpable stent. The leaflets can be derived from a biological membrane which is affixed to the absorbable stent. The leaflets can also be derived from a sigmoid valve of human or animal origin, the sigmoid valve being placed inside the absorbable stent and affixed thereto. Methods of treatment using the bioprosthetic heart valve and methods of making the valve are also provided.

Abstract: A holder for a prosthetic heart valve is disclosed. The holder, comprising a holder assembly disposed at the distal end of an elongate handle, includes a plurality of distally-projecting fingers adapted to engage the commissure posts of a stented prosthetic valve. The commissure-engaging fingers are movable in a radially-inward direction toward the longitudinal axis of the holder. A mechanism is provided for retaining the fingers in an inwardly-moved position. When the commissure posts of the valve are coupled to the fingers, inward movement of the fingers causes the commissure posts to be deflected inward with respect to the valve, improving the implanting surgeon's access to the valve's suture ring and surrounding tissue.

Abstract: A heart valve prothesis is formed from a support having a textile covering. The support is formed from a single piece of flat, preferably thermoplastic material, arranged to form an annular structure, which preferably is either a hollow cylinder or a hollow cone.

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: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) are secured to the projecting apices (4).The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion.The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Abstract: A prosthetic valve comprises a poppet, a seat and a restraining element. The poppet, seat and restraining element include an insertion form for percutaneously inserting into a fluid passageway within a living body and an operational form for operating within the fluid passageway. The valve is self-expanding so that upon insertion the valve automatically assumes the operational form. In the operational form the poppet is movably restrained between the valve seat and restraining element. The poppet seals against the valve seat to prevent fluid flow through the valve and unseats from the valve seat to permit fluid flow through the valve.

Abstract: A prosthetic mechanical heart valve with an annular valve body and with a suture ring and stiffening ring combination wherein the stiffening ring is compressible before contacting a wall of the valve body. The inside diameter of the stiffening ring is consistently greater than the outside diameter of the annular valve body, forming a gap. This inhibits compressive forces from being transmitted to the annular valve body. The heart valve also has beveled stops or recesses for controlling the opening angle of leaflets mounted in the valve body. Because of the gap between the valve body and the stiffening ring, the body can deform in a spring-like manner, providing a spring-closing action.

Abstract: A method of producing flexible closing members, especially artificial heart valves, and a flexible closing member, especially an artificial heart valve, which can be produced according to such a method. According to the method of producing the housing of the closing member is radially expanded, the closing element of the closing member is formed as substantially plane two-dimensional element, and the plane two-dimensional element is connected to the housing in the expanded condition of the same. This method is preferably realized as dip method according to which the closing element is shaped and formed to the housing in a single working step. The described flexible closing member is an artificial three-sail heart valve which is characterized by a special shape of the three closing elements.

Abstract: A sigmoid heart valve annuloplasty prosthetic ring is disclosed which has a biocompatible stent molded into a scalloped shape, having three sinusoidal struts, to adapt to the anatomical shape of the annulus of the human sigmoid valves. The prosthetic ring is covered with biocompatible cloth. The prosthetic ring can be incorporated into the extremity of a biocompatible tubular cloth which serves as a vascular prosthesis in order to permit the total replacement of the ascending aorta or pulmonary artery without replacing the sigmoid valve.

Abstract: A prosthetic device which includes a turbostratic biocompatible carbon film firmly adherent to a substrate and having a density of at least 2.1 g/cm.sup.3. The carbon preferably is very thin, e.g. , less than about one micron. The thin carbon biocompatible film covers at least that portion of the substrate which will be in contact with body tissue and/or fluids to insure against physiological rejection and degradation of the prosthetic device. The carbon can be deposited on a variety of substrates, including low temperature substrates, in situ, without adversely affecting the mechanical properties of the substrate. The prosthetic device of the invention is formed by triode sputtering vacuum deposition at a relatively low temperature to achieve the desired results with respect to the deposited carbon and the substrate and with respect to the required adherence therebetween.

Abstract: The occluder supporter of the present invention is installed to the valve of a mammalian heart and is a device for preventing valve reflux. The characterizing feature of the present invention is the provision of a plurality of stitched attachments which are sewn on to the edge of the occluder and of a support which supports and maintains the edges of the occluder in a mutually close position and which is provided between the stitched attachments in such a way as to transect the valve aperture.

Abstract: Metallic surfaces of medical devices or components of medical devices are provided that have enhanced biocompatibility properties. The surfaces are prepared by a two-step procedure including covalently linking an organosilane having amine reactive sites with the surface of the metallic member, typically through a metal oxide thereof. Thereafter, a biologically active agent is covalently linked to the organosilane coating. The two-step process is particularly advantageous for preparing medical devices in the form of stents which need to be bent and flexed during implantation procedures.

Abstract: An assembly for holding a substantially flexible annuloplasty ring in a substantially taunt position for suturing about a valve annulus. The assembly includes a portion which is formed with a surface against which the annuloplasty ring is positioned and held in a shape substantially equivalent to at least a portion of the valve annulus. The assembly further includes a mechanism for releasably binding the annuloplasty ring to this surface.

Abstract: A cardiac valve comprises a plurality of flexible trapezoidal membranes, each having an edge joined to an edge of another of the membranes to form an unsupported frusto-conical body. The body has an oval end portion and a plurality of flexible flap portions integral with and extending from the end portions, the flap portions being formed by substantially parabolic scallops. The membranes are so sized, and the scallops are so positioned as to form flap portions of unequal size. The flexible membranes may be provided to the surgeon as separate membranes for construction of the artificial valve, or the valve may be provided to the surgeon as a complete unit. Alternatively, the surgeon may construct a valve using pericardium mapped and sized in accordance with the present invention.

Abstract: A stentless aortic heart valve having a disposable holder with a removable handle can be manually reversed by the physician during suturing to provide a relatively unobstructed view into the patient's aorta. A covering applied to strategic regions on the exterior and interior of the device provides a firm ground for suturing the prosthetic heart valve into position, and for attaching the detachable holder.

Abstract: A cardiac valve implanted within the heart is given where a expansible valve maintained in a collapsed form by cold temperature is percutaneously inserted along a releasable guide wire in a cooled sheath and when positioned is expanded by withdrawing the cold temperature.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: Adjustable, flexible suture 2ings, mitral and tricuspid annuloplasty 2ings having internal drawstrings that emerge from the 2ings on the annular faces so that the drawstring knots are out of the bloodstream, the drawstrings being contained in clearly marked channels, the mitral 2ing having a curved semi-flexible stiffener member in the anteri/r segment to maintain intertrigonal distance during implantati/n are disclosed.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: A thermal packaging unit for a biocompatible implant. The thermal packaging unit includes a first compartment for storing the biocompatible implant. In addition, the thermal packaging unit further includes a second compartment which is operable to contain a chemical composition which is able to heat the biocompatible implant by means of an exothermic reaction.

Abstract: The invention provides synthetic metallic heart valves fabricated of zirconium or zirconium alloys that are coated with blue-black zirconium oxide or zirconium nitride to provide a surface that is hard, biocompatible, resistant to impact, cavitation, and microfretting wear and exhibits improved hemocompatibility.

Abstract: A sigmoid heart valve annuloplasty prosthetic ring is disclosed which has a biocompatible stent molded into a scalloped shape, having three sinusoidal struts, to adapt to the anatomical shape of the annulus of the human sigmoid valves. The prosthetic ring is covered with biocompatible cloth. The prosthetic ring can be incorporated into the extremity of a biocompatible tubular cloth which serves as a vascular prosthesis in order to permit the total replacement of the ascending aorta or pulmonary artery without replacing the sigmoid valve.

Abstract: A stentless aortic heart valve having a disposable holder with a removable handle can be manually reversed by the physician during suturing to provide a relatively unobstructed view into the patient's aorta. A covering applied to strategic regions on the exterior and interior of the device provides a firm ground for suturing the prosthetic heart valve into position, and for attaching the detachable holder.

Abstract: In a suture ring for heart valve prostheses, the internal surface of the ring which is intended to be exposed to the blood flow is covered by a substantially water-repellent material so that it absorbs substantially no blood and has little haemolytic effect. The outer surface of the ring which is intended to be exposed to the tissue to which the prosthesis is sutured is covered by a substantially hydrophilic, porous material so as to encourage the colonization of the ring by the tissue.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: A stent for a heart valve. The valve has a flap valve of biological material. The stent has a generally toroidal body formed of a flexible coil of wire. A plurality of posts extend upwardly from the body to mount the flap valves. The stent in combination with a percutaneous balloon dilatable catheter is also described. The catheter is positioned intraluminal of the valve and dilation of the balloon exerts stress to overcome the elastic limit of the stent to increase stent circumference.

Abstract: A bioprosthetic heart valve comprising leaflets with free edges which do not impinge on adjacent leaflets when the leaflets are closed before being implanted and subject to body fluids and cardiac pressure cycles. Commissures supporting the leaflets have semi-permeable membranes which reduce the pressure load on the leaflets during implantation. In response to immersion in body fluids, the membranes become substantially impermeable. The leaflets can stretch in response to loads and hydration, so that the free edges mate shortly after implantation. First and second mechanisms for supporting leaflets to provide multiple effective spring constants. An inner frame supporting commissures of the valve is elastic, permitting the commissures to bend in toward the center of the prosthetic heart valve at very low loads. A relatively rigid annular support ring supports the elastic frame and provides the second spring constant mechanism.

Abstract: A method of producing flexible closing members, especially artificial heart valves, and a flexible closing member, especially an artificial heart valve, which can be produced according to such a method. According to the method of producing the housing of the closing member is radially expanded, the closing element of the closing member is formed as substantially plane two-dimensional element, and the plane two-dimensional element is connected to the housing in the expanded condition of the same. This method is preferably realized as dip method according to which the closing element is shaped and formed to the housing in a single working step. The described flexible closing member is an artificial three-sail heart valve which is characterized by a special shape of the three closing elements.

Abstract: Method and apparatus for placing therapeutic devices such as embolic coils includes a probe assembly carried within a catheter. The probe assembly includes a fiber-optic cable with a connector retained thereon by crimping. The connector has a cable-receiving end resembling a ferrule, which is crimped about the cable. The other end of the connector provides mounting of a therapeutic device, such as an embolic coil. Heat releasable adhesive bonds the therapeutic device to the mounting portion of the connector. Laser energy transmitted through the fiber-optic cable is converted to heat by the connector, which thereupon becomes heated, releasing the adhesive bond between the connector and the therapeutic device. The probe assembly can then be withdrawn from the treatment site.