Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a “button” or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Abstract: A heart valve with a structural stent and radially moveable cusps and commissures. The stent may be of three separate elements, each having a cusp portion and two commissure portions. The commissures may be pivotally or flexibly coupled, and may separate into independent leaflets. A connecting band may be provided that follows the cusps and commissures and extend outwardly. The valve may be connected to the natural tissue along the undulating connecting band. A multi-legged holder having legs alternating between each cusp and commissure may be used for implantation. A method of implantation is also disclosed, as is a system for implanting independent valve leaflets in the native annulus.

Abstract: A vascular access graft that is radially supported and self-sealing upon puncture with, for example, a dialysis needle. The graft has at least one access segment that is formed by an inner layer, an intermediate layer, and outer layer. The intermediate layer has, in longitudinal cross-section, regions of different densities. Radial support members within the intermediate layer prevent collapse of vascular access graft and may be formed of a material that has a lower melting temperature than the other components of the graft. A porous or low-density material is provided between the radial support members to permit blood seepage therein, and the graft is formed by heating to cause the radial support members to melt slightly into the interstitial spaces of the low-density material. The radial support members may be individual turns of a helical coil of FEP, and the low-density material may be compressed PTFE “cotton”. The inner and outer layers may also be formed of PTFE.

Abstract: A simple and reliable silver recovery system including a series of silver recovery processing containers through which solution flows by gravity to a waste container. The reservoir container holding a silver-rich solution is positioned above the processing containers. The outlet of the reservoir container is positioned above the outlet of the first processing container so that when the first processing container is full, fluid flows from the first processing container to a second processing container. The fluid flow is metered by a pinch clamp provided in the conduit between the reservoir container and the first processing container. Steel wool may be used as the silver recovery medium. An inlet manifold insures unobstructed inlet flow and distributes that flow within the processing container. A polymer filter may be positioned above the steel wool to capture large particulate matter and prevent clogging of the system.

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 graft forming apparatus and method including a plurality of mandrels for receiving tubular grafts thereon and an adjacent cutting instrument for forming regular and repeated patterns of small holes therein and for severing the ends of the graft. The cutting instrument is preferably a low-powered laser to form clean and non-frayed holes and lines in fabric grafts. The mandrel are mounted for rotation about an axis underneath the cutting instrument which is movable along the axis. By computer control, the motion of the cutting instrument and mandrel can be accurately and precisely choreographed. The mandrel may be a straight cylinder for forming straight grafts, or may be a bifurcated mandrel formed of several components. The bifurcated mandrel includes a trunk portion and pair of detachable leg portions. Adapter disks are provided so that the bifurcated mandrel can be rotated either about the axis of the trunk portion, or about the axis of one of the leg portions.

Abstract: A method for improving the radial enlargeability and other properties of tape-reinforced tubular vascular graft formed of sintered fluoropolymer(s), such as expanded, sintered PTFE. Broadly, the method comprises the step of radially shrinking the reinforcement tape layer of the graft, or the entire tape-reinforced graft, after sintering thereof. Such radial shrinkage of the reinforcement tape layer, or of the entire graft, renders the graft subsequently radially enlargeable by more than 5%, without tearing or breaking of the reinforcement tape layer of the graft. Radially enlargeable grafts of the present invention may be combined with various types of stents or anchoring systems, to form endovascular graft devices which are transluminally insertable and implantable within the lumen of a host blood vessel.

Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve.

Abstract: A catheter-based material removal device includes an elongated tube having a distal material removal tip thereon. The material removal tip includes a one- or two-piece housing affixed to the tube, and a rotating member therein. The rotating member includes a screw thread for coarsely chopping material received within the housing and an outwardly projecting flange for finely chopping the material. The housing includes at least one shearing member located axially adjacent the outwardly projecting flange. The shearing member has a relatively small circumferential size and a shearing edge that removes any material buildup on the axially-facing surface of the flange. Two shearing members may be provided, one each on both the proximal and distal sides of the flange. There may be three flanges restrained within a groove formed with the housing.

Abstract: An infra-annular annuloplasty prosthesis is disclosed including a flexibly semi-rigid frame, a portion of which is shaped to conform to the scalloped configuration of the normal circumference of an arterial heart valve annulus. Axially projecting legs spaced circumferentially to correspond to the location of tissue adjacent to the valve commissures are provided for support and anchoring of the annulus-conforming portion to the dense fibrous tissues adjacent each commissure. The prosthesis includes a one-or two-part frame having scalloped upper and lower edges defining peaks and valleys. The upper edge is shaped to follow the contour of the tissue underneath the valve leaflets, and thus supports the leaflets and aortic wall from below. The lower edge is similarly scallop-shaped, but with less pronounced peaks and valleys than the upper edge, and is thus shaped to conform to the aortic annulus shape and provide support directly thereto.

Abstract: A method of surgery including bending a multi-purpose surgical implement handle that has proximal and distal ends. A gripping section is located toward the proximal end, and an attachment section is located toward the distal end. An adjusting section is interposed between the gripping section and the attachment section. The adjusting section may be bent by a human user at virtually any discrete location along the section. The adjusting section may include an increased-adjustability portion which is easier to bend than other portions of the adjusting section. The method includes attaching a surgical implement to the attaching section of the handle, and bending the adjusting section at least once prior to inserting the implement through a surgical opening to a surgical field. The method further may include bending the adjusting section more than once to form multiple bends therein.

Abstract: An expandable annuloplasty ring which may either expand spontaneously, in situ, as the patient grows or be expanded by surgical intervention by balloon dilatation. The distensible annuloplasty ring of the invention may be usable in pediatric patients whose growth, subsequent to surgical implantation of the ring, will necessitate subsequent enlargement of the ring to accommodate growth of the annulus. The ring may include relatively expandable segments to enable the enlargement thereof. The ring segments may include engaging teeth which cooperate with notches or slots formed in the tubes to provide some resistance to ring distention, while preventing collapse of the ring in the opposite direction. The teeth may be of different sizes or shapes to regulate the amount of force needed to expand the ring at different stages of the patient's growth.

Abstract: A method for fixation of biological tissues, and bioprosthetic devices prepared by such method. The method generally comprises the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to terminal sterilization.

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: In general, the present invention comprises an holding apparatus for facilitating implantation of a prosthetic heart valve within a mammalian heart. The holding apparatus generally comprises a cage or enclosure having a heart valve prosthesis retention space defined therewith. The proximal end of the holding apparatus is releasably attached to the proximal end of the heart valve prosthesis such that, when the holding apparatus is advanced in a forward direction, a “pulling” force will be exerted upon the proximal end of the prosthesis, rather than a “pushing” force being exerted upon the distal end of the prosthesis.

Abstract: A design and method of implantation is disclosed for a flexible annuloplasty system for repairing a valve in a patient's heart. The annuloplasty system includes an elongate, flexible band with a needle attached to one end of the band and a fit adjuster attached to the other end of the band. The band is made of silicone and includes a plurality of fibers that are configured to prevent axial elongation of the band. In addition, the plurality of fibers ensure that a suture will catch on the fibers and prevent the suture from tearing out of the band.

Abstract: A minimally invasive approach for surgery on portions of the heart and great vessels located between a point approximately three centimeters above supra annular ridge and the mid ventricular cavity. A parasternal incision is made extending across a predetermined number of costal cartilage, e.g., a right parasternal incision extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage. One or more costal cartilages, e.g., the third and fourth, are then excised to provide access to the portion of the heart or great vessels of interest, and a desired procedure completed. The minimally invasive approach enables repair or replacement of the mitral or aortic valve.

Abstract: Surgical apparatus and associated methods of use are provided for retracting tissue around an incision. The apparatus includes a member having an inner peripheral surface and an outer peripheral surface. An adjustable aperture is definable within the inner peripheral surface as the member is adjusted between a compressed condition in which the aperture is substantially closed and an expanded condition in which the aperture is substantially open. The apparatus is positioned within a surgical incision in the compressed condition, and is adjusted to the expanded condition in situ to define an opening within the incision through the aperture whereby a surgical field may be viewed and/or accessed.

Abstract: A suture ring for a rotatable artificial heart valve apparatus has a ring member covered by a fabric material. A portion of the fabric material covers a portion of the inner surface of the ring member. At least one protuberance is formed on the inner surface of the ring member so as to mitigate the frictional resistance to rotation which results from compression of the fabric between the suture ring and the heart valve. Thus, desirable rotation of the heart valve relative to the suture ring is assured over a range of thicknesses of the fabric material.

Abstract: Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices. The methods include forming individual leaflets with a template and using the template to attach the leaflets together to form a tissue leaflet subassembly. The template and leaflets include a straight edge terminating in oppositely directed tabs, and a curvilinear cusp edge extending opposite the straight edge.