Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: A system and method for assembling a prosthetic heart valve, including a procedure for tightly wrapping fabric around a heart valve support stent. The support stent typically includes alternating cusps and commissures that create a highly contoured undulating outflow edge. The system includes a mandrel for retaining tension without manual assistance in a tubular length of fabric wrapped over the support stent. The mandrel may include an inner clamping mechanism for holding the first end of the fabric tube, a pedestal tube on which the support stent rests and through which the fabric tube passes, and an outer clamping mechanism for holding the free end of the fabric tube. The inner and outer clamping mechanisms include discrete clamps spaced apart 120° from each other that pull the fabric only in the cusps of the support stent. The inner clamping mechanism, outer clamping mechanism, and pedestal are relatively axially movable.

Abstract: Methods of implanting an annuloplasty ring to correct maladies of the mitral annulus that not only reshapes the annulus but also reconfigures the adjacent left ventricular muscle wall. The ring may be continuous and is made of a relatively rigid material, such as Stellite. The ring has a generally oval shape that is three-dimensional at least on the posterior side. A posterior portion of the ring rises or bows upward from adjacent sides to pull the posterior aspect of the native annulus farther up than its original, healthy shape. In doing so, the ring also pulls the ventricular wall upward which helps mitigate some of the effects of congestive heart failure. Further, one or both of the posterior and anterior portions of the ring may also bow inward.

Abstract: A method of treating a biological tissue including crosslinking with glutaraldehyde; immersing the biological tissue in a first solution containing glutaraldehyde and heat in the first solution to a temperature of about 50° C. for a first period of time; immersing the biological tissue in a second solution containing a mixture of a crosslinking agent, a denaturing agent and a surfactant; and immersing the biological tissue in a sterilizing solution containing glutaraldehyde and heating the sterilizing solution to a temperature of 37.5±2.5° C. for a sterilizing period of time. The method may include a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include 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.

Abstract: An annuloplasty ring holder includes an angled post for improved visibility and access by the surgeon. The post may be configured to be adjusted in angle and rotation. The ring holder can include a relatively open lower template, including relatively narrow extending radial arms with short, generally arcuate ring-retaining distal portions. The invention includes placements of suture holes and cutting wells which, in combination with improved suture routing, afford the user improved access to cutting the suture that is used to retain the annuloplasty ring to the holder. Another annuloplasty ring and ring holder combination disclosed includes a generally triangular-shaped ring and a generally T-shaped holder. The ring holder has a base portion forming the top of the T shape and engaging against a first segment of the ring, with a radial arm extending from the base portion and forming the post of the T. The radial arm engages against a junction between two segments of the ring.

Abstract: A computational technique to construct a 3-D valve leaflet geometry. The invention pertains to methodology to construct a 3-D heart valve leaflet geometry using finite element analysis (FEA) to simulate the manual assembly process or, in other words, provide a virtual assembly process as an input to a subsequent simulated valve testing step. The simulated valves may be subjected to simulated cyclic valve opening and closings and the stress levels induced therein monitored. Simulated valve designs with lower principal stresses can then be selected for prototyping. Proposed valves can be subjected to cyclic fatigue stress testing under simulated physiologic conditions to study valve durability.

Abstract: A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve.

Abstract: A device for heart valve repair including at least one tension member having a first end and second end. A basal anchor is disposed at the first end of the tension member and a secondary anchor at the second end. The method includes the steps of anchoring the basal anchor proximate a heart valve and anchoring the secondary anchor at a location spaced from the valve such that the chamber geometry is altered to reduce heart wall tension and/or stress on the valve leaflets.

Abstract: A holder for an annuloplasty ring having a template defining a proximal face opposite the distal face, and a peripheral edge about which the annuloplasty ring conforms. The annuloplasty ring anchors to the template using one or more flexible filaments. The template includes a single cutting well on its proximal face over which the flexible filament is suspended. Desirably, the single cutting well is located adjacent the peripheral edge so as to be away from any handle connections for ease of access. The flexible filament emerges above the proximal face of the template at only one location at the cutting well, thus presenting a one cut quick-release structure that is highly visible to the surgeon. The annuloplasty ring may have a relatively rigid inner core surrounded by a suture-permeable cover, and the peripheral edge may be formed by a lower axial wall and an upper radial ledge that projects outward from the rigid inner core but not quite as far as a sewing margin of the ring.

Abstract: A system (1) for altering the geometry of a heart (100), comprising an annuloplasty ring; a set of elongate annulus-papillary tension members (21, 22, 23, 24), each of which tension members are adapted for forming a link between said ring (10) and a papillary muscle, each of said tension members (21, 22, 23, 24) having a first end (21b, 22b, 23b, 24b) and a second end (21a, 22a, 23a, 24a); and a first set of papillary anchors (30) for connecting each of the first ends (21b, 22b, 23b, 24b) of said tension members (21, 22, 23, 24) to said muscle; and where said annuloplasty ring (10) has at least one aperture (12, 13); where each of said annulus-papillary tension members (21, 22, 23, 24) are extendable through said ring (10) through said apertures (11, 12, 13), and through an atrium to an exterior side of said atrium, such that the distance of each link between the annulus and the muscles is adjustable from a position exterior to the heart.

Abstract: A prosthetic heart valve having spaced apart anchoring flanges that change shape when the valve is implanted and contact the surrounding annulus to prevent migration of the valve. The heart valve may be non-expandable and the anchoring flanges may provide the primary anchoring structure of the valve. Alternatively, the valve may be expandable wherein the anchoring flanges supplement the inherent anchoring capacity of the valve structure. The anchoring flanges are at least partly made of a material that increases in size, i.e., swells, due to absorption of body fluids. For instance, the anchoring flanges may be formed of an inner material that swells upon contact with body fluids enclosed by a cover. The anchoring flanges may be provided on an anchoring sleeve that changes shape to provide the spaced apart annular flanges for securing the valve around a fibrous annulus.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring.

Abstract: An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical.

Abstract: A simulated heart valve root used for training physicians in techniques of implantation of prosthetic heart valves as well as for more realistically testing the efficacy of prosthetic heart valves. The simulated heart valve root is made of the flexible, tubular body having an inner wall defining an annular ledge within which the prosthetic heart valve is implanted. Discrete nodes or areas of simulated calcification may be provided on the annular ledge. A simulated aortic root includes alternating cusps and commissures with calcification simulated at least at one of the commissures. A tear in the annular ledge may also be provided which simulates a tear that might occur from a valvuloplasty procedure. A reinforcing sleeve may surround the flexible tubular body to provide rigidity or hoop strength thereto. A method of testing includes mounting the simulated heart valve root in a flow conduit, implanting a prosthetic heart valve in the root, applying pulsatile flow to the assembly, and monitoring for leaks.

Abstract: A system and method for assembling a prosthetic heart valve, including a procedure for sewing fabric around a heart valve support stent. The system includes a support stent handling component that works in conjunction with a sewing machine component. The sewing machine has a bobbin, and the system includes a non-contact sensor to monitor the passage of a needle thread loop over the bobbin. The sensor may be a monitoring laser, and a controlling processor receives information therefrom for 100% real-time inspection of each stitch. The occurrence of an unsuccessful stitch may prompt the processor to repeat the stitch at a slower speed. The automation of the fabric sewing procedure greatly enhances manufacturing throughput and reduces ergonomic strain on workers.

Abstract: A method of treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.

Abstract: A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

Abstract: A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.