Abstract: A system and method for assembling a prosthetic heart valve, including a procedure for tightly wrapping fabric around a heart valve support stent having a highly contoured undulating outflow edge. A mandrel retains tension without manual assistance in a tubular length of fabric wrapped over the support stent, and includes relatively axially movable inner and outer clamping mechanisms and a pedestal tube on which the support stent rests. The clamping mechanisms include clamps that pull the fabric only in the support stent cusps. The mandrel assembly may be placed in a chuck of a sewing machine system for automatically forming the seam. A small shuttle with bobbin thread reciprocates within a channel inside of the support stent and cooperates with the sewing machine needle to form a lock-stitch in the fabric tube. The mechanization of the fabric covering procedure greatly enhances manufacturing throughput and reduces ergonomic strain on workers.

Abstract: A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves.

Abstract: An annular prosthesis for a mitral valve that may include a posterior half-ring and an anterior half-ring coupled to each other on a first transverse plane which defines a maximum width section of the prosthesis. The ratio between the distance between the anterior half-ring and the posterior half-ring, as measured along a second plane, perpendicular to the first plane and equidistant to the couplings, and the maximum width of the prosthesis is lower than 3/4.

Abstract: An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and ma y also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover.

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: The present invention provides methods for treating tissue to inhibit post-implant calcification of a biological tissue. In one method of this invention, a tissue is immersed in or otherwise contacted with a pretreated glutaraldehyde solution, i.e., a heat-treated or pH-adjusted glutaraldehyde solution. The tissue may be partially fixed with glutaraldehyde prior to, after, or concurrently with the step of contacting the tissue with the pretreated gluteraldehyde. Contact with the pretreated gluteraldehyde produces free amine groups on the tissue, which are subsequently blocked by contacting the crosslinked tissue with a blocking agent. In another embodiment, a tissue is contacted with either a non-pretreated glutaraldehyde or a pH-adjusted glutaraldehyde solution for a period of time sufficient to crosslink the tissue. The crosslinked tissue is then treated with a reducing agent that reduces aldehyde and carboxylic acid groups on the fixed tissue.

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.

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

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.

Abstract: A flexible support frame for a prosthetic heart valve having commissure tips that are shaped to even out stresses imposed during use. The support frame is an elongated wire-like element formed by a plurality, typically three, of arcuate cusp regions on an inflow end alternating with the same number of commissures terminating in tips on an outflow end. The commissure tips are elongated relative to more simple shapes. The commissure tips may be shaped with a complex curve having two enlarged convex flexure portions separated by a concave bridge portion at the midpoint of the commissure tip. The support frame may be fabricated by separating a two-dimensional blank from a sheet and then converting the blank into a three-dimensional support frame shape. The cross-sectional thickness of the support frame may be variable, such as by adjusting the thickness of the pattern of the two-dimensional blank in the sheet.

Abstract: A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.

Abstract: Medical devices and methods of producing same are provided. The medical device comprising a body member and a coating on at least a portion of the body member comprising an insitu condensation product of a first electrophilically active, high molecular weight polyalkylene oxide and a second high molecular weight polyoxyalkylene derivative.

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: 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. 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. The methods include securing the annuloplasty ring with the anterior portion against the annulus anterior aspect and the posterior portion against the annulus posterior aspect so that the ring posterior portion elevates, and may also pull radially inward, the annulus posterior aspect and corrects the mitral regurgitation.

Abstract: A mitral annuloplasty ring that has an outward and an upward posterior bow. The ring defines a closed, modified oval shape with a minor-major axis dimension ratio of between about 3.3:4 to 4:4. The ring is made of a material that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart. As a result, the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, or Barlow's syndrome, in which the leaflets tend to be elongated or floppy.

Abstract: A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50° C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as 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., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.

Abstract: A multi-part substitution infusion fluid for an extracorporeal blood treatment and methods for using same are provided. Generally, the multi-part substitution fluid comprises a first solution composed of electrolites but without divalent cations and a second solution comprising divalent cations. Another embodiment includes a third solution comprising a matching citrate/citric acid anticoagulant. The described methods of using the multi-part substitution infusion fluids significantly reduce risks associated with various extracorporeal blood treatments.

Abstract: Methods for forming a support frame for flexible leaflet heart valves from a starting blank include converting a two-dimensional starting blank into the three-dimensional support frame. The material may be superelastic, such as NITINOL, and the method may include bending the 2-D blank into the 3-D form and shape setting it. A merely elastic material such as ELGILOY may be used and plastically deformed in stages, possibly accompanied by annealing, to obtain the 3-D shape. Alternatively, a tubular blank could be formed to define a non-tubular shape, typically conical. A method for calculating the precise 2-D blank shape is also disclosed. A mandrel assembly includes a mandrel and ring elements for pressing the blank against the external surface of the mandrel prior to shape setting.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: An apparatus for treating fixed biological tissue to inhibit calcification of the biological tissue following implantation thereof in a mammalian body. The apparatus includes a container for placing the biological tissue in contact with a treatment solution, structure to induce relative tissue/solution movement, and structure to heat the solution. The relative movement may be induced by shaking a container in which the tissue is immersed in the treatment solution, or by stirring the solution within the container. The movement may also be induced by flowing a treatment solution past the tissue to be treated. The tissue may be free to move in the treatment container, or may be restrained from gross movements. The flow may be part of a circulation system having a reservoir, with a heater being provided to heat the treatment solution in the reservoir. Alternatively, a treatment apparatus, including a fluid circulation system if desired, may be enclosed in an incubator.