Abstract: A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device including a jacket adapted to be secured to the heart, and a non-adherent material in association with the jacket. The jacket is fabricated from a flexible material defining a volume between an upper and a lower end, the jacket being adapted to be adjusted on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain expansion of the heart beyond the maximum adjusted volume during diastole and permit substantially unimpeded contraction of the heart during systole. As a result of the flexible material, the jacket allows unimpeded diastolic filling of the heart.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: A pattern for a three dimensional cardiac support device that includes a proximal edge having a concave shape; and a seam edge that includes: first and second sides, wherein said first and second sides are substantially symmetrical along a vertical axis, first and second upward inflection regions, first and second downward inflection regions; and an intersection point. A three dimensional cardiac support device that includes: a pattern, wherein said pattern is substantially symmetrical along a vertical axis, and wherein said pattern includes a proximal edge having a concave shape, and a seam edge that includes: first and second sides, first and second downward inflection regions, first and second downward inflection regions, and an intersection point; and a seam wherein the seam is formed by folding the pattern across the vertical axis and joining the seam edge to itself.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: A highly compliant and elastic cardiac support device is provided. The device is constructed from a biocompatible material is applied to an external surface of a heart. The device can be used to resist dilatation of the heart, to provide acute wall support, or to enhance reduction in the size of the heart using stored potential energy, without interfering with systolic contraction.

Abstract: An apparatus for treating congestive heart disease and related cardiac complications such as valvular disorders that includes a support device placed on the heart. Support devices such as jackets of flexible material of knit construction defining a volume between an open upper end and a lower end are included in the invention. Such support devices can be dimensioned and sized based in part on the desired function of the device. The support device includes at least one indicator marker along the longitudinal axis of the device for indicating and/or monitoring the level of tension of the device or for selecting a predetermined level of tension of the support device.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.

Abstract: A prosthetic heart valve includes an orifice ring adapted to carry blood therethrough. An annular recess is formed in an outer surface of the orifice ring and has first and second axially spaced walls. A sewing cuff is adapted to be coupled to a native tissue annulus of a heart and includes an inner annular cuff portion adapted to conform to the first and second recess walls in the orifice ring. A cuff retaining ring extends around the inner annular fabric portion such that the inner annular cuff portion is positioned between the cuff retaining ring and the annular recess.

Abstract: A bi-leaflet prosthetic heart valve, comprising an annular body having an upstream edge, a downstream edge and a passageway therebetween includes first and second leaflets pivotally mounted in the annular body. Each leaflet has an upstream edge, a downstream edge and a leaflet length therebetween. First and second pivot axes associated respectively with the first and second leaflets are provided and each leaflet rotates about its respective pivot axes between an open position allowing blood flow through the passageway of the annular body and a closed position blocking blood flow. The valve is configured such that the leaflets have an angle in the naturally open position of more than about 85°.

Abstract: A prosthetic heart valve for implantation in a heart includes an outer orifice ring for coupling to a tissue annulus of a heart. An inner orifice ring includes at least one leaflet occluder carried in a lumen of the inner orifice ring which is movable between an open position, which allows blood flow through the lumen, and a closed position which blocks blood flow through the lumen. The inner orifice ring is adapted to be coupled to the outer orifice ring after the outer orifice ring has been attached to the tissue annulus.

Abstract: A method and apparatus for treating congestive heart disease and related cardiac complications such as valvular disorders and includes a constraining device placed on the heart. The constraining device is a jacket of flexible material of knit construction defining a volume between an open upper end and a lower end. The jacket is dimensioned for the apex of the heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. The jacket is further dimensioned for the jacket to have a longitudinal dimension between the upper and lower ends sufficient for said jacket to constrain said lower portion of the heart. The jacket adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart beyond.

Abstract: A jacket for placement over a heart to constrain congestive heart failure related expansion includes a biocompatible fabric formed into a pouch having a base end and an apical end with an interior of the pouch sized to receive a patient's heart. The base end has a peripheral edge defining a base opening sized to pass an apex of the heart through the base opening. The heart is slipped into the interior of the pouch with the apical end facing the apex of the heart and with the base end facing toward a base of the heart. At the base end, the fabric is folded over for the peripheral edge to have at least a double layer of the fabric. The double layer terminates at a free edge on an outer surface of the pouch and is spaced from the peripheral edge. In an additional embodiment, the fabric includes a side edge of opposing fabric surfaces extending from the apical end to the base end. The opposing fabric surfaces are joined by a stitch assembly.

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 heart valve prosthesis comprises an occluder pivoting with respect to an annular body member. The annular body member includes a stop having a stop surface for limiting pivotal displacement of the occluder. In order to reduce wear upon a surface of the occluder contacting the stop surface, the stop includes an edge extending from a portion of the stop surface to a second surface. The edge has a beginning point a selected depth from the second surface greater than a first distance and less than a second distance wherein a distance of the edge from a plane including the stop surface increases for increasing distances away from the point and toward the second surface.

Abstract: The present invention includes a prosthetic heart valve having a stent and a piece of biocompatible material. The stent includes an inflow ring and a plurality of posts, each post extending from the ring to a post tip. The piece of material extends over the stent and substantially conforms to a profile of the stent. The piece of material includes a portion which extends adjacent a post tip. A clip is provided which has a shape generally conforming to the post tip to thereby clamp the portion of the piece of material to the post tip.

Abstract: The invention provides a sewing cuff assembly for mounting to the body of a heart valve prosthesis. The sewing cuff assembly comprises a resiliently deformed spring for exerting a force directed toward the orifice structure. When a torque is applied to the valve, the force results in a rotation-resisting torque sufficient to resist rotation during normal operation of the valve after implantation but low enough to permit assisted rotation, as during surgery.

Abstract: An annuloplasty prosthesis ring for implantation proximate a heart valve orifice includes a core having a size and shape to generally conform to the heart valve orifice. A sheath formed about the core is adapted for receiving a suture therethrough to attach the annuloplasty ring to the heart valve orifice. The suture is knotted on a knot surface of the sheath to form a suture knot thereon. A moveable suture guard is provided which is moveable between an open position in which the knot surface and suture knot are exposed and a closed position in which the knot surface and the suture knot carried on the knot surface are covered.

Abstract: A heart valve prosthesis for use in a heart includes an orifice defining a lumen therethrough for blood flow. An occluder is carried in the orifice and is movable between an open position which allows blood flow through the lumen and a closed position in which flow through the lumen is blocked. A suture cuff coupled to the orifice extends around an outer circumference of the orifice and is used for attaching the heart valve to a heart tissue annulus using sutures. The sutures are knotted proximate the suture cuff to secure the cuff to the annulus. A suture guard is coupled to the suture cuff and is movable between an open position in which the suture knot is exposed and a closed position in which the suture, suture knot and suture cuff are covered.