Abstract: A tissue valve holder for holding a tissue heart valve bioprosthesis such that the tissue valve may be supported without contacting any surface, regardless of whether or not the valve is in a container. The tissue valve holder includes a holder assembly adapted to be secured to the tissue valve. The holder assembly may include a holder body and a removable disk. The holder assembly and the tissue valve secured thereto rest on a support structure. The support structure may comprise a support surface and a plurality of support legs. The support surface, in turn, may comprise an annular ring with the support legs connected thereto. The holder assembly rests on the support surface with the tissue valve suspended in the center of the ring.

Abstract: A prosthetic stentless aortic tissue valve includes a substantially annular valve body having a leaflet carried therein for occluding blood flow therethrough. A root extends generally coaxially from the valve body. Visual marking are provided on the root and act as a sculpting guide for a surgeon during implantation of the prosthetic heart valve to sculpt portions of sinus areas of the root.

Abstract: A driver tool which drives helical fasteners through a heart valve component into tissue. The tool has a tool housing with a distal end couplable to engage the implanted component. A drive shaft at the proximal end of the driver tool couples to a driving force. Multiple driver tips couple to helical fasteners for the heart valve component. A drive train in the tool housing distributes the drive to the driver tips.

Abstract: A bileaflet heart valve prosthesis includes an orifice body or housing defining an orifice or opening for the passage of blood therethrough. First and second leaflets or occluders are disposed in the orifice and pivotally attached to the orifice body. The first and second occluders pivot about axes between an open position and a closed position, and the axes are non-parallel. The orifice is substantially open when the first and second occluders are in their open positions and substantially closed when the occluders are in their closed position. The bileaflet heart valve may be either a central opening valve, or a side opening valve.

Abstract: A prosthetic heart valve holder includes a set of jaws. Each jaw includes a distal end adapted for coupling to the prosthetic heart valve and a proximal end. A hinge assembly pivotally couples the jaws together between the distal and proximal ends. The hinge assembly allows movement of the jaws between an engaged position for grasping the prosthetic heart valve and an disengaged position in which the prosthetic heart valve is free from the distal ends. A locking collar is attached to the jaws and is movable between a first position in which the proximal ends are free from the collar, and a second position in which the collar holds the proximal ends of the jaws whereby the distal ends are held in position to engage the prosthetic heart valve.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: A device for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the device 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 includes a member which couples to the circular valve body thereby affixing the device to the heart valve prosthesis. The thickness of the device which extends in a direction above the heart valve prosthesis is reduced. The device is selectively removable from the heart valve prosthesis following implantation of the prosthesis in the heart tissue annulus of a patient.

Abstract: A microprocessor couples to a voltage sensor through an analog to digital converter. The voltage sensor is adapted to be coupled across terminals of a battery. A small current source is also provided and adapted to be coupled across the terminal to the battery. The current source is momentarily applied to the battery and the resulting change in voltage is monitored using the microprocessor. The microprocessor calculates battery conductance based upon the magnitude of the differential current and the change in voltage and thereby determines the condition of the battery.

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: A device for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the device 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 annulus and is movable between an open position and a closed position. The occluder is carried on a strut coupled to a valve body. The attachment mechanism includes a member which couples to the strut, thereby affixing the device to the heart valve prosthesis. The attachment mechanism may be actuated to disengage the heart valve prosthesis.

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: 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: Packaging is provided for a heart valve prosthesis. A holder is adapted to grasp the heart valve prosthesis and includes a post. The packaging includes a collar for holding the post of the holder. An inner tray of the packaging receives the collar such that the prosthesis is suspended within the inner tray. An outer tray receives the inner tray. An inner tray lid seals the inner tray and an outer tray lid seals the outer tray.

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.

Abstract: An apparatus for manipulating an annuloplasty ring implantation device during implantation includes an elongated handle having a proximal end for grasping by a surgeon and a distal end. A locking surface is provided adjacent the distal end of the elongated handle. The elongated handle carries an engaging tip which extends distally from the locking surface. A locking key extends radially from the engaging tip. The annuloplasty ring implantation device includes an engaging tip opening formed therein adapted for receiving the engaging tip. A key slot is defined in the implantation device and extends radially from the engaging tip opening. The engaging tip and locking key may be inserted into the device at the engaging tip opening and key slot. The elongated handle is locked to the device by inserting the engaging tip and rotating the handle relative to the device such that the locking key and key slot are not aligned. This causes the device to be locked between the locking key and the locking surface.

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 holder for an artificial heart valve includes a holder body, a handle, and a safety member. The holder body is configured to selectively couple to the heart valve. The handle extends from the holder body. The safety member is spaced apart from the holder body, and extends from the handle and is configured to mate with the heart valve in exactly one orientation. The safety member prevents the holder body from mating with the heart valve in other orientations.

Abstract: A holder for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the device 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 includes a member which couples to the suture cuff thereby affixing the device to the heart valve prosthesis. The attachment mechanism may be actuated to disengage the heart valve prosthesis.

Abstract: A device for engaging a heart valve prosthesis during implantation includes a heart valve prosthesis holder. The holder includes a distal engaging surface adapted for engaging the heart valve prosthesis. The distal engaging surface carries a compliant member which maintains an occluder of the heart valve in a closed position during implantation.