Abstract:
A collapsible valve prosthesis includes an armature and a set of prosthetic valve leaflets supported by the armature. The armature is expandable from a contracted condition to an expanded condition for anchoring at an annulus of a natural valve site, and includes a tubular intra-annular portion defining a blood flow lumen having an inflow side and an outflow side. The tubular intra-annular portion supports the prosthetic valve leaflets in the blood flow lumen and is provided with outward formations for coupling with the natural valve site. The armature includes an over-annular portion linked to the intra-annular portion to extend collar-like over the annulus of the natural valve site at the inflow side of the blood flow lumen. The armature may also include an under-annular portion to extend collar-like at the outflow side of the blood flow lumen. The prosthesis may permit mitral valve replacement (MVR) without removing the native valve leaflets and the chordae tendineae.
Abstract:
A method of treating a biological tissue for biological prostheses includes steps of fixation of the biological tissue via a fixing solution including glutaraldehyde and detoxification of the fixed biological tissue via treatment with a detoxifying solution. The detoxification step includes one or both of eliminating phospholipids via treatment with an elimination solution and a treatment with a detoxifying solution. The elimination solution includes 1,2-octanediol and ethanol. The detoxifying solution includes taurine or homocysteic acid.
Abstract:
A support device for implanting a stentless heart valve prosthesis having three leaflets adapted for coapting and defining three corresponding commissures is disclosed. The support device includes a shaft defining a manipulation axis, the shaft having a proximal portion and a distal portion, and three support formations integrally formed and extending from the proximal end of the shaft, the support formations angularly distributed about the manipulation axis of the shaft, such that each of the support formations correspond to locations of each of the commissures of the stentless heart valve prosthesis. The shaft includes a connection portion flexibly connecting the shaft and the support formations to permit a displacement of the manipulation axis with respect to the support formations. The shaft, the plurality of support formations and the connection portion are integrally formed from a single tubular element.
Abstract:
A kit for implanting a prosthetic vascular conduit includes a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion. The conduit includes a terminal collar member for receiving the valve. The kit further includes a holder including a shaft and a hub including a receiving portion configured for housing a prosthetic valve. The conduit is fitted on the holder so that at least a portion of the conduit wraps over the receiving portion of the hub. A sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, and a portion of the collar member is wrapped or folded over the sleeve member. The sleeve member is slidable away from the hub to unwrap the collar member such that it is disposed around the annular portion of a prosthetic valve.
Abstract:
A device for measuring an internal dimension of a native cardiac valve annulus includes an elongated support member having a proximal portion and a distal portion. A measuring portion is coupled to the distal portion, and an indicator is coupled to the proximal portion of the support member. The measuring portion is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.
Abstract:
A collapsible valve prosthesis includes an armature and a set of prosthetic valve leaflets supported by the armature. The armature is expandable from a contracted condition to an expanded condition for anchoring at an annulus of a natural valve site, and includes a tubular intra-annular portion defining a blood flow lumen having an inflow side and an outflow side. The tubular intra-annular portion supports the prosthetic valve leaflets in the blood flow lumen and is provided with outward formations for coupling with the natural valve site. The armature includes an over-annular portion linked to the intra-annular portion to extend collar-like over the annulus of the natural valve site at the inflow side of the blood flow lumen. The armature may also include an under-annular portion to extend collar-like at the outflow side of the blood flow lumen. The prosthesis may permit mitral valve replacement (MVR) without removing the native valve leaflets and the chordae tendineae.
Abstract:
A kit for implanting a prosthetic vascular conduit includes a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion. The conduit includes a terminal collar member for receiving the valve. The kit further includes a holder including a shaft and a hub including a receiving portion configured for housing a prosthetic valve. The conduit is fitted on the holder so that at least a portion of the conduit wraps over the receiving portion of the hub. A sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, and a portion of the collar member is wrapped or folded over the sleeve member. The sleeve member is slidable away from the hub to unwrap the collar member such that it is disposed around the annular portion of a prosthetic valve.
Abstract:
A kit for implanting a prosthetic vascular conduit includes a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion. The conduit includes a terminal collar member for receiving the valve. The kit further includes a holder including a shaft and a hub including a receiving portion configured for housing a prosthetic valve. The conduit is fitted on the holder so that at least a portion of the conduit wraps over the receiving portion of the hub. A sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, and a portion of the collar member is wrapped or folded over the sleeve member. The sleeve member is slidable away from the hub to unwrap the collar member such that it is disposed around the annular portion of a prosthetic valve.
Abstract:
A kit for facilitating crimping of a prosthetic heart valve for implantation at an aortic valve site in a human heart, the aortic valve site including a plurality of valve sinuses, the kit comprising a prosthetic aortic heart valve having a tubular structure and a first central axis including an anchoring structure comprising an annular outflow member, an annular inflow member, and a plurality of axial connection formations arranged in pairs angularly distributed around the central axis, and a plurality of leaflets coupled to the anchoring structure and adapted to substantially allow blood flow in a first direction and to substantially prevent blood flow in a second direction. The kit further includes a holder member comprising a first disc support member that includes a central hub and a plurality of bridge elements, wherein the hub and the bridge elements extend axially from opposite sides of the disc support member; and a second ring support member that includes receptacles for coupling with the bridge elements, and a plurality of finger formations protruding axially from the ring member and extending lengthwise along at least a portion of the prosthetic aortic heart valve.
Abstract:
A method of treating a biological tissue for biological prostheses includes steps of fixation of the biological tissue via a fixing solution including glutaraldehyde and detoxification of the fixed biological tissue via treatment with a detoxifying solution. The detoxification step includes one or both of eliminating phospholipids via treatment with an elimination solution and a treatment with a detoxifying solution. The elimination solution includes 1,2-octanediol and ethanol. The detoxifying solution includes taurine or homocysteic acid.