摘要:
A heart valve assembly including an annular prosthesis implantable within a biological annulus, a prosthetic valve including a multiple lobular shape for implantation above the biological annulus, and one or more connectors for securing the prosthetic valve to the annular prosthesis. A flexible sewing cuff extends radially from the annular prosthesis that is resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve to enhance a seal between the prosthetic valve and the annular prosthesis. The sewing cuff may include a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core.
摘要:
A valve introducer is provided for delivering a valve prosthesis into a biological annulus. During use, a gasket member is introduced into the biological annulus, and secured relative to the biological annulus. A distal end of a valve introducer is introduced into a passage communicating with the biological annulus, and disposed adjacent the gasket member. A valve prosthesis is advanced through the valve introducer towards the gasket member, and secured to the gasket member. In one embodiment, the valve introducer and valve prosthesis have corresponding shapes, requiring the valve prosthesis to be oriented to properly align the valve prosthesis before advancing the valve prosthesis into the valve introducer. Optionally, the valve introducer is compressed or otherwise manipulated to reduce a profile of the distal end before introduction into the passage, which may facilitate introducing the valve introducer through the passage, e.g., past the sino-tubular junction.
摘要:
A heart valve assembly includes a prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity. The prosthesis includes an annular member implantable within the biological annulus for contacting tissue surrounding the biological annulus to provide an opening through the biological annulus, a collar extending upwardly from the annular member, and a sewing cuff extending radially outwardly from the annular member and/or collar. Optionally, the annular member and/or collar may be resiliently compressible, expandable, and/or otherwise biased. A valve member, e.g., a mechanical or bioprosthetic valve may be coupled to the collar, e.g., using a drawstring, sutures, or other connectors, to secure the valve member to the gasket member.
摘要:
A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.
摘要:
A heart valve assembly includes an annular prosthesis including an annular member and a sewing cuff extending radially from the annular member, and a valve member including a frame and a plurality of leaflets carried by struts. The annular prosthesis includes a plurality of pockets extending upwardly from the annular prosthesis for receiving a portion of the frame for securing the valve member to the annular prosthesis. Each pocket may include a flexible rim extending upwardly the sewing cuff and a cover at least partially defining a recess. The rim may be deflectable radially outwardly to accommodate a portion of the frame being received in the recess, and may be resiliently biased to return inwardly when released to cover the portion of the frame with the respective cover. The valve member may be further secured to the annular prosthesis by an interference fit between the rim and the frame.
摘要:
A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.
摘要:
A percutaneous heart valve assembly includes a gasket member or other first prosthesis and a valve member or other second prosthesis. The first and second prostheses are contractible from an enlarged or relaxed condition into a contracted or delivery condition. The prostheses may be loaded into the same or separate catheters or other delivery devices for delivery through a patient's vasculature to an implantation site, e.g., a biological annulus within a heart. The first prosthesis may be deployed adjacent or within the biological annulus and secured at least partially into the biological annulus. The second prosthesis may then be deployed adjacent the biological annulus, expanded, and docked to the first prosthesis. In one embodiment, the first and/or second prostheses may be advanced over one or more sutures or other filaments secured to tissue surrounding or adjacent the biological annulus.
摘要:
Devices for attaching a first mass and a second mass and methods of making and using the same are disclosed. The devices can be made from an resilient, elastic or deformable materials. The devices can be used to attach a heart valve ring to a biological annulus. The devices can also be used for wound closure or a variety of other procedures such as anchoring a prosthesis to surrounding tissue or another prosthesis, tissue repair, such as in the closure of congenital defects such as septal heart defects, tissue or vessel anastomosis, fixation of tissue with or without a reinforcing mesh for hernia repair, orthopedic anchoring such as in bone fusing or tendon or muscle repair, ophthalmic indications, laparoscopic or endoscopic tissue repair or placement of prostheses, or use by robotic devices for procedures such as those above performed remotely.
摘要:
A heart valve assembly includes an annular prosthesis and a plurality of guide shields removably attached around a circumference of the annular prosthesis. A plurality of elongate guide rails extend from the annular prosthesis, which are releasably retained by the guide shields. During use, the annular prosthesis is directed into a biological annulus, e.g., with the guide rails retained by the guide shields, and secured to tissue surrounding the biological annulus using fasteners. The guide rails are released from the guide shields, and a valve prosthesis is advanced over the leaders and through a passage defined by the guide shields towards the annular prosthesis. The guide rails may include retentions elements that secure the valve prosthesis to the annular prosthesis. The guide shields are removed from the annular prosthesis, the guide rails are separated from the annular prosthesis, and are removed from the biological annulus.
摘要:
A fastener delivery tool includes a loading chamber for receiving a fastener having a pair of tines overlapping one another to define a loop in a parent or relaxed state. A retaining member retains the fastener in the loading chamber. The fastener delivery tool also includes a tongue, pusher member, and an ejection track communicating with the loading chamber. An actuator causes the tongue to move to engage the tines of the fastener to transform the fastener from the relaxed state to a constrained state defining a U-shape. The actuator also causes the pusher member to release the retaining member and advance the fastener down the ejection track in the constrained state. The tool also includes a trigger for ejecting the fastener completely from the ejection track. The fastener may be used to secure a prosthetic heart valve or components thereof into surrounding tissue, e.g., within a tissue annulus.