Abstract: Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Abstract: One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leaden. Methods of making and using the devices are also disclosed.

Abstract: Described here are methods and devices for forming tracts in tissue. Some of the devices feature an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices feature more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device features one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Abstract: A heart valve assembly comprises a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen. The heart valve assembly also comprises a second prosthesis comprising a valve, and a connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference.

Abstract: A method may comprise creating a first passage across a wall with a sharpened member at a first angle relative to a lumen; advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the blood vessel; applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly; and while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall, wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the expandable tract.

Abstract: One embodiment is directed to a device for forming a tract, comprising an anchor assembly wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of a blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage; and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood vessel and into contact with a saddle-shaped needle receiving structure, thereby creating an expandable tract between overlapping tissue portions of the vessel wall.

Abstract: A method of using a prosthetic heart valve assembly can include implanting a first prosthesis directly into a native annulus. The first prosthesis can have a central longitudinal axis and a first engagement element. The method can also include engaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis. The second prosthesis can have a prosthetic valve. The first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.

Abstract: One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Abstract: One embodiment is directed to a geometric adaptor apparatus for assisting with translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Abstract: One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Abstract: Biologically implantable prostheses and methods of using the same are disclosed. In one embodiment, a heart valve assembly includes a first annular prosthesis sized for introduction into a tissue annulus in a heart; a first magnet in the first prosthesis; a second valve prosthesis separate and disconnected from the first prosthesis and comprising a heart valve crown with leaflets, the second prosthesis configured for introduction into the tissue annulus after introducing the first prosthesis into the tissue annulus; and a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis to attach the second prosthesis to the first prosthesis in the tissue annulus.

Abstract: A method for implanting a heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a multi-lobed connection adapter to secure the second prosthesis to the first prosthesis. In one embodiment, the adapter is arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The adapter secures the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Abstract: Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel's intima and adventitia. Methods for using the device are also disclosed.

Abstract: Space-occupying devices for treating voids within the body are disclosed. The devices can have multiple elements connected to a flexible leader. The devices can be coated by a binding agent. The devices can also be fillable. Methods of making and using the devices are also disclosed.

Abstract: Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.