Abstract: Described here are methods for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods comprise advancing a tissue-locating member adjacent to a tissue wall, deforming at least a portion of the tissue wall with the tissue-locating member, and advancing a tissue-piercing member through the deformed tissue to form the tract, where the tract provides access for one or more tools. Also described here are methods of forming tracts through rotated or tented tissue. Any of the methods described here may also be used with tissue having at least one irregular surface.

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: 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: 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: 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 is inserted through a penetration and actuated extend the foot carrying suturing attachment cuffs. 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 cuffs lockingly engage the needles and can be withdrawn along the needle paths and through the tissue tract to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Abstract: A heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a plurality of magnets on the first and second prostheses to secure the second prosthesis to the first prosthesis. In one embodiment, the magnets are 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 magnets orient 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: A biologically implantable prosthesis is disclosed. The prosthesis can have a circumferentially expandable wall and elements that prevent the wall from collapsing once the wall is expanded. Methods of making and using the prosthesis are also disclosed.

Abstract: Described here are methods, devices and kits for locating tissue and/or forming one or more tracts in tissue. In some variations, tissue may be located (e.g., using one or more optical sensors, ultrasound sensors, thermal sensors, or the like) and one or more tracts may be formed through the tissue after it has been located. In certain variations, the same device may be used both to locate tissue and to form one or more tracts in the tissue. In some variations, a tissue-piercing member for forming one or more tracts in tissue may comprise a first elongated portion and a second elongated portion, and an angle therebetween.

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: 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: Tissue tract-forming devices, methods, and kits are disclosed. In some variations, a method for forming a tract in a tissue wall having an interior surface and an exterior surface may comprise advancing an anchor member through the tissue wall and into a lumen defined by the tissue wall, the anchor member comprising a proximal portion, a distal portion, and an intermediate portion therebetween, wherein the proximal and intermediate portions are angled with respect to each other and the intermediate and distal portions are angled with respect to each other, positioning the anchor member so that the intermediate portion contacts the interior surface of the tissue wall and the distal portion is angled toward the interior surface of the tissue wall, and advancing a tissue-piercing member into the tissue wall while the intermediate portion is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.

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: 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: 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: 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 intimae and adventitia. Methods for using the device 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.

Abstract: A heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a plurality of magnets on the first and second prostheses to secure the second prosthesis to the first prosthesis. In one embodiment, the magnets are 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 magnets orient 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: Described here are devices, methods, and kits for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods may comprise advancing a tissue-piercing member along a predetermined path of a tract-forming device to form one or more tracts in tissue (e.g., a vessel wall). The tract or tracts may, for example, provide access for one or more tools.

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 is inserted through a penetration and actuated extend the foot carrying suturing attachment cuffs. 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 cuffs lockingly engage the needles and can be withdrawn along the needle paths and through the tissue tract to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.