Abstract: The present invention is directed to a method for sealing a puncture in a wall of a lumen of a body including the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the elastic nature of the membrane to force the sealing element against the puncture; and retracting the device from the puncture.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: An apparatus for sealing a passage through tissue includes a plug including external threads, a lumen extending between its proximal and distal ends, and an annular collet slidably disposed within the lumen. The plug is carried on a distal end of a handle device that includes an inner member with a distal end that is slidable axially within the lumen of the body for moving the collet into a reduced cross-sectional region of the lumen, thereby compressing the collet to seal the lumen, and for deploying the plug from the handle device. During use, the plug is delivered into a passage through tissue over a guide wire. Once a desired location is reached, the plug is deployed from the handle device, thereby compressing the collet and sealing the lumen. The guide wire and handle device are removed, leaving the plug to seal the passage.

Abstract: Configurations are described for assisting execution of a percutaneous procedure while protecting the vascular pathway to the operational theater. One embodiment is directed to a system for deploying a device to a distal location across a diseased vessel, comprising a sheath comprising an expandable distal portion comprising a porous wall defining a lumen therethrough, the distal portion having a collapsed configuration, wherein the sheath has a first cross sectional outer diameter and a first lumen inner diameter, and an expanded configuration, wherein the sheath has a second cross sectional outer diameter and a second lumen inner diameter; wherein in the collapsed configuration, the sheath is configured to be advanced across at least a portion of the diseased vessel to a position adjacent the distal location without substantial size interference between the first cross sectional outer diameter of the sheath and an inner diameter profile of a lumen of the vessel.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: A closure system and methods of use are provided for use in sealing an opening in a body tissue, such as a vascular puncture site. A method of closing the opening in the body tissue can be performed with the closure system having a closure clip. The method can include positioning the closure clip in a first closure clip position adjacent to the opening in the body tissue such that a plurality of spikes of the closure clip are inserted into the tissue at a location outward from a central axis of the opening. Subsequently, the closure clip can be positioned in a second closure clip position such that the plurality of spikes are pulled inward toward the central axis of the opening so as to pull the tissue between the opening and each of the spikes together and close the opening.

Abstract: An apparatus for sealing a vascular puncture and for properly locating and deploying a sealing member. The apparatus comprises a lumen which extends from an opening in the distal region of the apparatus to another opening in the proximal region of the apparatus. A sealing member is located at the end of the lumen. When the distal opening is positioned within the blood vessel lumen, blood flows through the distal opening, through the lumen and out of the proximal opening indicating that the sealing member is within the blood vessel lumen. When the sealing member is withdrawn from the vessel lumen, it blocks the blood flow into the distal opening. The sealing member may be further withdrawn a predetermined distance so that no part of the sealing member extends into the blood vessel lumen. The sealing device is then detached from the delivery apparatus to seal the vascular puncture.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: A medical device that includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. A plurality of tissue engaging portions are associated with the plurality of struts, with each tissue engaging portion extending towards the longitudinal axis in a deployed configuration.

Abstract: A method that includes locating an opening in tissue by advancing a member through the opening in tissue and following locating the opening, deploying a medical device to aid with sealing the opening. The medical device includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. The medical device further includes a plurality of tissue engaging portions associated with the plurality of struts, each tissue engaging portion being disposed between adjacently positioned generally diamond-shaped openings.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: An apparatus for sealing a passage through tissue communicating with a body lumen is provided. The apparatus includes an elongate member having a proximal end a distal end and a lumen extending from the distal end toward the proximal end defining a longitudinal axis. A plug member is disposed on the distal end and extends distally from the elongate member in a pre-deployed and deployed configuration. The plug member includes a distal port therein in communication with the lumen and has a cross-sectional diameter at a plug proximal end and a plug distal end greater than a cross-sectional diameter of the distal end of the elongate member in the pre-deployed configuration. The apparatus also includes a member extendable distally from the distal port, the member including a proximal end and a distal end.

Abstract: Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes a fastener and an advanceable, deformable clip having a delivery configuration in which opposing sides do not contact one another, and a deployed configuration, in which the fastener causes opposing sides of the deformable clip to close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The clip is then deformed with the fastener to draw opposing sides of the puncture together, and the sheath is withdrawn to seal the wound. The clip and fastener preferably are bioabsorbable.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

Abstract: A method for closing an opening in a wall of a body lumen using a clip can include advancing a distal end of an elongate member within the body lumen, the elongate member having a distal portion that assists in presenting the wall for receiving a clip having a plurality of tissue engaging portions having tips that point generally toward a central axis of the clip. The clip can be advanced relative to the elongate member and the wall of the body lumen until the plurality of tissue engaging portions penetrate the wall of the body lumen. Once the clip penetrates the wall, the elongate member can be withdrawn from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

Abstract: An apparatus for sealing a passage through tissue includes a tubular member, a plug, and a locator member. The plug is disposed on a distal end of the tubular member and includes an external thread. The locator member is inserted into a lumen of the tubular member until a distal portion is disposed beyond the plug. The distal portion includes a helically wound wire and a tether coupled to the wire that is movable for causing the wire to buckle. To seal a passage communicating with a blood vessel, the distal portion of the locator member is inserted into the passage, and the plug is threaded into the passage until the distal portion extends into the vessel. The tether is pulled to buckle the wire, and the plug is unthreaded until the buckled wire contacts a wall of the vessel, whereupon the plug is released to seal the passage.

Abstract: An apparatus for sealing a passage through tissue includes a tubular member, a plug, and a locator member. The plug is disposed on a distal end of the tubular member and includes an external thread. The locator member is inserted into a lumen of the tubular member until a distal portion is disposed beyond the plug. The distal portion includes a helically wound wire and a tether coupled to the wire that is movable for causing the wire to buckle. To seal a passage communicating with a blood vessel, the distal portion of the locator member is inserted into the passage, and the plug is threaded into the passage until the distal portion extends into the vessel. The tether is pulled to buckle the wire, and the plug is unthreaded until the buckled wire contacts a wall of the vessel, whereupon the plug is released to seal the passage.

Abstract: The present disclosure relates to a clip manufactured according to a method which can be used to engage body tissue for the purpose of closing wounds. Such clips are generally annular in shape and have radially inwardly extending tines. The present disclosure first forms a precursor which, in one embodiment, has the tines extending radially outwardly from the annular body and then forms the clip by inverting the precursor such that the tines extend radially inwardly. In an alternate embodiment, the precursor is formed with an over-sized lateral dimension and then compressed inwardly to bring the tines closer together and to reduce the lateral dimension of the precursor. Such clips may be manufactured from a superelastic alloy such as nickel-titanium, in which case the inverted or compressed precursor must be heated and quenched to heat set the clip in its final shape.