Abstract: An apparatus for sealing a puncture through tissue to a vessel includes an elongate occlusion member including an expandable member, a cartridge carried on the occlusion member, and a sealant carried within the cartridge. The cartridge includes an outer member and a pusher member within the outer member. The sealant is disposed within the outer member adjacent the expandable member distal to the pusher member. During use, the occlusion member is introduced into a puncture until the expandable member and the sealant extend from the puncture into the vessel. The expandable member is expanded, and withdrawn until the expanded expandable member contacts the vessel wall, thereby withdrawing the sealant back into the puncture. The outer member is withdrawn to expose the sealant within the puncture, while the pusher member prevents removal of the sealant, and then the cartridge, occlusion member, and pusher member are successively removed.

Abstract: An apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.

Abstract: A sealant is provided for sealing a puncture through tissue that includes an elongate first section including a proximal end, a distal end, and a cross-section sized for delivery into a puncture through tissue, and a second section fused to and extending from the distal end of the first section. The first section may be formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within a puncture. The second section may be formed from a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, the precursors remaining in an unreactive state until exposed to an aqueous physiological, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section. Apparatus and methods for delivering the sealant into a puncture through tissue are also provided.

Abstract: A method for facilitating treatment of catheter induced vascular injuries may first involve introducing a guide wire into a vascular sheath residing in a blood vessel, where the guide wire has a distal end and an inflatable balloon at least 15 cm proximal of the distal end. The method may further involve proximally retracting the vascular sheath while leaving the wire in place and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may involve positioning the inflatable balloon at or near the vascular injury and inflating the balloon to reduce blood flow past the vascular injury, while leaving the guide wire in place to provide subsequent access to the injury.

Abstract: An apparatus for sealing a puncture includes a cartridge, a pusher member, a sealant, and a tamping device on a proximal end of the cartridge. During use, the cartridge, sealant, and pusher member are advanced over a positioning member and into the puncture by advancing a cartridge hub carrying the tamping device. When further distal advancement of the cartridge is limited, the cartridge hub is further advanced, activating the tamping device, and causing the pusher member to advance relative to the sealant to compress the sealant within the puncture.

Abstract: Methods for sealing a puncture communicating with a blood vessel are provided that include introducing a porous carrier formed from lyophilized hydrogel or other material into the puncture. The plug may include at least first and second hydrogel precursors and a pH adjusting agent carried by the porous carrier in an unreactive state prior to exposure to an aqueous physiological environment. Once exposed to bodily fluids, the carrier expands as the lyophilized material hydrates to enhance and facilitate rapid hemostasis of the puncture. When the plug is placed into the puncture, the natural wetting of the plug by bodily fluids (e.g., blood) causes the first and second precursors to react and cross-link into an adhesive or “sticky” hydrogel that aids in retaining the plug in place within the puncture.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a bioabsorbable sealing member secured to one end of a filament or other retaining member. The sealing member is delivered through the puncture into the vessel, and refracted against the wall of the vessel to provide temporary hemostasis. The sealing member is rapidly absorbed after exposure within the vessel, e.g., to an aqueous or heated physiological environment (e.g., exposure to blood or body temperature), immediately or shortly after completing a medical procedure via the puncture, e.g., within the time period that the patient is ambulatory. Optionally, extravascular sealing material is delivered into the puncture proximal to the sealing member. The retaining member and/or extravascular material may be bioabsorbable, being absorbed at a slower rate than the sealing member. Alternatively, the filament is removed from the puncture after hemostasis is established.

Abstract: Apparatus for sealing a puncture through tissue to a blood vessel includes a cartridge including a proximal end, a distal end sized for insertion into a puncture, and a lumen extending therebetween. A bioabsorbable plug is disposed within the lumen adjacent the distal end, and an anchoring element is disposed within the lumen proximal to the plug. A pusher member is disposed within the lumen for deploying the plug and anchoring element out the distal end of the cartridge. The plug may be formed from lyophilized hydrogel and the anchoring element may be formed from air-dried hydrogel, the anchoring element hydrating slower than the plug when exposed to an aqueous environment. During use, the plug and anchoring element are delivered into the puncture, the plug is cinched against the vessel wall. Protrusions on the anchoring element engage tissue surrounding the puncture to prevent proximal movement of the plug.

Abstract: An apparatus for sealing a puncture includes a cartridge, a pusher member, a sealant, and a tamping device on a proximal end of the cartridge. During use, the cartridge, sealant, and pusher member are advanced over a positioning member and into the puncture by advancing a cartridge hub carrying the tamping device. When further distal advancement of the cartridge is limited, the cartridge hub is further advanced, activating the tamping device, and causing the pusher member to advance relative to the sealant to compress the sealant within the puncture.

Abstract: A method for facilitating treatment of catheter induced vascular injuries may first involve introducing a guide wire into a vascular sheath residing in a blood vessel, where the guide wire has a distal end and an inflatable balloon at least 15 cm proximal of the distal end. The method may further involve proximally retracting the vascular sheath while leaving the wire in place and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may involve positioning the inflatable balloon at or near the vascular injury and inflating the balloon to reduce blood flow past the vascular injury, while leaving the guide wire in place to provide subsequent access to the injury.

Abstract: An apparatus for sealing a puncture through a vessel wall including an elongate tubular body, a balloon carried by the body, an outer tubular member carried over the tubular body, and a sealant carried by the tubular body adjacent the balloon. Retracting the outer tubular member exposes the sealant.

Abstract: A method for sealing a puncture through a vessel wall using a sealing device including an elongate tubular body, a balloon carried by the body, an outer tubular member carried over the elongate tubular body, and a sealant carried by the elongate tubular body adjacent the balloon. Retracting the outer tubular member exposes the sealant.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a bioabsorbable sealing member secured to one end of a filament or other retaining member. The sealing member is delivered through the puncture into the vessel, and retracted against the wall of the vessel to provide temporary hemostasis. The sealing member is rapidly absorbed after exposure within the vessel, e.g., to an aqueous or heated physiological environment (e.g., exposure to blood or body temperature), immediately or shortly after completing a medical procedure via the puncture, e.g., within the time period that the patient is ambulatory. Optionally, extravascular sealing material is delivered into the puncture proximal to the sealing member. The retaining member and/or extravascular material may be bioabsorbable, being absorbed at a slower rate than the sealing member. Alternatively, the filament is removed from the puncture after hemostasis is established.

Abstract: Apparatus and methods are provided for sealing a puncture through the wall of a patient's heart into a heart chamber, e.g., at the apex of the heart into the left ventricle. A positioning member is advanced into the puncture until a positioning element thereon is disposed within the chamber, the positioning element is expanded within the chamber, and the positioning member is withdrawn until the expanded positioning element contacts the endocardial wall of the chamber. A cartridge carrying a solid sealant is advanced over the positioning member, and the sealant is deployed within the puncture, e.g., offset proximally from the endocardial wall, the sealant expanding upon exposure to fluid within the puncture to seal the puncture.

Abstract: A method for sealing a puncture through a vessel wall using a sealing device including an elongate tubular body, a balloon carried by the body, an outer tubular member carried over the elongate tubular body, and a sealant carried by the elongate tubular body adjacent the balloon. Retracting the outer tubular member exposes the sealant.

Abstract: An apparatus for sealing a puncture through a vessel wall including an elongate tubular body, a balloon carried by the body, an outer tubular member carried over the tubular body, and a sealant carried by the tubular body adjacent the balloon. Retracting the outer tubular member exposes the sealant.

Abstract: An apparatus for sealing a puncture through tissue having an introducer sheath therein includes an elongate positioning member including a housing on a proximal end and an expandable member on a distal end, and a cartridge advanceable along the positioning member from a proximal position to a distal position. The cartridge includes a tubular member including a sealant and an advancer member disposed within lumen of the tubular member. A sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member, the tubular member distal end enters the introducer sheath while the sleeve is stopped and slides over the tubular member to expose the tubular member distal end within the introducer sheath. The introducer sheath and cartridge are then withdrawn, exposing the sealant within the puncture.

Abstract: Apparatus for sealing a puncture through tissue to a blood vessel includes a cartridge including a proximal end, a distal end sized for insertion into a puncture, and a lumen extending therebetween. A bioabsorbable plug is disposed within the lumen adjacent the distal end, and an anchoring element is disposed within the lumen proximal to the plug. A pusher member is disposed within the lumen for deploying the plug and anchoring element out the distal end of the cartridge. The plug may be formed from lyophilized hydrogel and the anchoring element may be formed from air-dried hydrogel, the anchoring element hydrating slower than the plug when exposed to an aqueous environment. During use, the plug and anchoring element are delivered into the puncture, the plug is cinched against the vessel wall. Protrusions on the anchoring element engage tissue surrounding the puncture to prevent proximal movement of the plug.

Abstract: A sealant is provided for sealing a puncture through tissue that includes an elongate first section including a proximal end, a distal end, and a cross-section sized for delivery into a puncture through tissue, and a second section fused to and extending from the distal end of the first section. The first section may be formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within a puncture. The second section may be formed from a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, the precursors remaining in an unreactive state until exposed to an aqueous physiological, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section. Apparatus and methods for delivering the sealant into a puncture through tissue are also provided.

Abstract: An apparatus for sealing a puncture communicating with a blood vessel includes an inner member slidable within an outer member, and a balloon coupled to distal ends of the inner and outer members. A proximal end of the outer member includes a port for delivering fluid into the balloon, and a cylinder that communicates with the port. A piston coupled to the inner member is slidable and biased to move distally within the cylinder. The apparatus is introduced into the puncture until the collapsed balloon is disposed within the vessel. Fluid is introduced into the port, moving the inner member proximally to shorten the balloon as it expands. The balloon is withdrawn to seal the puncture, and a hydrogel is introduced into the puncture. Fluid is removed via the port, moving the inner member distally to extend the balloon as it collapses, and the apparatus is withdrawn.