Abstract: A vessel puncture closure device includes a balloon catheter and a sealant delivery device. The balloon catheter has an inflatable balloon positioned at a distal end thereof. The sealant delivery catheter has a sealant lumen configured to delivery a volume of sealant to a vessel puncture. The sealant delivery catheter is configured to move axially relative to the balloon between a first position in which the sealant delivery catheter delivers a first volume of sealant to the vessel puncture, and a second position spaced proximal of the first position to deliver a second volume of sealant to the vessel puncture.

Abstract: A closure assembly includes an insertion sheath insertable into a tissue puncture and a tissue puncture closure device insertable through the insertion sheath and into the tissue puncture. The tissue puncture closure device includes a dual lumen delivery tube, a first sealing sleeve, and a second sealing sleeve. The dual lumen delivery tube has a first lumen configured to deliver a volume of sealing material to the tissue puncture, and a second lumen sized for insertion of a balloon location device. The first sealing sleeve is positioned between an outer surface of the dual lumen delivery tube and an inner surface of the insertion sheath to limit backflow of the sealing material into the insertion sheath. The second sealing sleeve is positioned between an outer surface of the balloon location device and an inner surface of the second lumen to limit backflow of the sealing material into the second lumen.

Abstract: A tissue puncture access assembly that includes a sheath and a dilator. The sheath is operable between an expanded position with a first maximum outer diameter, and a collapsed position with a second maximum outer diameter that is less than the first maximum outer diameter. The dilator is insertable through the sheath and has a leading end positionable distal of a distal end of the sheath. The sheath is operated into the collapsed position prior to and during insertion with the dilator into a tissue puncture. The sheath is operated into the expanded position once positioned in the tissue puncture.

Abstract: A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

Abstract: In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

Abstract: A vascular closure device includes an inflation balloon and a delivery tube. The delivery tube includes an inflation lumen configured to deliver inflation fluid to the inflation balloon, a sealant lumen configured to deliver a sealant to a vessel puncture, and a delivery tip in flow communication with the sealant lumen and having a plurality of outlet openings.

Abstract: An occlusion device may comprise a first tube having a first balloon positioned at a distal end, and a second tube having a second balloon positioned at a distal end. The first balloon may be sized and configured to occlude a vascular lumen upstream of a vascular puncture, and the second balloon may be sized and configured to simultaneously occlude the vascular lumen downstream of the vascular puncture. A method of occluding a vascular puncture may comprise positioning a distal end of an occlusion device comprising a first balloon and a second balloon through the vascular puncture and into a vascular lumen. The first balloon may be positioned downstream of the vascular puncture, and the second balloon may be positioning upstream of the vascular puncture.

Abstract: A vascular closure system includes a carrier tube, an expandable anchor, a bioadhesive material, a sealing tip, and a filament. The expandable anchor is mounted to the carrier tube and configured to extend through a vessel puncture to temporarily seal the vessel puncture from within a vessel. The bioadhesive material is disposed outside of the vessel and configured to seal the vessel puncture. The sealing tip is mounted to the carrier tube distal of the expandable anchor. The filament is connected to and extends proximally from the sealing tip. Applying tension in the filament maintains connection of the sealing tip to the carrier tube, and releasing the tension in the filament permits release of the sealing tip within a channel formed in the bioadhesive material upon removal of the anchor through the bioadhesive material to seal the channel.

Abstract: A deployment device having a carrier tube, for bringing a sealing plug into position within a puncture tract or incision and deploying the sealing plug within the incision or puncture tract, towards the outer surface of a tissue puncture, is provided. The carrier tube is designed to facilitate easier deployment and improved compaction of the sealing plug, the sealing plug often made of collagen. The carrier tube is adapted to prevent the premature hydration of the sealing plug, where premature hydration of the sealing plug may result in difficulty in deploying the sealing plug. The carrier tube is designed to facilitate easier loading of puncture tract closing elements into the distal end of the carrier tube.

Abstract: A tissue puncture access assembly that includes a sheath and a dilator. The sheath is operable between an expanded position with a first maximum outer diameter, and a collapsed position with a second maximum outer diameter that is less than the first maximum outer diameter. The dilator is insertable through the sheath and has a leading end positionable distal of a distal end of the sheath. The sheath is operated into the collapsed position prior to and during insertion with the dilator into a tissue puncture. The sheath is operated into the expanded position once positioned in the tissue puncture.

Abstract: A vascular closure system includes a suture and an anchor assembly. The anchor assembly includes a first anchor portion having a plurality of petal members automatically expandable from a retracted position for delivery through a vessel puncture in a vessel, and an expanded position when deployed within the vessel. The anchor assembly also includes a second anchor portion connected to the suture and positioned distal of the first anchor portion within the vessel. Withdrawing the suture pulls the second anchor portion against the first anchor portion to contact the first anchor portion against an inner surface of the vessel adjacent to the vessel puncture. The vascular closure system may also include an automatic compaction assembly that automatically compacts a sealing member against the anchor assembly to seal closed the vessel puncture upon withdrawal of the vascular closure system.

Abstract: In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

Abstract: A vascular closure system includes a suture and an anchor assembly. The anchor assembly includes a first anchor portion having a plurality of petal members automatically expandable from a retracted position for delivery through a vessel puncture in a vessel, and an expanded position when deployed within the vessel. The anchor assembly also includes a second anchor portion connected to the suture and positioned distal of the first anchor portion within the vessel. Withdrawing the suture pulls the second anchor portion against the first anchor portion to contact the first anchor portion against an inner surface of the vessel adjacent to the vessel puncture. The vascular closure system may also include an automatic compaction assembly that automatically compacts a sealing member against the anchor assembly to seal closed the vessel puncture upon withdrawal of the vascular closure system.

Abstract: This invention relates to a pre-configured compressible transcatheter prosthetic cardiovascular valve having an improved anterior leaflet sealing component comprising an inflatable annular sealing device made of a shell of elastomeric material, stabilized tissue or synthetic material, attached to the stent, and wherein during deployment of the valve the shell is filled to form a subvalvular seal. The invention also relates to methods for deploying such a valve for treatment of a patient in need thereof.

Abstract: A procedural sheath holding device includes a base member and a securing member. The base member is positionable in contact with an outer skin surface adjacent to an incision. The securing member is attached to the base member and includes a securing portion operable to releasably secure a procedural sheath in a fixed axial position relative to the skin surface when a vascular closure device is inserted through the procedural sheath to seal the incision. The securing member may be pivotal relative to the base member.

Abstract: A tissue puncture closure device includes a vessel locator and a sealing plug delivery member. The vessel locator includes an expandable member. The sealing plug delivery member includes a carrier tube, a sealing plug, and a locking member. The carrier tube includes a distal end and a side opening, the side opening extending proximally from the distal end along at least a portion of a length of the carrier tube to provide lateral insertion of the vessel locator into an interior of the carrier tube. The sealing plug includes a lumen and a slot extending from a distal end to a proximal end of the sealing plug, wherein the slot provides lateral access of the vessel locator into the lumen. The locking member is operable to retain the vessel locator within the sealing plug delivery member.

Abstract: A vascular closure system (10) includes a dual lumen tube (14), an inflatable balloon (16), and a distal sealing assembly (18). The dual lumen tube includes a proximal end portion, a distal end portion, a first lumen, and a second lumen. The first lumen is coupled in fluid communication with an inflation fluid and has a first distal opening at a distal end of the dual lumen tube. The second lumen extends from the proximal end portion to the distal end portion. The inflatable balloon is mounted to the dual lumen tube in fluid communication with the first lumen, and is inflatable within a vessel to temporarily seal closed a tissue puncture. The distal sealing assembly includes a distal sealing member (74) positioned distal of the inflatable balloon, and is detachable from the distal sealing assembly at a location exterior and adjacent to the vessel.

Abstract: A bioadhesive sealant storage and preparation system may comprise a plurality of containers and an adapter. The plurality of containers may comprise a first container having a first bioadhesive sealant component therein, and a second container having a second bioadhesive sealant component therein. The adapter may comprise a manifold comprising a plurality of channels formed therein, an inlet region sized and configured to receive the plurality of containers and facilitate fluid communication between each container of the plurality of containers and a respective channel of the plurality of channels, and an outlet region sized and configured to receive a syringe and provide fluid communication between the syringe and the plurality of channels.

Abstract: A bioadhesive delivery catheter includes a manifold, a dual lumen tube, and a mixing member. The manifold includes a delivery device passage and an injection port. The tube is insertable into the delivery device passage and includes first and second lumens positioned side-by-side. The first lumen extends proximal of the second lumen within the delivery device passage, and the second lumen is in flow communication with the injection port. The mixing member is positioned between a proximal inlet of the injection port and the second lumen and is configured to help mix a bioadhesive material that is delivered through the injection port into the second lumen.

Abstract: A vascular closure assembly configured to seal a puncture in a vessel that is accessible through a tissue tract. The vascular closure assembly includes a vascular closure device comprising a handle assembly, an insertion shaft, an anchor assembly, and at least one suture member. The insertion shaft extends distally from the handle assembly and carries a plurality of needles. The needles are operable to position at least one suture across the vessel puncture. The anchor assembly is positioned distal of the insertion shaft. The at least one suture member is positioned distal of the insertion shaft. The insertion shaft extends into the tissue tract to position the anchor assembly through the puncture and into the vessel and includes a first depth indicator on an outer surface thereof that indicates a depth of the tissue tract.