Abstract: A tissue puncture closure device includes an anchor, a sealing plug, a compaction member, a suture, a handle portion, a sheath attachment member, and a sheath adapter. The compaction member is configured to compress the sealing plug towards the anchor. The suture is coupled to the sealing plug and anchored. The handle portion is arranged proximal of the sealing plug and anchor. The sheath attachment member extends from the handle portion. The sheath adapter has a first end portion configured to mount to the sheath attachment member, and a second end portion configured to mount to a procedural sheath that is inserted into a tissue puncture.

Abstract: A vascular closure assembly is configured to seal a vascular puncture in a vessel. The vascular closure assembly includes a balloon location device and a sealant delivery device. The balloon location device includes an inflation tube and an inflatable balloon positioned at a distal end of the inflation tube and operable, when inflated, between a first position blocking blood flow through the vessel and a second position sealing the puncture from within the vessel. The sealant delivery device includes a sealant delivery tube having a first lumen sized to advance over the inflation tube to the puncture, and a second lumen configured to deliver a volume of sealant to the puncture. The first lumen may include a rapid exchange feature.

Abstract: A vascular closure device includes a catheter, a balloon, an introducer, and a guidewire lumen. The catheter includes an inflation lumen. The balloon is positioned at a distal end portion of the catheter. The introducer is positioned distal of the balloon. The guidewire lumen extends along at least a portion of the introducer and terminates at a rapid exchange port positioned distal of the balloon. The guidewire lumen is receptive of a guidewire to guide the catheter through a vessel puncture in a vessel to position the balloon within the vessel.

Abstract: A closure device operable to seal a vessel puncture and including a delivery member and a sealant material applicator. The delivery member is insertable through a tissue tract to the vessel puncture. The sealant material applicator is configured to supply a volume of sealant material to the delivery member and includes a housing, a plunger assembly, and at least one container. The housing includes at least first and second chambers, wherein the first chamber carries a first sealant component and the second chamber carries a second sealant component. The container is insertable into the first or second chamber and carries a third sealant component of the sealant material. The sealant material applicator creates flow communication between the container and at least one of the first and second chambers to mix the third sealant component with the first and second sealant components.

Abstract: A sealant delivery device includes a delivery tube, a bioadhesive container, and an adapter. The delivery tube includes proximal and distal ends. The bioadhesive container holds a sealant activator and a sealant precursor separated from each other. The adapter is interposed between the delivery tube and the bioadhesive container. The adapter includes a first channel member that couples a first lumen of the delivery tube to the sealant activator, and a second channel member that couples the first lumen to the sealant precursor. The adapter provides separation of the sealant activator and the sealant precursor until a position distal of the bioadhesive container.

Abstract: A suture cutting device including a housing, a cutting member, a suture recess, and an actuator. The cutting member is positioned in the housing. The suture recess is formed in the housing and configured to releasably connect the housing to the suture. The actuator is accessible outside of the housing and operable to move the cutting member laterally relative to the suture within the housing from a first position out of contact with the suture to a second position cutting the suture.

Abstract: A vascular closure device includes a handle, a carrier tube, a sealing tip, a sealing tip connection member, and an actuator. The carrier tube extends from the handle. The sealing tip is positioned at a distal end of the carrier tube. The sealing tip connection member extends from the sealing tip to the handle. The actuator is mounted to the handle and operable to move the sealing tip connection member to release the sealing tip from the carrier tube.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve. In some embodiments, after a prosthetic valve has been at least partially delivered from a delivery sheath into the left atrium of a heart, a valve positioning device can be used to engage with and position the prosthetic valve within the mitral annulus. The valve positioning device can include an alignment member configured to engage with a prosthetic valve such that the alignment member can control the distal, proximal, lateral and/or rotational movement of the prosthetic valve. The prosthetic valve can include a tether that can be inserted or threaded through the alignment member such that the alignment member can be moved along the tether into engagement with the prosthetic valve.

Abstract: A device 10 for gathering tissue of a heart valve leaflet 2 may include an outer tube 16 extending in an elongation direction, a capture tool 22 moveable in the outer tube between a contained position and a use position, and a tissue securing component 32 disposed at a distal end 17 of the outer tube and adapted to be applied to tissue 8 captured by the capture tool to hold the captured tissue in a gathered configuration. The capture tool may include a first element 20 and a second element 22 that are moveable relative to one another in the elongation direction. The first and second elements 20, 22 may be operable to capture tissue 8 of the heart valve leaflet 2 therebetween and to draw the captured tissue into the outer tube 16 in the gathered configuration.

Abstract: A tissue puncture closure device includes an anchor, a sealing plug, a filament, a compaction member assembly, a spool, a stop feature, a driving plate, and a release member. The filament attaches the sealing plug to the anchor. The compaction member assembly applies an axially directed compressive force to compact the sealing plug toward the anchor. The spool has a portion of the filament wound thereon. The stop feature is coupled to the spool. The driving plate is connected to the spool and arranged to apply a force to a proximal end of the compaction member assembly upon rotation of the driving plate to advance the compaction member assembly. The release member is operable from a first position contacting the stop feature to limit rotation of the spool, and a second position out of contact with the stop feature to permit rotation of the spool.

Abstract: A device 10 for gathering tissue of a heart valve leaflet 2 may include an outer tube 16 extending in an elongation direction, a capture tool 22 moveable in the outer tube between a contained position and a use position, and a tissue securing component 32 disposed at a distal end 17 of the outer tube and adapted to be applied to tissue 8 captured by the capture tool to hold the captured tissue in a gathered configuration. The capture tool may include a first element 20 and a second element 22 that are moveable relative to one another in the elongation direction. The first and second elements 20, 22 may be operable to capture tissue 8 of the heart valve leaflet 2 therebetween and to draw the captured tissue into the outer tube 16 in the gathered configuration.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Abstract: Wound closure devices, systems, and methods may be used to close an opening, such as a puncture wound or incision, formed in tissue, such as heart tissue. A wound closure device may be configured and adapted to be placed within the puncture wound or incision to close and/or seal the puncture wound or incision. A bioadhesive may be used to strengthen the closure and/or seal of the puncture wound after placement of the wound closure device relative to the puncture wound.

Abstract: A vascular closure system includes a body portion, an anchor, at least one suture member, and a plurality of needles. The anchor assembly includes a hub and a wire assembly. The hub has at least one aperture defined in a sidewall thereof. The wire assembly includes an actuator member extending proximally through the body portion and hub, and at least one pre-formed wire having a free proximal end and a distal end that is connected to the actuator member. Withdrawing the actuator member extends the proximal end of the at least one pre-formed wire out of the at least one aperture to capture a portion of the vessel wall between the pre-formed wire and the body portion. The plurality of needles extend through the vessel wall adjacent to the vessel puncture and are configured to connect to the at least one suture member.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

Abstract: A tissue closure system includes a sheath and a tissue closure device. The sheath includes a tensioner assembly. The tissue closure device is insertable through and connected to the sheath, and includes an expandable member positionable distal of a distal end of the sheath. Operating the tensioner assembly applies a biasing force to the tissue closure device that withdraws the expandable member.

Abstract: Methods and apparatus are disclosed for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The methods and apparatus provide for a compaction device or a tamping device that improves control of the amount of force exerted upon the sealing plug. Further, the compaction tube or tamping device can deform upon application of excessive compaction force, thereby reducing the possibility of damage to the sealing plug, anchor, or artery.

Abstract: A bioadhesive mixing assembly includes first and second syringes and an adapter. The first syringe includes first and second chambers holding a first sealant component and an activator, respectively. The second syringe includes third and fourth chambers holding a second sealant component and one of an activator or a third sealant component, respectively. The adapter is mounted to the first syringe and includes first and second channels in flow communication with the first and second chambers, a first seal member providing sealed access to the first and second channels, first and second needles connected in flow communication with the third and fourth chambers, and a second seal member enclosing the first and second needles. Connecting the adapter to the second syringe punctures the first and second seal members with the first and second syringes to create flow communication between the first and third chambers and the second and fourth chambers.

Abstract: A vascular closure device may comprise an elongate shaft, a vascular sealing structure, and a carriage. The vascular sealing structure may be located on the elongate shaft and configured to apply a pressure to an interior wall of a lumen. The carriage may be slidably coupled to the elongate shaft, and at least one elastically deformable structure may be configured to transfer at least a portion of a force applied to the carriage to the elongate shaft. A method of vascular closure may comprise positioning a vascular sealing structure located on the elongate shaft within a lumen, transferring at least a portion of a force applied to a carriage to the elongate shaft via at least one elastically deformable structure, and applying a pressure to an interior wall of the lumen with the vascular sealing structure to close a vascular opening.