The present invention generally relates to the field of transcatheter device closure techniques for closing an opening in a tissue and more particularly, to occlusion devices for closing anatomical defects in tissue such as defects consisting of an opening connecting a front side and a back side of a tissue. More particularly the present invention relates to occlusion devices for closing septal abnormalities such as atrial septal defects and patent foramen ovale, delivering systems for such occlusion devices, kits comprising the occlusion devices and the delivering systems and to methods of closing an anatomical defect in a tissue consisting of an opening connecting a front side and a back side of a tissue.

An occlusion device (20) includes a compliant balloon (5) including an inflation port (3) for filling and unfilling a fluid into and from a balloon chamber (26). A distal tip element (10) and a proximal base element (4) are disposed at distal and proximal sides (28B, 28A) of the balloon (5), respectively. An elongate actuating element (9) is disposed longitudinally slidable in a balloon lumen (6) forming a longitudinal passage (27) from the proximal side (28A) to the distal side (28B) of the balloon (5), connected to the distal tip element (10), and longitudinally moveable with respect to the proximal base element (4) so as to set a distance between the distal tip element (100 and the proximal base element (4). A locking mechanism (2) is configured to maintain, between the distal tip element (10) and the proximal base element (4), the distance set using the elongate actuating element (9).

A puncture sealing system for sealing a vascular puncture comprises an inner member comprising an expandable member at an inner member distal end and an inflation lumen that extends from an inner member proximal end to an interior of the expandable member. The puncture sealing system also comprises an outer member comprising a lumen sized and shaped to allow the inner member to slide therein, an occlusion balloon at an outer member distal end, and an inflation lumen that extends from an outer member proximal end to the interior of the occlusion balloon. The expandable member can be inflated by fluid flowing through the inner member inflation lumen so that the expandable member can inflate in a subcutaneous vessel of a living being, and the occlusion balloon can be inflated by fluid flowing through the outer member inflation lumen so that the occlusion balloon can enable the occlusion of a vascular puncture and contact and apply pressure to a puncture tract extending from the vascular puncture. In one version, the inner member further comprises a vessel locator system. In one version, the puncture sealing system further comprises an obturator slidably receivable within the outer member and having a distal end adapted to at least partially cover the puncture.

An implant delivery system, comprising: an implantable device comprising a plurality of supports extending between a proximal end and a distal end, the supports being moveable between a collapsed configuration and an expanded configuration, a proximal guide tube at the proximal end of the supports extending toward the distal end, and a distal guide tube at the distal end of the supports extending toward the proximal end, wherein the proximal and distal guide tubes are telescoping and become further engaged as the supports move from the collapsed to the expanded configuration.

Apparatus for permanent placement across an ostium of a left atrial appendage in a patient, which includes a filtering membrane configured to extend across the ostium of the left atrial appendage. The filtering membrane has a permeable structure which allows blood to flow through but substantially inhibits thrombus from passing therethrough. The apparatus also includes a support structure attached to the filtering membrane which retains the filtering membrane in position across the ostium of the left atrial appendage by permanently engaging a portion of the interior wall of the left atrial appendage. The support structure may be radially expandable from a first configuration to a second configuration which engages the ostium or the interior wall of the left atrial appendage. The filtering membrane may define an opening therethrough that is configured to expand from a first size which inhibits the passage of thrombus therethrough to a second size which allows an interventional device, e.g., an expansion balloon, to pass therethrough, and wherein the opening is resiliently biased towards the first size.

Disclosed is a biomedical device being introduced by a hollow tube having a longitudinal axis in a subject in a minimally invasive surgery procedure for watertight sealing of an opening including at least two assemblies, each assembly including one flap connected to one arm, the arm having an longitudinal axis; the assemblies including a delivery configuration, a deployed configuration, and a sealed configuration and outwards deployment unit for switching from the delivery configuration to the deployed configuration and inwards deployment unit for switching from the deployed configuration to the sealed configuration. Also disclosed is a kit of parts including an outer hollow tube, an inner hollow tube, and a related biomedical device.

An apparatus for sealing a puncture includes a positioning member including a proximal end, a distal end sized for insertion into a puncture, an expandable element on the distal end, and a tension indicator on the proximal end. The tension indicator includes a distal housing portion fixed relative to the proximal end, and a proximal housing portion or handle movable proximally relative to the distal housing portion. The handle is biased towards the distal housing portion such that, when sufficient tensile force is applied between the expandable element and the handle, the handle moves away from the distal housing portion. During use, the distal end is introduced through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is applied.

System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween. The first gripping element and the second gripping element each includes a plurality of barbs extending therefrom, the plurality of barbs of each of the first gripping element and the second gripping element being aligned transversely in at least one row. The fixation device further includes a covering disposed on each of the first gripping element and the second gripping element, wherein the plurality of barbs of the first gripping element and the second gripping element, respectively, protrude through the covering.

A delivery device includes an inner shaft, an outer sheath, a nosecone, and a tether component. The outer sheath is slidably disposed over the inner shaft. The nosecone is removably coupled to the inner shaft. The nosecone includes a delivery configuration for delivery to a treatment site, a radially compressed configuration in which a portion of the nosecone is configured to traverse through a heart wall, and a radially expanded configuration in which an outer surface of the nosecone contacts an outer surface of the heart wall. The tether component includes a first end coupled to the nosecone. The nosecone is configured to plug a piercing in the heart wall when in the radially expanded configuration.

A closure device system for sealing a percutaneous puncture in a vessel wall can comprise a toggle configured to engage an interior surface of the vessel wall, a plug configured to engage an exterior sur-face of the vessel wall, and a suture that extends through the plug and through the toggle along at least a first direction so as to couple the toggle to the plug. The system can further comprise a tube that extends through the plug and through the toggle along the first direction such that a distal end of the tube is disposed distally to the toggle. The tube can define a guidewire lumen that extends therethrough along the first direction. And the guidewire lumen can be configured to receive a guidewire that protrudes from the vessel wall such that the plug, toggle, and tube are slidable along the guidewire toward the vessel wall.