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through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is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.

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.

The present invention describes systems and methods for treating a hole in the septum, such as a patent foramen ovale or an atrial septal defect, with a closure implant designed to fluidly seal the hole to prevent blood from flowing between the right atrium to the left atrium. The closure implant includes two structures positioned on opposite sides of the hole in septum configured to close and seal the hole. The first structure is an expandable petal anchor having multiple petal groups with multiple petals of different sizes and/or shapes made of shape memory wire configured to be positioned on a distal side of the hole in the septum wall, and the second structure is a braided disk made of shape memory mesh positioned the proximal side of the hole in the septum wall, opposite the petal anchor. The braided disk is sized to cover the hole once it is expanded. The petal anchor is designed to pull and compress the braided disk against the septum wall to cover and fluidly seal the hole. The closure implant is designed to be delivered to the heart using a catheter-based delivery system.

An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

An occlusion device (210) is provided for occluding a left atrial appendage (LAA), including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal end portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice-support stent (290) is fixed to and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

A closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including at least one of a toggle configured to engage an interior surface of the body passageway or a plug configured to engage an exterior surface of the body passageway and a guide wire configured to extend from an outside of the body to inside the body passageway, wherein at least one of the toggle and the plug is associated with the guide wire.

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.

Disclosed is an occluder for occluding a defect in a vasculature. The occluder includes: two occluding disks and a tightening element. The two occluding disks is configured for covering different openings of the defect; wherein the tightening element includes a tightening thread, the tightening thread passing through the defect and being connected to the two occluding disks, the tightening thread has a length between the two occluding disks and the length is adjustable by means of a free end of the tightening thread. Further provided are an occluding system provided with the occluder, a knotting method for the tightening element of the occluder and a method for occluding an oval foramen with the occluder.

Methods for sealing a percutaneous puncture in a wall of a body passageway are disclosed herein. The methods include inserting a deployment instrument into the puncture via a toggle along the guidewire, and actuating the deployment instrument to move the first component and the second component relative to each other such that the toggle abuts the wall of the artery proximate the puncture to seal the puncture.

The invention relates to a medical implant (1) that is adapted to repair or close defect (D), in particular an opening in a ventricular, atrial, or septal wall (W). The medical implant (1) may, in particular, be a patch. It comprises an adhesive composition (6). It further comprises two states, wherein in the first state, the medical implant (1) can be deployed to an implant site while the adhesive composition (6) is inactive. It can be brought into a second state by an activation mechanism. The adhesive composition (6), in the second state, is curable by a curing mechanism.