Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

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.

Devices and methods for occluding or promoting fluid flow through openings are disclosed. In one exemplary embodiment an occlusion device is provided having an expandable outer elongate tubular body, a guide member extending from a distal end of the outer body, and a slide tube disposed within the outer body, the proximal portions of the outer body and the slide tube being fixedly mated. The slide tube is configured to slide distally within the outer tubular body when the tubular body is expanded to form wings. A tether can be included as part of the device and it can be used to assist in positioning and locking a location of the device in an opening. Exemplary methods for delivering devices disclosed herein are also provided.

The present disclosure provides embodiments of a method for improving coaptation of the anterior and posterior mitral valve leaflets by applying a remodeling force to the posterior leaflet. In particular embodiments, a tension member is secured at a location on or proximate to the posterior leaflet. Tension can be applied to the tension member in a direction superiorly and anteriorly toward the interatrial septum. The tension member can be secured at a location proximate the septum to maintain the tension. The tension provides the remodeling force, pulling the posterior leaflet superiorly and anteriorly to improve coaptation with the anterior leaflet.

A small diameter delivery device capable of delivering a tissue loaded scaffold arthroscopically to a tissue defect or injury site without reducing the pressure at the injury site is provided. The scaffold delivery device of the present invention comprises a plunger system that includes two main components: an insertion tube and an insertion rod. The insertion tube has a flared proximal end for holding a tissue scaffold prior to delivery. An elongate, hollow body extends from the flared proximal end to a distal end of the insertion tube, and defines a passageway that extends through the body for delivery of the tissue scaffold. The insertion rod has an elongate body that extends into a handle at a proximal end and a tip at a distal end. The insertion rod is configured to be removably disposed within the insertion tube for sliding along the passageway to effect delivery of the tissue scaffold through the insertion tube.

An occlusion device and a production process for it are described. The occlusion device consists of a mesh or braiding of at least one wire or thread wherein the occlusion device has been given a suitable design using a reshaping and/or heat-treatment process, is self-expandable, and is configured for secure anchoring in an atrial appendage of the left or right atrium of a heart. The occlusion device comprises a proximal retention region on a proximal end of the occlusion device a distal retention region and a central region between the proximal retention region and said distal retention region and wherein the occlusion device has a closed distal end without a holder, and wherein the occlusion device is at least partly of essentially spherical form, and hollow.

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

An occlusion balloon device includes a shaft comprising at least one inflation lumen and an inflatable balloon, the inflatable balloon having a plurality of independently inflatable and deflatable balloon portions and being in communication with the at least one inflation lumen. A method and a system comprising the occlusion balloon device enable assessment and treatment of a perforation in a vessel of a patient.

Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.