The present invention provides a percutaneous vascular surgical system for performing endovascular/neurovascular interventions, the system incorporating a sheath having a proximal end and a distal end and defining a main lumen extending between the proximal and distal ends, an auxiliary lumen also defined by the sheath, a reversibly inflatable balloon located about the sheath adjacent the distal end and in fluid communication with the auxiliary lumen, a syringe selectively connectable to the main lumen to create suction through the main lumen, and a vessel closure device for the closure of the arteriotomy, the surgical system and method of the invention having utility in a large number of percutaneous vascular procedures such as carotid artery stenosis or neurovascular interventions and enabling four procedures to be performed with one system, being percutaneous access, emboli removal, flow reversal and arteriotomy closure.

Electrophysiology mapping and visualization systems are described herein where such devices may be used to visualize tissue regions as well as map the electrophysiological activity of the tissue. Such a system may include a deployment catheter and an attached hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. A position of the catheter and/or hood may be tracked and the hood may also be used to detect the electrophysiological activity of the visualized tissue for mapping.

A closure device for sealing an atrial septal defect is provided. The closure device includes a distal closure portion and a proximal closure portion. The distal closure portion includes a distal membrane covering a plurality of distal fingers that extend in a distal plane. The proximal closure portion includes a proximal membrane covering a plurality of proximal fingers that extend in a proximal plane. The closure device also includes a waist section extending axially between the plurality of distal fingers and the plurality of proximal fingers. The distal closure portion is configured to sealingly engage one of the left or right side of a septal wall, the proximal closure portion is configured to sealingly engage the other of the left or right side of the septal wall, and the waist section is configured to be positioned and centered in an atrial septal defect between the left and the right septal wall.

The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Medical devices, systems and methods for forming an occlusive material for occluding a left atrial appendage of a heart are provided. In one embodiment, the occlusive material includes a foam portion that extends as a single piece, seamless monolithic structure that is sized to couple to an external side of a framework of a medical device. In another embodiment, the occlusive material may include a polymeric laminate. Such polymeric laminate may be adhered to an outer side of the foam portion. Further, various embodiments for forming a polymer laminate are provided.

A system for treating a heart includes a catheter that is advanceable into a chamber of the heart and that is repositionable within the chamber between a septal wall and an external wall to enable penetration of the septal and external walls via a needle that is disposed within a lumen of the catheter. A first guidewire is deliverable through the penetration of the septal wall so that a distal end of the first guidewire is disposed within another chamber of the heart. A second guidewire is deliverable through the penetration of the external wall so that a distal end of the second guidewire is disposed externally of the external wall. The first guidewire is connectable to the second guidewire to join or form a path within the chamber that extends between the septal wall and the external wall.

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.

A closure system includes a catheter having an internal diameter D1 [mm]; and a closure device to be delivered to the hole or duct in the tissue through the catheter. The closure device includes: a first plate including a first center part, and a first extension part extending around the first center part and containing a resin having elastic restorability; and a waist part connected to the first center part. The first extension part has a thickness A1 [mm]. The waist part has a maximum dimension T1 [mm] in a plan view. The internal diameter D1 of the catheter is larger than 2×A1+T1.

Systems, devices, and methods for providing an endoluminal transhepatic access to a patient pancreaticobiliary system in an endoscopic procedure are disclosed. An example of a transhepatic access procedure comprises navigating a steerable elongate instrument through a body cavity or channel and exiting to a access site of liver, puncturing the liver from the access site, extending the steerable elongate instrument through the liver and into the pancreaticobiliary system and performing an operation therein. Following the operation, the steerable elongate instrument can be retreated, and the access site of liver can be closed with a closure means. Apparatus and methods of training a machine-learning model and using said model to identify patient candidacy for retrograde access based on images of patient anatomy are also disclosed.

An insertable catheter device includes a shaft including a proximal end and a distal end, an expandable balloon, and an actuator configured to expand and retract the expandable balloon. The actuator includes a fluid conduit that extends through the shaft and is coupled with the expandable balloon to enable inflation and retraction of the expandable balloon via injection or withdrawal of a fluid to or from the expandable balloon via the fluid conduit. The expandable balloon is displaceably retractable into the shaft and extendable from the shaft. A fluid pump is coupled with the fluid conduit to pump the fluid through the fluid conduit. A patch is positioned to be displaced by the expandable balloon when the expandable balloon is inflated, and the expandable balloon is displaceably retractable into the shaft and displaceably extendable from the shaft.