Expandable trans-septal sheath

Abstract

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. 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 through the atrial septum into the left atrium. The distal end of the sheath is expanded using a radial dilator. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of atrial implants, valve repair, or the like.

Description

PRIORITY CLAIM [0001] This application claims priority to U.S. application Ser. No. 60 / 709,240, filed Aug. 18, 2005, U.S. application Ser. No. 60 / 674,226, filed Apr. 22, 2005, U.S. application Ser. No. 60 / 660,512, filed on Mar. 9, 2005, and U.S. Provisional Application Ser. No. 60 / 608,355, filed on Sep. 9, 2004, the entirety of which are hereby incorporated by reference herein.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention relates to medical devices and, more particularly, to methods and devices for accessing the cardiovascular system. [0004] 2. Description of the Related Art [0005] A wide variety of diagnostic or therapeutic procedures involves the introduction of a device into the vasculature through a percutaneous incision at an access site. Such regions of the vasculature, preferred for access, include both the arteries and veins, typically at peripheral locations in the body. Typical access sites include the jugular vein, the subclavian artery...

AI Technical Summary

Benefits of technology

[0013] Accordingly, an embodiment of the present invention comprises an expandable endovascular access sheath for providing minimally invasive access to a left atrium. An axially elongate sheath tube includes a proximal end, a distal end, and a central through lumen. The sheath has a distal region which is expandable in circumference in response to outward pressure applied therein. A hub is coupled to the proximal end of the sheath tube. The hub is configured to facilitate the passage of instrumentation. An obturator extends through the central lumen and is configured to occlude the central lumen of the sheath during insertion. The obturator comprises an obturator hub that is releasably coupled to the hub of the sheath. A guidewire lumen is within the obturator. The obturator is a balloon dilator capable of expanding the distal region of the sheath from a collapsed configuration to an expanded configuration.

Problems solved by technology

However, problems sometime arise, when trying to pass the guide catheter across the atrial septum, in that the tract generated by the Brockenbrough needle and Mullins catheter closes too tightly to allow passage of the guide catheter.

A risk of atrial septal punctures includes potentially perforating the aorta, a high-pressure outlet line, which resides quite close to the atrial septum.

One of the primary issues that arise during electrophysiology procedures in the heart is the need to remove and replace multiple instruments multiple times, which is highly expensive and adds substantial time to the conduct of the procedure.

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