Device with biological tissue scaffold for percutaneous closure of an intracardiac defect and methods thereof

Abstract

The invention provides an intracardiac occluder, which has biological tissue scaffolds as occlusion shells, for the percutaneous transluminal treatment of an intracardiac defect. The intracardiac occluder includes a proximal support structure supporting the proximal occlusion shell and a distal support structure supporting the distal occlusion shell. In one embodiment, biological tissue derived from the tunica submucosa layer of the porcine small intestine forms the occlusion shells.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application incorporates by reference, and claims priority to and the benefit of, U.S. provisional application Ser. No. 60 / 385,274, which was filed Jun. 3, 2002.TECHNICAL FIELD [0002] The invention generally relates to devices and related methods for treating intracardiac defects. More particularly, the invention provides an intracardiac occluder with a biological tissue scaffold, and related methods, for the percutaneous closure of intracardiac defects. BACKGROUND [0003] The human heart is divided into four compartments or chambers. The left and right atria are located in the upper portion of the heart and the left and right ventricles are located in the lower portion of the heart. The left and right atria are separated from each other by a muscular wall, the intraatrial septum, while the ventricles are separated by the intraventricular septum. [0004] Either congenitally or by acquisition, abnormal openings, holes, or shunts can oc...

AI Technical Summary

Benefits of technology

[0007] The present invention provides a device for occluding intracardiac defects. The device includes a biological tissue scaffold, as opposed to a synthetic scaffold (e.g., a polyester fabric, ePTFE, Ivalon®, or a metal mesh) as presently used by devices known in the art. In a preferred embodiment, the biological tissue scaffold is fabricated from collagen. In one embodiment, a specific type of biological tissue, derived from the tunica submucosa layer of the porcine small intestine, forms the tissue scaffold. As a result of this structure, the aforementioned disadvantages associated with the devices known in the art are minimized or eliminated.

Problems solved by technology

The deformities result from the incomplete formation of the septum, or muscular wall, between the chambers of the heart and can cause significant problems.

Ultimately, the deformities add strain on the heart, which may result in heart failure if they are not corrected.

This is particularly worrisome to patients who are prone to forming venous thrombus, such as those with deep vein thrombosis or clotting abnormalities.

Such devices suffer, however, from several disadvantages, including thrombus formation, chronic inflammation, and residual leaks.

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