Patent foramen ovale (PFO) closure method and device

Abstract

The present invention provides methods and devices for closing two overlapping layers of tissue in a mammalian heart, for example a patent foramen ovale (PFO). The closure devices may take a number of different forms and may be retrievable. In some embodiments, a device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, such that the first and second ends cooperate to provide a compressive force to the overlapping layers of tissue. In some embodiments, the closure devices may be delivered with a catheter capable of puncturing mammalian tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This Application is a Divisional of U.S. patent application Ser. No. 10 / 341,802, entitled Patent Foramen Ovale (PFO) Closure Method and Device, filed Jan. 14, 2003, and incorporated herein by this reference.FIELD OF THE INVENTION [0002] The invention relates to occlusion devices and methods for the closure of physical anomalies, like septal apertures, such as patent foramen ovale and other septal and vascular defects. BACKGROUND OF THE INVENTION [0003] A patent foramen ovale (PFO) as shown in FIG. 1, is a persistent, one-way, usually flap-like opening in the wall between the right atrium 10 and left atrium 12 of the heart. Since left atrial (LA) pressure is normally higher than right atrial (RA) pressure, the flap typically stays closed. Under certain conditions, however, RA pressure can exceed LA pressure creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. In utero, the fora...

AI Technical Summary

Benefits of technology

The present invention provides a method for closing two overlapping layers of tissue in a mammalian heart, such as a patent foramen ovale (PFO), using a closure device that applies a compressive force to at least one of the layers of tissue. The closure device may be retrievable, such as a ring with a gap or a folded ring, and may be delivered with a catheter capable of puncturing mammalian tissue in at least one location. The ends of the closure device may take various forms, such as a disc or a closure device anchor, and may be adjusted to alter the compressive force applied to the overlapping layers of tissue. The closure device may be made of flexible polymer materials, bioabsorbable materials, shape memory materials, metals, or swellable foams, and may be inserted into the heart through a puncture in the septum primum or between the overlapping layers of tissue. The technical effect of the invention is to provide a reliable and effective method for closing overlapping layers of tissue in the heart.

Problems solved by technology

Under certain conditions, however, RA pressure can exceed LA pressure creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation.

While there is currently no proof for a cause-effect relationship, many studies have confirmed a strong association between the presence of a PFO and the risk for paradoxical embolism or stroke.

In addition, there is good evidence that patients with PFO and paradoxical embolism are at increased risk for future, recurrent cerebrovascular events.

These patients are commonly treated with oral anticoagulants, which have the potential for adverse side effects, such as hemorrhaging, hematoma, and interactions with a variety of other drugs.

Currently available designs of septal closure devices, however, present such drawbacks as technical complexity of implantation procedure, high complication rates (thrombus, fractures, conduction system disturbances, perforations, residual leaks), high septal profile, large masses of foreign material, and lack of anatomic conformability especially to the PFO flap-like anatomy, as most were originally designed to close ASD's, which are true holes.

Additionally, some septal closure devices are complex to manufacture, which can result in lack of consistency in product performance.

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