Transseptal closure of a patent foramen ovale and other cardiac defects

Abstract

The present invention provides for therapeutic treatment methods, devices, and systems for the partial or complete closure or occlusion of a patent foramen ovale (“PFO”). In particular, various methods, devices, and systems for joining or welding tissues, in order to therapeutically close a PFO are described. In yet another aspect of the invention, various methods, devices, and systems for the penetration of the interatrial septum enabling left atrial access are also provided.

Description

COPYRIGHT NOTICE [0001] A portion of this patent document contains material that is subject to copyright protection. The copyright owner does not object to the facsimile reproduction of the patent document as it appears in the U.S. Patent and Trademark Office patent file or records but otherwise reserves all copyright rights whatsoever. FIELD OF THE INVENTION [0002] The present invention relates generally to the field of cardiology, and in particular to methods, devices, and systems to close or occlude a patent foramen ovale or “PFO.”BACKGROUND OF THE INVENTION [0003] A closed foramen ovale is formed after birth when two fetal structures, the septum secundum (“secundum”) and septum primum (“primum”), become fused and fibrose together. Usually, the fusion of these two anatomical structures occurs within the first two years of life ensuring the formation of a normal functioning heart. However, in about 25-27% of the general population, the secundum and the primum either do not fuse or...

AI Technical Summary

Benefits of technology

[0016] A sixth aspect of the invention involves various medical kits comprising one or more catheters, tissue penetrating devices, and other like means for transseptal penetration of the interatrial septum, thus allowing left atrial access. These devices and catheters embody various techniques and other aspects for easily identifying, positioning, and penetrating the septum at a pre-determined location.

Problems solved by technology

Nevertheless, in instances of physical exertion or when pressures are greater in the right atrium, inappropriate right-to-left shunting of blood can occur introducing venous blood and elements, such as clots or gas bubbles within the blood, into the left atrium and the systemic atrial system, posing serious health risks including: hemodynamic problems; cryptogenic strokes; venous-to-atrial gas embolism; migraines; and in some cases even death.

However, these procedures carry high attendant risks such as postoperative infection, long patient recovery, and significant patient discomfort and trauma.

That they are not well suited or designed for the long tunnel-like anatomical shape of a PFO, is a significant drawback of many PFO devices currently on the market including: the Cardia® PFO Closure Device, Amplatzer® PFO Occluder, and CardioSEAL® Septal Occlusion Device, just to name a few.

As a result, device deformation and distortion is not uncommon and instances of mechanical failure, migration or even device dislodgement have been reported.

Further, these devices can irritate the cardiac tissues at, or near, the implantation site, which in turn can potentially cause thromboembolic events, palpitations, and arrhythmias.

Other reported complications include weakening, erosion, and tearing of the cardiac tissues around the implanted devices.

Yet another disadvantage of these mechanical devices is that the occlusion of the PFO is not instantaneous or complete immediately following implantation.

This endothelization process can be very gradual and can take several months or more to occur.

Thus, “occlusion” of the PFO is not immediate but can be a rather slow and extended process.

Finally, the procedure to implant these devices can be technically complicated and cumbersome, requiring multiple attempts before the device can be appropriately and sufficiently delivered to the PFO.

Accordingly, use of these devices may require long procedure times during which the patient must be kept under conscious sedation posing further risks to patients.

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