Method and apparatus for performing catheter-based annuloplasty using local plications

Abstract

A minimally invasive method of performing annuloplasty. According to one aspect, a method for performing annuloplasty includes creating a first plication in the tissue near a mitral valve of a heart, using at least a first plication element, and creating a second plication in the tissue near the mitral valve such that the second plication is substantially coupled to the first plication.

Description

[0001] This application is a continuation of PCT / US03 / 33382 filed on Oct. 21, 2003 which claims priority of U.S. Provisional Patent Application No. 60 / 420,095, filed Oct. 21, 2002. The disclosure of each priority application is hereby incorporated by reference herein in its entirety.CROSS REFERENCE TO RELATED APPLICATIONS [0002] The present invention is related to U.S. Pat. No. 6,619,291 entitled “Method and Apparatus for Catheter-Based Annuloplasty,” filed Apr. 24, 2001 and issued Sep. 16, 2003, and to co-pending U.S. patent application Ser. No. 09 / 866,550, entitled “Method and Apparatus for Catheter-Based Annuloplasty Using Local Plications, which are each incorporated herein by reference in their entireties. BACKGROUND OF THE INVENTION [0003] 1. Field of Invention [0004] The present invention relates generally to techniques for treating mitral valve insufficiencies such as mitral valve leakage. More particularly, the present invention relates to systems and methods for treating a...

AI Technical Summary

Benefits of technology

[0027] The present invention relates to a non-invasive method of performing annuloplasty. Performing an annuloplasty on a mitral valve by accessing the left ventricle of the heart, as for example using a catheter, enables complicated surgical procedures to be avoided when treating mitral valve leakage. Avoiding open-heart surgical procedures generally makes annuloplasty more accessible to patients who may benefit from annuloplasty. As mitral valve leakage is often considered to be an early indicator of congestive heart failure, a minimally invasive annuloplasty procedure that corrects for leakage problems, such as one which involves positioning discrete plications in fibrous tissue around the mitral valve, may greatly improve the quality of life of many patients who might not be suitable for invasive annuloplasty procedures.

Problems solved by technology

Congestive heart failure (CHF), which is often associated with an enlargement of the heart, is a leading cause of death.

Many problems relating to mitral valve 116 may occur and these insufficiencies may cause many types of ailments.

Treatments used to correct for mitral valve leakage or, more generally, CHF, are typically highly invasive, open-heart surgical procedures.

The implantation of a ventricular assist device is often expensive, and a patient with a ventricular assist device must be placed on extended anti-coagulant therapy.

While reducing the risks of blood clots associated with the ventricular assist device is desirable, anti-coagulant therapies may increase the risk of uncontrollable bleeding in a patient, e.g., as a result of a fall, which is not desirable.

While the implantation of a bi-ventricular pacing device may be effective, not all heart patients are suitable for receiving a bi-ventricular pacing device.

Further, the implantation of a bi-ventricular pacing device is expensive.

While the use of a pig valve may relatively successfully replace a mitral valve, such valves generally wear out, thereby requiring additional open surgery at a later date.

However, when a mechanical valve is implanted, there is an increased risk of thromboembolism, and a patient is generally required to undergo extended anti-coagulant therapies.

In addition, the use of edge-to-edge stitch 404 is generally not suitable for a patient with an enlarged, dilated heart, as blood pressure causes the heart to dilate outward, and may put a relatively large amount of stress on edge-to-edge stitch 404.

That is, like other conventional procedures, a suture-based annuloplasty procedure is invasive.

While invasive surgical procedures have proven to be effective in the treatment of mitral valve leakage, invasive surgical procedures often have significant drawbacks.

Any time a patient undergoes open-heart surgery, there is a risk of infection.

Opening the sternum and using a cardiopulmonary bypass machine has also been shown to result in a significant incidence of both short and long term neurological deficits.

Further, given the complexity of open-heart surgery, and the significant associated recovery time, people who are not greatly inconvenienced by CHF symptoms, e.g., people at a Class 1 classification, may choose not to have corrective surgery.

In addition, people who most need open heart surgery, e.g., people at a Class 4 classification, may either be too frail or too weak to undergo the surgery.

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