Expandable clip for tissue repair

Abstract

An apparatus, system, and method for repairing openings such as septal defects includes advancing a catheter to the site of the defect, grasping opposing edges of the defect, passing one or more suture lines through the opposing edges, tightening the suture lines, and deploying and expanding a fastener to secure the suture lines and close the defect. The fastener can include tissue-growth-inducing materials to encourage tissue growth onto or into the fastener and / or suture. The fastener includes a locking clip portion and a plug portion, which may be an expandable portion and / or tissue-growth-inducing portion.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]The present application claims priority to U.S. Provisional Patent Application No. 60 / 843,267, filed on Sep. 8, 2006, the disclosure of which is incorporated by reference herein in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to medical devices and methods. In particular, the present invention relates to a system, apparatus, and method for repairing tissue, and particularly for repairing septal defects, such as a patent foramen ovale (PFO).BACKGROUND OF THE INVENTION[0003]Septal defects are a relatively common occurrence. While many septal defects are relatively benign and have little or no impact on a person's health, other septal defects can be more serious.[0004]One type of septal defect is a patent foramen ovale (PFO), which is an opening between the right atrium and the left atrium. Because the fetal lungs do not provide air prior to birth, fetal blood is oxygenated by the mother via the umbilical cord and p...

AI Technical Summary

Benefits of technology

[0011]Embodiments of the present invention provide devices and methods for effectively treating a tissue opening, such as a PFO or other septal defect, and particularly for effectively treating an opening that may be unsuitable for closure using suture alone. Preferred embodiments of the invention provide devices and methods wherein a PFO is treated via a catheter from a remote insertion location.

[0014]In one aspect, the present invention is directed to a system and method for repairing a PFO with a treatment catheter capable of applying at least one suture to the tissue adjacent the PFO. The invention can further use a fastener catheter capable of attaching at least one fastener to the suture. In addition, the fastener catheter can include at least one cutting member configured to cut the suture to a desired length. The fastener of the invention can be configured so that it expands upon deployment, so that the bulk of the expanded fastener itself helps to close the septal defect.

[0017]In another embodiment of the invention, tissue-irritating materials are used to speed the healing process whereby the tissue adjacent the PFO grows over the suture, fastener, and / or patch. The fastener may include tissue-irritating materials in its structure, including tissue-irritating materials in the expandable portion of the fastener. The patch may also include tissue-irritating materials, such as tissue-irritating cloth. In a further embodiment, the suture has enhanced tissue-irritating characteristics.

[0018]The present invention also discloses various methods of treating a PFO within the body of a patient. In one aspect, a method of treating a PFO is disclosed which includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a PFO, advancing a PFO treatment catheter through the guide catheter to the PFO, deploying a first suture into the stabilized first adjacent tissue portion, deploying a second suture into the second adjacent tissue portion, reducing the distance between the first and second sutures, advancing an expandable clip along the first and second sutures to the PFO, expanding the expandable clip adjacent or within the PFO, assessing the efficacy of the PFO repair, and deploying the expandable clip adjacent or within the PFO. The method may also include stabilizing the first and second adjacent tissue portions, which may be performed by applying a vacuum. The vacuum may first be applied to stabilizing a first adjacent tissue portion with the treatment catheter, then removed to release the first adjacent tissue portion, followed by application of the vacuum to stabilize the second tissue portion, then removed to release the second adjacent tissue portion.

Problems solved by technology

While many septal defects are relatively benign and have little or no impact on a person's health, other septal defects can be more serious.

After birth, the infant's lungs typically provide oxygenation to the blood, and it is generally undesirable to continue having blood flow from the venous circulation to the arterial circulation without first passing through the lungs.

In a significant percentage of persons, however, the tissue flap does not heal to permanently occlude the foreman ovale.

Although relatively simple, such open-heart surgical treatment is associated with all the usual risks of cardiac surgery.

Many of these percutaneous methods are often complicated and may involve relatively large implanted devices or uncertain tissue treatments.

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