Tissue closure system and methods of use

This application incorporates each of the following references in their entirety: U.S. Pat. No. 6,780,197, entitled “Apparatus and Methods for Delivering a Vascular Closure Device to a Body Lumen”, and filed Dec. 7, 2000; U.S. Pat. No. 6,942,674 entitled “Apparatus and Methods for Delivering a Closure Device”, and filed Feb. 21, 2002; and U.S. patent application Ser. No. 11/427,297, entitled “Clip Applier and Methods of Use”, and filed Jun. 28, 2006.

The present invention relates generally to apparatus and methods for closing and/or sealing openings through tissue, and more particularly to a closure element for closing a puncture in a blood vessel or other body lumen formed during a diagnostic or therapeutic procedure.

Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient\'s skin and tissue into the vascular system. A guidewire may be advanced through the needle and into the patient\'s blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath are removed, leaving a puncture site in the vessel wall. Traditionally, external pressure had often been applied to the puncture site until clotting and wound sealing would occur; however, the patient must remain bedridden for a substantial period of time after clotting to ensure closure of the wound. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physician\'s or nurse\'s time. It is also uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing a vascular puncture by occluding the puncture site. For example, U.S. Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the use of a biodegradable plug that may be delivered through an introducer sheath into a puncture site. Another technique has been suggested that involves percutaneously suturing the puncture site, such as that disclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.

To facilitate positioning devices that are percutaneously inserted into a blood vessel, “bleed back” indicators have been suggested. For example, U.S. Pat. No. 5,676,689, issued to Kenseyet al., discloses a bleed back lumen intended to facilitate positioning of a biodegradable plug within a puncture site. This device, however, requires that an anchor of the plug be positioned within the vessel, and therefore, may increase the risk of over-advancement of the plug itself into the vessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al., discloses a deployable loop that may be advanced through a sheath into a vessel. The loop is intended to resiliently expand in order to engage the inner wall of the vessel, thereby facilitating holding the sheath in a desired location with respect to the vessel. Accordingly, additional apparatus and methods for delivering a device for closing a vascular puncture site or other opening through tissue would be useful.

The present disclosure is directed to a closure element that is delivered through tissue and into an opening formed in, or adjacent to, a wall of a blood vessel or other body lumen of any size. The closure element is configured to be deployed using a clip applier. The apparatus can be configured to receive and retain the closure element so that the closure element can be disposed substantially within the apparatus.

Other aspects and features of the present invention will become apparent from consideration of the following description in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings.

FIG. 1A is a perspective view of an embodiment of a closure element according to one example.

FIG. 1B is a top view of an embodiment of a closure element in an unexpanded state according to one example.

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