Apparatus and methods for sealing a vascular puncture

Inventors

Bagaoisan, Celso J. • Duong, Sieu

Assignees

Access Closure Inc

Abstract

An apparatus for sealing a puncture includes a positioning member including a proximal end, a distal end sized for insertion into a puncture, an expandable element on the distal end, and a tension indicator on the proximal end. The tension indicator includes a distal housing portion fixed relative to the proximal end, and a proximal housing portion or handle movable proximally relative to the distal housing portion. The handle is biased towards the distal housing portion such that, when sufficient tensile force is applied between the expandable element and the handle, the handle moves away from the distal housing portion. During use, the distal end is introduced through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is applied.

Core Innovation

The invention relates to an apparatus and method for sealing a puncture extending through tissue to a body lumen. An elongate member is introduced through the puncture until a positioning element on the distal end is disposed within the body lumen, and the positioning element is deployed within the body lumen. The elongate member is then retracted until the deployed positioning element contacts a wall of the body lumen adjacent the puncture.

A tension indicator indicates that a desired tension is being applied by the positioning element to the wall of the body lumen. In some embodiments, retracting the positioning element further comprises separating a first housing portion of the tension indicator from a second housing portion of the tension indicator. In related embodiments, the tension indicator includes a spring such that separating the housing portions requires overcoming a biasing force.

Sealant is delivered using a tubular member carrying sealant and positioned proximate the deployed positioning element. A tubular member is introduced simultaneously with the elongate member so that sealant positioned within the tubular member at a distal end is proximate the positioning element, and the tubular member is retracted at least partially to expose at least a portion of the sealant within the puncture distally beyond the tubular member. In related methods, sealant is advanced through an introducer sheath, and the tubular member and introducer sheath are retracted at least partially to expose at least a portion of the sealant within the puncture distally beyond the introducer sheath.

Claims Coverage

The independent claims cover three main inventive methods for sealing a puncture into a body lumen using an elongate member with a distal positioning element, a tension indicator to confirm desired tension, and sealant delivery via a tubular member or introducer sheath. Across the independent claims, three inventive features are emphasized: lumen wall contact based on tension indication, sealant exposure beyond the tubular member or sheath, and housing separation of the tension indicator in one independent claim.

Across the independent claims, the coverage centers on applying desired tension to a body lumen wall using a deployed positioning element with a tension indicator, and delivering sealant through a tubular member or introducer sheath such that sealant is exposed within the puncture distally beyond the tubular member or sheath. An additional inventive aspect in one independent claim is that retracting the positioning element includes separating first and second housing portions of the tension indicator.

Stated Advantages

Documented Applications