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through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is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 disclosure relates to a system for sealing a puncture extending through tissue. The system includes an elongate positioning member having a proximal end, a distal end sized for insertion into a puncture extending through tissue, and a positioning element on the distal end. A sealant is disposed near the distal end of the elongate positioning member and proximal to the positioning element.

The disclosure provides a single housing on the positioning member proximal end that includes a first portion substantially fixed to the proximal end and a second portion movable relative to the first portion from a first position to a second position. The movable second portion is biased towards the first position and provides a visual indicator that indicates that a force being applied to a blood vessel by the positioning element is within a predetermined range when the second portion is in the second position.

The disclosure further describes a cartridge-based delivery of sealant using a tubular member with a lumen and a pusher that deploys sealant distally when the cartridge is retracted relative to the pusher. The positioning element is described as an expandable member for introduction into a puncture in a collapsed condition, including an expandable member comprising a balloon.

Claims Coverage

The partial content includes three independent claims. Across these independent claims, the coverage centers on an elongate positioning member with a distal positioning element, a tension indicator with a movable biased portion providing a visual marker or indicator of applied force within a predetermined or desired range, and sealant disposed near the distal end proximal to the positioning element.

Across the independent claims, the central inventive concept is a tension indicator integrated with an elongate positioning member such that, upon contact to a blood vessel by a distal positioning element, a biased slideable portion moves from a first position to a second position and provides a visual indicator or marker that the applied force is within a predetermined or desired range. Where claimed as a system, sealant is disposed near the distal end proximal to the positioning element, and in the sheath-based system an introducer sheath with a lumen is included.

Stated Advantages

Documented Applications