Apparatus and method for sealing a vascular puncture

Inventors

Hundertmark, Ronald Ray • To, Kevin • Guyer, Curt • REPP, RICK • Schnitzer, Martin • Avuthu, Sravanthi

Assignees

Access Closure Inc

Abstract

A closure system for delivering a sealant to an arteriotomy. A distal section of the closure system can include overlapping inner and outer sleeves that can expand with expansion of the sealant. A proximal section of the closure system can include a handle portion and a sheath adapter extending from the handle portion. The handle portion can comprise one or more actuators that when depressed or engaged can assist in deployment of the sealant in the arteriotomy and can further include tamping of the sealant and/or retraction of an expandable member. The sheath adapter can removably engage a side port or an irrigation line of a standard procedural sheath. When the sheath adapter is secured to the procedural sheath, movement of the closure system can also move the procedural sheath.

Core Innovation

The invention relates to a vascular puncture closure system for closing a puncture in a vessel wall. An inner catheter includes an expandable structure at a distal end, and a sealant is positioned proximal to the expandable structure. A support tube is positioned proximal to the sealant, and a handle portion is at a proximal end of the inner catheter.

The system uses a handle actuator configured to bend a portion of the inner catheter and retract the expandable structure proximally. The actuator includes an arm configured to engage with the inner catheter to bend the inner catheter away from a central axis of the handle portion, thereby causing the expandable structure to retract into the support tube. The disclosed concepts tie catheter bending and proximal retraction to containment and placement of the sealant while closing the puncture.

In embodiments, the handle portion further comprises an inflation indicator at a proximal end that moves from a first position to a second position when the expandable structure is fully expanded. The inflation indicator provides a lockout mechanism configured to prevent the actuator from being actuated when the expandable structure is in an expanded state. The inflation indicator may include protrusions that physically block actuation when the expandable structure is expanded and shift after deflation.

The system also includes a sheath adapter designed for releasable attachment to a procedural sheath without sheath exchange. The sheath adapter has an attachment structure that creates a passageway enabling releasable attachment by inserting a side port or an irrigation line into the passageway. The disclosed embodiments include multiple sheath-adapter attachment/passsageway designs suitable for different side-port or irrigation-line geometries.

Claims Coverage

The partial content includes two independent claims. Across these claims, there are two main inventive feature sets: an actuator-driven retraction mechanism that bends the inner catheter away from a central axis, and an inflation-indicator lockout feature that moves between first and second positions while preventing actuation during an expanded state, with optional sheath-adapter passageway releasable attachment.

Overall, the claims cover a puncture-closing system combining a distal expandable structure, proximal sealant, and support tube with an actuator that retracts the expandable structure by bending the inner catheter away from a central axis. The claims further require an inflation indicator that moves between defined positions and performs an actuator lockout while the expandable structure is in an expanded state, and optionally add a sheath adapter that forms a passageway for releasable attachment to a procedural sheath using a side port or irrigation line.

Stated Advantages

Documented Applications