Apparatus and method for sealing a vascular puncture

Inventors

Hundertmark, Ronald R. • 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 include 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 catheter-based vascular puncture and arteriotomy closure systems and methods that seal an arteriotomy using a closure system advanced through a procedural sheath extending through the arteriotomy. The closure system includes a handle portion, an outer catheter, and an inner catheter, with a sealant positioned in a distal section of the outer catheter. A sheath adapter extending from the handle portion defines an attachment structure with a passageway for releasably securing the sheath adapter to the procedural sheath.

The sheath adapter is releasably secured to the procedural sheath by positioning a side port or an irrigation line of the procedural sheath into the passageway of the attachment structure. The method continues by retracting the outer catheter relative to the inner catheter to expose the sealant, where exposure enables deployment within the arteriotomy. The disclosed structure includes an inner catheter extending through the outer catheter, with the outer catheter removably secured to the inner catheter.

The disclosed embodiments also include a radially positioned support tube between the outer catheter and the inner catheter to tamp the sealant against a vessel wall of the arteriotomy. In other embodiments, an expandable member positioned at a distal section of the inner catheter is used in conjunction with actuator mechanisms to deploy the sealant within the arteriotomy and tamp the sealant against a vessel wall. Additional actuator-related features include actuator mechanisms and state-dependent lockouts tied to an inflated state of an expandable structure, and the document describes overlapping inner and outer distal sleeves with slits to reduce friction and jamming.

Claims Coverage

The partial content provides two independent methods for sealing an arteriotomy, each centered on advancing a closure system through a procedural sheath, releasably securing a sheath adapter via a passageway that receives a side port or irrigation line, and then exposing and deploying sealant using catheter retraction and actuator actuation. Across the independent claims, the inventive coverage centers on a passageway-defined sheath adapter, catheter-relative motion to expose distal sealant, and actuator-driven deployment and tamping with a radially positioned support tube and/or an expandable member.

Claim coverage is grounded in a passageway-defined sheath adapter that releasably couples to a procedural sheath via a side port or irrigation line, combined with catheter-relative retraction to expose a distal sealant and actuator-driven deployment and tamping. Additional coverage includes a support tube positioned radially between catheters and, in another independent claim, an expandable member positioned at a distal section of the inner catheter.

Stated Advantages

Documented Applications