Apparatus and methods for sealing a vascular puncture

Inventors

Hundertmark, Ronald R. • Uchida, Andy H. • Fiscella, David L. • Zilversmit, Moshe • Fell, Brandon R. • Ku, Vincent • Guyer, Curt • Repp, Richard E. • Sponsel, Mark

Assignees

Access Closure Inc

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Publication Number

US-10499893-B2

Patent

Publication Date

2019-12-10

Expiration Date


Abstract

An apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.

Core Innovation

The invention relates to an apparatus and method for sealing an arteriotomy in a vessel using a positioning assembly that includes an elongate member and a positioning element at a distal portion. A sealant is disposed at a distal portion of the positioning assembly and a support tube is proximal to the sealant. A positioning assembly retraction lock is provided in a first position that prevents the positioning assembly from moving proximally relative to the support tube, and the lock moves to a second position when the support tube is advanced distally.

The method positions the apparatus relative to the arteriotomy by inserting a distal end into the arteriotomy and positioning the positioning element within the vessel having the arteriotomy. The positioning element is expanded and locked in an expanded state such that it abuts the arteriotomy, and the sealant is exposed and tamped by distally advancing the support tube. Distal advancement moves the positioning assembly retraction lock to a second position that allows at least a portion of the positioning assembly to move proximally relative to the support tube.

After tamping, the method retracts the positioning element from the sealant by withdrawing at least a portion of the positioning assembly proximally while the support tube maintains the position of the sealant. The method then retracts the positioning assembly and the support tube from the arteriotomy, leaving the sealant to seal the arteriotomy. The recited ordering of positioning, expanding, locking, exposing, tamping, unlocking or reducing the positioning element, and retracting is supported by the positioning assembly retraction lock that prevents unintended proximal movement relative to the support tube during early steps.

Claims Coverage

The partial content includes two independent claims for a method for sealing an arteriotomy in a vessel. Across these independent claims, the coverage emphasizes the combination of a positioning assembly, a sealant disposed at a distal portion, a support tube for tamping, and a positioning assembly retraction lock that enables controlled transition from a first position to a second position to allow proximal movement during later steps. Claim 13 additionally recites expanding and locking the positioning element, unlocking and reducing its cross-section, and abutting the arteriotomy before exposing and tamping the sealant.

Repositioning with a retraction lock controlled support-tube tamping sequence

Position an apparatus relative to an arteriotomy, the apparatus including an elongate member with a distal positioning element, a sealant at a distal portion, a support tube proximal to the sealant, and a positioning assembly retraction lock in a first position preventing the positioning assembly from moving proximally relative to the support tube; expose the sealant; tamp the sealant by distally advancing the support tube, wherein distal advancement moves the positioning assembly retraction lock to a second position that allows at least a portion of the positioning assembly to move proximally relative to the support tube; retract the positioning element from the sealant by withdrawing at least a portion of the positioning assembly proximally while the support tube maintains the position of the sealant; and retract the positioning assembly and the support tube from the arteriotomy, leaving the sealant to seal the arteriotomy.

Expanded-state positioning element abutting the arteriotomy followed by unlocking and cross-section reduction

Insert a distal end of an apparatus into an arteriotomy, the apparatus including an elongate member with a distal positioning element, a sealant at a distal portion, a support tube proximal to the sealant, and a positioning assembly retraction lock in a first position preventing the positioning assembly from moving proximally relative to the support tube; position the positioning element within the vessel having the arteriotomy; expand the positioning element; lock the positioning element in an expanded state; withdraw the positioning element within the vessel until the positioning element abuts the arteriotomy; expose the sealant; tamp the sealant by distally advancing the support tube, wherein distal advancement moves the positioning assembly retraction lock to a second position; unlock the positioning element to allow a cross-section of the positioning element to be reduced; reduce the cross-section; retract the positioning element from the sealant by withdrawing at least a portion of the positioning assembly proximally while the support tube maintains the position of the sealant; and retract the positioning assembly and the support tube from the arteriotomy, leaving the sealant to seal the arteriotomy.

The independent claims cover a sealing method defined by a positioning assembly with a positioning element and distal sealant, a support tube used to tamp the sealant, and a positioning assembly retraction lock that is in a first position to prevent proximal movement relative to the support tube and transitions to a second position to allow proximal movement during retraction of the positioning element. Claim 13 further requires expanding and locking the positioning element to abut the arteriotomy prior to sealant exposure and tamping, followed by unlocking and reducing the cross-section before retracting the positioning element while maintaining the sealant position.

Stated Advantages

Documented Applications

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