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
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Publication Number
US-12144495-B2
Publication Date
2024-11-19
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 for sealing a puncture through a vessel wall by using a positioning assembly with an expandable positioning member disposed at a distal portion and configured to move between an unexpanded state and an expanded state. The positioning assembly is configured to move axially within a support member, and the sheath releasably engages with the positioning assembly to guide a sealant and the positioning assembly to the puncture in the vessel wall.
The apparatus further includes a handle having an outer housing and an inner housing. The inner housing is coupled with the support member, and the outer housing is configured to move relative to the inner housing. A first actuator controls fluid flow to the expandable positioning member via an inflation line, while a second actuator is at least partially exposed outside the outer housing to permit manipulation by a user and is configured to control movement of the sheath relative to the expandable positioning member.
The disclosed variants include mechanisms configured to control deployment sequences and prevent premature movement, including delayed deployment using discontinuous teeth, auto-retraction assemblies, retraction locks, and locking mechanisms that prevent actuation. Indication mechanisms include bleed-back ports and outlet indicators based on blood flow through inlet openings to indicate when a distal portion of the sheath enters the vessel, as well as inflation indicators based on pressure or shaft position.
Claims Coverage
The independent claim defines an apparatus with six core inventive elements: an expandable positioning member, a support member enabling axial movement, a sheath releasably engaged to guide sealant and positioning assembly to the puncture, a handle with outer and inner housings with relative movement, a first actuator controlling expansion via an inflation line, and a user-manipulable second actuator controlling sheath movement relative to the expandable positioning member to permit or inhibit sealant exposure.
Expandable positioning member with unexpanded and expanded states
An expandable positioning member disposed at a distal portion configured to move between an unexpanded state and an expanded state.
Axial movement of positioning assembly within a support member
A support member, the positioning assembly configured to move axially within the support member.
Sheath releasably engaged to guide sealant and positioning to the puncture
A sheath releasably engaged with the positioning assembly with the sheath configured to guide a sealant and the positioning assembly to the puncture in the vessel wall.
Handle with outer housing and inner housing with relative movement
A handle comprising an outer housing and an inner housing, the inner housing coupled with the support member, the outer housing configured to move relative to the inner housing.
First actuator controlling fluid flow to expandable member via inflation line
A first actuator configured to control fluid flow to the expandable positioning member via an inflation line.
Second actuator exposed for user manipulation to control sheath movement
The handle further comprising a second actuator, the second actuator at least partially exposed to the outside of the outer housing to permit manipulation by a user and the second actuator configured to control movement of the sheath relative to the expandable positioning member.
The claim coverage centers on a sheath-guided sealant system with a user-manipulable second actuator controlling sheath movement relative to an inflation-expanded positioning member, together with a first actuator for expansion via an inflation line and a handle arrangement with outer and inner housings.
Stated Advantages
Delayed deployment and mechanisms to prevent premature movement.
Bleed-back ports and outlet indicators indicate when a distal portion of the sheath enters the vessel.
Inflation indicators based on pressure or shaft position.
Documented Applications
Sealing a puncture through a vessel wall.
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