Apparatus and method for sealing a vascular puncture
Inventors
Joe, Wesley Chung • Avuthu, Sravanthi • GUYER, CURT D. • Repp, Richard • Schnitzer, Martin
Assignees
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Publication Number
US-12329368-B2
Publication Date
2025-06-17
Expiration Date
Abstract
Closure devices for sealing a puncture and methods of sealing a puncture are described herein. A closure device may be used to position a sealant in a puncture. The sealant may be provided in a sheath which is retracted to expose the sealant in the puncture. A support member may be advanced to compress the sealant. The device may have a lock that prevents the support member from advancing prematurely. The lock may be unlocked when the sheath is at least partially retracted. The device may have an actuator that controls movement of the sheath and the support member. The lock may remain in a locked position until the sheath is at least partially retracted.
Core Innovation
The invention provides a system for closing a puncture using a housing, a frame positioned within the housing and axially movable within the housing, and a sealant sleeve movable with the frame. A support member is positioned within a lumen of the sealant sleeve and movable with the frame, and a sealant is positioned in a distal end of the sealant sleeve with a distal end of the support member positioned adjacent a proximal end of the sealant. A deployment actuator coupled to the housing actuates the sealant sleeve in a first direction and actuates the support member in a second direction opposite the first direction.
The frame prevents actuation of the deployment actuator in a first position and allows actuation of the deployment actuator in a second position. The configuration includes resting, locating, pre-deployment, partially deployed, and fully deployed configurations, with coordinated lockout mechanisms that prevent premature movement. The system also coordinates rack and frame interactions, including lockout features that block tamping until the sealant sleeve is retracted and features that prevent withdrawal until after tamping and proper positioning element state.
During operation, the sealant sleeve is retracted to expose the sealant, and subsequent actuation of the support member tamp-compresses the exposed sealant. The described support member is a tamp tube, and a positioning element such as a balloon, wire mesh, or foot plate expands or is otherwise positioned to confirm vessel wall tactile confirmation. The described sealant includes proximal and distal sealant sections in different geometric states, and example sealant materials include collagen and freeze-dried hydrogels, hydrogel precursors, and chitosan.
Claims Coverage
The independent claim defines a puncture-closing system with a housing, an axially movable frame, a retractable sealant sleeve carrying sealant, and an opposite-directionly movable support member for tamping. The claim includes a frame-based lockout that blocks deployment actuator actuation in a first frame position and allows actuation in a second frame position.
Frame movable between actuator lockout positions
The frame is movable between a first position in which the frame prevents actuation of the deployment actuator and a second position in which the frame allows actuation of the deployment actuator.
Opposite-direction actuation of sealant sleeve and support member
A deployment actuator coupled to the housing is actuatable to actuate the sealant sleeve in a first direction and the support member in a second direction opposite the first direction, with the distal end of the support member positioned adjacent a proximal end of the sealant.
Sealant sleeve retracts to expose sealant and support member tamping
Actuating the sealant sleeve retracts it to expose at least a portion of the sealant, and actuating the support member causes the support member to tamp the exposed sealant.
Selective engagement between deployment actuator features and rack features
The distal end of the sealant sleeve is coupled to a first rack member selectively engagable with the frame and the deployment actuator, and the distal end of the deployment actuator includes an actuation feature configured to engage a corresponding actuation feature of the first rack member when the frame is in the second position.
Complementary protrusion and groove coupling
The deployment actuator includes a protrusion actuation feature, and the corresponding actuation feature of the first rack member is a groove.
Directional angularity of grooves relative to housing ends
The first rack member’s actuation feature is a groove angled toward a distal end of the housing, and the frame’s actuation feature is a groove angled toward a proximal end of the housing.
Frame reaches the second position in response to tension on an elongate member
The frame includes an elongate member with a positioning element at a distal end, and the frame moves to the second position upon application of tension to the elongate member.
Across the independent claim and described dependent refinements, the core claim coverage centers on a sealant-sleeve/support-member system driven in opposite directions by a deployment actuator, gated by a frame that locks out actuator actuation in a first position and enables actuation in a second position. Additional described features refine coupling via rack member engagement with complementary protrusion/groove actuation features, add directional groove/angular constraints, define a retract-then-tamp sequence, and specify how the frame transitions to the second position via tension on an elongate member.
Stated Advantages
Documented Applications
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