Apparatus and methods for sealing a vascular puncture
Inventors
Bagaoisan, Celso J. • Domingo, Juan • Duong, Sieu
Assignees
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Publication Number
US-11707266-B2
Publication Date
2023-07-25
Expiration Date
Abstract
An apparatus for sealing a puncture includes a cartridge, a pusher member, a sealant, and a tamping device on a proximal end of the cartridge. During use, the cartridge, sealant, and pusher member are advanced over a positioning member and into the puncture by advancing a cartridge hub carrying the tamping device. When further distal advancement of the cartridge is limited, the cartridge hub is further advanced, activating the tamping device, and causing the pusher member to advance relative to the sealant to compress the sealant within the puncture.
Core Innovation
The invention relates to sealing a puncture extending through tissue, where an elongate member with a distal expandable member is sized for insertion into the puncture and a cartridge includes a lumen containing sealant adjacent the cartridge distal end. A pusher member disposed within the cartridge lumen biases the sealant so that it is moved toward and compresses within the puncture in association with expansion of the distal expandable member, with hemostasis achieved when the sealant hydrates or expands.
A tamping device is provided on the cartridge proximal end for biasing the pusher member distally relative to the sealant when activated. The activation is coordinated with distal cartridge advancement being limited, such that the activation advances the pusher relative to the sealant to compress the sealant within a puncture while an occlusion or positioning element expands in the blood vessel; after compression, the sealant then hydrates or expands to achieve hemostasis.
The invention also includes structural tamping device variants and activation and latching mechanisms that govern timing, biasing, and control of relative motion between the pusher member and the elongate member. Embodiments describe secondary pusher member structures and latch engagement, including catch and latch element engagement, markers indicating an active position, and mechanical features such as latch gates, locking members, and peel-away locks, as well as configurations for delivering and tamping sealant around an expanded positioning or occlusion member.
Claims Coverage
Independent claim clm-00001 defines an apparatus for sealing a puncture through tissue using an elongate member with a distal expandable member, a sealant-loaded cartridge, and a tamping device that biases a pusher distally to move and compress the sealant in coordination with expansion. The dependent claims refine control of actuation and movement, including engagement features that prevent later proximal movement of the pusher relative to the elongate member, as well as refinements to sequencing and specific tamping subcomponents and indicators.
Apparatus including elongate member with distal expandable member and cartridge receiving the elongate member
An elongate member comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and an expandable member on the distal end; a cartridge comprising a proximal end, a distal end sized for insertion into the puncture, and a lumen extending between the proximal and distal ends sized for receiving the elongate member therein; a sealant disposed within the cartridge lumen adjacent the cartridge distal end; and a pusher member disposed within the cartridge lumen adjacent to the sealant.
Tamping device biasing pusher distally relative to sealant upon activation with secondary pusher and latch engagement
A tamping device on the cartridge proximal end for biasing the pusher member distally relative to the sealant when activated, wherein the tamping device comprises a secondary pusher member and the elongate member comprises a catch for engaging a latch element on the secondary pusher member when the secondary pusher member is advanced distally beyond the catch.
Sequence of expandable member expansion before cartridge distal advancement
The expandable member is expandable to an expanded state before the cartridge is advanced to the distal position, wherein the tamping device is activated to compress the sealant between the pusher member and the expanded expandable member.
Slider-and-spring tamping device with defined slider positions during cartridge advancement
A cartridge hub slidably coupled to the cartridge proximal end, wherein the tamping device comprises a slider member and a spring member that bias a pusher member distally as the slider moves between first and second positions during cartridge advancement to the distal position.
Support member that couples to pusher to prevent subsequent proximal pusher movement
A support member fixed in the cartridge hub that couples to the pusher member when the cartridge is advanced to the distal position to prevent subsequent proximal movement of the pusher relative to the elongate member.
Marker indicating tamping device active position
A marker on the elongate member for indicating that the tamping device is in an active position.
Across the independent claim and associated refinements, the coverage centers on a sealant-containing cartridge and a distal expandable member coordinated with a tamping device that biases a pusher distally to compress sealant, with dependent features capturing sequencing of expansion relative to cartridge advancement, slider-and-spring actuation, a support or coupling structure that prevents subsequent proximal pusher movement, and a marker indicating an active position.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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