Apparatus and methods for sealing a vascular puncture
Inventors
Uchida, Andy H. • Spizuoco, Anthony P. • To, Kevin • Lim, Florencia • Sershen, Scott R
Assignees
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Publication Number
US-12433577-B2
Publication Date
2025-10-07
Expiration Date
Abstract
A sealant is provided for sealing a puncture through tissue that includes an elongate first section including a proximal end, a distal end, and a cross-section sized for delivery into a puncture through tissue, and a second section fused to and extending from the distal end of the first section. The first section may be formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within a puncture. The second section may be formed from a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, the precursors remaining in an unreactive state until exposed to an aqueous physiological, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section. Apparatus and methods for delivering the sealant into a puncture through tissue are also provided.
Core Innovation
The invention relates to a sealant for sealing a puncture through tissue that includes an elongate first section formed from a freeze-dried hydrogel. The first section includes a proximal end and a distal end, and it has a cross-section sized for delivery into a puncture through tissue. The freeze-dried hydrogel expands when exposed to physiological fluid within the puncture, thereby providing a swelling portion for puncture sealing.
The sealant further includes a second section fused to and extending from the distal end of the first section. The second section is formed from non-freeze-dried, non-crosslinked hydrogel precursors, where the precursors remain in an unreactive state until exposed to an aqueous physiological environment. Upon exposure, the hydrogel precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section.
The documented embodiments also include an apparatus for sealing a puncture extending through tissue, using a tubular member with a lumen and a distal opening. A sealant disposed within the lumen includes an elongate first section and a second section fused to and extending from the distal end of the first section, where the second section is disposed closer to the distal opening than the first section. An advancer member disposed within the lumen deploys the sealant from the lumen out the distal opening when the tubular member is retracted from the puncture relative to the advancer.
Claims Coverage
The provided material includes four independent claims. Across these independent claims, the main inventive features are grouped into a two-section hydrogel sealant with an expanding freeze-dried first section and an in-situ crosslinking precursor second section forming an adhesive layer, and an apparatus that deploys the sealant from a tubular lumen using an advancer member.
Two-section freeze-dried expanding hydrogel with in-situ crosslinking adhesive second section
A sealant for sealing a puncture through tissue comprising an elongate first section formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within the puncture, and a second section fused to and extending from the distal end of the first section formed from non-freeze-dried, non-crosslinked hydrogel precursors that remain in an unreactive state until exposed to an aqueous physiological environment, whereupon the precursors undergo in-situ crosslinking to provide an adhesive layer bonded to the first section.
Consisting-essentially first freeze-dried expanding section fused to solid non-freeze-dried precursor section adhesive bonding layer
A sealant for sealing a puncture through tissue comprising an elongate first section consisting essentially of a freeze-dried hydrogel that expands when exposed to physiological fluid within the puncture, and a second section fused to and extending from the distal end of the first section consisting essentially of a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, the precursors remaining in an unreactive state until exposed to an aqueous physiological environment, whereupon the precursors undergo in-situ crosslinking to provide an adhesive layer to bond the first section relative to adjacent tissue.
Reinforcement included with solid precursor section fused to expanding freeze-dried section
A sealant for sealing a puncture through tissue comprising an elongate first section consisting essentially of a freeze-dried hydrogel that expands when exposed to physiological fluid within the puncture, and a second section fused to and extending from the distal end of the first section consisting essentially of a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors and one or more reinforcement elements, the precursors remaining in an unreactive state until exposed to an aqueous physiological environment, whereupon the precursors undergo in-situ crosslinking to provide an adhesive layer to bond the first section relative to adjacent tissue.
Tubular deployment apparatus with advancer deploying a two-section sealant to a distal opening
An apparatus for sealing a puncture extending through tissue comprising a tubular member having a proximal end, a distal end sized for insertion into a puncture, a lumen extending between the proximal and distal ends, and a distal opening in communication with the lumen; a sealant disposed within the lumen comprising an elongate first section and a second section fused to and extending from the distal end of the first section, the sealant disposed such that the second section is disposed closer to the distal opening than the first section, the first section formed from a freeze-dried hydrogel that expands when exposed to a physiological fluid within the puncture, the second section formed from non-crosslinked hydrogel precursors remaining in an unreactive state until exposed to an aqueous physiological environment, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the elongate first section; and an advancer member disposed within the lumen for deploying the sealant from the lumen out the distal opening when the tubular member is retracted from the puncture relative to the advancer member.
Across the independent claims, the core claim scope centers on a two-section sealant structure: an elongate freeze-dried hydrogel section that expands in physiological fluid, fused to a non-freeze-dried, non-crosslinked precursor section that remains unreactive until exposed to an aqueous physiological environment and then undergoes in-situ crosslinking to provide an adhesive layer bonded to the first section and bonding relative to adjacent tissue. The independent claim set further includes an apparatus claim that uses a tubular member with a lumen and distal opening and an advancer member to deploy the sealant out the distal opening during relative retraction.
Stated Advantages
Documented Applications
No documented applications found
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