Apparatus and methods for sealing a vascular puncture
Inventors
Uchida, Andy H. • Spizuoco, Anthony P. • To, Kevin • Lim, Florencia • Sershen, Scott R.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10874384-B2
Publication Date
2020-12-29
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 rolled proximal section and a distal section extending from the distal end of the rolled proximal section. The proximal section is formed from a freeze-dried, crosslinked polyethylene glycol (PEG) hydrogel that expands when exposed to physiological fluid within a puncture, and the proximal section comprises pores. The rolled proximal section defines a lumen extending between a proximal end and a distal end of the proximal section.
The distal section comprises a solid mass formed from non-freeze-dried, non-crosslinked hydrogel precursors that remain in an unreactive state until exposed to an aqueous physiological environment. After exposure, the hydrogel precursors undergo in-situ crosslinking with one another to provide adhesion to the tissue. The precursors of the distal section comprise previously melted precursors applied to a dried distal end of the proximal section.
The melted precursors permeate into the distal end of the proximal section to at least partially reside within the pores of the proximal section, thereby creating a transition zone within the distal end of the proximal section. This fusion between the distal precursors and the porous proximal hydrogel is used to provide an adhesive layer by crosslinking within the aqueous physiological environment, while the proximal freeze-dried crosslinked hydrogel expands in the puncture.
Claims Coverage
The independent claims are clm-00001 and clm-00022. Both claims share a proximal rolled freeze-dried, crosslinked PEG hydrogel that expands with pores and lumen formation, together with a distal portion of non-freeze-dried, non-crosslinked hydrogel precursors that remain unreactive until exposed and then crosslink in situ for tissue adhesion, including melted distal precursor permeation to create a transition zone aligned with the proximal lumen/passage.
Freeze-dried expanded porous proximal PEG hydrogel with lumen
An elongate rolled proximal section formed from a freeze-dried, crosslinked polyethylene glycol (PEG) hydrogel that expands when exposed to physiological fluid within a puncture, wherein the proximal section comprises pores and the rolled proximal section comprises a sheet having a tubular shape via a mandrel, thereby defining a lumen extending between the proximal end and the distal end of the proximal section.
Unreactive distal hydrogel precursors crosslinked in situ for tissue adhesion
A distal section extending from the distal end of the rolled proximal section, the distal section comprising a solid mass formed from non-freeze-dried, non-crosslinked hydrogel precursors having an outer diameter similar to an outer diameter of the proximal section, the 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 adhesion to the tissue.
Permeation of melted distal precursors into proximal pores to form a transition zone
The precursors of the distal section comprise previously melted precursors applied to a dried distal end of the proximal section, and the melted precursors permeate into the distal end of the proximal section to at least partially reside within the pores of the proximal section to create a transition zone within the distal end of the proximal section.
Partially contained distal section with aligned passage
The distal section extending from the distal end of the rolled proximal section being partially contained within the pores of the proximal section at the distal end, the distal section defines a passage aligned with the lumen of the proximal section, and the precursors of the distal section comprise previously melted precursors applied to a dried distal end of the proximal section.
Across the independent claims, the inventive coverage centers on combining an expanding freeze-dried crosslinked porous PEG hydrogel proximal section with a distal solid mass of non-freeze-dried, non-crosslinked PEG precursors that crosslink in situ upon aqueous exposure to adhere to tissue, where previously melted distal precursors permeate into proximal pores to create a transition zone and form an aligned passage/lumen relationship.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?