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-11103224-B2
Publication Date
2021-08-31
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 disclosure provides a vascular puncture sealant system that uses an elongate freeze-dried, crosslinked hydrogel first section that expands on exposure to physiological fluid. A fused distal second section is provided from non-freeze-dried, non-crosslinked hydrogel precursors that remain unreactive until exposed to aqueous fluid.
Exposure enables in-situ crosslinking to form an adhesive layer. The freeze-dried crosslinked hydrogel includes pores, with non-freeze-dried, non-crosslinked hydrogel precursors present in pore-containing regions at a distal end or a distal transition zone, creating a spatially separated construction in which pore-accessible precursors are associated with the distal portion.
The system further describes optional reinforcement and pH adjusting agents to enhance precursor crosslinking and adhesion. An apparatus is described for percutaneous delivery that includes a positioning member with an expandable element and a cartridge or tubular delivery member with an advancer, with deployment involving delivery into the puncture and exposure/compression to achieve hemostasis.
Claims Coverage
The independent claims are directed to a puncture sealant having a porous freeze-dried crosslinked PEG hydrogel combined with a distally positioned solid mass of non-freeze-dried, non-crosslinked hydrogel precursors. Across the independent claims, four main inventive elements are recurring: pores in the freeze-dried crosslinked PEG hydrogel; a substantially distal solid mass of non-freeze-dried, non-crosslinked precursors; pore-region placement of the precursors in a distal end or distal transition zone; and structural format features such as a lumen and a tubular/rolled-sheet configuration.
Puncture sealant with pores in freeze-dried crosslinked PEG hydrogel
A sealant for sealing a puncture through tissue comprising a freeze-dried hydrogel comprising crosslinked polyethylene glycol (PEG), the freeze-dried hydrogel having pores.
Substantially distal solid mass of non-freeze-dried, non-crosslinked precursors
A sealant for sealing a puncture through tissue comprising a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, wherein the solid mass of hydrogel precursors is substantially distal to the freeze-dried hydrogel.
Distal pore placement of non-freeze-dried, non-crosslinked precursors
Wherein the pores in a distal end of the freeze-dried hydrogel contain non-freeze-dried, non-crosslinked hydrogel precursors.
Distal transition zone containing pore-region precursors
A transition zone in a distal end of the freeze-dried hydrogel, wherein the pores of the freeze-dried hydrogel at the transition zone contain non-freeze-dried, non-crosslinked hydrogel precursors.
Distally positioned precursors formed by melting, drawing into pores, and solidifying
Wherein the solid mass of hydrogel precursors is formed by melting the hydrogel precursors, drawing the melted hydrogel precursors toward a distal end of the freeze-dried hydrogel such that some of the melted precursors permeate into the pores in the distal end of the freeze-dried hydrogel, and allowing the melted hydrogel precursors to solidify.
Lumen extending between freeze-dried hydrogel proximal end and distal precursor solid mass
The sealant comprises a lumen that runs from a proximal end of a freeze-dried hydrogel to a distal end of the solid mass of hydrogel precursors.
Freeze-dried hydrogel formed as a rolled sheet tubular shape
The freeze-dried hydrogel comprises a sheet rolled into a tubular shape.
The independent claims collectively define a porous freeze-dried, crosslinked PEG hydrogel sealant combined with a distally positioned solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, with the precursors located in distal pores via either a distal end or a distal transition zone. Additional claim coverage specifies formation via melting/drawing/solidifying and structural features such as a lumen spanning between proximal and distal portions, and a rolled-sheet tubular freeze-dried hydrogel format.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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