US 11,751,857 B2
Chitosan and polyethylene glycol copolymers and methods and devices for using same for sealing a vascular puncture
Andreas Mylonakis, Fremont, CA (US); and Florencia Lim, Union City, CA (US)
Assigned to ACCESS CLOSURE, INC., Santa Clara, CA (US)
Filed by ACCESS CLOSURE, INC., Santa Clara, CA (US)
Filed on Nov. 21, 2017, as Appl. No. 15/819,514.
Application 15/819,514 is a continuation of application No. 14/724,591, filed on May 28, 2015, granted, now 9,861,348.
Claims priority of provisional application 62/004,806, filed on May 29, 2014.
Prior Publication US 2018/0168563 A1, Jun. 21, 2018
Int. Cl. A61B 17/00 (2006.01); A61L 24/00 (2006.01); A61L 24/08 (2006.01); A61L 31/04 (2006.01); A61L 31/06 (2006.01); A61L 31/14 (2006.01)
CPC A61B 17/0057 (2013.01) [A61L 24/0031 (2013.01); A61L 24/08 (2013.01); A61L 31/042 (2013.01); A61L 31/06 (2013.01); A61L 31/145 (2013.01); A61L 31/148 (2013.01); A61B 2017/0065 (2013.01); A61B 2017/00623 (2013.01); A61L 2400/04 (2013.01)] 33 Claims
OG exemplary drawing
1. An apparatus for sealing a puncture through tissue, the puncture having a first French size, the apparatus comprising:
a sealant having
a first section including a proximal end, a distal end, a cross-section sized for delivery into the puncture through tissue,
wherein the first section is formed from a freeze-dried polyethylene glycol (PEG) and a chitosan hydrogel that expands when exposed to physiological fluid within the puncture and seals the puncture through the tissue, wherein the hydrogel was formed by reacting the PEG and chitosan, and subsequently frozen, freeze-dried, and then conditioned with one or more humidity and temperature cycles, and wherein the PEG comprises PEG-amine and PEG-ester, the PEG-ester being present in excess of PEG-amine, wherein a molar ratio of chitosan to PEG-ester is between about 0.0005 to about 0.001; and
a second section extending from the distal end of the first section, wherein the second section comprises non-cross-linked PEG precursors, wherein at least some of the non-cross linked PEG precursors are in an unreactive state; and
a sheath having a lumen,
wherein the sealant is positioned in the lumen of the sheath, and
wherein the apparatus has a second French size smaller than the first French size.