US 12,383,710 B2
Drug-coated balloon catheters for body lumens
Lixiao Wang, Henderson, NV (US); Peter Barnett, Shakopee, MN (US); and David Hendrickson, Coon Rapids, MN (US)
Assigned to Urotronic, Inc., Plymouth, MN (US)
Filed by Urotronic, Inc., Plymouth, MN (US)
Filed on Apr. 25, 2024, as Appl. No. 18/645,654.
Application 18/645,654 is a continuation of application No. 17/255,701, granted, now 12,005,206, previously published as PCT/US2020/019274, filed on Feb. 21, 2020.
Claims priority of provisional application 62/859,396, filed on Jun. 10, 2019.
Claims priority of provisional application 62/809,048, filed on Feb. 22, 2019.
Prior Publication US 2024/0269439 A1, Aug. 15, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61M 25/10 (2013.01); A61L 29/16 (2006.01)
CPC A61M 25/10 (2013.01) [A61L 29/16 (2013.01); A61L 2300/416 (2013.01); A61M 2025/105 (2013.01); A61M 2025/1059 (2013.01); A61M 2025/1068 (2013.01); A61M 2210/105 (2013.01); A61M 2210/1057 (2013.01); A61M 2210/106 (2013.01); A61M 2210/1064 (2013.01); A61M 2210/1085 (2013.01); A61M 2210/1089 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A drug-coated balloon catheter comprising:
an elongated balloon; and
a coating layer overlaying an exterior surface of the balloon, the coating layer comprising an initial drug load of a therapeutic agent comprising paclitaxel, and
at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof;
wherein the coating layer directly contacts the exterior surface of the balloon; and
wherein a soaking procedure for treating a target site in a body lumen with the drug-coated balloon catheter is sufficient for the coating layer to release 37 wt % to 97 wt % of the initial drug load of the therapeutic agent from the coating layer, wherein the soaking procedure consists of
passing the drug-coated balloon catheter through an introducer sheath into a cylindrical vessel, the cylindrical vessel comprising 0.9% saline at 37° C.,
soaking the drug-coated balloon catheter in the saline in the cylindrical vessel for 1 minute,
inflating the drug-coated balloon catheter for 1 minute, and
withdrawing the drug-coated balloon catheter from the cylinder.