US 12,214,107 B2
Drug-coated medical devices
Jingnan Luo, Medtech Hub (SG); Qian Yi Michele Lee, Medtech Hub (SG); and Honglei Wang, Medtech Hub (SG)
Assigned to Vascuros Medical (Shanghai) Co., Ltd., (CN); and Vascuros Medical Pte Ltd., Singapore (SG)
Filed by Vascuros Medical (Shanghai) Co., Ltd., Shanghai (CN); and Vascuros Medical Pte Ltd., Jtc Medtech Hub (SG)
Filed on Jun. 24, 2022, as Appl. No. 17/849,426.
Application 17/849,426 is a continuation of application No. 15/742,828, abandoned, previously published as PCT/SG2016/050318, filed on Jul. 8, 2016.
Claims priority of application No. 1512030 (GB), filed on Jul. 9, 2015.
Prior Publication US 2023/0057153 A1, Feb. 23, 2023
Int. Cl. A61F 2/00 (2006.01); A61K 31/337 (2006.01); A61K 31/436 (2006.01); A61L 29/08 (2006.01); A61L 29/16 (2006.01); A61M 25/10 (2013.01)
CPC A61L 29/16 (2013.01) [A61K 31/337 (2013.01); A61K 31/436 (2013.01); A61L 29/085 (2013.01); A61M 25/1029 (2013.01); A61L 2300/416 (2013.01); A61L 2300/62 (2013.01); A61L 2300/622 (2013.01); A61L 2300/624 (2013.01); A61L 2420/02 (2013.01); A61M 2025/1004 (2013.01); A61M 2025/1031 (2013.01); A61M 2025/105 (2013.01); A61M 2025/1075 (2013.01)] 18 Claims
 
1. A drug-coated medical device comprising:
a balloon having an inner surface and an outer hydrophobic surface;
an adhesion balance layer directly on the outer hydrophobic surface of the balloon, comprising a hydrophilic polymer and/or a hydrophilic compound, where the hydrophilic polymer has a number average molecular weight of from 10,000 to 10,000,000 Daltons and the hydrophilic compound is a sugar with a molecular weight of less than 1,000 Daltons; and
a therapeutic layer directly on the adhesion balance layer comprising a therapeutic agent and a pharmaceutically acceptable carrier, wherein:
the therapeutic agent is a hydrophobic therapeutic agent with one or more hydrogen-bonding groups and is provided as discrete drug particles in the therapeutic layer;
the drug particles have at least one dimension that is less than 25 μm and are uniformly distributed on the surface of the balloon; and
the pharmaceutically acceptable carrier is hydrophilic and has a molecular weight of less than 1,000 Daltons, and is selected from one or more of the group consisting of tartaric acid, a sugar, and a sugar alcohol; and
the amount of the pharmaceutically acceptable carrier to therapeutic agent in the therapeutic layer is from 1:8 to 4:1 wt/wt.