Abstract
We have developed a new balloon catheter device with multifunction: inflation of coronary stenosis, drug delivery, and perfusion of distal vessel and evaluated in vitro and in vivo using canine model. This balloon catheter has eight perfusion ports at the proximal site of balloon, and a drug delivery port at the distal site of balloon. Extended balloon distal tube was used as drug delivery region. The flow-rate was obtained around 42 cc to 52 cc/min. The simulated drug was stained in the drug delivery region under the low pressure in balloon inside with continuous infusion (1 cc/min.), whereas the simulated drug was wash out without continuous infusion. The distal perfusion % flow-rate was obtained 12.2±5.9% comparing with control in a dog carotid artery. A continuous infusion of both FITC-labeled drug resulted in its local accumulation on and in a injured vessel wall, respectively. This new device may promise to realize local delivery of therapeutic agents at the balloon injury site after mechanical balloon dilatation to protect restenosis.
