INFILTRATOR ANGIOPLASTY BALLOON CATHETER - A DEVICE FOR COMBINED ANGIOPLASTY AND INTRAMURAL SITE-SPECIFIC TREATMENT

Objectives: We describe a new angioplasty device (Infiltrator Angiopla sty Balloon Catheter; IABC) with intramural drug delivery capability, The conventional balloon part of the device, when inflated, dilates th e vessel or has three rows of longitudinally mounted infiltrator nippl es to penetrate the tunica media, Through an independent infiltrator p ort and nipples, drugs can be infiltrated directly into the vessel wal l. Methods: The device was tested in 117 normal coronary arteries of 5 8 farm pigs, Results: (1) The infiltration procedure does not damage t he vessel angiographically or histologically. At the infiltration site , the endothelial layer and the internal elastic lamina has a controll ed interruption, and the infiltrated fluid is distributed among the me dial layers, causing a mild focal edema and medial thickening (1.8 tim es on average). (2) Rhodamine tracer is circularly and evenly distribu ted through the whole width of the vessel wall within 10 min after inf iltration, (3) Two weeks after the infiltration procedure, the medial layer reveals mild local thickening and remodeling without luminal nar rowing. (4) Of the intramurally infiltrated Tcm99-labeled surfurcolloi d, 83.8% is detectable at 5 min after the delivery procedure by gamma camera. (5) The IABC, if oversized, is able to achieve angiographic di latation in normal pig coronary arteries, causing histologic damage si milar to or less than that induced by conventional balloon dilatation. Conclusions: The IABC can deliver fluid-phase substances directly int o the vessel wall with microliter accuracy and with 90% efficiency wit hout significant acute and subacute damage to the vessel wall, It is a lso suitable for combined dilatation and local drug delivery. (C) 1997 Wiley-Liss, Inc.