Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.