Directional needle injection drug delivery device and method use

Abstract

The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

1 .- 18 . (canceled)  
   
   
       19 . A device for delivering a drug directly to a target site comprising: 
 an elongate body having a first lumen and a needle lumen;    a retractable ultrasonic element positionable in said first lumen;    a retractable needle positionable in said needle lumen; and    an intravascular ultrasound (IVUS) system connected to a proximal end of said retractable ultrasonic element.    
   
   
       20 . A device for delivering a drug directly to a target site comprising: 
 an elongate body having a first lumen and a needle lumen;    a retractable ultrasonic element positionable in said first lumen and adapted to generate a real-time image of the target site; and    a retractable needle housed within said needle lumen.    
   
   
       21 . A device for delivering a drug directly to a target site comprising: 
 an elongate body having a first lumen and a needle lumen;    a retractable ultrasonic element positionable in said first lumen;    a retractable needle positionable in said needle lumen; and    an intravascular ultrasound (IVUS) system connected to a proximal end of said retractable ultrasonic element adapted to process images generated by the ultrasonic element when positioned distal the target site and when moved in a proximal direction.    
   
   
       22 . A device as in  claim 20  further comprising: 
 an inflatable balloon coupled near a distal portion of the elongate body.