Devices and methods for the delivery and injection of therapeutic and diagnostic agents to a target site within a body

Abstract

The present invention includes systems, devices and methods for delivering and injecting a solution or agent into a target site within the body for the purpose of treating or diagnosing the target site. The target site may be bodily tissue (such as an organ, vessel or bodily lumen), bodily substances (such as a tumor, plaque and thrombus) or synthetic material attached to bodily tissue (such as an artificial graft). The systems and devices of the present invention include injection systems and components for accurately and precisely delivering, injecting and perfusing a therapeutic or diagnostic agent, preferably in a fluid form, directly into the target site without the need to penetrate the tissue with anything other than the agent itself. More specifically, none of the embodiments employ a needle or other penetrating device for creating a space within which the agent is injected. The injection systems include embodiments for use in intraoperative and interventional clinical settings, and generally comprise, at least in part, a propulsion apparatus, a reservoir, often called a syringe or ampule, for receiving and holding the solution or agent, and a dispersion means for transporting the solution or agent from the reservoir to the target site and for perfusing or dispersing it within the target site. The surgical and endovascular methods of the present invention include methods for injecting an agent into a target site within the body for the purpose of treating and/or diagnosing a target site or tissue adjacent a target site. Various therapeutic applications in which the invention may be employed include but are not limited to the treatment of cardiac, cardiovascular, peripheral vascular, and neurovascular diseases, AV access graft stenosis and thrombus formation, cancer, rheumatoid arthritis, etc. More specific examples of the types of applications that can be accomplished by the present invention include, for example, the administration of angiogenic solutions to an ischemic area of myocardium, the delivery of a thrombolytic drug to a thrombus within a chamber of the heart or to the peripheral or neuro vasculature, administration of a solution to a portion of the atria contributing to atrial fibrillation, or the delivery of an anti-angiogenic solution to a solid tumor or through the vasculature supplying blood to a malignancy.

What is claimed is:  
     
         1 . A system for injecting an agent into a target site within the body, comprising: 
 an ampule having a reservoir for holding a volume of agent, the reservoir having at least one reservoir orifice;    a dispersion means distal to the ampule and having at least one dispersion orifice;    at least one pathway in fluid communication between the at least one reservoir orifice and the at least one dispersion orifice; and    a propulsion mechanism operatively coupled to the reservoir for propelling the agent from within the reservoir, through the at least one reservoir orifice, the at least one pathway, and the at least one dispersion orifice and into the target site at a pressure sufficient to cause the agent to penetrate the target site without penetrating the target site with the dispersion means;    wherein:    the dispersion means comprises a fixture having an atraumatic target-facing surface within which the at least one dispersion orifice is located; and    the target-facing surface is smooth and substantially planar.    
     
     
         2 . The system of  claim 1 , wherein the fixture has a cylindrical cap configuration  
     
     
         3 . The system of  claim 1  wherein the target-facing surface has a circular shape.  
     
     
         4 . The system of  claim 1  wherein the target-facing surface has an oval shape.  
     
     
         5 . The system of  claim 1  wherein the target-facing surface has an elliptical shape.  
     
     
         6 . The system of  claim 1  wherein the target-facing surface has an arched cone configuration having a vertex and an arched portion.  
     
     
         7 . The system of  claim 1  wherein the target-facing surface has a single dispersion orifice.  
     
     
         8 . The system of  claim 1  wherein the target-facing surface has a plurality of dispersion orifices in a quadrangle arrangement.  
     
     
         9 . The system of  claim 1  wherein the target-facing surface has a plurality of dispersion orifices arranged along the perimeter of the target-facing surface.  
     
     
         10 . The system of  claim 1  wherein the target-facing surface has a plurality of dispersion orifices arranged in an annular array.  
     
     
         11 . The system of  claim 6  wherein the target-facing surface has a plurality of dispersion orifices arranged along the perimeter of the arched portion.  
     
     
         12 . The system of  claim 7  having a single pathway in fluid communication between the single reservoir orifice and the single dispersion orifice.  
     
     
         13 . The system of  claim 1  wherein the dispersion means has a profile sufficient to be delivered through a less invasive opening.  
     
     
         14 . The system of  claim 13  wherein the less invasive opening is a port positioned within the patient's body.  
     
     
         15 . The system of  claim 13  further comprising an endoscope integrally coupled with the system.  
     
     
         16 . The system of  claim 8  wherein the dispersion means comprises a cannula having a proximal end and a distal end having an atraumatic distal tip, and having a lumen extending there between.  
     
     
         17 . The system of  claim 16  wherein the atraumatic distal tip comprises a target-facing surface.