Cea system and method for delivering a self-expanding stent

Abstract

Self-expanding stent delivery systems and methods having an introducer that receives a delivery catheter. The delivery catheter includes an outer body, an inner body and a stent loaded onto a stent bed within the inner body. The outer body receives the inner body with the stent loaded on the stent bed thereof. The outer body helps constrain the stent in its undeployed state in the stent bed until the stent is deployed by retraction of the outer body of the delivery catheter when the stent is identified as positioned across an intended treatment site. At least one anchoring mechanism provided on the inner body helps maintain the undeployed loaded stent appropriately in the stent bed during deployment. The at least one anchoring mechanism can include radiopaque material to increase fluoroscopic visualization of the stent during deployment, and the self-expanding stent can be a bio-absorbable material including drugs or other bio-active agents incorporated therein or provided thereon. The at least one anchoring mechanism can instead comprise a set of at least two bumpers between which the stent is loaded until deployed by retraction of the outer body of the delivery catheter when the stent has been appropriately positioned across an intended treatment site. After deployment of the stent at the intended treatment site, removal of the inner body and outer body of the delivery catheter and of the introducer occurs. Reliable and accurate emplacement of the stent across an intended treatment site is rendered more likely as a result.

1 . A method for delivering a self-expanding stent to an intended treatment site, the method comprising:
 providing a self-expanding stent delivery system as in  claim 1 ; and   loading the self-expanding stent onto the stent bed and engaging the at least one anchoring mechanism with the stent in its constrained state;
 receiving the loaded stent and inner body into the outer body so as to maintain the stent in its constrained state by the outer body; 
 creating an incision into a vasculature of a patient; 
 inserting the introducer through into the patient through the vasculature of the patient through the incision; 
 inserting the delivery catheter with loaded self-expanding stent through the introducer and into the vasculature of the patient; 
 navigating the delivery catheter with loaded self-expanding stent through the vasculature of the patient to the intended treatment site; 
 withdrawing the outer body; 
 disengaging the stent from the inner body, the stent bed and the at least one anchoring mechanism by expansion of the stent; and 
 withdrawing the inner body, the stent bed and the at least one anchoring mechanism. 
   
   
   
       2 . The method of  claim 1 , further comprising:
 providing radiopaque material in the at least one anchoring mechanism; and   visualizing the location of the stent prior to withdrawal of the outer body by visualizing the at least one anchoring mechanism.   
   
   
       3 . The method of  claim 2 , wherein the at least one anchoring mechanism is one anchoring mechanism at or adjacent a proximal end of the stent bed and one anchoring mechanism at or adjacent a distal end of the stent bed. 
   
   
       4 . The method of  claim 3 , wherein the at least one anchoring mechanism is a set of at least two bumpers between which the stent is loaded. 
   
   
       5 . The method of  claim 4 , wherein the set of at least two bumpers comprises at least one bumper at or adjacent a proximal end of the stent bed and at least one bumper at or adjacent a distal end of the stent bed.