Device and method for preventing stenosis at an anastomosis site

A method for preventing stenosis in a vascular structure having an anastomosis wherein the vascular structure is an artery, a vein or a graft, comprising the steps of:

• a. forming an anastomosis;
• b. deploying a drug-free stent within the lumen of a vascular structure at or in the vicinity of the anastomosis;
• and
• c. applying a sleeve locally and externally to the vascular structure containing the stent, the sleeve consisting essentially of a biocompatible matrix material and an anti-vasculoproliferative drug;
• wherein the steps of the method are performed in a single surgical procedure.

A method for preventing stenosis in a vascular structure having an anastomosis wherein the vascular structure has an external surface, comprising the steps of:

• a. Forming an anastomosis;
• b. Inserting a drug-free stent into the vascular structure at or in the vicinity of the anastomosis wherein the stent comprises a structure defining an essentially tubular body with a longitudinal axis and a circumferential diameter, the structure being expandable from a contracted configuration to an expanded configuration, wherein the stent is beveled at an edge and/or curved along the longitudinal axis for placement at or in the vicinity of the anastomosis;
• and
• c. Applying a sleeve to the external surface of the vascular structure containing the stent, wherein the sleeve comprises a biocompatible matrix material imbibed with an anti-proliferative agent;
• wherein the steps of the method are performed in a single surgical procedure.

A method for preventing stenosis in a vascular structure having an anastomosis wherein the vascular structure is an artery, a vein or a graft, the method comprising the steps of:

• a. Forming an anastomosis;
• b. Deploying a self-expanding stent
• within the vascular structure at or in the vicinity of the anastomosis, wherein the stent has a longitudinal axis and a circumferential diameter, the stent being expandable from a contracted configuration to an expanded configuration, and wherein the stent is beveled at an edge and/or curved along the longitudinal axis for placement at the anastomosis;
• and
• c. Applying a sleeve comprising a biocompatible matrix material imbibed with a therapeutic agent to the external surface of the vascular structure containing the stent;
• wherein the method is performed in a single surgical procedure.

A method for preventing stenosis in an AV fistula, comprising the following steps performed in a single surgical procedure:

• a. creating the AV fistula by joining a vein to an artery;
• b. deploying a drug-free stent at the anastomosis and the adjacent vein and/or artery, wherein the stent comprises a structure defining an essentially tubular body with a longitudinal axis and a circumferential diameter, the structure being expandable from a contracted configuration to an expanded configuration;
• and
• c. applying locally and externally to the anastomosis and adjacent vein and/or artery containing the stent an effective amount of rapamycin or everolimus or zotarolimus or other analogue of rapamycin via a biocompatible matrix material that carries the rapamycin or everolimus or zotarolimus or other analogue of rapamycin.