Stent assembly for the treatment of vulnerable plaque

Abstract

An intravascular stent assembly for implantation in a body lumen, such as a coronary artery, is designed to treat a lesion with vulnerable plaque by reducing the fibrous cap stresses. A polymeric sleeve having first and second ends interconnects a first metallic stent and a second metallic stent. The first end is bonded to a distal end region of the first stent and the second end to a proximal end region of the second stent. The polymeric sleeve can be loaded with a therapeutic drug or agent to further control local thrombosis and/or induce healing if the plaque fibrous cap ruptures during or after implantation. Methods of making an intravascular stent assembly for the treatment of vulnerable plaque are also provided.

1 - 33 . (canceled) 
   
   
       34 . An intravascular stent assembly for treating vulnerable plaque within a body lumen, comprising:
 a first polymeric sleeve in a tubular configuration having first and second ends, wherein its first end is attached to a first stent and its second end is attached to a second stent and a second polymeric sleeve in a tubular configuration having first and second ends, wherein its first end is attached to the second stent and its second end is attached to a third stent, and wherein a substantial portion of said polymeric sleeves are unsupported by a stent structure;   wherein the polymeric sleeves are loaded with at least one therapeutic drug or agent and are configured to appose a vulnerable plaque region when the stent assembly is deployed within a body lumen having a region of vulnerable plaque.   
   
   
       35 . The stent assembly of  claim 34 , wherein the stents include a plurality of flexible cylindrical rings being expandable in a radial direction, each of the rings having a first delivery diameter and a second implanted diameter and being aligned on a common longitudinal axis. 
   
   
       36 . The stent assembly of  claim 34 , wherein the stents include at least one link being attached between adjacent rings to form the stent. 
   
   
       37 . The stent assembly of  claim 34 , wherein the stents are formed from a metallic material. 
   
   
       38 . The stent assembly of  claim 37 , wherein the metallic material forming the stents consists of stainless steel, titanium, nickel titanium, and cobalt-chromium. 
   
   
       39 . The stent assembly of  claim 34 , wherein the polymer material forming the polymeric sleeves is taken from the group of polymers consisting of ePTFE, polyurethanes, polyetherurethanes, polyesterurethanes, ultra high molecular weight polyethylene, polypropylene, PVDF, silicone, thermoplastic elastomer (C-flex), polyether-amide thermoplastic elastomer (Pebax), fluoroelastomers, fluorosilicone elastomer, styrene-butadiene-styrene rubber, styrene-isoprene-styrene rubber, polybutadiene, polyisoprene, neoprene (polychloroprene), ethylene-propylene elastomer, chlorosulfonated polyethylene elastomer, butyl rubber, polysulfide elastomer, polyacrylate elastomer, nitrile rubber, a family of elastomers composed of styrene, ethylene, propylene, aliphatic polycarbonate polyurethane, polymers augmented with antioxidents, polymers augmented with image enhancing materials, polymers having a proton (H+) core, polymers augmented with protons (H+), butadiene and isoprene (Kraton) and polyester thermoplastic elastomer (Hytrel). 
   
   
       40 . The stent assembly of  claim 34 , wherein the polymeric sleeves each have a length that is longer than the vulnerable plaque consisting of about 1 to 20 mm. 
   
   
       41 . The stent assembly of  claim 34 , wherein the polymeric sleeves are configured so as to each have a length that is about equal to the length of the vulnerable plaque in said body lumen. 
   
   
       42 . The stent assembly of  claim 34 , wherein the polymeric sleeves have a thickness in a range of about 0.001 to 0.010 inch. 
   
   
       43 . (canceled) 
   
   
       44 . (canceled) 
   
   
       45 . (canceled) 
   
   
       46 . The stent assembly of  claim 34 , wherein a primer is disposed about the metallic portions of the stents that contact the polymeric sleeve. 
   
   
       47 . The stent assembly of  claim 34 , wherein an adhesive, disposed about the metallic portions that contact the polymeric sleeve and cured thereon, is the medium by which the polymeric sleeve is attached to the metallic portions of the stents. 
   
   
       48 . The stent assembly of  claim 47 , wherein the adhesive is silicone. 
   
   
       49 . The stent assembly of  claim 34 , wherein the polymeric sleeves are microporous. 
   
   
       50 . The stent assembly of  claim 34 , wherein the at least one therapeutic drug or agent includes antiplatelets, anticoagulants, antifibrins, antithrombins, and antiproliferatives. 
   
   
       51 . An intravascular stent assembly for treating vulnerable plaque within a body lumen, comprising:
 three stents interconnected by two polymeric sleeves having a tubular configuration wherein a substantial portion of said polymeric sleeves are unsupported by a stent structure;   wherein the polymeric sleeves are loaded with at least one therapeutic drug or agent and are configured to appose a vulnerable plaque region when the stent assembly is deployed within a body lumen having a region of vulnerable plaque.   
   
   
       52 . The stent assembly of  claim 51 , wherein the stents include a plurality of flexible cylindrical rings being expandable in a radial direction, each of the rings having a first delivery diameter and a second implanted diameter and being aligned on a common longitudinal axis. 
   
   
       53 . The stent assembly of  claim 51 , wherein the stents include at least one link being attached between adjacent rings to form the stent. 
   
   
       54 . The stent assembly of  claim 51 , wherein the stents are formed from a metallic material. 
   
   
       55 . The stent assembly of  claim 54 , wherein the metallic material forming the stents consists of stainless steel, titanium, nickel titanium, and cobalt-chromium. 
   
   
       56 . The stent assembly of  claim 51 , wherein the polymer material forming the polymeric sleeves is taken from the group of polymers consisting of ePTFE, polyurethanes, polyetherurethanes, polyesterurethanes, ultra high molecular weight polyethylene, polypropylene, PVDF, silicone, thermoplastic elastomer (C-flex), polyether-amide thermoplastic elastomer (Pebax), fluoroelastomers, fluorosilicone elastomer, styrene-butadiene-styrene rubber, styrene-isoprene-styrene rubber, polybutadiene, polyisoprene, neoprene (polychloroprene), ethylene-propylene elastomer, chlorosulfonated polyethylene elastomer, butyl rubber, polysulfide elastomer, polyacrylate elastomer, nitrile rubber, a family of elastomers composed of styrene, ethylene, propylene, aliphatic polycarbonate polyurethane, polymers augmented with antioxidents, polymers augmented with image enhancing materials, polymers having a proton (H+) core, polymers augmented with protons (H+), butadiene and isoprene (Kraton) and polyester thermoplastic elastomer (Hytrel). 
   
   
       57 . The stent assembly of  claim 51 , wherein the polymeric sleeves each have a length that is longer than the vulnerable plaque consisting of about 1 to 20 mm. 
   
   
       58 . The stent assembly of  claim 51 , wherein the polymeric sleeves are configured so as to each have a length that is about equal to the length of the vulnerable plaque in said body lumen. 
   
   
       59 . The stent assembly of  claim 51 , wherein the polymeric sleeves have a thickness in a range of about 0.001 to 0.010 inch. 
   
   
       60 . The stent assembly of  claim 51 , wherein a primer is disposed about the metallic portions of the stents that contact the polymeric sleeve. 
   
   
       61 . The stent assembly of  claim 51 , wherein an adhesive, disposed about the metallic portions that contact the polymeric sleeve and cured thereon, is the medium by which the polymeric sleeve is attached to the metallic portions of the stents. 
   
   
       62 . The stent assembly of  claim 61 , wherein the adhesive is silicone. 
   
   
       63 . The stent assembly of  claim 51 , wherein the polymeric sleeves are microporous. 
   
   
       64 . The stent assembly of  claim 63 , wherein the at least one therapeutic drug or agent includes antiplatelets, anticoagulants, antifibrins, antithrombins, and antiproliferatives.