US2017360993A1PendingUtilityA1

Coated endovascular prostheses for aneurism treatment

Assignee: MEDTRONIC VASCULAR INCPriority: Jun 21, 2016Filed: Jun 13, 2017Published: Dec 21, 2017
Est. expiryJun 21, 2036(~9.9 yrs left)· nominal 20-yr term from priority
A61F 2/06A61F 2/07A61L 31/16A61F 2002/072A61F 2002/077A61F 2210/0061A61L 27/58A61L 27/52A61L 2300/42A61L 27/56A61L 27/54A61L 31/10
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Claims

Abstract

The present technology relates generally to endovascular prostheses. More particularly, the disclosure relates to endovascular prostheses having an outer surface of a graft material thereof associated with a hydrogel composition, which may swell upon implantation within a blood vessel, thereby mediating various complications associated with endovascular procedures. The hydrogel compositions can also include various stabilizing polymers and active agents to further aid their use in the body.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An endovascular prosthesis having a compressed configuration for delivery within a vasculature and a radially-expanded configuration for deployment within a target blood vessel of a patient, the endovascular prosthesis comprising:
 an anchor stent for engaging an inner wall of the target blood vessel when the prosthesis is in the radially-expanded configuration;   a tubular body formed from a graft material defining a central lumen from a first end to a second end thereof, wherein the anchor stent is attached to the first end of the tubular body, the tubular body having an inner surface and an outer surface;   a body stent attached to the outer surface of the tubular body for maintaining the tubular body in the radially-expanded configuration; and   a hydrogel composition associated with about 20% to about 100% of the outer surface of the tubular body, the hydrogel composition comprising a hydrogel polymer and one or more of a stabilizing polymer, a biologically active agent and a bioabsorbable polymer, wherein the hydrogel composition is in a non-expanded state and capable of expanding to an expanded state following introduction into the target blood vessel of the patient.   
     
     
         2 . The endovascular prosthesis of  claim 1 , wherein the hydrogel composition is adapted to expand within the target blood vessel so as to mediate an endoleak, to prevent prosthesis migration and/or to aid in sealing one or more ends of the prosthesis when implanted within a short neck aneurysm. 
     
     
         3 . The endovascular prosthesis of  claim 1 , wherein the hydrogel polymer is selected from the group consisting essentially of poly(hydroxyethyl methacrylate) (pHEMA), poly (vinylpyrrolidinone) (PVP), poly(acrylamide) (pAM), and poly(acrylic acid) (pAA). 
     
     
         4 . The endovascular prosthesis of  claim 1 , wherein the stabilizing polymer is one of poly(ethylene terephthalate) and poly(urethane). 
     
     
         5 . The endovascular prosthesis of  claim 1 , wherein the biologically active agent is selected from the group consisting essentially of collagen, fibrin, thrombin, and dipyridamole. 
     
     
         6 . The endovascular prosthesis of  claim 1 , wherein the bioabsorbable polymer is selected from the group consisting essentially of poly(lactic-co-glycolic acid), poly(lactic acid) and poly(glycerol sebacate). 
     
     
         7 . The endovascular prosthesis of  claim 1 , wherein the graft material is a flexible sheet of a material selected from the group consisting essentially of polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), ultra-high-molecular-weight polyethylene (UHMWPE), polyurethane and polyester. 
     
     
         8 . The endovascular prosthesis of  claim 1 , wherein the hydrogel composition is associated with about 20% to about 50% of the outer surface of the tubular body. 
     
     
         9 . The endovascular prosthesis of  claim 1 , wherein the hydrogel composition is associated with about 50% to about 100% of the outer surface of the tubular body. 
     
     
         10 . An endovascular prosthesis comprising:
 a tubular body formed from a graft material, the tubular body having an inner surface and an outer surface; and   a hydrogel composition associated with at least a portion of the outer surface of the tubular body,   wherein the hydrogel composition in a non-expanded state and capable of expanding to an expanded state following introduction into a target blood vessel of a patient.   
     
     
         11 . The endovascular prosthesis of  claim 10 , wherein the hydrogel composition is associated with about 20% to about 50% of the outer surface of the tubular body. 
     
     
         12 . The endovascular prosthesis of  claim 10 , wherein the hydrogel composition is associated with between about 50% to about 100% of the outer surface of the tubular body. 
     
     
         13 . The endovascular prosthesis of  claim 10 , wherein the hydrogel composition comprises a hydrogel polymer. 
     
     
         14 . The endovascular prosthesis of  claim 13 , wherein the hydrogel polymer is selected from the group consisting essentially of poly(hydroxyethyl methacrylate) (pHEMA), poly (vinylpyrrolidinone) (PVP), poly(acrylamide) (pAM), and poly(acrylic acid) (pAA). 
     
     
         15 . The endovascular prosthesis of  claim 13 , wherein the hydrogel composition further comprises a stabilizing polymer. 
     
     
         16 . The endovascular prosthesis of  claim 15 , wherein the stabilizing polymer is poly(ethylene terephthalate) or poly(urethane). 
     
     
         17 . The endovascular prosthesis of  claim 10 , wherein the hydrogel composition forms a hydrogel coating on the at least a portion of the outer surface of the tubular body. 
     
     
         18 . The endovascular prosthesis of  claim 17 , wherein the hydrogel coating covers the entire outer surface of the tubular body. 
     
     
         19 . The endovascular prosthesis of  claim 13 , wherein the hydrogel composition further comprises a biologically active agent. 
     
     
         20 . The endovascular prosthesis of  claim 19 , wherein the biologically active agent is selected from the group consisting essentially of collagen, fibrin, thrombin, and dipyridamole. 
     
     
         21 . The endovascular prosthesis of  claim 13 , wherein the hydrogel composition further comprises a bioabsorbable polymer. 
     
     
         22 . The endovascular prosthesis of  claim 21 , wherein the bioabsorbable polymer is selected from the group consisting of poly(lactic-co-glycolic acid), poly(lactic acid) and poly(glycerol sebacate). 
     
     
         23 . The endovascular prosthesis of  claim 10 , wherein the graft material is a flexible sheet of a material selected from the group consisting essentially of polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), ultra-high-molecular-weight polyethylene (UHMWPE), polyurethane and polyester. 
     
     
         24 . The endovascular prosthesis of  claim 17 , wherein an outer coating that comprises a material for promoting conversion of thrombus into fibro-cellular tissue is formed on at least a portion of the tubular body having the hydrogel coating. 
     
     
         25 . The endovascular prosthesis of  claim 24 , wherein the outer coating is not applied to portions of the tubular body that contact a wall of the vessel. 
     
     
         26 . The endovascular prosthesis of  claim 24 , wherein the material is one of a bioabsorbable polymer and a biologically active agent. 
     
     
         27 . A method of delivering a hydrogel-associated endovascular prosthesis to a target blood vessel of a patient, the method comprising:
 providing a hydrogel-associated endovascular prosthesis having a compressed configuration for delivery within a vasculature and a radially-expanded configuration for deployment within the target blood vessel, the prosthesis comprising:
 an anchor stent for engaging an inner wall of the target blood vessel when the prosthesis is in the radially-expanded configuration; 
 a tubular body formed from a graft material defining a central lumen from a first end to a second end thereof, wherein the anchor stent is attached to the first end of the tubular body, the tubular body having an inner surface and an outer surface; 
 a body stent attached to the outer surface of the tubular body for maintaining the tubular body in the radially-expanded configuration; and 
 a hydrogel composition associated with about 20% to about 100% of the outer surface of the tubular body, the hydrogel composition comprising a hydrogel polymer and one or more of a stabilizing polymer, a biologically active agent and a bioabsorbable polymer, wherein the hydrogel composition in a non-expanded state and capable of expanding to an expanded state following introduction into the target blood vessel of the patient; 
   introducing the hydrogel-associated endovascular prosthesis transluminally into a selected portion of the target blood vessel, wherein the hydrogel composition is in the non-expanded state;   radially expanding the endovascular prosthesis into contact with the target blood vessel; and   expanding the hydrogel composition to the expanded state within the target blood vessel.   
     
     
         28 . A method of mediating a complication during an endovascular treatment of a target blood vessel of a patient, the method comprising:
 providing an endovascular prosthesis having a compressed configuration for delivery within a vasculature and a radially-expanded configuration for deployment within the target blood vessel, the prosthesis comprising:
 an anchor stent for engaging an inner wall of the target blood vessel when the prosthesis is in the radially-expanded configuration; 
 a tubular body formed from a graft material defining a central lumen from a first end to a second end thereof, wherein the anchor stent is attached to the first end of the tubular body, the tubular body having an inner surface and an outer surface; 
 a body stent attached to the outer surface of the tubular body for maintaining the tubular body in the radially-expanded configuration; and 
 a hydrogel composition associated with about 20% to about 100% of the outer surface of the tubular body, the hydrogel composition comprising a hydrogel polymer and one or more of a stabilizing polymer, a biologically active agent and a bioabsorbable polymer, wherein the hydrogel composition in a non-expanded state and capable of expanding to an expanded state following introduction into the target blood vessel of the patient; 
   introducing the endovascular prosthesis transluminally into a selected portion of the target blood vessel, wherein the hydrogel composition is in the non-expanded state;   radially expanding the endovascular prosthesis into contact with the target blood vessel; and   expanding the hydrogel composition to the expanded state within the target blood vessel, thereby mediating the complication.   
     
     
         29 . The method of  claim 28 , wherein the complication is an endoleak, a stent graft migration or a sealing of the body lumen in short neck aneurysms.

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