Biodegradable self-expanding prosthesis

Abstract

Disclosed herein is a biodegradable prosthesis that includes a first end, a second end, and an elongate tubular body with a lumen therethrough. The prosthesis can have a first layer comprising a set of flexible interbraided bioabsorbable filaments, and optionally a set of flexible interbraided metallic filaments. Also, the prosthesis can have a second layer comprising a porous thermoplastic material that can be either an outer layer or an inner layer relative to the first layer. The prosthesis can include other features including branch apertures, folded portions, and attachment mechanisms for the first and second layers.

1 . An intraluminal prosthesis, comprising:
 a first end, a second end, and an elongate tubular body with a lumen therethrough;   a first layer comprising flexible interbraided filaments, wherein a first group of filaments comprise a biodegradable material,   wherein the prosthesis has a first cross-sectional outer diameter at the first end, a second cross-sectional outer diameter at the second end, and a third cross-sectional outer diameter at a mid-point on the prosthesis axially displaced from the first end and the second end of the prosthesis, wherein the prosthesis is configured such that the first end and the second end both comprise a first wall, wherein a portion of the first wall is folded over to form a second wall, wherein the second wall is secured to the first wall, wherein the first cross-sectional outer diameter and the second cross-sectional outer diameter are both larger than the third cross-sectional outer diameter when the prosthesis is in a first, radially compressed configuration for delivery as well as when the prosthesis is in a second, radially enlarged configuration within a blood vessel, wherein the prosthesis has a continuous, cylindrical cross-sectional inner diameter throughout its axial length, wherein the prosthesis comprises a bioactive agent delivery reservoir between the first wall and the second wall.   
     
     
         2 . The prosthesis of  claim 1 , further comprising a second group of filaments, wherein the second group of filaments comprises a metallic material. 
     
     
         3 . The prosthesis of  claim 2 , wherein the first group of filaments comprising a biodegradable material make up 70% or more of the total number of filaments and the second group of filaments make up 30% or less of the total number of filaments. 
     
     
         4 . The prosthesis of  claim 1 , wherein the bioactive agent reservoir comprises a drug. 
     
     
         5 . The prosthesis of  claim 4 , wherein the drug is selected from the group consisting of: paclitaxel, rapamycin, zotarolimus, and tacrolimus. 
     
     
         6 . The prosthesis of  claim 1 , wherein the first bioactive agent comprises a stem cell. 
     
     
         7 . The prosthesis of  claim 1 , wherein the second wall is secured to the first wall with sutures. 
     
     
         8 . The prosthesis of  claim 1 , wherein the second wall is bonded to the first wall. 
     
     
         9 . The prosthesis of  claim 1 , further comprising at least one side orifice along the elongate tubular body. 
     
     
         10 . The prosthesis of  claim 1 , further comprising at least one radiopaque marker secured between the first wall and the second wall. 
     
     
         11 . The prosthesis of  claim 1 , further comprising a second layer, wherein the second layer comprises a porous material. 
     
     
         12 . The prosthesis of  claim 11 , wherein the second layer is the outer layer relative to the first layer. 
     
     
         13 . The prosthesis of  claim 11 , wherein the second layer is the inner layer relative to the first layer. 
     
     
         14 . An intraluminal prosthesis, comprising:
 a first end, a second end, and an elongate tubular body with a lumen therethrough;   a first layer comprising flexible biodegradable interbraided filaments,   wherein the prosthesis has a first cross-sectional outer diameter at the first end, a second cross-sectional outer diameter at the second end, and a third cross-sectional outer diameter at a point on the prosthesis axially displaced from the first end and the second end of the prosthesis, wherein the prosthesis is configured such that the first end and the second end both comprise a first wall, wherein a portion of the first wall is folded over to form a second wall, wherein the second wall is secured to the first wall, wherein the first cross-sectional outer diameter and the second cross-sectional outer diameter are both larger than the third cross-sectional outer diameter when the prosthesis is in a first, radially compressed configuration for delivery as well as when the prosthesis is in a second, radially enlarged configuration within a blood vessel, wherein the prosthesis has a continuous, cylindrical cross-sectional inner diameter throughout its axial length, wherein the prosthesis comprises a bioactive agent between the first wall and the second wall.   
     
     
         15 . An intraluminal prosthesis, comprising:
 a first end, a second end, and an elongate tubular body with a lumen therethrough;   a first layer comprising flexible biodegradable interbraided filaments; and   a second layer comprising a bioactive agent;   wherein the prosthesis has a first cross-sectional outer diameter at the first end, a second cross-sectional outer diameter at the second end, and a third cross-sectional outer diameter at a mid-point on the prosthesis axially displaced from the first end and the second end of the prosthesis, wherein the prosthesis is configured such that the first end and the second end both comprise a first wall, wherein a portion of the first wall is folded over to form a second wall, wherein the second wall is secured to the first wall, wherein the first cross-sectional outer diameter and the second cross-sectional outer diameter are both larger than the third cross-sectional outer diameter when the prosthesis is in a first, radially compressed configuration for delivery as well as when the prosthesis is in a second, radially enlarged configuration within a blood vessel, wherein the prosthesis has a continuous, cylindrical cross-sectional inner diameter throughout its axial length, wherein the prosthesis comprises a reservoir of the bioactive agent and at least one radiopaque marker element between the first wall and the second wall.   
     
     
         16 . The prosthesis of  claim 15 , wherein the first cross-sectional outer diameter is at least about 1.0× of the third cross-sectional outer diameter. 
     
     
         17 . The prosthesis of  claim 15 , wherein the first cross-sectional outer diameter is at least about 1.02× of the third cross-sectional outer diameter. 
     
     
         18 . The prosthesis of  claim 15 , wherein the first cross-sectional outer diameter is at least about 1.05× of the third cross-sectional outer diameter. 
     
     
         19 . The prosthesis of  claim 15 , wherein the bioactive agent comprises a stem cell. 
     
     
         20 . The prosthesis of  claim 15 , wherein the bioactive agent comprises a drug. 
     
     
         21 . The prosthesis of  claim 15 , wherein the drug prevents restenosis. 
     
     
         22 . The prosthesis of  claim 15 , wherein the second layer is spray-dipped on the first layer. 
     
     
         23 . The prosthesis of  claim 15 , wherein the second layer is annealed to the first layer. 
     
     
         24 . The prosthesis of  claim 15 , wherein the second layer is covalently bound to the first layer. 
     
     
         25 . The prosthesis of  claim 15 , wherein the second layer is non-covalently bound to the first layer.