Systems and Methods for Producing Gastrointestinal Tissues

Abstract

Aspects of the disclosure relate methods and synthetic scaffolds for regenerating gastrointestinal tissue (e.g., esophageal tissue).

1 . A method, comprising the steps of:
 resecting a portion of a tubular organ in a subject, the resection step producing a resected organ portion, the resected organ portion remaining in the subject;   implanting a synthetic scaffold at the site of resection, the synthetic scaffold including an outer polymeric surface and a cellularized sheath layer overlying at least a portion of the outer polymeric surface;   maintaining the synthetic scaffold at the resection site for a period of time sufficient to achieve guided tissue growth along the synthetic scaffold, the guided tissue growth derived from and in contact with the tissue present in the resected organ portion remaining in the subj ect; and   after achieving guided tissue growth, removing the synthetic scaffold from the implantation site, the removing step occurring in a manner such that the guided tissue growth remains in the contact with the resected portion of the tubular organ remaining in the subject.   
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1  wherein the gastrointestinal organ is an esophagus. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The synthetic scaffold of  claim 19  wherein the synthetic scaffold comprises a tubular member wherein the outwardly oriented surface includes electrospun polymeric fibers and wherein the sheath layer spans at least a portion of the outwardly positioned electrospun fibers. 
     
     
         12 . (canceled) 
     
     
         13 . The removable insert device of  claim 28  wherein the polymeric body is configured as a the tubular gastrointestinal organ. 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . A synthetic scaffold comprising:
 a body section, the body section having a first end and a second end opposed to the first end, the body section further having a least one portion configured as a tubular member, the body section comprising an outwardly oriented surface, the outwardly oriented surface having at least one region composed of spun polymeric fibers, the spun polymeric fibers having an average fiber diameter between 15 nm and 10 microns, at least a portion of the spun polymeric fibers interlinked to form pores having an average diameter less than 50 microns; and   at least one sheath layer, the sheath layer composed of cellular material, the cellular material including at least one of mesenchymal cells, stem cells and pluripotent cells, the cellular material present in a defined layer the defined layer being between 1 and 100 cells thick.   
     
     
         20 . The synthetic scaffold of  claim 19  wherein the spun polymeric fibers are electropsun, are interconnected and form an outer layer of the body section and the body section further comprises at least one inner layer, the inner layer composed of at least one of a polymeric mesh, a polymeric braided support material, a solid polymeric member, an electrospun layer, the outer layer in overlying contact with the inner layer. 
     
     
         21 . The synthetic scaffold of  claim 19  wherein the electrospun material has an average fiber diameter of 3 to 10 micrometers and is composed of at least one of one of the following polymeric materials: polyvinylidene fluoride, syndiotactic polystyrene, copolymer of vinylidene fluoride and hexafluoropropylene, polyvinyl alcohol, polyvinyl acetate, poly(acrylonitrile), copolymers of polyacrylonitrile and acylic acid, copolymers of polyacrylonitrile and methacrylates, polystyrene, poly(vinyl chloride), copolymer is of poly(vinyl chloride), poly(methyl methacrylate), copolymers of poly(methyl methacrylate), polyethylene terephthalate, polyurethane. 
     
     
         22 . The synthetic scaffold of  claim 19  wherein at least one layer is a polymeric material containing polyethylene terephthalate, polyurethane, blends of polyethylene terephthalate and polyurethane. 
     
     
         23 . The synthetic scaffold of  claim 20  polymeric braided support material is composed of at least one of polyethylene terephthalate, polyurethane, nitinol and mixtures thereof. 
     
     
         24 . (canceled) 
     
     
         25 . The synthetic scaffold of  claim 19  wherein the sheath layer of cellular material overlays the electrospun fibers present on the outer surface such that the cellular material is located on the outer surface and spans pores defined therein. 
     
     
         26 . The synthetic scaffold of  claim 19  further comprising at least one hole, indent, protrusion, or a combination thereof defined proximate to at least one of the first or second ends that is adapted to assist in at least one of the following: retrieval of the scaffold from a subject after tissue regeneration has occurred around the scaffold at the site of implantation in the subject or implanting the synthetic scaffold in a location in the body of a subject. 
     
     
         27 . the synthetic scaffold of  claim 19  wherein the spun polymeric fibers are electropsun, are interconnected and form an outer layer of the body section, the electrospun fibers having an average diameter less than 40 microns. 
     
     
         28 . A removable scaffold device comprising:
 a polymeric body having a first end and a second end opposed to the first end, the polymeric body further having a least one portion configured as a tubular member, the polymeric body comprising an outwardly oriented surface, the outwardly oriented surface having at least one region composed of electrospun polymeric fibers, the electrospun polymeric fibers having an average fiber diameter between 15 nm and 10 microns, at least a portion of the spun polymeric fibers interlinked to form pores having an average diameter less than 50 microns; and   at least one sheath layer, the sheath layer composed of cellular material derived from seeded cells, the cellular material including mesenchymal cells and stem cells present in a defined layer, the defined layer being between 1 and 100 cells thick.   
     
     
         29 . The removable scaffold device of  claim 28  wherein the sheath layer is suspended in overlying relationship to at least a portion of the outwardly oriented surface of the polymeric body. 
     
     
         30 . The removable scaffold device of  claim 29  wherein the cells in the sheath layer has an outer edge configured for proximal contact with at least one body region internal to a patient. 
     
     
         31 . The removable scaffold device of  claim 28  wherein the cellular material present in the cellular sheath includes mesenchymal cells, stem cells and wherein the removable scaffold device further includes materials produced by cellular material present in the cellular sheath. 
     
     
         32 . The removable scaffold device of  claim 31  wherein the cellular sheath has a thickness of between 10 and 100 cells and wherein the sheath layer is suspended in overlying relationship to at least a portion of the outwardly oriented surface of the polymeric body. 
     
     
         33 . The removable scaffold device of  claim 28  wherein the polymeric body has at least one layer and has a thickness between 100 nm and 1000 microns. 
     
     
         34 . The removable scaffold device of  claim 33  wherein the electrospun polymeric fibers of the electrospun material has an average fiber diameter of 3 to 10 micrometers and is composed of at least one of one of the following polymeric materials: polyvinylidene fluoride, syndiotactic polystyrene, copolymer of vinylidene fluoride and hexafluoropropylene, polyvinyl alcohol, polyvinyl acetate, poly(acrylonitrile), copolymers of polyacrylonitrile and acylic acid, copolymers of polyacrylonitrile and methacrylates, polystyrene, poly(vinyl chloride), copolymer is of poly(vinyl chloride), poly(methyl methacrylate), copolymers of poly(methyl methacrylate), polyethylene terephthalate, polyurethane.