Bioerodible Wraps and Uses Therefor

Abstract

A tubular tissue graft device is provided comprising a tubular tissue and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft comprising depositing a fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and a restrictive fiber matrix of a bioerodible polymer about a circumference of the vein also is provided.

1 - 17 . (canceled) 
     
     
         18 . A graft device for a patient, comprising:
 a harvested vein segment comprising an outer surface;   a fiber matrix comprising one or more electrospun synthetic fibers;   wherein the one or more electrospun synthetic fibers are deposited about the harvested vein segment by positioning the fiber matrix in substantial contact with the outer surface; and   wherein the fiber matrix restricts expansion of the resulting graft device when grafted.   
     
     
         19 . The graft device according to  claim 18 , wherein the one or more electrospun synthetic fibers are deposited about the outer surface of the harvested vein segment while the harvested vein segment is positioned about a spinning mandrel. 
     
     
         20 . The graft device according to  claim 18 , wherein the harvested vein segment comprises a saphenous vein. 
     
     
         21 . The graft device according to  claim 18 , wherein the one or more electrospun synthetic fibers comprise at least one polymer comprising urethane linkages. 
     
     
         22 . The graft device according to  claim 18 , wherein the one or more electrospun synthetic fibers comprise a polymer derived from a material selected from the group consisting of: an alpha-hydroxy acid; a polylactide; a poly(lactide-co-glycolide); a poly(L-lactide-co-caprolactone); a polyglycolic acid; a poly(dl-lactide-co-glycolide); a poly(l-lactide-co-dl-lactide); a polymer comprising a lactone monomer; a polycaprolactone; a polymer comprising carbonate linkages; a polycarbonate; a polyglyconate; a poly(glycolide-co-trimethylene carbonate); a poly(glycolide-co-trimethylene carbonate-co-dioxanone); a polymer comprising urethane linkages; a polyurethane; a poly(ester urethane) urea; a poly(ester urethane) urea elastomer; a polymer comprising ester linkages; a polyalkanoate; a polyhydroxybutyrate; a polyhydroxyvalerate; a polydioxanone; a polygalactin; a natural polymer; chitosan; collagen; elastin; alginate; cellulose; hyaluronic acid; gelatin; and combinations thereof. 
     
     
         23 . The graft device according to  claim 18 , wherein the one or more electrospun synthetic fibers are electrospun from a fluid comprising between 1% and 15% polymer by weight. 
     
     
         24 . The graft device according to  claim 18 , wherein the fiber matrix is formed over less than the entire outer surface of the harvested vein segment. 
     
     
         25 . The graft device according to  claim 18 , wherein the restriction of expansion of the graft device provided by the restrictive fiber matrix decreases over time. 
     
     
         26 . The graft device according to  claim 18 , wherein the fiber matrix comprises a porous mesh of the one or more electrospun synthetic fibers. 
     
     
         27 . The graft device according to  claim 18 , wherein the fiber matrix comprises an anisotropic arrangement of the one or more electrospun synthetic fibers. 
     
     
         28 . The graft device according to  claim 18 , wherein the graft device comprises an arterial bypass graft device. 
     
     
         29 . The graft device according to  claim 18 , further comprising one or more cells, active agents, or a combination thereof, associated with the fiber matrix. 
     
     
         30 . The graft device according to  claim 18 , further comprising the one or more active agents that comprise a drug. 
     
     
         31 . The graft device according to  claim 30 , wherein the drug comprises a drug selected from the group consisting of: a non-steroidal anti-inflammatory drug; an antibiotic; an anticlotting factor; an immunosuppressant; a glucocorticoid; a drug acting on an immunophilin; an interferon; a TNF binding protein; a taxane; a statin; a nitric oxide donor; a nitric oxide precursor; and any combination thereof. 
     
     
         32 . The graft device according to  claim 30 , wherein the drug comprises a drug selected from the group consisting of: an NSAID; salicylic acid; indomethacin; sodium indomethacin trihydrate; salicylamide; naproxen; colchicine; fenoprofen; sulindac; diflunisal; diclofenac; indoprofen sodium salicylamide; antiinflammatory cytokines; antiinflammatory proteins; steroidal anti-inflammatory agents; heparin; Pebac; enoxaparin; aspirin; hirudin; Plavix; bivalirudin; prasugrel; idraparinux; warfarin; coumadin; clopidogrel; PPACK; GGACK; tissue plasminogen activator; urokinase; streptokinase; a glucocorticoid; hydrocortisone; betamethasone; dexamethasone; flumethasone; isoflupredone; methylpred-nisolone; prednisone; prednisolone; triamcinolone acetonide; an antiangiogenic; fluorouracil; paclitaxel; doxorubicin; cisplatin; methotrexate; cyclophosphamide; etoposide; pegaptanib; lucentis; tryptophanyl-tRNA synthetase; retaane; CA4P; AdPEDF; VEGF-TRAP-EYE; AG-103958; Avastin; JSM6427; TG100801; ATG3; OT-551; endostatin; thalidomide; becacizumab; neovastat; an antiproliferative; sirolimus; perillyl alcohol; famesyl transferase inhibitors; FPTIII; L744; antiproliferative factor; Van 10/4; 5-FU; Daunomycin; Mitomycin; azathioprine; chlorambucil; mofetil; vasoactive intestinal polypeptide; an antibody; a drug acting on immunophilins; cyclosporine; zotarolimus; everolimus; tacrolimus; an interferon; a TNF binding protein; a taxane; docetaxel; a statin; atorvastatin; lovastatin; simvastatin; pravastatin; fluvastatin; rosuvastatin; a nitric oxide donor; a nitric oxide precursor; Angeli's Salt; L-Arginine; Free Base; Diethylamine NONOate; Diethylamine NONOate/AM; Glyco-SNAP-1; Glyco-SNAP-2; (O)—S-Nitroso-N-acetylpenicillamine; S-Nitrosoglutathione; NOC-5; NOC-7; NOC-9; NOC-12; NOC-18; NOR-1; NOR-3; SIN-1; Hydrochloride; Sodium Nitroprusside; Dihydrate; Spermine NONOate; Streptozotocin; an antibiotic; acyclovir; afloxacin; amphotericin B; atovaquone; azithromycin; ciprofloxacin; clarithromycin; clindamycin; clofazimine; dapsone; diclazaril; doxycycline; erythromycin; ethambutol; fluconazole; fluoroquinolones; foscarnet; ganciclovir; gentamicin; iatroconazole; isoniazid; ketoconazole; levofloxacin; lincomycin; miconazole; neomycin; norfloxacin; ofloxacin; paromomycin; penicillin; pentamidine; polymixin B; pyrazinamide; pyrimethamine; rifabutin; rifampin; sparfloxacin; streptomycin; sulfadiazine; tetracycline; tobramycin; trifluorouridine; trimethoprim sulphate; Zn-pyrithione; silver salts such as chloride, bromide, iodide and periodate; and any combination thereof. 
     
     
         33 . The graft device according to  claim 18 , wherein a thickness of the fiber matrix is from 150 to 200 micrometers (μm). 
     
     
         34 . The graft device according to  claim 18 , wherein the harvested vein segment is a living harvested vein segment. 
     
     
         35 . The graft device according to  claim 34 , wherein a tissue viability of the living harvested vein segment is not reduced by the one or more electrospun synthetic fibers deposited thereabout. 
     
     
         36 . The graft device according to  claim 18 , wherein a compliance of the graft device is similar to a native carotid artery.