Bioerodible wraps and uses therefor

• US 20080208323A1
• Filed: 01/30/2008
• Published: 08/28/2008
• Est. Priority Date: 01/30/2007
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: El-Kurdi, Mohammed S., Stankus, John J., Soletti, Lorenzo, Wagner, William R., Vorp, David A., Hong, Yi
• Granted Patent: US 9,237,945 B2
• Time in Patent Office: Days
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C12N 2533/40 : Polyhydroxyacids, e.g. polymers of glycolic or lactic acid (PGA, PLA, PLGA); Bioresorbable polymers
• CPC Class Codes: C12N 5/0068 : General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: D01D 5/0007 : Electro-spinning non-woven fabrics produced by electro-spinning D04H1/728
• CPC Class Codes: D01D 5/0076 : characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid D01D5/0046 takes precedence
• CPC Class Codes: D10B 2331/10 : polyurethanes
• CPC Class Codes: D10B 2401/12 : biodegradable
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

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.

Claims

1. A tubular tissue graft device comprising a tubular tissue and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue.

2. The device of claim 1, wherein the tubular tissue is venous.

3. The device of claim 2, wherein the venous tubular tissue is obtained from a saphenous vein.

4. The device of claim 2, wherein the device is prepared by electrospinning the polymer fibers onto the venous tissue.

5. The device of claim 4, wherein the fibers comprise a polymer comprising ester and urethane linkages.

6. The device of claim 5, wherein the fibers comprise a poly(ester urethane)urea.

7. The device of claim 1, wherein the tubular tissue is chosen from one or more of an artery, urethra, intestine, esophagus, ureter, trachea, bronchi, and fallopian tube.

8. The device of claim 1, wherein the device is prepared by electrospinning the polymer fibers onto the tubular tissue.

9. The device of claim 1, wherein the fibers comprise a polymer chosen from one or more of:

a polymer derived from 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(1-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 and gelatin.

10. The device of claim 1, wherein the fibers comprise a polymer derived from an alpha-hydroxy acid.

11. The device of claim 10, wherein the fibers comprise one or more polymer chosen from a polylactide, a poly(lactide-co-glycolide), a poly(L-lactide-co-caprolactone), a polyglycolic acid, a poly(dl-lactide-co-glycolide) and a poly(1-lactide-co-dl-lactide).

12. The device of claim 1, wherein the fibers comprise a polymer comprising a lactone monomer.

13. The device of claim 12, wherein the fibers comprise a polycaprolactone.

14. The device of claim 1, wherein the fibers comprise a polymer comprising carbonate linkages.

15. The device of claim 14, wherein the fibers comprise one or more polymers chosen from polycarbonate, polyglyconate, poly(glycolide-co-trimethylene carbonate) and poly(glycolide-co-trimethylene carbonate-co-dioxanone).

16. The device of claim 1, wherein the fibers comprise a polymer comprising urethane linkages.

17. The device of claim 16, wherein the fibers comprise one or more polymers chosen from a polyurethane and a poly(ester urethane) urea elastomer.

18. The device of claim 17, wherein the fibers comprise a poly(ester urethane) urea elastomer.

19. The device of claim 18, wherein the fibers comprise collagen.

20. The device of claim 19, wherein the fibers comprise from about 25% wt. to about 75% wt. collagen.

21. The device of claim 19, wherein the fibers further comprise elastin.

22. The device of claim 21, wherein the fibers comprise from about 25% wt. to about 75% wt. of a mixture of collagen and elastin.

23. The device of claim 21, wherein elastin and collagen are present in the fibers in approximately equal amounts.

24. The device of claim 1, wherein the fibers comprises ester linkages.

25. The device of claim 24 wherein the polyester is a polyalkanoate.

26. The device of claim 25, wherein the polyhydroxyalkanoate is chosen from one or more of a polyhydroxybutyrate, polyhydroxyvalerate and polydioxanone.

27. The device of claim 24, wherein the polymer is polygalactin.

28. The device of claim 1, wherein the fibers comprise a natural polymer.

29. The device of claim 28, wherein the fibers comprise one or more natural polymers chosen from chitosan, collagen, elastin, alginate, cellulose, polyalkanoates, hyaluronic acid and gelatin.

30. The device of claim 1, wherein the fibers comprise collagen.

31. The device of claim 30, wherein the fibers comprise elastin.

32. The device of claim 30, wherein the matrix bioerodes in situ over a time period ranging from 12 hours to two weeks.

33. The device of claim 1, further comprising one or both of a cell and an active agent associated with the matrix.

34. The device of claim 33, wherein one or more of cells chosen from stem cells, progenitor (precursor) cells, smooth muscle cells, skeletal myoblasts, myocardial cells, endothelial cells, endothelial progenitor cells, bone-marrow derived mesenchymal cells and genetically modified cells are associated with the matrix.

35. The device of claim 33, wherein a growth factor is associated with the matrix.

36. The device of claim 35, wherein a growth factor chosen from one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factors (IGF), transforming growth factor-beta pleiotrophin protein, midkine protein and IGF-1 is associated with the matrix.

37. The method of claim 33, wherein a drug is associated with the matrix.

38. The method of claim 37, wherein the drug is chosen from one or more 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 proteins, a taxane, a statin, and a nitric oxide donor.

39. The method of claim 37, wherein the drug is chosen from one or more 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, enoxaprin, aspirin, hirudin, plavix, bivalirudin, prasugrel, idraparinux, warfarin, coumadin, clopidogrel, PPACK, GGACK, tissue plasminogen activator, urokinase, streptokinase, a glucocorticoid, hydrocortisone, betamethisone, 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, paclitaxel, perillyl alcohol, farnesyl transferase inhibitors, FPTIII, L744, antiproliferative factor, Van 10/4, doxorubicin, 5-FU, Daunomycin, Mitomycin, dexamethasone, azathioprine, chlorambucil, cyclophosphamide, methotrexate, mofetil, vasoactive intestinal polypeptide, an antibody, a drug acting on immunophilins, cyclosporine, zotarolimus, everolimus, tacrolimus, sirolimus, an interferon, a TNF binding protein, a taxane, paclitaxel, docetaxel, a statin, atorvastatin, lovastatin, simvastatin, pravastatin, fluvastatin, rosuvastatin a nitric oxide donor or 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, ampicillin, 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, and silver salts such as chloride, bromide, iodide and periodate.

82. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and the restrictive fiber matrix of a bioerodible polymer about a circumference of the vein as claimed in claim 1.

40. A method of preparing a tubular graft, comprising depositing a restrictive contiguous fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device.

41. The method of claim 40, wherein the matrix is deposited by electrospinning.

42. The method of claim 40, wherein the tubular tissue is obtained from a vein.

43. The method of claim 40, wherein the tubular tissue is obtained from a portion of a saphenous vein.

44. The method of claim 40, wherein the device is prepared by electrospinning the polymer fibers onto the tubular tissue.

45. The method of claim 40, wherein the fibers comprise a polymer chosen from one or more of:

a polymer derived from 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(1-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 and gelatin.

46. The method of claim 44, wherein the fibers comprise a polymer comprising ester and urethane linkages.

47. The method of claim 46, wherein the fibers comprise a poly(ester urethane)urea.

48. The method of claim 40, wherein the tubular tissue is chosen from one or more of an artery, urethra, intestine, esophagus, ureter, trachea, bronchi, and fallopian tube.

49. The method of claim 40, wherein the device is prepared by electrospinning the polymer fibers onto the tubular tissue.

50. The method of claim 40, wherein the fibers comprise a polymer derived from an alpha-hydroxy acid.

51. The method of claim 50, wherein the fibers comprise one or more polymer chosen from a polylactide, a poly(lactide-co-glycolide), a poly(L-lactide-co-caprolactone), a polyglycolic acid, a poly(dl-lactide-co-glycolide) and a poly(1-lactide-co-dl-lactide).

52. The method of claim 40, wherein the fibers comprise a polymer comprising a lactone monomer.

53. The method of claim 52, wherein the fibers comprise a polycaprolactone.

54. The method of claim 40, wherein the fibers comprise a polymer comprising carbonate linkages.

55. The method of claim 54, wherein the fibers comprise one or more polymers chosen from polycarbonate, polyglyconate, poly(glycolide-co-trimethylene carbonate) and poly(glycolide-co-trimethylene carbonate-co-dioxanone).

56. The method of claim 40, wherein the fibers comprise a polymer comprising urethane linkages.

57. The method of claim 56, wherein the fibers comprise one or more polymers chosen from a polyurethane and a poly(ester urethane) urea elastomer.

58. The method of claim 57, wherein the fibers comprise a poly(ester urethane) urea elastomer.

59. The method of claim 58, wherein the fibers comprise a collagen.

60. The method of claim 59, wherein the fibers comprise from about 25% wt. to about 75% wt. collagen.

61. The method of claim 59, wherein the fibers further comprise elastin.

62. The method of claim 40, wherein the matrix bioerodes in situ over a time period ranging from 12 hours to two weeks.

63. The method of claim 61, wherein the fibers comprise from about 25% wt. to about 75% wt. of a mixture of collagen and elastin.

64. The method of claim 61, wherein elastin and collagen are present in the fibers in approximately equal amounts.

65. The method of claim 40, wherein the fibers comprises ester linkages.

66. The method of claim 65 wherein the polyester is a polyalkanoate.

67. The method of claim 66, wherein the polyhydroxyalkanoate is chosen from one or more of a polyhydroxybutyrate, polyhydroxyvalerate and polydioxanone.

68. The device of claim 66, wherein the polymer is polygalactin.

69. The method of claim 40, wherein the fibers comprise a natural polymer.

70. The method of claim 69, wherein the fibers comprise one or more natural polymers chosen from chitosan, collagen, elastin, alginate, cellulose, polyalkanoates, hyaluronic acid and gelatin.

71. The method of claim 40, wherein the fibers comprise collagen.

72. The method of claim 71, wherein the fibers comprise elastin.

73. The method of claim 40, wherein the tubular tissue is a saphenous vein.

74. The method of claim 40, further comprising prior to depositing the matrix on the tubular tissue, removing the tubular tissue from a patient, and subsequent to depositing the matrix on the tubular tissue, grafting the device into the patient.

75. The method of claim 40, further comprising associating one or both of a cell or a therapeutic substance with the matrix.

76. The method of claim 75, wherein one or more of cells chosen from stem cells, progenitor (precursor) cells, smooth muscle cells, skeletal myoblasts, myocardial cells, endothelial cells, endothelial progenitor cells, bone-marrow derived mesenchymal cells and genetically modified cells are associated with the matrix.

77. The method of claim 75, wherein a growth factor is associated with the matrix.

78. The method of claim 77, wherein a growth factor chosen from one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factors (IGF), transforming growth factor-beta pleiotrophin protein, midkine protein and IGF-1 is associated with the matrix.

79. The method of claim 75, wherein a drug is associated with the matrix.

80. The method of claim 79, wherein the drug is chosen from one or more 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 proteins, a taxane, a statin, and a nitric oxide donor or precursor.

81. The method of claim 79, wherein the drug is chosen from one or more 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, enoxaprin, aspirin, hirudin, plavix, bivalirudin, prasugrel, idraparinux, warfarin, coumadin, clopidogrel, PPACK, GGACK, tissue plasminogen activator, urokinase, streptokinase, a glucocorticoid, hydrocortisone, betamethisone, 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, paclitaxel, perillyl alcohol, farnesyl transferase inhibitors, FPTIII, L744, antiproliferative factor, Van 10/4, doxorubicin, 5-FU, Daunomycin, Mitomycin, dexamethasone, azathioprine, chlorambucil, cyclophosphamide, methotrexate, mofetil, vasoactive intestinal polypeptide, an antibody, a drug acting on immunophilins, cyclosporine, zotarolimus, everolimus, tacrolimus, sirolimus, an interferon, a TNF binding protein, a taxane, paclitaxel, docetaxel, a statin, atorvastatin, lovastatin, simvastatin, pravastatin, fluvastatin, rosuvastatin a nitric oxide donor or precursor, Angeli'"'"'s Salt, L-Arginine, Free Base, Diethylamine NONOate, Diethylamine NONOate/AM, Glyco-SNAP-1, Glyco-SNAP-2, (±

)-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, ampicillin, 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, and silver salts such as chloride, bromide, iodide and periodate.