Adventitial fabric reinforced porous prosthetic graft

• US 20030055494A1
• Filed: 07/23/2002
• Published: 03/20/2003
• Est. Priority Date: 07/27/2001
• Status: Abandoned Application

• Current Assignee: Kips Bay Medical, Inc.
• Original Assignee: Kips Bay Medical, Inc.
• Inventors: Yeoman, Mark, Zilla, Peter, Millam, Ross, Bezuidenhout, Deon
• Application Number:
  US10/201,498
• Publication Number:
  US 20030055494A1
• Time in Patent Office: Days
• US Class Current: 623/1.39
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A vascular prosthesis is constructed of an inner porous tube which allows uninterrupted cellular growth and which is connected to an adventitial sock surrounding the porous tube. The adventitial sock produces a non-linear elastic response to stress-strain on the prosthesis to optimize compliance and prevent over dilatation.

Claims

1. A vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising:

an inner material shaped as a tube structure which allows uninterrupted cellular growth; and

an outer adventitial material connected to the inner tube which allows for cellular in-growth, said adventitial material being characterized by a non-linear elastic response.

2. The vascular graft prosthesis of claim 1 in which the outer adventitial material is constructed to enable substantially uninterrupted tissue ingrowth into the inner tube structure.

3. The vascular graft prosthesis of claim 1 in which the inner material is porous.

4. The vascular graft prosthesis of claim 3 wherein said inner porous tube comprises a polymer structure having a wall, and interconnecting shaped pores in the tube wall;

wherein porosity is optimized to maximize cellular in-growth.

5. The vascular graft prosthesis of claim 1 wherein said outer adventitial material comprises a fabric structure with interconnecting shaped pores;

wherein the fabric is aligned to allow desired directional growth of tissue through the adventitial structure for maximum cellular in-growth.

6. The vascular graft prosthesis of claim 1 in which the outer adventitial material comprises fibers containing controlled release material.

7. The vascular graft prosthesis of claim 1 wherein said inner tube comprises hyper-elastic isotropic material.

8. The vascular graft prosthesis of claim 1 wherein said inner tube comprises weak orthotropic elastic material.

9. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a non-linear anisotropic fabric-reinforcing sock having properties that increase stiffness with strain.

10. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a non-linear transversely isotropic fabric reinforcing material having properties that increase stiffness with strain.

11. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a non-linear transversely orthotropic fabric reinforcing material having properties that increases stiffness with strain.

12. The vascular graft prosthesis of claim 1 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve any desired dynamic diameter compliance.

13. The vascular graft prosthesis of claim 1 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve any desired static diameter compliance.

14. The vascular graft prosthesis of claim 1 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve any desired quasi-static diameter compliance.

15. The vascular graft prosthesis of claim 1 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve a dynamic diameter compliance value of 6%/100 mm Hg.

16. The vascular graft prosthesis of claim 1 wherein said adventitial outer material is thinner than said inner tube structure.

17. The vascular graft prosthesis of claim 1 wherein said adventitial outer material has a thickness in the range of 0.020-1.0 mm.

18. The vascular graft prosthesis of claim 1 wherein said adventitial outer material has pores with an average diameter in a range of 0.1-3.0 mm.

19. The vascular graft prosthesis of claim 1 wherein said adventitial outer material has pores with an average diameter in a range of 0.1-3.0 mm, allowing for un-interrupted tissue growth;

and wherein the overall tube diameter is between about 2.0 -8.0 mm.

20. The vascular graft prosthesis of claim 1 wherein the diameter and internal lumen of said prosthesis is optimized for positional and mechanical requirements depending on the location in the human body.

21. The vascular graft prosthesis of claim 1 wherein said outer material is wound around said inner material.

22. The vascular graft prosthesis of claim 1 wherein said outer material is loosely connected to said inner material.

23. The vascular graft prosthesis of claim 1 wherein said outer material is connected at pre-defined points along a length of said inner tube structure.

24. The vascular graft prosthesis of claim 1 wherein said outer material comprises a combination of stiff and elastic material.

25. The vascular graft prosthesis of claim 1 wherein a portion of the adventitial material is biodegradable.

26. The vascular graft prosthesis of claim 1 in which the inner material is selected from polyurethane, a biomer, a polyurethane/Siloxane copolymer, Estane 5714, and segmented polyurethane.

27. The vascular graft prosthesis of claim 1 in which at least one of the inner material and the outer adventitial material comprises ingrowth matrix material.

28. The vascular graft prosthesis of claim 24 wherein said stiff and elastic materials are in contact with each other so that when said elastic material is stretched it takes the initial strain while said stiff material starts to un-bundle, then producing the non-linear elastic response.

29. The vascular graft prosthesis of claim 24 wherein said stiff and elastic materials are combined as a mesh.

30. The vascular graft prosthesis of claim 24 wherein said stiff and elastic materials are combined as a spiral wind.

31. The vascular graft prosthesis of claim 24 wherein said combination of stiff and elastic materials is attached loosely to a surface of said inner tube.

32. The vascular graft prosthesis of claim 24 wherein said combination of stiff and elastic materials is wound around said tube structure.

33. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure woven together in a tubular form that allows said textile fabric to increase its stiffness with strain.

34. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure knitted together in a tubular form that allows said textile fabric to increase its stiffness with strain.

35. The vascular graft prosthesis of claim 1 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure braided together in a tubular form that allows said textile fabric to increase its stiffness with strain.

36. The vascular graft prosthesis of claim 1 wherein said adventitial material is a textile fabric structure that is woven together as a weave having at least one set of yarns interlaced at angles to each other.

37. The vascular graft prosthesis of claim 1 wherein said adventitial material is a textile fabric structure, and said textile fabric structure is woven together as a knit having inter-meshed loops of yarn in either weft or warp form.

38. The vascular graft prosthesis of claim 1 wherein said adventitial material is a textile fabric structure, and said textile fabric structure is woven together as a braid having a plurality of yarns crossed over each other sequentially.

39. The vascular graft prosthesis of claim 1 wherein said adventitial material is a textile fabric structure, and said textile fabric structure is a non-woven structure formed by needle-felting yarn into said structure.

40. A vascular graft prosthesis having a wall structure configured to optimize mechanical compliance, diameter, non-linear stiffening characteristics and wall compression to a host vessel, comprising:

an inner material shaped as a tubular structure which allows cellular growth; and

an outer adventitial material positioned around the inner material, said adventitial material being characterized by a non-linear elastic response.

41. The vascular graft prosthesis of claim 40 in which the outer adventitial material is constructed to enable substantially uninterrupted tissue ingrowth into the inner tube structure.

42. The vascular graft prosthesis of claim 40 in which the inner material is porous.

43. The vascular graft prosthesis of claim 40 wherein said inner porous tube comprises a polymer structure having a wall, and interconnecting shaped pores in the tube wall;

wherein porosity is optimized to maximize cellular in-growth.

44. The vascular graft prosthesis of claim 40 wherein said adventitial outer material comprises a non-linear anisotropic fabric-reinforcing sock having properties that increase stiffness with strain.

45. The vascular graft prosthesis of claim 40 wherein said adventitial outer material comprises a non-linear transversely isotropic fabric reinforcing material having properties that increase stiffness with strain.

46. The vascular graft prosthesis of claim 40 wherein said adventitial outer material comprises a non-linear transversely orthotropic fabric reinforcing material having properties that increases stiffness with strain.

47. The vascular graft prosthesis of claim 40 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve any desired dynamic diameter compliance.

48. The vascular graft prosthesis of claim 40 wherein said adventitial outer material, when combined with the inner material, is configurable to achieve a dynamic diameter compliance value of 6%/100 mm Hg.

49. The vascular graft prosthesis of claim 40 wherein said adventitial outer material has a thickness in the range of 0.02-1.0 mm.

50. The vascular graft prosthesis of claim 40 wherein said adventitial outer material has pores with an average diameter in a range of 0.1-3.0 mm, allowing for un-interrupted tissue growth;

and wherein the overall tube diameter is between about 2.0-8.0 mm.

51. A vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising:

an inner porous tube comprising a polymer structure having a circumferential wall; and

interconnecting generally uniformly shaped pores in the tube wall;

wherein porosity is optimized to maximize uninterrupted cellular growth; and

an outer adventitial material connected to the inner porous tube, said adventitial material being characterized by a non-linear elastic response.

52. The vascular graft prosthesis of claim 51 wherein said adventitial outer material comprises a non-linear anisotropic fabric-reinforcing sock having properties that increases stiffness with strain.

53. The vascular graft prosthesis of claim 51 wherein said adventitial outer material, when combined with the porous material, is configurable to achieve any desired dynamic diameter compliance.

54. The vascular graft prosthesis of claim 51 wherein said adventitial outer material, when combined with the porous material, is configurable to achieve a dynamic diameter compliance of 6%/100 mm Hg.

55. A vascular graft prosthesis having a bi-layer wall structure configured to optimize compliance to a host vessel, comprising:

an inner tubular shaped material structurally configured to promote uninterrupted cellular growth; and

an outer adventitial material contiguous to the inner material, said adventitial material comprising a fabric-reinforcing sock having properties that increase stiffness with strain and being characterized by a non-linear elastic response.

56. A vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising:

an inner porous tube which allows uninterrupted cellular growth; and

an outer material connected to the inner porous tube, said adventitial material comprising a non-linear anisotropic fabric-reinforcing sock having properties that increase stiffness with strain and being characterized by a non-linear elastic response.

57. The vascular graft prosthesis of claim 56 wherein said outer material, when combined with the porous material, is configurable to achieve any desired dynamic diameter compliance.

58. The vascular graft prosthesis of claim 56 wherein said outer material, when combined with the porous material, is configurable to achieve a dynamic diameter compliance of 6%/100 mm Hg.

59. A vascular graft prosthesis having a wall structure configured to optimize mechanical compliance, diameter, non-linear stiffening characteristics and wall compression to a host vessel, comprising:

an inner material configured to allow cellular ingrowth; and

an outer adventitial material positioned around the inner material, said adventitial material being characterized by a non-linear elastic response, so that the graft prosthesis matches the compliance values of the host vessel.

60. A vascular graft prosthesis having a wall structure configured to optimize mechanical compliance, diameter, non-linear stiffening characteristics and wall compression to a host vessel, comprising:

an inner material configured to facilitate cellular ingrowth; and

an outer adventitial material positioned around the inner material, said adventitial material being characterized by a non-linear elastic response and a structure to allow uninterrupted tissue ingrowth into said inner material, so that the graft prosthesis matches the compliance values of the host vessel.

61. A vascular graft prosthesis having a wall structure configured to optimize mechanical compliance, diameter, non-linear stiffening characteristics and wall compression to a host vessel, comprising:

an inner material configured to facilitate cellular ingrowth; and

an outer adventitial material positioned around the inner material, said adventitial material being characterized by a configurable non-linear elastic response and a structure to allow uninterrupted tissue ingrowth into said inner material so that the graft prosthesis provides compliance values, which match those of the host vessel at the graft location.

62. A vascular graft prosthesis having a wall structure configured to approximate the natural compliance in a host vessel wall, comprising:

an inner material configured to facilitate cellular ingrowth; and

a fabric reinforcing material in contact with the inner material, said fabric reinforcing material having a structure which allows virtually uninterrupted tissue ingrowth into said inner material and which has a non-linear elastic response to stress which approximates the natural compliance values of the host vessel.

63. A vascular graft prosthesis having a wall structure configured to substantially match the natural compliance values to a host vessel, comprising:

an inner material configured to facilitate cellular ingrowth; and

an outer adventitial material positioned around the inner material and having a thickness of between about 0.020-1.0 mm, said adventitial material having a fabric-like structure which allows substantially uninterrupted tissue ingrowth into said inner material and which has an increased stiffness with strain which regulates the prosthesis shape so as to substantially match the compliance values of the host vessel.

64. A vascular graft prosthesis having a wall structure configurable to desired compliance values appropriate for a host vessel, comprising:

an inner material configured to facilitate cellular ingrowth; and

an outer adventitial material positioned around the inner material and having a thickness of between about 0.020-1.0 mm, said adventitial material having a fabric-like structure which forms pores having an average diameter in a range of about 100 μ

m-3 mm and which allows uninterrupted tissue ingrowth into said inner material;

the adventitial material further having a characteristic of increased stiffness with strain which allows for configuring the compliance values of the graft prosthesis to those which are appropriate for a host vessel.

65. A vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising:

an inner porous tube comprising a polymer structure having a circumferential wall; and

interconnecting uniformly shaped pores in the tube wall;

wherein porosity is optimized to maximize uninterrupted cellular growth; and

an adventitial material connected to the inner porous tube, said adventitial material comprising a non-linear anisotropic fabric-reinforcing sock having properties that increase stiffness with strain and being characterized by a non-linear elastic response.

66. The vascular graft prosthesis of claim 65 wherein said adventitial outer material, when combined with the porous material, is configurable to achieve any desired dynamic diameter compliance.

67. The vascular graft prosthesis of claim 65 wherein said adventitial outer material, when combined with the porous material, is configurable to achieve a dynamic diameter compliance of 6%/100 mm Hg.

68. The vascular graft prosthesis of claim 65 wherein said adventitial outer material is thinner than said inner porous tube structure.

69. The vascular graft prosthesis of claim 65 wherein said adventitial outer material has a thickness in the range of 0.020-1.0 mm.

70. The vascular graft prosthesis of claim 65 wherein said adventitial outer material has pores with an average diameter in a range of 0.1-3.0 mm, allowing for un-interrupted tissue growth;

and wherein the overall tube diameter is between about 2.0-8.0 mm.

71. The vascular graft prosthesis of claim 65 wherein the diameter of said prosthesis is optimized for position and mechanical requirements depending on the location and age in the human body.

72. The vascular graft prosthesis of claim 65 wherein said outer material is wound around said inner porous tube.

73. The vascular graft prosthesis of claim 65 wherein said outer material is loosely connected to said inner porous tube.

74. The vascular graft prosthesis of claim 65 wherein said outer material is connected at pre-defined points along a length of said inner porous tube.

75. The vascular graft prosthesis of claim 65 wherein said outer material comprises a combination of stiff and elastic material.

76. The vascular graft prosthesis of claim 65 wherein a portion of said fabric-reinforcing sock is biodegradable.

77. The vascular graft prosthesis of claim 65 wherein a portion of said inner porous tube is biodegradable.

78. The vascular graft prosthesis of claim 65 further comprising an outer layer of material surrounding the adventitial material and inner porous tube.

79. The vascular graft prosthesis of claim 75 wherein said stiff and elastic materials are in contact with each other so that when said elastic material is stretched it takes the initial strain while said stiff material starts to un-bundle, then producing the non-linear elastic response.

80. The vascular graft prosthesis of claim 75 wherein said stiff and elastic materials are combined as a mesh.

81. The vascular graft prosthesis of claim 75 wherein said stiff and elastic materials are combined as a spiral wind.

82. The vascular graft prosthesis of claim 75 wherein said combination of stiff and elastic materials is attached loosely to a surface of said inner tube.

83. The vascular graft prosthesis of claim 75 wherein said combination of stiff and elastic materials is wound around said tube structure.

84. The vascular graft prosthesis of claim 75 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure woven together in a tubular form that allows said textile fabric to increase its stiffness with strain.

85. The vascular graft prosthesis of claim 75 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure knitted together in a tubular form that allows said textile fabric to increase its stiffness with strain.

86. The vascular graft prosthesis of claim 75 wherein said adventitial outer material comprises a geometrical construction of reinforcing textile fabric structure braided together in a tubular form that allows said textile fabric to increase its stiffness with strain.

87. The vascular graft prosthesis of claim 75 wherein said adventitial material is a textile fabric structure that is woven together as a weave having at least one set of yarns interlaced at angles to each other.

88. The vascular graft prosthesis of claim 87 wherein said textile fabric structure is woven together as a knit having inter-meshed loops of yarn in either weft or warp form.

89. The vascular graft prosthesis of claim 87 wherein said textile fabric structure is woven together as a braid having at least three yarns crossed over each other sequentially.

90. The vascular graft prosthesis of claim 87 wherein said textile fabric structure is a non-woven structure formed by needle-felting yarn into said structure.

91. A computer implemented method of designing a vascular graft prosthesis having desired mechanical characteristics, which mimic the characteristics of natural vessels, comprising the steps of:

entering parameters of fabric graft material and graft data into an encoding processor;

implementing a plurality of computer implemented optimization algorithms which implement a numerical composite graft model analysis and numerical composite circumferential and longitudinal tensile model analyses on a number of parameters; and

forming new data generations using the optimization algorithms performing iterations until desired mechanical characteristics are achieved.

92. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

forming an inner graft structure of a first material; and

attaching an adventitial material to the inner graft structure, wherein the adventitial material is more elastic and less stiff than the first material of the inner graft structure and is characterized by a non-linear elastic response.

93. The method of claim 92 further comprising the step of attaching an outer layer of material to the structure formed by the inner graft structure and the adventitial material.

94. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps of designing a vascular graft prosthesis including entering parameters of fabric material and graft data into an encoding processor, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired characteristic is met;

using the outcome of the design steps to form an inner material structure which allows uninterrupted cellular growth; and

then

surrounding the inner material structure in contacting relation with an outer adventitial material, wherein the outer adventitial material is characterized by a non-linear elastic response to achieve specific compliance values.

95. A method of designing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps using entering parameters of fabric material and graft data in an encoding processor, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired compliance value characteristic is met for an outer adventitial portion of a graft prosthesis; and

using the outcome of the computer implemented steps to form an inner material structure of the graft which allows uninterrupted cellular growth and which when formed used inside of the outer adventitial portion provides a graft prosthesis which demonstrates desired characteristics of mechanical compliance for use in a specific host vessel.

96. A method of designing an inner layer of a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps using entering parameters of fabric material and graft data in an encoding processor, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired compliance value characteristic is met for an outer adventitial portion of a graft prosthesis; and

using the outcome of the computer implemented steps to form an inner material structure of the graft which allows uninterrupted cellular growth and which when formed used inside of the outer adventitial portion provides a graft prosthesis which demonstrates desired characteristics of mechanical compliance for use in a specific host vessel.

97. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps of designing a vascular graft prosthesis including entering parameters of fabric and graft data in an encoding processor, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired compliance value characteristic is met for an outer adventitial portion of the graft;

using the outcome of the design steps to form an inner material structure which allows uninterrupted cellular growth and;

attaching the outer adventitial portion to the inner material, wherein the adventitial material is characterized by a non-linear elastic response to achieve specific compliance values.

98. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

implementing computer implemented steps of designing a vascular graft prosthesis including entering parameters of fabric and graft data into an encoding processor, implementing a plurality of computer implemented optimization algorithms, which implement graft numerical and mathematical model analyses and numerical and mathematical circumferential and longitudinal tensile model analyses on a number of parameters; and

forming new data generations using numerical algorithms performing iterations until desired mechanical compliance characteristics are met;

using the outcome of the design steps to form a tube structure having a circumferential wall with interconnecting pores in the tube wall;

wherein porosity is optimized to maximize uninterrupted cellular growth; and

then

attaching an outer adventitial material to the tube structure, wherein the adventitial material is characterized by a non-linear anisotropic fabric-reinforcing sock having properties that increase stiffness with strain and being characterized by a non-linear elastic response to achieve specific compliance values.

99. A vascular graft prosthesis having a wall structure configured to optimize mechanical compliance, diameter and wall compression and to prevent over-dilatation of the prosthesis to a host vessel, comprising:

an inner material shaped as a tubular structure which allows cellular growth; and

an outer adventitial material positioned around the inner material, said adventitial material being characterized by a non-linear elastic response having a β

value, which is matched to the optimal β

value for that portion of the natural host tissue.

100. The vascular graft prosthesis of claim 99 in which the β

value is age adjusted for a specific host.

101. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

forming an inner graft structure;

determining the optimal β

value for the graft at the location of the host vessel;

manufacturing an outer adventitial material having a characteristic non-linear elastic response which allows the graft prosthesis to have a β

value that substantially matches the optimal β

value; and

surrounding the inner graft structure with the outer adventitial material.

102. A method of manufacturing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

determining the optimal β

value for the graft at the location of the host vessel;

manufacturing an outer adventitial material having a characteristic non-linear elastic response, which allows the graft prosthesis to have a β

value that substantially matches the optimal β

value;

forming an inner graft structure; and

surrounding the inner graft structure with the outer adventitial material.

103. A method of designing a vascular graft prosthesis having a bi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps of designing a vascular graft prosthesis including entering parameters of fabric and graft data in an encoding processor which includes time dependent features replicating tissue ingrowth mechanical impact on the fabric, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired compliance value characteristic is met for an outer adventitial portion of the graft;

using the outcome of the design steps to form an inner material structure which allows uninterrupted cellular growth and;

attaching the outer adventitial portion to the inner material, wherein the adventitial material is characterized by a non-linear elastic response to achieve specific compliance values.

104. A method of making a vascular graft prosthesis having a multi-layer wall structure configured to optimize mechanical compliance to a host vessel, comprising the steps of:

performing computer implemented steps of designing a vascular graft prosthesis including entering parameters of fabric and graft data in an encoding processor which includes time dependent features replicating tissue ingrowth mechanical impact on the fabric and degradation of the fabric and graft while tissue ingrowth occurs, executing a plurality of computer implemented calculations and models on a plurality of parameters, and forming new data generations using the calculations performing iterations until a desired compliance value characteristic is met for an adventitial portion of the graft;

using the outcome of the design steps to form an inner material structure which allows uninterrupted cellular growth and;

attaching the adventitial portion to the inner material, wherein the adventitial material is characterized by a non-linear elastic response to achieve specific compliance values.