Implantable device formed from polymer and plasticizer blends having modified molecular structures

Abstract

A biocompatible material may be configured into any number of implantable medical devices including intraluminal stents. Polymeric materials may be utilized to fabricate any of these devices, including stents. The stents may be balloon expandable or self-expanding. The polymeric materials may include additives such as drugs or other bioactive agents as well as radiopaque agents. By preferential mechanical deformation of the polymer, the polymer chains may be oriented to achieve certain desirable performance characteristics.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will be apparent from the following, more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.

FIG. 1 is a planar representation of an exemplary stent fabricated from biocompatible materials in accordance with the present invention.

FIG. 2 is a representation of a section of hoop component of an exemplary stent that demonstrates two high strain zones to accommodate axial orientation in accordance with the present invention.

FIG. 3 is a representation of a section of hoop component of an exemplary stent that demonstrates one high strain zone to accommodate circumferential orientation in accordance with the present invention.

FIG. 4 is a representation of a section of hoop component of an exemplary stent that demonstrates three high strain zones to accommodate biaxial orientation in accordance with the present invention.

FIG. 5 is a representation of a section of flexible connector component of an exemplary stent that demonstrates two high strain zones to accommodate circumferential orientation in accordance with the present invention.

FIG. 6 is a representation of a section of flexible connector component of an exemplary stent that demonstrates one high strain zone to accommodate axial orientation in accordance with the present invention.

FIG. 7 is a representation of a section of flexible connector component of an exemplary stent that demonstrates three high strain zones to accommodate biaxial orientation in accordance with the present invention.

FIG. 8 is a schematic representation of a stress-strain curve of a stiff and brittle material and a plasticized material in accordance with the present invention.

FIG. 9 is a schematic representation of a stress-strain curve of a stiff and brittle material, a soft and elastomeric material and a blend of the stiff and elastomeric material in accordance with the present invention.

Claims

1. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer and at least one plasticizer blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections.

2. The implantable medical device according to claim 1, wherein the at least one polymer is bioabsorbable.

3. The implantable medical device according to claim 1, wherein the at least one polymer is non-bioabsorbable.

4. The implantable medical device according to claim 1, wherein the at least one plasticizer is bioabsorbable.

5. The implantable medical device according to claim 1, wherein the at least one plasticizer is non-bioabsorbable.

6. The implantable medical device according to claim 1, wherein the frame structure comprises a stent.

7. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer and at least one plasticizer blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively.

8. The implantable medical device according to claim 7 wherein the at least one polymer is bioabsorbable.

9. The implantable medical device according to claim 7 wherein the at least one polymer is non-bioabsorbable.

10. The implantable medical device according to claim 7 wherein the at least one plasticizer is bioabsorbable.

11. The implantable medical device according to claim 7, wherein the at least one plasticizer is non-bioabsorbable.

12. The implantable medical device according to claim 7, wherein the frame structure comprises a stent.

13. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and at least one therapeutic agent blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections.

14. The implantable medical device according to claim 13 wherein the at least one polymer is bioabsorbable.

15. The implantable medical device according to claim 13 wherein the at least one polymer is non-bioabsorbable.

16. The implantable medical device according to claim 13, wherein the at least one plasticizer is bioabsorbable.

17. The implantable medical device according to claim 13, wherein the at least one plasticizer is non-bioabsorbable.

18. The implantable medical device according to claim 13, wherein the at least one therapeutic agent comprises a rapamycin.

19. The implantable medical device according to claim 13, wherein the at least one therapeutic agent comprises heparin.

20. The implantable medical device according to claim 13, wherein the at least one therapeutic agent comprises paclitaxel.

21. The implantable medical device according to claim 13, wherein the frame structure comprises a stent.

22. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and at least one therapeutic agent blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively.

23. The implantable medical device according to claim 22 wherein the at least one polymer is bioabsorbable.

24. The implantable medical device according to claim 22 wherein the at least one polymer is non-bioabsorbable.

25. The implantable medical device according to claim 22, wherein the at least one plasticizer is bioabsorbable.

26. The implantable medical device according to claim 22, wherein the at least one plasticizer is non-bioabsorbable.

27. The implantable medical device according to claim 22, wherein the at least one therapeutic agent comprises a rapamycin.

28. The implantable medical device according to claim 22, wherein the at least one therapeutic agent comprises heparin.

29. The implantable medical device according to claim 22, wherein the at least one therapeutic agent comprises paclitaxel.

30. The implantable medical device according to claim 22, wherein the frame structure comprises a stent.

31. An implantable medical device comprising: a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer and at least one plasticizer blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections; andat least one therapeutic agent affixed to the frame structure.

32. The implantable medical device according to claim 31, wherein the at least one polymer is bioabsorbable.

33. The implantable medical device according to claim 31, wherein the at least one polymer is non-bioabsorbable.

34. The implantable medical device according to claim 31, wherein the at least one plasticizer is bioabsorbable.

35. The implantable medical device according to claim 31, wherein the at least one plasticizer is non-bioabsorbable.

36. The implantable medical device according to claim 31, wherein the at least one therapeutic agent is affixed directly to a surface of the frame structure.

37. The implantable medical device according to claim 31, wherein the at least one therapeutic agent is incorporated into a polymeric vehicle and affixed to a surface of the frame structure.

38. The implantable medical device according to claim 31, wherein the at least one therapeutic agent comprises a rapamycin.

39. The implantable medical device according to claim 31, wherein the at least one therapeutic agent comprises heparin.

40. The implantable medical device according to claim 31, wherein the at least one therapeutic agent comprises paclitaxel.

41. The implantable medical device according to claim 31, wherein the frame structure comprises a stent.

42. An implantable medical device comprising: a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer and at least one plasticizer blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively; andat least one therapeutic agent affixed to the frame structure.

43. The implantable medical device according to claim 42, wherein the at least one polymer is bioabsorbable.

44. The implantable medical device according t claim 42, wherein the at least one polymer is non-bioabsorbable.

45. The implantable medical device according to claim 42, wherein the at least one plasticizer is bioabsorbable.

46. The implantable medical device according to claim 42, wherein the at least one plasticizer is non-bioabsorbable.

47. The implantable medical device according to claim 42, wherein the at least one therapeutic agent is affixed directly to a surface of the frame structure.

48. The implantable medical device according to claim 42, wherein the at least one therapeutic agent is incorporated into a polymeric vehicle and affixed to a surface of the frame structure.

49. The implantable medical device according to claim 42, wherein the at least one therapeutic agent comprises a rapamycin.

50. The implantable medical device according to claim 42, wherein the at least one therapeutic agent comprises heparin.

51. The implantable medical device according to claim 42, wherein the at least one therapeutic agent comprises paclitaxel.

52. The implantable medical device according to claim 42, wherein the frame structure comprises a stent.

53. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and a radiopaque material blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections.

54. The implantable medical device according to claim 53, wherein the at least one polymer is bioabsorbable.

55. The implantable medical device according to claim 53, wherein the at least one polymer is non-bioabsorbable.

56. The implantable medical device according to claim 53, wherein the at least one plasticizer is bioabsorbable.

57. The implantable medical device according to claim 53, wherein the at least one plasticizer is non-bioabsorbable.

58. The implantable medical device according to claim 53, wherein the radiopaque material comprises barium sulfate.

59. The implantable medical device according to claim 53, wherein the frame structure comprises a stent.

60. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and a radiopaque material blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively.

61. The implantable medical device according to claim 60, wherein the at least one polymer is bioabsorbable.

62. The implantable medical device according to claim 60, wherein the at least one polymer is non-bioabsorbable.

63. The implantable medical device according to claim 60, wherein the at least one plasticizer is bioabsorbable.

64. The implantable medical device according to claim 60, wherein the at least one plasticizer is non-bioabsorbable.

65. The implantable medical device according to claim 60 wherein the radiopaque material comprises barium sulfate.

66. The implantable medical device according to claim 60, wherein the frame structure comprises a stent.

67. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer, a radiopaque material and at least one therapeutic agent blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections.

68. The implantable medical device according to claim 67 wherein the at least one polymer is bioabsorbable.

69. The implantable medical device according to claim 67 wherein the at least one polymer is non-bioabsorbable.

70. The implantable medical device according to claim 67, wherein the at least one plasticizer is bioabsorbable.

71. The implantable medical device according to claim 67, wherein the at least one plasticizer is non-bioabsorbable.

72. The implantable medical device according to claim 67, wherein the radiopaque material comprises barium sulfate.

73. The implantable medical device according to claim 67, wherein the at least one therapeutic agent comprises a rapamycin.

74. The implantable medical device according to claim 67, wherein the at least one therapeutic agent comprises heparin.

75. The implantable medical device according to claim 67, wherein the at least one therapeutic agent comprises paclitaxel.

76. The implantable medical device according to claim 67, wherein the frame structure comprises a stent.

77. An implantable medical device comprising a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer, a radiopaque material and at least one therapeutic agent blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively.

78. The implantable medical device according to claim 77, wherein the at least one polymer is bioabsorbable.

79. The implantable medical device according to claim 77, wherein the at least one polymer is non-bioabsorbable.

80. The implantable medical device according to claim 77, wherein the at least one plasticizer is bioabsorbable.

81. The implantable medical device according to claim 77, wherein the at least one plasticizer is non-bioabsorbable.

82. The implantable medical device according to claim 77, wherein the radiopaque material comprises barium sulfate.

83. The implantable medical device according to claim 77, wherein the at least one therapeutic agent comprises a rapamycin.

84. The implantable medical device according to claim 77, wherein the at least one therapeutic agent comprises heparin.

85. The implantable medical device according to claim 77, wherein the at least one therapeutic agent comprises paclitaxel.

86. The implantable medical device according to claim 77, wherein the frame structure comprises a stent.

87. An implantable medical device comprising: a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and a radiopaque material blended to create a deformable frame structure having increased toughness, and wherein at least one of the one or more sections having an amount of alignment of the polymer chains of the blend in a direction of the at least one or more sections greater than an amount of alignment of the polymer chains of the blend in a direction of another of the at least one or more sections; andat least one therapeutic agent affixed to the frame structure.

88. The implantable medical device according to claim 87, wherein the at least one polymer is bioabsorbable.

89. The implantable medical device according to claim 87, wherein the at least one polymer is non-bioabsorbable.

90. The implantable medical device according to claim 87, wherein the at least one plasticizer is bioabsorbable.

91. The implantable medical device according to claim 87, wherein the at least one plasticizer is non-bioabsorbable.

92. The implantable medical device according to claim 87, wherein the radiopaque material comprises barium sulfate.

93. The implantable medical device according to claim 87, wherein the frame structure comprises a stent.

94. The implantable medical device according to claim 87, wherein the at least one therapeutic agent is affixed directly to a surface of the frame structure.

95. The implantable medical device according to claim 87, wherein the at least one therapeutic agent is incorporated into a polymeric vehicle and affixed to a surface of the frame structure.

96. The implantable medical device according to claim 87, wherein the at least one therapeutic agent comprises a rapamycin.

97. The implantable medical device according to claim 87, wherein the at least one therapeutic agent comprises heparin.

98. The implantable medical device according to claim 87, wherein the at least one therapeutic agent comprises a paclitaxel.

99. An implantable medical device comprising: a frame structure, the frame structure including at least one element having one or more sections being formed from at least one polymer, at least one plasticizer and a radiopaque material blended to create a deformable frame structure having increased toughness, and wherein each of the one or more sections having a substantially equal amount of alignment of the polymer chains of the blend in directions substantially parallel to the directions of each of the at least one or more sections respectively; andat least one therapeutic agent affixed to the frame structure.

100. The implantable medical device according to claim 99, wherein the at least one polymer is bioabsorbable.

101. The implantable medical device according to claim 99, wherein the at least one polymer is non-bioabsorbable.

102. The implantable medical device according to claim 99, wherein the at least one plasticizer is bioabsorbable.

103. The implantable medical device according to claim 99, wherein the at least one plasticizer is non-bioabsorbable.

104. The implantable medical device according to claim 99, wherein the radiopaque material comprises barium sulfate.

105. The implantable medical device according to claim 99, wherein the frame structure comprises a stent.

106. The implantable medical device according to claim 99, wherein the at least one therapeutic agent is affixed directly to a surface of the frame structure.

107. The implantable medical device according to claim 99, wherein the at least one therapeutic agent is incorporated into a polymeric vehicle and affixed to a surface of the frame structure.

108. The implantable medical device according to claim 99, wherein the at least one therapeutic agent comprises a rapamycin.

109. The implantable medical device according to claim 99, wherein the at least one therapeutic agent comprises heparin.

110. The implantable medical device according to claim 99, wherein the at least one therapeutic agent comprises a paclitaxel.