Thin film radiation source

• US 6,287,249 B1
• Filed: 02/19/1999
• Issued: 09/11/2001
• Est. Priority Date: 02/19/1998
• Status: Expired due to Fees

• Current Assignee: Radiance Medical Systems, Inc.
• Original Assignee: Radiance Medical Systems, Inc.
• Inventors: Trauthen, Brett A., Tam, Lisa A.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US09/256,337
• Time in Patent Office: 935 Days
• Field of Search: 600/1-8, 604/19, 604/53, 604/104, 604/106-107, 604/202, 606/194
• US Class Current: 600/3
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61K 51/1279 Plasters, bandages, dressings, patches or adhesives
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: G03C 5/02 Sensitometric processes, e.g. determining sensitivity, colour sensitivity, gradation, graininess, density; Making sensitometric wedges
• CPC Class Codes: G21G 4/06 characterised by constructional features

Abstract

Disclosed is a thin film radiation source, which may be used to deliver a radioactive dose to a site in a body lumen. The source comprises a thin flexible substrate, and a layer of radioisotope attached thereto. The source may further comprise additional layers such as one or more tie layers disposed between the substrate and the radioisotope layer and one or more outer coating layers. In one embodiment, the source is wrapped around an inflatable balloon. Inflation of the balloon at a treatment site positions the source directly adjacent to the vessel wall, and allows irradiation of the site following or simultaneously with a balloon angioplasty, stent implantation, or stent sizing procedure.

Claims

1. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a thin film layer which is an inflatable balloon; and

an isotope layer on at least the first side of the substrate, wherein said isotope layer comprises a metal salt or oxide, and at least one isotope.

2. The source of claim 1, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

3. The source of claim 1, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

4. The source of claim 1, wherein the thin film layer comprises polyester polyimide, or nylon.

5. The source of claim 1, wherein the thin film layer is in the form of a tube.

6. The source of claim 5, wherein the tube comprises a material selected from the group consisting of polyester terephthalate, polyimide, and nylon.

7. The source of claim 1, further comprising a coating layer.

8. The source of claim 7, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

9. The source of claim 7, wherein said coating layer comprises a biocompatible substance.

10. The source of claim 1, wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with an inflation lumen extending axially through the tubular body.

11. The source of claim 10, further comprising a guide wire lunen extending axially throughout at least a distal portion of the tubular body.

12. The source of claim 11 further comprising a proximal guide wire access port on the tubular body.

13. The source of claim 12, wherein the guide wire access port is spaced distally apart from proximal end.

14. The source of claim 10, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the balloon.

15. The source of claim 10, further comprising a stent carried by the balloon.

18. The source of claim 10, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

19. The source of claim 10, wherein said thin film layer is in the form of a tube.

20. The source of claim 10, wherein said thin film layer comprises a material selected from the group consisting of polyester, polyimide, and nylon.

21. The source of claim 18, wherein the thin film layer is a sheet having a thickness of no more than about 0.001 inches.

22. The source of claim 21, wherein the sheet comprises a material selected from the group consisting of polyester, polyimide, and nylon.

16. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a thin film layer which is an inflatable balloon;

a tie layer on at least the first side of the substrate; and

an isotope layer bound to the tie layer, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

17. The source of claim 16, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

23. The source of claim 16, wherein said tie layer comprises a material selected from the group consisting of a metal, metal oxide, metal salt, metal alloy, polyester, and polyimide.

24. The source of claim 16, further comprising a coating layer.

25. The source of claim 24, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, polyvinylidine chloride, and other polymeric materials.

26. The radiation delivery source of claim 16, wherein said isotope layer is on the inside surface of the balloon.

27. The source of claim 16, Wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with aninflation lumen extending axially through the tubular body.

28. The source of claim 27, further comprising a guide wire lumen extending axially throughout at least a distal portion of the tubular body.

29. The source of claim 28, further comprising a proximal guide wire access port on the tubular body.

30. The source of claim 29, wherein the guide wire access port is spaced distally apart from the proximal end.

31. The source of claim 27, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the balloon.

32. The source of claim 27, further comprising a stent carried by the balloon.

33. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a porous thin film layer; and

an isotope layer on at least the first side of the substrate, wherein said isotope layer comprises a metal salt or metal oxide, at least one isotope.

34. The source of claim 33, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

35. The source of claim 33, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

36. The source of claim 33, wherein the thin film layer comprises a material selected from the group consisting of polyester, polyimide, and nylon.

37. The source of claim 36, wherein the thin film layer comprises polyethylene terephthalate or polyimide.

38. The source of claim 33, wherein the thin film layer is in the form of a tube.

39. The source of claim 33, wherein the thin film layer is a sheet having a thickness of no more than about 0.001 inches.

40. The source of claim 39, wherein the sheet comprises a material selected from the group consisting of polyester, polyimide, nylon, and a thin metal film.

41. The source of claim 33, wherein the substrate layer is carried by an inflatable balloon.

42. The source of claim 33, further comprising a coating layer.

43. The source of claim 42, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

44. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a portion of an inflatable balloon; and

an isotope layer on at least the first side of the substrate, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

45. The source of claim 44, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

46. The source of claim 44, wherein said isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

47. The source of claim 44, wherein the substrate comprises a material selected from the group consisting of polyester, polyimide, and nylon.

48. The source of claim 47, wherein the substrate comprises polyethylene terephthalate or polyimide.

49. The source of claim 44, further comprising a coating layer.

50. The source of claim 49, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

51. The source of claim 44, wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with an inflation lumen extending axially through the tubular body.

52. The source of claim 51, further comprising a guide wire lumen extending axially throughout at least a distal portion of the tubular body.

53. The source of claim 52, further comprising a proximal guide wire access port on the tubular body.

54. The source of claims 53, wherein the guide wire access port is spaced distally apart from the proximal end.

55. The source of claim 51, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the balloon.

56. The source of claim 51, further comprising a stent carried by the balloon.

57. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a porous thin film layer;

a tie layer on at least the first side of the substrate; and

an isotope layer bound to the tie layer, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

58. The source of claim 57, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

59. The source of claim 57, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

60. The source of claim 57, wherein said tie layer comprises a material selected from the group consisting of a metal, metal oxide, metal salt, metal alloy, polyester, and polyimide.

61. The source of claim 57, wherein the thin film layer comprises a material selected from the group consisting of polyester, polyimide, and nylon.

62. The source of claim 61, wherein the thin film layer comprises polyethylene terephthalate or polyimide.

63. The source of claim 57, wherein the thin film layer is in the form of a tube.

64. The source of claim 57, wherein the thin film layer is a sheet having a thickness of no more than 0.001 inches.

65. The source of claim 64, wherein the sheet comprises a material selected from the group consisting of polyester, polyimide, nylon, and a thin metal film.

66. The source of claim 57, wherein the substrate layer is carried by an inflatable balloon.

67. The source of claim 57, further comprising a coating layer.

68. The source of claim 67, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

72. The source of claim 66, wherein said tie layer comprises a material selected from the group consisting of a metal metal oxide, metal salt, metal alloy, polyester, and polyimide.

75. The source of claim 66, comprising a coating layer.

76. The source of claim 75, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

69. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a portion of an inflatable balloon;

a tie layer on at least the first side of the substrate; and

an isotope layer bound to the tie layer, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

70. The source of claim 69, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

71. The source of claim 69, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

73. The source of claim 69, wherein the substrate comprises a material selected from the group consisting of polyester, polyimide, and nylon.

74. The source of claim 69, wherein the substrate comprises polyethylene terephthalate or polyimide.

77. The source of claim 69, wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with an inflation lumen extending axially through the tubular body.

78. The source of claim 77, further comprising a guide wire lumen extending axially throughout at least a distal portion of the tubular body.

79. The source of claim 78, further comprising a proximal guide wire access port on the tubular body.

80. The source of claim 79, wherein the guide wire access port is spaced distally apart from the proximal end.

81. The source of claim 77, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the balloon.

82. The source of claim 77, further comprising a stent carried be the balloon.

83. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a thin film layer carried by an inflatable balloon; and

an isotope layer on at least the first side of the substrate, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

84. The source of claim 83, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

85. The source of claim 83, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

86. The source of claim 83, wherein the thin film layer comprises polyester or polyimide.

87. The source of claim 83, wherein the thin film layer is in the form of a tube.

88. The source of claim 87, wherein the tube comprises a material selected from the group consisting of polyesterterephtalate, polyimide, and nylon.

89. The source of claim 83, wherein the thin film layer is a sheet having a thickness of no more than about 0.001 inches.

90. The source of claim 89, wherein the sheet comprises a material selected from the group consisting of polyester, polyimide, nylon, and a thin metal film.

91. The source of claim 83, further comprising a coating layer.

92. The source of claim 91, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

93. The source of claim 83, wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with an inflation lumen extending axially through the tubular body.

94. The source of claim 93, further comprising a guide wire lumen extending axially throughout, least a distal portion of the tubular body.

95. The source of claim 94, further comprising a proximal guide wire access port on the tubular body.

96. The source of claim 95, wherein the guide wire access port is spaced distally apart from the proximal end.

97. The source of claim 83, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the balloon.

98. The source of claim 83, further comprising a stent carried by the balloon.

99. A radiation delivery source, comprising:

a substrate having at least a first side, wherein the substrate is a thin film layer carried by an inflatable balloon;

a tie layer on at least the first side of the substrate; and

an isotope layer bound to the tie layer, wherein said isotope layer comprises a metal salt or metal oxide, and at least one isotope.

100. The source of claim 99, wherein said isotope is a gamma emitting isotope or a beta emitting isotope.

101. The source of claim 99, wherein the isotope is selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, Gd-153, and combinations thereof.

102. The source of claim 99, wherein said tie layer comprises a material selected from the group consisting of a metal, metal oxide, metal salt, metal alloy, polyester, and polyimide.

103. The source of claim 99, wherein the substrate comprises a material selected from the group consisting of polyester, polyimide, and nylon.

104. The source of claim 99, wherein the substrate comprises polyethylene terephthalate or polyimide.

105. The source of claim 99, further comprising a coating layer.

106. The source of claim 105, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidene chloride.

107. The source of claim 99, wherein the inflatable balloon is mounted on a catheter, said catheter comprising an elongate flexible tubular body, having a proximal end and a distal end, said inflatable balloon being near the distal end of the tubular body and in fluid communication with an inflation lumen extending axially through the tubular body.

108. The source of claim 107, further comprising a guide wire lumen extending axially throughout at least a distal portion of the tubular body.

109. The source of claim 108, further comprising a proximal guide wire access port on the tubular body.

110. The source of claim 109, wherein the guide wire access port is spaced distally apart from the proximal end.

111. The source of claim 107, further comprising a perfusion conduit extending from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the proximal side of the balloon and at least a second perfusion port on the distal side of the baron.

112. The source of claim 107, further comprising a stent carried by the balloon.