Devices and methods for radiation treatment of an internal body organ

• US 5,863,284 A
• Filed: 08/20/1996
• Issued: 01/26/1999
• Est. Priority Date: 11/13/1995
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Klein, Enrique J.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/697,190
• Time in Patent Office: 889 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1025 Wires
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

The invention provides methods and devices for delivering low level radiation to inhibit neointimal hyperplasia following angioplasty or other intravascular procedures. In an exemplary method, a balloon is inflated within a stenosed region of a blood vessel to produce a treated region. The balloon is then deflated and a radioactive source within a sleeve is aligned over the deflated balloon. The balloon is again inflated at the treated region to engage the sleeve having the radioactive source against the blood vessel within the treated region for from 1 to 40 minutes to deliver a sufficient dose of radiation to inhibit neointimal hyperplasia.

Claims

1. A catheter system comprising:

an elongate catheter body having a proximal end and a distal end;

at least one radioactive element operably attached to the catheter body near the distal end;

an expansible member which radially expands the radioactive element away from the catheter body and toward a vessel wall; and

an energy attenuator disposed about at least a portion of the radioactive element so as to produce a generally uniform circumferential radiation dose distribution having a lesser radial energy gradient at the vessel wall upon expansion of the expansible member.

2. A catheter system as in claim 1, wherein the radioactive element comprises a seed, and wherein the seed comprises a housing and an arrangement of radionuclides contained within the housing.

3. A catheter system as in claim 2, wherein the radionuclides are spherical in geometry and are arranged in a row within the housing.

4. A catheter system as in claim 2, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

5. A catheter system as in claim 2, wherein the seed is uniformly distributed about the periphery of the catheter body.

6. A catheter system as in claim 2, wherein the seed housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding, and wherein the housing is flexible in the transverse direction.

7. A catheter system as in claim 2, wherein the seed housing is constructed of a material displaying superelastic properties, and wherein the housing is flexible in the transverse direction.

8. A catheter system as in claim 7, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

9. A catheter system as in claim 1, further comprising at least one fluoroscopic marker disposed at a known position relative to the catheter body so that the catheter is visible fluoroscopically within a body lumen.

10. A catheter system as in claim 2, wherein the housing is constructed at least partially of nickel titanium to make the housing fluoroscopically visible.

11. A catheter system as in claim 2, further comprising end caps for enclosing and sealing the seed.

12. A catheter system as in claim 11, wherein the seed housing and the end caps are constructed of a metallic material, and wherein the end caps and the housing are staked together.

13. A catheter system as in claim 11, wherein the end caps and the housing are welded together.

14. A catheter system as in claim 2, wherein the seed housing is constructed of a material displaying superelastic properties and includes an eccentric lumen for holding the radionuclides, the eccentric lumen forming an arcuate thick wall portion and an arcuate thin wall portion of the housing, and wherein the attenuator comprises the thick wall portion of the housing.

15. A catheter system as in claim 2, wherein the seed is cylindrical in geometry, and wherein the attenuator comprises an arcuate eccentric cap positioned around at least a portion of the seed.

16. A catheter system as in claim 2, wherein the seed is housed within a radiation resistant polymeric channel, and wherein the attenuator comprises a nickel titanium clip which captures the seed within the channel.

17. A catheter system as in claim 2, wherein the seed is operably attached to the radially expansible member.

18. A catheter system as in claim 17, wherein the radially expansible member comprises an elastomeric balloon, and wherein the seed is embedded within a wall of the balloon.

19. A catheter system as in claim 2, further comprising a sleeve which is slidable over the catheter body, and wherein the seed is included in the sleeve.

20. A catheter system as in claim 19, wherein the sleeve comprises a flexible material which is folded until deployed by the radially expansible member.

21. A catheter system as in claim 19, wherein the sleeve comprises an elastomeric material.

22. A catheter system as in claim 19, wherein the sleeve includes a plurality of slits, and wherein the seed is aligned on the sleeve in the direction of the slits.

23. A catheter system as in claim 2, wherein the radionuclides include ⁹⁰ Strontium and ⁹⁰ Yttrium.

24. A catheter system as in claim 1, wherein the catheter body further comprises a removable head, and wherein the radioactive element is operably attached to the head.

25. A catheter system as in claim 2, wherein the seed includes a fluoroscopically visible marker which is constructed at least partially of a fluoroscopically visible material selected from the group consisting of nickel titanium, tungsten, gold, platinum, and tantalum.

26. A catheter system as in claim 1, further comprising a plurality of radioactive elements operably attached to the catheter body.

27. A catheter system as in claim 2, wherein the seed is folded into an expansible cage structure.

28. A catheter system as in claim 27, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

29. A catheter system as in claim 27, wherein the seed is longer than the expansible member.

30. A method for providing radiation therapy to a patient, the method comprising:

performing angioplasty on a coronary artery to produce a treatment region;

introducing a catheter to the treatment region, the catheter comprising a catheter body having a proximal end and a distal end, at least one radioactive element operably attached to the catheter body near the distal end and a balloon; and

inflating the balloon when at the treatment region to radially move the radioactive element toward the artery so that the radioactive element is spaced apart from the artery wall by a predetermined distance in the range from about 0.25 mm to about 0.5 mm;

wherein the irradiation energy from the radiation emitting element is attenuated when travelling outward so as to provide a generally uniform circumferential radiation treatment. to the treatment region.

31. A method as in claim 30, wherein the balloon is constructed of an elastomeric material, and wherein the radioactive element is formed within the balloon.

32. A method as in claim 30, further comprising a sleeve which is slidable over the catheter body, wherein the radioactive element is housed in the sleeve, and further comprising placing the sleeve over the balloon before inflating the balloon.

33. A method as in claim 32, wherein the sleeve comprises a flexible material which is folded until deployed by the radially expansible member.

34. A catheter as in claim 32, wherein the sleeve includes a plurality of slits, and wherein the seed is aligned on the sleeve in the direction of the slits.

35. A method as in claim 30, wherein the catheter further comprises an attachable head, wherein the radioactive elements are operably attached to the head, and further comprising attaching the head to the catheter body prior to introducing the catheter to the treatment region.

36. A method as in claim 30, further comprising introducing at least some beta radiation to the treatment region with the radioactive element.

37. A method as in claim 30, further comprising maintaining the catheter at the treatment region for a period of time not exceeding about three minutes.

38. A method as in claim 30, wherein the radioactive element comprises a seed, and further comprising removing the seed from the catheter after treating the treatment region and reusing the seed on another catheter.

39. A method as in claim 38, wherein the seed is folded into an expansible cage structure.

40. A method as in claim 39, wherein the seed is longer than the balloon.

41. A catheter system, comprising:

an elongate catheter body having a proximal end, a distal end and a longitudinal axis;

a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis;

at least one radioactive element operably attached to the head; and

an expansible member operably attached to the catheter body which radially expands the radioactive element away from longitudinal axis of the catheter body.

42. A system as in claim 41, wherein the attachment mechanism includes a lock which locks the head to the catheter body.

43. A system as in claim 41, wherein the catheter body includes an inflation lumen and a guidewire lumen.

44. A system as in claim 43, wherein the guidewire lumen proximally terminates in a guidewire exit port on a side of the catheter body.

45. A system as in claim 43, wherein the guidewire lumen terminates at a proximal catheter fitting at the proximal end of the catheter body.

46. A system as in claim 41, further comprising an energy attenuator which is disposed about at least a portion of the radioactive element so as to produce a generally uniform circumferential radiation dose distribution at a vessel wall.

47. A system as in claim 41, further comprising a docking module defining an enclosure for housing the head, the docking module absorbing the release of radioactive energy from the radioactive element.

48. A system as in claim 41, further comprising a packaging enclosure, wherein the head is vacuum or nitrogen packed within the packaging enclosure.

49. A system as in claim 41, wherein the radioactive element comprise a seed, the seed comprising a housing and a plurality of radionuclides contained within the housing.

50. A system as in claim 49, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

51. A system as in claim 49, wherein the seed is uniformly distributed about the periphery of the head.

52. A system as in claim 49, wherein the seed housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding, and wherein the housing is flexible in the transverse direction.

53. A system as in claim 49, wherein the seed housing is constructed of a material displaying superelastic properties, and wherein the housing is flexible in the transverse direction.

54. A system as in claim 53, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the seed.

55. A system as in claim 49, wherein the seed includes end caps which are insertable into ends of the seed housing to seal the seed.

56. A method for providing radiation therapy to a patient, the method comprising:

performing angioplasty on a body lumen to produce a treatment region;

providing a catheter comprising an elongate catheter body having a proximal end, a distal end, a longitudinal axis, a head adapted for attachment to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis, at least one radioactive elements operably attached to the head, and an expansible member operably attached to the head, with the head being aligned with the longitudinal axis;

fixedly attaching the head to the catheter body;

introducing the catheter to the treatment region;

inflating the balloon when at the treatment region to move the radioactive element towards the body lumen.

57. A method as in claim 56, further comprising attaching the head to the catheter body while the head is disposed within a radioactive shield.

58. A method as in claim 56, further comprising attenuating the energy from the radiation emitting element with an attenuator so as to provide a generally uniform circumferential radiation treatment to the treatment region.

59. A method as in claim 56, further comprising inflating the balloon until the balloon moves the radioactive element to a predetermined distance from the artery wall.

60. A method as in claim 56, wherein the radioactive element comprise a seed, and further comprising removing the seed from the catheter after treating the treatment region and reusing the seed on another catheter.

64. A catheter as in claim 60, wherein the radially expansible member comprises an elastomeric balloon.

65. A catheter as in claim 60, wherein the seeds are uniformly distributed about the balloon.

61. A catheter comprising:

an elongate catheter body having a proximal end and a distal end;

a radially expansible member near the distal end;

a radially expansible sleeve which is positionable over the expansible member to allow the sleeve to be radially expanded by the expansible member; and

a plurality of seeds operably attached to the sleeve, each seed comprising an elongate flexible housing having an axial lumen and a plurality of radionuclides, and wherein a row of the radionuclides is housed within each lumen.

62. A catheter as in claim 61, wherein the seed is folded into an expansible cage structure.

63. A catheter as in claim 61, wherein the radionuclides are spherical in geometry.

66. A catheter as in claim 61, wherein the flexible housing comprises a radiation resistant polymer reinforced with a flexible stainless steel braiding.

67. A catheter as in claim 61, wherein the flexible housing is constructed of a material displaying superelastic properties.

68. A catheter as in claim 67, wherein the material displaying superelastic properties comprises nickel titanium.

69. A catheter as in claim 61, wherein the seed includes end caps for enclosing ends of the seed housing.

70. A catheter as in claim 69, wherein the end caps are constructed of a non-metallic material selected from the group consisting of cyanoacrylates and epoxy.

71. A catheter as in claim 69, wherein the end caps are constructed of a metallic material and are attached to the housing by cyanoacrylates or epoxies.

72. A catheter as in claim 61, wherein the radionuclides include ⁹⁰ Strontium and ⁹⁰ Yttrium.

73. A catheter as in claim 72, wherein the radionuclides further include a ceramic material.

74. A catheter comprising:

an elongate catheter body having a proximal end and a distal end;

an elastomeric balloon near the distal end of the catheter body; and

at least one radioactive element integrally formed within the elastomeric balloon such that the radioactive element is evenly circumferentially spaced about the balloon when expanded.

75. A catheter as in claim 74, further comprising a plurality of radioactive elements integrally formed within the balloon.

76. A catheter as in claim 74, wherein the radioactive element comprises a seed, the seed comprising an elongate flexible housing having an axial lumen and a row of radionuclides within the lumen, and wherein the seed is integrally formed within the balloon.

77. A catheter as in claim 76, wherein the seed is folded into an expansible cage structure.

78. A catheter system comprising:

a catheter comprising a catheter body having a proximal end, a distal end, and a longitudinal axis;

a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body such that the head is disposed distally of the catheter body and is generally aligned with the longitudinal axis;

an elastomeric balloon operably attached to the head of the catheter body; and

a plurality of seeds, each seed comprising an elongate flexible housing having an axial lumen and a plurality of radionuclides within the lumen;

wherein the seeds are integrally formed within the elastomeric balloon such that the seeds are evenly circumferentially spaced about the balloon when expanded.

79. A catheter system as in claim 78, further comprising a docking module defining an enclosure for housing the head and the balloon, the docking module absorbing the release of energy from the seeds.

80. A method for providing radiation therapy to a patient, the method comprising:

performing angioplasty on a body lumen to produce a treatment region;

introducing a catheter system to the treatment region, the catheter system comprising a catheter having a catheter body defining a central lumen, a balloon, and a sleeve having an expansible region and a plurality of radioactive elements which are generally disposed over and aligned with the balloon;

inflating the balloon when at the treatment region; and

introducing a radioactive member through the central lumen so that the radioactive member is axially aligned with the radioactive elements of the sleeve to provide a generally uniform circumferential radiation dose to the treatment region.

81. A method as in claim 80, wherein the radioactive elements of the sleeve are generally evenly distributed around the circumference of the balloon when inflated.

82. A method as in claim 80, wherein the catheter is introduced over a first guide wire, and further comprising removing the first guide wire after inflating the balloon, and introducing a second guide wire having the radioactive member.

83. A method as in claim 82, further comprising fluoroscopically visualizing the catheter and the second guide wire when introducing the catheter to the treatment region to align the radioactive elements and the radioactive member with the treatment region.

84. A method as in claim 80, wherein the radioactive elements and the radioactive member emit at least some beta radiation, and further comprising maintaining the combined catheter and sleeve at the treatment region for a time in the range from about 1 min to about 3 min to achieve a dose of from about 5 Gy to about 50 Gy at a luminal surface of the body lumen.

85. A radiation emitting catheter system, comprising:

an elongate catheter body having a proximal end, a distal end and a central lumen;

an elastomeric balloon attached near the distal end of the catheter body;

at least one radiation emitting element attached to the elastomeric balloon; and

a guide wire which is receivable in the central lumen.

86. A system as in claim 85, wherein the guide wire includes a radiation emitting source, the guide wire being adapted to be received in the central lumen with the radiation emitting source being surrounded by the radiation emitting element on the balloon so as to produce a generally uniform circumferential radiation dose distribution.

87. A system as in claim 85, further comprising a plurality of radiation emitting elements, wherein the radiation emitting elements are disposed within polymeric housings, and wherein the housings are evenly distributed about the periphery of the balloon, whereby the radiation emitting elements are evenly circumferentially spaced when the balloon is inflated.

88. A system as in claim 85, wherein the radioactive element comprises a seed, and wherein the seed comprises a housing and a row of radionuclides contained within the housing.

89. A system as in claim 85, wherein the balloon is constructed of materials selected from the group consisting of polyurethane, natural rubbers and synthetic rubbers, wherein the catheter body centers the radiation emitting source within the balloon.

90. A method for performing angioplasty, the method comprising:

introducing an angioplasty catheter having an angioplasty balloon to a body lumen and inflating the angioplasty balloon to produce a treatment region;

removing the angioplasty catheter from the patient;

introducing a radiation emitting catheter having a central lumen, an elastomeric balloon and a plurality of radiation emitting elements around the elastomeric balloon to the treatment region and inflating the elastomeric balloon to provide radiation treatment to the treatment region.

91. A method as in claim 90, further comprising introducing a radioactive source through the central lumen so that the radioactive source is axially aligned with the radioactive elements on the elastomeric balloon.

92. A method as in claim 90, wherein the radioactive elements on the elastomeric balloon are evenly distributed around the circumference of the elastomeric balloon when inflated.

93. A method as in claim 91, wherein the angioplasty catheter is introduced over a first guide wire, and further comprising removing the angioplasty balloon after inflating the angioplasty balloon, introducing the radiation emitting catheter over the first guide wire, removing the first guide wire, and introducing a second guide wire having the radioactive source.

94. A method as in claim 93, further comprising fluoroscopically visualizing the radiation emitting catheter and the second guide wire when introducing the radiation emitting catheter and the second guide wire to the treatment region to align the radioactive elements and the radioactive member with the treatment region.

95. A method as in claim 91, wherein the radioactive elements and the radioactive source emit at least some beta radiation, and further comprising maintaining the combined radiation emitting catheter at the treatment region for a time in the range from about 1 min to about 3 min.

96. A method as in claim 91, wherein the elastomeric balloon is filled with a predetermined volume of fluid to inflate the balloon to a known size, and wherein the inflated elastomeric balloon centers the radiation emitting source within the body lumen.

97. A catheter system comprising:

a balloon catheter having a catheter body with a proximal end, a distal end, a lumen extending therebetween, and a balloon disposed near the distal end;

a sleeve having a radially expansible and contractible region, wherein at least one radioactive element is evenly distributed about the expansible region; and

wherein the catheter body includes orifices proximal and distal to the balloon for allowing blood to pass by the balloon through the lumen.

98. A catheter system as in claim 97, wherein the sleeve includes orifices proximal to the radially expansible region to allow blood to flow through the sleeve and to the proximal catheter body orifices.

99. A catheter system as in claim 98, wherein the sleeve includes axial slits, and wherein the radioactive element is aligned with the slits.

100. A catheter system as in claim 98, wherein the sleeve is configured to have an offset slitting pattern.

101. A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material which is disposed about the balloon, and wherein the radioactive element is attached to an outer surface of the sleeve.

102. A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material which is disposed about the balloon, and wherein the radioactive element is held between an inner surface of the sleeve and the balloon.

103. A catheter system as in claim 97, wherein the sleeve comprises an elastomeric material and wherein the radioactive element is embedded within the sleeve.

104. A catheter system as in claim 97, further comprising an elongate rod attached to a proximal end of the sleeve.

105. A method for providing radiation therapy to a patient, the method comprising:

performing angioplasty on a body lumen to produce a treatment region;

introducing a catheter to the treatment region, the catheter comprising a catheter body having a central lumen, a balloon, and a sleeve having an expansible and contractible region disposed over the balloon, wherein the sleeve includes at least one radioactive elements distributed about the sleeve so as to be axially aligned with the balloon, and wherein the catheter body includes perfusion orifices proximal to the balloon; and

aligning the balloon and the sleeve with the treatment region and inflating the balloon, wherein blood is allowed to flow through the treatment region of the coronary artery by passing through the perfusion orifices and the central lumen.

106. A method as in claim 105, wherein the sleeve includes orifices proximal to the radially expansible region to allow blood to flow through the sleeve and to the catheter body orifices.

107. A method as in claim 105, wherein the radioactive element of the sleeve is evenly distributed around the circumference of the balloon when the balloon is inflated.

108. A method as in claim 105, further comprising fluoroscopically visualizing the catheter when aligning the balloon with the treatment region.

109. A method as in claim 105, wherein the radioactive element emits at least some beta radiation, and further comprising maintaining the catheter at the treatment region for a time in the range from about 1 min to about 20 min.

110. A catheter system comprising:

a balloon catheter having a catheter body with a proximal end, a distal end, a lumen extending therebetween, and a balloon disposed near the distal end;

a perfusion catheter having a radially deployable and contractible balloon containment region which defines an axial lumen and at least one perfusion lumen;

at least one radioactive element distributed about the radially deployable region; and

wherein the balloon catheter is insertable into the axial lumen of the perfusion catheter, wherein the balloon is expansible within the radially deployable region to move the radioactive element radially outward while allowing blood to flow past the inflated balloon through the perfusion lumen, and wherein the balloon containment region is contractible upon deflation of the balloon.

111. A catheter system as in claim 110, wherein the perfusion catheter includes orifices proximal and distal to the radially deployable region which are in communication with the perfusion lumen.

112. A catheter system as in claim 110, further comprising an elastomeric sleeve disposed over the radially deployable region of the perfusion catheter.

113. A catheter system as in claim 112, wherein the radioactive element is attached to an outer surface of the sleeve.

114. A catheter system as in claim 112, wherein the radioactive element is held between an inner surface of the sleeve and the perfusion catheter.

115. A catheter system comprising:

an elongate housing which is folded into an expansible cage structure;

at least one radioactive element disposed within the housing; and

an elongate push rod having a proximal end and a distal end, wherein the distal end is operably attached to the housing, and wherein the push rod is sufficiently rigid to allow the rod to be pushed from the proximal end to move the distal end through a body lumen.

116. A catheter system as in claim 115, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the cage structure.

117. A catheter system as in claim 115, wherein the housing defines a plurality of folded regions where the housing is folded to form the cage structure, and wherein the folded regions have a reduced cross sectional area to facilitate expansion of the cage structure from a collapsed configuration to an expanded configuration.

118. A catheter system as in claim 115, further comprising a balloon catheter having a proximal end, a distal end, and a balloon near the distal end, wherein the cage structure is positionable over the balloon.

119. A method for providing radiation therapy to a patient, the method comprising:

performing angioplasty on a body lumen to produce a treatment region;

providing a catheter having a catheter body defining an inflation lumen and a balloon;

placing an expansible cage structure over the balloon, the cage structure comprising a folded elongate housing and at least one radioactive element disposed within the housing, wherein an elongate push rod having a proximal end and a distal end is attached to the cage structure at the distal end;

introducing the combined catheter and cage structure to the treatment region and inflating the balloon; and

manipulating the proximal end of the push rod which is outside of the body lumen to manipulate the cage structure when within the body lumen.

120. A method as in claim 119, wherein the housing includes at least one necked region having a reduced cross sectional area to increase the transverse flexibility of the cage structure.

121. A method as in claim 119, wherein the housing defines a plurality of folded regions where the housing is folded to form the cage structure, and wherein the folded regions have a reduced cross sectional area to facilitate expansion and the cage structure from a collapsed configuration to an expanded configuration upon inflation of the balloon.

122. A catheter system, comprising:

an elongate catheter body having a proximal end, a distal end;

a head having an attachment mechanism for fixedly attaching the head to the distal end of the catheter body;

at least one radioactive element operably attached to the head;

an expansible member operably attached to the catheter body which radially expands the radioactive element away from a central axis of the catheter body; and

a docking module defining an enclosure for housing the head, the docking module absorbing the release of radioactive energy from the radioactive element.