System and Method for Intracranial Implantation of Therapeutic or Diagnostic Agents

• US 20090192487A1
• Filed: 07/18/2007
• Published: 07/30/2009
• Est. Priority Date: 07/27/2006
• Status: Active Grant

• Current Assignee: University of Virginia Patent Foundation (University of Virginia), Virginia Commonwealth University
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Mahajan, Rahul, Gillies, George T., Broaddus, William C.
• Granted Patent: US 9,669,198 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 6/508 for non-human patients
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A system and related method for delivering the anti-tumoral agent carmustine or other types of diagnostic or therapeutic agents into the brain of a patient with a brain tumor includes an insertion device, a skull mount, and a reformulated geometry of the carmustine compound (or other material) optimized for use in the insertion device and for maximized biodegradation time. The insertion device may be front loaded with the carmustine material (or other material) and inserted through the mount on a skull, to the location of the brain tumor, where the carmustine (or other material) is then released. It should be appreciated that the diagnostic and/or therapeutic system and related method thereof are not necessarily limited to the brain of a subject. It may also be used in the organ structures or tubular structures, as well as portions and locations thereof.

Claims

1. A system for intracranial delivery of a diagnostic or therapeutic solid agent to the brain of a subject, said system comprising:

an insertion device for delivery of a diagnostic or therapeutic solid agent to the brain.

2. The system of claim 1, wherein said insertion device being adapted to retain and release the diagnostic or therapeutic solid agent for delivery to the brain.

3. The system of claim 2, wherein said retaining device comprises a sleeve and an obturator.

4. The system of claim 3, wherein said obturator being sized to fit in said sleeve.

5. The system of claim 1, further comprising:

an interface member disposed on the skull, wherein said interface member being adapted to accommodate said insertion device.

6. The system of claim 5, wherein the accommodation of said insertion device comprises alignment of insertion device to a predetermined trajectory in the brain.

7. The system of claim 6, wherein the accommodation of said insertion device comprises locking said insertion device to a predetermined position in the brain.

8. The system of claim 7, wherein said interface member comprises a navigation system for tracking the position of said insertion device.

9. The system of claim 5, wherein the accommodation of said insertion device comprises locking said insertion device to a predetermined position in the brain.

10. The system of claim 5, wherein said interface member comprises a navigation system for tracking the position of said insertion device.

11. The system of claim 5, wherein said interface member comprises a capture mechanism for retaining said insertion device for removal from the brain while insuring that the diagnostic or therapeutic solid agent remains placed within the brain.

12. The system of claim 1, wherein the diagnostic or therapeutic solid agent is detachably connected to said insertion device.

13. The system of claim 1, wherein said diagnostic or therapeutic solid agent has a biodegradation rate optimized to insure desired dosage over time for the subject.

14. The system of claim 1, wherein said retaining device comprises a sleeve and an obturator.

15. The system of claim 1, wherein said diagnostic or therapeutic solid agent is having a geometry o commensurate with the dimensions of the insertion device.

16. The system of claim 1, wherein additional agents can be delivered.

17. The system of claim 1, wherein a catheter may be introduced into the brain for the delivery of additional agents.

18. The system of claim 1, further comprising an imaging system.

19. The system of claim 18, wherein said imaging system comprises:

a magnetic resonance imager, a CT scanner, a fluoroscope, a bi-planar fluoroscope, a PET scanner, a nuclear medicine camera, or any other such biomedical imaging device.

20. The system of claim 19, wherein said imaging system for monitoring any or all parts of the agent delivery process.

21. The system of claim 1, wherein the insertion device being adapted for withdrawing unused portions of the diagnostic or therapeutic solid agent from the brain.

22. The system of claim 1, wherein the insertion device being adapted for withdrawing materials other than the diagnostic or therapeutic solid agent from the brain.

23. The system of claim 1, wherein the diagnostic or therapeutic solid agent may be co-formulated with another diagnostic or therapeutic agent, such as an MR contrast enhancing agent.

24. The system of claim 1, wherein the diagnostic or therapeutic solid agent is a carmustine material.

25. The system of claims 1, wherein said insertion device being adapted for other delivery applications to the brain such as deep brain electrodes or other sustained release devices.

26. A method for intracranial delivery of diagnostic or therapeutic solid agent to the brain of a subject, said method comprising:

inserting a device for the delivery of a diagnostic or therapeutic solid agent to the brain.

27. The method of claim 26, wherein said inserting comprises retaining and releasing the diagnostic or therapeutic solid agent material for delivery to the brain.

28. The method of claim 26, further comprising:

mounting said insertion device on the skull.

29. The method of claim 26, further comprising aligning said insertion device to a predetermined trajectory in the brain.

30. The method of claim 29, further comprising locking said insertion device to a predetermined position in the brain.

31. The method of claim 29, further comprises navigating and tracking the position of said insertion device.

32. The method of claim 26, further comprising locking said insertion device to a predetermined position in the brain.

33. The method of claim 26, further comprises navigating and tracking the position of said insertion device.

34. The method of claim 26, further comprises detachably connecting the diagnostic or therapeutic solid agent.

35. The method of claim 26, further comprises optimizing the biodegradation rate of the diagnostic or therapeutic solid agent to insure desired dosage over time for the subject.

36. The method of claim 26, wherein said delivery comprises retaining said device for removal from the brain while insuring that the diagnostic or therapeutic solid agent remains place within the brain.

37. The method of claim 26 wherein said delivering further comprises delivering additional agents for delivery to the brain.

38. The method of claim 26, further comprises inserting a catheter into the brain for delivering additional agents.

39. The method of claim 26, further comprises monitoring and/or imaging of any or all parts of the agent delivery process.

40. The method of claim 39, wherein said imaging and/or monitoring being provided by a radiological imaging system, such as a magnetic resonance imager, a CT scanner, a fluoroscope, a bi-planar fluoroscope, a PET scanner, a nuclear medicine camera, or any other such biomedical imaging device.

41. The method of claim 26, further comprises withdrawing unused portions of the diagnostic or therapeutic solid agent from the brain.

42. The method of claim 26, further comprises withdrawing materials other than the diagnostic or therapeutic solid agent from the brain.

43. The method of claim 26, further comprises co-formulating the diagnostic or therapeutic solid agent with another diagnostic or therapeutic agent, such as an MR contrast enhancing agent.

44. The method of claim 26, wherein the diagnostic or therapeutic solid agent is a carmustine material.

45. The method of claim 26, wherein said delivery further comprises delivering applications to the brain such as deep brain electrodes or other sustained release devices.

46. A system for intracranial delivery of a diagnostic or therapeutic solid agent to one or more locations of the subject, said system comprising:

an insertion device for delivery of a diagnostic or therapeutic solid agent to the one or more locations of the subject.

47. The system of claim 46, wherein said insertion device being adapted to retain and release the diagnostic or therapeutic solid agent for delivery to the one or more locations of the subject.

48. The system of claim 47, wherein said retaining device comprises a sleeve and an obturator.

49. The system of claim 48, wherein said obturator being sized to fit in said sleeve.

50. The system of claim 46, further comprising:

an interface member disposed on a portion of the subject, wherein said interface member being adapted to accommodate said insertion device.

51. The system of claim 50, wherein the accommodation of said insertion device comprises alignment of insertion device to a predetermined trajectory in the one or more locations of the subject.

52. The system of claim 51, wherein the accommodation of said insertion device comprises locking said insertion device to a predetermined position in the one or more locations of the subject.

53. The system of claim 52, wherein said interface member comprises a navigation system for tracking the position of said insertion device.

54. The system of claim 50, wherein the accommodation of said insertion device comprises locking said insertion device to a predetermined position in the one or more locations of the subject.

55. The system of claim 50, wherein said interface member comprises a navigation system for tracking the position of said insertion device.

56. The system of claim 50, wherein said interface member comprises a capture mechanism for retaining said insertion device for removal from the one or more locations of the subject while insuring that the diagnostic or therapeutic solid agent remains placed within the one or more locations of the subject.

57. The system of claim 46, wherein the diagnostic or therapeutic solid agent is detachably connected to said insertion device.

58. The system of claim 46, wherein said diagnostic or therapeutic solid agent has a biodegradation rate optimized to insure desired dosage over time for the subject.

59. The system of claim 46, wherein said retaining device comprises a sleeve and an obturator.

60. The system of claim 46, wherein said diagnostic or therapeutic solid agent is having a geometry o commensurate with the dimensions of the insertion device.

61. The system of claim 46, wherein additional agents can be delivered.

62. The system of claim 46, wherein a catheter may be introduced into the one or more locations of the subject for the delivery of additional agents.

63. The system of claim 46, further comprising an imaging system.

64. The system of claim 63, wherein said imaging system comprises:

a magnetic resonance imager, a CT scanner, a fluoroscope, a bi-planar fluoroscope, a PET scanner, a nuclear medicine camera, or any other such biomedical imaging device.

65. The system of claim 64, wherein said imaging system for monitoring any or all parts of the agent delivery process.

66. The system of claim 46, wherein the insertion device being adapted for withdrawing unused portions of the diagnostic or therapeutic solid agent from the one or more locations of the subject.

67. The system of claim 46, wherein the insertion device being adapted for withdrawing materials other than the diagnostic or therapeutic solid agent from the one or more locations of the subject.

68. The system of claim 46, wherein the diagnostic or therapeutic solid agent may be co-formulated with another diagnostic or therapeutic agent, such as an MR contrast enhancing agent.

69. The system of claim 46, wherein the diagnostic or therapeutic solid agent is a carmustine material.

70. The system of claims 46, wherein said insertion device being adapted for other delivery applications to the one or more locations of the subject such as electrodes or other sustained release devices.

71. The system of claim 46, wherein the one or more locations of the body comprises at least a portion of an organ.

72. The system of claim 71, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

73. The method of claim 46, where the one or more locations of the body comprises at least a portion of a tubular structure.

74. The method of claim 73, wherein said tubular structure comprises a blood vessel.

75. A method for intracranial delivery of diagnostic or therapeutic solid agent to one or more locations of a subject, said method comprising:

inserting a device for the delivery of a diagnostic or therapeutic solid agent to the one or more locations of the subject.

76. The method of claim 75, wherein said inserting comprises retaining and releasing the diagnostic or therapeutic solid agent material for delivery to the one or more locations of the subject.

77. The method of claim 75, further comprising:

mounting said insertion device a portion of the subject.

78. The method of claim 75, further comprising aligning said insertion device to a predetermined trajectory in the one or more locations of the subject.

79. The method of claim 78, further comprising locking said insertion device to a predetermined position in the one or more locations of the subject.

80. The method of claim 78, further comprises navigating and tracking the position of said insertion device.

81. The method of claim 75, further comprising locking said insertion device to a predetermined position in the one or more locations of the subject.

82. The method of claim 75, further comprises navigating and tracking the position of said insertion device.

83. The method of claim 75, further comprises detachably connecting the diagnostic or therapeutic solid agent.

84. The method of claim 75, further comprises optimizing the biodegradation rate of the diagnostic or therapeutic solid agent to insure desired dosage over time for the subject.

85. The method of claim 75, wherein said delivery comprises retaining said device for removal from the one or more locations of the subject while insuring that the diagnostic or therapeutic solid agent remains place within the one or more locations of the subject.

86. The method of claim 75 wherein said delivering further comprises delivering additional agents for delivery to the one or more locations of the subject.

87. The method of claim 75, further comprises inserting a catheter into the one or more locations of the subject for delivering additional agents.

88. The method of claim 75, further comprises monitoring and/or imaging of any or all parts of the agent delivery process.

89. The method of claim 88, wherein said imaging and/or monitoring being provided by a radiological imaging system, such as a magnetic resonance imager, a CT scanner, a fluoroscope, a bi-planar fluoroscope, a PET scanner, a nuclear medicine camera, or any other such biomedical imaging device.

90. The method of claim 75, further comprises withdrawing unused portions of the diagnostic or therapeutic solid agent from the one or more locations of the subject.

91. The method of claim 75, further comprises withdrawing materials others than the diagnostic or therapeutic solid agent from the one or more locations of the subject.

92. The method of claim 75, further comprises co-formulating the diagnostic or therapeutic solid agent with another diagnostic or therapeutic agent, such as an MR contrast enhancing agent.

93. The method of claim 75, wherein the diagnostic or therapeutic solid agent is a carmustine material.

94. The method of claim 75, wherein said delivery further comprises delivering applications to the one or more locations of the subject such as deep electrodes or other sustained release devices.

95. The system of claim 75, wherein the one or more locations of the body comprises at least a portion of an organ.

96. The system of claim 95, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

97. The method of claim 75, where the one or more locations of the body comprises at least a portion of a tubular structure.

98. The method of claim 97, wherein said tubular structure comprises a blood vessel.