Method of delivering drugs to specific regions of the spinal cord

• US 20040220545A1
• Filed: 12/23/2003
• Published: 11/04/2004
• Est. Priority Date: 12/23/2002
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Lent, Mark S., Blanco, Justin A.
• Application Number:
  US10/745,750
• Publication Number:
  US 20040220545A1
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

Devices, systems and methods for delivering one or more drugs to one or more internal body locations (such as the cerebrospinal fluid) are disclosed. In various aspects, the systems and methods may involve catheters having infusion sections with permeable membranes that develop significant back pressure to enhance uniform delivery of the drug over an infusion section; catheters that have two or more infusion sections spaced apart along the length of the same catheter, catheters that include two or more infusion sections serviced by independent lumens (such that, e.g., different drug solutions can be delivered to the different infusion sections); implantable drug delivery systems with pumps and multiple reservoirs from which drugs can be delivered; systems that are capable of delivering drug solutions with selected densities; etc. Methods for treating diseases, including pain and spasticity are also discussed, as well as methods for screening patients and optimizing therapies. In addition, methods for delivering a drug to a brain through a spinal canal are described.

Claims

1. A method of delivering one or more therapeutic compositions to two or more locations within the spinal region of a patient, the method comprising:

delivering a first therapeutic composition to a first location within the spinal region of a patient; and

delivering a second therapeutic composition to a second location within the spinal region of a patient;

wherein the first therapeutic composition and the second therapeutic composition are the same or different.

2. The method of claim 1, the first therapeutic composition and the second therapeutic composition are delivered through the same catheter.

3. The method of claim 2, wherein the first therapeutic composition is delivered through a first lumen in the catheter and wherein the second therapeutic composition is delivered through a second lumen in the catheter.

4. The method of claim 1, wherein the first therapeutic composition and the second therapeutic composition are delivered through one or more catheters.

5. The method of claim 4, wherein the first therapeutic composition is delivered through a first infusion section in the one or more catheters and wherein the second therapeutic composition is delivered through a second infusion section in the one or more catheters

6. The method of claim 5, wherein the first infusion section comprises an axial length of 20 mm or more.

7. The method of claim 5, wherein the first infusion section comprises an axial length of 240 mm or less.

8. The method of claim 5, wherein the first infusion section comprises an axial length of 20 mm to 120 mm.

9. The method of claim 5, wherein the first infusion section comprises an axial length of 40 mm or more.

10. The method of claim 5, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance of one human vertebral level or more.

11. The method of claim 5, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance of 40 mm or more.

12. The method of claim 5, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance that is a whole number multiple of one human vertebral level.

13. The method of claim 5, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance that is a whole number multiple of 40 mm.

14. The method of claim 1, wherein delivering the first therapeutic composition to the first location and delivering the second therapeutic composition to the second location are performed simultaneously.

15. The method of claim 1, wherein the first therapeutic composition is the same as the second therapeutic composition.

16. The method of claim 1, wherein the first therapeutic composition and the second first therapeutic composition are different drugs.

17. The method of claim 16, wherein the first therapeutic composition and the second therapeutic composition comprise the same one or more drugs.

18. The method of claim 17, wherein the first therapeutic composition and the second therapeutic composition comprise the different amounts of the same one or more drugs.

19. The method of claim 17, wherein the first therapeutic composition is of a different density than the second therapeutic composition.

20. A method for treating pain in a subject in need thereof, the method comprising

administering a first therapeutic composition comprising a pain treating effective amount of one or more drugs to a first location of the subject'"'"'s spinal cord, wherein the first therapeutic composition has a density and a hydrophobicity;

and

administering a second therapeutic composition comprising a pain treating effective amount of amount of a one or more drugs to a second location of the subject'"'"'s spinal cord.

21. The method of claim 20, wherein the first therapeutic composition and the second therapeutic composition are administered intrathecally through one or more catheters.

22. The method of claim 21, wherein the first therapeutic composition and the second therapeutic composition are delivered by separate catheters.

23. The method of claim 21, wherein the first and second therapeutic compositions are delivered by a single catheter.

24. The method of claim 23, wherein the catheter comprises a first infusion site and a second infusion site, wherein the first drug is delivered through the first infusion site and the second drug is delivered through the second infusion site.

25. The method of claim 24, wherein the catheter comprises a first and a second lumen, the first lumen being fluidly coupled to the first infusion site and the second lumen being fluidly coupled to the second infusion site.

26. The method of claim 25, wherein a permeable membrane covers the first infusion site.

27. The method of claim 25, wherein a permeable membrane covers the second infusion site.

28. The method of claim 25, wherein a first permeable membrane covers the first infusion site and a second permeable membrane covers the second infusion site.

29. The method of claim 21, wherein the catheter is coupled to a pump.

30. The method of claim 29, wherein the pump is implantable.

31. The method of claim 25, wherein the first and second lumen are coupled to a pump.

32. The method of claim 31, wherein the pump is coupled to a first reservoir housing the first therapeutic composition and to a second reservoir housing the second therapeutic composition.

33. The method of claim 24, wherein the first infusion section comprises an axial length of 20 mm or more.

34. The method of claim 24, wherein the first infusion section comprises an axial length of 240 mm or less.

35. The method of claim 24, wherein the first infusion section comprises an axial length of 20 mm to 240 mm.

36. The method of claim 24, wherein the first infusion section comprises an axial length of 40 mm or more.

37. The method of claim 24, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance of one human vertebral level or more.

38. The method of claim 24, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance of 40 mm or more.

39. The method of claim 20, further comprising switching from administering the first therapeutic composition to a first spinal location to administering the first therapeutic composition to a third spinal location.

40. The method of claim 39, wherein the therapeutic composition is delivered to the first spinal location through a lumen of a catheter and the switching occurs by delivering the first therapeutic composition through a different lumen of the catheter.

41. The method of claim 20, further comprising altering the density of the first therapeutic composition.

42. The method of claim 20, further comprising altering the hydrophobicity of the first therapeutic composition.

43. The method of claim 20, wherein the first therapeutic composition is administered at a flow rate.

44. The method of claim 43 , further comprising altering the flow rate.

45. The method of claim 20, wherein the first and second drugs are administered to the subject by different routes.

46. The method of claim 45, wherein the routes are selected from the group consisting of intrathecal, epidural, intradiscal, into nerve routes, into ligaments or tendon surrounding or between vertebrae, subcutaneous, and intramuscular, wherein subcutaneous and intramuscular administration is in proximity to a spinal region.

47. The method of claim 20, wherein the first and second drugs are administered to the subject by the same route.

48. The method of claim 20, wherein the first and second therapeutic compositions comprise the same one or more drugs.

49. The method of claim 20, wherein the first and second therapeutic compositions comprise one or more drug selected from the group consisting of a local anesthetic, an opioid agonist, an alpha2 adrenergic agonist, an anti-inflammatory agent, a GABA agonist, an anticonvulsant, and an antidepressant.

50. The method of claim 49, wherein the first and second therapeutic compositions comprise one or more drug selected from the group consisting of a local anesthetic and an opioid agonist.

51. The method of claim 20, wherein the first and second therapeutic compositions comprise one or more drug selected from the group consisting bupivacaine, morphine, clonidine, prednisone, ketorolac, and baclofen.

52. The method of claim 20, wherein the pain is low back pain, leg pain, or low back and leg pain.

53. The method of claim 52, wherein the first spinal location is between S2 and L1.

54. The method of claim 53, wherein the first therapeutic composition comprises a local anesthetic.

55. The method of claim 54, wherein the local anesthetic is bupivacaine.

56. The method of claim 52, wherein the second spinal location is between L1 and T10.

57. The method of claim 56, wherein the second therapeutic composition comprises an opioid agonist.

58. The method of claim 57, wherein the opioid agonist is morphine.

59. The method of claim 52, wherein the first spinal location is between S2 and L1 and the second spinal location is between L1 and T10.

60. The method of claim 59, wherein the first therapeutic composition comprises a local anesthetic and the second therapeutic composition comprises an opioid agonist.

61. The method of claim 60, wherein the local anesthetic is bupivacaine and the opiod agonist is morphine.

62. The method of claim 60, wherein the first and second therapeutic compositions are administered intrathecally.

63. The method of claim 61, wherein the bupivacaine is administered at a daily dose of between 0.5 mg/day and 0/75 mg/day and the morphine is administered at a daily dose of between 0.5 mg/day to 20 mg/day.

83. The method of claim 61, further comprising switching from administering the first therapeutic composition to a first spinal location to administering the first therapeutic composition to a third spinal location.

84. The method of claim 83, wherein the therapeutic composition is delivered to the first spinal location through a lumen of a catheter and the switching occurs by delivering the first therapeutic composition through a different lumen of the catheter.

90. The method of claim 61, wherein the routes are selected from the group consisting of intrathecal and epidural.

64. A method for treating spasticity in a subject in need thereof, the method comprising:

administering a first therapeutic composition comprising a spasticity treating effective amount of one or more drugs to a first location of the subject'"'"'s spinal cord, wherein the first therapeutic composition has a density and a hydrophobicity; and

administering a second therapeutic composition comprising a spasticity treating effective amount of a one or more drugs to a second location of the subject'"'"'s spinal cord.

65. The method of claim 64, wherein the first therapeutic composition and the second therapeutic composition are administered intrathecally through one or more catheters.

66. The method of claim 65, wherein the first therapeutic composition and the second therapeutic composition are delivered by separate catheters.

67. The method of claim 65, wherein the first and second therapeutic compositions are delivered by a single catheter.

68. The method of claim 67, wherein the catheter comprises a first infusion site and a second infusion site, wherein the first drug is delivered through the first infusion site and the second drug is delivered through the second infusion site.

69. The method of claim 68, wherein the catheter comprises a first and a second lumen, the first lumen being fluidly coupled to the first infusion site and the second lumen being fluidly coupled to the second infusion site.

70. The method of claim 69, wherein a permeable membrane covers the first infusion site.

71. The method of claim 69, wherein a permeable membrane covers the second infusion site.

72. The method of claim 69, wherein a first permeable membrane covers the first infusion site and a second permeable membrane covers the second infusion site.

73. The method of claim 65, wherein the catheter is coupled to a pump.

74. The method of claim 73, wherein the pump is implantable.

75. The method of claim 69, wherein the first and second lumen are coupled to a pump.

76. The method of claim 75, wherein the pump is coupled to a first reservoir housing the first therapeutic composition and to a second reservoir housing the second therapeutic composition.

77. The method of claim 68, wherein the first infusion section comprises an axial length of 20 mm or more.

78. The method of claim 68, wherein the first infusion section comprises an axial length of 240 mm or less.

79. The method of claim 68, wherein the first infusion section comprises an axial length of 20 mm to 120 mm.

80. The method of claim 68, wherein the first infusion section comprises an axial length of 40 mm or more.

81. The method of claim 68, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance equivalent to a distance from a spinal location associated with lower limb movement and a spinal location associated with upper limb movement.

82. The method of claim 65, wherein the first infusion section and the second infusion section are spaced apart from each other by an axial distance of 400 mm

85. The method of claim 64, further comprising altering the density of the first therapeutic composition.

86. The method of claim 64, further comprising altering the hydrophobicity of the first therapeutic composition.

87. The method of claim 64, wherein the first therapeutic composition is administered at a flow rate.

88. The method of claim 87, further comprising altering the flow rate.

89. The method of claim 64, wherein the first and second drugs are administered to the subject by different routes.

91. The method of claim 64, wherein the first and second drugs are administered to the subject by the same route.

92. The method of claim 64, wherein the first and second therapeutic compositions comprise the same one or more drugs.

93. The method of claim 64, wherein the first and second therapeutic compositions comprise one or more drug selected from the group consisting of a GABA agonist, a benzodiazepine, an opioid agonist, and an alpha2 adrenergic agonist.

94. The method of claim 93, wherein the first and second therapeutic compositions comprise a GABA agonist.

95. The method of claim 64, wherein the first and second therapeutic compositions comprise one or more drug selected from the group consisting baclofen, diazepam, clonazepam, and tizanidine.

96. The method of claim 64, wherein first and second therapeutic compositions comprise baclofen.

97. The method of claim 96, wherein the baclofen is administered intrathecally at a daily dose of between 0.02 mg/day and 20 mg/day.