Apparatus and method for delivering therapeutic and/or other agents to the inner ear and to other tissues

• US 20060264897A1
• Filed: 01/24/2006
• Published: 11/23/2006
• Est. Priority Date: 01/24/2005
• Status: Abandoned Application

• Current Assignee: NeuroSystec Corporation
• Original Assignee: NeuroSystec Corporation
• Inventors: McCormack, Stephen J., Pananen, Jacob E., Lenarz, Thomas H.R., Lobl, Thomas J., Nagy, Anna Imola, Schloss, John V.
• Application Number:
  US11/337,815
• Publication Number:
  US 20060264897A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 2039/0241 having means for filtering
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 2210/0687 Skull, cranium
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61P 27/16 Otologicals

Abstract

An apparatus may include a needle for sustained delivery of drugs and other agents to the inner ear or other tissues of a human or an animal. The needle can include an insertion stop, and can be placed through the round window membrane or through a surgically-prepared hole in a bone. The needle can be in fluid communication with a port and/or with a micro-infusion or osmotic pump. A cochlear implant electrode can be used instead of a needle.

Claims

1. An apparatus for sustained delivery of a drug or other agent to an inner ear or other tissue of a human or an animal, comprising:

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end;

an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop; and

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct, the lumen being formed from a fluoropolymer.

2. The apparatus of claim 1, further comprising a flange attached to the needle shaft at or near the proximal end thereof, said flange being at least partially encased within the catheter.

3. The apparatus of claim 2, wherein the flange is formed from a metal.

4. The apparatus of claim 2, wherein the flange is formed from a polymer.

5. The apparatus of claim 1, wherein the needle shaft distal end is of a size between about 22 gauge and about 35 gauge.

6. The apparatus of claim 1, wherein the needle shaft extends from an end of the catheter, and wherein the insertion stop is attached to the catheter around the catheter end.

7. The apparatus of claim 1, wherein the catheter includes at least one suture anchor.

8. The apparatus of claim 1, further comprising at least one in-line anti-bacterial filter in fluid communication with the catheter.

9. The apparatus of claim 8, wherein the at least one in-line filter includes a three-dimensional filter element.

10. The apparatus of claim 9, wherein the three-dimensional filter element is formed from a metal or a polymer.

11. The apparatus of claim 1, further comprising a quick-disconnect coupling having mating first and second portions, and wherein the catheter is attached to and in fluid communication with the first portion.

12. The apparatus of claim 11, wherein the first portion includes a septum and the second portion includes a needle positioned to pierce the septum when the first and second portions are mated, and wherein the first and second portions include internal fluid passageways formed from a fluoropolymer.

13. The apparatus of claim 1, further comprising a syringe housed within a micro-infusion pump, said syringe being in fluid communication with the catheter lumen.

14. The apparatus of claim 1, further comprising an osmotic pump in fluid communication with the catheter lumen.

15. The apparatus of claim 1, further comprising a port in fluid communication with the catheter lumen.

16. The apparatus of claim 1, wherein the catheter includes multiple lumens.

17. The apparatus of claim 1, wherein the needle shaft distal end is sharpened and configured to pierce a membrane or tissue of a human or an animal.

18. The apparatus of claim 1, wherein the needle shaft distal end is blunt and configured for insertion into a surgically prepared hole in a human or an animal bone.

19. The apparatus of claim 18, wherein the needle shaft is bent.

20. The apparatus of claim 18, wherein the insertion stop is formed from one or more porous biocompatible materials configured for fusion to the human or animal bone.

21. An apparatus for sustained delivery of a drug or other agent to an inner ear or other tissue of a human or an animal, comprising:

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end;

an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop;

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct;

at least one in-line anti-bacterial filter in fluid communication with the catheter;

a dispensing device configurable to automatically dispense the drug or other agent at rates of between 1 nanoliter/hour through 200 microliters/hour over a period of at least one hour.

22. The apparatus of claim 21, wherein the at least one in-line filter includes a three-dimensional filter element.

23. The apparatus of claim 22, wherein the three-dimensional filter element is formed from a metal or a polymer.

24. The apparatus of claim 23, wherein the at least one in-line filter includes first and second rigid tubular connectors, and wherein

the three-dimensional filter element is positioned between the first and second connectors,

at least one layer of a polymer material encases the three-dimensional filter element and portions of the first and second connectors adjacent to the three-dimensional filter element, and

the at least one polymer material layer and the first and second connectors form a fluid-tight conduit.

25. The apparatus of claim 24, wherein the needle shaft, the catheter lumen, the first and second connectors, the at least one polymer material and the three-dimensional filter element are formed from one or more materials selected from the group that includes titanium, stainless steel and fluoropolymers.

26. The apparatus of claim 24, wherein at least one of the tubular connectors has a flared end.

27. The apparatus of claim 24, wherein at least one of the tubular connectors has a barbed end.

28. The apparatus of claim 23, wherein the three-dimensional filter element is contained within a rigid housing formed from a metal or a polymer.

29. The apparatus of claim 21, further comprising a quick disconnect fitting in fluid communication with the catheter.

30. The apparatus of claim 29, wherein the quick disconnect fitting comprises internal fluid passages formed from a fluoropolymer.

31. The apparatus of claim 30, further comprising a second catheter and a luer connector, wherein

the second catheter is in fluid communication with the quick disconnect fitting,

the second catheter includes an internal lumen formed from a fluoropolymer, and

the luer connector includes internal fluid passages formed from a fluoropolymer.

32. The apparatus of claim 31, further comprising a syringe in fluid communication with the luer connector, the syringe including a barrel having an interior surface, wherein the interior barrel surface is formed from at least one of a fluoropolymer and acid-washed glass.

33. The apparatus of claim 21, wherein the needle shaft distal end is sharpened and configured to pierce a membrane or tissue of a human or an animal.

34. The apparatus of claim 21, wherein the needle shaft distal end is blunt and configured for insertion into a surgically prepared hole in a human or an animal bone.

35. The apparatus of claim 34, wherein the needle shaft is bent.

36. The apparatus of claim 34, wherein the insertion stop is formed from one or more porous biocompatible materials configured for fusion to the human or animal bone.

37. The apparatus of claim 21, further comprising a flange attached to the needle shaft at or near the proximal end thereof, said flange being at least partially encased within the catheter.

38. The apparatus of claim 21, wherein the needle shaft extends from an end of the catheter, and wherein the insertion stop is attached to the catheter around the catheter end.

39. An apparatus for sustained delivery of a drug or other agent to an inner ear or other tissue of a human or an animal, comprising:

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end;

an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop;

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct;

at least one in-line anti-bacterial filter in fluid communication with the catheter; and

a quick disconnect fitting in fluid communication with the catheter.

40. The apparatus of claim 39, wherein the needle shaft extends from an end of the catheter, and wherein the insertion stop is attached to the catheter around the catheter end.

41. The apparatus of claim 39, further comprising a flange attached to the needle shaft at or near the proximal end thereof, said flange being at least partially encased within the catheter.

42. The apparatus of claim 39, wherein the needle shaft, the catheter lumen, internal fluid passageways of the at least one in-line anti-bacterial filter and internal fluid passageways of the quick disconnect fitting are formed from one or more materials selected from the group that includes titanium, stainless steel and fluoropolymers.

43. The apparatus of claim 39, wherein the catheter includes at least one suture anchor.

44. The apparatus of claim 39, wherein the needle shaft distal end is sharpened and configured to pierce a membrane or tissue of a human or an animal.

45. The apparatus of claim 39, wherein the needle shaft distal end is blunt and configured for insertion into a surgically prepared hole in a human or an animal bone.

46. The apparatus of claim 45, wherein the needle shaft is bent.

47. The apparatus of claim 45, wherein the insertion stop is formed from one or more porous biocompatible materials configured for fusion to the human or animal bone.

48. An apparatus for sustained delivery of a drug or other agent to an inner ear or other tissue of a human or an animal, comprising:

a needle including a bent shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end;

an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop; and

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct.

49. The apparatus of claim 48, wherein the needle shaft is bent at an angle of approximately 100°

.

50. The apparatus of claim 48, wherein the portion of the needle shaft extending free of the insertion stop is straight, and wherein a portion of the needle shaft having the bend is located on a proximal side of the insertion stop.

51. The apparatus of claim 50, wherein the needle shaft is bent at an angle of approximately 100°

.

52. The apparatus of claim 48, wherein the distal end is pointed and configured for piercing a membrane or other tissue of a human or animal.

53. The apparatus of claim 48, wherein the needle has a size between 22 gauge and 35 gauge.

54. The apparatus of claim 48, wherein the distal end is located a distance of between 0.5 mm and 2.0 mm from the insertion stop.

55. An apparatus for sustained delivery of a drug or other agent to an inner ear or other tissue of a human or an animal, comprising:

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end;

a flexible insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop; and

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct.

56. The apparatus of claim 55, wherein the insertion stop is transparent.

57. The apparatus of claim 55, wherein the insertion stop is formed from a silicone elastomer.

58. The apparatus of claim 55, wherein the needle shaft is bent.

59. The apparatus of claim 55, wherein the insertion stop has a thickness of between about 0.2 mm and about 1 mm.

60. The apparatus of claim 55, wherein the insertion stop is round and has a diameter of about 1 mm to about 3 mm.

61. The apparatus of claim 55, wherein the needle shaft is bent and the insertion stop is transparent.

62. The apparatus of claim 61, wherein the insertion stop has a thickness of between about 0.2 mm and about 1 mm.

63. The apparatus of claim 62, wherein the insertion stop is round and has a diameter of about 1 mm to about 3 mm.

64. The apparatus of claim 63, wherein the needle has a size between 22 gauge and 35 gauge.

65. The apparatus of claim 64, wherein the distal end is located a distance of between 0.5 mm and 2.0 mm from the insertion stop.

66. The apparatus of claim 65, wherein the needle shaft is bent at an angle of approximately 100°

.

67. A port configured for sub-cutaneous or partially subcutaneous implantation in a human or an animal, comprising:

a reservoir having a cavity formed therein;

a cap, the cap and reservoir being cooperable to attach to one another;

an elastomeric septum covering the cavity when secured to the reservoir by the cap; and

at least one attachment fixture extending from the port, the at least one attachment fixture including an opening configured to receive a bone screw, the opening sufficiently spaced from the port to avoid cracking bone adjacent a depression in said bone in which the reservoir rests when the port is screwed in place.

68. The port of claim 67, further comprising an outlet tube having an internal passageway in fluid communication with the reservoir cavity.

69. The port of claim 67, wherein the reservoir includes one or more fixtures of a first type and the cap includes one or more fixtures of a second type, and wherein the first and second type fixtures cooperate to attach the cap to the reservoir.

70. The port of claim 69, wherein the first type fixtures include one or more tabs and the second type fixtures include one or more slots.

71. The port of claim 67, wherein the at least one attachment fixture is attached to the reservoir.

72. The port of claim 67, wherein the port comprises a three-dimensional antibacterial filter.

73. The port of claim 72, wherein the filter is inside the reservoir.

74. The port of claim 72, wherein the filter is outside the reservoir.

75. The port of claim 72, further comprising an outlet tube having an internal passageway in fluid communication with the reservoir cavity, wherein the outlet tube is external to the reservoir, and wherein the filter is inside the outlet tube.

76. The port of claim 67, wherein the reservoir cavity is tapered.

77. The port of claim 67, further comprising:

a catheter having a lumen in fluid communication with the reservoir cavity; and

a cochlear implant electrode having an internal duct in fluid communication with the catheter lumen and a plurality of outlet holes, wherein the outlet holes are in fluid communication with the duct.

78. The port of claim 67, further comprising:

a catheter having a lumen in fluid communication with the reservoir cavity; and

a needle having an internal duct and an insertion stop, wherein the internal duct is in fluid communication with the catheter lumen.

79. A port configured for sub-cutaneous or partially subcutaneous implantation in a human or an animal, comprising:

a reservoir having a cavity formed therein;

an elastomeric septum covering the cavity;

a catheter having a lumen in fluid communication with the reservoir cavity; and

a cochlear implant electrode having an internal duct in fluid communication with the catheter lumen and a plurality of outlet holes, wherein the outlet holes are in fluid communication with the duct.

80. The port of claim 79, wherein the port comprises a three-dimensional antibacterial filter.

81. The port of claim 80, wherein the filter is inside the reservoir.

82. The port of claim 80, wherein the filter is outside the reservoir.

83. The port of claim 80, further comprising an outlet tube having an internal passageway in fluid communication with the reservoir cavity, wherein the outlet tube is external to the reservoir, and wherein the filter is inside the outlet tube.

84. The port of claim 79, wherein the reservoir cavity is tapered.

85. A port configured for sub-cutaneous or partially subcutaneous implantation in a human or an animal, comprising:

a reservoir having a cavity formed therein;

an elastomeric septum covering the cavity;

a catheter having a lumen in fluid communication with the reservoir cavity;

a needle including a shaft with proximal and distal ends, the needle shaft including an internal duct in fluid communication with an opening formed in the distal end and with the catheter lumen; and

wherein

the needle shaft bent,

the needle shaft includes an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop, or

the needle shaft is bent and includes an insertion stop coupled to and extending outward from the needle shaft, a portion of the needle shaft proximate to and including the distal end extending free of the insertion stop.

86. The port of claim 85, wherein the port comprises a three-dimensional antibacterial filter.

87. The port of claim 86, wherein the filter is inside the reservoir.

88. The port of claim 86, wherein the filter is outside the reservoir.

89. The port of claim 86, further comprising an outlet tube having an internal passageway in fluid communication with the reservoir cavity, wherein the outlet tube is external to the reservoir, and wherein the filter is inside the outlet tube.

90. The port of claim 85, wherein the reservoir cavity is tapered.

91. A port configured for sub-cutaneous or partially subcutaneous implantation in a human or an animal, comprising:

a reservoir having a cavity formed therein;

an elastomeric septum covering the cavity; and

a three-dimensional antibacterial filter inside the reservoir.

92. The port of claim 91, wherein the reservoir cavity is tapered.

93. A port configured for sub-cutaneous or partially subcutaneous implantation in a human or an animal, comprising:

a reservoir having a cavity formed therein;

an elastomeric septum covering the cavity when secured to the reservoir by the cap; and

an outer surface formed from a porous biocompatible material coated with biomaterials that allow binding of human or animal cells to the outer surface.

94. The port of claim 93, wherein the biomaterials include at least one of extracellular matrices such as collagen, laminin, glycosoaminoglycan, fibronectin and fibronectin fragments such as peptides that contain the ArgGlyAsp epitope for cell adhesion.

95. The port of claim 93, wherein the port comprises a three-dimensional antibacterial filter.

96. The port of claim 95, wherein the filter is inside the reservoir.

97. The port of claim 95, wherein the filter is outside the reservoir.

98. The port of claim 95, further comprising an outlet tube having an internal passageway in fluid communication with the reservoir cavity, wherein the outlet tube is external to the reservoir, and wherein the filter is inside the outlet tube.

99. The port of claim 93, wherein the reservoir cavity is tapered.

100. A method of treating an inner ear of a human or an animal, the method comprising the steps of:

inserting an injection end of a needle into the inner ear, the needle being in fluid communication with a catheter, and the catheter being in fluid communication with a source of an agent, wherein the agent is selected from the group consisting of an NMDA receptor antagonist, a subtype-specific NMDA receptor antagonist;

an anxiolytic, an anti-depressant, a selective serotonin reabsorption inhibitor, an anti-convulsant, an anti-epilepsy drug, an anti-seizure drug, a calcium channel blocker, a sodium channel blocker, an anti-migraine agent, a muscle relaxant, a hypnotic, an anti-inflammatory steroid, and mixtures thereof; and

dispensing the agent through the needle over a period of at least one hour and without removing the injection end from the inner ear.

101. The method of claim 100, wherein the agent includes one or more of carbamathione, an N-methyl analog of carbamathione or an N-benzyl analog of carbamathione.

102. The method of claim 100, wherein the dispensing step includes dispensing the agent as a bolus injection or as multiple doses given as an intermittent or continuous infusion.

103. The method of claim 100, wherein the agent is selected from the group consisting of alprazolam, memantine, cyclandelate, caroverine, lidocaine, tocainide, gabapentin, mephobarbital, sodium pentobarbital, lorazepam, clonazepam, clorazepate dipotassium, diazepam, tiagabine, β

-hydroxypropionic acid, phenyltoin, fosphenyloin sodium, lamotrigine, methsuximide, ethosuximide, carbamazepine, divalproex sodium, felbamate, levetiracetam, primidone, zonisamide, topiramate, sodium valproate, LY 274614, LY 235959, LY 233053, NPC 12626, reduced or oxidized glutathione, carbamathione, the N-methyl or N-benzyl analogs of carbamathione, AP5, CPP, CGS-19755, CGP-37849, CGP-39551, SDZ 220-581, S-nitrosoglutathione, amantadine, aptiganel, caroverine, dextrophan, dextromethorphan, fullerenes, gacyclidine (GK-11), ibogaine, ketamine, dizocilpine (MK-801), neramexane (MRZ 2/579), NPS 1506 (delucemine), phencyclidine, tiletamine, remacemide, acamprosate, arcaine, conantokin-G, eliprodil (SL 82-0715), haloperidol, ifenprodil, traxoprodil (CP-101,606), Ro 25-6981, aminocyclopropanecarboxylic acid (ACPC), 7-chlorokynurenic acid, D-cycloserine, gavestinel (GV-150526), GV-196771A, licostinel (ACEA

     1021), MRZ-2/576, L-701,324, HA-966, ZD-9379, sodium nitroprusside, ebselen, disulfiram, CNQX, DNQX, argiotoxin636, Co 101244 (PD 174494, Ro 63-1908), despiramine, philanthotoxin343, Ro 04-5595, spermine, spermidine, NVP-AAM077, nortriptyline, fluoxetine, paroxetine, trimipramine, oxacarbazepine, eperisone, misoprostol, pregnenolone, triamcinolone, or methylprednisolone and mixtures thereof.

104. The method of claim 100, wherein the agent includes one or more of gacyclidine, traxoprodil, ifenprodil and eliprodil.

105. The method of claim 100, wherein the step of inserting includes inserting the injection end of the needle into the inner ear of a patient suffering an inner ear disorder selected from the group of disorders selected from the group consisting of tinnitus, vertigo, noise-induced hearing loss, drug-induced hearing loss, chronic ear pain, neurodegeneration, Meniere'"'"'s disease, surgical trauma or neurodegeneration of the auditory nerve, sprial ganglion or neurological connections therein.

106. The method of claim 100, wherein the agent is a neuroprotectant or an anti-apoptic agent.

107. The method of claim 100, wherein the agent includes one or more agents capable of restoring hearing or preventing progression of an ongoing chronic hearing disorder.

108. The method of claim 100, wherein the step of inserting includes inserting the injection end of the needle into the inner ear of a patient after noise-induced or other type of trauma, and wherein the agent is a neuroprotectant or an anti-apoptic agent.

109. The method of claim 100, wherein the step of inserting includes inserting the injection end of the needle into the inner ear of a patient after drug or chemically induced trauma, and wherein the agent is a neuroprotectant or an anti-apoptic agent.

110. A method of treating a disorder comprising the step of:

injecting a therapeutic agent directly into an area of a patient'"'"'s body to be treated with the agent using a device that includes

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end, and

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct, the lumen being formed from a fluoropolymer.

111. The method of claim 110, wherein the therapeutic agent is selected from the group consisting of an NMDA receptor antagonist, a subtype-specific NMDA receptor antagonist;

an anxiolytic, an anti-depressant, a selective serotonin reabsorption inhibitor, an anti-convulsant, an anti-epilepsy drug, an anti-seizure drug, a calcium channel blocker, a sodium channel blocker, an anti-migraine agent, a muscle relaxant, a hypnotic, an anti-inflammatory steroid, and mixtures thereof.

112. The method of claim 110, wherein the agent is selected from the group consisting of alprazolam, memantine, cyclandelate, caroverine, lidocaine, tocainide, gabapentin, mephobarbital, sodium pentobarbital, lorazepam, clonazepam, clorazepate dipotassium, diazepam, tiagabine, β

-hydroxypropionic acid, phenyltoin, fosphenyloin sodium, lamotrigine, methsuximide, ethosuximide, carbamazepine, divalproex sodium, felbamate, levetiracetam, primidone, zonisamide, topiramate, sodium valproate, LY 274614, LY 235959, LY 233053, NPC 12626, reduced or oxidized glutathione, carbamathione, the N-methyl or N-benzyl analogs of carbamathione, AP5, CPP, CGS-19755, CGP-37849, CGP-39551, SDZ 220-581, S-nitrosoglutathione, amantadine, aptiganel, caroverine, dextrophan, dextromethorphan, fullerenes, gacyclidine (GK-11), ibogaine, ketamine, dizocilpine (MK-801), neramexane (MRZ 2/579), NPS 1506 (delucemine), phencyclidine, tiletamine, remacemide, acamprosate, arcaine, conantokin-G, eliprodil (SL 82-0715), haloperidol, ifenprodil, traxoprodil (CP-101,606), Ro 25-6981, aminocyclopropanecarboxylic acid (ACPC), 7-chlorokynurenic acid, D-cycloserine, gavestinel (GV-150526), GV-196771A, licostinel (ACEA

     1021), MRZ-2/576, L-701,324, HA-966, ZD-9379, sodium nitroprusside, ebselen, disulfiram, CNQX, DNQX, argiotoxin636, Co 101244 (PD 174494, Ro 63-1908), despiramine, philanthotoxin343, Ro 04-5595, spermine, spermidine, NVP-AAM077, nortriptyline, fluoxetine, paroxetine, trimipramine, oxacarbazepine, eperisone, misoprostol, pregnenolone, triamcinolone, or methylprednisolone and mixtures thereof.

113. A method of treating a disorder comprising the step of:

injecting a therapeutic agent directly into an area of a patient'"'"'s body to be treated with the agent using a device that includes

a needle including a shaft with proximal and distal ends, the shaft including an internal duct in fluid communication with an opening formed in the distal end,

a catheter coupled to the needle shaft proximal end and including a lumen in fluid communication with the needle shaft internal duct;

at least one in-line anti-bacterial filter in fluid communication with the catheter;

a dispensing device configurable to automatically dispense the drug or other agent at rates of between a 1 nanoliter/hour through 200 microliters/hour over a period of at least one hour.

114. The method of claim 113, wherein the therapeutic agent is selected from the group consisting of an NMDA receptor antagonist, a subtype-specific NMDA receptor antagonist;

an anxiolytic, an anti-depressant, a selective serotonin reabsorption inhibitor, an anti-convulsant, an anti-epilepsy drug, an anti-seizure drug, a calcium channel blocker, a sodium channel blocker, an anti-migraine agent, a muscle relaxant, a hypnotic, an anti-inflammatory steroid, and mixtures thereof.

115. The method of claim 113, wherein the agent is selected from the group consisting of alprazolam, memantine, cyclandelate, caroverine, lidocaine, tocainide, gabapentin, mephobarbital, sodium pentobarbital, lorazepam, clonazepam, clorazepate dipotassium, diazepam, tiagabine, β

-hydroxypropionic acid, phenyltoin, fosphenyloin sodium, lamotrigine, methsuximide, ethosuximide, carbamazepine, divalproex sodium, felbamate, levetiracetam, primidone, zonisamide, topiramate, sodium valproate, LY 274614, LY 235959, LY 233053, NPC 12626, reduced or oxidized glutathione, carbamathione, the N-methyl or N-benzyl analogs of carbamathione, AP5, CPP, CGS-19755, CGP-37849, CGP-39551, SDZ 220-581, S-nitrosoglutathione, amantadine, aptiganel, caroverine, dextrophan, dextromethorphan, fullerenes, gacyclidine (GK-11), ibogaine, ketamine, dizocilpine (MK-801), neramexane (MRZ 2/579), NPS 1506 (delucemine), phencyclidine, tiletamine, remacemide, acamprosate, arcaine, conantokin-G, eliprodil (SL 82-0715), haloperidol, ifenprodil, traxoprodil (CP-101,606), Ro 25-6981, aminocyclopropanecarboxylic acid (ACPC), 7-chlorokynurenic acid, D-cycloserine, gavestinel (GV-150526), GV-196771A, licostinel (ACEA

     1021), MRZ-2/576, L-701,324, HA-966, ZD-9379, sodium nitroprusside, ebselen, disulfiram, CNQX, DNQX, argiotoxin636, Co 101244 (PD 174494, Ro 63-1908), despiramine, philanthotoxin343, Ro 04-5595, spermine, spermidine, NVP-AAM077, nortriptyline, fluoxetine, paroxetine, trimipramine, oxacarbazepine, eperisone, misoprostol, pregnenolone, triamcinolone, or methylprednisolone and mixtures thereof.