Drug delivery system for conscious sedation

• US 8,393,321 B2
• Filed: 10/17/2002
• Issued: 03/12/2013
• Est. Priority Date: 10/17/2001
• Status: Expired due to Fees

• Current Assignee: Piramal Critical Care, Inc.
• Original Assignee: Piramal Critical Care, Inc.
• Inventors: Burns, William H. Jr., McNeirney, John C., Terrell, Ross C.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US10/272,794
• Publication Number:
  US 20030233086A1
• Time in Patent Office: 3,799 Days
• Field of Search: 604/23, 604/24, 128/204.18, 128/204.22, 128/205.11, 128/203.12, 128/203.13
• US Class Current: 128/203.11
• CPC Class Codes: A61K 31/06 the aromatic ring being substituted by nitro groups
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/109 the humidifying liquid or the beneficial agent
• CPC Class Codes: A61M 16/18 Vaporising devices for anaesthetic preparations
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives

Abstract

Inhalant anesthetics are developed with a number of properties including rapid onset and recovery, controllability, and, ideally, a broad safety profile. The efficacy of these agents is measured by their ability to create anesthesia within the framework of the other desirable properties. The instant invention focuses on the dosage level where analgesia occurs but amnesia or lack of consciousness does not. In addition to identifying the dosage level where pain is sharply reduced or eliminated but awareness remains, a delivery system for safe and effective delivery of the agent is described.

Claims

1. A method for delivery of a mixture to a patient effective to produce analgesia without loss of consciousness in a patient wherein the method comprises:

forming a gaseous mixture of oxygen and a halogenated material selected from the group consisting of halogenated ethers and halothane by mixing oxygen with the halogenated material in a delivery manifold, the manifold having a controller configured to provide a gas having a concentration of the halogenated material that is limited to not more than about 0.636 MAC; and

b) controlling the proportions of oxygen and halogenated material in the gaseous mixture by metering a liquid flow of the halogenated material into a gas containing the oxygen such that the gaseous mixture comprises a ratio of oxygen to halogenated material effective for producing analgesia without loss of consciousness in the patient;

c) delivering said gaseous mixture to the patient to produce analgesia without loss of consciousness in the patient; and

d) performing a medical or dental intervention or procedure during analgesia while the patient is conscious.

2. The method of claim 1 wherein the halogenated material is enflurane.

3. The method of claim 1 wherein the halogenated material is isoflurane.

4. The method of claim 1 wherein the halogenated material is sevoflurane.

5. The method of claim 1 wherein the halogenated material is desflurane.

6. A system for delivering gas to a patient to produce analgesia without loss of consciousness in the patient comprising:

a) an oxygen source;

b) a reservoir suitable for storing a liquid phase of an analgesia producing agent, the agent being a halogenated material selected from the group consisting of halogenated ethers and halothane;

a delivery manifold having a pair of inputs connected to the oxygen source and to the reservoir, respectively, and having an output, the manifold providing a gaseous mixture of oxygen and the analgesia producing agent by metering a flow of the liquid halogenated material into the oxygen, the manifold having a controller configured to provide the gaseous mixture such that the halogenated material is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness; and

d) means for conveying the gaseous mixture from the output of the delivery manifold to a patient for producing analgesia without loss of consciousness in the patient while a medical or dental intervention or procedure is carried out.

7. The gas delivery system of claim 6, wherein the delivery manifold comprises a pressure regulator and a flow meter connected in fluid communication, the flow meter being in fluid communication with the output of the delivery manifold.

8. The gas delivery system of claim 7, wherein the pressure regulator is in fluid communication with the input of the delivery manifold connected to the oxygen source and the flow meter is in fluid communication with the input of the delivery manifold connected to the reservoir.

9. The gas delivery system of claim 6, further including heating means operatively associated with the reservoir containing analgesia producing agent and ambient temperature sensing means in controlling relation to a heating means to provide compensation for changes in environmental temperature conditions.

10. The gas delivery system of claim 6, further including an oxygen flush arrangement operatively coupled between the oxygen source and a patient.

11. The gas delivery system of claim 6 wherein the oxygen source comprises a cylinder.

12. The gas delivery system of claim 6 wherein the reservoir comprises a cylinder.

13. The gas delivery system of claim 6 wherein the reservoir has a mated index.

14. The gas delivery system of claim 6 wherein the pressure regulator is digital.

15. The gas delivery system of claim 6 wherein the pressure regulator is analog.

16. The gas delivery system of claim 6 wherein a gas scavenging system is provided.

17. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halogenated ethers and halothane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure.

18. The drug delivery system of claim 17, wherein the halogenated material is halothane.

19. The drug delivery system of claim 17, wherein the halogenated material is enflurane.

20. The drug delivery system of claim 17, wherein the halogenated material is isoflurane.

21. The drug delivery system of claim 17, wherein the halogenated material is sevoflurane.

22. The drug delivery system of claim 17, wherein the halogenated material is desflurane.

23. A drug delivery system according to claim 17 in a configuration selected from the group consisting of a portable version for military use, a wall mounted configuration, an office cabinetry configuration and a version as part of a gas delivery system.

24. A drug delivery system according to claim 23 with scavenging of exhaled patient gases.

25. A drug delivery system according to claim 23 without scavenging of exhaled patient gases.

26. A drug delivery system according to claim 17 or 23 operatively associated with means for holding patient monitors selected from the group consisting of devices for oxygen monitoring, oximetry, EKG monitoring, blood pressure monitoring, carbon dioxide monitoring and depth of consciousness monitoring.

27. A drug delivery system according to claim 17 or 23 integrated with patient monitors selected from the group consisting of oxygen monitoring, oximetry, EKG monitoring, blood pressure monitoring, carbon dioxide monitoring and depth of consciousness monitoring.

28. A drug delivery system according to claim 17 or 23 further including a regulator system to sense depth of patient inhalation measured in units selected from the group consisting of pressure per square inch (PSI) and millimeters of mercury.

29. A drug delivery system according to claim 17 with scavenging of exhaled patient gases.

30. A drug delivery system according to claim 17 without scavenging of exhaled patient gases.

31. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC and having a delivered oxygen concentration effective for use with patients having poor myocardial or cerebral oxygenation or coronary artery disease and to produce analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

32. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC and featuring an absence of nitrous oxide so as to provide increased occupational safety particularly among women of child bearing age and/or persons addicted to nitrous oxide and to produce analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure analgesia while the patient is conscious.

33. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC and having MR-safety (1.5 tesla) so as to reduce anxiety in a patient related to a medical or dental procedure, claustrophobia or mental incapacitation and so as to produce analgesia without loss of consciousness in the patient facing prolonged periods of inactivity such as during nuclear magnetic resonance (MRI), wherein the patient is undergoing the procedure during analgesia while the patient is conscious.

34. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC and is in operative relationship with an intensive care unit (ICU), critical care unit (CCU) or cardiac catheterization laboratory in conjunction with situations such as prolonged intubation and depth of consciousness measurement and patient interventions such as dressing changes and implantable cardiac defibrillator or pacemaker adjustment and general pain relief to produce analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

35. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC to produce analgesia without loss of consciousness in a patient and operating with scavenging of exhaled patient gases wherein the patient is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

36. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC to produce analgesia without loss of consciousness in a patient and operating without scavenging of exhaled patient gases wherein the patient is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

37. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient, and further including a regulator system to sense depth of patient inhalation measured in units selected from the group consisting of pressure per square inch (PSI) and millimeters of mercury while producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

38. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of the halogenated material that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient and having an absence of nitrous oxide so as to provide increased occupational safety particularly among women of child bearing age and/or persons addicted to nitrous oxide while producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure.

39. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide the gaseous mixture having a concentration of halogenated agent that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious, and having an increased delivered oxygen concentration for use with patients having poor myocardial or cerebral oxygenation or coronary artery disease.

40. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide the gaseous mixture having a concentration of halogenated agent that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient undergoing a medical or dental intervention or procedure and having an absence of nitrous oxide so as to provide increased occupational safety particularly among women of child bearing age and/or persons addicted to nitrous oxide while producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

41. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide the gaseous mixture having a concentration of halogenated agent that is limited to not more than about 0.636 MAC for producing analgesia without loss of consciousness in a patient and having MR-safety (1.5 tesla) so as to reduce anxiety related to procedure, claustrophobia or mental incapacitation and so as to provide analgesia without loss of consciousness to patients facing prolonged periods of inactivity such as during nuclear magnetic resonance (MRI) wherein the patient is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious.

42. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide the gaseous mixture having a concentration of halogenated agent that is limited to not more than about 0.636 MAC and for producing analgesia without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during analgesia while the patient is conscious, and in operative relationship with intensive care unit (ICU), critical care unit (CCU) or cardiac catheterization laboratory in conjunction with situations such as prolonged intubation and depth of consciousness measurement and patient interventions such as dressing changes and implantable cardiac defibrillator or pacemaker adjustment and general pain relief.

43. A method for delivery of a mixture of gases to a patient effective to produce a sedative state without loss of consciousness in a patient wherein the method comprises:

a) forming a gaseous mixture of oxygen and halogenated material selected from the group consisting of halogenated ethers and halothane by mixing oxygen with halogenated material;

b) controlling the proportions of oxygen and halogenated material in the gaseous mixture with a delivery manifold having a controller configured to provide the gaseous mixture, which comprises a ratio of oxygen to halogenated material in a concentration that is limited to not more than about 0.636 MAC and is effective for producing the sedative state without loss of consciousness in the patient wherein the halogenated material is stored in a liquid phase in a reservoir and a flow of the liquid halogenated material is metered into the oxygen to form the gaseous mixture; and

c) delivering said gaseous mixture to the patient to produce the sedative state without loss of consciousness in the patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

44. The method of claim 43 wherein the halogenated material is halothane.

45. The method of claim 43 wherein the halogenated material is enflurane.

46. The method of claim 43 wherein the halogenated material is isoflurane.

47. The method of claim 43 wherein the halogenated material is sevoflurane.

48. The method of claim 43 wherein the halogenated material is desflurane.

49. A system for delivering gas to a patient to produce a sedative state without loss of consciousness in the patient comprising:

a) an oxygen source;

b) a reservoir containing a liquid-phase sedation-producing agent in the form of halogenated material selected from the group consisting of halogenated ethers and halothane;

c) a delivery manifold having a pair of inputs connected to the oxygen source and to the reservoir, respectively, and having an output, the manifold providing a gaseous mixture of oxygen and halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold having a controller configured to provide a concentration of the halogenated material that is limited to not more than about 0.636 MAC for producing the sedative state without loss of consciousness such that the gaseous mixture comprises a ratio of oxygen to halogenated material effective for producing the sedative state without loss of consciousness in a patient; and

d) means for conveying the gaseous mixture from the output of the delivery manifold to a patient for producing the sedative state without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

50. The gas delivery system of claim 49, wherein the delivery manifold comprises a pressure regulator and a flow meter connected in fluid communication, the flow meter being in fluid communication with the output of the delivery manifold.

51. The gas delivery system of claim 50, wherein the pressure regulator is in fluid communication with the input of the delivery manifold connected to the oxygen source and the flow meter is in fluid communication with the input of the delivery manifold connected to the reservoir containing a halogenated material producing sedation without loss of consciousness.

52. The gas delivery system of claim 49, further including heating means operatively associated with the reservoir containing sedation producing agent and ambient temperature sensing means in controlling relation to the heating means to provide compensation for changes in environmental temperature conditions.

53. The gas delivery system of claim 49, further including an oxygen flush arrangement operatively coupled between the oxygen source and a patient.

54. The gas delivery system of claim 49, wherein the oxygen source comprises a cylinder.

55. The gas delivery system of claim 49, wherein the halogenated material reservoir comprises a cylinder.

56. The gas delivery system of claim 49, wherein the halogenated material reservoir has a mated index.

57. The gas delivery system of claim 49, wherein the pressure regulator is digital.

58. The gas delivery system of claim 49, wherein the pressure regulator is analog.

59. The gas delivery system of claim 49, wherein a gas scavenging system is provided.

60. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halogenated ethers and halothane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

61. The use of halothane in the delivery system of claim 60 as an inhaled analgesic for producing sedation without loss of consciousness in a patient.

62. The use of enflurane in the delivery system of claim 60 as an inhaled analgesic for producing sedation without loss of consciousness in a patient.

63. The use of isoflurane in the delivery system of claim 60 as an inhaled analgesic for producing sedation without loss of consciousness in a patient.

64. The use of sevoflurane in the delivery system of claim 60 as an inhaled analgesic for producing sedation without loss of consciousness in a patient.

65. The use of desflurane in the delivery system of claim 60 as an inhaled analgesic for producing sedation without loss of consciousness in a patient.

66. A drug delivery system according to claim 60 in a configuration selected from the group consisting of a portable version for military use, a wall mounted configuration, an office cabinetry configuration and a version as part of a gas delivery system.

67. A drug delivery system according to claim 66 with scavenging of exhaled patient gases.

68. A drug delivery system according to claim 66 without scavenging of exhaled patient gases.

69. A drug delivery system according to claim 60 or 66 operatively associated with means for holding patient monitors selected from the group consisting of devices for oxygen monitoring, oximetry, EKG monitoring, blood pressure monitoring, carbon dioxide monitoring and depth of consciousness monitoring.

70. A drug delivery system according to claim 60 or 66 integrated with patient monitors selected from the group consisting of devices for oxygen monitoring, oximetry, EKG monitoring, blood pressure monitoring, carbon dioxide monitoring and depth of consciousness monitoring.

71. A drug delivery system according to claim 60 or 66 further including a regulator system to sense depth of patient inhalation measured in units selected from the group consisting of pressure per square inch (PSI) and millimeters of mercury.

72. A drug delivery system according to claim 60 with scavenging of exhaled patient gases.

73. A drug delivery system according to claim 60 without scavenging of exhaled patient gases.

74. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of halogenated material that is limited to not more than about 0.636 MAC and having MR-safety (1.5 tesla) so as to reduce anxiety related to procedure, claustrophobia or mental incapacitation and so as to produce a sedative state without loss of consciousness in patients facing prolonged periods of inactivity such as during nuclear magnetic resonance imaging (MRI) wherein the patient is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

75. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC to produce a sedative state without consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious, and operating with scavenging of exhaled patient gases.

76. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC to produce a sedative state without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious, and operating without scavenging of exhaled patient gases.

77. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient and further including a regulator system to sense depth of patient inhalation measured in units selected from the group consisting of pressure per square inch (PSI) and millimeters of mercury while producing sedation without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

78. A drug delivery system having a reservoir to provide halogenated material, the halogenated material being selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein the reservoir is suitable for storing the halogenated material in a liquid phase, and a delivery manifold for providing a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient and having an absence of nitrous oxide so as to provide increased occupational safety particularly among women of child bearing age and/or persons addicted to nitrous oxide while producing sedation without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

79. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of halogenated material that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious, and having an increased delivered oxygen concentration for use with patients having poor myocardial or cerebral oxygenation or coronary artery disease.

80. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a concentration of the halogenated material in a gas phase that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient and having an absence of nitrous oxide so as to provide increased occupational safety particularly among women of child bearing age and/or persons addicted to nitrous oxide while producing sedation without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

81. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of halogenated material that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient and having MR-safety (1.5 tesla) so as to reduce anxiety related to procedure, claustrophobia or mental incapacitation and so as to provide sedation without loss of consciousness to patients facing prolonged periods of inactivity such as during nuclear magnetic resonance (MRI) wherein the patient is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious.

82. A therapeutic drug delivery method utilizing halogenated material selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane, wherein a reservoir stores the halogenated material in a liquid phase, and wherein a delivery manifold provides a gaseous mixture of oxygen and the halogenated material by metering a flow of the liquid halogenated material into the oxygen, the manifold including a controller configured to provide a gaseous concentration of halogenated material that is limited to not more than about 0.636 MAC for producing a sedative state without loss of consciousness in a patient that is undergoing a medical or dental intervention or procedure during the sedative state while the patient is conscious, and in operative relationship with intensive care unit (ICU), critical care unit (CCU) or cardiac catheterization laboratory in conjunction with situations such as prolonged intubation and depth of consciousness measurement and patient interventions such as dressing changes and implantable cardiac defibrillator or pacemaker adjustment and general pain relief.