Drug delivery system for conscious sedation

• US 20030233086A1
• Filed: 10/17/2002
• Published: 12/18/2003
• Est. Priority Date: 10/17/2001
• Status: Active Grant

• Current Assignee: Piramal Critical Care, Inc.
• Original Assignee: Piramal Critical Care, Inc.
• Inventors: Terrell, Ross C., McNeirney, John C., Burns, William H. Jr.
• Granted Patent: US 8,393,321 B2
• Time in Patent Office: Days
• US Class Current: 604/512
• 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 of gases to a patient effective to produce analgesia in the patient wherein the method comprises:

a) forming a mixture of oxygen and halogenated ether by mixing oxygen with halogenated ether; and

b) controlling the proportions of oxygen and halogenated ether in the mixture such that the mixture comprises a ratio of oxygen to halogenated ether effective for producing analgesia in a patient; and

c) delivering said mixture to said patient.

2. The method of claim 1 wherein the halogenated ether is halothane.

3. The method of claim 1 wherein the halogenated ether is enflurane.

4. The method of claim 1 wherein the halogenated ether is isoflurane.

5. The method of claim 1 wherein the halogenated ether is sevoflurane.

6. The method of claim 1 wherein the halogenated ether is desflurane.

7. A system for delivering gas to a patient to produce analgesia in the patient comprising:

a) an oxygen source;

b) a reservoir containing analgesia producing gas;

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 mixture of oxygen and analgesia producing gas, the manifold controlling the proportions of oxygen and analgesia producing gas in the mixture such that the mixture comprises a ratio of oxygen tp analgesia producing gas effective for producing analgesia in a patient; and

d) means for conveying the mixture from the output of the delivery manifold to a patient.

10. The gas delivery system of claim 7, further including heating means operatively associated with the reservoir containing analgesia producing gas and ambient temperature sensing means in controlling relation to the heating means to provide compensation for changes in environmental temperature conditions.

11. The gas delivery system of claim 7, further including an oxygen flush arrangement operatively coupled between the oxygen source and a patient.

12. The gas delivery system of claim 7 wherein the oxygen source comprises a cylinder.

13. The gas delivery system of claim 7 wherein the gas reservoir comprises a cylinder.

14. The gas delivery system of claim 7 wherein the gas reservoir has a mated index.

15. The gas delivery system of claim 7 wherein the pressure regulator is digital.

16. The gas delivery system of claim 7 wherein the pressure regulator is analog.

17. The gas delivery system of claim 7 wherein a gas scavenging system is provided.

8. The gas delivery system of claim 8, 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.

9. The gas delivery system of claim 9, 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 analgesia producing gas.

18. A drug delivery system for producing analgesia in a patient and characterized by means for providing safe and effective use of vaporized halogenated ethers for conscious sedation.

19. The use of halothane in the delivery system of claim 18 as an inhaled analgesic for conscious sedation.

20. The use of enflurane in the delivery system of claim 18 as an inhaled analgesic for conscious sedation.

21. The use of isoflurane in the delivery system of claim 18 as an inhaled analgesic for conscious sedation.

22. The use of sevoflurane in the delivery system of claim 18 as an inhaled analgesic for conscious sedation.

23. The use of desflurane in the delivery system of claim 18 as an inhaled analgesic for conscious sedation.

28. A drug delivery system according to claim 18 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.

29. A drug delivery system according to claim 18 with scavenging of exhaled patient gases.

30. A drug delivery system according to claim 18 without scavenging of exhaled patient gases.

31. A drug delivery system according to claim 28 with scavenging of exhaled patient gases.

32. A drug delivery system according to claim 28 without scavenging of exhaled patient gases.

35. A drug delivery system according to claims 18 or 28 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.

36. A drug delivery system according to claims 18 or 28 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.

37. A drug delivery system according to claims 18 or 28 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.

24. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and characterized by an increased delivered oxygen concentration for use with patients having poor myocardial or cerebral oxygenation or coronary artery disease.

25. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and characterized by 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.

26. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and characterized by MR-safety (1.5 telsa) so as to reduce anxiety related to procedure, claustrophobia or mental incapacitation and so as to provide pain relief to patients facing prolonged periods of inactivity such as during nuclear magnetic resonance (MRI).

27. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane 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.

33. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and operating with scavenging of exhaled patient gases.

34. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and operating without scavenging of exhaled patient gases.

38. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane 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.

39. A drug delivery system utilizing halogenated ether and selected from the group consisting of halothane, enflurane, isoflurane, sevoflurane and desflurane and characterized by 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.

40. A therapeutic drug delivery method utilizing agents selected from the group consisting of:

halothane, enflurane, isoflurane, sevoflurane and desflurane characterized by an increased delivered oxygen concentration for use with patients having poor myocardial or cerebral oxygenation or coronary artery disease.

41. A therapeutic drug delivery method utilizing agents selected from the group consisting of:

halothane, enflurane, isoflurane, sevoflurane and desflurane characterized by 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.

42. A therapeutic drug delivery method utilizing agents selected from the group consisting of:

halothane, enflurane, isoflurane, sevoflurane and desflurane further characterized by MR-safety (1.5 telsa) so as to reduce anxiety related to procedure, claustrophobia or mental incapacitation and so as to provide pain relief to patients facing prolonged periods of inactivity such as during nuclear magnetic resonance (MRI).

43. A therapeutic drug delivery method utilizing agents selected from the group consisting of:

halothane, enflurane, isoflurane, sevoflurane and desflurane 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.