Claims
- 1. A medical device for using heliox gas to deliver a drug to the lungs of a patient in need thereof comprising:
an aerosolization subassembly which comprises:
a gas inlet for connection to a first heliox gas source, a drug reservoir for containing a drug to be administered, an atomization means for forming an aerosol of particles or droplets dispersed in a heliox driving gas received from the first heliox gas source, wherein the particles or droplets comprise the drug, and a discharge outlet for discharging the aerosol; a gas mask which can be secured over a patient's mouth and nose, the gas mask comprising a source gas aperture; a secondary gas inlet for connection to a second heliox gas source; and a branched conduit means which comprises a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in communication with the discharge outlet of the aerosolization subassembly, the second inlet port is in communication with the secondary gas inlet, and the outlet port is in communication with the source gas aperture of the gas mask; wherein the device is operable as a closed system to prevent dilution of the aerosol with ambient air before and during inhalation of the aerosol by the patient.
- 2. The device of claim 1, further comprising a reservoir bag in communication with the second inlet port of the branched conduit means.
- 3. The device of claim 1, further comprising a source of compressed heliox gas connected to the gas inlet of the aerosolization subassembly.
- 4. The device of claim 3, wherein the source of compressed heliox gas is also connected to the secondary gas inlet.
- 5. The device of claim 4, wherein the source of compressed heliox gas comprises a tank coupled to a single regulator valve having two discharge outlets.
- 6. The device of claim 5, wherein the single regulator valve provides identical flow rates of heliox through each of the two discharge outlets.
- 7. The device of claim 1, wherein the aerosolization subassembly comprises a jet nebulizer or pneumatic nebulizer.
- 8. The device of claim 1, wherein the aerosolization subassembly comprises an ultrasonic nebulizer.
- 9. The device of claim 1, wherein the aerosolization subassembly comprises an electrostatic nebulizer.
- 10. The device of claim 1, wherein the aerosolization subassembly is adapted for dry powder drug delivery.
- 11. The device of claim 10, wherein the drug reservoir comprises a blister or pouch containing a dose of the drug.
- 12. The device of claim 1, wherein the gas mask further comprises an exhalation port which comprises a one-way valve to allow exhaled gases to be expelled from the gas mask.
- 13. The device of claim 1, wherein the first inlet port of the branched conduit means is co-axial with the outlet port of the branched conduit means.
- 14. The device of claim 13, wherein the branched conduit means comprises a T-shaped conduit connector.
- 15. The device of claim 1, wherein the branched conduit means comprises a Y-shaped conduit connector.
- 16. The device of claim 1, wherein the branched conduit comprises a parallel Y-shaped conduit connector.
- 17. The device of claim 1, further comprising a one-way valve positioned between the branched conduit means and the secondary gas inlet, the one-way valve being operable to prevent the aerosol from flowing out through the secondary gas inlet.
- 18. The device of claim 1, which produces an aerosol wherein greater than 55 wt % of the drug is in the form of particles having an aerodynamic diameter of greater than or equal to 0.7 micron and less than 5.8 micron.
- 19. A method for the pulmonary administration of a drug to a patient in need thereof comprising:
providing a medical device which comprises an aerosolization means, a conduit means, a gas mask, and at least one source of heliox gas, wherein the medical device is operable as a closed system to prevent entrainment of ambient air into an aerosol produced within said medical device; providing a dose of a drug in a liquid or dry powder form; using the aerosolization means to form an aerosol of particles or droplets dispersed in a first portion of heliox gas flowing at a first flow rate, wherein said particles or droplet comprise the drug and said first portion of heliox gas is from said at least one source of heliox gas; and flowing the aerosol through the conduit means and into the gas mask which is secured over a patient's mouth and nose in a manner for the patient to inhale the aerosol without dilution of the aerosol with ambient air before and during inhalation of the aerosol by the patient.
- 20. The method of claim 19, further comprising simultaneously introducing a second heliox portion into the conduit means or into the gas mask at a second flow rate.
- 21. The method of claim 20, wherein said conduit means, said gas mask, or both are in fluid communication with a reservoir bag.
- 22. The method of claim 21, wherein the conduit means comprises a branched conduit which comprises a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in communication with a discharge outlet from an aerosolization subassembly comprising the aerosolization means, the second inlet port is in communication with the reservoir bag, the outlet port is in communication with a source gas aperture in the gas mask.
- 23. The method of claim 20, wherein the first and second heliox portions together comprise between about 50 and 85 vol. % helium.
- 24. The method of claim 23, wherein the first and second heliox portions together comprise between about 60 and 85 vol. % helium.
- 25. The method of claim 24, wherein the first and second heliox portions together comprise between 70 and 80 vol. % helium.
- 26. The method of claim 20, wherein the first and second heliox portions together comprise 80 vol. % helium.
- 27. The method of claim 20, wherein the first and second heliox portions each comprises 80 vol. % helium.
- 28. The method of claim 19, wherein the first flow rate is between 6 and 30 liters per minute.
- 29. The method of claim 28, wherein the first flow rate is between 15 and 20 liters per minute.
- 30. The method of claim 20, wherein the second flow rate is between 6 and 30 liters per minute.
- 31. The method of claim 30, wherein the second flow rate is between 15 and 20 liters per minute.
- 32. The method of claim 20, wherein the first flow rate and the second flow rate each are about 18 liters per minute.
- 33. The method of claim 20, wherein the combined flow rate of the first and second heliox portions provided to the medical device is between 6 and 60 liters per minute.
- 34. The method of claim 33, wherein the combined flow rate of the first and second heliox portions provided to the medical device is between 25 and 45 liters per minute.
- 35. The method of claim 34, wherein the combined flow rate of the first and second heliox portions provided to the medical device is between 30 and 40 liters per minute.
- 36. The method of claim 35, wherein the combined flow rate of the first and second heliox portions provided to the medical device is about 36 liters per minute.
- 37. The method of claim 19, wherein the aerosolization means comprises a jet nebulizer or pneumatic nebulizer.
- 38. The method of claim 19, wherein the drug is in a dry powder form.
- 39. The method of claim 19, wherein the drug comprises a monoclonal antibody.
- 40. The method of claim 19, wherein the drug comprises a protein or peptide.
- 41. The method of claim 19, wherein the drug is selected from the group consisting of bronchodilators, anti-inflammatory agents, antibiotics, antineoplastic, and combinations thereof.
- 42. The method of claim 19, wherein the amount of drug provided and the manner of operation of the aerosolization means are effective to delivery the drug over a period between 1 and 30 minutes.
- 43. The method of claim 20, wherein the aerosolization means comprises a jet nebulizer or pneumatic nebulizer, the first and second heliox portions together comprise 80 vol. % helium, and the combined flow rate of the first and second heliox portions provided to the medical device is between 30 and 40 liters per minute.
- 44. The method of claim 19, wherein, following aerosolization of the dose, greater than 55 wt % of the drug is in the form of particles having a diameter of greater than or equal to 0.7 micron and less than 5.8 micron.
- 45. A method of treating a patient suffering from acute partial upper airway obstruction and/or inflammation comprising:
providing a medical device which comprises an aerosolization means, a conduit means, a gas mask, and at least one source of heliox gas, wherein the medical device is operable as a closed system to prevent entrainment of ambient air into an aerosol produced within said medical device; providing a dose of a drug in a liquid or dry powder form, said drug including a bronchodilator, an anti-inflammatory agent, or both; using the aerosolization means of the medical device to form an aerosol of particles or droplets dispersed in heliox gas from said at least one source of heliox, wherein said particles or droplet comprise said drug; and flowing the aerosol through the conduit means and into the gas mask which is secured over a patient's mouth and nose in a manner for the patient to inhale the aerosol.
- 46. The method of claim 45, wherein the helium concentration in the aerosol inhaled by the patient is between 60 and 85 vol. %.
- 47. The method of claim 45, wherein the helium concentration in the aerosol inhaled by the patient is 80 vol. %.
- 48. The method of claim 45, wherein the drug is a bronchodilator which comprises an alpha agonist, a beta agonist, or a racemic mixture thereof.
- 49. The method of claim 48, wherein the bronchodilator comprises a beta agonist selected from the group consisting of albuterol, formoterol, salmeterol, pirbuterol, metaproterenol, terbutaline, and bitolterol mesylate.
- 50. The method of claim 48, wherein the bronchodilator comprises a racemic mixture of epinephrine.
- 51. The method of claim 45, wherein the drug is a bronchodilator which comprises an anticholinergic.
- 52. The method of claim 51, wherein the anticholinergic comprises ipratropium bromide.
- 53. The method of claim 45, wherein the drug is an anti-inflammatory agent selected from the group consisting of steroids, cromolyn, nedocromil, and leukotriene inhibitors.
- 54. The method of claim 53, wherein the anti-inflammatory agent comprises a corticosteroid.
- 55. The method of claim 54, wherein the corticosteroid is selected from the group consisting of beclomethasone, betamethasone, ciclomethasone, dexamethasone, triamcinolone, budesonide, butixocort, ciclesonide, fluticasone, flunisolide, icomethasone, mometasone, tixocortol, loteprednol, budesonide, fluticasone propionate, beclomethasone dipropionate, mometasone, fometerol, flunisolide, triamcinolone acetonide, testosterone, progesterone, and estradiol.
- 56. The method of claim 45, wherein the drug is provided in a liquid form and the aerosolization means comprises a nebulizer.
- 57. The method of claim 19, wherein the drug is tobramycin.
- 58. The method of claim 19, wherein the drug is doxorubicin.
- 59. A medical device for using heliox gas to deliver a drug to the lungs of a patient in need thereof comprising:
an aerosolization subassembly which comprises:
a gas inlet for connection to a heliox gas source, a drug reservoir for containing a drug to be administered, an atomization means for forming an aerosol of particles or droplets dispersed in a heliox driving gas received from the heliox gas source, wherein the particles or droplets comprise the drug, and a discharge outlet for discharging the aerosol; a gas mask which can be secured over a patient's mouth and nose, the gas mask comprising a source gas aperture; a reservoir bag comprising an inlet in communication with the discharge outlet of the aerosolization subassembly and an outlet in communication with the source gas aperture of the gas mask; and at least one exhalation port in communication with the gas mask, said one exhalation port comprising a one-way valve, such that the device is operable as a closed system to prevent dilution of the aerosol with ambient air before and during inhalation of the aerosol by the patient.
- 60. A method of treating a patient suffering from acute partial upper airway obstruction and/or inflammation comprising:
providing a medical device which comprises an aerosolization means, a conduit means, and first source of heliox gas, wherein the medical device is operable as a closed system to prevent entrainment of ambient air into an aerosol produced within said medical device; providing a dose of a drug in a liquid or dry powder form; providing a breathing assistance apparatus comprising a breathing tube inserted into the patient's airway, said apparatus delivering heliox from a second source through the breathing tube into the patient's lungs; using the aerosolization means of the medical device to form an aerosol of particles or droplets dispersed in heliox gas from said first source of heliox, wherein said particles or droplet comprise said drug; and flowing the aerosol through the conduit means and into the breathing tube in a manner for the patient to inhale the aerosol with the heliox from the second source.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Priority is claimed under 35 U.S.C. § 119 to U.S. provisional application Serial No. 60/337,609, filed Dec. 5, 2001.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60337609 |
Dec 2001 |
US |