Pulmonary dosing system and method

• US 6,705,316 B2
• Filed: 03/11/2002
• Issued: 03/16/2004
• Est. Priority Date: 03/11/2002
• Status: Expired due to Fees

• Current Assignee: Ventaira Pharmaceuticals Inc. (Battelle Memorial Institute)
• Original Assignee: Ventaira Pharmaceuticals Inc. (Battelle Memorial Institute)
• Inventors: Imondi, Anthony Rocco, Blythe, Kevin Sanford, Meek, Daniel Duane, Ross, Andrew O.
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US10/095,250
• Publication Number:
  US 20030168062A1
• Time in Patent Office: 736 Days
• Field of Search: 128/200.18, 128/203.12, 128/203.14, 128/204.23, 239/504, 239/590, 239/590.5
• US Class Current: 128/204.18
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0088 with variable volume
• 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 16/0093 by adsorption, absorption or filtration
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path

Abstract

A pulmonary dosing system and method for supplying to a patient a predetermined amount of respirable therapeutically active material is disclosed. The system comprises a patient interface to introduce the material into the patient'"'"'s lungs and an apparatus for providing pulsed amounts of the material to a plenum chamber. The plenum chamber has a diffuser baffle which increases the efficiency of the dosing system by preventing axial flow of the active material thereby utilizing the available volume of the chamber for holding the aerosolized drug prior to inhalation.

Claims

1. A pulmonary dosing system for supplying a predetermined amount of a therapeutically active material to a patient, said system comprising:

an apparatus for providing an aerosolized amount of a therapeutically active material said apparatus having an outlet for conveying said aerosolized amount of active material; and

a plenum chamber having an inlet for receiving said aerosolized amount of active material and an outlet for connection to a mouthpiece for delivering said aerosolized amount of active material to a patient, wherein said inlet and said outlet of said plenum chamber and said outlet of said apparatus are oriented along a common axis, and at least one diffuser baffle interposed between said inlet and said outlet of said plenum chamber wherein said diffuser baffle disrupts flow of said aerosolized amount of active material along said common axis in said plenum chamber thereby causing said aerosolized amount of active material to be retained in said chamber until inhaled by the patient.

2. The pulmonary dosing system of claim 1 wherein said aerosolized amount of a therapeutically active material is aerosolized from a solution, suspension or emulsion of said active material.

3. The pulmonary dosing system of claim 2 wherein said apparatus generates a pulsed amount of said active material in aerosolized form.

4. The pulmonary dosing system of claim 3 wherein said pulsed amount of active material is aerosolized in atmospheric air.

5. The pulmonary dosing system of claim 1 wherein said diffuser baffle comprises at least one impact portion which diverts flow of said aerosolized active material and at least one non-impact portion through which said aerosolized active material flows after impacting said impact portion.

6. The pulmonary dosing system of claim 5 wherein said inlet is cylindrical and said impact portion of said diffuser baffle includes at least one cross section perpendicular to said common axis having an area approximately equal to or greater than the cross sectional area of said inlet.

7. The pulmonary dosing system of claim 5 wherein said impact portion of said diffuser baffle comprises a conical portion having an apex proximal said inlet.

8. The pulmonary dosing system of claim 7 wherein said diffuser baffle further comprises a plurality of spokes extending radially from said conical portion.

9. The pulmonary dosing system of claim 1 wherein said plenum chamber comprises a first section including said inlet and a second section including said outlet wherein said diffuser baffle is disposed between said first and second sections of said plenum chamber.

10. The pulmonary dosing system of claim 1 wherein said therapeutic active material comprises a chemotherapy drug.

11. A pulmonary dosing system for supplying to a patient a predetermined amount of respirable therapeutically active material, said system comprising a patient interface connected to an inhalation tube and an exhalation tube, a check valve provided in association with said exhalation tube to prevent inhalation therethrough, a first filter having an inlet and an outlet, said exhalation tube being connected to said inlet of said first filter, said outlet of said first filter being in fluid communication with atmosphere, a second filter having an inlet and an outlet, with the second filter inlet in fluid communication with atmosphere and said second filter outlet having a second check valve to prevent said therapeutically active material from escaping to atmosphere, said second filter outlet being connected to said inhalation tube, an apparatus for providing pulsed amounts of said therapeutically active material aerosolized in filtered atmospheric air, a plenum chamber connected to said apparatus, said plenum chamber comprising an inlet for receiving said pulsed amounts of therapeutically active material aerosolized in filtered air and an outlet for connection to said inhalation tube wherein said inlet and said outlet of said plenum chamber are located on a common axis and said plenum chamber comprises at least one diffuser baffle positioned on said axis whereby said diffuser baffle reduces axial flow of said aerosolized active material from said inlet to said outlet of the plenum chamber, and a control unit for pulsing air to entrain said therapeutically active material in a cycle synchronous with a patient'"'"'s exhalations for inhalation in conjunction with the patient'"'"'s natural breathing.

12. The pulmonary dosing system claimed in claim 11 wherein said active material comprises a chemotherapy drug.

13. The pulmonary dosing system claimed in claim 11 wherein said apparatus for providing pulsed amounts of said therapeutically active material comprises a nebulizer having a first inlet connected to a source of pulsed air from said control unit, said nebulizer having a second inlet for receipt of a predetermined amount of said therapeutically active material, said nebulizer having an outlet, a T-fitting having first and second concentric ports and a third intermediate port, said nebulizer outlet being connected to said first T-fitting port, said plenum chamber inlet being connected to said T-fitting second port, said plenum chamber outlet being connected to said inhalation tube, said second filter being connected to said intermediate port of said T-fitting to supply air to said plenum chamber.

14. The pulmonary dosing system of claim 11 wherein said aerosolized amount of a therapeutically active material is aerosolized from a solution, suspension or emulsion of said active material.

15. The pulmonary dosing system of claim 11 wherein said diffuser baffle comprises at least one impact portion which diverts flow of said aerosolized active material and at least one non-impact portion through which said aerosolized active material flows after impacting said impact portion.

16. The pulmonary dosing system of claim 15 wherein said inlet is cylindrical and said impact portion of said diffuser baffle includes at least one cross section perpendicular to said common axis having an area approximately equal to or greater than the cross sectional area of said plenum chamber inlet.

17. The pulmonary dosing system of claim 15 wherein said impact portion of said diffuser baffle comprises a conical portion having an apex proximal said inlet.

18. The pulmonary dosing system of claim 17 wherein said diffuser baffle further comprises a plurality of spokes extending radially from said conical portion.

19. The pulmonary dosing system of claim 11 wherein said plenum chamber comprises a first section including said inlet and a second section including said outlet wherein said diffuser baffle is disposed between said first and second sections of said plenum chamber.

20. The pulmonary dosing system claimed in claim 17 wherein said therapeutically active material comprises a chemotherapy drug.

21. A pulmonary dosing system for delivering a drug to the lungs of a patient wherein the patient is breathing without mechanical assistance and has an established breathing cycle comprising an inhalation phase during which an inspired volume of gas is inhaled and an exhalation phase during which gas is exhaled, said system comprising:

a) a plenum for holding aerosolized drug for inhalation as the first part of the inspired volume of gas for the inhalation phase, said plenum comprising;

an inlet for receiving an aerosolized drug,

an outlet for connection to a patient interface, and

at least one diffuser baffle, wherein said at least one diffuser baffle is interposed between said inlet and said outlet to divert at least a portion of said aerosolized drug as said aerosolized drug flows from said inlet to said outlet,

b) an aerosol-producing device for delivering aerosolized drug to the plenum,

c) a controller for signaling the aerosol-producing device to deliver a selected volume of drug aerosol to the plenum prior to the inhalation phase of the patient,

d) a source of air for delivering a volume of air which makes up the latter part of the inspired volume of gas for the inhalation phase, said air being drawn into the plenum through a filter with an inlet connected to ambient air and an outlet having a check valve through which said air is introduced into said plenum, and

e) a patient interface for delivering the selected volume of drug aerosol from the plenum and the volume of air to the patient whereby the selected volume of drug aerosol that makes up the first part of the inspired volume of gas and the volume of air makes up the latter part of the inspired volume of gas for the inhalation of the patient directly following said pulse to help push the selected volume of drug aerosol making up the first part, into the lung in conjunction with the patient'"'"'s natural breathing.

22. The pulmonary dosing system claimed in claim 21 wherein said inlet and said outlet of said plenum are oriented along a common axis.

23. The pulmonary dosing system claimed in claim 21 wherein said aerosol-producing device comprises a nebulizer.

24. The pulmonary dosing system claimed in claim 21 wherein said aerosolized drug is aerosolized from a solution, suspension or emulsion of said active material drug.

25. The pulmonary dosing system of claim 21 wherein said diffuser baffle comprises at least one impact portion which diverts flow of said aerosolized active material and at least one non-impact portion through which said aerosolized active material flows after impacting said impact portion.

26. The pulmonary dosing system of claim 25 wherein said inlet is cylindrical and said impact portion of said diffuser baffle includes at least one cross section perpendicular to said common axis having an area approximately equal to or greater than the cross sectional area of said inlet.

27. The pulmonary dosing system of claim 25 wherein said impact portion of said diffuser baffle comprises a conical portion having an apex proximal said inlet.

28. A method for delivering a drug to the lungs of a patient wherein the patient has an established breathing cycle comprising an inhalation phase during which an inspired volume of gas is inhaled and an exhalation phase during which gas is exhaled, comprising the steps of aerosolizing the drug to produce a selected volume of drug aerosol, and delivering the selected volume of drug aerosol to a plenum during the patient exhalation phase, said plenum comprising an inlet for receiving said drug aerosol, an outlet for connection to a patient interface, and a diffuser baffle interposed between said inlet and outlet wherein said inlet and outlet are positioned on a common axis and said diffuser baffle disrupts flow of said drug aerosol along said axis through said plenum.

29. The method of claim 28 comprising the additional steps of delivering the selected volume of drug aerosol from the plenum to the patient as the first part of the inspired volume of gas on the inhalation phase;

and delivering a volume of air which makes up the latter part of the inspired volume of gas on the inhalation phase to help push the selected volume of drug aerosol, making up the first part, into the lung in conjunction with the patient'"'"'s natural breathing.

30. The method for delivering a drug as claimed in claim 28 wherein said diffuser baffle comprises at least one impact portion which diverts flow of said aerosolized active material and at least one non-impact portion through which said aerosolized active material flows after impacting said impact portion.

31. The pulmonary dosing system of claim 30 wherein said inlet is cylindrical and said impact portion of said diffuser baffle includes at least one cross section perpendicular to said common axis having an area approximately equal to or greater than the cross sectional area of said inlet.

32. The pulmonary dosing system of claim 30 wherein said impact portion of said diffuser baffle comprises a conical portion having an apex proximal said inlet.

33. The method for delivering a drug as claimed in claim 28 wherein said drug is aerosolized using a nebulizer.

34. The method for delivering a drug as claimed in claim 28 wherein said drug comprises a chemotherapy drug.

35. A plenum for use in a pulmonary dosing system comprising:

a first section including an inlet, a second section including an outlet and a diffuser, the first section and the second section being assembled to form a chamber in which the inlet and the outlet are oriented along a common axis, and at least one baffle interposed between the first section and the second section on the common axis so as to direct the flow of a gas as it passes from the inlet to the outlet.