Pulmonary dosing system and method

• US 6,269,810 B1
• Filed: 03/05/1999
• Issued: 08/07/2001
• Est. Priority Date: 03/05/1998
• Status: Expired due to Fees

• Current Assignee: Zivena, Inc.
• Original Assignee: Battelle Memorial Institute
• Inventors: Kotnik, Paul T., Mosholder, Michael B., Zimlich, William C. Jr., Brooker, Michael J., Placke, Michael E., Frye, John E.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): WEISS JR, JOSEPH
• Application Number:
  US09/263,986
• Time in Patent Office: 886 Days
• Field of Search: 128/200.14, 128/200.18, 128/200.21, 128/200.22, 128/203.12, 128/203.18, 128/203.24, 128/203.25, 128/203.29, 128/205.12, 128/200.16, 128/909
• US Class Current: 128/203.12
• 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 15/008 Electronic counters
• 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. The system comprises a patient interface to introduce the material into the patient'"'"'s lungs. The patient interface is connected to a flexible inhalation tube and a flexible exhalation tube. The exhalation tube is connected to a filter having an outlet connected to atmosphere. The inhalation tube is connected to an apparatus for providing pulsed amounts of the material entrained in filtered atmospheric air. A control unit operates the pulmonary dosing system in accordance with operator inputs regarding the number of patent exhales between pulses, and pulse length. The exhaust filter and the apparatus for providing pulsed amounts of the therapeutically active material may be enclosed in a containment case and the patient'"'"'s interface may comprise a mouth tube-mask combination when the therapeutically active material comprises at least one toxic drug.

Claims

1. A pulmonary dosing system for supplying to a patient breathing without mechanical assistance a predetermined amount of respirable therapeutically active material, said system comprising a patient interface connected to a flexible inhalation tube and a flexible 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, said inhalation tube being connected to said apparatus 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.

2. The pulmonary dosing system claimed in claim 1 wherein said respirable therapeutically active material comprises a single respirable drug or a mixture of at least two respirable drugs.

3. The pulmonary dosing system claimed in claim 1 wherein said active material comprises at least one toxic drug.

4. The pulmonary dosing system claimed in claim 1 wherein said patient is chosen from the class consisting of a human patient and an animal patient.

5. The pulmonary dosing system claimed in claim 1 wherein said patient interface is chosen from the class consisting of a mouthpiece, a mask, a combined mask and mouthpiece, a trachea tube, a nasal tube, a tent and a small room.

6. The pulmonary dosing system claimed in claim 1 wherein said patient interface comprises a mask covering the patient'"'"'s mouth and nose area, a mouthpiece located within said mask and extending therethrough in sealed fashion, said mouthpiece being operatively connected to said inhalation tube and said exhalation tube, said mask also having a connection therein and therethrough to a filter to capture any therapeutically active material should the patient cough.

7. The pulmonary dosing system claimed in claim 1 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, a plenum chamber having an inlet and an outlet, 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.

8. The pulmonary dosing system claimed in claim 7 including a containment case having a body and a lid which are sealed together when said lid is closed, said exhalation tube being connected to a first fitting extending in sealed fashion through a wall of said containment case, said fitting being operatively connected to said inlet of said first filter, said outlet of said first filter being connected to an outlet port to atmosphere passing in sealed fashion through a wall of said containment case, said inhalation tube being connected to a second fitting extending in sealed fashion through a wall of said containment case, said second fitting being operatively connected to said apparatus for providing pulsed amounts of said therapeutically active material, a source of pulsed air from said control unit being operatively connected to said apparatus through a wall of said containment case in sealed fashion, a source of vacuum from said control unit being connected through a wall of said containment case in sealed fashion to a second filter whereby to maintain a negative pressure within said containment case, a port formed in a wall of said containment case, said port being connected to said apparatus for providing pulsed amounts of said therapeutically active material in sealed fashion to supply said apparatus with ambient air, a sensor in association with said vacuum filter providing a signal to said control unit indicating the absence of a vacuum within the containment case.

9. The pulmonary dosing system claimed in claim 8 including a first sensor associated with said exhalation tube, said sensor providing an output signal to said control unit at some point during each exhalation of the patient.

10. The pulmonary dosing system claimed in claim 9 including a third sensor associated with said second filter, said third sensor having an output signed to said control unit indicating the absence of a vacuum in said containment case.

11. The pulmonary dosing system claimed in claim 10 wherein said control unit comprises a housing containing a compressor, said compressor having an outlet connected to a pressure regulator, said pressure regulator being connected to a pulse generating valve, said pulse generating valve being connected to a pressure sensing safety switch and to said nebulizer, said housing containing a vacuum pump connected to said third filter to provide said negative pressure in said containment case, said computer having on and off outputs to said compressor and said vacuum pump, said computer having inputs from said first and second sensors, a keypad comprising an interface between said operator and said computer, and comprises the means by which the operator sets the number of patient exhales between pulses and the pulse duration, a liquid crystal display comprising an interface between said computer and said operator and patient, a remote on/pause switch comprising an operator/patient interface with said computer, said computer being configured to control said pulmonary dosing unit within the parameters input by said operator.

12. The pulmonary dosing system claimed in claim 11 wherein said drug is at least one toxic drug.

13. The pulmonary dosing system claimed in claim 12 wherein said patient interface comprises a mask covering the patient'"'"'s mouth and nose area, a mouthpiece located within said mask and extending therethrough in sealed fashion, said mouthpiece being operatively connected to said inhalation tube and said exhalation tube, said mask also having a connection therein and therethrough to a filter to capture any therapeutically active material should the patient cough.

14. The pulmonary dosing system claimed in claim 1 including a first sensor having an output to said control unit during some portion of the exhalation of the patient.

15. The pulmonary dosing system claimed in claim 1 including a containment case having a body and a lid which are sealed together when said lid is closed, said exhalation tube being connected to a first fitting extending in sealed fashion through a wall of said containment case, said fitting being operatively connected to said inlet of said first filter, said outlet of said first filter being connected to an outlet port to atmosphere passing in sealed fashion through a wall of said containment case, said inhalation tube being connected to a second fitting extending in sealed fashion through a wall of said containment case, said second fitting being operatively connected to said apparatus for providing pulsed amounts of said therapeutically active material, a source of pulsed air from said control unit being operatively connected to said apparatus through a wall of said containment case in sealed fashion, a source of vacuum from said control unit being connected through a wall of said containment case in sealed fashion to a second filter whereby to maintain a negative pressure within said containment case, a port formed in a wall of said containment case, said port being connected to said apparatus for providing pulsed amounts of said therapeutically active material in sealed fashion to supply said apparatus with ambient air, a sensor in association with said second filter providing a signal to said control unit indicating the absence of a vacuum within the containment case.

16. The pulmonary dosing system claimed in claim 1 wherein said control unit comprises a housing containing a compressor, said compressor having an outlet connected to a pressure regulator, said pressure regulator being connected to a pulse generating valve, said pulse generating valve being connected both to a pressure sensing safety switch and to said apparatus for providing pulsed amounts of said therapeutically active material, said control unit further comprising a keypad interface, a liquid crystal display interface, a connection to ordinary current, a main on/off switch, a remote on/pause switch and a computer which, in accordance with operator input, determines the number of patent exhalations between pulses and the pulse length.

17. The pulmonary dosing system claimed in claim 1 wherein said control unit is programmed to initiate an air pulse during each patient exhalation.

18. The pulmonary dosing system claimed in claim 17 wherein the inspired volume of each breath has an air to drug aerosol volume ratio of from about 1:

1 to about 3;

1.

19. The pulmonary dosing system claimed in claim 17 wherein the inspired volume of each breath has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

20. The pulmonary dosing system claimed in claim 1 wherein said control unit is programmed to provide air pulses timed such that there is at least one exhalation of said patient between consecutive air pulses.

21. The pulmonary dosing system claimed in claim 20 wherein the inspired volume of the first breath after an air pulse has an air to drug aerosol ratio of from about 1:

1 to about 3;

1.

22. The pulmonary dosing system claimed in claim 20 wherein the inspired volume of the first breath after an air pulse has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

23. 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 plenum for holding aerosolized drug for inhalation as the first part of the inspired volume of gas for the inhalation phase, an aerosol-producing device for delivering aerosolized drug to the plenum, 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, 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 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.

24. The pulmonary dosing system claimed in claim 23 wherein the inspired volume of the first breath after an air pulse has an air to drug aerosol ratio of from about 1:

1 to about 3;

1.

25. The pulmonary dosing system claimed in claim 24 wherein the inspired volume of the first breath after an air pulse has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

26. The pulmonary dosing system claimed in claim 23 wherein said control unit is programmed to initiate an air pulse during each patient exhalation.

27. The pulmonary dosing system claimed in claim 23 wherein said control unit is programmed to provide air pulses timed such that there is at least one exhalation of said patient between consecutive air pulses.

28. A method 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, 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;

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, said method further comprising the steps of providing a patient interface, connecting said patient interface to a flexible inhalation tube and a flexible exhalation tube, providing a check valve in said exhalation tube to prevent inhalation therethrough, providing a first filter, connecting the inlet of said filter to said exhalation tube and the outlet of said filter to atmosphere, providing an apparatus to aerosolize said selected volume of drug and deliver said aerosolized drug to said plenum, providing a second filter with an inlet connected to ambient air and an outlet having a check valve through which said volume of air is introduced into said plenum, and providing a control unit for pulsing said air entrained drug in a cycle synchronous with said patient'"'"'s exhalations.

29. The method for delivering a drug as claimed in claim 28 which further comprises the step of generating a signal related to the exhalation phase of the patient'"'"'s breathing cycle;

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 in response to the generated signal.

30. The method for delivering a drug as claimed in claim 28 which further comprises delivering a volume of drug aerosol to the plenum equal to about ¼

to ½

of the patient'"'"'s inspired volume of inhaled gas.

31. The method for delivering a drug as claimed in claim 28 which further comprises the step of delivering a volume of drug aerosol to the plenum equal to about ⅓

of the patient'"'"'s inspired volume of inhaled gas.

32. The method for delivering a drug as claimed in claim 28 wherein the inspired volume of each breath has an air to drug aerosol volume ratio of from about 1:

1 to about 3;

1.

33. The method for delivering a drug as claimed in claim 28 wherein the inspired volume of each breath has an air to drug aerosol volume ratio of from about 1:

1 to about 2;

1.

34. The method for delivering a drug as claimed in claim 28 wherein the inspired volume of the first breath after each delivery of drug and air to the plenum has an air to drug aerosol volume ratio of from about 1:

1 to about 3;

1.

35. The method for delivering a drug as claimed in claim 28 wherein the inspired volume of the first breath after each delivery of drug and air to the plenum has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

36. The method for delivering a drug as claimed in claim 28 including the step of providing said patient interface in the form of a mask covering the patient'"'"'s mouth and nose area, providing a mouth piece within and extending through said mask and being connected to said inhalation and exhalation tubes, and providing said mask with a connection to a filter to capture any of said drug should the patient cough.

37. The method for delivering a drug as claimed in claim 30 wherein said apparatus to aerosolize said drug comprises a nebulizer.

38. The method for delivering a drug as claimed in claim 30 including the step of providing a sealable containment case, and locating said first and second filters, said plenum and said aerosolizing apparatus within said containment case.

39. The method for delivering a drug as claimed in claim 30 including the step of programming said control unit to initiate a pulse during each patient'"'"'s exhalation.

40. The method for delivering a drug as claimed in claim 30 including the step of programming said control unit to provide at least one exhalation between pulses.

41. The method for delivering a drug as claimed in claim 30 wherein said drug comprises at least one toxic drug.

42. The method for delivering a drug as claimed in claim 30 wherein said patient is chosen from the class consisting of a human patient and an animal patient.