Pulmonary dosing system and method

• US 6,805,118 B2
• Filed: 08/02/2001
• Issued: 10/19/2004
• Est. Priority Date: 03/05/1998
• Status: Expired due to Fees

• Current Assignee: Zivena, Inc.
• Original Assignee: Zivena, Inc.
• Inventors: Kotnik, Paul T., Mosholder, Michael B., Brooker, Michael J., Placke, Michael E., Frye, John E., Zimlich, William C. Jr.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): Ragonese, Andrea M.
• Application Number:
  US09/921,331
• Publication Number:
  US 20020026940A1
• Time in Patent Office: 1,174 Days
• Field of Search: 128/200.14, 128/200.16, 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, 128/909
• 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 capable of normal 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 the atmosphere;

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 means for pulsing air to entrain said therapeutically active material in a cycle which is triggered by and is synchronous with said patient'"'"'s unassisted exhalations, for inhalation in conjunction with patient'"'"'s natural breathing;

said pulmonary dosing system designed solely for use independent of a respirator or ventilator.

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 which does not include a connection for hookup with a respirator or ventilator.

8. The pulmonary dosing system claimed in claim 1 wherein said pulsing means permits at least one exhalation between air pulses.

9. The pulmonary dosing system claimed in claim 8 wherein said respirable therapeutically active material comprises at least one toxic drug.

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

1 to about 3;

1.

11. The pulmonary dosing system claimed in claim 10 wherein the inspired volume of each breath has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

12. A pulmonary dosing system for supplying to a patient capable of normal 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 the atmosphere;

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 which is triggered by and is synchronous with said patient'"'"'s unassisted exhalations, for inhalation in conjunction with patient'"'"'s natural breathing;

said pulmonary dosing system designed solely for use independent of a respirator or ventilator.

13. The pulmonary dosing system claimed in claim 12 wherein said respirable therapeutically active material comprises a single respirable drug or a mixture of at least two respirable drugs.

14. The pulmonary dosing system claimed in claim 12 wherein said active material comprises at least one toxic drug.

15. The pulmonary dosing system claimed in claim 12 wherein said patient is chosen from the class consisting of a human patient and an animal patient.

16. The pulmonary dosing system claimed in claim 12 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.

17. 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.

18. The pulmonary dosing system claimed in claim 12 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 12 wherein said control unit is programmed to initiate an air pulse during each patient exhalation.

20. The pulmonary dosing system claimed in claim 12 wherein said control unit is programmed to provide air pulses such that there is at least one exhalation of said patient between consecutive air pulses.

21. The pulmonary dosing system claimed in claim 12 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 apparatus for providing pulsed amounts of aerosolizable drug, said housing containing a vacuum pump connected to a filter to provide said negative pressure in containment case holding said pulmonary dosing system, computer having on and off outputs to said compressor and said vacuum pump, said computer having inputs from said pressure sensor, 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.

22. The pulmonary dosing system claimed in claim 12 wherein said apparatus for providing pulsed amounts of aerosolized material permits at least one exhaltation between air pulses.

23. The pulmonary dosing system according to claim 12 wherein said therapeutically active material comprises at least one toxic drug.

24. The pulmonary dosing system claimed in claims 12 wherein said apparatus for providing pulsed amounts of said therapeutically active material comprises a plenum for holding said material in aerosolized form for inhalation by a patient, an aerosol producing device for delivering aerosolized material to said plenum, a control unit for signaling said aerosol producing device to deliver a selected volume of said aerosolized material to said plenum, said delivered aerosolized material comprising the first part of the inspired volume of the patient'"'"'s inhalation following said pulse, a source of air for delivering a volume of air making up the latter part of said inspired volume, whereby said air helps to force said volume of aerosolized material deep into the patient'"'"'s lungs.

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 3;

1.

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

1 to about 3;

1.

27. The pulmonary dosing system claimed in claim 26 wherein the inspired volume of each breath has an air to drug aerosol ratio of from about 1:

1 to about 2;

1.

28. A pulmonary dosing system for delivering a drug to the lungs of a patient wherein the patient is capable of breathing without mechanical assistance and has an established unassisted breathing cycle comprising an inhalation phase during which a normal inspired volume of gas is inhaled and an exhalation phase during which a normal volume of 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; 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 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 unassisted inhalation by the patient into the lungs in conjunction with the patient'"'"'s natural breathing;

said pulmonary dosing system designed solely for use independent of a respirator or ventilator.

29. The pulmonary dosing system claimed in claim 28 wherein said control unit is programmed to initiate an air pulse during each patient exhalation.

30. The pulmonary dosing system claimed in claim 28 wherein said control unit is programmed to provide air pulses such that there is at least one exhalation of said patient between consecutive air pulses.

31. The pulmonary dosing system claimed in claim 28 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.

32. The pulmonary dosing system claimed in claim 31 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.

33. A method of delivering a drug to the lungs of a patient comprising administering said drug to a patient capable of normal breathing without mechanical assistance and having an established unassisted breathing cycle, wherein said administration includes an inhalation phase during which a normal inspired volume of gas is inhaled and an exhalation phase during which a normal volume of gas is exhaled, comprising the steps of aerosolized 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 for inhalation by the patient into the lungs in conjunction with the patient'"'"'s natural unassisted breathing; and

wherein said method is not practiced in conjunction with a respirator or ventilator.

34. The method for delivering a drug as claimed in claim 33 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.

35. The method for delivering a drug as claimed in claim 33 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.

36. The method for delivering a drug as claimed in claim 33 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.

37. The method of delivering a drug as claimed in claim 33 including 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 introduced into said plenum, and providing a control unit for pulsing said air entrained drug in a cycle synchronous with said patient'"'"'s exhalations.

38. The method for delivering a drug as claimed in claim 33 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.

39. The method for delivering a drug as claimed in claim 33 wherein said apparatus to aerosolize said drug comprises a nebulizer.

40. The method for delivering a drug as claimed in claim 33 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.

41. The method for delivering a drug as claimed in claim 33 including the step of programming said control unit to initiate a pulse during each patient'"'"'s exhalation.

42. The method for delivering a drug as claimed in claim 33 including the step of programming said control unit to provide at least one exhalation between pulses.

43. The method for delivering a drug as claimed in claim 33 wherein said drug comprises at least one toxic drug.

44. The method for delivering a drug as claimed in claim 33 wherein said patient is chosen from the class consisting of a human patient and an animal patient.

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

1 to about 3;

1.

46. The method for delivering a drug as claimed in claim 45 wherein the inspired volume of each breath has an air to drug aerosol volume ratio of from about 1:

1 to about 2;

1.

47. The method for delivering a drug as claimed in claim 33 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.

48. The method for delivering a drug as claimed in claim 47 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.