Pulmonary aerosol delivery device and method

• US 20020153006A1
• Filed: 06/03/2002
• Published: 10/24/2002
• Est. Priority Date: 12/23/1998
• Status: Active Grant

• Current Assignee: Battelle Memorial Institute
• Original Assignee: Ventaira Pharmaceuticals Inc. (Battelle Memorial Institute)
• Inventors: Peters, Richard D., Dvorsky, James E., Busick, David R., Zimlich, William C. Jr.
• Granted Patent: US 6,796,303 B2
• Time in Patent Office: Days
• US Class Current: 128/200.14
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• 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 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: B05B 5/002 comprising means for neutralising the spray of charged droplets or particules
• CPC Class Codes: B05B 5/0255 spraying and depositing by electrostatic forces only
• CPC Class Codes: B05B 5/1691 Apparatus to be carried on or by a person or with a container fixed to the discharge device

Abstract

A device and method for delivering an aerosolized liquid having therapeutic properties to a user'"'"'s lungs. The compact and convenient device includes a housing of such size that it can be held in a user'"'"'s one hand with an exit opening in the housing for directing the aerosol to the user'"'"'s mouth. The housing encloses a dispensing system for containing the liquid to be aerosolized and delivering it to an electrohydrodynamic apparatus and an electrohydrodynamic apparatus for aerosolizing the liquid and delivering the aerosol to the exit opening. The electrohydrodynamic apparatus produces a cloud of aerosolized liquid droplets having a monodispersed respirable droplet size and near zero velocity. The aerosolizing apparatus includes a plurality of spray sites each having a tip end, the spray sites cooperating with a charge source to result in an aerosolized spray from at least one tip end, a plurality of discharge electrodes downstream of the tip ends, and a plurality of reference electrodes downstream of the plurality of discharge electrodes.

Claims

1. A pulmonary aerosol delivery device, comprising a housing of such size that the housing can be held in a user'"'"'s one hand, the housing having an exit opening for directing an aerosol to a user'"'"'s mouth and including therein:

a dispensing system for containing a liquid to be aerosolized and delivering the liquid to an electrohydrodynamic apparatus;

an electrohydrodynamic apparatus for aerosolizing the liquid and delivering the aerosolized liquid to the exit opening; and

a power supply system for providing sufficient voltage to the electrohydrodynamic apparatus to aerosolize the liquid.

2. The device of claim 1, wherein the power supply system comprises a battery and a DC to DC high voltage converter.

3. The device of claim 2, wherein the device is cordless.

4. The device of claim 1, wherein the liquid comprises a therapeutic agent.

5. The device of claim 4, wherein the dispensing system includes a containment vessel for containing the therapeutic agent.

6. The device of claim 5, wherein the dispensing system delivers a single dose of the therapeutic agent from the containment vessel to the electrohydrodynamic apparatus.

7. The device of claim 4, wherein the dispensing system includes a metering system for delivering a single dose of the therapeutic agent to the electrohydrodynamic apparatus.

8. The device of claim 5, wherein the containment vessel has antimicrobial properties.

9. The device of claim 5, wherein the containment vessel is selected from a holder for a therapeutic agent enclosed in single dose units, a plurality of sealed chambers each holding a single dose of a therapeutic agent, and a vial for enclosing a bulk supply of a therapeutic agent.

10. The device of claim 5, wherein the containment vessel is capable of maintaining the sterility of a sterile therapeutic agent placed therein.

11. The device of claim 1, wherein the electrohydrodynamic apparatus is capable of aerosolizing the liquid at a flow rate of at least about 20 μ

L/sec.

12. The device of claim 1, wherein the electrohydrodynamic apparatus is capable of aerosolizing the liquid into droplets such that at least about 80% of the droplets have a diameter of less than or equal to about 5 microns.

13. The device of claim 1, wherein the device is disposable.

14. The device of claim 1, wherein the device is reusable.

15. The device of claim 1, wherein the housing has antimicrobial properties.

16. The device of claim 1, wherein the exit opening of the housing may be moveable to assist in directing the aerosolized liquid to a user'"'"'s mouth.

20. The method of claim 19, further including the step of:

neutralizing the electrical charge imparted to the aerosolized liquid.

21. The method of claim 19, wherein the electrical actuation step is initiated by a user'"'"'s inhalation of breath.

17. A pulmonary aerosol delivery device, comprising:

a housing of such size that the housing can be held in a user'"'"'s one hand, the housing having an exit opening for directing an aerosol to a user'"'"'s mouth;

a containment vessel holding a liquid to be aerosolized;

an electrohydrodynamic apparatus for aerosolizing the liquid and delivering the aerosolized liquid to the exit opening;

a power supply for providing sufficient voltage to the electrohydrodynamic apparatus to aerosolize the liquid; and

a dispensing system for delivering the liquid to be aerosolized from the containment vessel to the electrohydrodynamic system, the containment vessel, the electrohydrodynamic apparatus, the power supply, and the dispensing system being enclosed within the housing.

18. A pulmonary aerosol delivery device, comprising a housing of such size that the housing can be held in a user'"'"'s one hand, the housing having an exit opening for directing an aerosol to a user'"'"'s mouth and including therein:

a dispensing system for containing a liquid to be aerosolized and delivering the aerosolized liquid to an electrohydrodynamic apparatus;

an electrohydrodynamic apparatus for aerosolizing the liquid and delivering the aerosolized liquid to the exit opening, said electrohydrodynamic device including at least one spray site having a sufficient electric field strength that when a liquid is caused to flow over the spray site, a net electrical charge is imparted to the surface of the flowing liquid, the charge imparted to the liquid surface initially balancing the surface tension of the liquid to cause the liquid to form a cone adjacent to the spray site with the cone tip extending away from the spray site, the charge imparted to the surface eventually overcoming the surface tension of the liquid in the region of the cone tip to generate a thin jet of liquid that breaks into an aerosolized liquid consisting substantially of droplets of respirable size; and

a power supply system for providing sufficient voltage to the electrohydrodynamic apparatus to aerosolize the liquid.

19. A method of orally administering an aerosolized liquid therapeutic agent, comprising the steps of:

storing a liquid therapeutic agent in a containment vessel;

dispensing the liquid from the containment vessel to an electrohydrodynamic apparatus including at least one spray site;

electrically actuating the electrohydrodynamic apparatus to impart a net electrical charge to the surface of the liquid flowing over a spray site sufficient to cause the liquid to be aerosolized;

metering a desired amount of liquid to be dispensed from the containment vessel to the electrohydrodynamic apparatus; and

.

enclosing the containment vessel and electrohydrodynamic apparatus within a cordless housing of such size that the housing can be held in a user'"'"'s one hand, the housing including an exit opening for directing the aerosolized liquid to a user'"'"'s mouth.

22. A method of orally administering an aerosolized liquid therapeutic agent, comprising the steps of:

storing a liquid therapeutic agent in a containment vessel;

metering a desired amount of liquid to be dispensed from the containment vessel to an electrohydrodynamic apparatus including at least one spray site;

dispensing the liquid from the containment vessel to the electrohydrodynamic apparatus;

causing the dispensed liquid to flow over at least one spray site;

electrically actuating the electrohydrodynamic apparatus to impart a net electrical charge to the surface of the liquid flowing over a spray site sufficient to cause the liquid to be aerosolized;

treating the aerosolized liquid to modify an electrical charge imparted to the aerosolized liquid by the electrohydrodynamic apparatus; and

enclosing the containment vessel and electrohydrodynamic apparatus within a cordless housing of such size that the housing can be held in a user'"'"'s one hand, the housing including an exit opening for directing the treated aerosolized liquid to a user'"'"'s mouth.

23. The method of claim 22, wherein the electrical actuation step is initiated by a user'"'"'s inhalation of breath.

26. The apparatus of claim 25, further comprising:

a charge source for charging the plurality of spray sites sufficiently to result in an electrohydrodynamic spray from a least one tip end.

27. The apparatus of claim 25, wherein the plurality of discharge electrodes and the plurality of reference electrodes are oriented toward the aerosolized spray.

28. The apparatus of claim 27, wherein the plurality of discharge electrodes and the plurality of reference electrodes are oriented radially toward an axis defined by the base end and tip end of one of the plurality of spray sites.

29. The apparatus of claim 28, wherein the plurality of discharge electrodes are spaced equidistant from one another and the plurality of reference electrodes are located in the interstices between the discharge electrodes.

30. The apparatus of claim 29, further comprising:

a dielectric material between the plurality of discharge electrodes and the plurality of reference electrodes.

31. The apparatus of claim 30, wherein the reference electrodes extend through slots provided in the dielectric material.

32. The apparatus of claim 25, wherein at least one of the plurality of spray sites has a sufficient electric field strength that when a liquid is caused to flow over said spray site, a net electrical charge is imparted to the surface of the liquid flowing over said spray site, the charge imparted to the liquid surface initially balancing the surface tension of the liquid to cause the liquid to form a cone adjacent to the spray site with the cone tip extending away from the spray site, the charge imparted to the surface eventually overcoming the surface tension of the liquid in the region of the cone tip to generate a thin jet of liquid that breaks into an aerosolized liquid consisting substantially of droplets of respirable size.

33. The apparatus of claim 32, wherein at least one of the plurality of discharge electrodes has a sufficient electric field strength to substantially neutralize a charge on the droplets generated by said spray site.

34. The apparatus of claim 25, wherein at least one of the plurality of spray sites has a sufficient electric field strength that when a liquid is caused to flow over said spray site, a net electrical charge is imparted to the surface of the liquid flowing over said spray site, the charge imparted to the liquid surface causing the liquid to form a cone adjacent to the spray site with the cone tip extending away from the spray site and then generate a thin jet of liquid in the region of the cone tip that breaks into an aerosolized liquid consisting substantially of droplets of respirable size.

35. The apparatus of claim 25, wherein the tip ends of the plurality of spray sites are oriented vertically downward from the base.

36. The apparatus of claim 35, wherein the plurality of spray sites are arranged in a generally circular pattern.

37. The apparatus of claim 36, wherein the plurality of spray sites are spaced equidistant from one another.

38. The apparatus of claim 36, wherein the tip end of at least one of the plurality of spray sites is chamfered.

39. The apparatus of claim 36, wherein the exterior of at least one of the plurality of spray sites is coated with a material having a low surface energy.

24. A pulmonary aerosol delivery device, comprising a housing of such size that the housing can be held in a user'"'"'s one hand, the housing having an exit opening for directing an aerosol to a user'"'"'s mouth and including therein:

a dispensing system for containing a liquid to be aerosolized and delivering the aerosolized liquid to an apparatus for aerosolizing the liquid;

an apparatus for aerosolizing the liquid and delivering the aerosolized liquid to the exit opening, the apparatus comprising

a base;

a plurality of spray sites each having a base end connected to the base and a tip end, an electrohydrodynamic spray being formed from at least one tip end when the liquid is caused to flow over the spray sites and the plurality of spray sites is placed in electrical communication with a power source;

a plurality of discharge electrodes connected to the base, the plurality of discharge electrodes being spaced further from the base than the tip ends; and

a plurality of reference electrodes connected to the base, the reference electrodes being spaced further from the base than the discharge electrodes; and

a power supply system for providing sufficient voltage to the aerosolizing apparatus to aerosolize the liquid.

25. An apparatus for aerosolizing a liquid, comprising:

a base;

a plurality of spray sites each having a base end connected to the base and a tip end, an aerosolized spray being formed from at least one tip end when a liquid is caused to flow over the spray sites and the plurality of spray sites is placed in electrical communication with a charge source;

a plurality of discharge electrodes connected to the base, the plurality of discharge electrodes being spaced further from the base than the tip ends; and

a plurality of reference electrodes connected to the base, the reference electrodes being spaced further from the base than the discharge electrodes.

40. An apparatus for aerosolizing a liquid, comprising:

a tubular base having a generally circular cross-section;

a plurality of spray sites each having a base end connected to the base and a tip end extending axially into a first end of the base, an aerosolized spray being formed from at least one tip end when the liquid is caused to flow over the spray sites and the plurality of spray sites is placed in electrical communication with a charge source;

a plurality of discharge electrodes each connected to the interior of the base at a distance further from the first base end than the spray site tip ends; and

a plurality of reference electrodes each connected to the interior of the base at a distance further from the first base end than the plurality of discharge electrodes.

41. The apparatus of claim 40, further comprising:

a charge source for charging the plurality of spray sites sufficiently to result in an electrohydrodynamic spray from at least one tip end.

42. The apparatus of claim 40, wherein the plurality of discharge electrodes and the plurality of reference electrodes are oriented toward the aerosolized spray.

43. The apparatus of claim 40, wherein the plurality of discharge electrodes are located in the area of the tip ends of the plurality of spray sites.

44. The apparatus of claim 40, wherein at least one of the plurality of spray sites has a sufficient electric field strength that when a liquid is caused to flow over said spray site, a net electrical charge is imparted to the surface of the liquid flowing over said spray site, the charge imparted to the liquid surface initially balancing the surface tension of the liquid to cause the liquid to form a cone adjacent to the spray site with the cone tip extending away from the spray site, the charge imparted to the surface eventually overcoming the surface tension of the liquid in the region of the cone tip to generate a thin jet of liquid that breaks into an aerosolized liquid consisting substantially of droplets of respirable size.

45. The apparatus of claim 43, wherein at least one of the plurality of discharge electrodes has a sufficient electric field strength to substantially neutralize a charge on the droplets generated by said spray site.

46. The apparatus of claim 40, wherein the plurality of reference electrodes and the plurality of discharge electrodes extend radially inwardly toward an axis defined by the base end and tip end of one of the plurality of spray sites.

47. The apparatus of claim 46, wherein the plurality of discharge electrodes are spaced equidistant from one another and the plurality of reference electrodes are located in the interstices between the discharge electrodes.

48. The apparatus of claim 40, further comprising:

a dielectric material within the base between the discharge electrodes and the reference electrodes.

49. The apparatus of claim 48, wherein the reference electrodes extend through slots provided in the dielectric material.

50. The apparatus of claim 40, wherein the tip ends of the plurality of spray sites are oriented vertically downward from the base.

51. The apparatus of claim 40, wherein the plurality of spray sites are arranged in a predetermined pattern.

52. The apparatus of claim 51, wherein the plurality of spray sites are arranged in a generally circular pattern.

53. An apparatus for aerosolizing a liquid, comprising:

a base plate having upper and lower surfaces each defining a generally circular perimeter;

a plurality of spray sites arranged in a circular pattern along the perimeter of the lower surface of the base plate, each of the spray sites having a base end mounted to the base plate and a tip end, an aerosolized spray being formed from at least one tip end when a liquid is caused to flow over the spray sites and the plurality of spray sites is placed in electrical communication with a charge source;

a skirt extending downward from the base plate;

a dielectric material enclosed by the skirt;

a plurality of discharge electrodes extending from the skirt at a distance further from the base plate than the spray site tip ends; and

a plurality of reference electrodes each extending from the skirt at a distance further from the base plate than the discharge electrodes.

54. The apparatus of claim 53, wherein the dielectric material is a discrete member provided within the skirt.

55. The apparatus of claim 53, wherein the skirt is comprised of a dielectric material.

56. The apparatus of claim 53, wherein the plurality of reference electrodes are positioned in interstices between the discharge electrodes.

57. The apparatus of claim 53, wherein the plurality of discharge electrodes are spaced equidistant from one another and the plurality of reference electrodes are located in the interstices between the discharge electrodes.

58. The apparatus of claim 57, wherein the reference electrodes extend through slots provided in the dielectric material.

59. The apparatus of claim 53, wherein at least one of the plurality of spray sites has a sufficient electric field strength that when a liquid is caused to flow over said spray site, a net electrical charge is imparted to the surface of the liquid flowing over said spray site, the charge imparted to the liquid surface initially balancing the surface tension of the liquid to cause the liquid to form a cone adjacent to the spray site with the cone tip extending away from the spray site, the charge imparted to the surface eventually overcoming the surface tension of the liquid in the region of the cone tip to generate a thin jet of liquid that breaks into an aerosolized liquid consisting substantially of droplets of respirable size.

60. The apparatus of claim 59, wherein at least one of the plurality of discharge electrodes has a sufficient electric field strength to substantially neutralize a charge on the droplets generated by said spray site.