Pulmonary aerosol delivery device and method

• US 6,397,838 B1
• Filed: 12/21/1999
• Issued: 06/04/2002
• Est. Priority Date: 12/23/1998
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/469,042
• Time in Patent Office: 896 Days
• Field of Search: 128/200.14, 128/200.23, 128/203.12, 128/203.24, 128/200.16, 128/204.25, 239/332, 239/349, 222/636
• 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, the dispensing system including a containment vessel and a metering system for delivering a single dose of the liquid from the containment vessel to an electrohydrodynamic apparatus, the metering system including;

a chamber for collecting a predetermined volume of liquid having an inlet communicating with the containment vessel and outlet communicating with an electrohydrodynamic apparatus;

a chamber housing above the chamber;

a chamber housing spring adjacent to the chamber;

an actuator button accessible through the housing;

a button spring above the chamber housing and in communication with the actuator button, the actuator button exerting downward force against the chamber housing when the actuator button is depressed to force liquid in the chamber through the outlet, the chamber housing spring exerting upward force against the chamber housing when the actuator button is released, the upward travel of the chamber housing inducing a vacuum in the chamber to draw liquid through the chamber inlet, the chamber volume being controlled by an adjustable stop that limits the upward travel of the chamber housing;

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 metering system further includes check valves at the chamber inlet and outlet to provide unidirectional liquid flow.

3. The device of claim 1, wherein the containment vessel has antimicrobial properties.

4. The device of claim 1, wherein the containment vessel is selected from the group comprising a holder for a liquid enclosed in single dose units, a plurality of sealed chambers each holding a single dose of a liquid, and a vial for enclosing a bulk supply of a liquid.

5. The device of claim 1, wherein the containment vessel is capable of maintaining the sterility of a sterile liquid placed therein.

6. 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;

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

a control circuit communicating with the dispensing system, the electrohydrodynamic apparatus, and the power supply system.

7. The device of claim 6, wherein the control circuit includes at least one feature selected from the group comprising an on/off power indicator, a power save mode, and a lockout to prevent use by an unauthorized user.

8. The device of claim 6, wherein the control circuit includes an actuation device for initiating the flow of aerosolized liquid.

9. The device of claim 8, wherein the actuation device comprises a sensor for detecting a user'"'"'s inhalation of breath.

10. The device of claim 9, wherein the sensor cooperates with the electrohydrodynamic apparatus to initiate the flow of aerosolized liquid.

11. The device of claim 10, wherein the sensor is selected from the group comprising a flapper switch, a pressure transducer, an air motion detector, and an air velocity detector.

12. The device of claim 9, wherein the sensor is capable of detecting multiple inhalations of a user'"'"'s breath.

13. The device of claim 8, wherein the actuation device is a manual actuator on the exterior of the housing.

14. The device of claim 6, wherein the housing has antimicrobial properties.

15. The device of claim 6, wherein the exit opening of the housing may be moveable to assist in directing the aerosolized liquid to a user'"'"'s mouth.

16. 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;

a dispensing system for delivering the liquid to be aerosolized from the containment vessel to an electrohydrodynamic system, the dispensing system including a metering system for dispensing a desired amount of the liquid to the electrohydrodynamic apparatus;

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 control circuit communicating with the metering system, the electrohydrodynamic apparatus, and the power supply system;

the containment vessel, dispensing system, electrohydrodynamic apparatus, power supply, and control circuit being enclosed within the housing.

17. The device of claim 16, wherein the electrohydrodynamic apparatus comprises:

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 lower surface of the base plate and a tip end oriented vertically downward from the base plate;

a skirt extending downward from the base plate;

a plurality of discharge electrodes each extending radially inward from the skirt in the area of the spray site tip ends;

a plurality of reference electrodes each extending radially inward from the skirt, the plurality of reference electrodes being spaced further from the base plate than the discharge electrodes; and

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

18. The device of claim 17, wherein the dielectric material is enclosed by the skirt.

19. The device of claim 17, wherein the skirt is comprised of a dielectric material.

20. The device of claim 17, wherein the tip end of at least one of the plurality of spray sites is chamfered.

21. The device of claim 17, wherein the exterior of at least one of the plurality of spray sites is coated with a material having a low surface energy.

22. The device of claim 17, wherein the electrohydrodynamic apparatus further includes a manifold extending between the dispensing system and the base ends of each of the spray sites.

23. The device of claim 16, wherein the control circuit and the metering system cooperate to provide a dose counter.

24. The device of claim 23, wherein the control circuit includes a memory for recording the dose history.

25. The device of claim 23, wherein the control circuit and the metering system cooperate to provide a dose display.

26. The device of claim 25, wherein the information shown in the dose display is selected from the group comprising doses administered and doses remaining.

27. The device of claim 16, wherein the control circuit includes a timer that limits the delivery of the liquid by the metering system.

28. The device of claim 16, wherein the control circuit includes a timer and a signal that cooperate to alert a user that a dose is due.

29. The device of claim 28, wherein the signal is selected from the group comprising an alarm and a visual display showing the time when the next dose is due.

30. The device of claim 16, wherein the control circuit includes a memory for storing dose information to be provided to the metering system.

31. The device of claim 16, wherein the metering system comprises a mechanically-actuated piston pump.

32. The device of claim 16, wherein the electrohydrodynamic apparatus includes a charge neutralizer for aiding in the delivery of the aerosolized liquid to a user'"'"'s lungs.

33. 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 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 plate;

a skirt having first and second ends, the first end attached to the base plate;

a plurality of spray sites attached to the base plate and enclosed by the skirt, each of the plurality of spray sites having a tip end;

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

a plurality of discharge electrodes within the skirt between the tip ends and the second skirt end; and

a plurality of reference electrodes within the skirt between the plurality of discharge electrodes and the second skirt end; and

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

34. The apparatus of claim 33, wherein the skirt defines a generally circular cross-section, the plurality of discharge electrodes and the plurality of reference electrodes being oriented radially inward from the skirt.

35. The apparatus of claim 34, 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.

36. The apparatus of claim 35, further comprising:

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

37. 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 apparatus for aerosolizing the liquid;

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

a plurality of spray sites each having a tip end;

a plurality of discharge electrodes surrounding the aerosolized liquid between the tip ends and the exit opening, the plurality of discharge electrodes being oriented toward the aerosolized spray and spaced equidistant from one another; and

a plurality of reference electrodes surrounding the aerosolized liquid between the plurality of discharge electrodes and the exit opening, the plurality of discharge electrodes being oriented toward the aerosolized spray and located in the interstices between the discharge electrodes; and

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

38. The apparatus of claim 37, further comprising:

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

39. The apparatus of claim 38, wherein the reference electrodes extend through slots provided in the dielectric material.

40. The apparatus of claim 37, wherein a liquid having a surface tension is caused to flow over the spray site and the charging of at least one of the plurality of spray sites causes said spray site to have a sufficient electric field strength that a net electrical charge is imparted to the surface of said liquid, the charge imparted to said liquid surface initially balancing the surface tension of said liquid to cause said liquid to form a cone having a tip and eventually overcoming the surface tension of said liquid in the region of the cone tip to generate a thin jet of liquid that breaks into aerosolized droplets of respirable size.

41. The apparatus of claim 40, wherein at least one of the plurality of discharge electrodes has a sufficient electric field strength to substantially neutralize a charge on the aerosolized droplets generated by said spray site.

42. The apparatus of claim 37, wherein the plurality of spray sites are arranged in a generally circular pattern.

43. The apparatus of claim 42, wherein the plurality of spray sites are spaced equidistant from one another.

44. The apparatus of claim 42, wherein the tip end of at least one of the plurality of spray sites is chamfered.

45. The apparatus of claim 42, wherein the exterior of at least one of the plurality of spray sites is coated with a material having a low surface energy.

46. An apparatus for aerosolizing a liquid, comprising:

a tubular base having a closed end and an opposing open end, an interior extending between the ends, and a generally circular cross-section, the tubular base defining an axis extending between the ends;

a plurality of spray sites enclosed within the tubular base and having a tip end extending axially into the closed end of the base;

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

a plurality of discharge electrodes each connected to the interior of the base between the spray site tip ends and the open end; and

a plurality of reference electrodes each connected to the interior of the base between the plurality of discharge electrodes and the open end, the plurality of discharge electrodes and the plurality of reference electrodes being oriented inward toward the axis of the base.

47. The apparatus of claim 46, wherein the plurality of discharge electrodes are located in the area of the tip ends of the plurality of spray sites.

48. 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.

49. The apparatus of claim 48, further comprising a dielectric material within the base between the discharge electrodes and the reference electrodes.

50. The apparatus of claim 46, wherein the plurality of spray sites are arranged in a generally circular pattern.

51. The apparatus of claim 50, wherein the reference electrodes extend through slots provided in the dielectric material.

52. 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 lower surface of the base plate and a tip end;

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

a skirt extending downward from the base plate;

a dielectric material extending downward from the base plate;

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

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

53. The apparatus of claim 52, wherein the dielectric material is a discrete member provided within the skirt.

54. The apparatus of claim 52, wherein the skirt is comprised of a dielectric material.

55. The apparatus of claim 52, wherein the plurality of reference electrodes are positioned in the interstices between the discharge electrodes.

56. The apparatus of claim 52, wherein the plurality of discharge electrodes are spaced equidistant from one another and the plurality of reference electrodes are positioned in the interstices between the discharge electrodes.