DEVICE, SYSTEM AND METHOD FOR TARGETING AEROSOLIZED PARTICLES TO A SPECIFIC AREA OF THE LUNGS

• US 20090056708A1
• Filed: 07/31/2008
• Published: 03/05/2009
• Est. Priority Date: 08/02/2007
• Status: Active Grant

• Current Assignee: Vectura GmbH (Vectura Group Ltd.)
• Original Assignee: Cardinal Health 200 Incorporated (Cardinal Health, Inc.), Activaero GmbH (Philip Morris Limited)
• Inventors: Fischer, Axel, Hoffmann, Tobias, Wenker, Andreas, Zimlich, William C., Mullinger, Bernhard, Kolb, Tobias, Roeder, Sascha, Stenzler, Alex, Scheuch, Gerhard
• Granted Patent: US 8,534,277 B2
• Time in Patent Office: Days
• US Class Current: 128/200.140
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/08 Pocket atomisers of the injector type aerosol cans A61M15/009
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0013 with inhalation check valves
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/40 Respiratory characteristics

Abstract

The present invention is directed to the administration of aerosolized particles to specific area of the lungs, and in particular to the targeted delivery of aerosolized pharmaceutical formulations to a specific area of the lungs. More specifically, the present invention relates to devices and methods for depositing aerosolized particles to a specific area of the lungs by regulating aerosolizing parameters of the device. The present invention also relates to devices, systems and methods for disease management, where the aerosolizing parameters are adjusted based on monitoring at least one health parameter.

Claims

1. A device for depositing aerosol particles to specific area of the lungs, preferable the peripheral or central airways of the lungs, the device comprising:

a) flow rate limiter for limiting inhalation flow rate in a flow path to a preset flow rate range; and

b) a timer to initiate, once a subject begins inhalation and has inhaled a first predefined time period of aerosol particle free air, a predefined volume of aerosolized particles to be introduced into the flow path, and to initiate after said predefined volume of aerosolized particles a second predefined time period of aerosol particle free air, such that the aerosolized particles are directed to bronchial and/or peripheral airways of the lungs.

2. The device of claim 1, wherein said first predefined time period of aerosol particle free air is up to about 10 seconds, said second predefined time period of aerosol particle free air is up to about 10 seconds and said predefined volume of aerosolized particles is up to about 3000 ml.

3. The device of claim 1, wherein said first predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being about up to about 6 liters.

4. The device of claim 1, wherein said predefined volume of aerosolized particles is introduced into the flow path for a preset time period.

5. The device of claim 1, wherein said second predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to about 3 liters.

6. The device of claim 1, wherein flow rate limiter is responsive to the timer and adapted to seal the flow path after the subject has inhaled the second predefined time period of aerosol particle free air.

7. The device of claim 1, wherein the timer is adapted to indicate to the subject to stop inhaling after the subject has inhaled for the second predefined time period of aerosol particle free air or the device further comprises an indicator to alert the subject to stop inhaling after the subject has inhaled for the second predefined time period of aerosol particle free air.

8. The device of claim 1, further comprising an air control valve for enabling a pre-settable volumetric flow of compressed air.

9. The device of claim 8, wherein said air control valve comprises a piezo-controlled valve, diaphragm-activated motor, solenoid, air piston or a mechanical valve operable with a timer.

10. The device of claim 1, further comprising a sensor for detecting when a subject is inhaling through the flow path.

11. The device of claim 10, wherein said sensor comprises a pressure gauge responsive to suction pressure due to the subject'"'"'s inhalation.

12. The device of claim 10, wherein said sensor comprises a diaphragm responsive to audible intensity of the inhalation flow rate, said diaphragm preferably being a microphone.

13. The device of claim 10, wherein said sensor comprises a mechanical switch or a piezo membrane.

14. The device of claim 1, wherein the flow rate limiter enables flow rate limitation at low differential pressures, preferably less than 30 mbar, most preferably between 0.1 and 10 mbar.

15. The device of claim 1, wherein the flow rate limiter is a discretely or continuously variable flow limiter or a controllable valve.

16. The device of claim 1, wherein the flow limiter comprises a housing having at least one aspiration orifice, at least one inhalation orifice, and a flow region with at least one flexible wall disposed therebetween, which region has a cross-section which is adapted to be reduced, as a function of the differential pressure prevailing between said inhalation orifice and said aspiration orifice and of the flexibility of the material of each wall, down to a predefined size for predetermined volumetric maximum inhalation flow.

17. The device of claim 16, wherein said housing further includes at least one ventilation opening defined therein at least in the central region between said aspiration and inhalation orifices, said at least one ventilation opening providing fluid communication between the environment and each wall.

18. The device of claim 16, wherein said flow region comprises at least one flow passage having a stratified structure, and wherein each flow passage is formed by a closed wall, a frame-shaped intermediate wall of the same size as the closed wall, and an equally sized wall including said aspiration and inhalation orifices.

19. The device of claim 16, wherein said flow region comprises at least one flow passage, wherein the flexible material used to form each flow passage consists of a biologically tolerable material, wherein the cross-section of each flow passage is formed to have opposing large-area passage walls, and wherein at least said large-area passage walls consist of silicone mats or foils.

20. The device of claim 16, wherein each wall has a chamber section with a bore on its outside at least in the central region between said aspiration and inhalation orifices, with each of the respective bores of the walls communicating with said aspiration orifice through a passage.

21. The device of claim 16, wherein said flow region comprises at least one flow passage having an annular cross-section, wherein each flow passage is symmetrically disposed in a cylindrical housing at a spacing from the inner walls of said cylinder, between radial retainer disks.

22. The device of claim 21, wherein said retainer disks comprise inlets and outlets having the shape of ring segments, with the retainer disks including said inlets being provided with pressure-equalizing bores for a cylindrical interior space and an annular zone surrounding said flow passage.

23. The device of claim 16, wherein said flow region comprises at least one flow passage having an annular cross-section, wherein each annular flow passage is formed by silicone mats or foils.

24. The device of claim 16, wherein said flow region is formed between a central aspiration orifice and inhalation orifices radially surrounding the central aspiration orifice as well as star-shaped webs extending from a common bottom surface to said at least one flexible wall and forming flow passages.

25. The device of claim 16, wherein each wall is open on its outside, at least in the central region between said aspiration and inhalation orifices, to the environment, and wherein said device is adapted such that substantially all flow between said aspiration orifice and said inhalation orifice is confined to a flow passage defined by the inside of each wall.

26. The device of claim 15, wherein the controllable valve comprises a housing, a membrane, an optional pressure plate, a closure element, a set piston and an adjusting screw, wherein the housing is essentially tubular and comprises a plurality of radially arranged webs one web being longer than the others, wherein on one side of the webs the housing is designed so as to adjustably receive the set piston and on the opposite side so as to receive the membrane, the optional pressure plate and the closure element.

27. The device of claim 1, wherein the flow limiter comprises a piezo bimorph actuator.

28. The device of claim 1, wherein the flow limiter comprises a valve actuated by an inflatable balloon.

29. The device of claim 1, further comprising a particle size means for enabling a predetermined aerosol particle size.

30. The device of claim 1, wherein the flow rate is a predetermined fixed flow rate.

31. The device of claim 1, further comprising a mouthpiece, preferably releaseably, connected in fluid communication with said inhalation flow path.

32. The device of claim 1, further comprising at least one orifice connected, preferably releaseably, to a source of aerosolized particles.

33. The device of claim 1, further comprising means for aerosolizing solid or liquid particles, said means being preferably a nebulizer.

34. The device of claim 1, being adapted to receive at least one receptacle containing an active agent.

35. The device of claim 1, wherein the device is a hand-held, portable device.

36. The device of claim 1, further comprising a controller having a memory for storing a subject'"'"'s individual parameters and/or aerosol depositing parameters.

37. The device of claim 1, further comprising a reader for reading a memory means having a subject'"'"'s individual parameters and/or aerosol depositing parameters stored thereon.

38. The device of claim 1, further comprising a communication means for receiving and/or sending data associated with a subject'"'"'s individual parameters and/or aerosol depositing parameters.

39. The device of claim 1, wherein said aerosol depositing parameters comprise the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles.

40. The device of claim 1, further comprising at least one monitor for measuring a health parameter, wherein said device is adaptable in response to measurements from one of said at least one monitor.

41. The device of claim 40, wherein said at least one monitor is a spirometer for measuring a pulmonary function parameter, preferably indicative of exhalation and/or inhalation capacity.

42. The device of claim 40, wherein the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles are adjusted based on measurements.

43. A system for monitoring aerosol particle deposition, the system comprising:

a) the device of claim 1, and

b) at least one monitor for measuring a health parameter, wherein said device is adaptable in response to measurements from one of said at least one monitor.

44. The system of claim 43, wherein said at least one monitor is a spirometer for measuring a pulmonary function parameter, preferably indicative of exhalation and/or inhalation capacity.

45. The system of claim 43, wherein the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles are adjusted based on measurements.

46. A method of targeting aerosol particles to a specific area of the lungs comprising at least the steps of:

a) delivering a predefined volume of aerosolized particles to be inhaled into the flow path; and

b) providing a predefined time period of aerosol particle free air into the lungs at a flow rate within the preset flow rate range to move the aerosolized particles to a targeted area of the lungs.

47. The method of claim 46, further comprising a step before step a) of providing a first predefined time period of aerosol particle free air through a flow path into the lungs at a flow rate within a preset flow rate range.

48. The method of claim 46, further comprising a step preventing flow through the flow path after step b).

49. The method of claim 46, further comprising a step providing indication to the subject to stop inhaling after step b).

50. The method of claim 46, wherein the predefined time period in step b) enables a predefined volume of aerosol particle free air, the predefined volume being up to about 3 liters.

51. The method of claim 46 wherein the first predefined time period of aerosol particle free air is up to about 10 seconds, the predefined time period of aerosol particle free air in step b) is up to about 10 second and the predefined volume of aerosolized particles is up to about 3000 ml.

52. A method for depositing aerosol particles to the central airways of the lungs comprising:

a) providing a first predefined time period of aerosol particle free air through a flow path into the lungs at a flow rate within a preset flow rate range;

b) delivering a predefined volume of aerosolized particles to be inhaled into the flow path; and

c) providing a second predefined time period of aerosol particle free air into the lungs at a flow rate within the preset flow rate range to move the aerosolized particles out of the upper airway region.

53. The method of claim 52, further comprising a step preventing flow through the flow path after providing the second predefined time period of aerosol particle free air.

54. The method of claim 52, further comprising providing indication to the subject to stop inhaling after providing the second predefined time period of aerosol particle free air for the preset time period.

55. The method of claim 52, further comprising detecting when the subject is inhaling through the flow path.

56. The method of claim 52, wherein the flow rate is a predetermined fixed flow rate.

57. The method of claim 52, wherein the first predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to about 6 liters.

58. The method of claim 52, wherein the predefined volume of aerosolized particles is introduced into the flow path for a preset time period.

59. The method of claim 52, further comprising the steps of measuring and adapting the first predefined time period, the second predefined time period and/or the predefined volume of aerosolized particles based on measurements of at least one health parameter.

60. The method of claim 52, wherein the first predefined time period of aerosol particle free air is up to about 10 seconds, the second predefined time period of aerosol particle free air is up to about 10 seconds and the predefined volume of aerosolized particles is up to about 3000 ml.

61. The method of claims 52, wherein the second predefined time period enables a predefined volume of aerosol particle free air, the predefined volume being up to about 3 liters.