CONTINUOUS HIGH PRESSURE DELIVERY SYSTEM

• US 20080110458A1
• Filed: 10/02/2007
• Published: 05/15/2008
• Est. Priority Date: 10/02/2006
• Status: Active Grant

• Current Assignee: Philip Morris USA Incorporated (Altria Group, Inc.)
• Original Assignee: Philip Morris USA Incorporated (Altria Group, Inc.)
• Inventors: Sprinkel, F. Murphy, Ammann, David, Grollimund, Gary, Srinivasan, Sudarsan, McRae, Douglas D., Brookman, Donald, Maharajh, Niranjan
• Granted Patent: US 8,251,055 B2
• Time in Patent Office: Days
• US Class Current: 128/203.26
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/041 using heaters
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches

Abstract

A drug delivery system, which includes an aerosol generator unit, a pumping unit, a flow tube, at least one condensate collector and an aerosol transition adapter. The aerosol generator forms an aerosol from a liquid formulation, which is partially vaporized. The pumping unit supplies the liquid formulation to the aerosol generator unit and a flow tube having an inlet end in fluid communication with an outlet of the aerosol generator unit and an outlet adapted for connection to a patient interface, which supplies ventilation to a patient'"'"'s lungs. The system also includes at least one condensate collector adapted to collect condensed liquid or liquid produced by the aerosol generator unit, and a transition adapter arranged to mix aerosol produced by the aerosol generator unit with heated air and directs the mixed aerosol into the inlet end of the flow passage.

Claims

1. A drug delivery system, comprising:

an aerosol generator unit wherein a liquid formulation is partially vaporized to form an aerosol;

a pumping unit adapted to supply a liquid formulation to the aerosol generator unit;

a flow passage having an inlet end in fluid communication with an outlet of the aerosol generator unit and an outlet adapted for connection to a patient interface which supplies ventilation to a patient'"'"'s lungs;

at least one condensate collector adapted to collect condensed liquid or liquid produced by the aerosol generator unit; and

an aerosol transition adapter arranged to mix aerosol produced by the aerosol generator unit with heated air and directs the mixed aerosol into the inlet end of the flow passage.

2. The drug delivery system of claim 1, wherein the pumping unit includes one syringe pump and a pair of valves operable to supply liquid formulation into an inlet of the aerosol generator unit.

3. The drug delivery system of claim 1, wherein the pumping unit includes two syringe pumps and a valving arrangement operable to supply liquid formulation into an inlet of one syringe pump during delivery of liquid formulation to the aerosol generator unit by the other syringe pump.

4. The drug delivery system of claim 3, wherein the valving arrangement includes an inlet which can be connected to a source of a liquid formulation, first and second flow paths in fluid communication with the inlet, an outlet in fluid communication with an inlet of the aerosol generator unit, first and second valves along the first flow path and third and fourth valves along the second flow path, the valves arranged such that the first flow path supplies liquid formulation to the first syringe pump when the first valve is open and the second valve is closed, the second flow path supplies liquid formulation to the second syringe pump when the third valve is open and the fourth valve is closed, the first flow path supplying liquid formulation to the aerosol generator unit when the first valve is closed and the second valve is open, and the second flow path supplying liquid formulation to the aerosol generator unit when the third valve is closed and the fourth valve is open.

5. The drug delivery system of claim 1, wherein the aerosol generator unit includes a capillary passage in which the liquid formulation is at least partially vaporized, at least one heater body operable to heat the capillary passage to a temperature range effective to at least partially volatilize liquid formulation in the capillary passage, and at least one air passage arranged such that air is heated by the heater body and the heated air is combined with aerosol produced by the aerosol generator unit.

6. The drug delivery system of claim 5, wherein the capillary passage is a capillary tube adapted to fit within the heater body, and wherein the at least one air passage is a tubular member adapted to fit with a sheath air subassembly arranged such that the air is heated by the sheath air subassembly.

7. The drug delivery system of claim 1, wherein the aerosol transition adapter includes at least one baffle therein and/or a drainage port at a lower end thereof adapted to attach to a condensate collection device.

8. The drug delivery system of claim 1, wherein the pumping unit and aerosol generator unit includes disposable parts and reusable parts, the disposable parts including a capillary flow tube through which the liquid formulation is ejected as an aerosol and wetted parts of the pumping unit, the wetted parts including a screening member operable to trap particles in the liquid formulation above a predetermined size, the screening member located upstream of the inlet to the aerosol generator unit.

9. The drug delivery system of claim 4, further comprising a control system operable to activate the aerosol generator unit and the pumping unit, the control system effecting initial filling of the syringe pumps via retraction of a first piston of the first syringe pump and a second of the second syringe pump while maintaining the first and third valves open and the second and fourth valves closed, delivering liquid formulation to the aerosol generator unit via advancement of the first piston while maintaining the first and fourth valves closed, activating the second syringe pump near the end of a delivery cycle of the first syringe pump via advancement of the second piston while maintaining the fourth valve open and the third valve closed, refilling the first syringe pump via retraction of the first piston while maintaining the first valve open and the second valve closed, activating the first syringe pump near the end of the delivery cycle of the second syringe pump via advancement of the first piston while maintaining the a second valve open and the first valve closed.

10. The drug delivery system of claim 1, further comprising a source of liquid formulation containing a lung surfactant adapted for delivery as an aerosol to an infant'"'"'s lungs.

11. The drug delivery system of claim 1, further comprising a source of pressurized air connected to the aerosol transition adapter, the source of pressurized air supplying air at a flow rate of about 1 to 6 L/min (liters per minute).

18. The drug delivery system of claim 1, wherein the aerosol generator unit is a disposable assembly, the disposable assembly comprising:

a capillary tube adapted to form an aerosol when a liquid formulation in the capillary tube is heated to volatilize at least some of the liquid material therein;

a syringe assembly comprised of a syringe and a pair of valves operable to supply the liquid formulation into an inlet of the capillary tube;

a sheath air tube subassembly comprised of a sheath air tube operable to receive a ventilated or hospital air supply; and

the aerosol transition adapter.

19. The drug delivery system of claim 18, wherein the sheath air tube subassembly includes a sheath air tube and a turbine assembly, wherein the turbine assembly controls the flow of ventilated or hospital air supply to the aerosol transition adapter.

20. The drug delivery system of claim 18, further comprising a disposable assembly housing adapted to receive the disposable assembly, the disposable assembly housing comprising:

a heater body, the heater body comprising;

a lower heater subassembly having a channel adapted to receive the capillary tube and at least one heating unit positioned longitudinally within the lower heater subassembly;

an upper heater subassembly,

a lower sheath air subassembly having a channel operable to receive the sheath air tube and at least one heating unit positioned within the lower sheath air subassembly; and

an upper sheath air subassembly.

21. The drug delivery system of claim 20, wherein the disposable assembly housing further includes a syringe pump operable to the supply the liquid formulation into the inlet of the capillary tube.

12-17. -17. (canceled)

22. (canceled)

23. A disposable assembly operable to produce an aerosol, the disposable assembly comprising:

a capillary tube adapted to form an aerosol when a liquid formulation in the capillary tube is heated to volatilize at least some of the liquid material therein;

a syringe assembly comprised of at least one syringe and a plurality of valves operable to supply the liquid formulation into an inlet of the capillary tube;

a sheath air passage operable to receive a ventilated or hospital air supply; and

an aerosol transition adapter arranged to mix aerosol produced by the capillary tube with heated air from the sheath air tube and directs the mixed aerosol into the inlet end of a flow passage.

24. The assembly of claim 23, further comprising at least one condensate collector adapted to collect condensed liquid or liquid produced by the capillary tube.

25. The assembly of claim 23, further comprising a heater block in thermal contact with the capillary tube and adapted to receive the capillary tube, the heater block comprising:

an upper assembly and a lower assembly, which encases the capillary tube;

at least one heater cartridge positioned longitudinally within the upper assembly and the lower assembly; and

at least one thermocouple incorporated in the heater block.

26. The assembly of claim 23, wherein the sheath air passage includes a sheath air tube and a turbine assembly, and wherein the turbine assembly controls the flow of ventilated or hospital air supply to the aerosol transition adapter.

27. A base unit adapted to receive a disposable assembly having an aerosol generator unit therein, the base unit comprising:

a disposable assembly housing adapted to receive the disposable assembly;

a syringe pump operable to supply a liquid formulation to the aerosol generator unit; and

a control system operable to activate the aerosol generator unit and the syringe pump, such that the liquid formulation is partially vaporized to form an aerosol.

28. The base unit of claim 27, wherein the disposable assembly housing further includes a heater body comprising:

a lower heater subassembly having a channel adapted to receive a capillary tube and at least one heating unit positioned longitudinally within the lower heater subassembly;

an upper heater subassembly,

a lower sheath air subassembly having a channel operable to receive a sheath air tube and at least one heating unit positioned within the lower sheath air subassembly; and

an upper sheath air subassembly.

29. (canceled)

30. An apparatus to produce an aerosol comprising:

a heated capillary aerosol generator;

an arrangement to produce a flow of heated air; and

a mixer to mix the flow of heated air with an output of the heated capillary aerosol generator.

31. A method of producing an aerosol comprising:

generating an aerosol with a heated capillary; and

admixing heated air with the generated aerosol so as to reduce condensation.

32. The method of claim 31, further comprising:

wherein admixing heated air with the generated aerosol produces a heated aerosol of increased flow rate; and

communicating said heated aerosol along a passage to a remote location.

33. The method of claim 31, further comprising:

pressurizing a liquid formulation within a syringe assembly; and

delivering the pressurized liquid formulation to an aerosol generation unit, which includes the heated capillary in which the liquid formulation is at least partially vaporized.

63. The method of claim 31, further comprising:

supplying a source of liquid formulation to a syringe assembly comprised of a first syringe pump and a second syringe pump, each syringe pump having an aspiration cycle and discharge cycle, the discharge cycle being longer than the aspiration cycle, and wherein the first and second syringe pumps are in communication with the heated capillary of an aerosol generation unit via a plurality of valves and flow passages; and

discharging the liquid formulation to the heated capillary such that at a later portion of each of the discharge cycles, the first and second syringe pumps simultaneously discharge liquid formulation to the heated capillary of the aerosol generation unit.

34-61. -61. (canceled)

62. An aerosol generator capable of delivering an aerosol with a drug concentration of 2.3 milligrams per liter of air from a liquid formulation with a drug concentration of 10 milligrams per milliliter (mg/ml) and commensurately higher aerosol concentrations from formulations with higher concentrations.