Electronically-controlled, high pressure flow control valve and method of use

• US 9,010,329 B2
• Filed: 02/10/2010
• Issued: 04/21/2015
• Est. Priority Date: 02/10/2009
• Status: Active Grant

• Current Assignee: Aerophase Inc.
• Original Assignee: Aerophase Inc.
• Inventors: Hansen, Brian N.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US12/703,351
• Publication Number:
  US 20100199982A1
• Time in Patent Office: 1,896 Days
• Field of Search: 236/12.11, 600/399, 604/891.1, 606/181, 128/205.24
• US Class Current: 128/205.24
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: B65D 83/54 Metering valves ; Metering valve assemblies
• CPC Class Codes: F16K 1/14 with ball-shaped valve member check valves F16K15/04
• CPC Class Codes: F16K 31/02 electric F16K31/004 takes precedence; magnetic

Abstract

A fluid flow control valve comprises (a) a high pressure region adapted to contain a fluid at its supercritical or nearcritical temperature and pressure conditions and connected via an orifice to a low pressure region, (b) a seat adjacent the orifice, (c) a sealing element positionable against the seat to form a seal between the high pressure region and the low pressure region, and (d) an electrically and/or electronically controlled actuator operable to move the sealing element against and/or away from the seat to allow control of fluid flow from the high pressure region to the low pressure region. In a specific embodiment, the high pressure region contains a fluid at its supercritical or nearcritical temperature and pressure conditions. The valve may be used, for example, to provide very low flow rates, for example, for supercritical fluid chromatography, supercritical fluid extraction, critical point drying, supercritical fluid cleaning, and supercritical fluid separation methods. In another embodiment, the valve is suitable for use in methods of delivering a biologically active substance to a patient in need thereof.

Claims

1. An inhaler for aerosol delivery of a biologically active material, comprising:

a. a high pressure container containing a pressurized fluid and a biologically active material dissolved and/or suspended in the pressurized fluid,

b. a low pressure region connected via an orifice to the high pressure container, wherein the orifice is configured to deliver the pressurized fluid and biologically active material as an aerosol to the low pressure region and the low pressure region is configured to allow inhalation administration of the aerosol by a user,

c. a seat adjacent the orifice,

d. a sealing element positioned against the seat to form a seal between the high pressure container and the low pressure region,

e. an electrically and/or electronically controlled actuator operable to move the sealing element away from the seat to allow fluid flow from the high pressure container to the low pressure region, and

f. an electronic component operable to actuate the actuator to meter a dose of the pressurized fluid and biologically active material from the high pressure container through the orifice to the low pressure area where the pressurized fluid and biologically active material are delivered as an aerosol.

2. The inhaler device according to claim 1, wherein the pressurized fluid is at its supercritical or nearcritical temperature and pressure conditions.

3. The inhaler device according to claim 1, wherein the pressurized fluid is at its supercritical or nearcritical temperature and pressure conditions and comprises carbon dioxide, nitrogen, ethanol, difluoromethane, 1,1,1,2-tetrafluoroethane, or 1,1,1,2,3,3,3-heptafluoropropane, or a mixture of two or more thereof.

4. The inhaler device according to claim 3, wherein the actuator is positioned in the low pressure region.

5. The inhaler device according to claim 3, wherein the actuator is positioned in the high pressure container.

6. The inhaler device according to claim 3, wherein the sealing element is a metal pin.

7. The inhaler device according to claim 6, wherein the actuator comprises one or more shape memory alloy wires.

8. The inhaler device according to claim 3, wherein the sealing element is a metal or ceramic ball.

9. The inhaler device according to claim 8, wherein the actuator comprises one or more shape memory alloy wires.

10. The inhaler device according to claim 8, wherein the actuator comprises an electromagnetic coil operable to counteract a spring force holding the sealing element ball against the seat.

11. The inhaler device according to claim 8, wherein the actuator comprises an electromagnetic voice coil assembly.

12. The inhaler device according to claim 8, wherein the actuator comprises a bimetallic strip positioned to press the sealing element ball against the seat and operable to bend away from the seat when current is applied through the actuator.

13. The inhaler device according to claim 3, wherein the sealing element comprises a deformable film on a piezoelectric bender, wherein the piezoelectric bender is positioned to press the film against the seat, and wherein the piezoelectric bender bends away from the orifice when voltage is applied.

14. The inhaler device according to claim 13, wherein the deformable film comprises an elastomeric material.

15. The inhaler device according to claim 14, wherein the elastomeric film comprises polyurethane, fluoropolymer, or polyimide.

16. The inhaler device according to claim 13, wherein the piezoelectric bender is actuated with both a direct current voltage and an alternating current voltage to cause the piezoelectric bender to move away from the orifice and to oscillate away from and towards the orifice.

17. The inhaler device according to claim 3, wherein the actuator comprises a piezoelectric bender.

18. The inhaler device according to claim 17, wherein the piezoelectric bender is actuated with both a direct current voltage and an alternating current voltage to cause the piezoelectric bender to move away from the orifice and to oscillate away from and towards the orifice.

19. The inhaler device according to claim 1, wherein the biologically active substance comprises an agent for treating at least one pulmonary condition.

20. The inhaler device according to claim 19, wherein the pulmonary condition comprises asthma, emphysema, pneumonia, chronic obstructive pulmonary disease, cystic fibrosis, or lung cancer.

21. The inhaler device according to claim 3, further comprising an electronic control operable to trigger, count, record, and/or limit actuations of the valve for metered dose delivery of the biologically active substance to a patient.

22. A method of delivering a biologically active substance to a patient in need thereof, comprising actuating the actuator of the inhaler device of claim 1.