Continuous flow nebulizer apparatus and method, having means maintaining a constant-level reservoir

• US 5,277,175 A
• Filed: 07/12/1991
• Issued: 01/11/1994
• Est. Priority Date: 07/12/1991
• Status: Expired due to Term

• Current Assignee: Medex Incorporated (Smiths Group International Holdings Ltd.)
• Original Assignee: Barry Mangum, John H. Riggs
• Inventors: Riggs, John H., Mangum, Barry
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Asher, Kimberly L.
• Application Number:
  US07/729,518
• Time in Patent Office: 914 Days
• Field of Search: 128/200.19, 128/200.14, 128/200.21, 128/200.18, 128/203.12, 128/203.19, 128/203.21, 128/203.24, 128/203.25, 128/203.29 , 128/204.21, 128/204.23, 128/204.26, 128/203.14, 128/200.16, 73/149, 73/290 R, 73/293, 239/305, 239/338, 604/31, 604/65-67, 604/80, 604/81, 604/246, 604/251-255, 604/257, 604/258, 604/260, 604/262, 137/256
• US Class Current: 128/200.21
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/162 Water-reservoir filling system, e.g. automatic
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2209/08 Supports for equipment

Abstract

A continuous flow nebulizing device for patients receiving long term nebulized medicant respiratory therapy. The nebulizing device comprises a nebulizer vial through which nebulizing fluids are delivered from a large supply vessel to conventional nebulizing apparatus. Thereby, the nebulizing apparatus connected to the continuously replenished nebulizer vial, delivers a larger volume of nebulized medicants on a continuous basis to a patient than can be provided by a conventional nebulizer vial without removing the conventional nebulizer vial from the nebulizer. For critially ill patients, the nebulizing device is used as part of a nebulizer/ventilator circuit. For voluntary respiratory patients, the nebulizer device output is used without a ventilator. Medicant supplying circuits are provided whereby a single medicant is selectably delivered from a plurality of large supply vessels without disconnecting the nebulizing vial from the nebulizer. Liquid level control circuits are provided whereby the level of liquid in the nebulizer vial is electrically or fluidically controlled. Nebulizing gas flow, synchronized with inhalation and exhalation rates, provides a plurality of options of aerosolized mist production patterns. Such synchronization is defined by a ventilator. An add-site device which provides direct access by a syringe needle into the nebulizer vial for addition of medicants and withdrawal of fluid is disclosed. Adjustable temperature control is provided for ventilating and nebulizeable fluids.

Claims

1. An apparatus for delivering an aerosolized medication to a patient for administration, comprising:

(a) a non-ultrasonic nebulizer assembly, comprising;

(i) a nebulizer vial including a vertically extending housing comprising at least one side wall and defining a reservoir for holding liquid medication therein in a volume defining a gas-liquid interface within the housing;

(ii) a nebulization mechanism constructed and arranged to effect gas-liquid contacting of gas with liquid medication from the volume of liquid medication held in the reservoir, and produce said aerosolized medication;

(iii) a liquid medication feed passage member extending transversely through a side wall of said vertically extending housing for transverse introduction of liquid medication into the reservoir, said liquid medication feed passage member being disposed at an elevation above the gas-liquid interface defined by liquid medication held in the reservoir; and

(iv) a gas feed passage member for feeding gas to the nebulization mechanism;

(b) means for supplying gas to the nebulizer assembly including the gas feed passage member thereof;

(c) means for monitoring the rate of flow of gas supplied to the gas feed passage member of the nebulizer assembly;

(d) means for discharging aerosolized medication from the nebulizer assembly and delivering same to a patient for administration;

(e) a supply vessel for containing a source volume of the liquid medication wherein said source volume is greater than the volume of liquid medication held in said reservoir of said nebulizer vial;

(f) a liquid medication flow circuit interconnecting said supply and said liquid medication feed passage member, for flowing liquid medication from the supply vessel to the liquid medication feed passage member for introduction of liquid medication into the reservoir; and

(g) liquid medication flow control means disposed in said liquid medication flow circuit for controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member during operation of said treatment apparatus involving delivery of aerosolized medication to a patient for administration, and arranged for controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member, with respect to the rate of flow of gas supplied to the nebulizer assembly, and in accordance with a nomogramic relationship between the flow rate of gas and the flow rate of liquid medication. the liquid medication flow control means controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member to be substantially equal to the rate of loss of liquid medication from the reservoir in the aerosolized medication discharged from the nebulizer assembly and delivered to the patient for administration and continuously maintaining the gas-liquid interface at a selected position and continuously maintaining a constant volume of liquid medication in the reservoir of the nebulizer vial during said operation.

2. An apparatus according to claim 1, wherein the nebulizer vial has a cylindrical-shaped upper part and a generally conical-shaped lower part joined thereto.

3. An apparatus according to claim 1, wherein the nebulization mechanism comprises means for entraining liquid medication, from the volume of liquid medication held in the reservoir, in a carrier gas to produce said aerosolized medication.

4. An apparatus according to claim 3, wherein the nebulization mechanism further comprises means for dispersing liquid medication entrained in said carrier gas.

5. An apparatus according to claim 1, wherein the nebulization mechanism comprises:

(A) a nozzle which is constructed and arranged for connection to a source of gas, to discharge a gas stream as nebulization carrier gas; and

(B) a generally downwardly extending aspiration tube having (i) a lower inlet end disposed in a lower portion of the housing at an elevation below the gas-liquid interface defined by liquid medication held in the reservoir, and (ii) an upper part including an aspiration port in liquid aspiration relationship to the nozzle, for aspiratingly flowing liquid medication through the aspiration tube, from the lower inlet end, when in liquid flow communication with the volume of liquid medication in the reservoir of the nebulizer vial during said operation, to said aspiration port for entrainment in the gas stream discharged from the nozzle as nebulization carrier gas.

6. Apparatus according to claim 5, wherein the nebulization mechanism further comprises a baffle plate in impingement relationship to the gas stream discharged from the nozzle as nebulization carrier gas, whereby liquid medication entrained in the nebulization carrier gas is impacted against the baffle plate to enhance aerosolization thereof.

7. Apparatus according to claim 1, wherein the liquid medication flow control means (g) comprise a variable rate pump.

8. Apparatus according to claim 1, wherein the liquid medication flow control means (g) comprises a syringe infusion pump.

9. Apparatus according to claim 1, wherein the liquid medication feed passage member extending transversely through the side wall of the vertically extending housing is devoid of any flow restriction means therein.

10. Apparatus according to claim 1, wherein the liquid medication feed passage member is generally perpendicular to the side wall of the vertically extending housing.

11. Apparatus according to claim 1, wherein the liquid medication feed passage member and the flow circuit interconnecting the supply vessel and the feed passage member are devoid of any check valve or directional flow restriction means therein.

12. An apparatus according to claim 1, wherein the nebulization mechanism comprises a means for effecting aspiration of liquid medication onto a baffle surface to effect the dispersion into droplets of the liquid medication.

13. An apparatus according to claim 1, wherein the liquid medication feed passage member extending transversely through a side wall of the vertically extending nebulizer vial housing has a terminus at said side wall.

14. An apparatus for delivering an aerosolized medication from a nebulizer containing a volume of liquid medication to a patient for administration, comprising:

(a) a nebulizer assembly, comprising;

(i) a nebulizer vial including a vertically extending housing comprising at least one side wall and defining a reservoir for holding therein a volume of liquid medication defining a gas-liquid interface within the housing,

(ii) a nebulization mechanism constructed and arranged to effect gas-liquid contacting of gas with liquid medication from the volume of liquid medication held in the reservoir, and produce said aerosolized medication; and

(iii) a feed passage member extending transversely through a side wall of said vertically extending housing for transverse introduction of liquid medication into the reservoir, said feed passage member being disposed at an elevation above the gas-liquid interface defined by liquid medication held in the reservoir;

(b) a supply vessel for containing a source volume of the liquid medication within said source volume which is greater than the volume of liquid medication held in said reservoir of said nebulizer vial;

(c) a flow circuit interconnecting said supply vessel and said feed passage member, for flowing liquid medication from the supply vessel to the feed passage member for introduction of liquid medication into the reservoir;

(d) flow control means disposed in said flow circuit for controlling flow rate of liquid medication from the supply vessel to the feed passage member during operation of said treatment apparatus involving delivery of aerosolized medication to a patient for administration, to continuously maintain the gas-liquid interface at a selected position and to continuously maintain a constant volume of liquid medication in the reservoir of the nebulizer vial during said operation; and

(e) means for discharging aerosolized medication from the nebulizer assembly when delivering same to said patient for administration;

wherein;

said nebulization mechanism is constructed and arranged to provide a selected effluent rate of aerosolization of liquid medication from said reservoir, as discharged by said aerosolized medication discharging means (e) from the nebulizer assembly;

said nebulizer assembly comprises an overflow passage member extending through said vertically extending housing in liquid flow communication with the volume of liquid medication;

said flow circuit (c) is part of a fluidic closed loop comprising a second flow circuit interconnecting said supply vessel and said overflow passage member exteriorly of said housing; and

said flow control means (d) comprise a pump which is constructed and arranged to provide a flow rate of liquid medication from the supply vessel to the feed passage member which is higher than said effluent rate of aerosolization from the nebulization mechanism (a)(ii);

whereby the gas-liquid interface is continuously maintained at said selected position and said constant volume of liquid medication is continuously maintained in the reservoir of the nebulizer vial following said operation.

15. An apparatus for delivering an aerosolized medication to a patient for administration, comprising:

(a) a nebulizer assembly comprising;

(i) a nebulizer vial including a vertically extending housing comprising at least one side wall and defining a reservoir for holding liquid medication therein in a volume defining a gas-liquid interface within the housing;

(ii) a nebulization mechanism constructed and arranged to effect gas-liquid contacting of gas with liquid medication from the volume of liquid medication held in the reservoir, and produce said aerosolized medication;

(iii) a liquid medication feed passage member extending transversely through a side wall of said vertically extending housing for transverse introduction of liquid medication into the reservoir, said liquid medication feed passage member being disposed at an elevation above the gas-liquid interface defined by liquid medication held in the reservoir; and

(iv) a gas feed passage member for feeding gas to the nebulization mechanism;

(b) means for supplying gas to the nebulizer assembly including the gas feed passage member thereof;

(c) means for monitoring the rate of flow gas supplied to the gas feed passage member of the nebulizer assembly;

(d) means for discharging aerosolized medication from the nebulizer assembly and delivering same to a patient for administration;

(e) a supply vessel for containing a source volume of the liquid medication wherein said source volume is greater than the volume of liquid medication held in said reservoir of said nebulizer vial;

(f) a liquid medication flow circuit interconnecting said supply vessel and said liquid medication feed passage member, for flowing liquid medication from the supply vessel to the liquid medication feed passage member for introduction of liquid medication into the reservoir; and

(g) liquid medication flow control means disposed in said liquid medication flow circuit for controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member during operation of said treatment apparatus involving delivery of aerosolized medication to a patient for administration, and arranged for controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member, with respect to the rate of flow of gas supplied to the nebulizer assembly, and in accordance with a nomogramic relationship between the flow rate of gas and the flow rate of liquid medication the liquid medication flow control means controlling the flow rate of liquid medication from the supply vessel to the liquid medication feed passage member to be substantially equal to the rate of loss of liquid medication from the reservoir in the aerosolized medication discharged from the nebulizer assembly and delivered to the patient.