Drug delivery device

• US 5,178,138 A
• Filed: 09/11/1990
• Issued: 01/12/1993
• Est. Priority Date: 09/11/1990
• Status: Expired due to Term

• Current Assignee: Dennis R. Walstrom, Steven R. Maslonka, Wade J. Scoles
• Original Assignee: Dennis R. Walstrom, Steven R. Maslonka, Wade J. Scoles
• Inventors: Walstrom, Dennis R., Scoles, Wade J., Maslonka, Steven R.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US07/580,804
• Time in Patent Office: 854 Days
• Field of Search: 128/203.12, 128/203.25, 128/205.11, 128/203.23, 128/203.15, 128/203.21, 128/203.24, 128/200.21, 128/200.23, 128/200.14, 222/3, 222/635
• US Class Current: 128/200.23
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• 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

Abstract

A spacer for delivering a maximum amount of a therapeutic agent to the lungs. The spacer may be connected in the inspiratory line running from a mechanical ventilator or hand held and operated manually by the nonintubated, spontaneously breathing patient or the intubated, spontaneously breathing patient. The spacer includes the following features to maximize dispersion of the agent into the fluid flow: a structure for spraying the therapeutic agent in a retrograde fashion to prevent loss of the therapeutic agent to the expiratory limb of the respiratory circuit; a frustoconical shape that reflects the cone-like pattern of an aerosol spray to minimize impaction of the sprayed agent on the inner surfaces of the spacer; and a baffle to readily mix the fluid with the therapeutic agent and deflect fluid flow along the inner walls of the spacer where the therapeutic agent may otherwise collect.

Claims

1. A drug delivery device for connection in a mechanical ventilator circuit having inspiratory and expiratory lines and being controlled by a mechanical ventilator, the circuit including a wye connection for connecting the inspiratory and expiratory lines, the device being connected to the inspiratory line between the mechanical ventilator and a patient for administering an aerosolized therapeutic agent to the patient, the mechanical ventilator conveying fluid from the ventilator, through the inspiratory line and drug delivery device, and to the patient, the drug delivery device comprising:

a spacer with an inlet and an outlet and being connected in the inspiratory line such that fluid flows from the inlet to the outlet, the spacer having a spacing portion with a width greater than the width of the outlet;

directing means for directing the therapeutic agent into the spacer, the directing means disposed adjacent to the spacing portion; and

means for minimizing loss of the therapeutic agent to the expiratory line, the means for minimizing loss including the spacer being connected adjacent to the wye connection and between the wye connection and the mechanical ventilator, the means for minimizing loss further including the directing means being structured to direct the therapeutic agent in a direction opposite the fluid flow and away from the wye connection such that loss of the therapeutic agent to the expiratory line is minimized and to facilitate a mixing of the therapeutic agent and fluid before the therapeutic agent and fluid are conveyed out of the outlet and into the lungs, the therapeutic agent being fluidly redirected after such mixing by the fluid flow from the inlet to the outlet.

2. The device according to claim 1, wherein the spacing portion includes a tapering portion with larger and smaller diametrical ends, the smaller diametrical end disposed adjacent to the outlet.

3. The device according to claim 1, wherein the spacer includes a baffle between the inlet and outlet to deflect at least a portion of the fluid in a direction oblique to fluid flow through the inlet.

4. The device according to claim 3 and the spacing portion including an inner surface, wherein the baffle includes a deflector adjacent the inlet and positioned obliquely to the fluid flow through the inlet such that the deflector directs at least a portion of the fluid to the inner surface of the spacing portion.

5. The device according to claim 3 and the spacing portion including an interior, wherein the baffle includes an aperture for allowing fluid to flow through the baffle and into the interior of the spacing portion.

6. The device according to claim 1., wherein the spacer includes a cylindrical portion with a diameter greater than the width of the outlet.

7. The device according to claim 1 and the spacer including an exterior and an interior, wherein the directing means comprises a stem including an inlet portion, an outlet portion, and a passage running from the inlet portion to the outlet portion, the inlet portion being accessible from the exterior of the spacer, the outlet portion being in the interior of the spacer and structured to direct the therapeutic agent toward the inlet of the spacer.

8. The device according to claim 7, and further comprising an aerosol canister with a nozzle, the aerosol canister housing an aerosolizable medication which includes the therapeutic agent, the nozzle being insertable in the inlet portion to spray the therapeutic agent into the spacer.

9. The device according to claim 8, wherein the directing means includes a retainer surrounding the inlet portion of the stem such that aerosol canister is stably receivable in the retainer and the nozzle is stably insertable in the inlet portion when the medication is aerosolized.

10. The device according to claim 9, wherein the height of the retainer is at least as great as the width of the retainer.

11. The device according to claim 2, wherein the tapering portion comprises a frustoconical portion.

12. The drug delivery device according to claim 1, wherein the spacer is disposed substantially horizontally when connected in the inspiratory line.

13. A drug delivery device for connection in a mechanical ventilator circuit having inspiratory and expiratory lines and being controlled by a mechanical ventilator, the device being connected to the inspiratory line between the mechanical ventilator and a patient for administering an aerosolized therapeutic agent to the patient, the mechanical ventilator conveying fluid from the ventilator, through the inspiratory line and drug delivery device, and to the patient, the drug delivery device comprising:

a spacer with an inlet and an outlet and being connected in the inspiratory line such that fluid flows from the inlet to the outlet, the inlet and outlet being coaxial, the spacer having a spacing portion with a width greater than the width of the outlet;

directing means on the spacer for directing the therapeutic agent into the spacer; and

a baffle between the inlet and outlet to deflect at least a portion of the fluid in a direction oblique to the fluid flow through the inlet, the baffle being coaxial with the inlet and outlet, the baffle including a deflector adjacent the inlet and positioned obliquely to the fluid flow through the inlet such that the deflector directs at least a portion of the fluid to flow along the inner surface of the spacer, the baffle further including apertures to permit at least a portion of the fluid to flow through the baffle, the directing means disposed to direct the therapeutic agent between the outlet and the baffle whereby the fluid engages the baffle before mixing substantially with the therapeutic agent.

14. A hand-held drug delivery device for mixing an aerosolized therapeutic agent with ambient air and for effective delivery of the aerosolized therapeutic agent to the lungs of a spontaneously breathing patient, the aerosolized therapeutic agent originating from a cylindrical aerosol canister, the drug delivery device comprising:

a spacer with an inlet and an outlet and the ambient air being drawn into the inlet and from the inlet to the outlet by the patient, the spacer having a spacing portion with a width greater than the width of the outlet;

directing means on the spacer for directing the therapeutic agent into the spacer and structured to direct the therapeutic agent in a direction from the outlet to the inlet;

a one-way inlet valve connectable to the inlet to allow fluid into the spacer and prevent fluid flow from the spacer via the inlet vale;

a T-piece connectable adjacent the outlet and comprising a one-way outlet valve to allow fluid flow out of the spacer and prevent fluid flow into the spacer via the outlet valve, the T-piece comprising three ports, one of the ports housing the outlet valve, another port being a mouthpiece, and still another port being connectable adjacent the outlet; and

a cylindrical retainer adjacent the directing means for engaging the cylindrical aerosol canister, the height of the retainer being at least as great as the diameter of the retainer to stably receive the cylindrical aerosol canister.

15. A drug delivery device for connection in a mechanical ventilator circuit having inspiratory and expiratory lines and being controlled by a mechanical ventilator, the device connected to the inspiratory line between the mechanical ventilator and a patient for administering an aerosolized therapeutic agent to the patient from a cylindrical aerosol canister with a nozzle, the mechanical ventilator conveying fluid from the ventilator, through the inspiratory line and drug delivery device, and to the patient, the drug delivery device comprising:

a spacer with an inlet and outlet connected in the inspiratory line such that fluid is conveyed from the inlet to the outlet, the inlet and outlet being cylindrical and coaxial with each other, the spacer having a spacing portion with a maximum width greater than the width of the outlet, the spacing portion having a length;

directing means for directing the therapeutic agent into the spacer, the directing means disposed adjacent to the spacing portion and structured to direct the therapeutic agent in a direction from the outlet to the inlet and coaxial with the inlet and outlet to facilitate a mixing of the therapeutic agent and fluid before the therapeutic agent and fluid are conveyed out of the outlet and into the lungs, the directing means further comprising a cylindrical retainer on the outlet to support the aerosol canister when its nozzle is in the inlet portion;

the spacing portion comprising a rigid frustoconical inner surface portion which extends outwardly from the outlet to the maximum width of the spacing portion, the spacing portion tapering from the maximum width to the inlet whereby the frustoconical portion reflects a cone-like spray pattern of the aerosolized therapeutic agent.

16. A hand-held drug delivery device for mixing an aerosolized therapeutic agent with ambient air for effective delivery of the aerosolized therapeutic agent to the lungs of a spontaneously breathing patient, the aerosolized therapeutic agent originating from a cylindrical aerosol canister having a nozzle, the drug delivery device comprising:

a spacer with an inlet and outlet and the ambient air being drawn into the inlet and from the inlet to the outlet by the patient, the inlet and outlet being cylindrical and coaxial with each other, the spacer having a spacing portion with a maximum width greater than the width of the outlet, the spacing portion extending to and between the inlet and outlet and being coaxial with the inlet and outlet, the spacing portion also having a length;

directing means for directing the therapeutic agent into the spacing portion, the directing means mounted on the outlet and structured to direct the therapeutic agent in a direction from the outlet to the inlet and said directing means being coaxial with the inlet and outlet to facilitate a mixing of the therapeutic agent and ambient air before the therapeutic agent and ambient air are drawn out of the outlet and into the lungs, the directing means further including a stem, the stem including an inlet portion, an outlet portion and a passage running from the inlet portion to the outlet portion, the outlet portion being in the outlet, the outlet portion being coaxial with the inlet and outlet, the directing means further comprising a cylindrical retainer surrounding the inlet portion to support the aerosol canister when its nozzle is in the inlet portion;

the spacing portion comprising a frustoconical and rigid portion which extends outwardly from the outlet to the maximum width of the spacing portion, the spacing portion tapering from the maximum width to the inlet whereby the tapering portion reflects the aerosolized therapeutic agent which forms a tapering pattern when aerosolized; and

valve means on the spacer for regulating inhalation and exhalation relative to the spacer.

17. A drug delivery device for connection in a mechanical ventilator circuit having inspiratory and expiratory lines and being controlled by a mechanical ventilator, the device being connected to the inspiratory line between the mechanical ventilator and a patient for administering an aerosolized therapeutic agent to the patient, the mechanical ventilator conveying fluid from the ventilator, through the inspiratory line and drug delivery device, and to the patient, the drug delivery device comprising:

a spacer with an inlet and an outlet and being connected in the inspiratory line such that fluid flows from the inlet to the outlet, the spacer having a spacing portion with a width greater than the width of the outlet;

directing means for directing the therapeutic agent into the spacer, the directing means disposed adjacent to the spacing portion; and

means for minimizing loss of the therapeutic agent to the expiratory line including the directing means being structured to direct the therapeutic agent in a direction opposite the fluid flow such that loss of the therapeutic agent to the expiratory line is minimized and to facilitate a mixing of the therapeutic agent and fluid before the therapeutic agent and fluid are conveyed out of the outlet and into the lungs, the therapeutic agent being fluidly redirected after such mixing by the fluid flow from the inlet to the outlet.