Catheter system for delivery of aerosolized medicine for use with pressurized propellant canister

• US 5,642,730 A
• Filed: 06/17/1994
• Issued: 07/01/1997
• Est. Priority Date: 06/17/1994
• Status: Expired due to Term

• Current Assignee: Trudell Medical Limited
• Original Assignee: Trudell Medical Limited
• Inventors: Baran, George
• Primary Examiner(s): Millin, V.
• Assistant Examiner(s): Deane, Jr., William J.
• Application Number:
  US08/261,490
• Time in Patent Office: 1,110 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 128/200.18, 128/200.21, 128/200.23, 128/203.12, 604/171
• US Class Current: 128/207.14
• 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 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0484 at the distal end
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices

Abstract

An improved system for delivery of an aerosolized medicine to a patient'"'"'s respiratory system. The system uses a pressurized canister that contains a mixture of a medicine and a propellant which may be in a liquid state. The canister has an outlet from which the mixture can exit. The system includes an extension catheter that connects at a proximal end to the outlet of the canister. The extension catheter has a length such that a distal end can be positioned either in an endotracheal tube or deep in the respiratory tract of the patient while the proximal end of the extension catheter is connected to the canister which is located outside the patient'"'"'s body. The extension catheter includes at least one lumen extending therethrough for conveying the medicine and liquid propellant mixture from the canister to a distal exit orifice where an aerosol can be generated as the propellant evaporates. The aerosolized medicine is carried by the patient'"'"'s inhalation and delivered to the lungs. The extension catheter may be positioned in an endotracheal tube or alternatively may be used with a patient who is not intubated.

Claims

1. An improved system for the delivery of an aerosolized medicine to a patient'"'"'s respiratory system comprising:

a pressurized canister that contains a mixture of fine particles of a medicine and a propellant in a liquid state and further that has an outlet from which the medicine and propellant can exit the canister;

an endotracheal tube having a ventilation lumen;

an extension catheter having a proximal end and a distal end and a lumen extending from the proximal end to a distal orifice located at said distal end, said extension catheter located in said ventilation lumen of said endotracheal tube, and extending distally of a distal end of said endotracheal tube into an air flow passage of the patient; and

a connection between said proximal end of said extension catheter and said outlet of said pressurized canister to provide a fluid connection between said canister and said lumen of said extension catheter to permit liquid medicine and propellant to be conveyed from said canister through said lumen of said extension catheter and out said distal orifice of said extension catheter where the propellant evaporates and an aerosol of the liquid medical agent is generated.

2. The system of claim 1 in which said extension catheter is removable with respect to said endotracheal tube.

3. The system of claim 1 further comprising:

a first centering device associated with a distal portion of said extension catheter to align said distal end of said catheter with respect the patient'"'"'s air flow passage.

4. The system of claim 3 further comprising:

a second centering device associated with said distal portion of said extension catheter to align said distal end of said extension catheter with respect the patient'"'"'s air flow passage.

5. The improved system of claim 1 further comprising:

means for sensing a physiological condition of the patient incorporated into said extension catheter.

6. The improved system of claim 1 in which said extension catheter further comprises:

a separate fiber optical viewing means.

7. The improved system of claim 1 further comprising:

means for synchronizing production of the aerosol with inhalation of the patient.

8. The improved system of claim 7 in which said synchronizing means further comprises:

means for producing the aerosol in advance of the inhalation of the patient.

9. An apparatus for delivery of an aerosolized medicine to a patient'"'"'s respiratory tract comprising:

a pressurized canister containing a mixture of fine particles of a medicine and a liquid propellant and further in which an aerosolized dose of the medicine can be generated when the mixture is expelled to ambient pressure at which the propellant in the mixture evaporates;

a catheter having a lumen extending therethrough and a length such that a proximal end of said catheter is located outside the patient'"'"'s body and a distal end is located in an air flow passage in the patient'"'"'s respiratory tract, said distal end having an exit orifice communicating with said lumen;

a proximal portion of said catheter and said canister having a permanent connection to each other so as to permit the mixture from said canister to be transmitted into the lumen of said catheter; and

an actuator valve located in at least one of said catheter and said canister to regulate the flow of mixture from said canister to said exit orifice.

10. An apparatus for delivery of an aerosolized medicine to a patient'"'"'s respiratory tract from a pressurized canister of a type that contains a mixture of fine particles of a medicine and a liquid propellant and further in which an aerosolized dose of the medicine is generated when the mixture is expelled to ambient pressure at which the propellant in the mixture evaporates, said apparatus comprising:

a catheter having a lumen extending therethrough and a length such that a proximal end of said catheter is located outside the patient'"'"'s body and a distal end is located in an air flow passage in the patient'"'"'s respiratory tract, said distal end having an exit orifice communicating with said lumen;

a connection between a proximal portion of said catheter and said canister to permit the mixture from said canister to be transmitted into the lumen of said catheter, said lumen and said exit orifice sized to maintain a pressure inside said lumen sufficient to maintain said mixture in a liquid state; and

a baffle located adjacent to said exit orifice.

11. The apparatus of claim 10 in which said exit orifice has an annular configuration, and in which said baffle further comprises:

a stem portion connected to said distal end of said catheter concentric with said annular configuration of said exit orifice.

12. The apparatus of claim 10 in which said baffle further comprises:

a proximal face located directly in front of said orifice.

13. The apparatus of claim 12 in which said proximal face defines a tapered surface increasing in diameter in a distal direction.

14. The apparatus of claim 13 in which said tapered surface is defines a concave curved surface.

15. The apparatus of claim 13 in which said tapered surface is defines a convex curved surface.

16. The apparatus of claim 15 in which said convex curved surface is spherical.

17. The apparatus of claim 10 in which said distal exit orifice has an annular configuration.

18. An apparatus for the delivery to a patient'"'"'s respiratory tract of an aerosolized medicine from a pressurized canister containing a mixture of a medicine and a liquid propellant that evaporates upon exiting to ambient pressure to generate an aerosolized dose of said medicine, said apparatus comprising:

a catheter having a shaft with a length such that a proximal end of said catheter is located outside the patient'"'"'s body and a distal end is located in an air flow passage in the patient'"'"'s respiratory tract, wherein at least of portion of said shaft has a plurality of parallel lumens extending therethrough; and

a connection between a proximal portion of said catheter and an outlet of a canister to permit the mixture of medicine and propellant from said canister to be transmitted through said plurality of parallel lumens and out at least one exit orifice located at the distal end of said catheter.

19. The apparatus of claim 18 in which said plurality of lumens terminate in a plurality of exit orifices located at the distal end of said catheter.

20. The apparatus of claim 19 further comprising:

a baffle located adjacent to said exit orifices.

21. The apparatus of claim 18 in which said plurality of lumens extend from a proximal to a distal end of said catheter shaft.

22. The apparatus of claim 21 in which the catheter shaft is formed of a multi-lumen extrusion.

23. The apparatus of claim 18 in which said catheter shaft comprises a portion having a single lumen, said single lumen communicating with said plurality of lumens.

24. The apparatus of claim 18 further comprising:

an insert plug located in a lumen of said catheter shaft, said insert plug having a plurality of lumens extending therethrough that define said plurality of lumens.

25. The apparatus of claim 18 further comprising:

a centering device associated with a distal portion of said catheter to align said distal end of said catheter with respect the air flow passage in a patient'"'"'s respiratory tract.

26. An apparatus for the delivery to a patient'"'"'s respiratory tract of an aerosolized medicine from a pressurized canister containing a mixture of a medicine and a liquid propellant that evaporates upon exiting to ambient pressure to generate an aerosolized dose of said medicine, said apparatus comprising:

a catheter having a shaft with a length such that a proximal end of said catheter is located outside the patient'"'"'s body and a distal end is located in an air flow passage in the patient'"'"'s respiratory tract, said catheter shaft having at least one lumen extending from said proximal end to said distal end, and further in which said catheter shaft includes a plurality of exit orifices located at said distal end, said distal exit orifices communicating with said at least one lumen; and

a connection between a proximal portion of said catheter and an outlet of said canister to permit the mixture of medicine and propellant from said canister to be transmitted through said at least one lumen and out said plurality of exit orifices.