Methods, devices and formulations for targeted endobronchial therapy

• US 20040011358A1
• Filed: 05/06/2003
• Published: 01/22/2004
• Est. Priority Date: 05/07/2002
• Status: Active Grant

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: State University of New York at Stony Brook (State University of New York)
• Inventors: Smaldone, Gerald C., Palmer, Lucy B.
• Granted Patent: US 7,334,580 B2
• Time in Patent Office: Days
• US Class Current: 128/200.24
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/107 in the inspiratory path

Abstract

The present invention provides an improved means of treating tracheobronchitis, bronchiectasis and pneumonia in the nosocomial patient, preferably with aerosolized anti gram-positive and anti-gram negative antibiotics administered in combination or in seriatim in reliably sufficient amounts for therapeutic effect. In one aspect, the invention assures this result when aerosol is delivered into the ventilator circuit. In one embodiment the result is achieved mechanically. In another embodiment, the result is achieved by aerosol formulation. In another aspect, the invention assures the result when aerosol is delivered directly to the airways distal of the ventilator circuit. The treatment means eliminates the dosage variability that ventilator systems engender when aerosols are introduced via the ventilator circuit. The treatment means also concentrates the therapeutic agent specifically at affected sites in the lung such that therapeutic levels of administrated drug are achieved without significant systemic exposure of the patient to the drug. The invention further provides a dose control device to govern this specialized regimen.

Claims

1. A method, comprising:

a) providing;

i) a patient, said patient intubated with a tube selected from endotracheal tubes and tracheostomy tubes, said tube having a lower end and an upper end;

ii) a formulation comprising a first antibiotic;

iii) a aerosol delivery device comprising an upper end and a lower end, said lower end comprising an aerosol delivery end configured to fit within said patient'"'"'s trachea;

b) inserting said aerosol delivery end of said device within said patient'"'"'s trachea to create a positioned device; and

c) aerosolizing said formulation under conditions such that said formulation is delivered through said aerosol delivery end of said positioned device to said patient, wherein said aerosol first contacts said trachea.

2. The method of claim 1, wherein said aerosol delivery device comprises an aerosol delivery catheter.

3. The method of claim 1, wherein said aerosol delivery device comprises a bronchoscope fitted with an aerosolizing nozzle.

4. The method of claim 1, wherein said aerosol delivery device comprises a metered dose inhaler fitted with a nozzle extension.

5. The method of claim 1, wherein said formulation further comprises a second antibiotic, wherein said first antibiotic has activity against gram positive bacteria and said second antibiotic has activity against gram negative bacteria.

6. A method, comprising:

a) providing;

i) an intubated patient exhibiting one or more symptoms of microbial infection,

ii) a formulation comprising a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria;

iii) a aerosol delivery catheter comprising an upper end and a lower end, said lower end comprising an aerosol delivery end configured to fit within said tube;

b) inserting said aerosol delivery end of said catheter within said tube to create a positioned catheter; and

c) aerosolizing said formulation under conditions such that said formulation is delivered through said positioned catheter to said patient.

7. The method of claim 6, wherein said tube is connected to a mechanical ventilator.

8. The method of claim 7, wherein said mechanical ventilator controls a breathing cycle, said cycle comprising an inspiration phase of the breathing cycle.

9. The method of claim 7, wherein said aerosolizing of step (c) is actuated on the inspiration phase of the breathing cycle.

10. The method of claim 6, wherein said aerosol delivery end of said positioned catheter extends below said lower end of said tube.

11. A method, comprising:

a) providing;

i) a patient exhibiting an elevated white blood cell count;

ii) a formulation comprising a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria;

iii) a aerosol delivery device comprising an upper end and a lower end, said lower end comprising an aerosol delivery end configured to fit within said patient'"'"'s trachea;

b) inserting said aerosol delivery end of said device within said patient'"'"'s trachea to create a positioned device; and

c) aerosolizing said formulation under conditions such that said formulation is delivered through said aerosol delivery end of said positioned device to said patient to create a treated patient, wherein said aerosol first contacts said trachea.

12. The method of claim 11, wherein said aerosol delivery device comprises an aerosol delivery catheter.

13. The method of claim 11, further comprising d) measuring the white blood cell count of said treated patient after step (c).

14. A device, comprising a fluid driving element attached to a dose metering element, said dose metering element engaged to an aerosolizing catheter, said catheter comprising an aerosol delivery end.

15. The device of claim 14, wherein said dose metering element is detachably engaged to said aerosolizing catheter.

16. The device of claim 15, wherein said dose metering element comprises a reservoir of defined volume.

17. The device of claim 16, wherein said reservoir is configured as a transparent or semi-transparent cylinder.

18. The device of claim 17, wherein said cylinder comprises visible measurement indicia.

19. The device of claim 14, wherein said fluid driving element comprises a plunger driven by compressed gas, said compressed gas stored in a canister.

20. The device of claim 14, wherein said aerosolizing catheter is of such dimensions such that it can to fit inside an endotracheal tube.

21. The device of claim 14, wherein said delivery end of said aerosolizing catheter, comprises a baffle.

22. A device comprising tubing configured approximately as a Y piece, said device having a first end attachable to a ventilator and a second end attachable to an endotracheal tube, wherein said second end comprises an aerosol generator.

23. The device of claim 22, wherein said aerosol generator is integral to said second end.

24. The device of claim 23, wherein said aerosol generator is drug-loaded.