Methods, devices and formulations for targeted endobronchial therapy

• US 20050211245A1
• Filed: 11/30/2004
• Published: 09/29/2005
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Smaldone, Gerald C., Palmer, Lucy B.
• Granted Patent: US 7,607,436 B2
• Time in Patent Office: Days
• US Class Current: 128/204.180
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/06 of the injector type
• 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 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0484 at the distal end
• CPC Class Codes: A61M 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• 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: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators
• CPC Class Codes: A61P 31/04 Antibacterial agents

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

1-15. -15. (canceled)

16. A method, comprising

a) providing a subject attached to a ventilator circuit via a tube selected from an endotracheal tube and a tracheostomy tube, said ventilator circuit comprising i) an inspiratory line and an expiratory line converging at a junction, ii) a nebulizer positioned in proximity to said junction and in fluid communication with said tube, wherein said nebulizer is not positioned in said inspiratory line or said expiratory line;

b) administering aerosolized antibiotic to said subject via said nebulizer.

17. The method of claim 16, wherein said subject is a patient exhibiting one or more symptoms of infection.

18. The method of claim 16, wherein said nebulizer, prior to step (b) contains an antibiotic formulation.

19. The method of claim 18, wherein said antibiotic formulation comprises a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria.

20. A method, comprising

a) providing a patient exhibiting one or more symptoms of microbial infection, said patient intubated with a tube selected from endotracheal tubes and tracheostomy tubes, said tube connected to a ventilator circuit comprising i) an inspiratory line and an expiratory line converging at a junction, ii) a nebulizer positioned in proximity to said junction and in fluid communication with said tube, wherein said nebulizer is not positioned in said inspiratory line or said expiratory line, and wherein said nebulizer contains a formulation comprising two or more antibiotics;

b) administering said formulation as an aerosol to said patient via said nebulizer.

21. The method of claim 20, wherein said formulation comprises a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria.

22. The method of claim 20, wherein said inspiratory and said expiratory lines are connected to a mechanical ventilator.

23. The method of claim 22, wherein said mechanical ventilator controls a breathing cycle, said cycle comprising an inspiration phase.

24. The method of claim 23, wherein said administering of said aerosol of step (b) is actuated on the inspiration phase of the breathing cycle.

25. The method of claim 22, wherein said mechanical ventilator comprises a humidifying element.

26. The method of claim 25, wherein said administering of said aerosol of step (b) is actuated when said humidifying element is not active.