Methods, Devices And Formulations For Targeted Endobronchial Therapy

• US 20130298904A1
• Filed: 07/01/2013
• Published: 11/14/2013
• 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 10,004,858 B2
• Time in Patent Office: Days
• US Class Current: 128/200.14
• 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

6. A device consisting of tubing configured approximately as a Y piece, said device having a first end attachable to an inspiratory line of a ventilator, a second end attachable to an expiratory line of said ventilator, and a stem attachable to an endotracheal tube, wherein said stem comprises consisting of a lumen and an aerosol generator, said aerosol generator comprising consisting essentially of a fluid-containing reservoir, a vibrational element, a dome-shaped aperture plate with tapered holes and lacking both a propellant and a fluid driving element.

7. The device of claim 6, wherein the fluid in said fluid-containing reservoir comprises an antibiotic.

8. The device of claim 7, wherein said antibiotic comprises amikacin.

9. The device of claim 6, wherein said aerosol generator is intermediate to said stem and to said endotracheal tube.

10. A method of administering medicaments to a mechanically ventilated patient, the method comprising:

1) providing a ventilator circuit, said ventilator circuit comprising;

a) a ventilator and an inspiratory line, said inspiratory line coupled to the ventilator and providing a flow of air to the patient;

b) an expiratory line coupled to the ventilator to conduct a flow of air from said patient;

c) an endotracheal tube inserted into said patient'"'"'s airway, and

d) a tubing device configured approximately as a Y piece, said device having a first end attached to said inspiratory line, a second end attached to said expiratory line, and a stem attached to said endotracheal tube and comprising a lumen through which air in the circuit flows, wherein said stem comprises an aerosol generator, said aerosol generator comprising a fluid-containing reservoir, a vibrational element, a dome-shaped aperture plate with tapered holes and lacking both a propellant and a fluid driving element, wherein the vibration of the plate causes fluid in said fluid-containing reservoir to be drawn through the tapered holes; and

2) administering aerosolized medicaments to said patient via said aerosol generator.

11. The device of claim 10, wherein said fluid in said fluid-containing reservoir comprises an antibiotic.

12. The device of claim 11, wherein said antibiotic comprises amikacin.

13. The device of claim 10 wherein said tubing device configured approximately as a Y-piece is adapted to replace a conventional Y-piece of a ventilator circuit, said conventional Y-piece lacking an aerosol generator.

14. A method of administering medicaments via an aerosol generator to a mechanically ventilated patient, the method comprising:

1) providing a ventilator circuit comprising, in fluidic communication;

a) a ventilator and an inspiratory line, said inspiratory line coupled to the ventilator and providing a flow of air to the patient;

b) an expiratory line coupled to the ventilator to conduct a flow of air from said patient;

c) an endotracheal tube inserted into said patient'"'"'s airway, and

d) a first tubing device lacking said aerosol generator and configured approximately as a first Y piece, said Y piece having a first end attached to said inspiratory line, a second end attached to said expiratory line, and a stem attached to said endotracheal tube and comprising a regular lumen through which air in the circuit is flowing;

2) providing a second tubing device configured approximately as a second Y piece to replace said first tubing device, said second Y piece having a stem, wherein said second Y piece stem comprises a lumen and said aerosol generator, said aerosol generator comprising a fluid-filled reservoir, a vibrational element, a dome shaped aperture plate with tapered holes, and lacking both a propellant and a fluid driving element, wherein the vibration of the plate causes fluid in said fluid-containing reservoir to be drawn through the tapered holes; and

wherein said second tubing device is not attached to said circuit;

3) opening said circuit and replacing said first tubing device with said second tubing device;

4) closing said circuit; and

5) administering aerosolized medicaments to said patient via said aerosol generator.

1. A device comprising tubing configured approximately as a Y piece, said device having a first end attachable to an inspiratory line of a ventilator, a second end attachable to an expiratory line of said ventilator, and a stem attachable to an endotracheal tube, wherein said stem comprises a lumen and an aerosol generator, said aerosol generator comprising a fluid-containing reservoir, a vibrational element, a dome-shaped aperture plate with tapered holes, and lacking both a propellant and a fluid driving element, wherein the vibration of the plate causes fluid in said fluid-filled reservoir to be drawn through the tapered holes.

2. The device of claim 1, wherein said aerosol generator is integral to said stem.

3. The device of claim 1, wherein said aerosol generator extends through said stem.

4. The device of claim 1, wherein said fluid in said fluid-containing reservoir comprises an antibiotic.

5. The device of claim 4, wherein said antibiotic comprises amikacin.

15. The method of claim 14, wherein the fluid of said fluid-containing reservoir comprises an antibiotic.

16. The method of claim 15 wherein said antibiotic is amikacin.

17. The method of claim 15, wherein said fluid further comprises a second antibiotic.

17-1. The method of claim 15, wherein said fluid further comprises a second antibiotic.