Methods, devices and formulations for targeted endobronchial therapy

• US 7,334,580 B2
• Filed: 05/06/2003
• Issued: 02/26/2008
• 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.
• Primary Examiner(s): Yu; Justine R.
• Assistant Examiner(s): DIXON, ANNETTE FREDRICKA
• Application Number:
  US10/430,658
• Publication Number:
  US 20040011358A1
• Time in Patent Office: 1,757 Days
• Field of Search: 128/200.11, 128/200.14, 128/200.21, 128/200.22, 128/200.24, 128/202.27, 128/203.12, 128/203.13, 128/203.14, 128/203.16, 128/203.17, 128/203.26, 128/204.14, 128/204.18, 128/207.14, 128/207.15, 128/911, 128/912, 128/DIG.26, 128/264.14
• US Class Current: 128/207.14
• 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 method and novel devices for treating tracheobronchitis, bronchiectasis and pneumonia in the intubated 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 devices eliminate the dosage variability that ventilator systems engender when aerosols are introduced via the ventilator circuit. The treatment 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 device, comprising a fluid driving element comprising a plunger driven by compressed gas, said compressed gas stored in a canister, wherein said fluid driving element is attached to a dose metering element, said dose metering element engaged to an aerosolizing catheter, said catheter comprising an aerosol delivery end wherein said aerosol is generated by nebulization, wherein said aerosolizing catheter is dimensioned to fit inside an endotracheal tube of an intubated patient, such that the delivery end of the catheter, out of which the aerosol is delivered, extends below the end of the tube, thereby delivering aerosol in a manner that bypasses the tube.

2. The device of claim 1, wherein said dose metering element is detachably engaged to said aerosolizing catheter.

3. The device of claim 2, wherein said dose metering element comprises a reservoir of defined volume.

4. The device of claim 3, wherein said reservoir is configured as a transparent or semi-transparent cylinder.

5. The device of claim 4, wherein said cylinder comprises visible measurement indicia.

6. The device of claim 1, wherein said delivery end of said aerosolizing catheter comprises a baffle.

7. A device, comprising a fluid driving element comprising a plunger driven by compressed gas, said compressed gas stored in a canister, wherein said fluid driving element is attached to a dose metering element, said dose metering element detachably engaged to an aerosolizing catheter, said catheter comprising an aerosol delivery end wherein said aerosol is generated by nebulization, wherein said aerosolizing catheter is dimensioned to fit inside an endotracheal tube of an intubated patient, such that the delivery end of the catheter, out of which the aerosol is delivered, extends below the end of the tube, thereby delivering aerosol in a manner that bypasses the tube.

8. The device of claim 7, wherein said dose metering element comprises a reservoir of defined volume.

9. The device of claim 8, wherein said reservoir is configured as a transparent or semi-transparent cylinder.

10. The device of claim 9, wherein said cylinder comprises visible measurement indicia.