# US 7,607,436 B2 · Methods, devices and formulations for targeted endobronchial therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,607,436 B2 - Document ID: US7607436B2 - Status: Granted - Kind: B2 - Application number: 10/999,679 - Filed: 2004-11-30 - Published: 2005-09-29 - Granted: 2009-10-27 - Earliest claimed: 2002-05-06 - Assignees: The Research Foundation of State University of New York - Inventors: Gerald C. Smaldone; Lucy B. Palmer - Web page: https://patentgrep.com/patent/US7607436B2 ## CPC - A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)} - A61M 11/00: Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14}) - A61M 11/06: of the injector type - A61M 16/0057: {Pumps therefor} - A61M 16/04: Tracheal tubes (catheters in general A61M25/00) - A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections} - A61M 16/0484: {at the distal end} - A61M 16/08: Bellows; Connecting tubes {(having means for taking samples G01N1/22); Water traps; Patient circuits} - A61M 16/0808: {Condensation traps} - A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece} - A61P 11/06: Antiasthmatics - A61P 11/08: Bronchodilators - A61P 31/04: Antibacterial agents - A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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 ### Claim 1 A method, comprising: a) identifying 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 as liquid droplets from said nebulizer to said subject. ### Claim 2 (depends on 1) The method of claim 1, wherein said subject is a patient exhibiting one or more symptoms of infection. ### Claim 3 (depends on 1) The method of claim 1, wherein said nebulizer, prior to step (b) contains an antibiotic formulation. ### Claim 4 (depends on 3) The method of claim 3, wherein said antibiotic formulation comprises a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria. ### Claim 5 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 of liquid droplets from said nebulizer to said patient. ### Claim 6 (depends on 5) The method of claim 5, wherein said formulation comprises a first antibiotic having activity against gram positive bacteria and a second antibiotic having activity against gram negative bacteria. ### Claim 7 (depends on 5) The method of claim 5, wherein said inspiratory and said expiratory lines are connected to a mechanical ventilator. ### Claim 8 (depends on 7) The method of claim 7, wherein said mechanical ventilator controls a breathing cycle, said cycle comprising an inspiration phase. ### Claim 9 (depends on 8) The method of claim 8, wherein said administering of said aerosol of step (b) is actuated on the inspiration phase of the breathing cycle. ### Claim 10 (depends on 7) The method of claim 7, wherein said mechanical ventilator comprises a humidifying element. ### Claim 11 (depends on 10) The method of claim 10, wherein said administering of said aerosol of step (b) is actuated when said humidifying element is not active. ### Claim 12 (depends on 1) The method of claim 1, wherein said administering comprises, in seriatim, a first antibiotic and a second antibiotic. ### Claim 13 (depends on 1) The method of claim 1, wherein said subject is asymptomatic for infection. ### Claim 14 (depends on 12) The method of claim 12, wherein said first antibiotic is an anti-gram positive antibiotic and said second antibiotic is an anti-gram negative antibiotic. ### Claim 15 (depends on 12) The method of claim 12, wherein said first antibiotic is an anti-gram negative antibiotic and said second antibiotic is an anti-gram positive antibiotic. ### Claim 16 (depends on 2) The method of claim 2, wherein said subject is being treated systemically with an antibiotic. ### Claim 17 (depends on 2) The method of claim 2, wherein said infection is selected from the group consisting of tracheobronchitis, biofilm, and pneumonia. ### Claim 18 A method of reducing the incidence of antibiotic-resistant infection in patients in an ICU, comprising: a) identifying a plurality of intubated subjects in an intensive care unit being treated with a systemic antibiotic; and b) administering an aerosolized antibiotic to said subjects. ### Claim 19 (depends on 18) The method of claim 18, wherein said subjects are attached to a mechanical ventilator. ### Claim 20 (depends on 1) The method of claim 1, wherein said aerosolized antibiotic is administered directly to a member of the group consisting of the trachea, the bronchi, and the lung mucosa.