Apparatus for pulmonary delivery of drugs with simultaneous liquid lavage and ventilation

• US 5,562,608 A
• Filed: 04/13/1995
• Issued: 10/08/1996
• Est. Priority Date: 08/28/1989
• Status: Expired due to Term

• Current Assignee: Temple University of The Commonwealth System of Higher Education
• Original Assignee: BioPulmonics, Inc. (Alliance Pharmaceutical Corporation), Temple University
• Inventors: Wolfson, Marla R., Shaffer, Thomas H., Sekins, K. Michael
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/424,577
• Time in Patent Office: 544 Days
• Field of Search: 604/19, 604/20, 128/200.14, 128/200.18, 128/200.21, 128/203.12, 128/200.24, 128/207.14, 128/207.15, 128/207.16, 128/898, 404/83
• US Class Current: 604/20
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61K 9/0026 Blood substitute; Oxygen transporting formulations; Plasma extender
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/0454 Redundant cuffs
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0479 above the cuff, e.g. giving access to the upper trachea
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61N 7/022 intracavitary
• CPC Class Codes: B06B 1/0633 Cylindrical array
• CPC Class Codes: Y10S 128/913 Breathable liquids
• CPC Class Codes: Y10T 137/87652 With means to promote mixing or combining of plural fluids

Abstract

An apparatus for producing a uniformly dispersed drug-containing phase within a continuous liquid delivery phase.

Claims

1. A method for pulmonary delivery of a biological agent, comprising the steps of:

providing a substantially homoqeneous liquid carrier comprising a fluorocarbon liquid;

suspending an immiscible biological agent in said liquid carrier; and

delivering said liquid carrier containing said biological agent through a human or animal'"'"'s pulmonary air passages.

2. The method of claim 1, wherein said suspending step is accomplished by dispersing said biological agent in droplet form into said liquid carrier.

3. The method of claim 2, wherein said dispersing accomplished by passing said biological agent through nozzles located within a flow of said liquid carrier.

4. A method for delivering a biological agent into a human or animal'"'"'s pulmonary system through the human or animal'"'"'s pulmonary air passages comprising the steps of:

a) providing an apparatus for delivery of a biological agent comprising a conduit having a proximal end adapted to receive a liquid carrier flow, at least one lumen defining a liquid carrier flow path within the conduit, a distal delivery end adapted for delivering the liquid carrier flow to a device that provides liquid communication to pulmonary air passages, a mechanical means for dispersing a biological agent in the liquid carrier flow path within the conduit comprising a plurality of nozzles disposed in spaced array within the liquid carrier flow path wherein each nozzle has a proximal end adapted to receive biological agent and a distal end adapted for delivering the biological agent as a dispersion in the liquid carrier flow;

b) introducing the apparatus for delivery of a biological agent into the pulmonary air passages of a human or animal;

c) establishing a flow of liquid carrier within the liquid carrier flow path;

d) establishing a flow of biological agent through the nozzles thereby dispersing the biological agent within the liquid carrier flow;

e) delivering the liquid carrier with dispersed biological agent into the pulmonary air passages of the human or animal.

5. The method of claim 4, wherein the liquid carrier comprises one or more of a fluorocarbon, a perfluorochemical, a perfluorocarbon, a breathable liquid, saline and silicon.

6. The method of claim 4, further comprising the step of providing the liquid carrier in a substantially degassed state as it is delivered into the pulmonary air passages.

7. The method of claim 4, further comprising a step of removing the liquid carrier from the pulmonary air passages.

8. The method of claim 4, further comprising a step of heating the pulmonary air passages, and tissues adjacent the pulmonary air passages, with an ultrasound producing device.

9. The method of claim 4, wherein the apparatus further comprises a temperature sensor and the method includes the step of sensing the temperature of the liquid carrier.

10. The method of claim 4, wherein the apparatus further comprises a pressure sensor and the method includes the step of sensing the pressure of the liquid carrier.

11. The method of claim 4, wherein the method further comprises the step of selectively sealing part of the pulmonary air passages from the remainder of the pulmonary air passages.

12. The method of claim 11, wherein the sealing step comprises inflating one or more inflatable cuffs.

13. The method of claim 4, wherein the introducing step is partially accomplished by using a fiber-optic system to locate the position of the apparatus within the pulmonary air passages.

14. The method of claim 8, wherein the heating step further comprises surgically entering the chest cavity to allow placement of the ultrasound producing device within the chest cavity.

15. The method of claim 4, wherein the biological agent is in a form comprising one or more of a suspension, a dispersion, a liquid, an emulsion, a powder and an encapsulation.

16. The method of claim 4, further comprising vibrating the nozzles.

17. The method of claim 4, further comprising providing oscillatory pulses of pressure to the nozzles.