Nebulizing catheter system and method of use and manufacture

• US 6,526,976 B1
• Filed: 03/10/1999
• Issued: 03/04/2003
• Est. Priority Date: 06/17/1994
• Status: Expired due to Fees

• Current Assignee: Trudell Medical Limited
• Original Assignee: Trudell Medical Limited
• Inventors: Baran, George
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/265,602
• Time in Patent Office: 1,455 Days
• Field of Search: 128/200.14, 128/200.22, 128/200.23, 128/203.12, 128/200.16, 128/200.26, 128/207.14
• US Class Current: 128/207.14
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/042 with separate conduits for in-and expiration gas, e.g. for limited dead volume
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0484 at the distal end
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 : Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026

Abstract

A method and apparatus for delivering a medicine to a patient via the patient'"'"'s respiratory system with control and efficiency. A nebulization catheter is positioned in the patient'"'"'s respiratory system so that a distal end of the nebulization catheter is in the respiratory system and a proximal end is outside the body. In a first aspect, the nebulization catheter may be used in conjunction with an endotracheal tube and preferably is removable from the endotracheal tube. The nebulization catheter conveys medicine in liquid form to the distal end at which location the medicine is nebulized by a pressurized gas or other nebulizing mechanism. The nebulized medicine is conveyed to the patient'"'"'s lungs by the patient'"'"'s respiration which may be assisted by a ventilator. By producing the aerosol of the liquid medicine at a location inside the patient'"'"'s respiratory system, the nebulizing catheter provides for increased efficiency and control of the dosage of medicine being delivered. In further aspects of the nebulizing catheter apparatus and method, alternative tip constructions, flow pulsation patterns, centering devices, sensing devices, and aspiration features afford greater efficiency and control of aerosolized medicine dosage delivery.

Claims

1. A method for delivering a medicine to a patient, comprising:

positioning an endotracheal tube in the patient;

positioning a nebulization catheter in the patient; and

operating the nebulization catheter to produce an aerosol of the medicine at a distal end of the nebulization catheter while the endotracheal tube is positioned in the patient by applying an electric signal to the distal end of the nebulization catheter to produce the aerosol from said distal end.

2. The method of claim 1, wherein the endotracheal tube and the nebulization catheter are positioned in a respiratory system of the patient, and wherein the aerosol is delivered to the respiratory system.

3. The method of claim 2 in which the step of operating the nebulization catheter further comprises:

delivering a liquid medicine to a first orifice located at the distal end of the nebulization catheter; and

delivering a pressurized gas to a second orifice located at the distal end of the nebulization catheter in proximity to the first orifice.

4. The method of claim 3 further comprising the steps of:

imparting pulsation to the liquid being delivered.

5. The method of claim 4 in which the pulsation is imparted at a frequency greater than 100 hertz.

6. The method of claim 4 in which the pulsation is applied to a proximal reservoir from which the liquid medicine is supplied.

7. The method of claim 4 in which the pulsation is associated with the delivery of less than approximately 10 microliters of liquid medicine.

8. The method of claim 4 in which the nebulization catheter is operated to produce the aerosol in synchronism with the patient'"'"'s inhalation.

9. The method of claim 2 further comprising:

centering the nebulization catheter in the endotracheal tube.

10. The method of claim 2 in which the step of positioning a nebulization catheter further comprises:

positioning a nebulization catheter through an auxiliary lumen of the endotracheal tube.

11. The method of claim 2 further comprising:

removing the nebulization catheter while leaving the endotracheal tube in position in the patient'"'"'s respiratory system.

12. The method of claim 2 further comprising:

providing a coaxial airflow to said distal end of said nebulization catheter to constrain aerosol therefrom.

13. The method of claim 2 further comprising:

providing humidification to the patient'"'"'s respiratory system.

14. The method of claim 2 in which the nebulization catheter is positioned in a patient who has a tracheotomy.

15. The method of claim 2 in which the nebulization catheter is positioned via a tracheotomy tube.

16. The method of claim 2 in which production of the aerosol at the distal end of the nebulization catheter is synchronized with inhalation of the patient.

17. The method of claim 16 further comprising the step of:

pulsing delivery of liquid.

18. The method of claim 17 further comprising the step of:

pulsing delivery of gas.

19. The method of claim 16 further comprising the step of:

pulsing delivery of gas.

20. The method of claim 16 in which production of the aerosol is begun in advance of the inhalation of the patient.

21. The method of claim 2 further comprising the steps of:

sensing a physiological condition of the patient, and

operating the nebulization catheter to produce the aerosol as a function of the condition sensed.

22. The invention of claim 2 wherein the aerosol is produced by vibrating a distal orifice of the nebulizing catheter.

23. The invention of claim 22 wherein the vibrating is produced by a mechanical means in a shaft of the nebulization catheter.

24. The invention of claim 22 wherein the vibrating is produced by a mechanical means near the distal orifice of he nebulization catheter.

25. The method of claim 1 in which the step of positioning the nebulization catheter further comprising:

receiving an indication of the position of the nebulization catheter relative to the endotracheal tube.

26. The method of claim 25 in which the indication is a tactile indication.

27. The method of claim 25 in which the step of receiving an indication further comprises:

receiving a indication of a pressure variation at a distal end of the endotracheal tube as the distal end of the nebulization catheter is moved past.

28. The invention of claim 1 wherein the electric signal applied to the distal end of the nebulization catheter causes a vibration that produces the aerosol.

29. The invention of claim 1 wherein the electric signal applied to the distal end of the nebulization catheter is applied to a piezoelectric material.

30. The invention of claim 1 wherein the electric signal applied to produce an aerosol by ultrasonic vibration.

31. The invention of claim 1 wherein the electric signal applied to produce an aerosol by electrospray.

32. The invention of claim 1 wherein the electric signal applied to produce an aerosol from a single lumen of the catheter.

33. A method for delivering a medicine to a patient, comprising:

positioning an endotracheal tube in the patient;

positioning a nebulization catheter in the patient; and

operating the nebulization catheter to produce an aerosol of the medicine at a distal end of the nebulization catheter while the endotracheal tube is positioned in the patient; and

balancing airflow at the distal end of the nebulization catheter by withdrawing air through a vacuum lumen extending through the nebulization catheter.

34. The method of claim 33, wherein the endotracheal tube and the nebulization catheter are positioned in a respiratory system of the patient, and wherein the aerosol is delivered to the respiratory system.

35. The method of claim 34 in which the step of operating the nebulization catheter further comprises:

delivering a liquid medicine to a first orifice located at the distal end of the nebulization catheter; and

delivering a pressurized gas to a second orifice located at the distal end of the nebulization catheter in proximity to the first orifice.

36. The method of claim 34 further comprising:

removing the nebulization catheter while leaving the endotracheal tube in position in the patient'"'"'s respiratory system.

37. The method of claim 34 further comprising:

providing a coaxial airflow to said distal end of said nebulization catheter to constrain aerosol therefrom.

38. The method of claim 34 in which the step of positioning the nebulization catheter further comprises:

receiving an indication of the position of the nebulization catheter relative to the endotracheal tube.

39. The method of claim 38 in which the indication is a tactile indication.

40. The method of claim 38 in which the step of receiving an indication further comprises:

receiving a indication of a pressure variation at a distal end of the endotracheal tube as the distal end of the nebulization catheter is moved past.

41. The method of claim 34 in which production of the aerosol at the distal end of the nebulization catheter is synchronized with inhalation of the patient.

42. The method of claim 41 further comprising the step of:

pulsing delivery of one of liquid arid gas through the nebulization catheter.

43. The method of claim 34 further comprising the steps of:

sensing a physiological condition of the patient, and

operating the nebulization catheter to produce the aerosol as a function of the condition sensed.

44. The method of claim 33 further comprising the step of:

positioning the nebulization catheter in a working channel of a bronchoscope.