Apparatus and method for isolated lung access

• US 6,398,775 B1
• Filed: 10/21/1999
• Issued: 06/04/2002
• Est. Priority Date: 10/21/1999
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Pulmonx
• Inventors: Kotmel, Robert, Soltesz, Peter P., Perkins, Rodney A.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/425,272
• Time in Patent Office: 957 Days
• Field of Search: 604/96.01, 604/28, 604/35, 604/43, 604/500, 604/514, 604/101.04, 604/101.02, 604/102.03, 604/164.01, 604/164.03, 604/164.13, 604/171, 604/523, 604/912, 604/915
• US Class Current: 604/514
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• 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 16/0484 at the distal end
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2210/1039 Lungs
• 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 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Apparatus, systems, methods, and kits are provided for isolating a target lung segment and treating that segment, usually by drug delivery or lavage. The systems include at least a lobar or sub-lobar isolation catheter which is introduced beyond a second lung bifurcation (i.e., beyond the first bifurcation in a lobe of the lung) and which can occlude a bronchial passage at that point. An inner catheter is usually introduced through the isolation catheter and used in cooperation with the isolation catheter for delivering and/or removing drugs or washing liquids from the isolated lung region. Optionally, the inner catheter will also have an occluding member near its distal end for further isolation of a target region within the lung.

Claims

1. A method for delivering a substance to an isolated region of the lung, said method comprising:

positioning a visualizing tracheal tube in a trachea;

positioning a distal end of an isolation catheter through a lumen of the visualizing tracheal tube within a bronchial passage beyond a first branching within a right or left lung;

positioning an inner catheter through a main lumen of the isolation catheter so that a distal end of the inner catheter lies in a bronchiole distally beyond the distal end of the isolation catheter;

expanding an occlusion element near the distal end of the isolation catheter within the bronchial passage to isolate a target region;

providing a substance; and

delivering the substance through the inner catheter to the isolated region of the lung.

2. A method as in claim 1, wherein the substance comprises pharmaceutical.

3. A method as in claim 1 or 2, wherein the substance comprises an aerosol or gas.

4. A method as in claim 1 or 2, wherein the substance comprises a liquid.

5. A method as in claim 1, further comprising aspirating the substance through the isolation catheter.

6. A method as in claim 1, further comprising expanding an occlusion cuff on the visualizing tracheal tube and controlling ventilation of the patient'"'"'s lungs through the visualizing tracheal tube.

7. A method as in claim 6, wherein the isolated region and the remainder of the lung are maintained at different pressures.

8. A method as in claim 7, wherein the pressure within the isolated region is maintained at a higher pressure than the remainder of the lung.

9. A method as in claim 7, wherein the pressure within the isolated region is maintained at a lower pressure than the remainder of the lung.

10. A method as in claim 1, further comprising positioning a guidewire to a point beyond the location in the bronchial passage where the occlusion element is to be expanded, wherein positioning the isolation catheter comprises introducing the isolation catheter over the guidewire.

11. A method as in claim 10, further comprising viewing the guidewire using optical and illumination fibers carried by the isolation catheter as the guidewire is steered through bifurcations in the lungs.

12. A method as in claim 10, further comprising viewing the guidewire fluoroscopically as the guidewire is steered through bifurcations in the lung.

13. A method as in claim 1, further comprising drawing or advancing the inner catheter through the bronchiole while delivering the substance.

14. A method as in claim 1, further comprising repositioning the inner catheter within the isolated region and delivering the substance to two or more locations.

15. A method as in claim 1, further comprising expanding an occlusion element near the distal end of the inner catheter to isolate a distal portion of the bronchial passage so that an isolated region is disposed between the occlusion element on the isolation catheter and the occlusion element on the inner catheter.

16. A method as in claim 15, wherein the substance is delivered through one or more delivering ports on the inner catheter proximal to the occlusion element.

17. A method for lavaging an isolated region of a lung, said method comprising:

positioning a visualizing endotracheal tube in a trachea;

positioning a distal end of an isolation catheter through a lumen of the visualizing tracheal tube within a bronchial passage beyond a first branching within a right or left lung;

positioning an inner catheter through a main lumen of the isolation catheter so that a distal end of the inner catheter lies in a bronchiole distally beyond the distal end of the isolation catheter;

expanding an occlusion element near the distal end of the isolation catheter within the bronchial passage to isolate a target region of the lung;

infusing a washing liquid through one of the inner catheter or the isolation catheter to the isolated region of the lung; and

aspirating the washing liquid from the isolated region through the other of the inner catheter or the isolation catheter.

18. A method as in claim 17, wherein the washing liquid is infused through the inner catheter and aspirated through the isolation catheter.

19. A method as in claim 17, wherein the washing liquid is infused through the isolation catheter and aspirated through the inner catheter.

20. A method as in claim 17, wherein the washing liquid is alternately infused through the inner catheter and the isolation catheter and aspirated through the isolation catheter and the inner catheter.

21. A method as in claim 17, wherein a bolus of the washing liquid is introduced and held within the isolated region for a retention time period prior to initiating aspiration.

22. A method as in claim 17, wherein the infusing and the aspirating of the washing liquid are performed simultaneously.

23. A method as in claim 17, wherein the washing liquid comprises a pharmaceutical substance.

24. A method as in claim 17, further comprising expanding an occlusion cuff on the visualizing tracheal tube and ventilating the patient'"'"'s lungs through the visualizing tracheal tube at a controlled pressure.

25. A method as in claim 24, further comprising controlling pressure of the target isolated region, wherein the isolated region and the remainder of the lung may be controlled at different pressures.

26. A method as in claim 25, wherein the pressure within the isolated region is maintained at a higher pressure than the remainder of the lung.

27. A method as in claim 25, wherein the pressure within the isolated region is maintained at a lower pressure than the remainder of the lung.

28. A method as in claim 17, further comprising positioning a guidewire to a point beyond the location in the bronchial passage where the occlusion element is to be expanded, wherein positioning the isolation catheter comprises introducing the catheter over the guidewire.

29. A method as in claim 28, further comprising viewing the guidewire using optical and illumination fibers carried by the isolation catheter as the guidewire is steered through bifurcations in the lungs.

30. A method as in claim 28 further comprising viewing the guidewire fluoroscopically as the guidewire is steered through bifurcations in the lung.

31. A method as in claim 17, further comprising drawing or advancing the inner catheter through the bronchiole while delivering the washing liquid.

32. A method as in claim 17, further comprising repositioning the inner catheter within the isolated region and delivering the washing liquid to two or more locations.

33. A method as in claim 17, further comprising expanding an occlusion element near the distal end of the inner catheter to isolate a distal portion of the bronchial passage so that the isolated region is disposed between the occlusion element on the isolation catheter and the occlusion element on the inner catheter.

34. A method as in claim 33, wherein the washing liquid is delivered through one or more delivering ports on the inner catheter proximal to the occlusion element.