Device and method for measuring the diameter of an air passageway

• US 7,476,203 B2
• Filed: 10/26/2005
• Issued: 01/13/2009
• Est. Priority Date: 09/24/2002
• Status: Expired due to Term

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Westman, Peter R., Kutsko, James M., Sirokman, William A., DeVore, Lauri J., Dillard, David H.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/260,012
• Publication Number:
  US 20060155217A1
• Time in Patent Office: 1,175 Days
• Field of Search: 600/587, 600/593, 600/505, 600/549, 600/114, 600/103, 600/119, 600/120, 600/158, 604/98.01, 604/103.1, 604/104, 604/913, 604/99.03, 604/247, 604/248, 604/920, 606/41, 606/192, 606/2, 606/7, 606/15, 607/101, 128/200.26, 128/207.14, 137/614.2
• US Class Current: 600/587
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence

Abstract

The invention provides a device for measuring an inside diameter of a body lumen, such as an air passageway. The device includes a flexible catheter having an inflation lumen, a fluid dispenser in fluid communication with the inflation lumen and operable to communicate a measurable fluid volume change with the inflation lumen, and an expandable member in fluid communication with the inflation lumen and having a known relationship between volume and a changeable transverse dimension, the transverse dimension being changeable in response to fluid volume changes of the fluid dispenser and arranged for placement adjacent to opposing portions of an interior wall of the air passageway. The expandable member may be dimensioned for transoral placement into the air passageway, and may comprise a balloon that includes a complaint material.

Claims

1. A method of measuring an inside diameter of a native body lumen in a lung, the method comprising

preparing a measuring device that comprises a non-cylindrical expandable member;

inserting the member into the body lumen; and

after positioning the member in the body lumen, expanding the member and, while the member is expanded, moving the member axially along the body lumen to a desired location in order to measure the size of the body lumen at the desired location;

and then retracting the member, changing a diameter of the member and then advancing the member toward the desired location again.

2. The method of claim 1, wherein the member is positioned within a naturally substantially tapered portion of the body lumen when the member is expanded into the expanded configuration.

3. The method of claim 1, wherein the member is substantially ellipsoidal in shape when the member is in the expanded configuration.

4. The method of claim 1, wherein the expandable member is substantially spheroidal in shape when the member is in the expanded configuration.

5. The method of claim 1, wherein positioning the member in the body lumen comprises transorally placing the member in the body lumen.

6. The method of claim 1, wherein inserting the member into the body lumen comprises transorally placing the catheter and the balloon into the trachea and steering the catheter and the balloon toward the desired location.

7. The method of claim 1, wherein preparing the measuring device comprises fluidly coupling the member to a fluid source.

8. The method of claim 1, wherein preparing the measuring device comprises removing air bubbles from the measuring device.

9. The method of claim 1, wherein the fluid source comprises a plunger and a scale and the scale corresponds to various measurable diameters.

10. The method of claim 7, wherein the fluid source comprises a graduated syringe with graduations correlating to measurable diameters.

11. The method of claim 1 further comprising visually inspecting a periphery of the member to determine if the member is in contact with the body lumen.

12. A method of measuring an inside diameter of a native body lumen in a lung, the method comprising:

preparing a measuring device for insertion into a patient by supplying fluid to a fluid source, a lumen of the measuring device and a collapsed balloon and by removing air bubbles from the fluid;

positioning a distal end of the measuring device into a trachea of the patient and steering the distal end of the measuring device to a desired location in the native body lumen for measurement;

expanding the balloon in the native body lumen to a first trial transverse dimension of a known first dimension and advancing the expanded balloon toward the desired location;

examining a periphery of the balloon to determine whether the first dimension is adjacent to the inside wall of the native body lumen at the desired location; and

retracting the balloon from the desired location and expanding or contracting the balloon in the native body lumen to a second trial transverse dimension of a known second dimension and readvancing the expanded balloon toward the desired location.

13. The method of claim 12, wherein preparing the measuring device comprises aligning a piston of the fluid source with a marking to indicate position.

14. The method of claim 12, wherein the distal end of the measuring device is steered by being positioned within a working channel of a bronchoscope.

15. The method of claim 12, wherein the distal end of the measuring device is steered by being associated with and then steered by a bronchoscope.

16. The method of claim 12, wherein the distal end of the measuring device is steered by moving along a shaft of an already-inserted bronchoscope.

17. The method of claim 12, wherein the distal end of the measuring device is steered using imaging or visualization techniques.

18. The method of claim 12, wherein the balloon of the measuring device is deployed once the distal end of the measuring device is proximate the desired location.

19. The method of claim 18, wherein the balloon is advanced until a transverse dimension of the balloon is about a balloon length from the desired location.

20. The method of claim 12, wherein expanding the balloon comprises opening a valve, inserting fluid into the balloon and closing the valve such that fluid cannot be forced out of the balloon once the balloon has been expanded.

21. The method of claim 12 further comprising reexamining the periphery of the balloon to determine whether the second dimension is adjacent to the inside wall of the native body lumen at the desired location.

22. The method of claim 12 further comprising collapsing the balloon and repositioning the distal end of the measurement device.

23. The method of claim 12 further comprising collapsing the balloon and removing the distal end of the measurement device from the patient.

24. A method of measuring an inside diameter of a native body lumen in a lung, the method comprising:

preparing a measuring device for insertion into a patient by supplying fluid to a fluid source, a lumen of the measuring device and a collapsed balloon and by removing air bubbles from the fluid;

positioning a distal end of the measuring device into a trachea of the patient and steering the distal end of the measuring device to a desired location in the native body lumen for measurement;

expanding the balloon in the native body lumen to a first trial transverse dimension of a known first dimension and advancing the expanded balloon toward the desired location; and

examining a periphery of the balloon to determine whether the first dimension is adjacent to the inside wall of the native body lumen at the desired location;

wherein the balloon of the measuring device is deployed once the distal end of the measuring device is proximate the desired location, and wherein the balloon is advanced until a transverse dimension of the balloon is about a balloon length from the desired location.

25. The method of claim 24, wherein preparing the measuring device comprises aligning a piston of the fluid source with a marking to indicate position.

26. The method of claim 24, wherein the distal end of the measuring device is steered by being positioned within a working channel of a bronchoscope.

27. The method of claim 24, wherein the distal end of the measuring device is steered by being associated with and then steered by a bronchoscope.

28. The method of claim 24, wherein the distal end of the measuring device is steered by moving along a shaft of an already-inserted bronchoscope.

29. The method of claim 24, wherein the distal end of the measuring device is steered using imaging or visualization techniques.

30. The method of claim 24, wherein expanding the balloon comprises opening a valve, inserting fluid into the balloon and closing the valve such that fluid cannot be forced out of the balloon once the balloon has been expanded.

31. The method of claim 30 further comprising reexamining the periphery of the balloon to determine whether the second dimension is adjacent to the inside wall of the native body lumen at the desired location.

32. The method of claim 24 further comprising collapsing the balloon and repositioning the distal end of the measurement device.

33. The method of claim 24 further comprising collapsing the balloon and removing the distal end of the measurement device from the patient.