Method of treating a bronchial tube with a bronchial stenter having diametrically adjustable electrodes

• US 6,283,989 B1
• Filed: 03/29/1999
• Issued: 09/04/2001
• Est. Priority Date: 04/07/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Broncus Technologies, Inc
• Inventors: Tanaka, Donald A., Laufer, Michael D., Loomas, Bryan E., Burger, Keith M.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/280,672
• Time in Patent Office: 890 Days
• Field of Search: 606/2, 606/13-19, 606/27-31, 606/41, 606/42, 606/49-50, 607/88-89, 607/92, 607/96, 607/98, 607/99-102, 607/104, 607/105, 607/116
• US Class Current: 607/96
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

A device and method for treating collapsed bronchial tubes found in patients with chronic obstructive pulmonary disease and asthma are provided. The device delivers energy so that the tissue is inductively heated by directing electromagnetic energy into the tissue. The device includes electrodes having adjustable diameters to enable the electrodes to contact the wall of the bronchial tubes. The method includes heating the bronchial tube to cause at least a portion of the cross links of the collagen in the wall to unlink/open and subsequently form new cross links after the collagen fibers have realigned. The procedure effectively reinforces the structural integrity of the wall and thereby prevents the lumen from collapsing.

Claims

1. A method of treating a bronchial tube comprising a lumen of an individual that comprises the step of:

heating a wall of the lumen to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall, the step of heating the wall comprises advancing a treatment device into the lumen of the bronchial tube, and activating the treatment device to raise the temperature of the wall to sufficiently effect a structural transformation in the wall; and

wherein the treatment device comprises at least one balloon that is attached to the treatment device wherein each balloon inflates upon the injection of a fluid into the balloon and each balloon has at least one electrode that is attached thereto and which when energized causes the wall of the lumen to undergo a structural transformation effective to render the wall capable of supporting a non-collapsed lumen;

a source of fluid having a conduit in fluid communication with said balloon;

a source of energy; and

means for transmitting energy from the source of energy to the at least one electrode.

2. The method of claim 1 wherein each electrode is positioned on an exterior surface of a balloon.

3. The method of claim 1 wherein the source of energy is an RF generator, and the at least one electrode comprises a first electrode which is connected to an electrode that is at one polarity of the RF generator and a second electrode which is connected to a second RF electrode that is at the opposite polarity of the RF generator.

4. The method of claim 1 wherein the source of energy produces energy that is selected from the group consisting of RF energy, alternating current, and microwaves and combinations thereof.

5. The method of claim 1 wherein the source of energy is an RF generator, and the treatment device comprises at least three electrodes.

6. The method of claim 5 wherein said at least three electrodes includes first electrode(s) that are connected to a positive electrode of the RF generator and second electrode(s) that are connected to the negative electrode of the RF generator.

7. The method of claim 5 wherein the treatment device comprises an external electrode and the RF generator having the first RF electrode that is at one polarity and the second RF electrode that is at the opposite polarity and wherein said at least three electrodes are connected to the first RF electrode and the external electrode is connected to second RF electrode of the RF generator.

8. The method of claim 7 wherein the step of activating the treatment device comprises operating the at least three electrodes simultaneously.

9. The method of claim 1 wherein the source of energy delivers 1 to 25 watts of power.

10. The method of claim 5 wherein said at least three electrodes comprises first, second, and third electrodes, and the step of activating the treatment device comprises the steps of:

connecting the first electrode to the first RF electrode having one polarity of the RF generator and connecting the second electrode to the second RF electrode having the opposite polarity of the RF generator and thereafter activating the RF generator and heating a first section of wall in the lumen;

deactivating the RF generator;

disconnecting the first electrode from said first RF electrode of the RF generator; and

connecting the third electrode to said first RF electrode of the RF generator and thereafter activating the RF generator and heating a second section of wall of the lumen.

11. The method of claim 1 wherein the wall is heated to a temperature in the range between about 60°

C. and about 95°

C.

12. The method of claim 11 wherein the wall is heated to a temperature in the range between about 70°

C. and about 85°

C.

13. The method of claim 1 wherein the wall is heated for about 0.1 to about 600 seconds.

14. The method of claim 13 wherein the wall is heated for about 5 to about 60 seconds.

15. A method of treating a bronchial tube comprising a lumen of an individual that comprises the step of:

heating a wall of the lumen to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall, the step of heating the wall comprises advancing a treatment device into the lumen of the bronchial tube, and activating the treatment device to raise the temperature of the wall to sufficiently effect a structural transformation in the wall; and

wherein the treatment device comprises at least one radially adjustable electrode;

means for applying force to the at least one radially adjustable electrode to change the diameter of the at least one electrode;

a source of energy; and

means for transmitting energy from the source of energy to the at least one electrode.

16. The method of claim 15 wherein the means for applying force applies torque to the at least one radially adjustable electrode to change the electrode diameter.

17. The method of claim 15 wherein the means for applying force changes the axial length of the at least one radially adjustable electrode.

18. The method of claim 15 wherein the means for applying force applies torque to the at least one radially adjustable electrode to change the electrode diameter and changes the axial length of the at least one radially adjustable electrode.

19. The method of claim 15 wherein the treatment device comprises an elongated rod that has a distal end, wherein the at least one radially adjustable electrode comprises a wire that is wound about and along the axis of the elongated rod and which has a first end and a second end, wherein the first end is connected to the distal end of the elongated rod.

20. The method of claim 19 wherein the wire defines a barrel configuration with a center having a first diameter and two ends having second and third diameters and wherein the first diameter is longer than that of the second diameter and of the third diameter.

21. The method of claim 16 wherein the treatment device comprises an elongated rod that has a distal end, wherein the treatment device comprises a plurality of electrodes that are designated the first electrode, second electrode, and final electrode, respectively, and that are positioned in tandem so that a first electrode is attached to the distal end of the elongated rod, wherein each electrode comprises a wire that is wound about and along the axis of the elongated rod and each electrode has a first end and a second end, with the proviso that when the number of electrodes is two, the treatment device includes a rotatable coupler which is attached to the second end of the first electrode and to the first end of the second electrode, and with the further proviso that when the number of electrodes is three or more, the electrodes are designated from one to n, and the first end of the electrode one is connected to the distal end of the elongated rod and the second end of the electrode n is connected to an end coupler, and each of the remaining electrodes is connected to an adjacent electrode by a rotatable coupler.

22. The method of claim 21 wherein the end coupler is stationary.

23. The method of claim 21 wherein the means for applying force applies torque that rotates the distal end of the elongated rod.

24. The method of claim 16 wherein the source of energy is an RF generator, and the treatment device comprises at least three electrodes.

25. The method of claim 24 wherein said at least three electrodes includes first electrode(s) that are connected to a positive electrode of the RF generator and second electrode(s) that are connected to the negative electrode of the RF generator.

26. The method of claim 24 wherein the first electrode(s) are electrically insulated from the second electrode(s).

27. The method of claim 24 wherein the treatment device comprises an external electrode and the RF generator having the first RF electrode that is at one polarity and the second RF electrode that is at the opposite polarity and wherein said at least three electrodes are connected to the first electrode and the external electrode is connected to second electrode of the RF generator.

28. The method of claim 15 wherein the source of energy produces energy that is selected from the group consisting of RF energy, alternating current, and microwaves and combinations thereof.

29. The method of claim 15 wherein the source of energy delivers 1 to 25 watts of power.

30. The method of claim 25 wherein the step of activating the treatment device comprises operating the at least three electrodes simultaneously.

31. The method of claim 24 wherein said at least three electrodes comprises first, second, and third electrodes, and the step of activating the treatment device comprises the steps of:

connecting the first electrode to the first RF electrode having one polarity of the RF generator and connecting the second electrode to the second RF electrode having the opposite polarity of the RF generator and thereafter activating the RF generator and heating a first section of wall in the lumen;

deactivating the RF generator;

disconnecting the first electrode from said first RF electrode of the RF generator; and

connecting the third electrode to said first RF electrode of the RF generator and thereafter activating the RF generator and heating a second section of wall of the lumen.

32. The method of claim 15 wherein the wall is heated to a temperature in the range between about 60°

C. and about 95°

C.

33. The method of claim 32 wherein the wall is heated to a temperature in the range between about 70°

C. and about 85°

C.

34. The method of claim 15 wherein the wall is heated for about 0.1 to about 600 seconds.

35. The method of claim 34 wherein the wall is heated for about 5 to about 60 seconds.

36. A method of training a person to treat a bronchial tube comprising a lumen of an individual that comprises demonstrating or instructing the performance of the following steps:

heating a wall of the lumen to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall, the heating step comprises advancing a treatment device into the lumen of the bronchial tube of the individual, and activating the treatment device to raise the temperature of the wall to cause the wall to undergo a structural transformation; and

wherein the treatment device comprises at least one balloon that is attached to the treatment device wherein each balloon inflates upon the injection of a fluid into the balloon and each balloon has at least one electrode that is attached thereto and which when energized causes the wall of the lumen to undergo a structural transformation effective to render the wall capable of supporting a non-collapsed lumen;

a source of fluid having a conduit in fluid communication with said balloon;

a source of energy; and

means for transmitting energy from the source of energy to the at least one electrode.

37. The method of claim 36 wherein the wall is heated to a temperature in the range between about 60°

C. and about 95°

C.

38. The method of claim 36 wherein the wall is heated for about 0.1 to about 600 seconds.

39. A method of training a person to treat a bronchial tube comprising a lumen of an individual that comprises demonstrating or instructing the performance of the following steps:

heating a wall of the lumen to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall, the heating step comprises advancing a treatment device into the lumen of the bronchial tube of the individual, and activating the treatment device to raise the temperature of the wall to cause the wall to undergo a structural transformation; and

wherein the treatment device comprises at least one radially expandable electrode;

means for applying force to the at least one radially expandable electrode to change the diameter of the at least one electrode;

a source of energy; and

means for transmitting energy from the source of energy to the at least one electrode.

40. The method of claim 39 wherein the wall is heated to a temperature in the range between about 60°

C. and about 95°

C.

41. The method of claim 39 wherein the wall is heated for about 0.1 to about 600 seconds.