Bronchial stenter

• US 6,083,255 A
• Filed: 12/19/1997
• Issued: 07/04/2000
• 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: Laufer, Michael D., Loomas, Bryan E., Burger, Keith M., Tanaka, Donald A.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US08/994,064
• Time in Patent Office: 928 Days
• Field of Search: 606/27-31, 606/41, 606/49, 606/50, 607/96, 607/98-101, 607/113
• 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 which has a balloon at a distal end delivers energy so that the tissue is indirectly, i.e., conductively, heated by contact with a heated surface of the balloon which has been in turn heated by a heated fluid. 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 in an individual that comprises the step of:

heating a wall of the lumen with an expandable heat treatment device to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall.

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

C. and about 95°

C.

3. The method of claim 2 wherein the wall is heated for about 1 to about 600 seconds.

4. The method of claim 1 wherein 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 cause a structural transformation in the collagen of the wall.

5. A method of treating a bronchial tube comprising a lumen in an individual that comprise 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, wherein the treatment device comprises;

an elongated member with a balloon that is attached to a distal end wherein the balloon deforms and expands upon the injection of a fluid into the interior of the balloon;

a source of fluid; and

means for heating the fluid to a temperature sufficient to cause the wall of the lumen to undergo a structural transformation effective to render the wall capable of supporting a non-collapsed lumen.

6. The method of claim 5 wherein the means for heating the fluid comprises:

a source of energy; and

means for transmitting energy from the source of energy to the fluid.

7. The method of claim 5 wherein the means for heating the fluid comprises at least two electrodes.

8. The method of claim 5 wherein the means for heating the fluid comprises a first electrode which is connected to the positive electrode of an RF generator and a second electrode which is connected to the negative electrode of the RF generator.

9. The method of claim 8 wherein the first electrode has a first pole and the second electrode has a second pole that are located in the interior of the balloon and are in contact with the fluid.

10. The method of claim 6 wherein the source of energy generates RF energy or alternating current.

11. The method of claim 5 wherein the fluid is saline.

12. The method of claim 5 wherein the balloon is made of an elastic material.

13. The method of claim 5 wherein the balloon is made of an inelastic material.

14. The method of claim 5 wherein the fluid is saline.

15. A method of treating a bronchial tube comprising a lumen in 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, wherein the treatment device comprises;

an elongated member with a balloon that is attached to a distal end wherein the balloon deforms and expands upon the introduction of a heated fluid into the balloon;

a source of fluid; and

means for introducing the heated fluid into the balloon.

16. The method of claim 15 wherein the source of heated fluid comprises:

at least one electrode locating in the elongated member and which when energized heats a fluid to a temperature sufficient to cause 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 energy; and

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

17. The method of claim 16 wherein the at least one electrode comprises a first electrode which is connected to the positive electrode of an RF generator and a second electrode which is connected to the negative electrode of the RF generator.

18. The method of claim 16 wherein the source of energy generates RF energy or alternating current.

19. The method of claim 15 wherein the fluid is saline.

20. The method of claim 15 wherein the means for introducing the heated fluid includes means for circulating a heated fluid into and out of the balloon.

21. The method of claim 15 wherein the balloon is made of an elastic material.

22. The method of claim 15 wherein the balloon is made of a non-elastic material.

23. 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 with an expandable heat treatment device to a temperature effective to cause the wall to undergo a structural transformation to improve the structural integrity of the wall.

24. The method of claim 23 wherein the wall is heated to a temperature in the range between about 60°

C. and about 95°

C.

25. The method of claim 24 wherein the wall is heated for about 1 to about 600 seconds.

26. The method of claim 23 wherein the step of heating the wall 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 sufficiently effect a structural transformation of the wall.

27. The method of claim 26 wherein the treatment device comprises:

a treatment device comprising an elongated member with a balloon that is attached to a distal end wherein the balloon deforms and expands upon the injection of a fluid into the interior of the balloon;

a source of fluid; and

means for heating the fluid to a temperature sufficient to cause the wall of the lumen to undergo a structural transformation effective to render the wall capable of supporting a non-collapsed lumen.

28. The method of claim 26 wherein the treatment device comprises:

an elongated member with a balloon that is attached to a distal end wherein the balloon deforms and expands upon the introduction of a heated fluid into the balloon;

a source of the heated fluid; and

means for introducing the heated fluid into the balloon.

29. A method of treating a bronchial tube comprising:

heating a wall of the bronchial tube to a temperature of at least 70°

C. to cause the wall to undergo a structural transformation to improve the structural integrity of the wall.

30. The method of claim 29 wherein the wall is treated with a treatment device having an expandable distal end for contacting and heating the bronchial tube wall.

31. The method of claim 29 wherein the wall is heated to a temperature of about 70°

C. to about 95°

C.

32. The method of claim 29 wherein 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 at least 70°

C. to cause the structural transformation and improve the integrity of the wall.