Modification of airways by application of energy

• US 7,198,635 B2
• Filed: 04/14/2003
• Issued: 04/03/2007
• Est. Priority Date: 10/17/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Loomas, Bryan, Danek, Christopher James, Keast, Thomas, Biggs, Michael, Haugaard, Dave, Burger, Keith M.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/414,253
• Publication Number:
  US 20030233099A1
• Time in Patent Office: 1,450 Days
• Field of Search: 606/41, 606 48- 50, 607/122, 607 96-102, 607113-116
• US Class Current: 607/96
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

This relates to methods and devices for treating reversible chronic obstructive pulmonary disease, and more particularly, relates to a device for exchanging energy with airway tissue such as that found in the airway of human lungs. The exchange of energy with this airway tissue in the airways reduces the ability of the air ways to constrict and/or reduces the resistance within the airway to the flow of air through the airway. This also relates to a method for decreasing responsiveness or decreasing resistance to airflow of airways involves the transfer of energy to or from the airway walls to prevent or reduce airway constriction and other symptoms of lung diseases. The treatment reduces the ability of the airway to contract during an acute narrowing of the airways, reduces mucus plugging of the airways, and/or increases the airway diameter. The methods according to the present invention provide a longer duration and/or more effective treatment for lung diseases than currently used drug treatments, and obviate patient compliance issues. This also includes additional steps that reduce the ability of the lung to produce at least one of the symptoms of reversible obstructive pulmonary disease and to reduce the resistance to the flow of air through a lung.

Claims

1. An apparatus for delivering energy to a wall of an airway in a human lung comprising:

a flexible elongated body having a proximal portion, a distal portion, a distal end, and at least one lumen extending therebetween;

a deployment member extending through said at least one lumen and terminating at a distal tip, said distal tip distal to said distal end of said elongated body;

an expandable basket, said expandable basket having a plurality of electrode legs, each of said electrode legs having a first end connected to the distal portion of the elongated body at a proximal joint and a second end connected to the deployment member at a distal joint adjacent to said distal tip, each of said plurality of electrode legs further having at least one energy insulated region and only one energy delivery region where expansion of the basket causes the energy delivery regions to contact the wall of the airway; and

at least one temperature sensing element comprising a thermocouple having a first lead and a second lead separately coupled to a portion of at least one of said energy delivery regions that contacts the wall of the airway when expanded such that the energy delivery region of the leg forms an intrinsic junction with the thermocouple.

2. The apparatus of claim 1 wherein said energy delivery region is midway between said first end and said second end of each of said electrode legs.

3. The apparatus of claim 1 wherein said first lead and second lead are separately coupled to an inwardly-facing surface of said energy delivery region.

4. The apparatus of claim 3 wherein said first lead and said second lead are wires coupled midway between said first end and said second end of each of said electrode legs.

5. The apparatus of claim 1 wherein at least one of said first lead and second lead is foil-shaped.

6. The apparatus of claim 1 wherein at least one of said first lead and second lead is a thin film.

7. The apparatus of claim 1 wherein said first lead and said second lead are wire.

8. The apparatus of claim 1 further comprising a proximally located handle, said handle having a movable first control member attached to said elongated body such that forward movement of said first control member forwardly moves said elongated body and deployment member, said handle further having a stiffener, said stiffener coaxially disposed around a segment of said elongated body preventing buckling when said elongated body is forwardly moved.

9. The apparatus of claim 8 wherein said deployment member includes a slidable wire extending from said handle through said lumen of said elongated body to said distal tip, said wire having an obstruct such that forward movement of said wire beyond a deployment point is prevented by said obstruct wherein continued forward movement of said elongated body causes said expandable basket to expand between said distal end of said elongated body and said distal tip of said wire.

10. The apparatus of claim 9 wherein said obstruct is a sleeve.

11. The apparatus of claim 9 wherein said handle farther comprises a switch for commencing delivery of said RF energy.

12. The apparatus of claim 11 wherein said switch is automatically activated when said control member is moved beyond a trigger point.

13. The apparatus of claim 1 further comprising a power supply configured to deliver RF energy to each of said electrode legs.

14. The apparatus of claim 13 wherein said power supply is configured to adjust the amount of energy being delivered such that a specified temperature is maintained.

15. The apparatus of claim 14 wherein said power supply is configured to deliver energy at said specified temperature for up to predetermined maximum amount of time per location.

16. The apparatus of claim 13 wherein said power supply is configured to stop delivery of energy if a predetermined temperature change is not detected within a predetermined time from commencing delivery of said energy.

17. The apparatus of claim 16 wherein said predetermined temperature change is at least about 10 degrees Celsius and said predetermined time is about 1 second.

18. The apparatus of claim 16 wherein said predetermined temperature change is positive.

19. The apparatus of claim 16 wherein said predetermined temperature change is negative.

20. The apparatus of claim 13 wherein said power supply is configured to stop delivery of energy if said at least one temperature sensing element detects a predetermined maximum temperature.

21. The apparatus of claim 20 wherein said predetermined maximum temperature is 75 degrees Celsius.

22. The apparatus of claim 13 wherein said power supply is configured to deliver modulated RF energy, said modulated RF energy being characterized by an RF power waveform and a modulation waveform.

23. The apparatus of claim 22 wherein said modulation waveform is a pulse train of square-edged pulses.

24. The apparatus of claim 22 wherein said modulation waveform is sinusoidal.

25. The apparatus of claim 22 wherein said RF power waveform is constant power.

26. The apparatus of claim 22 wherein said RF power waveform is adjusted such that a specified temperature is maintained.

27. The apparatus of claim 13 wherein said power supply is configured to measure the rate of temperature change defining a measured rate.

28. The apparatus of claim 27 wherein said power supply stops delivery of said RF energy if said measured rate is not within a predefined range.

29. The apparatus of claim 13 wherein said power supply comprises a microprocessor.

30. The apparatus of claim 1 further comprising at least one basket support, said basket support disposed inside of said expandable basket and preventing inward displacement of said electrode legs.

31. The apparatus of claim 30 wherein said at least one basket support is a spring coupled to said proximal joint.

32. The apparatus of claim 30 wherein said at least one basket support has at least one cone-shaped end.

33. The apparatus of claim 30 wherein said at least one basket support is an inner basket.

34. The apparatus of claim 30 wherein said at least one basket support is an expandable balloon.

35. The apparatus of claim 30 wherein said at least one basket support is an expandable foam material.

36. The apparatus of claim 1 wherein said temperature sensing element forms an intrinsic junction with said energy delivery region.

37. An apparatus for delivering energy to a wall of an airway in a human lung comprising:

a flexible elongated body having a proximal portion, a distal portion, a distal end, and at least one lumen extending therebetween, said distal portion having an expandable section expandable between a first state and a second state;

a deployment member extending through said at least one lumen and terminating at a distal tip distal to said distal end of said elongated body, said deployment member configured to move said expandable section between said first state and said second state;

at least one energy transfer element disposed along the exterior of said expandable section, each of said energy transfer elements being configured to contact the wall of the airway when said expandable section is in said second state;

a power supply configured to deliver energy to each of said energy transfer elements; and

at least one temperature sensing element coupled to at least one energy transfer element such that the temperature sensing element forms an intrinsic junction with the energy transfer element located on a portion of the expandable section that moves farthest away from the elongate body.

38. The apparatus of claim 37 wherein said power supply is configured to adjust the amount of energy being delivered such that a specified temperature is maintained.

39. The apparatus of claim 38 wherein said power supply is configured to deliver energy at said specified temperature for up to predetermined maximum amount of time per location.

40. The apparatus of claim 37 wherein said power supply is configured to stop delivery of energy if a predetermined temperature change is not detected within a predetermined time from commencing delivery of said energy.

41. The apparatus of claim 40 wherein said predetermined temperature change is at least about 10 degrees Celsius and said predetermined time is about 1 second.

42. The apparatus of claim 40 wherein said predetermined temperature change is positive.

43. The apparatus of claim 40 wherein said predetermined temperature change is negative.

44. The apparatus of claim 37 wherein said power supply is configured to stop delivery of energy if said at least one temperature sensing element detects a predetermined maximum temperature.

45. The apparatus of claim 44 wherein said predetermined maximum temperature is 75 degrees Celsius.

46. The apparatus of claim 37 wherein said power supply is configured to deliver modulated RF energy, said modulated RF energy being characterized by an RF power waveform and a modulation waveform.

47. The apparatus of claim 46 wherein said modulation waveform is a pulse train of square-edged pulses.

48. The apparatus of claim 46 wherein said modulation waveform is sinusoidal.

49. The apparatus of claim 46 wherein said RF power waveform is constant power.

50. The apparatus of claim 46 wherein said RF power waveform is adjusted such that a specified temperature is maintained.

51. The apparatus of claim 37 wherein said power supply is configured to measure the rate of temperature change defining a measured rate.

52. The apparatus of claim 51 wherein said power supply stops delivery of said RF energy if said measured rate is not within a predefined range.

53. The apparatus of claim 37 wherein said power supply comprises a microprocessor.