Methods of treating lungs having reversible obstructive pulmonary disease

• US 6,634,363 B1
• Filed: 03/27/2000
• Issued: 10/21/2003
• Est. Priority Date: 04/07/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Broncus Technologies, Inc
• Inventors: Danek, Christopher James, Shriner, Kelly, Laufer, Michael D., Loomas, Bryan, Kaplan, Gary, Biggs, Michael
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H.
• Application Number:
  US09/535,856
• Time in Patent Office: 1,303 Days
• Field of Search: 128/898
• US Class Current: 128/898
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• 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 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00803 : with temperature prediction
• 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: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2210/1039 : Lungs
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body

Abstract

This relates to treating a lung having at least one symptom of reversible obstructive pulmonary disease, and more particularly, relates to advancing a treatment device into the lung and treating the lung with the device to at least reduce the ability of the lung to produce at least one of the symptoms of reversible obstructive pulmonary disease. 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. A method for treating a lung having reversible obstructive pulmonary disease comprising the steps of:

a) advancing a treatment instrument into the lung; and

b) treating an airway wall of the lung with the instrument to at least reduce the ability of the lung to produce at least one reversible obstructive pulmonary disease symptom.

2. The method of claim 1 further comprising the steps of:

a) locating one or more treatment sites within an airway of the lung;

b) selecting at least one of the treatment sites located in said locating step; and

c) wherein said treating step comprises treating the at least one treatment site selected in said selecting step.

3. The method of claim 2 wherein said steps are performed while the lung is experiencing at least one symptom of reversible obstructive pulmonary disease.

4. The method of claim 2 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.

5. The method of claim 4 wherein said stimulating step is performed prior to said locating step.

6. The method of claim 2 wherein said locating step is performed by a non-invasive imaging technique.

7. The method of claim 6 where the non-invasive imaging technique is selected from a group consisting of a bronchogram, magnetic resonance imaging, computed tomography, chest x-ray, and ventilation perfusion scans.

8. The method of claim 2 further comprising the steps of:

a) testing the lung for at least one pre-treatment pulmonary function value prior to said treating step; and

b) re-testing the lung for at least one post-treatment pulmonary function value subsequent to said treating step.

9. The method of claim 8 further comprising the step of treating additional sites in the lung after said re-testing step to at least reduce the effect of at least one symptom of reversible obstructive pulmonary disease in the lung until a desired posttreatment pulmonary function value is measured.

10. The method of claim 8 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.

11. The method of claim 8 wherein the pulmonary function value is selected from a group consisting of FEV (forced expiratory volume), FVC (forced vital capacity), FEF (forced expiratory flow), Vmax (maximum flow), PEFR (peak expiratory flow rate), FRC (functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.

12. The method of claim 2 wherein said locating step comprises identifying treatment sites within the airway being susceptible to a symptom selected from the group consisting of airway inflammation, airway constriction, excessive mucous secretion, and any other symptom of reversible obstructive pulmonary disease.

13. The method of claim 12 wherein said identifying step comprises stimulating the airway to produce at least one of the symptoms to identify the treatment sites.

14. The method of claim 13 where said stimulating step comprises pharmacologically stimulating the airway.

15. The method of claim 13 where said stimulating step comprises electrically stimulating the airway.

16. The method of claim 1 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.

17. The method of claim 16 wherein said stimulating step comprises electrically stimulating the lung.

18. The method of claim 16 wherein said stimulating step comprises pharmacologically stimulating the lung.

19. The method of claim 16 further comprising the step of evaluating the result of said stimulating step.

20. The method of claim 19 wherein said evaluating step comprises visually evaluating the effect of said stimulating step on the airway.

21. The method of claim 19 wherein said evaluating step comprises measuring the pressure change in the lung before and after said stimulating step.

22. The method of claim 21 wherein said measuring step comprises measuring a global pressure change in the lung.

23. The method of claim 21 wherein said measuring step comprises measuring a local pressure change in an airway.

24. The method of claim 19 wherein said evaluating step comprises measuring the resistance to airflow within the lungs before and after the stimulating step.

25. The method of claim 19 wherein said evaluating step comprises measuring the electrical properties of the tissue before and after the stimulating step.

26. The method of claim 19 further comprising the step of selecting at least one treatment parameter based upon said evaluating step.

27. The method of claim 26 wherein said stimulating step, evaluating step, and selecting at least one treatment parameter step are performed subsequent to said treating step.

28. The method of claim 1 wherein said steps are performed while the lung is experiencing an attack of reversible obstructive pulmonary disease.

29. The method of claim 1 wherein said treating step comprises treating at least airway tissue within the lung, the method further comprising the step of determining the effect of the treatment by visually observing the airway for blanching of airway tissue.

30. The method of claim 29 further comprising the step of adjusting at least one treatment parameter based upon said determining step.

31. The method of claim 1 wherein said treating step comprises treating at least airway tissue at a treatment site within the lung, the method further comprising the step of monitoring impedance in the tissue.

32. The method of claim 31 wherein said monitoring step includes monitoring impedance at one or more points within the lung.

33. The method of claim 31 further comprising the step of adjusting at least one treatment parameter based upon said monitoring step.

34. The method of claim 1 wherein said treating step comprises treating at least airway tissue at a treatment site within the lung, the method further comprising the step of sub-mucosal sensing step of the treatment to the lung tissue.

35. The method of claim 34 wherein the sensing comprises non-invasive sensing.

36. The method of claim 34 wherein the sensing step comprises invasive sensing.

37. The method of claim 36 wherein the invasive sensing comprises temperature, impedance or blood flow monitoring.

38. The method of claim 1 wherein said step of treating the lung comprises depositing a radioactive substance in at least one treatment site within the lung.

39. The method of claim 1 further comprising the steps of scraping epithelial tissue from a wall of an airway within the lung prior to said treating step.

40. The method of claim 39 further comprising the step of depositing a substance on the scraped wall of the airway after said treatment step.

41. The method of claim 40 wherein said substance is epithelial tissue, collagen, growth factors, or any other tissue from the patient'"'"'s body.

42. The method of claim 1 wherein said treating step comprises treating an airway wall within the lung using a modality selected from the group consisting of mechanical, chemical, radio frequency, radioactive, heat, and ultrasound.

43. The method of claim 42 wherein said mechanical process comprises a process selected from the group consisting of cutting, punching, abrading, and rubbing.

44. The method of claim 1 further comprising the step of pre-treating the lung to at least reduce the ability of the lung to produce at least one symptom of reversible obstructive pulmonary disease prior to said treating step, wherein at least one parameter of said pre-treating step is lesser than at least one parameter of said treating step.

45. The method of claim 44 wherein a pre-treating step parameter of time or temperature is less than the treating step parameter of time or temperature.

46. The method of claim 1 wherein said treating step comprises separating said treating step into stages to reduce a healing load on the lung.

47. The method of claim 46 wherein said separating step comprises treating different regions of the lung at different times.

48. The method of claim 46 wherein said separating step comprises dividing a total number of treatment sites into at a plurality of groups of treatment sites, and treating each group at a different time.

49. The method of claim 1 wherein said treating step includes sensing movement of the lung and repositioning the treatment instrument in response to said sensing step.

50. The method of claim 1 further comprising the step of reducing or stabilizing the temperature of lung tissue adjacent to a treatment site.

51. The method of claim 50 wherein said reducing step comprises injecting a cold fluid into lung parenchyma, the method further comprising the step of removing the fluid from the lung.

52. The method of claim 1 wherein said treating step occurs below an epithelial layer of lung tissue.

53. The method of claim 1 further comprising the step of providing drug therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.

54. The method of claim 1 further comprising the step of providing exercise therapy to further reduce the effects of reversible obstructive pulmonary disease.

55. The method of claim 1 further comprising the step of providing respiratory therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.

56. The method of claim 1 further comprising the step of educating a patient on reversible obstructive pulmonary disease management techniques to reduce effects of reversible obstructive pulmonary disease.

57. A method for treating a lung having reversible obstructive pulmonary disorder was added to reduce the lung'"'"'s ability to produce at least one of symptom of reversible obstructive pulmonary disease, the method comprising:

advancing a treatment instrument into the lung; and

applying energy to an airway wall of an airway in the lung with the instrument.

58. The method of claim 57 further comprising the steps of:

locating one or more treatment sites within one or more airways of the lung;

selecting at least one of the treatment sites located in said locating step; and

repeating the act of applying energy to the one or more treatment sites.

59. The method of claim 58 wherein said locating step is performed by a non-invasive imaging technique.

60. The method of claim 59 wherein said locating step is performed prior to advancing the treatment instrument into the lung.

61. The method of claim 59 where the non-invasive imaging technique is selected from a group consisting of a bronchogram, magnetic resonance imaging, computed tomography, chest x-ray, and ventilation perfusion scans.

64. The method of claim 58 wherein the locating step comprises identifying treatment sites within the Airway being susceptible to a symptom selected from the group consisting of airway inflammation, airway constriction, excessive mucous secretion, and any other symptom of reversible obstructive pulmonary disease.

65. The method of claim 57 wherein applying energy to the airway wall comprises heating the airway wall.

66. The method of claim 65 where heating the airway wall comprises applying radio frequency energy or heat to the airway wall.

67. The method of claim 65 where heating the wall comprises heating the wall to a pre-determined temperature.

68. The method of claim 65 where heating the airway wall comprises heating the airway wall in a pre-determined pattern.

69. The method of claim 68 where the predetermined pattern comprises a pattern selected from the group consisting of painting-like motion, segments, stripes, and rings.

70. The method of claim 57 wherein said treating step comprises separating said treating step into stages to reduce a healing load on the lung.

71. The method of claim 70 wherein said separating step comprises treating different regions of the lung at different times.

72. The method of claim 70 wherein said separating step comprises dividing a total number of treatment sites into at a plurality of groups of treatment sites, and treating each group at a different time.

73. The method of claim 57 further comprising the step of providing drug therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.

74. The method of claim 57 further comprising the step of providing exercise therapy to further reduce the effects of reversible obstructive pulmonary disease.

75. The method of claim 57 further comprising the step of providing respiratory therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.

76. The method of claim 57 where the symptom of reversible obstructive pulmonary disease comprises a symptom selected from the group consisting of contraction of airway tissue, inflammation of airway tissue, edema of airway tissue, and mucus plugging of the airway.

77. The method of claim 57 where the at least one of symptom of reversible obstructive pulmonary disease comprises symptoms of asthma.

62. The method of claim further comprising the steps of:

a) testing the lung for at least one pre-treatment pulmonary function value prior to said treating step; and

b) re-testing the lung for at least one post-treatment pulmonary function value subsequent to the applying step.

63. The method of claim 62 wherein the pulmonary function value is selected from a group consisting of FEV (forced expiratory volume), FVC (forced vital capacity), FEF (forced expiratory flow), Vmax (maximum flow), PEFR (peak expiratory flow rate), FRC (functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.