APPARATUS AND METHODS FOR TREATING PULMONARY CONDITIONS

• US 20080208305A1
• Filed: 01/17/2008
• Published: 08/28/2008
• Est. Priority Date: 01/17/2007
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Rezai, Ali R., Deogaonkar, Milind, Ansarinia, Medhi
• Application Number:
  US12/016,115
• Publication Number:
  US 20080208305A1
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A method for treating a pulmonary condition in a subject includes one step of providing an implantable electrode assembly. The implantable electrode assembly includes a flexible member, at least one electrode operably secured to the flexible member, and an attachment mechanism for securing the at least one electrode to the flexible member. The implantable electrode assembly is implanted at a target site including an intraluminal location innervated by at least one nerve of the autonomic nervous system (ANS). The implantable electrode assembly is positioned at the target site such that the flexible member conforms to a portion of the inner surface of the target site, and the at least one electrode is positioned substantially adjacent the at least one nerve. Next, electric current is delivered to the at least one electrode to effect a change in the ANS of the subject.

Claims

1. A method for treating a pulmonary condition in a subject, said method comprising the steps of:

providing an implantable electrode assembly, the implantable electrode assembly comprising a flexible member, at least one electrode operably secured to the flexible member, and an attachment mechanism for securing the at least one electrode to the flexible member;

implanting the implantable electrode assembly at a target site, the target site comprising an intraluminal location innervated by at least one nerve of the autonomic nervous system (ANS);

positioning the implantable electrode assembly at the target site such that the flexible member conforms to a portion of an inner surface of the target site and the at least one electrode is positioned substantially adjacent the at least one nerve; and

delivering electric current to the at least one electrode to effect a change in the ANS of the subject.

2. The method of claim 1, wherein the intraluminal target site comprises an inner surface of an anatomical structure selected from the group consisting of a blood vessel, the esophagus, the tracheo-bronchial tree, the primary bronchi, and the distal bronchi.

3. The method of claim 2, the intraluminal target site comprising an inner surface of the trachea adjacent the carina.

4. The method of claim 1, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a superior cervical ganglion, a cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

5. The method of claim 1, wherein delivery of electric current to the at least one electrode effects a change in the parasympathetic nervous system (PNS) of the subject.

6. The method of claim 1, wherein delivery of electric current to the at least one electrode effects a change in the sympathetic nervous system (SNS) of the subject.

7. The method of claim 1, wherein delivery of electric current to the anterior pulmonary plexus effects a change in the SNS.

8. The method of claim 1, wherein delivery of electric current to the posterior pulmonary plexus effects a change in the PNS.

9. The method of claim 1, wherein delivery of electric current to the anterior pulmonary plexus effects a change in both the SNS and the PNS.

10. The method of claim 1, wherein delivery of electric current to the posterior pulmonary plexus effects a change in both the SNS and the PNS.

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

sensing a bodily activity associated with the pulmonary condition;

generating a sensor signal based on the bodily activity; and

activating the implantable electrode assembly to adjust application of electric current to the target site in response to the sensor signal to treat the pulmonary condition.

12. The method of claim 1, wherein the pulmonary condition is selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.

13. An implantable electrode assembly for positioning at a target site and for treating a pulmonary condition in a subject, said implantable electrode assembly comprising:

a flexible member having first and second end portions and oppositely disposed first and second surfaces, said first and second surfaces for securing said flexible member at the target site;

at least one electrode operably coupled to a portion of at least one of said first or second surfaces of said flexible member, said at least one electrode being adapted to selectively deliver electric current to the target site and effect a change in the ANS of the subject; and

an attachment mechanism for securing said at least one electrode to at least one of said first or second surfaces of said flexible member.

14. The implantable electrode assembly of claim 13, wherein said flexible member is adapted to conform to an extraluminal target site.

15. The implantable electrode assembly of claim 13, wherein the extraluminal target site is an outer surface of an anatomical structure selected from the group consisting of a blood vessel, the esophagus, the tracheo-bronchial tree, the primary bronchi, and the distal bronchi.

16. The implantable electrode assembly of claim 15, wherein said flexible member is adapted to conform to an outer surface of the trachea adjacent the carina.

17. The implantable electrode assembly of claim 13, wherein said flexible member is adapted to conform to an intraluminal target site.

18. The implantable electrode assembly of claim 13, wherein the target site is an intraluminal target site comprising an inner surface of an anatomical structure selected from the group consisting of a blood vessel, the esophagus, the tracheo-bronchial tree, the primary bronchi, and the distal bronchi.

19. The implantable electrode assembly of claim 18, wherein said flexible member is adapted to conform to an inner surface of the trachea adjacent the carina.

20. The implantable electrode assembly of claim 13, wherein said flexible member has a C-shaped configuration.

21. The implantable electrode assembly of claim 13, wherein said at least one electrode extends across a portion of said first surface of said flexible member.

22. The implantable electrode assembly of claim 13, wherein said at least one electrode extends across the entire portion of said first surface of said flexible member.

23. The implantable electrode assembly of claim 13, wherein said at least one electrode extends across a portion of said second surface of said flexible member.

24. The implantable electrode assembly of claim 13, wherein said at least one electrode extends across the entire portion of said second surface of said flexible member.

25. The implantable electrode assembly of claim 13, wherein electric current is delivered to said at least one electrode via a wireless energy source.

26. The implantable electrode assembly of claim 13, wherein said attachment mechanism comprises a metal member and a plurality of securing members, said metal member being operably coupled to at least one of said first or second surfaces of said flexible member via said securing members.

27. The implantable electrode assembly of claim 13, wherein at least a portion of said implantable electrode assembly is treated with a therapeutic agent for eluting into vascular tissue, the blood stream, or a combination thereof.

28. The implantable electrode assembly of claim 27, wherein a plurality of portions of said implantable electrode assembly are separately treated with a different one of said at least one therapeutic agent.

29. The implantable electrode assembly of claim 13, wherein at least a portion of said implantable electrode assembly is covered with a layer of biocompatible material.

30. The implantable electrode assembly of claim 13, wherein a sensor capable of sensing a bodily activity associated with the pulmonary condition is associated with said implantable electrode assembly.

31. The implantable electrode assembly of claim 30, wherein said sensor is operably coupled to a portion of said implantable electrode assembly.

32. The implantable electrode assembly of claim 13, the pulmonary disorder being selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.

33. The implantable electrode assembly of claim 13, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a cervical ganglion, a superior cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

34. A method for treating a pulmonary condition in a subject, said method comprising the steps of:

providing an implantable electrode assembly, the implantable electrode assembly comprising a flexible member, at least one electrode operably secured to the flexible member, and an attachment mechanism for securing the at least one electrode to the flexible member;

implanting the implantable electrode assembly at a target site, the target site comprising an extraluminal location innervated by at least one nerve of the ANS;

positioning the implantable electrode assembly at the target site such that the flexible member envelops a portion of the target site and the at least one electrode is in direct contact with the at one least nerve; and

delivering electric current to the at least one electrode to effect a change in the ANS of the subject.

35. The method of claim 34, wherein the extraluminal target site comprises an outer surface of an anatomical structure selected from the group consisting of a blood vessel, the esophagus, the tracheo-bronchial tree, the primary bronchi, and the distal bronchi.

36. The method of claim 34, wherein the extraluminal target site comprises an outer surface of the trachea adjacent the carina.

37. The method of claim 34, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a cervical ganglion, a superior cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

39. The method of claim 34, wherein delivery of electric current to the at least one electrode effects a change in the PNS of the subject.

40. The method of claim 34, wherein delivery of electric current to the at least one electrode effects a change in the SNS of the subject.

41. The method of claim 34, wherein delivery of electric current to the anterior pulmonary plexus effects a change in the SNS.

42. The method of claim 34, wherein delivery of electric current to the posterior pulmonary plexus effects a change in the PNS.

43. The method of claim 34, wherein delivery of electric current to the anterior pulmonary plexus effects a change in both the SNS and the PNS.

44. The method of claim 34, wherein delivery of electric current to the posterior pulmonary plexus effects a change in both the SNS and the PNS.

45. The method of claim 34 further comprising the steps of:

sensing a bodily activity associated with the pulmonary condition;

generating a sensor signal based on the bodily activity; and

activating the implantable electrode assembly to adjust application of electric current to the target site in response to the sensor signal to treat the pulmonary condition.

46. The method of claim 34, wherein the pulmonary condition is selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.

47. An implantable electrode assembly for treating a pulmonary condition in a subject, said implantable electrode assembly comprising:

a clip member including first and second flexible arm members integrally formed with an attachment member, said flexible arm members being adapted for placement about a target site, the target site comprising an extraluminal location innervated by at least one nerve of the ANS; and

an electrode operably coupled to at least one of said first or second flexible arm members, said electrode being adapted to selectively deliver electric current to the target site and effect a change in the ANS of the subject.

48. The implantable electrode assembly of claim 47, wherein said first and second flexible arm members respectively include first and second electrodes operably coupled thereto.

49. The implantable electrode assembly of claim 47, wherein the target site comprises an outer surface of an anatomical structure selected from the group consisting of a blood vessel, the esophagus, the tracheo-bronchial tree, the primary bronchi, and the distal bronchi.

50. The implantable electrode assembly of claim 49, wherein the target site comprises an outer surface of the trachea adjacent the carina.

51. The implantable electrode assembly of claim 47, wherein electric current is delivered to the electrode via a wireless energy source.

52. The implantable electrode assembly of claim 47, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a cervical ganglion, a superior cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

53. The implantable electrode assembly of claim 47, wherein the pulmonary condition is selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.

54. The implantable electrode assembly of claim 47, wherein at least a portion of said implantable electrode assembly is treated with a therapeutic agent for eluting into vascular tissue, the blood stream, or a combination thereof.

55. The implantable electrode assembly of claim 54, wherein a plurality of portions of said implantable electrode assembly are separately treated with a different one of said at least one therapeutic agent.

56. The implantable electrode assembly of claim 47, wherein at least a portion of said implantable electrode assembly is covered with a layer of biocompatible material.

57. The implantable electrode assembly of claim 47, wherein a sensor capable of sensing a bodily activity associated with the pulmonary condition is associated with said implantable electrode assembly.

58. The implantable electrode assembly of claim 57, wherein said sensor is operably coupled to a portion of said implantable electrode assembly.

59. A method for treating a pulmonary condition in a subject, said method comprising the steps of:

providing an implantable electrode assembly, the implantable electrode assembly comprising a clip member and an electrode, the clip member including first and second flexible arm members integrally formed with an attachment member, the flexible arm members being adapted for placement about a target site comprising an extraluminal location innervated by at least one nerve of the ANS, the electrode being operably coupled to at least one of the first or second flexible arm members and being adapted to selectively deliver electric current to the target site and effect a change in the ANS of the subject;

implanting the implantable electrode assembly at the target site;

positioning the implantable electrode assembly such that the first and second flexible arm members envelop a portion of the target site and the electrode is in direct contact with the at least one nerve; and

delivering electric current to the electrode to effect a change in the ANS of the subject.

60. The method of claim 59 further comprising the steps of:

attaching the attachment member to a delivery apparatus;

inserting the implantable electrode assembly into the subject; and

placing the first and second arm members adjacent the target site.

61. The method of claim 59, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a cervical ganglion, a superior cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

62. The method of claim 59, wherein delivery of electric current effects a change in the PNS of the subject.

63. The method of claim 59, wherein delivery of electric current effects a change in the ANS of the subject.

64. The method of claim 59, wherein electric current is delivered to the anterior pulmonary plexus to effect a change in the SNS.

65. The method of claim 59, wherein electric current is delivered to the posterior pulmonary plexus to effect a change in the PNS.

66. The method of claim 59, wherein delivery of electric current to the anterior pulmonary plexus effects a change in both the SNS and the PNS.

67. The method of claim 59, wherein delivery of electric current to the posterior pulmonary plexus effects a change in both the SNS and the PNS.

68. The method of claim 59, wherein the pulmonary condition is selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.