Devices for modification of airways by transfer of energy

• US 7,425,212 B1
• Filed: 11/08/1999
• Issued: 09/16/2008
• Est. Priority Date: 06/10/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Laufer, Michael D., Loomas, Bryan, Danek, Christopher James, Keast, Thomas, Biggs, Michael, Haugaard, Dave, Burger, Keith M., Ross, John Arthur
• Primary Examiner(s): Shay; David M.
• Application Number:
  US09/436,455
• Time in Patent Office: 3,235 Days
• Field of Search: 606/7, 606 10- 17, 606 41- 52
• US Class Current: 606/47
• 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 2018/1407 Loop
• 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

This relates to a device for treating lung disease, and more particularly, relates to a device for exchanging energy with airway tissue such as that found in the airways of human lungs. The exchange of energy with this airway tissue in the airways reduces the ability of the airways to constrict and/or reduces the resistance within the airway to the flow of air through the airway.

Claims

1. An energy transfer apparatus for facilitating energy transfer into a mass of airway tissue, the apparatus comprising:

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

distal tip located at a distal end of the apparatus;

a plurality of electrically conductive legs each having a distal end and a proximal end, wherein the distal end of each of the plurality of electrically conductive legs terminates in the distal tip, such that the plurality of electrically conductive legs are in electrical communication, each electrically conductive leg having a treatment section located between the distal and proximal ends, and being adapted to deflect away from an axis of the elongate body;

a proximal joint located on a distal portion of the elongated body, wherein the proximal end of each of the electrically conductive legs terminates in the proximal joint; and

an electrically conductive wire extending through the lumen of the elongated body and terminating at the distal tip, the wire being in electrical communication with the plurality of electrically conductive legs such that it may deliver current to the electrically conductive legs which when energized alter a bronchus or bronchiole wall so as to treat asthma, the wire also being moveable relative to the proximal joint to permit deflection of the plurality of conductive legs away from the wire.

2. The apparatus of claim 1 further comprising a handle containing an actuator adapted to move the proximal joint relative to the electrically conductive wire, the handle also adapted to electrically couple the electrically conductive wire to a power supply.

3. The energy transfer apparatus of claim 1 further comprising a power supply adapted to deliver energy to resistively heat the treatment section of the electrically conductive legs.

4. The energy transfer apparatus of claim 1 wherein each of said legs having a treatment section substantially parallel to said elongated body and each of said legs being spaced around a circumference of said elongated body to form a basket deflected away from the axis of the elongate body.

5. The energy transfer apparatus of claim 1 further comprising a power supply adapted to deliver radio frequency energy to the treatment section on the electrically conductive legs.

6. The energy transfer apparatus of claim 5 wherein the apparatus is monopolar.

7. The energy transfer apparatus of claim 5 wherein the apparatus is bipolar.

8. The apparatus of claim 1, further comprising a temperature detecting element coupled to at least one of the plurality of legs.

9. The apparatus of claim 8, where the temperature detecting element comprises a thermocouple having a first and second leads, where the first and second leads are electrically connected to a portion of the leg at separate locations on the leg such that the portion of the forms part of the thermocouple.

10. The energy transfer apparatus of claim 8 wherein said temperature detecting element is electrically coupled to a surface of said leg.

11. The energy transfer apparatus of claim 8 wherein the temperature detecting element is attached to an inside of one of the plurality of single legs.

12. The energy transfer apparatus of claim 8 further comprising at least one additional temperature detecting element attached at least one of the plurality of legs.

13. An energy transfer apparatus for facilitating energy transfer into a mass of airway tissue, said apparatus sized to enter a bronchus or bronchiole of a human lung and comprising:

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

a distally located expandable portion of said elongated body, said expandable portion having a first state and a second state, wherein said second state is radially expanded from said elongated body;

a distal tip located distally of said expandable portion;

at least one energy transfer element at an exterior of said expandable portion, wherein said at least one energy transfer elements is configured to contact a wall of the bronchus or bronchiole when said expandable portion is in said second state,

a proximal joint at an intersection of said distal portion and said expandable portion wherein said expandable portion comprises a plurality of legs, each of said legs having a first end extending from said proximal joint and a second end fixedly attached to a distal joint, said distal joint being adjacent to said distal tip;

a temperature detecting element attached to one of said plurality of legs wherein said temperature detecting element is in electrical communication with at least a portion of said leg such that said portion of said leg forms part of the temperature detecting element; and

a deployment member comprising a wire extending from said distal tip to said proximal portion, configured to move said expandable portion between said first and second state so as to permit deflection of the plurality of legs away from the wire, said wire extending at least between said expandable portion and said proximal portion of said elongated body and wherein said wire is also configured to provide a current to said at least one energy transfer element which when energized alters the bronchus or bronchiole so as to treat asthma.

14. The energy transfer apparatus of claim 13 wherein said temperature detecting element is attached to a surface of said leg.

15. The energy transfer apparatus of claim 13 wherein said energy transferring elements comprise at least one resistively heated element configured to heat the airway tissue and at least one radio frequency electrode configured to heat the airway tissue when connected to a radio frequency generator.

16. The energy transfer apparatus of claim 13 wherein a diameter of said expandable portion in said second state is less than 15 mm, and wherein said elongated body has a diameter less than said diameter of said expandable portion in said second state.

17. The energy transfer apparatus of claim 13 wherein each of said legs having a center section substantially parallel to said elongated body and each of said legs being spaced around a circumference of said elongated body to form a basket.

18. The energy transfer apparatus of claim 13 wherein each said leg of said expandable portion has a circular cross section.

19. The energy transfer apparatus of claim 13 wherein each said leg of said expandable portion has a rectangular cross section.

20. The energy transfer apparatus of claim 13 wherein said expandable portion has a length from said proximal joint to said distal joint of less than 35 mm when said basket is in said first state.

21. The energy transfer apparatus of claim 13 wherein said plurality of legs consists of four legs each spaced at approximately 90 degree intervals around said elongated body.

22. The energy transfer apparatus of claim 13 wherein said plurality of legs consists of five legs each spaced at approximately 72 degree intervals around said elongated body.

23. The energy transfer apparatus of claim 13 wherein a polymeric heating element is on at least a portion of each basket leg.

24. The energy transfer apparatus of claim 13 wherein an electrically conductive paint covers at least a portion of each leg of said expandable portion.

25. The energy transfer apparatus of claim 13 wherein a printed flex circuit is on at least a portion of each leg of said expandable portion.

26. The energy transfer apparatus of claim 13 wherein said deployment member is force compensated to limit a force which said expandable member can apply to the airway while in said second expanded state.

27. The energy transfer apparatus of claim 13 wherein said deployment member further comprises a deflection limiting stop to limit a size of said second state of said expandable member.

28. The energy transfer apparatus of claim 13 wherein said elongated body has a wall reinforced with a polymeric or metallic member.

29. The energy transfer apparatus of claim 13 wherein said flexible elongated member has a stiffness sufficient to pass through a working channel seal of a bronchoscope.

30. The energy transfer apparatus of claim 13 wherein a temperature detecting element is attached to a portion of said wire located within said expandable portion.

31. The energy transfer apparatus of claim 13 wherein a portion of said elongated body is radiopaque.

32. The energy transfer apparatus of claim 13 further comprising a steering member configured to deflect said distal tip in a desired direction.

33. The energy transfer apparatus of claim 13 wherein at least of one of said legs comprises an electrically conductive material, and said leg functions as said energy transfer element.

34. The energy transfer apparatus of claim 33 wherein said legs of said expandable portion comprise a stainless steel alloy.

35. The energy transfer apparatus of claim 13 wherein a resistively heated element is coiled around at least a portion of each of said legs.

36. The energy transfer apparatus of claim 35 wherein said temperature detecting element is placed between at least one of said legs and said resistively heated element.

37. The energy transfer apparatus of claim 13 wherein said plurality of legs is formed from a single sheet.

38. The energy transfer apparatus of claim 37 wherein said sheet is a stainless steel material.

39. The energy transfer apparatus of claim 13 wherein said apparatus is sized to fit within a working channel of a bronchoscope.

40. The energy transfer apparatus of claim 39 wherein a diameter of said working channel of said bronchoscope is less than or equal to 2 mm.

41. The energy transfer apparatus of claim 13 wherein said energy transferring element each comprises a radio frequency electrode configured to heat the airway tissue by delivering radio frequency energy when connected to a radio frequency generator.

42. The energy transfer apparatus of claim 41 wherein said radio frequency electrode is monopolar.

43. The energy transfer apparatus of claim 41 wherein said radio frequency electrode is bipolar.

44. The energy transfer apparatus of claim 13 wherein said legs are joined in electrical communication at either proximal, distal, or both joints by soldering, welding, or adhesive.

45. The energy transfer apparatus of claim 44 wherein said distal joint further comprise an adhesive which fixedly attaches said ends of legs to said joint.

46. The energy transfer apparatus of claim 44 wherein either said proximal or distal joint not in electrical communication is adhesively bonded or thermoformed.

47. The energy transfer apparatus of claim 13 wherein said distal tip is configured to minimize gouging of the airway.

48. The energy transfer apparatus of claim 47 further comprising a redundant joint attaching said distal tip to said elongated body.

49. The energy transfer apparatus of claim 47 wherein said distal tip is sized to fit within a bronchoscope.

50. The energy transfer apparatus of claim 13 further comprising a vision system.

51. The energy transfer apparatus of claim 50 wherein said vision system comprises a fiber optic cable extending through said elongated body.

52. The energy transfer apparatus of claim 50 wherein said vision system comprises a CCD chip.

53. The energy transfer apparatus of claim 13 wherein a radio frequency electrode is attached to each leg of said expandable portion.

54. The energy transfer apparatus of claim 53 wherein said radio frequency electrode is attached to each leg of said expandable portion by a heat shrink fastener.

55. The energy transfer apparatus of claim 54 wherein said temperature detecting element is placed between at least one of said legs and said heat shrink fastener.

56. The energy transfer apparatus of claim 13 wherein said temperature detecting element is attached to an inside of a first leg of said plurality of single legs.

57. The energy transfer apparatus of claim 56 further comprising at least one additional temperature detecting element attached to said plurality of legs.

58. The energy transfer apparatus of claim 56 wherein said temperature detecting element is attached by soldering, welding, or adhesive bonding.

59. The energy transfer apparatus of claim 58 wherein said temperature detecting element is a thermocouple having a first and second leads joined separately to said first leg, each lead in electrical communication with said first leg.

60. The energy transfer apparatus of claim 13 wherein said energy transferring element each comprises a resistively heated element configured to conductively heat the airway tissue.

61. The energy transfer apparatus of claim 60 wherein each of said resistively heated elements are conductively attached to said expandable portion.

62. The energy transfer apparatus of claim 60 wherein said resistively heated element uses AC current.

63. The energy transfer apparatus of claim 60 wherein said resistively heated element uses DC current.

64. The energy transfer apparatus of claim 60 wherein said resistively heated element uses RF energy.

65. The energy transfer apparatus of claim 13 wherein said deployment member comprises:

a handle adjacent to a proximal end of said elongated body;

and at least a first control member moveably attached to said handle.

66. The energy transfer apparatus of claim 65 further comprising

a sheath external to and covering said elongated body and said expandable portion, said sheath extending from said distal tip to said proximal portion;

and wherein

said handle is adjacent to a proximal end of said sheath, said sheath being slidably attached to said handle, said elongate body being rigidly attached to said handle;

said wire, and said distal tip are slidably moveable in distal and proximal directions;

said first control member being attached to said sheath, said first control member moveably secured to said handle, where distal movement of said first control member retracts said sheath distally on said elongate member uncovering said elongate member and said expandable portion; and

second control member attached to said wire, said second control member moveably secured to said handle, where distal movement of said second control member retracts said distal tip and said expandable portion against said non-moving elongated member causing said expandable portion to radially expand into said second state.

67. The energy transfer apparatus of claim 65 wherein said elongated body is slidably attached to said handle;

said elongated body, said wire, and said distal tip are slidably moveable in distal and proximal directions; and

further comprising

a stop configured to prevent distal movement of said wire beyond a deployment point, wherein beyond said deployment point distal movement of said elongated body against said non-moving distal tip causes said expansion member to expand to said second state.

68. The energy transfer apparatus of claim 67 further comprising a sheath, said sheath being slidably coupled and exterior to said elongated body and said expandable portion, wherein said expandable portion advances out of a distal end of said sheath to expand to said second state.

69. The energy transfer apparatus of claim 67 wherein said first control member is configured to advance said elongated body and said wire in distal and proximal directions.

70. The energy transfer apparatus of claim 69 further comprising a detent means for maintaining said elongated body distally of said deployment point.

71. The energy transfer apparatus of claim 69 wherein said control member is configured to frictionally maintain said elongated body distally of said deployment point.

72. The energy transfer apparatus of claim 13 further comprising a power supply configured to deliver energy to through said energy transfer elements to the airway walls.

73. The energy transfer apparatus of claim 72 wherein said power supply is configured to stop delivery of energy if said temperature detecting element detects a predetermined maximum temperature.

74. The energy transfer apparatus of claim 72 wherein said power supply is configured to stop delivery of energy if a predetermined temperature change is not detected within a predetermined time.

75. The energy transfer apparatus of claim 13 wherein said apparatus is sterile.

76. The energy transfer apparatus of claim 72 wherein said power supply is configured to deliver energy for 3-5 seconds.

77. The energy transfer apparatus of claim 76 wherein said power supply is configured to deliver 10-15 Watts of power.

78. The energy transfer apparatus of claim 72 wherein said power supply is configured to deliver energy for 5-10 seconds.

79. The energy transfer apparatus of claim 78 wherein said power supply is configured to deliver energy in a temperature control mode.