Lung treatment apparatus and method

• US 6,770,070 B1
• Filed: 03/17/2000
• Issued: 08/03/2004
• Est. Priority Date: 03/17/2000
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Balbierz, Daniel J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/527,906
• Time in Patent Office: 1,600 Days
• Field of Search: 606/27, 606/28, 606/213, 606/214, 606/41, 606/45, 606/48-50, 600/566, 600/567
• US Class Current: 606/41
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• 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 2017/00495 for two-component glue
• CPC Class Codes: A61B 2018/00029 open
• 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 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/183 characterised by the type of antenna
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A method and apparatus for obtaining a lung biopsy with an apparatus capable of sealing tears within the lung and pleural space to reduce the risk of pneumothorax or pulmonary hemorrhage. The apparatus includes an RF ablation apparatus having a lung biopsy device an energy delivery device including at least one electrode designed to be deployed into target lung tissue, and a sensor. A closure device is operatively coupled to the elongated member to produce an immediate tight seal and promote healing at the tissue interface. A feedback control device is operatively coupled to the sensor and a RF source for controlling energy delivered to the electrodes.

Claims

1. An improved ablation apparatus for lung treatment said apparatus having an elongated member including a lumen and a tissue piercing distal end, and an energy delivery device being positionable in said elongated member and including at least one electrode operatively coupled to a power source, the improvement comprising:

a lung biopsy device comprising a needle for obtaining a core sample; and

at least one sensor coupled to the elongated member;

wherein said energy delivery device is operatively coupled to the power source.

2. The apparatus of claim 1, wherein the sensor is coupled to one of an elongated member distal end, or the elongated member lumen.

3. The apparatus of claim 1, wherein the elongated member lumen terminates in at least one aperture for fluid delivery.

4. The apparatus of claim 3, further comprising:

a fluid source coupled to the elongated member lumen for fluid delivery to the at least one aperture.

5. The apparatus of claim 4, wherein said fluid source is coupled to feedback control resources or a control valve for controlling fluid delivery.

6. The apparatus of claim 4, wherein the fluid source includes a fluid delivery device.

7. The apparatus of claim 4, wherein the fluid source is selected from a gas source, a liquid source, a liquid polymer source, and an electrolytic solution source.

8. The apparatus of claim 7, wherein the liquid polymer is a curable liquid polymer selected from heat curable, chemically curable, and photactivated curable.

9. The apparatus of claim 7, wherein the liquid polymer has a viscoelestatic property alterable by an activating agent.

10. The apparatus of claim 4, wherein one of the elongated member lumen or the at least one aperture includes a valve selected from the group consisting of a one way valve, a control valve, and a control valve coupled to feedback control resources.

11. The apparatus of claim 7, wherein the liquid polymer source includes one of an elastomer, a collagen, a silicone, a bioabsorbably polymers, or a hydrogel.

12. The apparatus of claim 4, wherein the fluid source is an electrolytic solution delivered to the target tissue to create a fluid volume, to create an enhanced electrode.

13. The apparatus of claim 3, wherein the at least one aperture is a plurality of apertures.

14. The apparatus of claim 13, wherein the plurality of apertures are at the distal end of the elongated member.

15. The apparatus of claim 13, wherein the plurality of apertures are configured to deliver one of a fluid, a conductive fluid, or a cooling fluid to at least one of the energy delivery device or the target tissue.

16. The apparatus of claim 1, wherein the sensor is selected from the group consisting of a pressure sensor, a force sensor, a flow sensor, a thermal sensor, an acoustical sensor, an impedance sensor, and an optical sensor.

17. The apparatus of claim 1, wherein the sensor is operably coupled to detect one of an opening, a fluidic opening, a tear, a seal, a hermetic seal or a closure of the tissue void.

18. The apparatus of claim 1, wherein the sensor is detects a pressure differential.

19. The apparatus of claim 1, wherein the sensor is detects a fluid flow rate.

20. The apparatus of claim 1, wherein the at least one sensor comprises a plurality of sensors.

21. The apparatus of claim 1, wherein the at least one sensor comprises a first sensor and a second sensor, said second sensor having a more distal position on the elongated member with respect to the first sensor.

22. The apparatus of claim 1, wherein the elongate member distal end has one of an atraumatic surface, an atraumatic coating, or a lubricious coating.

23. The apparatus of claim 1, further comprising an advancement and retraction member coupled to the biopsy device.

24. The apparatus of claim 1, further comprising:

at least one sensor coupled to the biopsy device.

25. The apparatus of claim 1, further comprising a valve coupled to at least one of the elongated member, or the lung biopsy device.

26. The apparatus of claim 25, wherein the valve is a control valve.

27. The apparatus of claim 25, wherein the valve is a disc movably coupled to one of the elongated member, or the lung biopsy device.

28. The apparatus of claim 25, wherein the valve is a constrictable valve.

29. The apparatus of claim 28, wherein the constrictable valve comprises at least a portion of the elongated member, or the lung biopsy device.

30. The apparatus of claim 1, further comprising:

a handpiece coupled to a proximal portion of the elongated member.

31. The apparatus of claim 30, further wherein the handpiece includes one of a fitting, an infusion port, a lumen, or a deflection mechanism.

32. The apparatus of claim 1, wherein the energy delivery device is an RF electrode.

33. The apparatus of claim 32, wherein the RF electrode is selected from the group consisting of a ring electrode, a conical shaped electrode, a needle electrode and a porous electrode.

34. The apparatus of claim 32, wherein the at least one electrode is selected from a plurality of electrodes, an array of electrodes, an array of monopolar electrodes, an array of bipolar electrodes, and an array of multiplexed electrodes.

35. (currently amended) The apparatus of claim 34, further comprising:

a multiplexing device coupled to at least a portion of the plurality of electrodes and, the power supply.

36. The apparatus of claim 1, further comprising:

a ground pad electrode coupled to the skin and coupled to the power supply.

37. The apparatus of claim 36, further comprising:

feedback control resources coupled to at least one of the power supply, the energy delivery device, and the sensor.

38. The apparatus of claim 1, wherein the at least one electrode comprises a first set of electrodes, each electrode of the first set having a tissue piercing distal end and being positionable in the elongated member as the elongated member is advanced through tissue, the first set of electrodes being deployable with curvature from the elongated member.

39. The apparatus of claim 38, wherein the at least one electrode comprises a second set of electrodes, each electrode of the second set having a tissue piercing distal end and being positionable in the elongated member as the elongated member is advanced through tissue, the second set of RF electrodes being deployable with curvature from the elongated member.

40. The apparatus of claim 39, wherein the second set of RF electrodes being deployable a greater distance than the first set of electrodes.

41. The apparatus of claim 39, wherein at least one of the first or the second set of electrodes is deployable with at least one radius of curvature.

42. The apparatus of claim 1, further comprising:

a closure device coupled to the elongated member, the closure device configured to substantially close a tissue void space within the lung.

43. The apparatus of claim 42, wherein the closure device has a non-deployed state and a deployed state, the closure device being deliverable to the tissue void space in the non deployed state and put into the deployed state to engage tissue substantially adjacent the void space and substantially close the void space.

44. The apparatus of claim 43, wherein the closure device is detachable from the elongated member in one of the deployed state or the non-deployed state.

45. The apparatus of claim 44, wherein the closure device is deployable before detachment from the elongated member.

46. The apparatus of claim 44, wherein the closure device is deployable after detachment from the elongated member.

47. The apparatus of claim 43, wherein the closure device is selected from a spring device, a coiled spring, a tapered spring, a surgical staple, a suture, a mesh, a plug, a shaped plug, an expandable plug, and a plurality of mechanical coupled curved wires having tissue piercing distal tips.

48. The apparatus of claim 42, wherein the closure device is disposed within the elongated member lumen.

49. The apparatus of claim 42, wherein the closure device is configured to seal or substantially hermetically seal the tissue void.

50. The apparatus of claim 42, wherein the closure device is configured to prevent a pneumothorax through the tissue void space.

51. The apparatus of claim 42, wherein at least a portion of the closure device comprises at least one of a polymer, an elastomer, a bioabsorbable polymer, a metal alloy, or a shape memory alloy.

52. The apparatus of claim 42, wherein at least a portion of the closure device is curable in situ.

53. The apparatus of claim 52, wherein the at least a portion of the closure device is curable via the delivery of energy from the energy delivery device.

54. The apparatus of claim 42, wherein at least a portion of the closure device includes at least one of an imagable marker, a radio-opaque marker, or an echogenic marker.

55. The apparatus of claim 42, further comprising:

a sensor coupled to the elongated member, wherein the sensor detects a property of the lung.

56. The apparatus of claim 55, wherein the sensor is coupled to at least one of the elongated member distal end, the energy delivery device, the closure device, or the elongated member lumen.

57. The apparatus of claim 55, wherein the sensor is selected from the group consisting of a pressure sensor, a force sensor, a flow sensor, a thermal sensor, an acoustical sensor, an impedance sensor and an optical sensor.

58. The apparatus of claim 55, wherein the sensor is configured to detect one of an opening, a fluidic opening, a tear, a seal, a hermetic seal or a closure of the tissue void.

59. (original) The apparatus of claim 55, where in the sensor is configured to detect a pressure differential.

60. The apparatus of claim 42, wherein the sensor is configured to detect a fluid flow rate.

61. The apparatus of claim 1, wherein the lung biopsy device has a distal end that is configured to cut and collect a lung tissue sample.

62. The apparatus according to claim 1, wherein the power source is a RF power source.

63. The apparatus according to claim 62, further comprising:

a feedback control device operatively coupled to said sensor and the RF power source to control application of RF current to the at least one electrode.

64. The apparatus according to claim 1, wherein said lung biopsy device is selected from the group consisting of a lung biopsy needle, a tissue aspiration device, and a tissue collection device.

65. The apparatus according to claim 64, wherein when said lung biopsy device is a tissue aspiration device or a tissue collection device, the device is selected from the group consisting of a syringe, a vacuum source operatively coupled to a filter, and a vacuum source operatively coupled to a collection chamber.

66. The apparatus according to claim 1, further including a deflection mechanism operatively coupled to said elongated member for deflecting and steering said elongated member.

67. The apparatus according to claim 66, wherein said deflection mechanism is selected from the group consisting of a pull wire, a ratchet, a latch and lock mechanism, and a piezoelectric material.

68. The apparatus according to claim 1, wherein said elongated member is coated with a lubricious coating or a film.

69. The apparatus according to claim 1, further comprising a second lung biopsy device.

70. The apparatus according to claim 1, further comprising a ground pad electrode.

71. The apparatus according to claim 1, further comprising an imaging system operatively coupled to the elongated member.

72. The apparatus according to claim 1, further comprising one of an introducing device, a percutaneous introducing device, and a trocar for positioning said elongated member at said tissue site.