Apparatuses and methods for interstitial tissue removal

• US 20020072745A1
• Filed: 08/14/2001
• Published: 06/13/2002
• Est. Priority Date: 07/13/1998
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Novacept Inc. (Hologic Incorporated)
• Inventors: Truckai, Csaba, Sampson, Russel M., Hsei, Paul K.
• Granted Patent: US 6,663,626 B2
• Time in Patent Office: Days
• US Class Current: 606/47
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00625 Vaporization
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 2218/008 for smoke evacuation
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

Apparatuses and methods for removing solid tissue from beneath a tissue surface are described. The methods rely on positioning an energy conductive element at a target site beneath the tissue surface and energizing the element so that it can vaporize tissue. The element is then moved in a pattern which provides the desired tissue removal geometry, such as spherical, ovoid, or cylindrical. Usually, the shaft is moved, typically rotated or reciprocated, and the energy conductive element is moved relative to the shaft, typically by pivoting a rigid element or bowing a flexible element.

Claims

1. A method for removing a volume of solid tissue beneath a tissue surface, said method comprising:

positioning an energy conductive element at a target site in the solid tissue beneath the tissue surface;

energizing the energy conductive element; and

moving the energized element through successive tissue layers, wherein the element is energized with sufficient energy to vaporize tissue in said successive layers to produce a desired removal volume.

3. A method as in claim 1 or 2, wherein the solid tissue comprises an organ selected from the group consisting of breast, liver, kidney, prostate, uterus, and lung.

4. A method as in claim 1 or 2, further comprising imaging the solid tissue and positioning the energy conductive element based on the image.

5. A method as in claim 4, wherein imaging comprises fluoroscopic imaging, ultrasonic imaging, magnetic resonance imaging, optical imaging, or computer-assisted tomographic imaging.

6. A method as in claim 4, wherein the energy conductive device is manually positioned in real time by a user who is viewing the image.

7. A method as in claim 4, wherein the energy conductive device is automatically positioned by a positioning system in response to the image.

8. A method as in claim 1 or 2, further comprising collecting vapors produced as the tissue is vaporized and removing the vapors through the tissue surface.

9. A method as in claim 8, wherein collecting and removing the vapors comprises aspirating the vapors from the removal volume.

15. A method as in claim 1 or 2, wherein energizing the element comprises delivering high frequency electrical current.

20. A method as in claim 1 or 2, wherein energizing the element comprises heating the element.

24. A method as in claim 1 or 2, wherein the removal volume has a spherical or ovoid geometry.

25. A method as in claim 1 or 2, wherein the removal volume has a cylindrical geometry.

26. A method as in claim 1 or 2, wherein the removal volume has a volume in the range from 0.5 cm³ to 500 cm³.

60. A kit comprising:

a device having an energy conductive element which is connectable to a power supply which provides energy sufficient to vaporize successive layers of tissue as said element is moved therethrough; and

instructions for use setting forth a method as in claim 1 or 2.

2. A method for removing a volume of solid tissue beneath a tissue surface, said method comprising:

providing an instrument having a shaft and a repositionable energy conductive element;

advancing the element through the tissue surface to a target site in the solid tissue, wherein the element is in a low profile configuration and a proximal end of the shaft remains outside the solid tissue;

moving the shaft relative to the tissue surface;

repositioning the element relative to the shaft; and

energizing the element;

wherein the combined movement of the shaft and repositioning of the element cause the element to pass through successive tissue layers and wherein the element is energized with sufficient energy to vaporize tissue in said successive layers to produce a desired removal volume.

10. A method as in claim 2, further comprising aspirating vapors produced as the tissue is vaporized through a lumen in the shaft.

11. A method as in claim 2, wherein moving the shaft comprises rotating the shaft about its axis.

12. A method as in claim 2, wherein moving the shaft comprises reciprocating the shaft in an axial direction.

13. A method as in claim 2, wherein repositioning the element comprises pivoting the element about a pivot point on the shaft.

14. A method as in claim 2, wherein repositioning the element comprises bowing the element between a linear configuration and an arcuate configuration.

16. A method as in claim 15, wherein the high frequency energy is delivered in a bipolar manner between the element and an electrode positioned at or near the target site.

17. A method as in claim 15, wherein the high frequency energy is delivered in a monopolar manner between the element and a skin pad on the patient'"'"'s outer skin.

18. A method as in claim 15, wherein the high frequency energy has a cutting waveform, a frequency in the range from 100 kHz to 2 MHz and a current in the range from 1 mA to 50 A.

19. A method as in claim 18, further comprising applying radiofrequency having a coagulation waveform to the tissue which remains after removal.

21. A method as in claim 19, wherein the element is heated to a temperature in the range from 100°

C. to 3000°

C.

22. A method as in claim 19, wherein the element is heated by directing optical energy to the element.

23. A method as in claim 19, wherein the element is resistively heated with electrical current.

28. A device as in claim 26, wherein the shaft is substantially rigid.

29. A device as in claim 27 or 28, wherein the shaft has a diameter in the range from 0.1 mm to 20 mm and a length in the range from 0.5 cm to 50 cm.

30. A device as in claim 27, wherein the shaft is flexible and has a length in the range from 25 cm to 250 cm.

31. A device as in claim 26, further comprising a handle secured to the proximal end of the shaft.

32. A device as in claim 29, wherein the aspiration connector and/or the power supply connector are disposed on the handle.

33. A device as in claim 26, further comprising a motor attachable to the proximal end of the shaft.

34. A device as in claim 31, wherein the motor is attached to both rotate the shaft and move the energy conductive element relative to the shaft.

35. A device as in claim 26, wherein the energy conductive element comprises an electrode which conducts high frequency electrical energy.

36. A device as in claim 26, wherein the energy conductive element comprises a heating element.

37. A device as in claim 34, wherein the heating element comprises an optical fiber for delivering light energy to heat the energy conductive element.

38. A device as in claim 34, wherein the heating element comprises an electrical resistance heater.

39. A device as in claim 26, wherein the energy conductive element comprises a wire.

40. A device as in claim 26, wherein the element comprises a ribbon.

41. A device as in claim 26, comprising at least two or more energy conductive electrodes, wherein the bowing means is adapted to bow the elements at substantially the same rate.

42. A device as in claim 26, comprising at least one wire electrode and at least one ribbon electrode, wherein the electrical connector provides for connecting the wire and ribbon electrodes to opposite poles of a high frequency electrical power supply.

43. A device as in claim 40, wherein the bowing means advances the wire electrodes radially ahead of the ribbon electrodes.

45. A device as in claim 42, wherein the shaft is substantially rigid.

46. A device as in claim 42 or 43, wherein the shaft has a diameter in the range from 0.1 mm to 20 mm and a length in the range from 0.5 cm to 50 cm.

47. A device as in claim 42, wherein the shaft has a diameter in the range from 0.1 mm to 20 mm and a length in the range from 0.5 cm to 50 cm.

48. A device as in claim 42, further comprising a handle secured to the proximal end of the shaft.

50. A device as in claim 42, further comprising a motor attachable to the proximal end of the shaft.

52. A device as in claim 42, wherein the energy conductive element comprises an electrode which conducts high frequency electrical energy.

53. A device as in claim 42, wherein the energy conductive element comprises of a heating element.

54. A device as in claim 50, wherein the heating element comprises an optical fiber for delivering light energy to heat the energy conductive element.

55. A device as in claim 50, wherein the heating element comprises an electrical resistance heater.

56. A device as in claim 42, wherein the substantially rigid energy conductive element has a length in the range from 15 mm to 75 mm and a width in the range from 1 mm to 5 mm.

57. A device as in claim 53, wherein the substantially rigid energy conductive element is a circular or flat cross-section.

58. A device as in claim 42, wherein the substantially rigid energy conductive element comprises a straight pin which is pivotally attached near its middle to the shaft.

59. A device as in claim 42, wherein the substantially rigid energy conductive element comprises a straight pin which is pivotally attached near one end thereof to the shaft.

61. A kit as in claim 57, wherein the device is present in a sterile package and the instructions for use are printed on a portion of the package or on a separate instruction sheet accompanying the package.

27. A tissue ablation device comprising:

a shaft having a proximal end, a distal end, and a lumen therethrough;

at least one flexible energy conductive element disposed near the distal end of the shaft;

means for bowing the element between a substantially linear profile where the element lies directly over the shaft and a series of arcuate profiles spaced progressively away from the shaft;

an aspiration connector coupled to the lumen near the proximal end of the shaft; and

a power supply connector disposed near the proximal end of the shaft and electrically coupled to the energy conductive element.

44. A tissue ablation device comprising:

a shaft having a proximal end, a distal end, and a lumen therethrough, a substantially rigid energy conductive element pivotally attached to the shaft near its distal end;

means for causing the element to pivot relative to the shaft;

an aspiration connector coupled to the lumen near the proximal end of the shaft; and

a power supply connector disposed near the proximal end of the shaft and electrically coupled to the energy conductive element.

49. A device as in claim 45, wherein the aspiration connector and the power supply connector are disposed on the handle.

51. A device as in claim 47, wherein the motor is attached to both rotate the shaft and move the energy conductive element relative to the shaft.