Multiple electrode ablation apparatus

• US 6,071,280 A
• Filed: 02/14/1997
• Issued: 06/06/2000
• Est. Priority Date: 11/08/1993
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Edwards, Stuart D., Lax, Ronald G., Sharkey, Hugh
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/802,195
• Time in Patent Office: 1,208 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/100-102, 607/122, 607/154, 607/156, 600/372-374
• US Class Current: 606/41
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 18/1485 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00779 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/04 : Radiators for near-field treatment

Abstract

A tissue ablation apparatus includes a delivery catheter with distal and proximal ends. A handle is attached to the proximal end of the delivery catheter. At least partially positioned in the delivery catheter is an electrode deployment device. The electrode deployment devices includes a plurality of retractable electrodes. Each electrode has a non-deployed state when it is positioned in the delivery catheter. Additionally, each electrode has a distended deployed state when it is advanced out of the delivery catheter distal end. The deployed electrodes define an ablation volume. Each deployed electrode has a first section with a first radius of curvature. The first section is located near the distal end of the delivery catheter. A second section of the deployed electrode extends beyond the first section, ad has a second radius of curvature, or a substantially linear geometry.

Claims

1. A tissue ablation apparatus, comprising:

an introducer having a distal portion and a proximal portion;

an electrode device positionable within an interior of the introducer as the introducer is advanced through tissue, the electrode device including at least a first RF electrode, a second RF electrode and a third RF electrode, each of the first, second and third RF electrodes having a tissue piercing distal end, a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal portion of the introducer, the first, second and third RF electrodes being deployable with curvature from the introducer distal portion and including a section that is perpendicular to a longitudinal axis of the introducer, the first, second and third RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer;

an electrode advancement and retraction member coupled to the electrode device to advance the first, second and third RF electrodes in and out of the introducer distal portion.

2. The apparatus of claim 1, wherein the RF electrodes are retractable in and out of the distal portion of the introducer.

3. The apparatus of claim 1, wherein the ablation volume is defined substantially by the peripheries of the RF electrodes in the deployed state.

4. The apparatus of claim 1, wherein the ablation volume is defined between the RF electrodes in their deployed states.

5. The apparatus of claim 1, wherein the RF electrodes in their deployed state define a three-dimensional ablation volume.

6. The apparatus of claim 1, wherein the RF electrodes are pre-sprung while retained in the introducer such that on being advanced from the distal portion of the introducer the RF electrodes become deployed and fan out from the distal portion of the introducer.

7. The apparatus of claim 1, wherein the RF electrodes are pre-sprung while retained in the introducer such that on being advanced from the distal portion of the introducer the RF electrodes become deployed and fan out from the distal portion of the introducer through tissue in accordance with the curvature.

8. The apparatus of claim 1, wherein each of the RF electrodes changes direction along a length of the electrode in the deployed state.

9. The apparatus of claim 1, wherein at least one of the RF electrodes exhibits, in the deployed state, at least one curved section located near the distal portion of the introducer and a non-curved section beyond the curved section.

10. The apparatus of claim 1, wherein at least one of the RF electrodes exhibits, in the deployed state, a first section which has a first radius of curvature and a second section which extends beyond the first section and has a second radius of curvature.

11. The apparatus of claim 1, wherein at least one of the RF electrodes exhibits, in the deployed state, at least two radii of curvature.

12. The apparatus of claim 1, wherein at least one of the RF electrodes exhibits, in the deployed state, at least two radii of curvature in one plane.

13. The apparatus of claim 1, wherein at least one of the RF electrodes exhibits, in the deployed state, at least two radii of curvature in at least two planes.

14. The apparatus of claim 1, wherein each RF electrode is made of a memory metal or a sprung steel.

15. The apparatus of claim 1. wherein each RF electrode is hollow and includes a fluid distribution port.

16. The apparatus of claim 15, further comprising a source of infusing medium coupled to each of the RF electrodes.

17. The apparatus of claim 15, further comprising a source of chemotherapeutic agent coupled to each of the RF electrodes.

18. The apparatus of claim 1, further comprising an electrode insulator positioned adjacent to and in surrounding relationship to each of the RF electrodes to define an electrode energy delivery surface.

19. The apparatus of claim 1, wherein the electrode advancement and retraction member is removable from the introducer.

20. The apparatus of claim 1, further comprising:

a handle member coupled to the introducer.

21. The apparatus of claim 1, wherein each RF electrode is wire-like.

22. The apparatus of claim 1, wherein each RF electrode includes a hollow lumen.

23. The apparatus of claim 1, further comprising:

an energy source coupled to the RF electrodes.

24. The apparatus of claim 23, wherein the energy source is an RF source coupled to the RF electrodes.

25. The apparatus of claim 23 further comprising:

a thermal sensor coupled to electrode device.

26. The apparatus of claim 1, wherein the first second and third RF electrodes are bipolar RF electrodes.

27. The apparatus of claim 1, wherein the first second and third RF electrodes are monopolar electrodes.

28. A method of deploying electrodes for defining an ablation volume, the method comprising:

providing an ablation apparatus including at least a first RF electrode, a second RF electrode and an introducer with a proximal portion and a distal portion, each of the RF electrodes having a tissue piercing distal end and configured to be advanceable from the introducer distal with curvature from a non-deployed state when positioned within the introducer to a deployed state when advanced from the introducer distal portion, each of the RF electrodes including a section that is perpendicular to a longitudinal axis of the introducer in the deployed state, the first and second RF electrodes exhibiting a changing direction of travel along a length of electrode deployed from the introducer;

positioning the introducer in a solid tissue mass to a selected tissue site; and

advancing the first and second RF electrodes from the distal portion of the introducer to the deployed state.

29. The method of claim 28 further comprising:

retracting the RF electrodes in and out of the distal portion of the introducer.

30. The method of claim 28 further comprising:

inserting the RF electrodes into tissue so as to penetrate the tissue.

31. The method of claim 28, wherein the ablation volume is substantially defined by the peripheries of the RF electrodes in the deployed state.

32. The method of claim 28, wherein the ablation volume is defined between the deployed RF electrodes.

33. A method of claim 28 further comprising:

deploying the RF electrodes to define a three-dimensional ablation volume.

34. The method of claim 28 further comprising:

advancing the RF electrodes from the distal portion of the introducer such that the RF electrodes become deployed and fan out from the distal portion.

35. The method of claim 28, wherein the RF electrodes are pre-sprung while retained in the introducer such that on being advanced from the distal portion of the introducer the RF electrodes become deployed and fan out from the distal portion of the introducer through tissue in accordance with the radius of curvature.

36. A method of claim 28, wherein at least one of the RF electrodes changes direction along its length in the deployed state.

37. A tissue ablation apparatus, comprising:

an introducer having a distal portion, a distal end at a distal most position of the distal portion, an introducer aperture formed at the distal end and a proximal portion;

an electrode device positionable within an interior of the introducer as the introducer is advanced through tissue, the electrode device including at least a first RF electrode, a second RF electrode and a third RF electrode, each of the first, second and third RF electrodes having a tissue piercing distal end, a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal end of the introducer, the first, second and third RF electrodes being deployable with cuvature from the introducer distal end and including a section that is perpendicular to a longitudinal axis of the introducer, the first, second and third RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device, the electrode advancement and retraction member advancing and retracting the RF electrodes in and out of the introducer distal end.

38. A tissue ablation apparatus, comprising:

an introducer having a distal portion, a distal end and a proximal portion;

an electrode device positionable within an interior of the introducer as the introducer is advanced through tissue, the electrode device including at least a first RF electrode, a second RF electrode and a third RF electrode, each of the first, second and third RF electrodes having a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal end of the introducer, the first, second and third RF electrodes being deployable with curvature from the introducer distal end to define an ablation volume, the first, second and third RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device, the electrode advancement and retraction member advancing and retracting the RF electrodes in and out of the introducer distal end.

39. The apparatus of claim 38, further including an impedance measurement apparatus coupled to the electrode device.

40. A tissue ablation apparatus, comprising:

a rigid introducer having a distal portion and a proximal portion;

an electrode device positionable within an interior of the introducer as the introducer is advanced through tissue, the electrode device including at least a first RF electrode with a tissue piercing distal end and a second RF electrode with a tissue piercing distal end, each of the first and second RF electrodes having a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal portion of the introducer, the first and second RF electrodes being deployable with curvature from the introducer distal portion, the first and second RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device, the electrode advancement and retraction member advancing and retracting the RF electrodes in and out of the introducer distal portion.

41. A tissue ablation apparatus, comprising:

an introducer having a distal portion and a proximal portion;

an electrode device positionable within an interior of the introducer as the introducer is advanced through tissue, the electrode device including at least a first RF electrode with a tissue piercing distal end, a second RF electrode with a tissue piercing distal end and an electrode coupling, each of the first and second RF electrodes having a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal portion of the introducer, the first and second RF electrodes being deployable with curvature from the introducer distal portion, the first and second RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device, the electrode advancement and retraction member advancing and retracting the RF electrodes in and out of the introducer distal end, wherein the electrode device is physically coupled to the electrode advancement and retraction member.

42. The apparatus of claim 41, wherein the electrode advancement member is a rigid electrode introducer.

43. The apparatus of claim 42, further comprising:

a handpiece coupled of the rigid electrode introducer.

44. The apparatus of claim 43, wherein the rigid electrode introducer is coupled to the handpiece.

45. A tissue ablation apparatus, comprising:

an introducer having a distal portion and a proximal portion;

an obturator with a tissue piercing distal end, the obturator being positionable in an interior of the introducer as the obturator is advanced through tissue;

an electrode device positionable within the interior of the introducer, the electrode device including at least a first RF electrode, a second RF electrode and a third RF electrode, each of the first, second and third RF electrodes having a tissue piercing distal end, a non-deployed state when positioned within the introducer and a deployed state when advanced from the distal portion of the introducer, the first, second and third RF electrodes being deployable with curvature from the introducer distal portion and including a section that is perpendicular to a longitudinal axis of the introducer, the first, second and third RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device to advance the first, second and third RF electrodes in and out of the introducer distal portion.

46. A tissue ablation apparatus, comprising:

an introducer having a distal portion and a proximal portion;

an obturator with a tissue piercing distal end, the obturator being positionable in an interior of the introducer as the obturator is advanced through tissue;

an electrode device positionable within the interior of the introducer, the electrode device including an electrode housing and at least a first RF electrode, a second RF electrode and a third RF electrode positionable in the electrode housing, each of the first, second and third RF electrodes having a tissue piercing distal end, a non-deployed state when positioned within the electrode housing and a deployed state when advanced from the distal portion of the introducer, the first, second and third RF electrodes being deployable with curvature from the introducer distal portion and including a section that is perpendicular to a longitudinal axis of the introducer, the first, second and third RF electrodes exhibiting a changing direction of travel along a length of each electrode deployed from the introducer; and

an electrode advancement and retraction member coupled to the electrode device to advance the first, second and third RF electrodes in and out of the introducer distal portion.