Multiple electrode ablation apparatus and method

• US 6,090,105 A
• Filed: 11/17/1997
• Issued: 07/18/2000
• Est. Priority Date: 08/15/1995
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Zepeda, John, Lee, Kee, Hirsch, Chaya, Gough, Edward J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/971,415
• Time in Patent Office: 974 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/100-102, 607/115, 607/116, 604/114
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/00022 Sensing or detecting at the treatment site
• 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: A61M 3/0279 : Cannula; Nozzles; Tips; their connection means
• 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
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body

Abstract

An ablation apparatus includes an introducer with a distal end sufficiently sharp to penetrate tissue. An energy delivery device is configured to be coupled to an energy source. The energy delivery device includes a first electrode and a second electrode each with a tissue piercing distal portion. The first and second electrodes are at least partially positionable in the introducer and deployable from the introducer at a selected tissue site to an expanded state. In the expanded state the deployed first and second electrodes distend laterally away from the introducer with a radius of curvature to form a shaped array of deployed electrodes at the tissue site when positioned at the selected tissue site. The first electrode distal portion and the second electrode distal portion are each at least partially made of a shaped memory alloy material that displays stress induced martensite behavior above body temperature. A cable couples the energy source to the energy delivery device.

Claims

1. An ablation apparatus, comprising:

an introducer including with a distal end sufficiently sharp to penetrate tissue;

an energy delivery device configured to be coupled to an energy source, the energy delivery device including a first electrode and a second electrode each having a tissue piercing distal portion, the first and second electrodes being at least partially positionable in the introducer and deployable from the introducer at a selected tissue site to an expanded state of deployed first and second electrodes that distend laterally away from the introducer with a radius of curvature to form a shaped array of deployed electrodes at the tissue site when positioned at the selected tissue site, wherein the first electrode distal portion and the second electrode distal portion are each at least partially made of a shaped memory alloy material that displays stress induced martensite behavior above body temperature; and

a cable coupling the energy source to the energy delivery device.

2. The apparatus of claim 1, wherein a distal portion of the introducer is an electrode.

3. The apparatus of claim 1, further comprising:

an electrode advancement and retraction member coupled to the first and second electrodes.

4. The apparatus of claim 1, wherein the first and second electrodes are retractable in and out of the introducer.

5. The apparatus of claim 1, wherein each of the first and second electrodes has a tissue piercing distal end.

6. The apparatus of claim 1, wherein the first and second electrodes are in a non-stress induced martensite state when positioned in the introducer prior to deployment at the selected tissue site.

7. The apparatus of claim 1, wherein the shaped memory alloy material displays stress induced martensite behavior at a tempeature greater than 40 degrees C.

8. The apparatus of claim 1, wherein the first and second electrodes are in a non-restrained state when positioned in the introducer prior to deployment at the selected tissue site.

9. The apparatus of claim 1, further comprising:

a first sensor coupled to the first electrode.

10. The apparatus of claim 9, wherein the first sensor is positioned at the distal portion of the first electrode.

11. The apparatus of claim 9, wherein the first sensor is a temperature sensor.

12. The apparatus of claim 9, wherein the first sensor an impedance sensor.

13. The apparatus of claim 9, further comprising:

a second sensor.

14. The apparatus of claim 13, wherein the second sensor is positioned at the distal portion of the second electrode.

15. The apparatus of claim 13, wherein the second sensor is a thermal sensor.

16. The apparatus of claim 13, wherein the second sensor is an impedance sensor.

17. The apparatus of claim 9, further comprising:

a feedback control system coupled to the first sensor.

18. The apparatus of claim 17, wherein the feedback control system is responsive to a detected characteristic from the first sensor and provides a delivery of ablation energy output from the energy source to the first and second electrodes.

19. The apparatus of claim 13, further comprising:

a feedback control system coupled to the second sensor.

20. The apparatus of claim 19, wherein the feedback control system is responsive to a detected characteristic from the second sensor and provides a delivery of ablation energy output from the energy source to the first and second electrodes.

21. The apparatus of claim 2, wherein the introducer has an energy delivery surface with a length that is at least 20% of a length of an energy delivery surface of the first electrode.

22. The apparatus of claim 2, wherein the introducer has an energy delivery surface with a length that is at least one-third of a length of an energy delivery surface of the first electrode.

23. The apparatus of claim 2, wherein the introducer has an energy delivery surface with a length that is at least one-half of a length of an energy delivery surface of the first electrode.

24. The apparatus of claim 1, wherein the shaped memory alloy material is an alloy of nickel titanium.

25. The apparatus claim 1, further comprising:

a third electrode, wherein the third electrode distal portion is at least partially made of a shaped memory alloy material that displays stress induced martensite behavior above body temperature.

26. The apparatus of claim 25, wherein the first, second and third electrodes are retractable electrodes.

27. The apparatus of claim 26, wherein the retractable electrodes advance from the introducer and deploy in a lateral direction away from a periphery of the introducer and define a three dimensional ablation volume between the deployed retractable electrodes, each of the retractable electrodes in a deployed state exhibiting at least one radius of curvature outside of and away from the introducer to define the three dimensional ablation volume.

28. The apparatus of claim 1, further comprising:

an insulation sleeve positioned in a surrounding relationship around at least a portion of an exterior of the introducer.

29. The apparatus of claim 28, wherein the insulation sleeve is adjustably moveable along an exterior of the introducer.

30. The apparatus of claim 1, further comprising:

an insulation sleeve positioned in a surrounding relationship around at least a portion of an exterior of the first and second electrodes.

31. The apparatus of claim 1, further comprising:

a ground pad electrode.

32. The apparatus of claim 1, wherein the first and second electrodes are RF electrodes.

33. The apparatus of claim 2, wherein the first and second electrodes are operated in a monopolar mode.

34. The apparatus of claim 2, wherein the first and second electrodes are operated in a bipolar mode.

35. The apparatus of claim 1, wherein the first electrode is hollow and configured to be coupled to an infusion medium source.

36. A method for creating an ablation volume in a selected tissue mass, comprising:

providing an ablation apparatus including an introducer, an energy source, a first electrode and a second electrode at least partially positionable in the introducer, wherein a first electrode distal portion and a second electrode distal portion are each at least partially made of a shaped memory alloy material that displays stress induced martensite behavior above body temperature;

advancing the introducer through tissue to the selected tissue site;

applying energy to the first and second electrode distal portions while positioned in the introducer and creating a stress induced martensitic state in the first and second electrodes at a temperature above body temperature;

advancing the first and second electrodes from the introducer to surround a selected tissue mass;

delivering energy from the energy source to the first and second electrodes; and

creating an ablation volume in the selected tissue mass.

37. The method of claim 36, wherein a distal portion of the introducer is an electrode and the ablation volume is defined by the first and second electrodes and the distal portion of the introducer.

38. The method of claim 36, wherein the first and second electrodes are in a non-stress induced martensitic state when positioned in the introducer prior to deployment at the selected tissue site.

39. The method of claim 36, wherein the shaped memory alloy material displays stress induced martensite behavior at a tempeature greater than 40 degrees C.

40. The method of claim 36, wherein the first and second electrodes are in a non-restrained state when positioned in the introducer prior to deployment at the selected tissue site.

41. The method of claim 36, further comprising:

measuring a temperature with a first sensor coupled to the first electrode.

42. The method of claim 41, wherein the temperature is measured at a periphery of the selected tissue site.

43. The method of claim 41, wherein the temperature is measured outside of a periphery of the selected tissue site.

44. The method of claim 36, further comprising:

measuring an impedance at the selected tissue site after energy is delivered to the selected tissue site.

45. The method of claim 36, wherein the shaped memory alloy material is an alloy of nickel titanium.

46. The method of claim 36, wherein the apparatus further includes a third electrode, wherein the third electrode distal portion is at least partially made of a shaped memory alloy material that displays stress induced martensite behavior above body temperature.

47. The method of claim 46, wherein the first, second and third electrodes are advance from the introducer and deployed in a lateral direction away from a periphery of the introducer and define a three dimensional ablation volume between the deployed retractable electrodes, each of the retractable electrodes in a deployed state exhibiting at least one radius of curvature outside of and away from the introducer to define the three dimensional ablation volume.

48. The method of claim 47, wherein the first, second and third electrodes are RF electrodes.