Tissue ablation apparatus and method

• US 7,160,296 B2
• Filed: 05/10/2002
• Issued: 01/09/2007
• Est. Priority Date: 05/10/2001
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Balbierz, Daniel J., Daniel, Steve A., Liang, Jessica, Pearson, Rob, Lee, Kee S., Getaneh, Martha
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/142,713
• Publication Number:
  US 20030212394A1
• Time in Patent Office: 1,705 Days
• Field of Search: 606/41, 606/42, 606 45- 50, 607101-105, 607/113, 607/116
• US Class Current: 606/42
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00577 Ablation
• 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 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing

Abstract

A tissue-ablation method and apparatus are disclosed. The apparatus includes a plurality of RF ablation electrodes, and a plurality of sensor elements, each movable from retracted to deployed positions in a tissue to be ablated. A control device in the apparatus is operatively connected to the electrodes for supplying an RF power to the electrodes, to produce tissue ablation that advances from individual-electrode ablation regions to fill a combined-electrode ablation volume. The control device is operatively connected to the sensor elements for determining the extent of ablation in the regions of the sensor elements. The supply of RF power to the electrodes can thus be regulated to control the level and extent of tissue ablation throughout the combined-electrode volume. The electrodes are preferably hollow-needle electrodes through which liquid can be infused into the tissue, also under the control of the control unit, to modulate and optimize tissue ablation.

Claims

1. A tissue-ablation apparatus comprising:

(a) an elongate delivery device having a lumen terminating at a distal end,

(b) a plurality of electrodes carried in said device for movement between retracted positions at which the electrodes are disposed within the device'"'"'s lumen, and deployed positions at which the electrodes define a tissue volume, said electrodes being operatively connected to a power source for producing ablation within said volume in response to power supplied from the power source to said electrodes,

(c) a plurality of passive elongate sensor elements carried in said device for movement between retracted positions at which the sensor elements are disposed within the device'"'"'s lumen, and deployed positions at which the sensor elements are deployed from said distal end at a plurality of angularly spaced positions at which the deployed sensor elements are distributed within said volume, said sensor elements being unable to deliver ablative energy, and

(d) at least one sensor positioned on each of the elongate sensor elements for monitoring tissue ablation in said volume,

wherein the supply of power to said electrodes can be regulated to control a level and extent of tissue ablation throughout said volume according to the tissue ablation monitored by said sensors.

2. The apparatus of claim 1, wherein said electrodes and sensor elements are operatively connected for movement as a unit from their retracted to their deployed positions.

3. The apparatus of claim 1, wherein said electrodes are movable between their retracted and deployed positions independent of the movement of the sensor elements.

4. The apparatus of claim 1, wherein the sensors are thermal sensors.

5. The apparatus of claim 1, wherein said electrodes are hollow-needle electrodes, allowing liquid to be injected through said electrodes into tissue, with the electrodes deployed in tissue.

6. The apparatus of claim 5, which is designed to allow controlled fluid flow through each electrode individually.

7. The apparatus of claim 5, wherein at least one electrode has a plurality of infusion ports along its distal end regions, and is covered by a sheath that is axially movable between deployment and infusion positions at which the infusion ports are covered and exposed, respectively.

8. The apparatus of claim 5, wherein at least one electrode has a plurality of infusion ports along its distal end regions, and is covered by a sheath including a fixed gap.

9. The apparatus of claim 1, wherein said power source includes a display function for displaying to a user the extent of ablation in the tissue volume, and an adjustable power function by which the user can adjust the power applied to said electrodes.

10. The apparatus of claim 1, wherein said power source is operable to automatically adjust the power level applied to said electrodes in response to information received from said sensors relating to the extent of ablation in the regions of the sensor elements.

11. The apparatus of claim 1, wherein said electrodes are hollow-needle electrodes, allowing liquid to be injected through said electrodes into tissue, with the electrodes deployed in tissue, and said power source includes a display function for displaying to a user the extent of ablation in the tissue volume, and an adjustable fluid-control function by which the user can adjust the rate of liquid supplied to the individual electrodes.

12. The apparatus of claim 1, wherein said electrodes are hollow-needle electrodes, allowing liquid to be injected through said electrodes into tissue, with the electrodes deployed in tissue, and said power source is operable to control the rate of liquid flow through the electrodes in response to information received from said sensor elements relating to the extent of ablation in the tissue volume.

13. The apparatus of claim 1, wherein said electrodes, when deployed, are positioned near the center of the faces of a platonic solid that defines a desired combined-electrode ablation volume.

14. The apparatus of claim 13, wherein the sensor elements, when deployed, are positioned near vertices of the platonic solid.

15. The apparatus of claim 13, for ablating a substantially spherical volume that circumscribes a pyramid, which has four electrodes that are positioned near the center of the faces of the pyramid when deployed, and four sensor elements which are placed near the vertices of the pyramid when deployed.

16. The apparatus of claim 1, which further includes a body-surface electrode adapted to be applied to the surface of a patient, and the control device is operable to apply power between the plurality of electrodes and the body-surface electrode.

17. The apparatus of claim 1, wherein said apparatus is configured to operate in a bipolar mode.

18. The apparatus of claim 1, wherein all or a portion of the elongate delivery device distal end is plastic.

19. The apparatus of claim 1, wherein all or a portion of the elongate delivery device distal end is elastomer.

20. The apparatus of claim 1, wherein said elongate delivery device is configured to have a radiused or smooth inner leading edge.

21. The apparatus of claim 1, further comprising

a control device operatively connected to said electrodes and to said sensor elements for modulating power to said electrodes in response to information received from said sensors.

22. The apparatus of claim 1, wherein said electrodes are RF electrodes adapted to be operatively coupled to a RF energy source.

23. The apparatus of claim 1, wherein said electrodes are microwave electrodes adapted to be operatively coupled to a microwave energy source.

24. The apparatus of claim 1, further including an electrically insulative sleeve positioned over all of at least some of the sensor elements.

25. The apparatus of claim 1, wherein at least some of said sensor elements are not connected to the power source.

26. The apparatus of claim 1, wherein at least some of said sensor elements are formed of a non-conductive material.

27. The apparatus of claim 1, further comprising a multiplexing device coupled to at least some of the sensor elements.

28. A tissue-ablation apparatus for connection a power source comprising:

(a) an elongate delivery device having a lumen terminating at a distal end,

(b) a plurality of electrodes carried in said device for movement between retracted positions at which the electrodes are disposed within the device'"'"'s lumen, and deployed positions at which the deployed electrodes define a tissue volume, said electrodes being connected to said power for producing ablation within said volume in response to power supplied from the power source to said electrodes,

(c) a plurality of passive elongate sensor elements carried in said device for movement between retracted positions at which the sensor elements are disposed within the device'"'"'s lumen, and deployed positions at which the sensor elements are deployed from said distal end at a plurality of angularly spaced positions at which the deployed sensor elements are distributed within said volume, said sensor elements being unable to deliver ablative energy, and

(d) at least one sensor positioned on each of the elongate sensor elements for monitoring tissue ablation in said volume, said sensors being connected to said power source,

wherein the supply of power to said electrodes from said power source can be regulated to control a level and extent of tissue ablation throughout said volume according to the tissue ablation monitored by said sensors.