Multiple antenna ablation apparatus and method with cooling element

• US 6,059,780 A
• Filed: 11/04/1997
• Issued: 05/09/2000
• Est. Priority Date: 08/15/1995
• Status: Expired due to Term

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Gough, Edward J., Stein, Alan A.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/964,034
• Time in Patent Office: 917 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/100-105, 604/21, 604/22
• US Class Current: 606/42
• 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: 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

An ablation apparatus includes a handpiece, an electrode extending from a handpiece distal end, a probe, a thermal sensor and an energy source. The electrode includes a distal end and a lumen, a cooling medium inlet conduit and a cooling medium exit conduit. Both conduits extend through the electrode lumen to an electrode distal end. A sidewall port, isolated from a cooling medium flowing in the inlet and outlet conduits, is formed in the electrode. The probe is at least partially positionable in the electrode lumen and configured to be advanced and retracted in and out of the sidewall aperture. The thermal sensor is supported by the probe. The electrode is coupled to an energy source.

Claims

1. An ablation apparatus, comprising:

a handpiece;

an electrode coupled to the handpiece, the electrode including a distal end sufficiently sharp to pierce tissue, a lumen, a cooling medium inlet conduit and a cooling medium exit conduit both extending at least partially through the electrode lumen, the electrode further including a port isolated from a cooling medium flowing in the inlet and outlet conduits, wherein the electrode is configured to be coupled to an energy source;

a probe at least partially positionable in the electrode lumen, wherein the probe includes a distal portion configured to be advanced out of the port with at least one radius of curvature; and

a thermal sensor coupled to the probe.

2. The apparatus of claim 1, wherein the cooling medium inlet and exit conduits form a closed loop at the electrode distal end.

3. The apparatus of claim 1, wherein the electrode lumen is configured to receive an infusion medium that remains isolated from the cooling medium.

4. The apparatus of claim 3, wherein the infusion medium is introduced through a proximal end of the electrode lumen to a tissue site through the port.

5. The apparatus of claim 1, further comprising:

an advancement and retraction member coupled to the probe.

6. The apparatus of claim 1, wherein at least a portion of the probe is an electrode coupled to the energy source.

7. The apparatus of claim 1, wherein two thermal sensors are coupled to the probe.

8. The apparatus of claim 7, wherein a first thermal sensor is positioned at a distal end of the probe, and a second thermal sensor is positioned at a non-distal end location of the probe.

9. The apparatus of claim 1, wherein the thermal sensor is positioned at a distal end of the probe.

10. The apparatus of claim 1, further comprising:

an insulation sleeve positioned around an exterior surface of the electrode.

11. The apparatus of claim 10, wherein the insulation sleeve is moveable along a longitudinal axis of the electrode.

12. The apparatus of claim 1, further comprising:

a second port formed in the electrode.

13. The apparatus of claim 12, further comprising:

a second probe at least partially positionable in the electrode lumen, wherein the second probe includes a distal portion configured to be advanced out of the second port with at least one radius of curvature; and

a second thermal sensor coupled to the second probe.

14. The apparatus of claim 1, wherein the cooling medium inlet and exit conduits are constructed to add structural support to the electrode.

15. The apparatus of claim 1, wherein the probe has a distal end geometry configured to retain the electrode in a fixed position when the probe is deployed from the port.

16. The apparatus of claim 1, wherein the cooling medium inlet and exit conduits are positioned adjacent to each other in the electrode lumen.

17. The apparatus of claim 1, further comprising:

a comparator device coupled to the thermal sensor to compare a measured temperature of a tissue site to a predetermined temperature value and generating a signal representative of a difference between the measured temperature and the predetermined temperature.

18. The apparatus of claim 17, further comprising:

a fluid control device coupled to the inlet and outlet conduits for regulating a rate of flow of the cooling medium through the electrode lumen in response to the signal from the comparator device representative of the temperature difference to maintain the measured temperature at or below the predetermined temperature.

19. The apparatus of claim 1, further comprising:

an energy output control device coupled to the electrode.

20. The apparatus of claim 19, wherein the energy output control device comprises:

a impedance measuring device for measuring an impedance value of tissue based on an energy applied to the tissue;

an impedance comparator device for comparing the measured impedance value of tissue to a predetermined maximum impedance value, the impedance comparing device generating a disabling signal if the measured impedance value exceeds the predetermined maximum impedance value; and

a communication device for communicating the disabling signal to the energy source to cease further delivery of energy from the energy source to the electrode.

21. The apparatus of claim 20, further comprising:

a cooling medium control device for regulating rate of flow of cooling medium through the electrode lumen in response to the signal from the impedance comparing device representative of the impedance difference to maintain the measured impedance value at or below the predetermined maximum impedance value.

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

providing an ablation device including a handpiece, an electrode with a distal end, a lumen, and a sidewall port isolated from a cooling medium flowing through the electrode, a probe positionable in the electrode lumen and configured to be advanced and retracted in and out of the sidewall port and a thermal sensor supported by the probe;

inserting the electrode into the selected tissue mass;

creating a tissue interface adjacent to an electrode electromagnetic energy delivery surface;

positioning at least a portion of the probe in the electrode lumen;

advancing a distal end of the probe from the sidewall port into the selected tissue mass;

cooling at least a portion of the electrode electromagnetic energy delivery surface;

delivering electromagnetic energy from the electrode electromagnetic energy delivery surface to the selected tissue mass;

measuring temperature at a site in the selected tissue mass; and

creating an ablation volume in the selected tissue mass.

23. The method of claim 22, wherein the thermal sensor is positioned at a periphery of a selected ablation volume.

24. The method of claim 22, wherein the thermal sensor is positioned between the electrode and a periphery of a selected ablation volume.

25. The method of claim 22, wherein temperature is measured at more than one location in the selected ablation volume while electromagnetic energy is delivered from the electrode.

26. The method of claim 22, wherein temperature is adjustably measured in the selected ablation volume while electromagnetic energy is delivered from the electrode.

27. The method of claim 22, wherein a second sensor is supported by the probe.

28. The method of claim 22, wherein the sensor is positioned at a distal end of the probe, and a second sensor is positioned on the probe between the distal end of the probe and an exterior surface of the electrode.

29. The method of claim 22, further comprising:

introducing an infusion medium through the aperture.

30. The method of claim 29, wherein the infusion medium is isolated from the cooling medium.

31. The method of claim 22, wherein the tissue interface is heated to a temperature exceeding 50 degrees C when electromagnetic energy is delivered to the selected tissue site.

32. The method of claim 22, wherein a deployed distal end of the probe fixes the electrode in a selected position.

33. The method of claim 22, further comprising:

measuring a temperature of the selected tissue site at the sensor;

comparing the measured temperature of the selected tissue site at the sensor to a predetermined temperature value and generating a signal representative of a difference between the measured temperature and the predetermined temperature value; and

transmitting to an electromagnetic energy source coupled to the electrode a signal to cease further electromagnetic energy delivery if the measured temperature exceeds the predetermined temperature.

34. The method of claim 22, further comprising:

measuring an impedance of the selected tissue site at the sensor;

comparing the measured impedance of the selected tissue site at the sensor to a predetermined impedance value and generating a signal representative of a difference between the measured impedance and the predetermined impedance value; and

transmitting to an electromagnetic energy source coupled to the electrode a signal to cease further electromagnetic energy delivery if the measured impedance exceeds the predetermined impedance value.

35. The method of claim 22, further comprising:

measuring a temperature of the selected tissue site at the sensor;

comparing the measured temperature of the selected tissue site at the sensor to a predetermined temperature value; and

adjusting a flow rate of cooling medium through the electrode based on the difference between the measured temperature and the predetermined temperature value.

36. The method of claim 22, wherein a flow rate of cooling medium flowing through the inlet and outlet conduits is from 1 to 50 ml per minute.