Cool-tip radiofrequency thermosurgery electrode system for tumor ablation

• US 6,575,969 B1
• Filed: 08/21/2000
• Issued: 06/10/2003
• Est. Priority Date: 05/04/1995
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Sherwood Services AG
• Inventors: Cosman, Eric R., Rittman, William J. III
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/642,309
• Time in Patent Office: 1,023 Days
• Field of Search: 606/27-31, 606/41, 606/42, 606/45, 606/48-50, 607/101, 607/102, 600/439, 600/461, 600/463, 128/898
• US Class Current: 606/41
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00106 ultrasonic
• 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

This patent application is a continuation-in-part of the patent application of the present authors related to target volume ablation in the body using a cooled-tip tissue-heating probe such as a fluid cooled (perfusion cooled) high frequency electrode. The present application relates in part to examples of specific embodiments of high frequency and radiofrequency electrode designs and heating and cooling system designs. It further describes embodiments in conjunction with 3-D or 2-D image data and computer graphic workstions to control, monitor, and pre-plan the process of target ablation. Specific examples of cooled-tip electrode constructions will be given which have utility for percutaneous or intraoperative cancerous tumor ablation. Cooled tip electrode systems with modular or separable components involving an insertion cannula, a radiofrequency electrode element, a cooling element, and a thermo-monitoring and/or radiofrequency connection electrode will be given. A high frequency and cooling system which is controlled and regulated based on the “thermally clamped tip” concept together with control of power, current, or other high frequency power parameters to pre-plan and control lesion size will be shown. Pre- or contemporaneous monitoring methods using CT, MR, ultrasound, and acoustic imaging or monitoring modalities in conjugation with the cooled tip high frequency ablation system will be exemplified. Variations in electrode design for specific target sites in the body will be described and illustrated.

Claims

1. A process for the controlled ablation of tissue in the body of a subject, comprising the steps of:

providing a housing having a portion of its surface forming a high frequency electrode and defining an inner space;

inserting an inner probe into the inner space to define a channel within the inner space;

supplying high frequency electrical energy to the outer housing for the ablation of tissue in the body of the subject;

providing circulating coolant through the channel;

monitoring audio signals, positioning a microphone adjacent the tissue and detecting the audio signals emitted by the tissue using the microphone during an ablation procedure, emanating from the tissue in the body of the subject representative of physiological changes caused by the ablation; and

dynamically controlling and maintaining a degree of high frequency electrical energy supplied to the outer housing, the degree being responsive to indications of the audio signals emanating from the body of the subject.

2. The process in accordance with claim 1 further including the step of providing an insulation material over a substantial portion of the housing to prevent ablation of tissue in the body of a subject contiguous to the insulation material.

3. The process in accordance with claim 1 wherein the step of providing includes incorporating the microphone in the housing.

4. The process in accordance with claim 1 further including the step of displaying a graphic image of the audio signals.

5. The process in accordance with claim 1 further including the step of imaging the tissue during the ablation procedure with imaging means selected from the group consisting of ultrasound, CT, MRI, and PET imaging modalities.

6. The process in accordance with claim 5 further including the step of displaying a graphic image of the tissue produced by the imaging devices.

7. The process in accordance with claim 6 further including the step of displaying a previously scanned image of a tumor'"'"'s volume superimposed on the graphic image of the tissue.

8. A process for the controlled ablation of tissue in the body of a subject, comprising the steps of:

providing a housing having a portion of its surface forming a high frequency electrode and defining an inner space;

inserting an inner probe into the inner space to define a channel within the inner space;

supplying high frequency electrical energy to the outer housing for the ablation of tissue in the body of the subject;

wherein the high frequency electrode further comprises a first hemispherical portion and a second opposed hemispherical portion wherein the first hemispherical portion is electrically conductive and the second hemispherical portion is electrically insulated and wherein, during the step of supplying, the first hemispherical portion causes ablation of tissue adjacent thereto that extends in a direction opposite the second hemispherical portion;

providing circulating coolant through the channel;

monitoring audio signals, during an ablation procedure, emanating from the tissue in the body of the subject representative of physiological changes caused by the ablation; and

dynamically controlling and maintaining a degree of high frequency electrical energy supplied to the outer housing, the degree being responsive to indications of the audio signals emanating from the body of the subject.

9. A process for the controlled ablation of tissue in the body of a subject, comprising the steps of:

providing a housing having a portion of its surface forming a high frequency electrode and defining an inner space;

inserting an inner probe into the inner space to define a channel within the innerspace;

supplying high frequency electrical energy to the outer housing for the ablation of tissue in the body of the subject;

wherein the housing comprises an outer cannula having a closed tip portion disposed at its distal end, the tip portion further comprising a first hemispherical portion and a second opposed hemispherical portion, the first hemispherical portion forming the high frequency electrode and the second hemispherical portion being insulated and wherein, during the step of supplying, the first hemispherical portion causes ablation of tissue adjacent thereto that extends in a direction opposite the second hemispherical portion;

providing circulating coolant through the channel;

monitoring audio signals, during an ablation procedure, emanating from the tissue in the body of the subject representative of physiological changes caused by the ablation; and

dynamically controlling,.and maintaining a degree of high frequency electrical energy supplied to the outer housing, the degree being responsive to indications of the audio signals emanating from the body of the subject.

10. The process in accordance with claim 9 wherein the insulated tip portion and the electrically conductive tip portion each comprise approximately one half the periphery of the tip portion.

11. The process in accordance with claim 9, further including the step of displaying a graphic image of the audio signals.

12. The process in accordance with claim 9, further including the step of imaging the tissue during the ablation procedure with imaging means selected from the group consisting of ultrasound, CT, MRI, and PET imaging modalities.

13. The process in accordance with claim 12 further including the step of displaying a graphic image of the tissue produced by the imaging devices.

14. The process in accordance with claim 13 further including the step of displaying a previously scanned image of a tumor'"'"'s volume superimposed on the graphic image of the tissue.