System and method for ablating a tissue site by electroporation with real-time monitoring of treatment progress

• US 10,238,447 B2
• Filed: 11/13/2015
• Issued: 03/26/2019
• Est. Priority Date: 04/29/2008
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc., Virginia Tech Intellectual Properties, Inc.
• Original Assignee: Virginia Tech Intellectual Properties, Inc.
• Inventors: Neal, II, Robert, Davalos, Rafael V
• Primary Examiner(s): Peffley, Michael F
• Application Number:
  US14/940,863
• Publication Number:
  US 20160066977A1
• Time in Patent Office: 1,229 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: C12N 13/00 Treatment of microorganisms or enzymes with electrical or wave energy, e.g. magnetism, sonic waves

Abstract

A medical system for ablating a tissue site with real-time monitoring during an electroporation treatment procedure. A pulse generator generates a pre-treatment (PT) test signal having a frequency of at least 1 MHz prior to the treatment procedure and intra-treatment (IT) test signals during the treatment procedure. A treatment control module determines impedance values from the PT test signal and IT test signals and determines a progress of electroporation and an end point of treatment in real-time based on the determined impedance values while the treatment progresses.

Claims

1. A medical system for ablating a tissue site with real-time monitoring during an electroporation treatment procedure, comprising:

at least two electrodes adapted to be introduced near a target region of a tissue site;

a pulse generator configured to generate and apply between the electrodes a plurality of electroporation pulses for ablation of tissue in the target region, a pre-treatment (PT) test signal having a frequency of at least 1 MHz prior to the treatment procedure and intra-treatment (IT) test signals during the treatment procedure;

a treatment control module adapted to determine impedance values from the PT test signal and IT test signals and to determine a progress of electroporation based on the determined impedance values.

2. The medical system of claim 1, wherein:

the pulse generator is configured to generate and apply between the electrodes an alternating current signal as the PT test signal and a direct current signal as the IT test signals;

the treatment control module determines an end of treatment when the impedance value from the IT test signals reaches the impedance value from the PT test signal.

3. The medical system of claim 1, wherein:

the pulse generator is configured to generate and apply between the electrodes an alternating current signal as the PT test signal and a direct current signal as the IT test signals;

the treatment control module sets a baseline impedance value by adjusting the impedance value of the PT test signal by a selected impedance value, and determines an end of treatment when the impedance value from the IT test signals reaches the baseline impedance value.

4. The medical system of claim 1, wherein:

the pulse generator is configured to generate and apply between the electrodes an alternating current signal as the PT test signal and a direct current signal as the IT test signals;

the treatment control module sets an imaginary component of the impedance value of the PT test signal as a baseline impedance value, and determines an end of treatment when the impedance value from the IT test signals reaches the baseline impedance value.

5. The medical system of claim 1, wherein the treatment control module determines the progress of electroporation by monitoring the change of impedance values between successive IT test signals.

6. The medical system of claim 1, wherein the pulse generator is adapted to generate an alternating current PT test signal having a frequency of at least 100 MHz.

7. The medical system of claim 1, wherein the pulse generator is adapted to generate the PT test signal having a voltage of at most 500 volts/cm RMS.

8. The medical system of claim 1, wherein the pulse generator is adapted to generate the PT test signal having a voltage of at most 100 volts/cm RMS.

9. The medical system of claim 1, wherein:

the pulse generator is configured to generate and apply between the electrodes an alternating current signal having at most 500 volts/cm RMS as the PT test signal and a direct current signal as the IT test signals;

the treatment control module determines an end of treatment when the impedance value of the IT test signals reaches an imaginary component value of the impedance value of the PT test signal.

10. The medical system of claim 1, wherein:

the pulse generator is adapted to generate and apply a plurality of PT and IT test signals at a plurality of different frequencies;

the treatment control module determines the progress of electroporation based on the determined real impedance values from the PT and IT test signals.

11. A medical system for ablating a tissue site with real-time monitoring during an electroporation treatment procedure, comprising:

at least two electrodes adapted to be introduced near a target region of a tissue site of a patient;

a pulse generator configured to generate and apply between the electrodes a plurality of electroporation pulses for ablation of tissue in the target region, a pre-treatment alternating current (PT) test signal having a frequency of at least 1 MHz prior to the treatment procedure and a continuous intra-treatment direct current (IT) test signals during the treatment procedure;

a treatment control module adapted to determine an impedance value from the PT test signal to establish a baseline impedance value and continuous impedance values from the IT test signals, and to determine an end point of the treatment procedure based on a comparison between the baseline impedance value and the continuous impedance values from the IT test signals.

12. The medical system of claim 11, wherein:

the treatment control module sets an imaginary component of the impedance value of the PT test signal as a baseline impedance value and determines an end of treatment when the impedance value from the IT test signals reaches the baseline impedance value.

13. The medical system of claim 11, wherein the treatment control module determines the end point based on a change of impedance values between successive IT test signals.

14. The medical system of claim 11, wherein the pulse generator is adapted to generate the alternating current PT test signal having a frequency of at least 100 MHz.

15. The medical system of claim 11, wherein the pulse generator is adapted to generate the PT test signal having a voltage of at most 500 volts/cm RMS.

17. The method of claim 11, wherein:

the PT test signal is an alternating current al and, the IT test signals are a direct current signal;

the step of determining a progress of electroporation includes determining an end of treatment when the impedance value from the IT test signals reaches the impedance value from the PT test signal.

18. The method of claim 11, wherein the PT test signal is an alternating current signal and the IT test signals are a direct current signal, the method further comprising:

determining a baseline impedance value by adjusting the impedance value of the PT test signal by a predetermined impedance value;

wherein the step of determining a progress of electroporation includes determining an end of treatment when the impedance value from the IT test signals reaches the baseline impedance value.

19. The method of claim 11, wherein:

the PT test signal is an alternating current signal and the IT test signals are a direct current signal; and

the step of determining a progress of electroporation includes determining an end of treatment when the impedance value from the IT test signals reaches an imaginary component value of the impedance value from the PT test signal.

20. The method of claim 11, wherein the step of determining a progress of electroporation includes determining the progress of electroporation by monitoring the change of impedance values between successive IT test signals.

21. The method of claim 11, wherein the step of applying a PT test signal includes applying an alternating current PT test signal having a frequency of at least 100 MHz.

22. The method of claim 11, wherein the step of applying a PT test signal includes applying a PT test signal having a voltage of at most 500 volts/cm RMS.

23. The method of claim 11, wherein the step of applying a PT test signal includes applying a PT test signal having a voltage of at most 100 volts/cm RMS.

24. The method of claim 11, wherein:

the step of applying a PT test signal includes applying an alternating current PT test signal having a voltage of at most 500 volts/cm RMS;

the step of applying IT test signals includes applying direct current IT test signals;

the step of determining a progress of electroporation includes determining an end of treatment when the impedance value of the IT test signals reaches an imaginary component value of the impedance value of the PT test signal.

16. A method of determining a progress of an electroporation treatment procedure for ablating a tissue site comprising:

applying a pre-treatment (PT) test signal having a frequency of at least 1 MHz to a target region of a tissue site through at least one electrode;

determining an impedance value based on the applied PT test signal;

applying a plurality of intra-treatment (IT) test signals during the treatment procedure;

determining an impedance value for each applied IT test signal;

determining a progress of electroporation of the target issue site based on the determined impedance values of the IT test signals and PT test signal.