Electroporation ablation apparatus, system, and method

• US 8,449,538 B2
• Filed: 01/27/2010
• Issued: 05/28/2013
• Est. Priority Date: 02/15/2007
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Long, Gary L.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US12/694,452
• Publication Number:
  US 20100130975A1
• Time in Patent Office: 1,217 Days
• Field of Search: 606/32, 606/34, 606/38, 606/41, 606/42, 600/427, 600/411
• US Class Current: 606/41
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A surgical instrument, such as an endoscopic or laparoscopic instrument, includes an ablation device. The ablation device includes an elongate relatively flexible member having a proximal end and a distal end, the flexible member includes at least a first working channel. A first and second electrode extends from a working channel at the distal end of the flexible member. The first and second electrodes are adapted to be endoscopically located in a tissue treatment region. The first and second electrodes are adapted to couple to an electrical waveform generator to receive an irreversible electroporation electrical waveform sufficient to ablate tissue located between the first and second electrodes. The waveform parameters of the irreversible electroporation electrical waveform are determined based on image information received from the tissue treatment region.

Claims

1. A method comprising:

receiving image information of a diseased tissue region in a patient;

determining a volume and outline of a necrotic zone required to treat the diseased tissue based on the image information;

displaying an image of a virtual model of the diseased tissue on a monitor;

displaying an image of the diseased tissue based on the image information overlaid with the image of the virtual model of the diseased tissue;

determining waveform parameters to be generated by an electrical waveform generator suitable to destroy the diseased tissue located between first and second electrodes wherein the first and second electrodes are adapted to couple to the electrical waveform generator to receive an irreversible electroporation electrical waveform sufficient to ablate tissue located between the first and second electrodes; and

determining whether the generated waveform parameters are suitable to destroy the diseased tissue based on the image of the diseased tissue overlaid on the image of the virtual model.

2. The method of claim 1, comprising:

extracting geometric information from the image information; and

determining the volume and outline of the necrotic zone required to treat the diseased tissue based on the geometric information.

3. The method of claim 1, comprising:

providing the waveform parameters to an electrical waveform generator.

4. The method of claim 1, comprising:

determining amplitude, frequency, and pulse width waveform parameters suitable to destroy the diseased tissue.

5. An ablation system comprising:

an elongate member having a proximal end and a distal end, and comprising first and second working channels formed within the elongate member;

a first electrode extending from the first working channel at the distal end of the flexible member, and second electrode extending from the second working channel, the first and second electrodes are adapted to be endoscopically located in a diseased tissue region;

an image processing module configured to receive image information and a virtual model of the diseased tissue region and to display an image of the diseased tissue region overlaid with an image of the virtual model on a monitor;

an electrical waveform generator electrically coupled to the first and second electrodes and the image processing module, to generate an irreversible electroporation electrical (IRE) waveform based on waveform parameters, wherein the IRE waveform is sufficient to ablate tissue located between the first and second electrodes, wherein the electrical waveform generator is adapted to receive the waveform parameters from the image processing module, and wherein the waveform parameters are determined based on image information of the diseased tissue region in a patient overlaid with the image of the virtual model.

6. The ablation system of claim 5, wherein the waveform parameters are determined based on a volume and outline of a necrotic zone required to treat diseased tissue in the diseased tissue region based on the image information.

7. The ablation system of claim 5, wherein the volume and outline of the necrotic zone are determined from geometric information extracted from the image information.

8. The ablation system of claim 5, wherein the waveform parameters comprise amplitude, frequency, and pulse width of an electrical waveform suitable to destroy the diseased tissue.

9. The ablation system of claim 5, comprising:

an image sensor coupled to the image processing module and positioned to image tissue therethrough.

10. The ablation system of claim 9, comprising:

at least one illuminator positioned to illuminate tissue.

11. The ablation system of claim 5, comprising:

first and second probes disposed within the respective first and second channels, the first and second probes each defining a central axis;

wherein the first and second electrodes are coupled to distal ends of the respective first and second probes;

wherein a distance between the first and second electrodes is adjustable by rotating at least one of the first and second probes about the central axis of the at least one of the first and second probes.

12. The ablation system of claim 5, wherein the elongate member is flexible.

13. A method comprising:

receiving first image information of a diseased tissue in a patient;

creating a virtual model of the diseased tissue;

displaying an image of the virtual model of the diseased tissue on a monitor;

displaying an image of the diseased tissue based on the first image information overlaid with the image of the virtual model of the diseased tissue;

determining a first size of a necrotic zone required to treat the diseased tissue based on the first image information; and

determining a first set of waveform parameters of an irreversible electroporation electrical (IRE) waveform based on the image of the diseased tissue overlaid with the image of the virtual model of the diseased tissue to be generated by an electrical waveform generator suitable to be generated by an electrical waveform generator suitable to destroy the diseased tissue located between first and second electrodes wherein the first and second electrodes are adapted to couple to the electrical waveform generator to receive the irreversible electroporation electrical waveform.

14. The method of claim 13, comprising:

extracting geometric information from the first image information; and

determining the first size of the necrotic zone required to treat the diseased tissue based on the geometric information.

15. The method of claim 13, comprising:

providing the first set of waveform parameters to an electrical waveform generator.

16. The method of claim 13, comprising:

determining amplitude, frequency, and pulse width waveform parameters suitable to destroy the diseased tissue.

17. The method of claim 13, comprising:

after treating the diseased tissue with the IRE waveform, receiving second image information of the diseased tissue.

18. The method of claim 17, comprising:

determining a second size of the necrotic zone required to treat the diseased tissue based on the second image information.

19. The method of claim 18, comprising:

determining a second set of waveform parameters to be generated by an electrical waveform generator suitable to destroy the diseased tissue located between first and second electrodes.