Electroporation ablation apparatus, system, and method

• US 8,029,504 B2
• Filed: 12/10/2009
• Issued: 10/04/2011
• 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:
  US12/635,298
• Publication Number:
  US 20100087813A1
• Time in Patent Office: 663 Days
• Field of Search: 606 32- 52, 600/101, 600/104, 600/106, 600/137, 600/153, 600/160, 607 96-100
• US Class Current: 606/37
• 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 member comprising first and second channels. First and second probes are disposed within the respective first and second channels, where the first and second probes each define a central axis. First and second electrodes are coupled to distal ends of the respective first and second probes. 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.

Claims

1. An ablation device, comprising:

an elongate member comprising first and second channels;

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

first and second electrodes coupled to and juxtaposed with distal ends of the respective first and second substantially straight probes;

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

wherein the first probe comprises a sharp distal end and an aperture in communication with a bore formed within the first probe to receive a tissue sample therethrough.

2. The ablation device of claim 1, comprising:

at least one illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

3. The ablation device of claim 1, wherein at least one of the first and second channels is a working channel.

4. The ablation device of claim 1, wherein at least one of the first and second probes is a diagnostic probe.

5. The ablation device of claim 1, wherein the elongate member is flexible.

6. An ablation system, comprising:

an elongate member comprising first and second channels;

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

first and second electrodes coupled to and juxtaposed with distal ends of the respective first and second substantially straight probes; and

an electrical waveform generator electrically coupled to the first and second electrodes to generate an irreversible electroporation electrical (IRE) waveform sufficient to ablate tissue located proximate to the first and second electrodes;

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

wherein the first probe comprises a sharp distal end and an aperture in communication with a bore formed within the first probe to receive a tissue sample therethrough.

7. The ablation system of claim 6, comprising:

at least one illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

8. The ablation device of claim 6, wherein at least one of the first and second channels is a working channel.

9. The ablation device of claim 6, wherein at least one of the first and second probes is a diagnostic probe.

10. The ablation device of claim 6, wherein the elongate member is flexible.

11. The ablation system of claim 6, wherein the electrical waveform generator is adapted to receive IRE electrical waveform parameters from an image processing module;

and wherein the IRE electrical waveform parameters are determined based on image information of a tissue treatment region in a patient.

12. The ablation system of claim 11, wherein the IRE electrical waveform parameters are determined based on a volume and outline of a necrotic zone required to treat the tissue treatment region based on the image information.

13. The ablation system of claim 12, wherein the volume and outline of the necrotic zone are determined from geometric information extracted from the image information.

14. The ablation system of claim 11, wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width of an electrical waveform suitable to destroy the diseased tissue.

15. A method, comprising:

locating an elongate member comprising first and second channels within a body cavity proximate to a tissue treatment region, wherein a first and a second substantially straight probe are disposed within the respective first and second channels, the first and second substantially straight probes each defining a central axis, and wherein a first and a second electrode are coupled to and juxtaposed with distal ends of the respective first and second substantially straight probes;

adjusting a distance between the first and second electrodes by rotating at least one of the first and second substantially straight probes about the respective central axis of the at least one of the first and second substantially straight probes; and

receiving a tissue sample through a sharp distal end and an aperture in communication with a bore formed within either one of the first and second probes.

16. The method of claim 15, comprising:

illuminating the tissue treatment region with at least one illuminator positioned to illuminate tissue; and

imaging the tissue treatment region with an image sensor positioned to image tissue therethrough.

17. The method of claim 15, comprising:

applying an irreversible electroporation electrical (IRE) waveform sufficient to ablate tissue located proximate to the first and second electrodes with an electrical waveform generator electrically coupled to the first and second electrodes of the ablation device.

18. The method of claim 15, comprising:

determining IRE electrical waveform parameters based on image information of the tissue treatment region; and

receiving by the electrical waveform generator IRE electrical waveform parameters from an image processing module.

19. The method of claim 18, comprising determining the IRE electrical waveform parameters based on a volume and outline of a necrotic zone required to treat the tissue treatment region based on the image information.

20. The method of claim 19, comprising determining the volume and outline of the necrotic zone from geometric information extracted from the image information.

21. The method of claim 15, comprising applying an IRE electrical waveform suitable to destroy diseased tissue in the tissue treatment region, wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width.

22. An ablation device, comprising:

an elongate member comprising first and second channels;

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

first and second electrodes coupled to and juxtaposed with distal ends of the respective first and second substantially straight probes;

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

wherein the second probe comprises a sharp distal end and an aperture in communication with a bore formed within the second probe to receive a tissue sample therethrough.

23. The ablation device of claim 22, comprising:

at least one illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

24. The ablation device of claim 22, wherein at least one of the first and second channels is a working channel.

25. The ablation device of claim 22, wherein at least one of the first and second probes is a diagnostic probe.

26. The ablation device of claim 22, wherein the elongate member is flexible.

27. An ablation system, comprising:

an elongate member comprising first and second channels;

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

first and second electrodes coupled to and juxtaposed with distal ends of the respective first and second substantially straight probes; and

an electrical waveform generator electrically coupled to the first and second electrodes to generate an irreversible electroporation electrical (IRE) waveform sufficient to ablate tissue located proximate to the first and second electrodes;

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

wherein the second probe comprises a sharp distal end and an aperture in communication with a bore formed within the second probe to receive a tissue sample therethrough.

28. The ablation system of claim 27, comprising:

at least one illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

29. The ablation device of claim 27, wherein at least one of the first and second channels is a working channel.

30. The ablation device of claim 27, wherein at least one of the first and second probes is a diagnostic probe.

31. The ablation device of claim 27, wherein the elongate member is flexible.

32. The ablation system of claim 27, wherein the electrical waveform generator is adapted to receive IRE electrical waveform parameters from an image processing module;

and wherein the IRE electrical waveform parameters are determined based on image information of a tissue treatment region in a patient.

33. The ablation system of claim 32, wherein the IRE electrical waveform parameters are determined based on a volume and outline of a necrotic zone required to treat the tissue treatment region based on the image information.

34. The ablation system of claim 33, wherein the volume and outline of the necrotic zone are determined from geometric information extracted from the image information.

35. The ablation system of claim 32, wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width of an electrical waveform suitable to destroy the diseased tissue.