Electroporation ablation apparatus, system, and method

• US 20080200912A1
• Filed: 02/15/2007
• Published: 08/21/2008
• 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.
• Granted Patent: US 7,655,004 B2
• Time in Patent Office: Days
• 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 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.

Claims

1. An ablation device comprising:

an elongate relatively flexible member having a proximal end and a distal end, the flexible member comprising at least a first working channel; and

a first and second electrode extending 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;

wherein 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.

2. The ablation device of claim 1, comprising:

at least one diagnostic probe extending from at least one of the working channels at the distal end of the flexible member, the at least one diagnostic probe is attached to at least one of the first and second electrodes.

3. The ablation device of claim 2, wherein the at least one diagnostic probe comprises a bore formed therethrough to receive a tissue sample.

4. The ablation device of claim 1, comprising:

a second working channel;

wherein, the first electrode extends from the first working channel and the second electrode extends from the second working channel at the distal end of the flexible member.

5. The ablation device of claim 4 comprising:

a second diagnostic probe extending from the second working channel at the distal end of the flexible member, the second diagnostic probe is attached to the second electrode and the second diagnostic probe comprises a bore formed therethrough to receive a tissue sample.

6. The ablation device of claim 5, wherein the first and second electrodes are rotatable about a central axis defined through each of the first and second diagnostic probes, wherein a distance between the first and second electrodes is adjustable by rotating either one or both of the first and second diagnostic probes.

7. The ablation device of claim 1, comprising:

at least one illuminator supported on the device and positioned to illuminate tissue; and

an image sensor supported on the device and positioned to image tissue therethrough.

8. 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; and

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.

9. The method of claim 8, 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.

10. The method of claim 8, comprising:

providing the waveform parameters to an electrical waveform generator.

11. The method of claim 8, comprising:

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

12. An ablation system, comprising:

an ablation device comprising;

an elongate relatively flexible member having a proximal end and a distal end, the flexible member comprising at least a first working channel; and

a first and second electrode extending 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;

wherein the first and second electrodes are adapted to receive an irreversible electroporation electrical (IRE) waveform sufficient to ablate tissue located between the first and second electrodes; and

an electrical waveform generator electrically coupled to the ablation device to generate an IRE waveform sufficient to ablate tissue located between the first and second electrodes.

13. The ablation system of claim 12, wherein the ablation device comprises at least one diagnostic probe extending from at least one of the working channels at the distal end of the flexible member, the at least one diagnostic probe is attached to at least one of the first and second electrodes.

14. The ablation system of claim 13, wherein the at least one diagnostic probe comprises a bore formed therethrough to receive a tissue sample

15. The ablation system of claim 12, wherein the ablation device comprises a second working channel;

wherein, the first electrode extends from the first working channel and the second electrode extends from the second working channel at the distal end of the flexible member.

16. The ablation system of claim 15, wherein the ablation device comprises a second diagnostic probe extending from the second working channel at the distal end of the flexible member and the second diagnostic probe is attached to the second electrode;

wherein the second diagnostic probe comprises a bore formed therethrough to receive a tissue sample.

17. The ablation system of claim 16, wherein the first and second electrodes are rotatable about a central axis defined through each of the first and second diagnostic probes to adjust a distance between the first and second electrodes by rotating either one or both of the first and second diagnostic probes.

18. The ablation system of claim 12, wherein the ablation device comprises at least one illuminator supported on the device and positioned to illuminate tissue;

and an image sensor supported on the device and positioned to image tissue therethrough.

19. The ablation system of claim 18, wherein the electrical waveform generator is adapted to receive IRE electrical waveform parameters from an image processing module;

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

20. The ablation system of claim 19, wherein the IRE electrical waveform parameters are determined based on a volume and outline of a necrotic zone required to treat the diseased tissue based on the image information.

21. The ablation system of claim 20, wherein the volume and outline of the necrotic zone are determined from geometric information extracted from the image information.

22. The ablation system of claim 19, wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width of an electrical waveform suitable to destroy the diseased tissue.

23. A method comprising:

introducing an elongate relatively flexible member having a proximal end and a distal end into a natural opening of a patient, the flexible member comprising a working channel and a first and second electrode extending from the 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; and

ablating the tissue located between the first and second electrodes with an irreversible electroporation (IRE) electrical waveform.

24. The method of claim 23, comprising:

taking a tissue sample at the tissue treatment region with a diagnostic probe coupled to at least one of the first and second electrodes, the diagnostic probe comprises a bore therethrough;

retrieving the tissue sample through the bore by applying suction to a proximal end of the diagnostic probe.

25. The method of claim 23, comprising:

obtaining image information of the tissue treatment region in the patient;

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

determining IRE waveform parameters to be generated by an IRE waveform generator suitable to destroy the diseased tissue.

26. The method of claim 25, 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.

27. The method of claim 25, comprising:

providing the IRE waveform parameters to an electrical waveform generator.

28. The method of claim 25, comprising:

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

29. The method of claim 23, comprising introducing a conductive liquid into the tissue treatment region, wherein the conductive liquid has a conductivity that is relatively higher than the conductivity of the tissue in the tissue treatment region.

30. An electrical scalpel, comprising:

a blade that is adapted to couple to an electrical waveform generator, wherein an electrical waveform is applied to the blade creates a tissue destruction zone surrounding the blade.

31. The electrical scalpel of claim 30, wherein the blade is adapted to couple to an irreversible electroporation electrical waveform generator.

32. A method comprising:

obtaining a surgical instrument, wherein the surgical instrument comprises;

an elongate relatively flexible member having a proximal end and a distal end, the flexible member comprising at least a first working channel; and

a first and second electrode extending 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;

wherein 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;

sterilizing the surgical instrument; and

storing the surgical instrument in a sterile container.