Electroporation ablation apparatus, system, and method

• US 9,375,268 B2
• Filed: 05/09/2013
• Issued: 06/28/2016
• 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): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US13/890,589
• Publication Number:
  US 20130261389A1
• Time in Patent Office: 1,146 Days
• Field of Search: 606/41
• US Class Current: 1/1
• 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 reversible electroporation A61N1/327
• 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. An apparatus, comprising:

an elongate shaft;

a first channel and a second channel defined in the elongate shaft;

a first probe positioned at least partially within the first channel, wherein the first probe comprises a first distal-most portion and defines a first longitudinal axis extending to the first distal-most portion, wherein the first distal-most portion is laterally aligned with the first longitudinal axis, and wherein the first probe is rotatable within the first channel;

a first electrode coupled to the first distal-most portion of the first probe and laterally offset from the first longitudinal axis, wherein the first electrode is structured to rotate about the first longitudinal axis via the first probe, and wherein the first electrode is configured to couple to a bipolar electrical waveform generator;

a first conductor external to the first channel, wherein the first conductor is electrically coupled to the first electrode, and wherein the first conductor extends from a positive pole of the bipolar electrical waveform generator to the first electrode;

a second probe positioned at least partially within the second channel, wherein the second probe comprises a second distal-most portion and defines a second longitudinal axis extending to the second distal-most portion, and wherein the second distal-most portion is laterally aligned with the second longitudinal axis;

a second electrode coupled to the second distal-most portion of the second probe and laterally offset from the second longitudinal axis, wherein the second electrode is configured to couple to the bipolar electrical waveform generator;

a second conductor external to the second channel, wherein the second conductor is electrically coupled to the second electrode, and wherein the second conductor extends from a negative pole of the bipolar electrical waveform generator to the second electrode; and

an adjustable ablation region defined between the first and second electrodes, wherein the ablation region is adjustable by rotating the first probe.

2. The apparatus of claim 1, further comprising a strain reliever, wherein the first and second conductors extend through the strain reliever.

3. The apparatus of claim 1, wherein the first and second electrodes are configured to receive an irreversible electroporation electrical waveform, and wherein the irreversible electroporation electrical waveform generates an electrical field of at least 30,000 V/cm in the adjustable ablation region.

4. The apparatus of claim 1, wherein the second probe is rotatable within the second channel and wherein the ablation region is adjustable by rotating the first and second electrodes.

5. The apparatus of claim 1, further comprising an endoscope, wherein the endoscope comprises the first channel and the second channel.

6. The apparatus of claim 5, further comprising:

an illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

7. The apparatus of claim 1, wherein the first and second electrodes are configured to access a tissue treatment region in a lung.

8. An apparatus, comprising:

an elongate shaft;

a first channel and a second channel defined in the elongate shaft;

a first probe positioned at least partially within the first channel, wherein the first probe comprises a first distal-most portion and defines a first longitudinal axis, wherein the first distal-most portion is aligned with the first channel, and wherein the first probe is rotatable within the first channel;

a first electrode extending from the first distal-most portion of the first probe and laterally offset from the first longitudinal axis, wherein the first electrode is structured to rotate about the first longitudinal axis via the first probe, and wherein the first electrode is configured to couple to a bipolar electrical waveform generator;

a first conductor in electrical communication with the first electrode, wherein the first conductor is positioned outside the elongate shaft, and wherein the first conductor extends from one of a positive pole or a negative pole of the bipolar electrical waveform generator to the first electrode;

a second probe positioned at least partially within the second channel, wherein the second probe comprises a second distal-most portion and defines a second longitudinal axis, and wherein the second distal-most portion is aligned with the second channel;

a second electrode extending from the second distal-most portion of the second probe and laterally offset from the second longitudinal axis, wherein the second electrode is configured to couple to the bipolar electrical waveform generator;

a second conductor in electrical communication with the second electrode, wherein the second conductor is positioned outside the elongate shaft, and wherein the second conductor extends from the other of the positive pole or the negative pole of the bipolar electrical waveform generator to the second electrode;

wherein the first and second electrodes are configured to receive an irreversible electroporation electrical waveform through the respective first and second conductors; and

an adjustable ablation region defined between the first and second electrodes, wherein the ablation region is adjustable by rotating the first probe.

9. The apparatus of claim 8, further comprising a strain reliever, wherein the first and second conductors extend through the strain reliever.

10. The apparatus of claim 8, wherein the irreversible electroporation electrical waveform generates an electric field of at least 30,000 V/m in the adjustable ablation region.

11. The apparatus of claim 8, comprising:

an illuminator positioned to illuminate tissue; and

an image sensor positioned to image tissue therethrough.

12. The apparatus of claim 8, wherein the second probe is rotatable within the second channel and wherein the ablation region is adjustable by rotating the first and second electrodes.

13. A method, comprising:

positioning an elongate member comprising first and second channels within a body cavity, wherein a first and a second probe are disposed within the respective first and second channels, wherein the first and second probes each define a central axis, wherein the first and second probes each comprise a distal-most end aligned with the respective central axis, wherein a first and a second electrode are coupled to the distal-most ends of the respective first and second probes, wherein the first and second electrodes are laterally offset from the central axes of the respective first and second probes, and wherein a first and a second conductor disposed external to the respective first and second channels are electrically coupled to the respective first and second electrodes; and

rotating at least one of the first and second probes within the respective first and second channels about the central axis of the respective at least one first and second probes to adjust an ablation region positioned between the first and second electrodes; and

applying an irreversible electroporation (IRE) electrical waveform sufficient to ablate tissue positioned within the ablation region with a bipolar electrical waveform generator electrically coupled to the first and second electrodes through the respective first and second conductors that extend from a respective positive and negative pole of the bipolar electrical waveform generator to the respective first and second electrodes.

14. The method of claim 13, wherein the IRE electrical waveform is suitable to destroy diseased tissue in the ablation region, and wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width.

15. The method of claim 13, further comprising generating an electric field of at least 30,000 V/m in the ablation region.

16. The method of claim 13, further comprising injecting a fluid into the ablation region, wherein the fluid has a higher conductivity than diseased tissue in the ablation region.

17. The method of claim 13, further comprising:

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

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

18. The method of claim 17, further comprising modifying the IRE electrical waveform based on the imaged tissue in the ablation region.

19. The method of claim 13, further comprising positioning the elongate member in a tissue treatment region located in a lung.