Electroporation ablation apparatus, system, and method

• US 7,655,004 B2
• Filed: 02/15/2007
• Issued: 02/02/2010
• 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:
  US11/706,766
• Publication Number:
  US 20080200912A1
• Time in Patent Office: 1,083 Days
• Field of Search: 600/101, 600/104, 600/153, 600/160, 600/106, 600/137, 606 32- 50, 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 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 flexible member having a proximal end and a distal end. A first working channel is formed within the flexible member. A first diagnostic probe having a proximal end and distal end is located within the first working channel and extends through the distal end of the flexible member. A first electrode is connected to the distal end of the first diagnostic probe electrode is adapted to be endoscopically located in a tissue treatment region. The first electrode is adapted to couple to an electrical waveform generator to receive an irreversible electroporation electrical waveform sufficient to ablate tissue located proximate to the first electrode. A system further includes an electrical waveform generator electrically coupled to the first electrode of the ablation device to generate an IRE waveform sufficient to ablate tissue located proximate to the first electrode.

Claims

1. An ablation device, comprising:

an elongate flexible member having a proximal end and a distal end and comprising;

a first working channel formed within the flexible member;

a first diagnostic probe having a proximal end and a distal end, the first diagnostic probe located within the first working channel and extending through the distal end of the flexible member; and

a first electrode connected to the distal end of the first diagnostic probe;

wherein the first electrode is adapted to be endoscopically located in a tissue treatment region; and

wherein the first electrode is adapted to couple to an electrical waveform generator to receive an irreversible electroporation electrical waveform sufficient to ablate tissue located proximate to the first electrode;

a second working channel formed within the flexible member;

a second diagnostic probe having a proximal end and a distal end, the second diagnostic probe located within the second working channel and extending through the distal end of the flexible member; and

a second electrode connected to the distal end of the second diagnostic probe;

wherein the second electrode is adapted to be endoscopically located in a tissue treatment region;

wherein the second electrode is 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; and

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.

2. The ablation device of claim 1, wherein the first diagnostic probe comprises a sharp distal end and an aperture in communication with a bore formed within the first diagnostic probe to receive a tissue sample therethrough.

3. The ablation device of claim 1, wherein the second diagnostic probe comprises a sharp distal end and an aperture in communication with a bore formed within the second diagnostic probe to receive a tissue sample therethrough.

4. 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.

5. An ablation system, comprising:

an ablation device comprising;

an elongate flexible member having a proximal end and a distal end and comprising;

a first working channel formed within the flexible member;

a first diagnostic probe having a proximal end and a distal end, the first diagnostic probe located within the first working channel and extending through the distal end of the flexible member; and

a first electrode connected to the distal end of the first diagnostic probe;

wherein the first electrode is adapted to be endoscopically located in a tissue treatment region; and

wherein the first electrode is adapted to receive an irreversible electroporation electrical (IRE) waveform sufficient to ablate tissue located proximate to the first electrode;

a second working channel formed within the flexible member;

a second diagnostic probe having a proximal end and a distal end, the second diagnostic probe located within the second working channel and extending through the distal end of the flexible member; and

a second electrode connected to the distal end of the second diagnostic probe;

wherein the second electrode is adapted to be endoscopically located in a tissue treatment region;

wherein the second electrode is adapted to couple to an electrical waveform generator to receive an IRE waveform sufficient to ablate tissue located between the first and second electrodes; and

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; and

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

6. The ablation system of claim 5, wherein the first diagnostic probe comprises a sharp distal end and an aperture in communication with a bore formed within the first diagnostic probe to receive a tissue sample therethrough.

7. The ablation system of claim 5, wherein second diagnostic probe comprises a sharp distal end and an aperture in communication with a bore formed within the second diagnostic probe to receive a tissue sample therethrough.

8. The ablation system of claim 5, 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.

9. The ablation system of claim 8, 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 on image information of the diseased tissue region in a patient.

10. The ablation system of claim 9, 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.

11. The ablation system of claim 10, wherein the volume and outline of the necrotic zone are determined from geometric information extracted from the image information.

12. The ablation system of claim 9, wherein the IRE electrical waveform parameters comprise amplitude, frequency, and pulse width of an electrical waveform suitable to destroy the diseased tissue.