Electrical ablation devices and methods

• US 9,314,620 B2
• Filed: 02/28/2011
• Issued: 04/19/2016
• Est. Priority Date: 02/28/2011
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Long, Gary L., Plescia, David N., Bakos, Gregory J.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Zink, Amanda
• Application Number:
  US13/036,908
• Publication Number:
  US 20120220998A1
• Time in Patent Office: 1,877 Days
• Field of Search: 606 32- 45
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

An electrical ablation device may generally comprise first and second electrodes coupled to an energy source operative to generate and deliver a first sequence of electrical pulses and a second sequence of electrical pulses to tissue having a necrotic threshold, wherein the first sequence of electrical pulses delivers a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue and the second sequence of electrical pulses delivers a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue by irreversible electroporation. The first sequence of electrical pulses may each be independently characterized by a first amplitude, a first pulse width, and a first frequency. The second sequence of electrical pulses may be characterized by a second amplitude, a second pulse width, and a second frequency.

Claims

1. An ablation apparatus, comprising:

a housing extending along a housing axis;

a first electrode supported in the housing, wherein the first electrode extends along a first axis, and wherein the first axis is substantially parallel to the housing axis; and

a second electrode supported in the housing, wherein the second electrode extends along a second axis, wherein the second axis is substantially parallel to the housing axis, and wherein the second electrode is laterally-offset from the first electrode;

wherein the first and second electrodes are coupled to an energy source operative to generate and deliver a first sequence of electrical pulses and a second sequence of electrical pulses to tissue having a necrotic threshold, and wherein the first sequence of electrical pulses delivers a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue intermediate the laterally-offset first and second electrodes and the second sequence of electrical pulses delivers a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue intermediate the laterally-offset first and second electrodes by irreversible electroporation;

wherein the first electrode is electrically coupled to a first polarity of the energy source, wherein the second electrode is electrically coupled to a second polarity of the energy source, wherein the second polarity is opposite to the first polarity, and wherein the first sequence of electrical pulses and the second sequence of electrical pulses are transmitted laterally between the laterally-offset first and second electrodes substantially transverse to the first and second axes.

2. The ablation apparatus of claim 1, wherein the energy source is operative to generate and deliver a sequence interval between the first sequence and second sequence.

3. The ablation apparatus of claim 1, wherein the first sequence has a first sequence duration and the second sequence has a second sequence duration, and wherein the first sequence duration is greater than the second sequence duration.

4. The ablation apparatus of claim 1, wherein the first sequence has a first sequence total number of pulses and the second sequence has a second sequence total number of pulses, and wherein the first sequence total number of pulses is greater than the second sequence total number of pulses.

5. The ablation apparatus of claim 1, wherein the first sequence comprises a series of first pulse trains each having a first pulse train amplitude, a first pulse train pulse width, and a first pulse train frequency, and the second sequence comprises a series of second pulse trains each comprising a second pulse train amplitude, a second pulse train pulse width, and a second pulse train frequency.

6. The ablation apparatus of claim 5, wherein the first pulse train amplitude is less than the second pulse train amplitude, the first pulse train pulse width is equal to the second pulse train pulse width, and the first pulse train frequency is greater than the second pulse train frequency.

7. The ablation apparatus of claim 5, wherein each of the first pulse trains comprise a plurality of first pulses each having a first amplitude, a first pulse width, and a first frequency, and each of the second pulse trains comprise a plurality of second pulses each having a second amplitude, a second pulse width, and a second frequency.

8. The ablation apparatus of claim 7, wherein the first pulses and the second pulses are each independently characterized by first and second amplitudes in the range of about ±

100 VDC to about ±

10,000 VDC, first and second pulse widths in the range of about 1 μ

s to about 100 ms, and first and second frequencies in the range of about 1 Hz to about 10,000 Hz.

9. The ablation apparatus of claim 7, wherein the first amplitude is less than the second amplitude, the first pulse width is equal to the second pulse width, and the first frequency is equal to the second frequency.

10. The ablation apparatus of claim 7, wherein the plurality of second pulses comprise biphasic pulses.

11. The ablation apparatus of claim 1, comprising at least one of a temperature sensor and a pressure sensor adjacent at least one of the first and second electrodes.

12. The ablation apparatus of claim 1, comprising:

at least one of a temperature sensor and a pressure sensor located within the housing.

13. The ablation apparatus of claim 1, wherein the housing comprises

a distal end, a proximal end, and a body extending therebetween for supporting the first and second electrodes;

and wherein the ablation apparatus further comprises;

a temperature sensor located within the housing at the distal end; and

a pressure sensor located within the housing along the body.

14. The ablation apparatus of claim 1, wherein the housing comprises

a plurality of vents for supporting the first and second electrodes;

and wherein the ablation apparatus further comprises;

a pressure sensor located adjacent the plurality of vents.

15. The ablation apparatus of claim 1, wherein the energy source is operative to generate and deliver the second sequence when at least one of a predetermined temperature and a predetermined pressure is achieved.

16. The ablation apparatus of claim 1, wherein the energy source is operative to not generate and not deliver the second sequence when at least one of a predetermined temperature and a predetermined pressure is achieved.

20. The ablation apparatus of claim 1, further comprising a timing circuit coupled to the energy source, wherein the timing circuit is configured to switch from the first energy dose to the second energy dose after a predefined period.

17. An ablation apparatus, comprising:

a housing having a distal end, a proximal end, and a body extending along a longitudinal axis between the proximal end and the distal end;

a first electrode supported in the housing, wherein the first electrode extends along a first axis substantially parallel to the longitudinal axis, and wherein the first electrode is electrically coupled to a first polarity of an energy source;

a second electrode supported in the housing, wherein the second electrode extends along a second axis substantially parallel to the longitudinal axis, wherein the second axis is laterally-offset from the first axis, wherein the second electrode is electrically coupled to a second polarity of the energy source, wherein the second polarity is opposite to the first polarity, wherein the energy source is configured to generate and deliver a first sequence of electrical pulses and a second sequence of electrical pulses to tissue having a necrotic threshold, wherein the first sequence of electrical pulses and the second sequence of electrical pulses are transmitted laterally between the first and second electrodes substantially transverse to the longitudinal axis; and

at least one of a temperature sensor and a pressure sensor positioned within the housing and configured to detect a property of the tissue;

wherein the first sequence of electrical pulses delivers a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue and the second sequence of electrical pulses delivers a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue by irreversible electroporation;

wherein the energy source is configured to generate and deliver the first sequence until at least one of a predetermined temperature and a predetermined pressure is detected in the tissue by the at least one of a temperature sensor and a pressure sensor; and

wherein the energy source is configured to generate and deliver the second sequence when at least one of the predetermined temperature and the predetermined pressure is detected in the tissue by the at least one of a temperature sensor and a pressure sensor.

18. The ablation apparatus of claim 17, further comprising a feedback generator in signal communication with the at least one of a temperature sensor and a pressure sensor.

19. An ablation apparatus, comprising:

a housing having a distal end, a proximal end, and a body extending along a longitudinal axis between the proximal end and the distal end;

a sensor positioned at the distal end;

a first electrode supported in the housing, wherein the first electrode extends along a first axis substantially parallel to the longitudinal axis, and wherein the first electrode is electrically coupled to a first polarity of an enerqy source;

a second electrode supported in the housing, wherein the second electrode extends along a second axis substantially parallel to the longitudinal axis, wherein the second electrode is laterally-offset from the first electrode, wherein the second electrode is electrically coupled to a second polarity of the enerqy source, wherein the second polarity is opposite to the first polarity, wherein the energy source is configured to generate and deliver a first sequence of electrical pulses and a second sequence of electrical pulses to tissue having a necrotic threshold, wherein the first sequence of electrical pulses and the second sequence of electrical pulses are transmitted laterally between the laterally-offset first and second electrodes substantially transverse to the longitudinal axis; and

a feedback generator in communication with the sensor;

wherein the first sequence of electrical pulses delivers a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue and the second sequence of electrical pulses delivers a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue by irreversible electroporation.