Electrical ablation devices

• US 8,361,066 B2
• Filed: 01/12/2009
• Issued: 01/29/2013
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Long, Gary L., Plescia, David N., Vakharia, Omar J.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/352,375
• Publication Number:
  US 20100179530A1
• Time in Patent Office: 1,478 Days
• Field of Search: 606 31- 41
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1425 Needle

Abstract

An electrical ablation apparatus comprises first and second electrodes. Each electrode comprises a first end configured to couple an energy source and a second end configured to couple to a tissue treatment region. An energy source is coupled to the first and second electrodes. The energy source is configured to deliver a first series of electrical pulses sufficient to induce cell necrosis by irreversible electroporation and a second series of electrical pulses sufficient to induce cell necrosis by thermal heating, through at least one of the first and second electrodes. The first series of electrical pulses is characterized by a first amplitude, a first pulse length, and a first frequency. The second series of electrical pulses is characterized by a second amplitude, a second pulse length, and a second frequency.

Claims

1. An electrical ablation apparatus, comprising:

a shaft;

first and second selectably deployable electrodes slideably receivable within the shaft, each electrode comprising a first end configured to couple to an energy source and a second end configured to couple to a tissue treatment region, wherein the first selectably deployable electrode is deployable independent of the second selectably deployable electrode and the second selectably deployable electrode is deployable independent of the first selectably deployable electrode;

a sheath slideably coupled to the first and second electrodes, the sheath slideable with respect to the first and second electrodes and the shaft, the sheath is disposable in a first position and a second position, the first position covers the first and second electrodes in a deployed state and the second position exposes the first and second electrodes in a deployed state; and

an energy source coupled to the first and second selectably deployable electrodes, the energy source configured to deliver a first series of electrical pulses sufficient to induce cell necrosis by irreversible electroporation and a second series of electrical pulses sufficient to induce cell necrosis by thermal heating, through at least one of the first and second selectably deployable electrodes;

wherein the first series of electrical pulses is characterized by a first amplitude, a first pulse length, and a first frequency; and

wherein the second series of electrical pulses is characterized by a second amplitude, a second pulse length, and a second frequency.

2. The electrical ablation apparatus of claim 1, wherein the first amplitude is about 1000 VDC, the first pulse length is about 10 μ

s to about 15 μ

s, and the first frequency is about 10 Hz; and

wherein the second amplitude is about 500 VDC, the second pulse length is about 10 ms to about 15 ms, and the second frequency is about 10 Hz.

3. The electrical ablation apparatus of claim 1, wherein the first amplitude is selected in the range of about +100 to about +3000 VDC, the first pulse length is selected in the range of about 1 μ

s to about 100 ms, and the first period is selected in the range of about 1 Hz to about 10000 Hz.

4. The electrical ablation apparatus of claim 1, wherein the first series of electrical pulses comprises about 20 to about 40 pulses and the second series of electrical pulses comprises at least one pulse.

5. The electrical ablation apparatus of claim 1, wherein the first and second electrodes are needle electrodes each having a diameter in the range of about 0.5 mm to about 1.5 mm and are separated by a distance of about 5.0 mm to about 10.0 mm.

6. The electrical ablation apparatus of claim 5, wherein the first series of electrical pulses is sufficient to create a first necrotic zone in a first portion of tissue induced by irreversible electroporation in an area surrounding both the first and second electrodes and wherein the second series of electrical pulses is sufficient to create a second necrotic zones in a second portion of tissue induced by thermal heating in an area near the electrode-tissue-interface.

7. The electrical ablation apparatus of claim 6, wherein the first series of electrical pulses is sufficient to ablate basal cell carcinoma tissue.

8. The electrical ablation apparatus of claim 6, wherein the first series of electrical pulses is sufficient to ablate prostrate cancer tissue.

9. The electrical ablation apparatus of claim 1, wherein the first and second electrodes are ring electrodes.

10. The electrical ablation apparatus of claim 9, wherein the first series of electrical pulses is sufficient to create a first necrotic zone in a first portion of tissue induced by irreversible electroporation in a body lumen and wherein the second series of electrical pulses is sufficient to create a second necrotic zones in the body lumen by thermal heating to seal the body lumen.

11. The electrical ablation apparatus of claim 10, wherein the first series of pulses is sufficient to ablate varicose vein tissue resulting from reflux disease of the greater saphenous vein.

12. The electrical ablation apparatus of claim 1, wherein the first electrode comprises a plurality of electrodes.

13. The electrical ablation apparatus of claim 1, wherein the second electrode comprises a plurality of electrodes.

14. The electrical ablation apparatus of claim 1, wherein:

the first selectably deployable electrode may be retracted to allow the electrical ablation apparatus to pivot about a pivot point defined by the second selectably deployable electrode; and

the second selectably deployable electrode may be retracted to allow the electrical ablation apparatus to pivot about a point defined by the first selectably deployable electrode.