IRREVERSIBLE ELECTROPORATION DEVICE AND METHOD FOR ATTENUATING NEOINTIMAL

• US 20090248012A1
• Filed: 03/27/2009
• Published: 10/01/2009
• Est. Priority Date: 03/27/2008
• Status: Abandoned Application

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Maor, Elad, Ivorra, Antoni, RUBINSKY, BORIS
• Application Number:
  US12/413,332
• Publication Number:
  US 20090248012A1
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

Restenosis or neointimal formation may occur following angioplasty or other trauma to an artery such as by-pass surgery. This presents a major clinical problem which narrows the artery. The invention provides a device and a method whereby vascular cells in the area of the artery subjected to the trauma are subjected to irreversible electroporation which is a non-thermal, non-pharmaceutical method of applying electrical pulses to the cells so that substantially all of the cells in the area are ablated while leaving the structure of the vessel in place and substantially unharmed due to the non-thermal nature of the procedure.

Claims

1. A method of reducing neointima, comprising:

identifying a target area of an artery of a subject that is partially blocked;

performing a procedure on the blocked target area to unblock the artery in a manner which increases blood flow through the target area of the artery; and

subjecting vascular cells of the target area of the artery to irreversible electroporation (IRE) before neointima occurs in the target area of the artery.

2. The method of claim 1, wherein the procedure is balloon angioplasty and the IRE is performed without substantial damage to extra-cellular matrix components of the artery.

3. The method of claim 1, wherein the balloon angioplasty and the IRE are carried out during a single surgical procedure.

4. The method of claim 1, wherein the procedure is by-pass surgery and the target area comprises a point of surgical incision.

5. The method of claim 4, wherein the by-pass surgery and the IRE are carried out during a single event and substantially all smooth muscle cells of the target area are irreversibly electroporated.

6. The method of claim 1, wherein the IRE is carried out using a voltage and a current within defined ranges over a defined period of time and in absence of drug being delivered into the vascular cells and further wherein substantially all vascular cells are irreversibly electroporated.

7. The method of claim 6, wherein the IRE is carried out within voltage, current, and time ranges so as to avoid thermal damage to the target area and surrounding tissue leaving tissue scaffolding substantially undamaged.

8. The method of claim 3, wherein the angioplasty is carried out by:

inserting a balloon catheter into a vessel of the patient; and

positioning electrodes of the catheter at the target site to carry out the IRE and applying current in pulses wherein the pulses have a duration of from 50 to 200 microseconds.

9. The method of claim 2, wherein IRE is carried out immediately following the balloon angioplasty and from 5 to 20 pulses are administered.

10. The method of claim 1, wherein the IRE is carried out prior to the step of performing a procedure on the blocked target area.

11. A method of reducing restenosis, comprising:

diagnosing a subject as suffering from artery disease;

performing balloon angioplasty on a target area of an artery of the subject;

positioning electrodes at the target area; and

applying controlled electrical pulses to the target area and subjecting the cells of the target area to irreversible electroporation (IRE) before restenosis occurs wherein the IRE is carried out without structural damage to extra-cellular tissue of the target area.

12. The method of claim 11, wherein the balloon angioplasty and the IRE are carried out during a single surgical procedure.

13. The method of claim 12, wherein the IRE is carried out using a voltage and a current with defined ranges over a defined period of time at a level which avoids thermal damage to the artery thereby leaving elastin and collagen substantially unchanged relative to before the IRE.

14. The method of claim 11, wherein the IRE is carried out within voltage, current, and time ranges so as to avoid thermal damage to the target area and surrounding tissue and further wherein the balloon angioplasty and IRE are carried out during one surgical event.

15. The method of claim 14, further comprising:

inserting a catheter into a vessel of the patient; and

positioning the catheter at the target site to carry out the IRE.

16. The method of claim 14, wherein current is applied in a plurality of pulses.

17. The method of claim 16, wherein the pulses have a duration of from 50 to 200 microseconds.

18. The method of claim 17, wherein the pulses apply a current in a range of from 2,000 V/cm to 6,000 V/cm.

19. The method of claim 16, wherein between two and twenty-five pulses are applied.

20. The method of claim 16, wherein 10 pulses are applied for 100 microseconds each at a current of 3,800 V/cm.