Device and method for electroporation based treatment of stenosis of a tubular body part

• US 10,702,326 B2
• Filed: 07/16/2012
• Issued: 07/07/2020
• Est. Priority Date: 07/15/2011
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc., Virginia Tech Intellectual Properties, Inc.
• Original Assignee: Virginia Tech Intellectual Properties, Inc.
• Inventors: Neal, II, Robert E., Garcia, Paulo A., Davalos, Rafael V., Callas, Peter
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US13/550,307
• Publication Number:
  US 20130184702A1
• Time in Patent Office: 2,913 Days
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

The present invention relates to medical devices and methods for treating a lesion such as a vascular stenosis using non-thermal irreversible electroporation (NTIRE). Embodiments of the present invention provide a balloon catheter type NTIRE device for treating a target lesion comprising a plurality of electrodes positioned along the balloon that are electrically independent from each other so as to be individually selectable in order to more precisely treat an asymmetrical lesion in which the lesion extends only partially around the vessel.

Claims

1. A method of treating a stenosis of a tubular body part by non-thermal irreversible electroporation comprising:

placing into or through a tubular body part, a balloon catheter having electrodes electrically independent from one another and with circumferential spacing between one another;

expanding the balloon to bring one or more of the electrodes near a stenosis to be treated;

administering electrical energy with at least one pair, but less than all, of the electrodes disposed on a cross section of the balloon and in a manner which treats only a portion of a circumference of the tubular body part at a time, such that the administering is performed on only one side of a longitudinal plane in which a central longitudinal axis of the tubular body part is disposed, and which electrical energy is administered as biphasic pulses of 10 microseconds or less, at a frequency of up to 100 MHz, and in an amount which is sufficient to provide an electric field sufficient to induce non-thermal irreversible electroporation of cells of the stenosis.

2. The method of claim 1, wherein the step of administering electrical energy includes controlling a switch to output electrical pulses to only pairs of the identified electrodes.

3. The method of claim 1, further comprising determining at least one individualized electrical parameter for the at least one pair of electrodes based on the determination of which electrodes are near the stenosis.

4. The method of claim 3, wherein the at least one electrical parameter includes Voltage or pulse duration.

5. The method of claim 1, further comprising determining at least one individualized electrical parameter for the at least one pair of electrodes based on the depth and proximity of the stenosis in relation to the electrode positions.

6. The method of claim 5, wherein the step of determining at least one individualized electrical parameter includes determining an individualized voltage level to use for each pair of electrodes based on the depth of the stenosis near the at least one pair.

7. The method of claim 1, comprising determining which electrodes are near the stenosis by way of one or more imaging markers disposed in a manner to indicate a location of one or more of the electrodes.

8. The method of claim 7, wherein the one or more imaging markers include a radiopaque marker.

9. The method of claim 1, comprising determining which electrodes are near the stenosis by applying test pulses to different pairs of the electrodes and measuring at least one electrical characteristic of the stenosis cells for the different pairs of electrodes.

10. The method of claim 9, wherein the step of determining includes measuring an electrical resistance as the at least one electrical characteristic of the stenosis cells.

11. The method of claim 10, further comprising displaying a graphical representation and identification of the electrodes in positional relationship to the stenosis.

12. The method of claim 10, further comprising displaying a graphical representation of the stenosis and a graphical representation and identification of the electrodes in positional relationship to the stenosis.

13. The method of claim 1, wherein the electrodes are disposed in a circular array.

14. The method of claim 13, wherein the administering is performed with less than all of the electrodes disposed in the circular array.

15. The method of claim 1, wherein the electrical energy is administered in a manner such that only one side of the tubular body part is treated.

16. The method of claim 1, wherein the electrical energy is administered in a manner such that electrodes disposed on only one side of the balloon catheter are used at a time.

17. The method of claim 1, wherein only two adjacent electrodes at a time are used for applying the electrical energy.

18. The method of claim 1, wherein only pairs of electrodes are energized and are energized in succession.

19. The method of claim 1, wherein the administering comprises applying electrical energy with multiple pairs of electrodes selectively and sequentially as pairs of electrodes.

20. The method of claim 1, wherein only two non-adjacent electrodes at a time are used for applying the electrical energy.

21. The method of claim 1, wherein the at least one pair of electrodes is a pair of non-adjacent electrodes.

22. The method of claim 1, wherein the at least one pair of electrodes is a pair of adjacent electrodes.

23. The method of claim 1, wherein the at least one pair of electrodes is chosen from a pair of adjacent electrodes or a pair of non-adjacent electrodes.

24. The method of claim 1, wherein the administering comprises applying electrical energy with multiple pairs of electrodes sequentially to treat varying depths of a stenosis.

25. The method of claim 1, wherein an area proximate the at least one pair of electrodes is treated with electrical energy and an area proximate the remaining electrodes is untreated.

26. The method of claim 1, wherein activation of a first pair of the electrodes results in treating a first longitudinal portion of the tubular body part and activation of a second pair of the electrodes results in treating a second longitudinal portion of the tubular body part that coextends longitudinally with the first portion.

27. A method of treating a stenosis of a tubular body part by non-thermal irreversible electroporation comprising:

placing into or through a tubular body part, a balloon catheter having electrodes electrically independent from one another and with circumferential spacing between one another;

imaging the tubular body part and the balloon catheter using one or more imaging modality, and identifying from the imaging which of the electrodes to activate based on which of the electrodes are disposed near a stenosis to be treated;

expanding the balloon to bring one or more of the electrodes near the stenosis; and

applying electrical pulses using one or more of the identified electrodes with only one pair of the electrodes at a time and in a manner which treats only a portion of a circumference of the tubular body part at a time, such that the applying is performed on only one side of a longitudinal plane in which a central longitudinal axis of the tubular body part is disposed, the applied pulses being biphasic pulses of 10 microseconds or less, at a frequency of up to 100 MHz, and in an amount which is sufficient to provide an electric field sufficient to induce non-thermal irreversible electroporation of cells of the stenosis.

28. The method of claim 27, wherein the portion of the circumference is only one side of the tubular body part.