ELECTROPORATION DEVICE AND METHOD

• US 20090281477A1
• Filed: 05/08/2009
• Published: 11/12/2009
• Est. Priority Date: 05/09/2008
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: MIKUS, PAUL W., APPLING, WILLIAM M., HAMILTON, WILLIAM C. JR.
• Application Number:
  US12/437,843
• Publication Number:
  US 20090281477A1
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• 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 2017/3456 blunt
• CPC Class Codes: A61B 2018/00053 Mechanical features of the instrument of device
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327

Abstract

Disclosed herein are methods and devices configured for pulsed voltage ablation that have two or more voltage delivery regions separated along a probe by electrically insulating regions. The electrically insulating regions are of sufficient lengths to allow the voltage delivery regions to be oppositely energized for delivering voltage pulses to treat cells within a predetermined ablation volume that can be delineated through representations indicating pulsed voltage ablation thresholds for cells.

Claims

1. A tissue treatment device comprising:

a means for treating tissue using non-thermal irreversible electroporation, wherein the means comprises a probe having

a proximal end and a distal end;

at least a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has first voltage delivery region capable of delivering a voltage for irreversible electroporation;

at least a second voltage delivery member disposed along the probe and positioned coaxially in relation to the first voltage delivery member, wherein the second voltage delivery member has a second voltage delivery region capable of delivering a voltage for irreversible electroporation; and

at least one electrically insulating region coaxially disposed in relation to the first voltage delivery member.

2. The device of claim 1, Wherein the at least one electrically insulating region is positioned between at least a portion of the first voltage delivery region and at least a portion of the second voltage delivery region.

3. The device of claim 2, wherein the first voltage delivery region is substantially the same length as the second voltage delivery region.

4. The device of claim 2, wherein the first voltage delivery region is of a substantially different length than the second voltage delivery region.

5. The device of claim 2, wherein at least one of the first delivery region and the second voltage delivery region is substantially the same length as the at least one electrically insulating region.

6. The device of claim 2, wherein at least one of the first delivery region and the second voltage delivery region is of a substantially different length than the electrically insulating region.

7. The device of claim 1, wherein the device comprises a plurality of voltage delivery regions.

8. The device of claim 1, wherein the device comprises a plurality of electrically insulating regions.

9. The device of claim 8, wherein the plurality of electrically insulating regions comprises a first electrically insulating region and a second electrically insulating region.

10. The device of claim 9, wherein the first electrically insulating region has substantially the same length as the second electrically insulating region.

11. The device of claim 9, wherein the first electrically insulating region has a substantially different length than the second electrically insulating region.

12. The device of claim 1, wherein at least one of the first voltage delivery region and the second voltage delivery region comprises a single tip, wherein the tip is positioned at the distal end of the probe, such that the tip is capable of piercing tissue.

13. The device of claim 12, wherein the tip is a sharpened tip.

14. The device of claim 1, wherein at least one of the first voltage delivery region and the second voltage delivery region comprises a single tip, wherein the tip is positioned at the distal end of the probe, such that during treatment the tip is capable of contacting non-target tissue while allowing the non-target tissue to remain intact.

15. The device of claim 14, wherein the single tip is a blunt tip.

16. The device of claim 2, wherein the first voltage delivery region and the second voltage delivery region have an outer diameter, and the at least one electrically insulating region has an outer diameter, and wherein the outer diameter of the first and second voltage delivery regions is substantially equivalent to the outer diameter of the electrically insulating region.

17. The device of claim 2, wherein at least one of the first voltage delivery member and the second voltage delivery member comprises at least one lumen.

18. The device of claim 17, wherein the at least one lumen is capable of delivering substances to tissue, Wherein the substances are selected from the group consisting of fluids, media, solutions, suspensions, therapeutics, hydrogels, nanoparticles, and microparticles.

19. The device of claim 1, wherein the device is capable of extracting a substance selected from the group consisting of tissue, fluids, medium, solutions, suspensions, therapeutics, hydrogels, nanoparticles, and microparticles.

20. The device of claim 2, wherein at least one of the first voltage delivery region and the second voltage delivery region is independently energized.

21. The device of claim 2, wherein at least one of the first voltage delivery region and the second voltage delivery region is independently polarized.

22. The device of claim 2, wherein at least one of the first voltage delivery region and the second voltage delivery region is capable of applying at least one pulsed electric field gradient to target tissue at a level that is sufficient to non-thermally irreversibly electroporate the target tissue.

23. The device of claim 22, wherein the target tissue is selected from the group consisting of prostate, uterus, lung, liver, kidney, brain, head, neck, bone, stomach, colon, pancreas, vascular, adipose, lymph, breast, ovarian, duct, and mammalian.

24. The device of claim 22, wherein the target tissue comprises a mass of tissue selected from the group consisting of benign prostate hyperplasia (BPH), uterine fibroids, malignant tissues, cancers, tumors, and benign tissues.

25. The device of claim 1, wherein the device further comprises

a handle having

a proximal end and a distal end;

a handle body; and

at least one cable, wherein the at least one cable is positioned within at least a portion of the handle body, such that the at least one cable is adjacent to the proximal end of the probe, and at least a portion of the at least one cable extends outwardly from the distal end of the handle toward the distal end of the probe.

26. A tissue treatment device comprising:

a means for treating tissue using non-thermal irreversible electroporation, wherein the means comprises a probe having

a proximal end and a distal end;

a blunt tip disposed at the distal end of the probe;

a handle disposed at the proximal end of the probe;

a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has a first voltage delivery region capable of delivering a voltage for irreversible electroporation; and

a second voltage delivery member disposed along the probe and positioned coaxially in relation to the first voltage delivery member, wherein the second voltage delivery member has a second voltage delivery region capable of delivering a voltage for irreversible electroporation; and

at least one electrically insulating region coaxially disposed in relation to the first voltage delivery member.

27. A tissue treatment device comprising:

a probe having

a proximal end and a distal end;

a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has a first voltage delivery region; and

a second voltage delivery member disposed along the probe and positioned coaxially in relation to the first voltage delivery member, wherein the second voltage delivery member has a second voltage delivery region; and

at least one electrically insulating region coaxially disposed in relation to the first voltage delivery member;

a blunt tip disposed at the distal end of the probe; and

a handle disposed at the proximal end of the probe, wherein the handle has a proximal end and a distal end and a handle body.

28. The device of claim 27, wherein the device further comprises at least one cable, wherein at least a portion of the at least one cable is positioned within at least a portion of the handle body, such that the at least one cable is adjacent to the proximal end of the probe, and at least a portion of the at least one cable extends outwardly from the distal end of the handle toward the distal end of the probe.

29. The device of claim 27, wherein the cables are positioned such that a profile of the device is maintained, and a center of gravity of the device is present distally of the distal end of the handle.

30. The device of claim 28, wherein the cables are positioned such that a profile of the device is maintained, and a center of gravity of the device is present distally of the distal end of the handle.

31. A tissue treatment device comprising:

a first probe having

a proximal end and a distal end;

a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has a first voltage delivery region; and

a first blunt tip disposed at the distal end of the probe; and

a first handle disposed at the proximal end of the probe, wherein the first handle has a proximal end and a distal end and a first handle body.

a second probe having

a second voltage delivery member disposed along the entire length of the probe, wherein the second voltage delivery member has a second voltage delivery region; and

a second blunt tip disposed at the distal end of the probe; and

a second handle disposed at the proximal end of the probe, wherein the handle has a proximal end and a distal end and a second handle body.

33. The method of claim 31, wherein the device is positioned using a technique selected from the group consisting of percutaneous, laparoscopic, endoscopic, and natural orifice entry.

34. The method of claim 31, wherein the step of delivering comprises applying at least one pulsed electric field gradient to the target tissue at a level that is sufficient to non-thermally irreversibly electroporate the target tissue.

35. The method of claim 31, wherein the target tissue is selected from the group consisting of prostate, uterus, lung, liver, kidney, brain, head, neck, bone, stomach, colon, pancreas, vascular, adipose, lymph, breast, ovarian, duct, and mammalian.

36. The method of claim 31, wherein the target tissue comprises a mass of tissue selected from the group consisting of benign prostate hyperplasia (BPH), uterine fibroids, malignant tissues, cancers, tumors, and benign tissues.

37. The method of claim 33, wherein the pulsed electric field gradients are within the range of approximately 0.075 kV/cm to approximately 3 kV/cm.

38. The method of claim 33, wherein the pulsed electric field gradients are applied such that a duration of between approximately 0.15 seconds and 0.5 seconds exists between each pulsed electric field gradient.

39. The method of claim 33, wherein the temperature of the selected volume of tissue remains below approximately 50°

C. during treatment.

40. The method of claim 33, wherein duration of each pulsed electrical field gradient is between approximately 20 microseconds and 200 microseconds.

41. The method of claim 39, wherein the duration of each pulsed electrical field gradient is approximately 100 microseconds.

42. The method of claim 33, wherein the pulsed electrical field gradients are delivered in a train consisting of a series of approximately ten sequential pulses, with a duration of between approximately 0.25 and 3 seconds between each pulse.

43. The method of claim 41, wherein between approximately six and thirty trains are applied to ablate the tissue.

45. The method of claim 43, wherein the target tissue is selected from the group consisting of prostate, uterus, lung, liver, kidney, brain, head, neck, bone, stomach, colon, pancreas, vascular, adipose, lymph, breast, ovarian, duct, and mammalian.

46. The method of claim 43, wherein the target tissue comprises a mass of tissue selected from the group consisting of benign prostate hyperplasia (BPH), uterine fibroids, malignant tissues, cancers, tumors, and benign tissues.

32. A method of tissue treatment using irreversible electroporation, comprising:

providing a tissue treatment device wherein the device comprises;

a proximal end a distal end;

a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has a first voltage delivery region capable of delivering a voltage for irreversible electroporation of a selected volume of tissue; and

a second voltage delivered member disposed along the probe and positioned coaxially in relation to the first voltage delivery member, wherein the second voltage delivery member has a second voltage delivery region capable of delivering a voltage for irreversible electroporation; and

at least one electrically insulating region coaxially disposed in relation to the first voltage delivery member;

positioning the device within the selected volume of tissue;

delivering pulsed electric field gradients to the selected volume of tissue; and

ablating the selected volume of tissue using non-thermal irreversible electroporation.

44. A method of tissue treatment, comprising:

providing a tissue treatment device wherein the device comprises;

a probe having

a proximal end and a distal end;

a first voltage delivery member disposed along the entire length of the probe, wherein the first voltage delivery member has a first voltage delivery region; and

a second voltage delivery member disposed along the probe and positioned coaxially in relation to the first voltage delivery member, wherein the second voltage deliver member has a second voltage delivery region; and

at least one electrically insulating region coaxially disposed in relation to the first voltage delivery member probe,

a blunt tip disposed at the distal end of the probe; and

a handle disposed at the proximal end of the probe, wherein the handle has a proximal end and a distal end and a handle body;

positioning the device within the selected volume of tissue;

delivering pulsed electric field gradients to the selected volume of tissue; and

ablating the selected volume of tissue using non-thermal irreversible electroporation.