Flexible conductive polymer electrode and method for ablation

• US 8,118,809 B2
• Filed: 12/21/2007
• Issued: 02/21/2012
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Paul, Saurav, Cao, Hong, Thao, Chou
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US11/963,430
• Publication Number:
  US 20090163916A1
• Time in Patent Office: 1,523 Days
• Field of Search: 606 32- 50, 607101-105
• US Class Current: 606/41
• 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 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00136 with polymer
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple

Abstract

An electrode for ablation therapy includes a flexible conductive element for conducting electrical energy and a flexible conductive polymer member in electrically conductive contact with the conductive element. A catheter shaft may be coupled to the conductive element and/or the flexible conductive polymer member. The flexible conductive element may be formed as a helical coil, a mesh coating or wrap, or any other suitable form, and may surround (wholly or partially) a flexible electrically insulative, and optionally thermally conductive, member. A heat sink may be thermally coupled to at least one of the flexible conductive polymer member and the flexible electrically insulative member. The flexible electrically insulative member may include a passageway for coolant fluid to cool the electrode during ablation. The passageway may include at least one efflux hole to permit coolant fluid to flow from the passageway, or may define a closed loop.

Claims

1. An electrode for ablation therapy, the electrode comprising:

a flexible conductive element for conducting electrical energy; and

a flexible conductive polymer member that is in electrically conductive contact with the flexible conductive element, wherein the flexible conductive polymer member comprises a pressure sensitive conductive polymer.

2. The electrode according to claim 1, further comprising a catheter shaft coupled to at least one of the flexible conductive element and the flexible conductive polymer member.

3. The electrode according to claim 1, further comprising an ablation energy source coupled to the flexible conductive element such that ablation energy may be delivered via the flexible conductive polymer member.

4. The electrode according to claim 1, wherein the flexible conductive element comprises a helical coil.

5. The electrode according to claim 4, further comprising a flexible electrically insulative member surrounded by at least a portion of the helical coil.

6. The electrode according to claim 5, wherein the flexible electrically insulative member is made of a thermally conductive material.

7. The electrode according to claim 6, further comprising at least one temperature sensor located within the flexible electrically insulative member.

8. The electrode according to claim 5, further comprising a heat sink thermally coupled to at least one of the flexible conductive polymer member and the flexible electrically insulative member.

9. The electrode according to claim 5, wherein the flexible electrically insulative member includes a passageway for coolant fluid to cool the electrode during ablation.

10. The electrode according to claim 9, wherein the passageway includes at least one efflux hole at a distal end of the electrode to permit coolant fluid to flow from the passageway.

11. The electrode according to claim 10, wherein the passageway is defined by a flexible, electrically insulative, and thermally conductive material.

12. The electrode according to claim 10, further comprising:

a first sensor to measure the temperature of the coolant fluid near the efflux hole; and

a second sensor to measure the temperature of the coolant fluid at a location other than the efflux hole.

13. The electrode according to claim 12, wherein the second sensor is positioned where the coolant fluid enters the passageway.

14. The electrode according to claim 5, wherein the flexible electrically insulative member includes a passageway for coolant fluid to cool the electrode during ablation, the passageway defining a loop such that coolant fluid travels from a proximal end of the electrode, through a distal end of the electrode, and returns to the proximal end of the electrode via the passageway.

15. The electrode according to claim 1, wherein the flexible conductive element is shaped to form a mesh coating or wrap.

16. The electrode according to claim 15, further comprising a flexible electrically insulative member in mechanical contact with at least a portion of the mesh coating or wrap.

17. The electrode according to claim 16, further comprising a heat sink thermally coupled to at least one of the flexible conductive polymer member and the flexible electrically insulative member.

18. The electrode according to claim 17, wherein the flexible electrically insulative member includes a passageway for coolant fluid to cool the electrode during ablation and an efflux hole at a distal end of the electrode to permit coolant fluid to flow from the passageway.

19. An ablation electrode for ablation therapy, the ablation electrode comprising:

a flexible electrically insulative member, the member also being thermally conductive;

a passageway for a coolant fluid to flow through the flexible electrically insulative member to cool the electrode during use;

a flexible, conductive element for conducting RF energy, the flexible conductive element at least partially covering the flexible electrically insulative member; and

a layer of flexible conductive polymer that covers at least part of the flexible conductive element, wherein the flexible conductive polymer comprises a pressure sensitive conductive polymer.

20. The ablation electrode according to claim 19, wherein the passageway includes at least one efflux hole in the electrode to permit coolant fluid to flow from the passageway.

21. The ablation electrode according to claim 20, wherein the passageway is defined by an electrically and thermally insulative material that is different from that comprising the electrically insulative member, the electrode further comprising:

a first sensor to measure the temperature of coolant fluid where it exits one of the at least one efflux hole; and

a second sensor to measure the temperature of coolant fluid where it enters the passageway.

22. The ablation electrode according to claim 19, wherein the passageway defines a loop such that coolant fluid travels from a proximal end of the electrode, through a distal end of the electrode, and returns to the proximal end of the electrode via the passageway.

23. The ablation electrode according to claim 19, wherein the flexible conductive element is shaped to form a helical coil.

24. The ablation electrode according to claim 19, wherein the flexible conductive element is shaped to form a mesh coating or wrap.

25. The ablation electrode according to claim 19, further comprising a heat sink thermally coupled to at least one of the layer of flexible conductive polymer and the flexible electrically insulative member.

26. A method of manufacturing an electrode for ablation therapy, the method comprising:

forming an electrically insulative, thermally conductive, flexible shaft;

forming a flexible, electrically conductive element for conducting RF energy, the conductive element at least partially covering the electrically insulative, thermally conductive, flexible shaft; and

forming a layer of flexible conductive polymer that covers at least part of the flexible, electrically conductive element, wherein the flexible conductive polymer comprises a pressure sensitive conductive polymer.

27. The method according to claim 26, wherein the step of forming an electrically insulative, thermally conductive, flexible shaft comprises forming an electrically insulative, thermally conductive, flexible shaft, having a passageway through which coolant fluid may flow and having an efflux hole at a distal end of the electrode to permit coolant fluid to flow from the passageway.

28. The method according to claim 26, further comprising forming an electrically insulative, thermally conductive passageway within the electrically insulative, thermally conductive, flexible shaft, the passageway being formed of a material that is different from the material that is used to form the electrically insulative, thermally conductive, flexible shaft.

29. A method of treating tissue, the method comprising:

providing an electrode having a) a flexible conductive element for conducting RF energy and b) a layer of flexible conductive polymer that is in electrical contact with at least a portion of the flexible conductive element, wherein the flexible conductive polymer comprises a pressure sensitive conductive polymer;

coupling an RF energy supply to the flexible conductive element;

positioning the electrode in contact with a tissue specimen to be treated; and

delivering RF energy to the tissue specimen.

30. The method according to claim 29, further comprising:

delivering coolant fluid to an area of the tissue specimen to help control the temperature of the tissue specimen during treatment with RF energy; and

monitoring temperatures at a plurality of locations within the electrode in order to help control the temperature of the tissue specimen during treatment with RF energy.

31. The method according to claim 29, further comprising using a heat sink thermally coupled to the electrode to help control the temperature of the tissue specimen during treatment with RF energy.

32. An electrode for ablation therapy, the electrode comprising:

a conductive element for conducting electrical energy;

a flexible conductive polymer member in electrically conductive contact with the conductive element, wherein the flexible conductive polymer member comprises a pressure sensitive conductive polymer; and

at least one fluid passageway extending through at least a portion of the flexible conductive polymer member and including at least one efflux hole to permit a fluid to exit the flexible conductive polymer member.

33. The electrode according to claim 32, wherein the at least one efflux hole comprises an efflux hole located at a distal end of the electrode.

34. The electrode according to claim 32, wherein the at least one efflux hole comprises a plurality of efflux holes arranged along a length of the electrode.

35. The electrode according to claim 32, further comprising at least one electrically insulative tube extending through the electrode, wherein the at least one fluid passageway is defined by the at least one electrically insulative tube.

36. The electrode according to claim 35, wherein the conductive element is shaped to form a helical coil, and wherein at least a portion of the conductive element is helically coiled about at least a portion of the at least one electrically insulative tube.

37. The electrode according to claim 35, wherein the at least one electrically insulative tube is made of thermally conductive material.

38. The electrode according to claim 32, further comprising a catheter shaft coupled to at least one of the conductive element and the flexible conductive polymer member, wherein the catheter shaft includes at least one fluid passageway that is in fluid communication with the at least one fluid passageway of the electrode.

39. The electrode according to claim 38, wherein the at least one efflux hole comprises at least one efflux hole located at an interface between the ablation electrode and the catheter shaft.

40. The electrode according to claim 32, further comprising at least one temperature sensor located proximate the at least one fluid passageway.

41. The electrode according to claim 40, wherein the at least one temperature sensor is located proximate the at least one efflux hole to measure a temperature of a fluid exiting the at least one efflux hole.

42. The electrode according to claim 40, wherein the at least one temperature sensor is located proximate an inlet to the at least one fluid passageway to measure a temperature of a fluid entering the at least one fluid passageway.

43. The electrode according to claim 32, further comprising an ablation energy source coupled to the conductive element such that ablation energy may be delivered via the flexible conductive polymer member.

44. A method of manufacturing a tissue ablation device, the method comprising:

forming a conductive element;

forming an ablation electrode by covering at least a portion of the conductive element with a flexible conductive polymer material, wherein the flexible conductive polymer material comprises a pressure sensitive conductive polymer; and

forming at least one fluid passageway in the ablation electrode, the at least one fluid passageway including at least one efflux hole to permit a fluid to exit the ablation electrode.

45. The method according to claim 44, wherein the step of forming at least one fluid passageway in the ablation electrode comprises providing at least one electrically insulative tube extending through at least a portion of the flexible conductive polymer material.

46. The method according to claim 45, wherein the step of forming a conductive element comprises forming a conductive element covering at least part of the at least one electrically insulative tube.

47. The method according to claim 44, further comprising:

providing a catheter shaft having a distal end and at least one fluid passageway extending at least partway therethrough; and

coupling the ablation electrode to the distal end of the catheter shaft such that the at least one fluid passageway of the catheter shaft is in fluid communication with the at least one fluid passageway of the ablation electrode.

48. The method according to claim 44, further comprising:

forming an electrically insulative member,

wherein the step of forming a conductive element comprises forming a conductive element covering at least part of the electrically insulative member.

49. A method of treating tissue, the method comprising:

providing an electrode including a flexible conductive element for conducting ablation energy, a flexible conductive polymer material covering at least a portion of the conductive element, wherein the flexible conductive polymer material comprises a pressure sensitive conductive polymer, and a fluid passageway including at least one efflux hole that permits a fluid to exit the electrode;

coupling an ablation energy supply to the conductive element;

positioning the electrode in contact with a tissue specimen to be treated;

delivering ablation energy to the tissue specimen; and

flowing a coolant through the fluid passageway to cool the electrode.