Pressure-sensitive conductive composite electrode and method for ablation

• US 7,955,326 B2
• Filed: 12/29/2006
• Issued: 06/07/2011
• Est. Priority Date: 12/29/2006
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Original Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Inventors: Paul, Saurav, Cao, Hong, Belhe, Kedar Ravindra, Thao, Chou
• Primary Examiner(s): Dvorak; Linda C
• Assistant Examiner(s): SCOTT, AMANDA L
• Application Number:
  US11/647,316
• Publication Number:
  US 20080161889A1
• Time in Patent Office: 1,621 Days
• Field of Search: 606 40- 48
• US Class Current: 606/40
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

The present invention is directed to ablation devices and methods utilizing pressure sensitive conductive composites, such as quantum tunneling composites, or other contact-sensitive, conductive polymers. The materials provide for electrodes and methods capable of differentiating between a soft and a hard push. The present invention thus provides an electrode for delivering selective electrical energy for ablation that may be varied based upon the pressure exerted on the surface area of the targeted tissue.

Claims

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

a conductive element for conducting electrical energy;

a pressure sensitive conductive composite member that is in electrically conductive contact with the conductive element; and

a catheter base coupled to at least one of the conductive element and the pressure sensitive conductive composite.

2. The electrode of claim 1, wherein the pressure sensitive conductive composite comprises a pressure sensitive conductive polymer.

3. The electrode of claim 1 further comprising:

an ablation energy source coupled to the conductive element, such that ablation energy may be delivered via the pressure sensitive conductive composite when sufficient pressure is applied to transform the pressure sensitive conductive composite to an electrical conductor.

4. The electrode of claim 1, wherein the conductive element is shaped to form a helical coil, and wherein the conductive element is flexible.

5. The electrode of claim 4, further comprising:

an electrically insulative member which is surrounded by at least a portion of the helical coil.

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

7. The electrode of claim 6, further comprising:

at least one sensor located in the electrically insulative member for monitoring temperature.

8. The electrode of claim 5, further comprising:

a heat sink thermally coupled to at least one of;

the pressure sensitive conductive composite member; and

the electrically insulative member.

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

10. The electrode of claim 9, wherein the passageway includes an efflux hole at a distal end of the electrode to permit a cooling fluid to flow from the passageway.

11. The electrode of claim 10, wherein the passageway is defined by an electrically and thermally insulative material.

12. The electrode of claim 10, further comprising:

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

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

13. The electrode of claim 10, further comprising:

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

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

14. The electrode of claim 5, wherein the electrically insulative member includes a passageway for a cooling fluid to cool the electrode during ablation, said passageway comprising a loop such that a cooling 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 of claim 1, wherein the conductive element is shaped to form a mesh coating or wrap.

16. The electrode of claim 15, further comprising:

an electrically insulative member which is in mechanical contact with at least a portion of the mesh coating or wrap.

17. The electrode of claim 16, further comprising:

a heat sink thermally coupled to at least one of;

the pressure sensitive conductive composite member; and

the electrically insulative member.

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

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

an electrically insulative member, said member also being thermally conductive;

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

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

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

20. The ablation electrode of claim 19, wherein the passageway includes an efflux hole at a distal end of the electrode to permit coolant to flow from the passageway.

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

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

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

22. The ablation electrode of claim 19, wherein the passageway comprises a loop such that a 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 of claim 19, wherein the flexible conductive element is shaped to form a helical coil.

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

25. The ablation electrode of claim 19, further comprising:

a heat sink thermally coupled to at least one of;

the layer of pressure sensitive conductive composite; and

the electrically insulative member.

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

a catheter having a proximal end and a distal end;

an electrical conductor for conducting RF energy; and

a layer of quantum tunneling composite that is in electrical communication with the electrical conductor, said layer being located at least in part at the distal end of the catheter.

27. The electrode of claim 26, further comprising:

a flexible, electrically insulative, thermally conductive layer that is in thermal communication with at least a portion of the electrical conductor.

28. The electrode of claim 27, further comprising:

at least one sensor to measure a temperature of the flexible, electrically insulative, thermally conductive layer.

29. The electrode of claim 28, further comprising:

a heat sink thermally coupled to at least one of;

the layer of quantum tunneling composite; and

the flexible, electrically insulative, thermally conductive layer.

30. An electrode assembly for conducting ablative energy, said assembly comprising:

an electrode for conducting ablative energy;

a quantum tunneling composite member; and

an RF energy source coupled to the quantum tunneling composite member;

wherein the electrode is disposed relative to the quantum tunneling composite member such that pressure that is applied to the electrode is transferred to the quantum tunneling composite member and causes the quantum tunneling composite member to become electrically conductive such that it conducts electrical energy to the electrode.

31. The electrode assembly of claim 30, further comprising a conductor that is in electrical contact with the quantum tunneling composite member, said conductor being configured to conduct electrical energy sufficient to cause ablation.

32. The electrode assembly of claim 30, wherein the electrode is located on a distal end of the electrode assembly, and wherein the quantum tunneling composite member is disposed in physical contact with the electrode along the longitudinal axis of the electrode assembly.

33. The electrode assembly of claim 30, further comprising a processor that can sense a degree of contact between the electrode and a surface of a tissue to be ablated.

34. The electrode assembly of claim 30, further comprising:

a processor that monitors for a change in impedance of the quantum tunneling composite member, said processing being coupled to the generator to control the RF energy being generated based on a change in impedance of the quantum tunneling composite member.