Methods and apparatus for assessing and improving electrode contact with cardiac tissue

• US 8,504,132 B2
• Filed: 06/28/2007
• Issued: 08/06/2013
• Est. Priority Date: 06/28/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Friedman, Paul, Bruce, Charles J., Amara, Ryan, Johnson, Jeremiah, Kozel, Peter D.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US12/308,862
• Publication Number:
  US 20100198040A1
• Time in Patent Office: 2,231 Days
• Field of Search: 600/374, 600/393, 600/509, 606/41
• US Class Current: 600/374
• CPC Class Codes: A61B 18/1206 Generators 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• 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
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation

Abstract

Embodiments of the invention relate to methods for assessing and/or improving contact between an electrophysiology catheter and tissue, and catheters for performing the methods. One embodiment relates to a catheter comprising a braided conductive member coupled to the distal end of a shaft, wherein the braided conductive member comprises a plurality of pressure sensitive wires. Another embodiment relates to a catheter comprising a braided conductive member having a plurality of sectors and coupled to the distal end of a shaft, and a balloon assembly constructed and arranged to selectively apply distal pressure to one or more sectors of the braided conductive member.

Claims

1. An electrophysiology catheter comprising:

a handle;

a shaft coupled to a distal end of the handle; and

a braided conductive member coupled to a distal end of the shaft,

wherein the braided conductive member comprises a plurality of pressure sensitive wires and a plurality of sectors including a first sector and a second sector,

wherein the first sector comprises at least a first pressure sensitive wire for sensing a first degree of pressure between the first sector and first adjacent tissue, and

wherein the second sector comprises at least a second pressure sensitive wire for sensing a second degree of pressure between the second sector and second adjacent tissue.

2. The electrophysiology catheter of claim 1, wherein the plurality of pressure sensitive wires are disposed at least partially in a distally facing surface of the braided conductive member.

3. The electrophysiology catheter of claim 1, wherein the plurality of pressure sensitive wires are woven into the braided conductive member.

4. The electrophysiology catheter of claim 1, wherein the impedance of the plurality of pressure sensitive wires varies in response to the pressure applied to the wires.

5. The electrophysiology catheter of claim 1, wherein each of the plurality of sectors comprises at least one of the plurality of pressure sensitive wires.

6. The electrophysiology catheter of claim 5, wherein each of the plurality of sectors is electrically independent.

7. The electrophysiology catheter of claim 5, further comprising an indicator coupled to one or more of the pressure sensitive wires, and wherein the indicator is adapted to indicate whether the degree of pressure on one or more of the plurality of sectors has exceeded a predetermined threshold.

8. The electrophysiology catheter of claim 7, wherein the indicator comprises a light emitting diode (LED).

9. The electrophysiology catheter of claim 1, further comprising a balloon assembly constructed and arranged to selectively apply distal pressure to one or more sectors of the braided conductive member.

10. The electrophysiology catheter of claim 9, wherein the balloon assembly is disposed in an interior space formed by the braided conductive member.

11. The electrophysiology catheter of claim 9, wherein the catheter is adapted to automatically adjust an inflation of all or a portion of the balloon assembly in response to an indication of pressure received from one or more of the plurality of pressure sensitive wires.

12. A system, comprising:

the catheter of claim 1; and

a controller coupled thereto.

13. The system of claim 12, wherein the controller is adapted to indicate whether the degree of pressure on one or more of the plurality of sectors has exceeded a predetermined threshold.

14. The system of claim 12, wherein:

the controller comprises an ablation energy generator; and

the controller is adapted to determine if pressure detected by at least one of the plurality of pressure sensitive wires is below a predetermined threshold and prohibit application of ablation energy to at least a portion of the braided conductive member if the pressure is below the predetermined threshold.

15. The system of claim 12, wherein:

the controller comprises an ablation energy generator; and

the controller is adapted to determine if pressure detected by at least one of the plurality of pressure sensitive wires is above a predetermined threshold and automatically apply ablation energy to at least a portion of the braided conductive member if the pressure is above the predetermined threshold.

16. The system of claim 12, wherein:

the catheter further comprises a balloon assembly constructed and arranged to selectively apply distal pressure to one or more sectors of the braided conductive member;

wherein the controller further comprises an inflation mechanism adapted to automatically adjust an inflation of the balloon assembly in response to at least one signal received from the plurality of pressure sensitive wires.

17. The system of claim 12, wherein:

the controller comprises an ablation energy generator; and

the controller is adapted to apply ablation energy to the pressure sensitive wires.

18. The system of claim 12, wherein:

the controller comprises a recording device; and

the controller is adapted to transmit mapping signals from the pressure sensitive wires to the recording device.

19. A method, comprising:

introducing a catheter having a braided conductive member into a heart, the braided conductive member comprising a plurality of sectors including a first sector comprising at least a first pressure sensitive wire and a second sector comprising at least a second pressure sensitive wire;

positioning the braided conductive member at a desired location for performing ablation or mapping;

sensing a first degree of pressure between the first sector of the braided conductive member and first adjacent tissue at least in part by using the first pressure sensitive wire;

sensing a second degree of pressure between the second sector of the braided conductive member and second adjacent tissue at least in part by using the second pressure sensitive wire; and

providing an indication of contact between at least one sector of the braided conductive member and adjacent tissue based on the first degree of pressure and/or the second degree of pressure.

20. The method of claim 19, further comprising:

determining whether the first degree of pressure exceeds a predetermined threshold; and

determining whether the second degree of pressure exceeds the predetermined threshold,

wherein providing the indication comprises providing an indication that the first degree of pressure and/or the second degree of pressure has exceeded the predetermined threshold.

21. The method of claim 20, wherein the predetermined threshold is selected based on a degree of pressure required for successful lesion formation.

22. The method of claim 19, wherein providing the indication comprises providing an indication that each of the first degree of pressure and the second degree of pressure has exceeded a predetermined threshold.

23. The method of claim 19, wherein positioning the braided conductive member comprises positioning the braided conductive member at an orifice of the heart.

24. The method of claim 19, further comprising:

using the braided conductive member, forming a lesion in the first adjacent tissue in response to an indication that the first degree of pressure is acceptable for successful lesion formation.

25. The method of claim 24, wherein the step of forming the lesion comprises forming the lesion automatically in response to the indication that the first degree of pressure is acceptable for successful lesion formation.

26. The method of claim 19, further comprising:

detecting a mapping signal from the heart using at least one of the pressure sensitive wires.

27. The method of claim 19, further comprising:

applying ablation energy to the heart using at least one of the pressure sensitive wires.

28. The method of claim 19, further comprising:

adjusting a degree of contact between at least a portion of the braided conductive member and adjacent tissue in response to the indication.

29. The method of claim 28, wherein adjusting the degree of contact comprises adjusting the inflation of a balloon disposed within the braided conductive member.

30. The method of claim 29, wherein the first and second sectors are electrically independent, and wherein the balloon has dimensions corresponding to dimensions of the first electrically independent sector.

31. The method of claim 28, wherein adjusting the degree of contact comprises independently adjusting the inflation of a plurality of balloons disposed within the braided conductive member.

32. The method of claim 19, further comprising:

increasing the degree of contact between the first sector and the first adjacent tissue in response to an indication that the first pressure is below a predetermined threshold.

33. The method of claim 19, further comprising:

using the braided conductive member, applying ablation energy to the first adjacent tissue; and

using the braided conductive member, measuring a signal level from the first adjacent tissue; and

determining if the signal level is below a first predetermined threshold;

determining if the first degree of pressure exceeds a second predetermined threshold; and

if the signal level is below the first predetermined threshold and the first degree of pressure exceeds the second predetermined threshold, providing an indication of successful lesion formation in the first adjacent tissue.

34. The method of claim 33, wherein providing the indication of successful lesion formation in the first adjacent tissue comprises providing the indication on the catheter.

35. The method of claim 33, wherein providing the indication of successful lesion formation in the first adjacent tissue comprises providing the indication on a controller coupled to the catheter.

36. The method of claim 19, further comprising:

determining if the first degree of pressure is below a predetermined threshold; and

prohibiting application of ablation energy to the first sector if the first degree of pressure is below the predetermined threshold.