System and method for measuring subsurface temperature of tissue during ablation

• US 6,217,574 B1
• Filed: 01/20/1999
• Issued: 04/17/2001
• Est. Priority Date: 12/03/1998
• Status: Expired due to Term

• Current Assignee: Cordis Webster
• Original Assignee: Cordis Webster
• Inventors: Webster, Wilton W.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/234,365
• Time in Patent Office: 818 Days
• Field of Search: 606/41, 606/34, 606/49, 607/99, 607/105, 607/113
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00803 with temperature prediction
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1273 including multiple generators in one device
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

An RF ablation system comprises irrigated split tip electrode catheter, an RF generator and a signal processor. The catheter comprises four orthogonally arranged electrodes at the distal tip. The catheter is used to map the electrical activity of a heart chamber to locate site(s) of aberrant electrical pathways to be ablated. Once an ablation site has been located, the signal processor activates the RF generator to transmit a low level RF current to each electrode member of the split tip electrode. The signal processor receives signals indicative of the impedance between each electrode member and one or more surface indifferent electrodes and determines which electrode members are associated with the highest impedance. Such electrode members are those in greatest contact with the myocardium. The signal processor then automatically activates the RF generator to transmit an RF ablation current to the electrode members in contact with the myocardium to create a lesion.

Claims

1. A system for ablating tissue and estimating the maximum sub-surface temperature of said tissue comprising:

a split tip electrode catheter comprising;

an elongated catheter body having a proximal and distal end and at least one lumen extending therethrough;

a catheter tip section at the distal end of the catheter body comprising a section of flexible tubing having proximal and distal ends and at least one lumen therethrough, the proximal end of the flexible tubing being fixedly attached to the distal end of the catheter body, said catheter tip section further comprising a split tip electrode which comprises at least two electrically isolated electrode members fixedly attached to the distal end of the flexible tubing, each electrode member comprising at least one irrigation passage;

at least one indifferent electrode attachable to the exterior of a patient;

means for generating a low level RF impedance current and for transmitting said impedance current to each electrode member of the split tip electrode;

means for generating an RF ablation current and for transmitting said ablation current to each electrode member of the split tip electrode;

means for electrically connecting each electrode member of the split tip electrode to the low level RF impedance current generating means and the RF ablation current generating means;

means for receiving electrical signals indicative of the impedance between each electrode member and the at least one indifferent electrode during the transmission of RF ablation current and for separating such impedance indicating signals from other received signals; and

a programmable signal processor, electrically connected to the RF impedance current generating means, the RF ablation current generating means, each of the electrode members of the split tip electrode, the at least one indifferent electrode and the signal receiving means, said signal processor being programmed to simultaneously activate the RF impedance current generating means and the RF ablation current generating means to transmit RF impedance current and RF ablation current and to estimate the maximum subsurface temperature based on the received electrical impedance-indicating signals.

2. A system as claimed in claim 1 wherein the signal processor is further programmed to deactivate the RF ablation current generating means if the estimated maximum subsurface temperature reaches a predetermined temperature.

3. A system as claimed in claim 1 further comprising means for controllably deflecting the tip section in at least one direction.

4. A system as claimed in claim 1 wherein the split tip electrode comprises four electrode members.

5. A system as claimed in claim 4 wherein the four electrode members are generally the same and are arranged symmetrically around a longitudinal axis of the tip section.

6. A system as claimed in claim 5 further comprising a ring electrode adjacent proximally to the four electrode members.

7. A system as claimed in claim 1 wherein the low level RF impedance current has ampere level and frequency that allows detection of impedance without ablating tissue in contact with the split tip electrode and without creating fibrillation of a patient'"'"'s heart.

8. A system as claimed in claim 7 wherein the ampere level and frequency selected are ones with which there is a measurable difference in impedance of tissue as compared to the blood pool.

9. A system as claimed in claim 1 wherein the RF impedance current is about 2 microamperes at about 50 KHz.

10. A system as claimed in claim 1 wherein each of said at least two electrode members of the split tip electrode comprises at least one irrigation passage and wherein the system further comprises a metering pump for pumping a cooling fluid through the catheter and the at least one irrigation passage in each electrode member to cool the electrode members during ablation.

11. A system as claimed in claim 10 wherein the signal processor is further programmed to activate the pump to pump cooling fluid through the catheter to cool the electrode members while an RF ablation current is being transmitted to one or more electrode members.

12. A system for ablating tissue and estimating the surface and maximum subsurface temperature of said tissue comprising:

a split tip electrode catheter comprising;

an elongated catheter body having a proximal and distal end and at least one lumen extending therethrough;

a catheter tip section at the distal end of the catheter body comprising a section of flexible tubing having proximal and distal ends and at least one lumen therethrough, the proximal end of the flexible tubing being fixedly attached to the distal end of the catheter body, said catheter tip section further comprising a split tip electrode which comprises at least two electrically isolated electrode members fixedly attached to the distal end of the flexible tubing each electrode member comprising at least one irrigation passage;

at least one indifferent electrode attachable to the exterior of a patient;

means for generating a low level RF impedance current and for transmitting said impedance current to each electrode member of the split tip electrode;

means for generating an RF ablation current and for transmitting said ablation current to each electrode member of the split tip electrode;

means for electrically connecting each electrode member of the split tip electrode to the low level RF impedance current generating means and the RF ablation current generating means;

means, including a pump, for infusing a cooling fluid through the catheter and each of the electrode members to cool the electrode members during ablation;

temperature sensing means, attached to each electrode member of the split tip electrode, for generating a signal indicative of the temperature of the electrode member to which it is attached;

means for receiving electrical signals indicative of the impedance between each electrode member and the at least one indifferent electrode during the transmission of RF ablation current and for separating such impedance indicating signals from other signals received; and

signal processing means, electrically connected to the RF impedance current generating means, the RF ablation current generating means, the pump of the infusing means, each of the electrode members of the split tip electrode, the at least one indifferent electrode, the temperature sensing means and the signal receiving means, for activating the RF impedance generating means to transmit an impedance current to each of the electrode members of the split tip electrode, for receiving electrical signals indicative of the impedance between each of the electrode members of the split tip electrode and the at least one indifferent electrode and for identifying the electrode member(s) associated with the highest impedance signal(s) received as the electrode member(s) in contact with tissue, and thereafter for intermittently activating the pump of the infusing means and the RF ablation current generating means so that there are ON periods wherein cooling fluid is delivered to the electrode members and RF ablation current is transmitted to the identified tissue-contacting electrode members and OFF periods wherein no cooling fluid is delivered to the electrode members and no RF ablation energy is transmitted to the identified tissue-contacting electrode members for estimating the surface temperature of tissue in contact with the electrode members from the signals received from the temperature sensing means during the OFF periods, for activating the RF impedance current generating means to transmit impedance current to the electrode members of the split tip electrode during at least the ON periods and for estimating the maximum subsurface temperature of tissue heated by the RF ablation current from the received impedance-indicating signals.

13. A system as claimed in claim 12 further comprising means for controllably deflecting the tip section in at least one direction.

14. A system as claimed in claim 12 wherein the split tip electrode comprises four electrode members.

15. A system as claimed in claim 14 wherein the four electrode members are generally the same and are arranged symmetrically around a longitudinal axis of the tip section.

16. A system as claimed in claim 15 further comprising a ring electrode adjacent proximally to the four electrode members.

17. A system as claimed in claim 12 wherein the low level RF impedance current has ampere level and frequency that allows detection of impedance without ablating tissue in contact with the split tip electrode and without creating fibrillation of a patient'"'"'s heart.

18. A system as claimed in claim 17 wherein the ampere level and frequency selected are ones with which there is a measurable difference in impedance of tissue as compared to the blood pool.

19. A system as claimed in claim 18 wherein the RF impedance current is about 2 microamperes at about 50 KHz.

20. A system as claimed in claim 12 wherein the signal processing means is further programmed to deactivate the RF ablation current generating means if the estimated maximum subsurface temperature reaches a predetermined temperature.

21. A method for ablating tissue and for estimating the increase in subsurface temperature of tissue at an ablation site during an ablation procedure comprising:

providing a split tip electrode catheter comprising;

an elongated catheter body having a proximal and distal end and at least one lumen extending therethrough;

a catheter tip section at the distal end of the catheter body comprising a section of flexible tubing having proximal and distal ends and at least one lumen therethrough, the proximal end of the flexible tubing being fixedly attached to the distal end of the catheter body, said catheter tip section further comprising a split tip electrode which comprises at least two electrically isolated electrode members fixedly attached to the distal end of the flexible tubing;

introducing the catheter into a lumen in the body of a patient and positioning the catheter so that at least one electrode member of the split tip electrode is in contact with the tissue to be ablated and at least one other electrode member of the split tip electrode is only in contact with the blood pool;

positioning at least one indifferent electrode on the patient;

transmitting an RF ablation current to at least one tissue-contacting electrode member of the split tip electrode;

transmitting a low level RF impedance current through the at least one tissue contacting electrode member of the split tip electrode during transmission of RF ablation current to the at least one tissue-contacting electrode member;

monitoring the impedance between the at least one tissue-contacting electrode member and the at least one indifferent electrode and the impedance between the at least one non-tissue-contacting electrode member and the indifferent electrode; and

estimating the increase in subsurface tissue temperature from the change in the difference between the impedance associated with the at least one tissue-contacting electrode member and the impedance associated with the at least one non-tissue-contacting electrode member.

22. A method as claimed in claim 21 further comprising reducing or terminating the transmission of RF ablation current to the at least one tissue-contacting electrode member of the split tip electrode when the change in measured impedance reaches a predetermined level which indicates that a predetermined maximum subsurface temperature has been reached.

23. A method as claimed in claim 21 wherein the catheter further comprises means for controllably deflecting the tip section in at least one direction.

24. A method as claimed in claim 21 wherein the tip electrode further comprises four electrically isolated electrode members.

25. A method as claimed in claim 24 wherein the four electrode members are generally the same and are arranged symmetrically around a longitudinal axis of the tip section.

26. A method as claimed in claim 25 wherein the catheter further comprises a ring electrode adjacent proximally to the four electrically isolated electrode members.

27. A method as claimed in claim 21 wherein the low level RF impedance current has ampere level and frequency that allows detection of impedance without ablating tissue in contact with the tip electrode and without creating fibrillation of a patient'"'"'s heart.

28. A method as claimed in claim 27 wherein the ampere level and frequency selected are ones with which there is a measurable difference in impedance of tissue as compared to the blood pool.

29. A method as claimed in claim 28 wherein the RF impedance current is about 2 microamperes at about 50 KHz.

30. A method as claimed in claim 21 wherein the tip electrode comprises at least one irrigation passage and wherein cooling fluid is passed through the catheter and the least one irrigation passage to cool the tip electrode while an RF ablation current is being transmitted to the tip electrode.