RF ablation apparatus and method having electrode/tissue contact assessment scheme and electrocardiogram filtering

• US 6,391,024 B1
• Filed: 06/17/1999
• Issued: 05/21/2002
• Est. Priority Date: 06/17/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lockwood, Kathryn E., Anderson, Russ E., Simpson, John A., Bowe, Wade A., Sun, Weimin, Sherman, Marshall L., Castellano, Thomas M.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Kearney, R.
• Application Number:
  US09/335,200
• Time in Patent Office: 1,069 Days
• Field of Search: 607/96, 607/98, 607/99, 607/100, 607/101, 607/113, 607/115, 607/116, 607/119, 606/32, 606/34, 606/35, 606/39, 606/40, 606/41, 606/42, 606/46-50, 128/898
• US Class Current: 606/34
• 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 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

A method of assessing the adequacy of contact between an ablation electrode and biological tissue within a biological organ having biological fluid therein includes the steps of positioning the ablation electrode proximal the biological tissue; positioning a reference electrode a distance from the ablation electrode; measuring the impedance between the ablation electrode and the reference electrode at a first frequency and measuring the impedance between the ablation electrode and the reference electrode at a second frequency. The percentage difference between the first-frequency impedance and the second-frequency impedance provides an indication of the state of electrode/tissue contact. In general, a percentage difference of at least approximately 10% serves as an indication of substantially complete electrode/tissue contact. A percentage difference in the approximate range between 5% and 10% serves as an indication of partial electrode/tissue contact. A percentage difference less than approximately 5% serves as an indication of no electrode/tissue contact. Ratiometric measurements may also be used to assess the state of electrode/tissue contact.

Claims

1. A method of assessing the adequacy of contact between an ablation electrode carried by an electrode device and biological tissue within a moving biological organ having biological fluid therein, said method comprising the steps of:

positioning the ablation electrode in the biological fluid;

positioning a reference electrode a distance from a first electrode and the biological tissue;

obtaining a reference impedance value by measuring the impedance between the ablation electrode and the reference electrode, wherein the reference impedance value is the average of a plurality of reference impedance values obtained during a given time period sufficient to include a plurality of organ movements;

moving the ablation electrode to a position proximal the biological tissue;

obtaining an assessment impedance value by measuring the impedance between the ablation electrode and the reference electrode, wherein the assessment impedance value is the average of a plurality of assessment impedance values obtained during a given time period sufficient to include a plurality of organ movements;

analyzing the assessment impedance and the reference impedance; and

indicating the state of electrode/tissue contact.

2. The method of claim 1 wherein the step of analyzing the assessment impedance and the reference impedance comprises the step of calculating the percentage difference between the two and the step of indicating the state of electrode/tissue contact comprises the steps of:

when the percentage difference is at least approximately 10%, indicating substantially complete electrode/tissue contact;

when the percentage difference is in the approximate range between 5% and 10%, indicating partial electrode/tissue contact; and

when the percentage difference is less than approximately 5%, indicating no electrode/tissue contact.

3. The method of claim 1 wherein the reference electrode is positioned in the biological fluid.

4. The method of claim 1 wherein the reference electrode is positioned exterior to the biological organ.

5. The method of claim 1 wherein the electrode device carries a plurality of electrodes one of which comprises the ablation electrode and another of which comprises the reference electrode.

6. The method of claim 1 wherein the organ is a heart and the reference impedance and the assessment impedance are obtained using a drive signal having a frequency above that which induces pacing of the heart and a voltage level below that which induces pacing of the heart.

7. The method of claim 1 further comprising the step of, prior to obtaining an assessment impedance value, positioning an electrical insulator relative the ablation electrode so that when the ablation electrode is proximal the biological tissue the electrode is interposed between the electrical insulator and the tissue.

8. The method of claim 7 wherein the ablation electrode comprises a ring electrode and the electrical insulator comprises a dielectric material having normal thermal conductivity adhered to a portion of the ring electrode.

9. The method of claim 7 wherein the ablation electrode comprises a ring electrode and the electrical insulator comprises a half-pipe sheath surrounding a portion of the ring electrode.

10. The method of claim 9 wherein the ablation electrode comprises a half-ring electrode and the electrical insulator comprises a catheter sheath onto which the half-ring electrode is mounted.

11. A method of assessing the adequacy of contact between a plurality of ablation electrodes carried by an electrode device and biological tissue within a biological organ having biological fluid therein, said method comprising the steps of:

obtaining a reference impedance value by;

positioning the plurality of ablation electrodes in the biological fluid;

positioning a first reference electrode a distance from the plurality of ablation electrodes and the biological tissue;

measuring the impedance between at least one of the ablation electrodes and the reference electrode;

moving the plurality of ablation electrodes to a position proximal the biological tissue;

for each ablation electrode;

obtaining an assessment impedance value by positioning a second reference electrode a distance from the ablation electrode and the biological tissue and measuring the impedance between the ablation electrode and the reference electrode;

analyzing the assessment impedance and the reference impedance; and

indicating the state of electrode/tissue contact.

12. The method of claim 11 wherein the step of analyzing the assessment impedance and the reference impedance comprises the step of calculating the percentage difference between the two and the step of indicating the state of electrode/tissue contact comprises the steps of:

when the percentage difference is at least approximately 10%, indicating substantially complete electrode/tissue contact;

when the percentage difference is in the approximate range between 5% and 10%, indicating partial electrode/tissue contact; and

when the percentage difference is less than approximately 5%, indicating no electrode/tissue contact.

13. The method of claim 11 wherein the second reference electrode comprises one of the plurality of ablation electrodes.

14. The method of claim 11 wherein the second reference electrode comprises a backplate.

15. A method of assessing the adequacy of contact between a plurality of ablation electrodes carried by an electrode device and biological tissue within a biological organ having biological fluid therein, said method comprising the steps of:

obtaining a reference impedance value by;

positioning the plurality of ablation electrodes in the biological fluid;

positioning a first reference electrode a distance from the plurality of ablation electrodes and the biological tissue;

measuring the impedance between at least one of the ablation electrodes and the reference electrode;

moving the plurality of ablation electrodes to a position proximal the biological tissue;

obtaining an assessment impedance value by measuring the impedance between selected pairs of ablation electrodes;

analyzing the assessment impedance and the reference impedance; and

indicating the state of electrode/tissue contact.

16. The method of claim 15 wherein the step of analyzing the assessment impedance and the reference impedance comprises the step of calculating the percentage difference between the two and the step of indicating the likelihood of electrode/tissue contact comprises the steps of:

when the percentage difference is at least approximately 10%, indicating substantially complete electrode/tissue contact;

when the percentage difference is in the approximate range between 5% and 10%, indicating partial electrode/tissue contact; and

when the percentage difference is less than approximately 5%, indicating no electrode/tissue contact.

17. The method of claim 15 wherein the ablation electrodes are arranged in a linear array and the pairs of ablation electrodes comprise adjacent electrodes.

18. A method of assessing the adequacy of contact between an ablation electrode and biological tissue within a moving biological organ having biological fluid therein, said method comprising the steps of:

positioning the ablation electrode proximal the biological tissue;

positioning a reference electrode a distance from the ablation electrode;

applying a signal to the ablation electrode during a time period sufficient to include several movements of the organ;

obtaining a sequence of impedance values by periodically measuring the impedance between the ablation electrode and the reference electrode during the time period; and

monitoring the sequence of impedance values for variations indicative of electrode/tissue contact.

19. The method of claim 18 wherein the step of monitoring the sequence of impedance values for variations indicative of electrode/tissue contact comprises the steps of:

obtaining an average impedance value based on a plurality of the impedance values;

calculating the standard deviation of the impedance values relative the average impedance;

calculating a deviation percentage;

when the deviation percentage is at least approximately 2%, indicating substantially complete electrode/tissue contact;

when the deviation percentage is in the approximate range between 1% and 2%, indicating partial electrode/tissue contact; and

when the deviation percentage is less than approximately 1%, indicating no electrode/tissue contact.

20. A method of assessing the adequacy of contact between an ablation electrode and biological tissue within a biological organ having biological fluid therein, said method comprising the steps of:

positioning the ablation electrode proximal the biological tissue;

positioning a reference electrode a distance from the ablation electrode;

measuring the impedance between the ablation electrode and the reference electrode at a first frequency;

measuring the impedance between the ablation electrode and the reference electrode at a second frequency;

analyzing the first-frequency impedance and the second-frequency impedance; and

indicating the state of electrode/tissue contact.

21. The method of claim 20 wherein the step of analyzing the first-frequency impedance and the second-frequency impedance comprises the step of calculating the percentage difference between the two impedances and the step of indicating the state of electrode/tissue contact comprises the steps of:

when the percentage difference is at least approximately 10%, indicating substantially complete electrode/tissue contact;

when the percentage difference is in the approximate range between 5% and 10%, indicating partial electrode/tissue contact; and

when the percentage difference is less than approximately 5%, indicating no electrode/tissue contact.

22. The method of claim 20 wherein the step of analyzing the first-frequency impedance and the second-frequency impedance comprises the steps of calculating the ratio of the two impedances and comparing the ratio to a known value, and the step of indicating the state of electrode/tissue contact comprises the steps of:

when the ratio is approximately equal to the known value, indicating no electrode/tissue contact;

when the ratio deviates from the known value by an amount in the approximate range between ±

0.1 to ±

0.15, indicating at least partial electrode/tissue contact; and

when the ratio deviates from the known value by an amount approximately greater than ±

0.15, indicating substantially complete electrode/tissue contact.

23. The method of claim 20 wherein there is at least a two fold difference between the first frequency and second frequency.

24. The method of claim 23 wherein one of the frequencies is a low-frequency just above that which induces pacing of the heart and the other of the frequencies is a greater than the low frequency.

25. The method of claim 20 wherein the first-frequency impedance is the average of a plurality of impedances measured during a first time period and the second-frequency impedance is the average of a plurality of impedances measured during a second time period.

26. A method of assessing the adequacy of contact between an ablation electrode carried by an electrode device and biological tissue within a biological organ having biological fluid therein, said method comprising the steps of:

positioning the ablation electrode in the biological fluid;

positioning a reference electrode a distance from the ablation electrode;

measuring the impedance between the ablation electrode and the reference electrode at a first frequency;

measuring the impedance between the ablation electrode and the reference electrode at a second frequency;

obtaining a base-line ratio by calculating the ratio of the first-frequency impedance and the second-frequency impedance;

positioning the ablation electrode proximal the biological tissue;

positioning the reference electrode a distance from the ablation electrode;

measuring the impedance between the ablation electrode and the reference electrode at the first frequency;

measuring the impedance between the ablation electrode and the reference electrode at the second frequency;

obtaining a contact assessment ratio by calculating the ratio of the first-frequency impedance and the second-frequency impedance;

analyzing the base-line ratio and the contact-assessment ratio; and

indicating the state of electrode/tissue contact.

27. The method of claim 26 wherein the step of analyzing the base-line ratio and the contact-assessment ratio comprises the step of comparing the ratios and the step of indicating the state of electrode/tissue contact comprises the steps of:

when the assessment ratio is approximately equal to the base-line ratio, indicating no electrode/tissue contact;

when the assessment ratio deviates from the base-line ratio by a value in the approximate range between ±

0.1 to ±

0.15, indicating at least partial electrode/tissue contact; and

when the assessment ratio deviates from the base-line ratio by an amount approximately greater than ±

0.15, indicating substantially complete electrode/tissue contact.

28. An apparatus for assessing the adequacy of contact between an ablation electrode and biological tissue within a moving biological organ having biological fluid therein, said apparatus comprising:

an electrode device carrying the ablation electrode;

a signal generating device providing as output a drive signal to the ablation electrode and a reference potential;

a reference electrode spaced from the ablation electrode and responsive to the reference potential;

an impedance measurement device configured to;

provide a reference impedance indicative of the impedance between the ablation electrode and the reference electrode when the ablation electrode is positioned in the biological fluid, wherein the reference impedance value is the average of a plurality of reference impedance values obtained during a given time period sufficient to include a plurality of organ movements; and

provide an assessment impedance indicative of the impedance between the ablation electrode and the reference electrode when the ablation electrode is positioned proximal the biological tissue wherein the assessment impedance value is the average of a plurality of assessment impedance values obtained during a given time period sufficient to include a plurality of organ movements; and

a processor responsive to the reference and assessment impedance signals configured to analyze the impedance signals and indicate the state of electrode/tissue contact.

29. The apparatus of claim 28 wherein the processor comprises:

a calculator configured to determine the percentage difference between the reference impedance and the assessment impedance; and

a comparator configured to compare the percentage difference to a plurality of predetermined contact assessment criteria and provide an indication result, the criteria and results comprising, for a percentage difference at least approximately 10%, indicating substantially complete electrode/tissue contact, for a percentage difference in the approximate range between 5% and 10%, indicating partial electrode/tissue contact, and for a percentage difference less than approximately 5%, indicating no electrode/tissue contact.

30. The apparatus of claim 28 wherein the electrode device carries a plurality of electrodes one of which comprises the ablation electrode and another of which comprises the reference electrode.

31. The apparatus of claim 28 wherein the amplitude of the drive signal is limited to a level below that which induces pacing of a heart.

32. The apparatus of claim 31 wherein the voltage level is between 20 millivolts and 200 millivolts.

33. The apparatus of claim 32 wherein the voltage level is approximately 50 millivolts.

34. The apparatus of claim 28 wherein the electrode device comprises an electrical insulator positioned relative the ablation electrode so that when the ablation electrode is proximal the biological tissue the electrode is interposed between the electrical insulator and the tissue.

35. The apparatus of claim 34 wherein the ablation electrode comprises a ring electrode and the electrical insulator comprises a dielectric material having normal thermal conductivity adhered to a portion of the ring electrode.

36. The apparatus of claim 34 wherein the ablation electrode comprises a ring electrode and the electrical insulator comprises a half-pipe sheath surrounding a portion of the ring electrode.

37. The apparatus of claim 34 wherein the ablation electrode comprises a half-ring electrode and the electrical insulator comprises a catheter sheath onto which the half-ring electrode is mounted.

38. An apparatus for assessing the adequacy of contact between an ablation electrode and biological tissue within a moving biological organ having biological fluid therein, said apparatus comprising:

an electrode device carrying the ablation electrode;

a signal generating device providing as output a drive signal to the ablation electrode and a reference signal;

a reference electrode spaced from the ablation electrode and responsive to the reference signal;

an impedance measurement device configured to provide a sequence of assessment impedance values indicative of the impedance between the ablation electrode and the reference electrode; and

a processor responsive to the sequence of assessment impedance signals configured to monitor the sequence of impedance values for variations indicative of electrode/tissue contact.

39. The apparatus of claim 38 wherein the processor comprises:

a calculator configured to determine an average impedance value based on a plurality of the impedance values, calculate the standard deviation of the impedance values relative the average impedance and calculate a deviation percentage; and

a comparator configured to compare the deviation percentage to a plurality of predetermined contact assessment criteria and provide an indication result, the criteria and results comprising, for a deviation percentage at least approximately 2%, indicating substantially complete electrode/tissue contact, for a deviation percentage in the approximate range between 1% and 2%, indicating partial electrode/tissue contact; and

for a standard deviation percentage less than approximately 1%, indicating no electrode/tissue contact.

40. An apparatus for assessing the adequacy of contact between an ablation electrode carried by an electrode device and biological tissue within a biological organ having biological fluid therein, said apparatus comprising:

a signal generating device providing as output a reference signal and for a first time period, a first drive signal to the ablation electrode, the first drive signal having a first amplitude and first frequency, the signal generating device also providing as output for a second time period, a second drive signal to the ablation electrode, the second drive signal having a second amplitude and a second frequency;

a reference electrode spaced from a first electrode and responsive to the reference signal;

an impedance measurement device producing as output a first assessment impedance signal indicative of the impedance between the ablation electrode and reference electrode during the first time period and a second assessment impedance signal indicative of the impedance between the first and second electrodes during the second time period; and

a processor responsive to the first and second assessment impedance signals configured to compare the impedances to a predetermined value indicative of electrode/tissue contact.

41. The apparatus of claim 40 wherein the processor comprises:

a calculator configured to determine the percentage difference between the first-frequency impedance and the second-frequency impedance; and

a comparator configured to compare the percentage difference to a plurality of predetermined contact assessment criteria and provide an indication result, the criteria and results comprising, for a percentage difference at least approximately 10%, indicating substantially complete electrode/tissue contact, for a percentage difference in the approximate range between 5% and 10%, indicating partial electrode/tissue contact, and for a percentage difference less than approximately 5%, indicating no electrode/tissue contact.

42. The apparatus of claim 40 wherein the processor comprises:

a calculator configured to determine the ratio of the first-frequency impedance and the second-frequency impedance; and

a comparator configured to compare the ratio to a plurality of predetermined contact assessment criteria and provide an indication result, the criteria and results comprising, for a ratio of approximately 1, indicating no electrode/tissue contact and for a ratio that deviates significantly from 1, indicating electrode/tissue contact.

43. A method of providing ablation energy to biological tissue through an electrode device having at least one electrode while monitoring the electrical activity of the tissue, said method comprising the steps of:

positioning the at least one electrode proximal the tissue;

applying ablation power to the at least one electrode through a first lead, the ablation power comprising a high frequency component;

receiving, from the electrode and through the first lead, a feedback signal indicative of the electrical activity in the tissue;

filtering the feedback signal to remove any high frequency components; and

providing the filtered feedback signal to an instrument through a second lead.

44. The method of claim 43 wherein the ablation power comprises an RF component and the filter filters the RF component from the feedback signal.

45. The method of claim 44 wherein the RF component has a frequency of approximately 500 kHz.

46. The method of claim 43 wherein the filtered feedback signal comprises an electrocardiogram signal having a frequency less that 250 Hz and the instrument is an electrocardiogram amplifier/recorder.

47. An apparatus for providing ablation power to biological tissue through an electrode device having at least one electrode positioned proximal the tissue, said apparatus comprising:

a generator producing ablation power having a high-frequency component;

a high-frequency filter;

a first lead presenting the ablation power to the at least one electrode and the filter, the first lead further presenting a feedback signal from the electrode to the filter; and

a second lead presenting a filter output to an instrument.

48. The apparatus of claim 47 wherein the ablation power comprises an RF component and the high-frequency filter filters the RF component.

49. The apparatus of claim 48 wherein the RF component has a frequency of approximately 500 kHz.

50. The apparatus of claim 47 wherein the filter output comprises an electrocardiogram signal having a frequency less that 250 Hz and the instrument comprises an electrocardiogram amplifier/recorder.

51. An apparatus comprising:

a generator producing a plurality of ablation power signals, each having a high frequency component;

a plurality of high-frequency filters;

an electrode device having a plurality of electrodes;

a plurality of first leads, each presenting one of the ablation power signals to one of the electrodes and one of the filters, the first lead further presenting a feedback signal from the electrode to the filter; and

a plurality of second leads, each presenting a filter output to an instrument.