System and method for assessing the formation of a lesion in tissue

• US 8,603,084 B2
• Filed: 11/16/2010
• Issued: 12/10/2013
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Fish, Jeffrey M., Byrd, Israel A., Clark, Lynn E., Dando, Jeremy D., Geurkink, Christopher J., Puryear, Harry A., Paul, Saurav
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US12/946,941
• Publication Number:
  US 20110118727A1
• Time in Patent Office: 1,120 Days
• Field of Search: 606/27, 606/34, 606/41
• US Class Current: 606/34
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• 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 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/1079 using optical or photographic means
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence

Abstract

A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU) configured to acquire magnitudes for a component of a complex impedance between an electrode and tissue, and the power applied to the tissue during lesion formation. The ECU is configured to calculate a value responsive to the complex impedance component and the power. The value is indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, or a predicted tissue temperature. The method includes acquiring magnitudes for a component of a complex impedance between an electrode and tissue and the power applied during lesion formation. The method includes calculating a value responsive to the complex impedance component and the power, the value being indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, and/or a predicted tissue temperature.

Claims

1. A system for assessing the formation of a lesion in a tissue as a result of an ablation procedure being performed on said tissue, comprising:

an electronic control unit (ECU) configured to;

acquire a magnitude for the power applied to said tissue during the formation of said lesion in said tissue; and

acquire magnitudes for a plurality of components of a complex impedance between an electrode and said tissue, wherein said plurality of components of said complex impedance comprise;

a reactance between said electrode and said tissue at a point in time for which said value is to be calculated;

a resistance between said electrode and said tissue at a point in time for which said value is to be calculated;

an impedance between said electrode and said tissue at a point in time for which said value is to be calculated;

a first pre-ablation phase angle between said electrode and said tissue prior to said electrode contacting said tissue; and

a second pre-ablation phase angle between said electrode and said tissue following contact between said electrode and said tissue; and

calculate a value responsive to said magnitudes of said plurality of components of said complex impedance and said power, said value indicative of one of a predicted depth of said lesion in said tissue, a likelihood of said lesion having a predetermined depth in said tissue, and a predicted temperature of said tissue.

2. The system of claim 1 wherein said ECU is configured to:

acquire magnitudes for first and second components of said complex impedance, wherein said first and second components of said complex impedance comprise two of a resistance between said electrode and said tissue, a phase angle between said electrode and said tissue, an impedance magnitude between said electrode and said tissue, and a reactance between said electrode and said tissue;

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to a subsequent point in time for which said value is calculated, and further wherein said magnitude of power is a magnitude of the average power applied to said tissue during said time interval; and

calculate said value responsive to said magnitudes of said first and second components of said complex impedance, said magnitude of said change in time, and said average power magnitude.

3. The system of claim 2 wherein said first and second components of said complex impedance comprise resistance and phase angle, and said magnitudes of said resistance and said phase angle are first magnitudes of resistance and phase angle corresponding to the beginning of said time interval, and further wherein said ECU is configured to:

acquire second magnitudes of resistance and phase angle between said electrode and said tissue corresponding to the end of said time interval;

acquire a third magnitude of phase angle between said electrode and said tissue prior to the beginning of said time interval;

calculate;

the natural log of said average power magnitude;

a change in resistance over said time interval based on said first and second resistance magnitudes; and

a change in phase angle over said time interval based on said first and second phase angle magnitudes; and

calculate said value responsive to said third magnitude of said phase angle, said natural log of said average power magnitude, said change in time magnitude, said change in resistance, and said change in said phase angle.

4. The system of claim 3 wherein said ECU is configured to calculate said value by summing:

a predetermined constant;

the product of a first predetermined coefficient and said natural log of said average power magnitude;

the product of a second predetermined coefficient and said change in time magnitude corresponding to said time interval;

the product of a third predetermined coefficient and said third phase angle magnitude;

the product of a fourth predetermined coefficient and said change in said resistance; and

the product of a fifth predetermined coefficient and said change in phase angle.

5. The system of claim 2 wherein said first and second components of said complex impedance comprise resistance and reactance, and said magnitudes of said resistance and said reactance are first magnitudes of resistance and reactance corresponding to the resistance beginning of said time interval, and further wherein said ECU is configured to:

acquire second magnitudes of resistance and reactance between said electrode and said tissue corresponding to the end of said time interval;

calculate;

the natural log of said change in time magnitude;

a change in resistance over said time interval based on said first and second resistance magnitudes;

a change in reactance over said time interval based on said first and second reactance magnitudes; and

an electrical current magnitude by dividing said average power magnitude by said first resistance magnitude resulting in a quotient, and taking the square root of said quotient; and

calculate said value responsive to said natural log of said change in time magnitude, said change in resistance, said change in reactance, and said electrical current magnitude.

6. The system of claim 5 wherein said ECU is configured to calculate said value by summing:

a predetermined constant;

the product of a first predetermined coefficient and said natural log of said change in time magnitude;

the product of a second predetermined coefficient and said change in said resistance;

the product of a third predetermined coefficient and said electrical current magnitude; and

the product of a fourth predetermined coefficient and said change in reactance.

7. The system of claim 2 wherein said first and second components of said complex impedance comprise resistance and reactance, and said magnitudes of said resistance and reactance are first magnitudes of said resistance and reactance corresponding to the beginning of said time interval, and further wherein said ECU is configured to:

calculate a first electrical coupling index (ECI) responsive to said first magnitudes of said resistance and reactance;

acquire second magnitudes of resistance and reactance between said electrode and said tissue corresponding to the end of said time interval, and to calculate a second ECI responsive to said second resistance and reactance magnitudes;

calculate;

the natural log of said change in time magnitude corresponding to said time interval; and

a change in ECI between said first and second ECIs; and

calculate said value responsive to said magnitude of said average power, said natural log of said change in time magnitude and said change in ECI.

8. The system of claim 7 wherein said ECU is configured to calculate said value by summing:

a predetermined constant;

the product of a first predetermined coefficient and said magnitude of said average power;

the product of a second predetermined coefficient and said natural log of said change in time magnitude; and

the product of a third predetermined coefficient and said change in ECI.

9. The system of claim 1, further comprising a catheter having a proximal end and a distal end, and a temperature sensor disposed at said distal end of said catheter, and further wherein said ECU is configured to:

acquire a magnitude of a temperature of said catheter at said distal end at a point in time for which said value is to be calculated;

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to said point in time at which said value is to be calculated, and wherein said magnitude of power is a magnitude of the instantaneous power applied to said tissue at the end of said time interval;

calculate;

a product of said power magnitude and said change in time magnitude;

a change in pre-ablation phase angle between said first and second pre-ablation phase angles;

the natural log of said change in time magnitude; and

the natural log of said power magnitude; and

calculate said value responsive to said reactance magnitude, said resistance magnitude, said product of said power magnitude and said change in time magnitude, said change in pre-ablation phase angle, said natural log of said change in time magnitude, said power magnitude, said temperature magnitude, said impedance magnitude, and said natural log of said power magnitude.

10. The system of claim 9 wherein said ECU is configured to calculate said value by summing:

a predetermined constant;

the product of a first predetermined coefficient and said reactance magnitude;

the product of a second predetermined coefficient and said resistance magnitude;

the product of a third predetermined coefficient and said power magnitude;

the product of a fourth predetermined coefficient and said catheter temperature magnitude;

the product of a fifth predetermined coefficient and said impedance magnitude;

the product of sixth predetermined coefficient and said product of said power magnitude and said change in time magnitude;

the product of a seventh predetermined coefficient and said change in pre-ablation phase angle;

the product of an eighth predetermined coefficient and said natural log of said change in time magnitude; and

the product of a ninth predetermined coefficient and said natural log of said power magnitude.

11. The system of claim 1, wherein said ECU is configured to:

receive a magnitude of a temperature proximate said tissue at a point in time for which said value is to be calculated;

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to said point in time at which said value is to be calculated, and wherein said magnitude of power is a magnitude of the instantaneous power applied to said tissue at the end of said time interval;

calculate;

a product of said power magnitude and said change in time magnitude;

a change in pre-ablation phase angle between said first and second pre-ablation phase angles;

the natural log of said change in time magnitude; and

the natural log of said power magnitude; and

calculate said value responsive to said reactance magnitude, said resistance magnitude, said product of said power magnitude and said change in time magnitude, said change in pre-ablation phase angle, said natural log of said change in time magnitude, said power magnitude, said temperature magnitude, said impedance magnitude, and said natural log of said power magnitude.

12. The system of claim 1 wherein said ECU is configured to generate a lesion formation assessment map based on said calculated value.

13. The system of claim 1 wherein said value is indicative of a likelihood of said lesion having a predetermined depth in said tissue and said ECU is configured to:

compare said value with a predetermined threshold to determine whether it is likely said lesion has reached said determined depth; and

generate a signal corresponding to said determination.

14. The system of claim 1, wherein said ECU is further configured to at least one of generate and acquire one of an image and a model of said tissue.

15. The system of claim 14, wherein said ECU is configured to generate an indicator indicative of said calculated value and to place said indicator on said one of said image and model of said tissue.

16. A method for assessing the formation of a lesion in a tissue as a result of an ablation procedure being performed on said tissue, comprising the steps of

acquiring a magnitude for the power applied to said tissue during the formation of said lesion in said tissue;

and

acquiring magnitudes for a plurality of components of a complex impedance between an electrode and said tissue, wherein said plurality of components of said complex impedance comprise;

a reactance between said electrode and said tissue at a point in time for which said value is to be calculated;

a resistance between said electrode and said tissue at a point in time for which said value is to be calculated;

an impedance between said electrode and said tissue at a point in time for which said value is to be calculated;

a first pre-ablation phase angle between said electrode and said tissue prior to said electrode contacting said tissue; and

a second pre-ablation phase angle between said electrode and said tissue following contact between said electrode and said tissue; and

calculating a value responsive to said magnitudes of said plurality of components of said complex impedance and said power, said value indicative of one of a predicted depth of said lesion in said tissue, a likelihood of said lesion having a predetermined depth in said tissue, and a predicted temperature of said tissue.

17. The method of claim 16 wherein said acquiring step comprises acquiring magnitudes for first and second components of said complex impedance, wherein said first and second components comprise two of a resistance between said electrode and said tissue, a phase angle between said electrode and said tissue, and a reactance between said electrode and said tissue, said method further comprising the steps of:

determining a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to a subsequent point in time for which said value is calculated;

wherein said acquiring step comprises the substep of acquiring a magnitude of the average power applied to said tissue during said time interval; and

further wherein said calculating step comprises calculating said value responsive to said magnitudes of said first and second components of said complex impedance, said change in time magnitude, and said average power magnitude.

18. The method of claim 17 wherein said first and second components of said complex impedance comprise resistance and phase angle, and further wherein said acquiring step comprises acquiring first magnitudes of said resistance and said phase angle corresponding to the beginning of said time interval, said method further including the step of:

acquiring second magnitudes of resistance and phase angle between said electrode and said tissue corresponding to the end of said time interval;

acquiring a third magnitude of phase angle between said electrode and said tissue prior to the beginning of said time interval;

calculating the natural log of said average power magnitude;

calculating a change in resistance over said time interval based on said first and second resistance magnitudes; and

calculating a change in phase angle over said time interval based on said first and second phase angle magnitudes;

and wherein said calculating a value step comprising calculating said value responsive to said third magnitude of said phase angle, said natural log of said average power magnitude, said change in time magnitude, said change in resistance, and said change in said phase angle.

19. The method of claim 16 wherein said first and second components of said complex impedance comprise resistance and reactance, and further wherein said acquiring step comprises acquiring first magnitudes of said resistance and said reactance corresponding to the beginning of said time interval, said method further including the step of:

acquiring second magnitudes of resistance and reactance between said electrode and said tissue corresponding to the end of said time interval;

calculating the natural log of said change in time magnitude;

calculating a change in resistance over said time interval based on said first and second resistance magnitudes;

calculating a change in reactance over said time interval based on said first and second reactance magnitudes; and

calculating an electrical current magnitude by;

dividing said average power magnitude by said first resistance magnitude thereby resulting in a quotient; and

taking the square root of said quotient;

said calculating a value step comprising calculating said value responsive to said natural log of said change in time magnitude, said change in resistance, said change in reactance, and said electrical current magnitude.

20. The method of claim 16 wherein said acquiring step comprises acquiring first magnitudes of said resistance and said reactance corresponding to the beginning of said time interval;

said method further includes the steps of;

acquiring second magnitudes of resistance and reactance between said electrode and said tissue corresponding to the end of said time interval;

calculating;

a first electrical coupling index (ECI) responsive to said first magnitudes of said resistance and reactance;

a second ECI responsive to said second magnitudes of said resistance and reactance;

the natural log of the changing in time magnitude corresponding to said time interval; and

a change in ECI between said first and second ECIs;

said calculating a value step comprising calculating said value responsive to said natural log of said magnitude of said change in time, said change in ECI, and said magnitude of said average power.

21. The method of claim 16 wherein:

said acquiring step comprises acquiring magnitudes for a plurality of components of said complex impedance, wherein said plurality of components of said complex impedance comprise;

a reactance between said electrode and said tissue at a point in time for which said value is to be calculated;

a resistance between said electrode and said tissue at a point in time for which said value is to be calculated;

an impedance between said electrode and said tissue at a point in time for which said value is to be calculated;

a first pre-ablation phase angle between said electrode and said tissue prior to said electrode contacting said tissue; and

a second pre-ablation phase angle between said electrode and said tissue following contact between said electrode and said tissue;

said calculating step comprises calculating said value responsive to said magnitudes of said plurality of components of said complex impedance.

22. The method of claim 21 wherein said acquiring a magnitude of the power step comprises acquiring a magnitude of the instantaneous power applied to said tissue at the end of said time interval, said method further comprising the steps of:

providing a catheter having a proximal end, a distal end, and a temperature sensor disposed at said distal end;

acquiring a magnitude of a temperature of said catheter at said distal end at a point in time for which said value is to be calculated; and

determining a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to said point in time for which said value is to be calculated;

multiplying said power magnitude with said change in time magnitude;

calculating a change in pre-ablation phase angle between said first and second pre-ablation phase angles;

calculating the natural log of said change in time magnitude; and

calculating the natural log of said power magnitude;

and wherein said calculating a value step comprising calculating said value responsive to said reactance magnitude, said resistance magnitude, said product of said power and change in time magnitudes, said change in pre-ablation phase angle, said natural log of said change in time magnitude, said power magnitude, said temperature magnitude, said impedance magnitude, and said natural log of said power magnitude.

23. The method of claim 21 wherein said acquiring a magnitude of the power step comprises acquiring a magnitude of the instantaneous power applied to said tissue at the end of said time interval, said method further comprising the steps of:

acquiring a magnitude of a temperature proximate said tissue at a point in time for which said value is to be calculated; and

determining a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of ablative energy to said tissue commences to said point in time for which said value is to be calculated;

multiplying said power magnitude with said change in time magnitude;

calculating a change in pre-ablation phase angle between said first and second pre-ablation phase angles;

calculating the natural log of said change in time magnitude; and

calculating the natural log of said power magnitude;

and wherein said calculating a value step comprising calculating said value responsive to said reactance magnitude, said resistance magnitude, said product of said power and change in time magnitudes, said change in pre-ablation phase angle, said natural log of said change in time magnitude, said power magnitude, said temperature magnitude, said impedance magnitude, and said natural log of said power magnitude.

24. The method of claim 16, further comprising the steps of:

comparing said calculated value to a predetermined threshold to determine the likelihood said lesion has reached said predetermined depth; and

generating a signal representative of an indicator corresponding to said determination.

25. The method of claim 16, further comprising the step of generating a lesion assessment map based on said calculated value.

26. An automated guidance system, comprising:

a catheter manipulator assembly;

a catheter associated with said catheter manipulator assembly, said catheter including an electrode associated therewith configured to deliver RF power to a tissue in a body; and

a controller configured to control at least one of the movement of the catheter and the delivery of RF power to said tissue by said electrode in response to a value indicative of one of a predicted lesion depth in said tissue, a likelihood of said lesion having a predetermined depth in said tissue, and a predicted temperature of said tissue calculated from a magnitude of RF power applied to said tissue during the formation of a lesion in said tissue, and magnitudes for a plurality of components of a complex impedance between said electrode and said tissue, wherein said plurality of components of said complex impedance comprise;

a reactance between said electrode and said tissue at a point in time for which said value is to be calculated;

a resistance between said electrode and said tissue at a point in time for which said value is to be calculated;

an impedance between said electrode and said tissue at a point in time for which said value is to be calculated;

a first pre-ablation phase angle between said electrode and said tissue prior to said electrode contacting said tissue; and

a second pre-ablation phase angle between said electrode and said tissue following contact between said electrode and said tissue.